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European Union and Trade Act 2019 (Deficiencies) (DEFA) (No. 5) Regulations 2019 Index

c SD No.2019/0212

c EUROPEAN UNION AND TRADE ACT 2019

(DEFICIENCIES) (DEFA) (NO. 5) REGULATIONS 2019

Index Regulation Page

1 Title ................................................................................................................................... 3

2 Commencement .............................................................................................................. 3

3 Interpretation ................................................................................................................... 3

4 Application of regulation 4 (interpretation of prescribed EU regulations,

EU decisions and EU tertiary legislation) of the retention regulations ................... 4

5 Retained direct EU legislation amended ..................................................................... 4

6 Construction .................................................................................................................... 5

SCHEDULE 1 7

RETAINED DIRECT EU LEGISLATION CONCERNING AGRICULTURAL

TRADE AMENDED 7

SCHEDULE 2 71

RETAINED DIRECT EU LEGISLATION CONCERNING ANIMAL DISEASES

AMENDED 71

SCHEDULE 3 81

RETAINED DIRECT EU LEGISLATION CONCERNING ANIMAL BY-

PRODUCTS AND ANIMAL SLAUGHTER AMENDED 81

SCHEDULE 4 88

RETAINED DIRECT EU LEGISLATION CONCERNING ANIMAL

MOVEMENTS AND ANIMAL WELFARE AMENDED 88

SCHEDULE 5 90

RETAINED DIRECT EU LEGISLATION CONCERNING AQUACULTURE

AMENDED 90

SCHEDULE 6 94

RETAINED DIRECT EU LEGISLATION CONCERNING DAIRY PRODUCTS

AMENDED 94

Index European Union and Trade Act 2019 (Deficiencies) (DEFA) (No. 5)

Regulations 2019

SD No.2019/0212 c

SCHEDULE 7 96

RETAINED DIRECT EU LEGISLATION CONCERNING FISHERIES

AMENDED 96

SCHEDULE 8 102

RETAINED DIRECT EU LEGISLATION CONCERNING FOOD LABELLING

AMENDED 102

SCHEDULE 9 198

RETAINED DIRECT EU LEGISLATION CONCERNING FOOD SAFETY

AMENDED 198

SCHEDULE 10 200

RETAINED DIRECT EU LEGISLATION CONCERNING IMPORTATION OF

PRODUCTS FROM THIRD COUNTRIES AMENDED 200

SCHEDULE 11 217

RETAINED DIRECT EU LEGISLATION CONCERNING PLANT HEALTH

AND PLANT PROTECTION AMENDED 217

SCHEDULE 12 227

RETAINED DIRECT EU LEGISLATION CONCERNING RESIDUES

AMENDED 227

SCHEDULE 13 236

RETAINED DIRECT EU LEGISLATION CONCERNING ZOOTECHNICAL

AMENDED 236

European Union and Trade Act 2019 (Deficiencies) (DEFA) (No. 5) Regulations 2019 Regulation 1

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Statutory Document No. 2019/0212

c European Union and Trade Act 2019

EUROPEAN UNION AND TRADE ACT 2019

(DEFICIENCIES) (DEFA) (NO. 5) REGULATIONS 2019

Approved by Tynwald:

Coming into Operation in accordance with regulation 2

The Council of Ministers makes the following Regulations under section 12 of, and

paragraph 7 of Schedule 4 to, the European Union and Trade Act 2019.

The Council of Ministers is of the opinion that, by reason of urgency, it is necessary to

make these Regulations subject to the Tynwald procedure set out in section 31 of the

Legislation Act 2015 (“affirmative”) instead of the “approval required” Tynwald

procedure applied by virtue of sections 7(1) and 12(1) of the European Union and

Trade Act 2019.

1 Title

These Regulations are the European Union and Trade Act 2019 (Deficiencies)

(DEFA) (No. 5) Regulations 2019.

2 Commencement

These Regulations come into operation on exit day1.

3 Interpretation

In these Regulations, “retention regulations” means the European Union and

Trade Act 2019 (Retained Direct EU Legislation) (DEFA and OFT) Regulations

20192.

1 Paragraph 7 of Schedule 4 to the European Union and Trade Act 2019 provides that if a

statutory document contains a declaration that the Council of Ministers is of the opinion that, by

reason of urgency, it is necessary to make the statutory document subject to the Tynwald

procedure set out in section 31 of the Legislation Act 2015 (“affirmative”), that procedure

applies to the statutory document instead of the “approval required” Tynwald procedure

applied by virtue of any provision of the European Union and Trade Act 2019. 2 SD 2019/0037.

Regulation 4 European Union and Trade Act 2019 (Deficiencies) (DEFA) (No. 5)

Regulations 2019

SD No.2019/0212 c

4 Application of regulation 4 (interpretation of prescribed EU

regulations, EU decisions and EU tertiary legislation) of the retention

regulations

Regulation 4 (interpretation of prescribed EU regulations, EU decisions and EU

tertiary legislation) of the retention regulations does not apply to the provisions

of the retained direct EU legislation that are amended, substituted or inserted by

these Regulations.

5 Retained direct EU legislation amended

The retained direct EU legislation prescribed in —

(a) Part 1 (agricultural trade) of the Schedule to the retention

regulations is amended in accordance with Schedule 1 to these

Regulations;

(b) Part 2 (animal diseases) of the Schedule to the retention

regulations is amended in accordance with Schedule 2 to these

Regulations;

(c) Part 3 (animal by-products and animal slaughter) of the Schedule

to the retention regulations is amended in accordance with

Schedule 3 to these Regulations;

(d) Part 5 (animal movements and animal welfare) of the Schedule to

the retention regulations is amended in accordance with Schedule

4 to these Regulations;

(e) Part 6 (aquaculture) of the Schedule to the retention regulations is

amended in accordance with Schedule 5 to these Regulations;

(f) Part 7 (dairy products) of the Schedule to the retention regulations

is amended in accordance with Schedule 6 to these Regulations;

(g) Part 8 (fisheries) of the Schedule to the retention regulations is


(h) Part 9 (food labelling) of the Schedule to the retention regulations

is amended in accordance with Schedule 8 to these Regulations;

(i) Part 10 (food safety) of the Schedule to the retention regulations is


(j) Part 12 (importation of products from third countries) of the

Schedule to the retention regulations is amended in accordance

with Schedule 10 to these Regulations;

(k) Part 13 (plant health and plant protection) of the Schedule to the

retention regulations is amended in accordance with Schedule 11

to these Regulations;

European Union and Trade Act 2019 (Deficiencies) (DEFA) (No. 5) Regulations 2019 Regulation 6

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(l) Part 15 (residues) of the Schedule to the retention regulations is


and

(m) Part 17 (zootechnical) of the Schedule to the retention regulations

is amended in accordance with Schedule 13 to these Regulations.

6 Construction

To avoid doubt, any retained EU law is to be construed and have effect subject

to these Regulations.

MADE 11 APRIL 2019

W GREENHOW

Chief Secretary

European Union and Trade Act 2019 (Deficiencies) (DEFA) (No. 5) Regulations 2019 SCHEDULE 1

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SCHEDULE 1

[Regulation 5(a)]

RETAINED DIRECT EU LEGISLATION CONCERNING AGRICULTURAL

TRADE AMENDED

PART 1

AGRICULTURAL MARKETS REGULATIONS

1 Commission Implementing Regulation (EU) No 543/2011

(1) Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011

laying down detailed rules for the application of Council Regulation (EC)

No 1234/2007 in respect of the fruit and vegetables and processed fruit

and vegetables sectors3 is amended as follows.

(2) In Article 1(1) —

(a) for “Regulation 1234/2007”, in the first place it occurs, substitute

«Regulation (EU) No 1308/2013»; and

(b) for “Article 1(1)(i) of Regulation (EC) No 1234/2007” substitute

«Article 1(2)(i) of Regulation (EU) No 1308/2013».

(3) In Article 1(2,) for “Regulation (EC) No 1234/2007” substitute

«Regulation (EU) No 1308/2013».

(4) After Article 1(2) insert —

«3. In this Regulation, ‘third country’ means any country or territory

other than:

(a) the Isle of Man;

(b) the Bailiwick of Jersey;

(c) the Bailiwick of Guernsey;

(d) the United Kingdom.».

«4. For the purposes of this Regulation, ‘appropriate authority’ means

the Department of Environment, Food and Agriculture.».

(5) In Article 3(1), for “Article 113a(1) of Regulation (EC) No 1234/2007”

substitute «Article 76(1) of Regulation (EU) No 1308/2013».

(6) In Article 3(2), for “Article 113(1)(b) of Regulation (EC) No 1234/2007”

substitute «Article 75(1)(b) of Regulation (EU) No 1308/2013».

3 Paragraph 1(3) of the Schedule to the retention regulations.

SCHEDULE 1 European Union and Trade Act 2019 (Deficiencies) (DEFA) (No. 5)

Regulations 2019

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(7) In Article 3(3), for “Article 113a(3) of Regulation (EC) No 1234/2007”

substitute «Article 76(3) of Regulation (EU) No 1308/2013».

(8) In Article 4, for “Article 113a(3) of Regulation (EC) No 1234/2007”, in

each place it occurs, substitute «Article 76(3) of Regulation (EU) No

1308/2013».


(a) in point (c) —

(i) for “taken” substitute «issued before exit day»;

(ii) for the words from “a Member State” to “Regulation (EC)

No 1234/2007” substitute «the United Kingdom or a

member State»; and

(iii) for “that Member State” insert «the requesting country»;

and

(b) in point (e) for “Article 1(1)(i) and Part IX of Annex I to

Regulation (EC) No 1234/2007” substitute «Article 1(2)(i) and

Part IX of Annex I to Regulation (EU) No 1308/2013».

(10) In Article 4(3), for “Member States may exempt” substitute «nothing in

this Regulation prevents the appropriate authority from exempting».


(a) for “Member States may exempt” substitute «nothing in this

Regulation prevents the appropriate authority from exempting»;

and

(b) for “Member States”, in the second place it occurs, substitute

«the appropriate authority».

(12) In Article 4(7), omit “of the Member State”.

(13) In Article 5(3), for “Article 2(1) of Directive 97/7/EC of the European

Parliament and of the Council” substitute «Article 2(7) of Directive

2011/83/EU of the European Parliament and of the Council4».


(a) for “pre-packaged” substitute «prepacked»; and

(b) for “Directive 2000/13/EC of the European Parliament and of the

Council” substitute «Article 2(2)(e) of Regulation (EU) No

1169/2011».

(15) In Article 7(2), for “Article 1(1)(i) of Regulation (EC) No 1234/2007”

substitute «Article 1(2)(i) of Regulation (EU) No 1308/2013 of the

European Parliament and of the Council».

4 OJ No L 304 22.11.2011, p.64, as last amended by Directive (EU) 2015/2302 of the European

Parliament and of the Council (OJ No L 326 11.12.2015, p.1).


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(a) omit “Member State or third”;

(b) omit point (a);

(c) in point (b) for “non-EU” substitute «non-UK»; and

(d) in point (c) —

(i) for “EU” substitute «UK»; and

(ii) for “non-EU” substitute «non-UK».


«4. By way of derogation from paragraph 3, packages of fruit and

vegetables in a mix originating in more than one country:

(a) may remain on the market until stocks are exhausted if they were

placed on the market before exit day and are labelled in accordance with

paragraph 3, as it had effect immediately before exit day;

(b) may be placed on the market until 31 December 2020, and may

remain on the market until stocks are exhausted, if:

(i) the mix does not contain any fruit or vegetables originating in the

Island or the United Kingdom, and the package is labelled in accordance

with paragraph 3, as it had effect immediately before exit day, or

(ii) the mix contains fruit and vegetables originating in the Island or the

United Kingdom and:

(aa) does not contain any fruit or vegetables originating in the EU, and

the package is labelled in accordance with paragraph 3(b), as it had

effect immediately before exit day, or

(bb) also contains fruit and vegetables originating in the EU (whether or

not it also contains fruit and vegetables from any other country), and the

package is labelled in accordance with paragraph 3(c), as it had effect

immediately before exit day.».

(18) In Article 8, for “Articles 113 and 113a of Regulation (EC) No 1234/2007”

substitute «Articles 75 and 76 of Regulation (EU) No 1308/2013».


(a) omit the words before point (a);

(b) in point (a) —

(i) at the beginning insert «The appropriate authority shall

designate»; and

(ii) after “competent authority” insert «for the Island»;

(c) in point (b), at the beginning insert «The appropriate authority

shall designate»;


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(d) for “Member States” substitute «the appropriate authority»;

and

(e) at the end insert —

«Nothing in this Regulation affects the validity of any

designation of a coordinating authority or inspection body made

before exit day.».

(20) Omit Article 9(2).


(a) for “Commission” substitute «appropriate authority»;

(b) for “list of the coordinating authorities” substitute «name of the

coordinating authority»;

(c) for “Member States” substitute «appropriate authority»; and

(d) for “it” substitute «the appropriate authority».

(22) In Article 10(1) —

(a) for “Member States”, in the first place it occurs, substitute «The

appropriate authority»;

(b) for “Article 113 of Regulation (EC) No 1234/2007” substitute

«Article 75 of Regulation (EU) No 1308/2013»; and

(c) for “Member States”, in the second place it occurs, substitute

«the appropriate authority».

(23) In Article 10(2), in the second paragraph, in point (c) —

(a) for “Union” substitute «Island»;

(b) for “to third countries” substitute «from the Island»; and

(c) for “from third countries” substitute «into the Island».

(24) In Article 10(3), for “Member States” substitute «The appropriate

authority».

(25) In Article 10(4) for “coordinating” substitute «appropriate».

(26) In Article 10(6) —

(a) for “Member States consider”, in the first place it occurs,

substitute «the appropriate authority considers»;

(b) for “Member States”, in the second place it occurs, substitute

«The appropriate authority»; and

(c) for “their” substitute «its».

(27) In the heading of Section 2 omit “carried out by the Member States”.

(28) In Article 11(1) —


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(a) in the first subparagraph —

(i) for “Member States” substitute «The appropriate

authority»; and

(ii) for “Articles 113 and 113a of Regulation (EC) No

1234/2007” substitute «Articles 75 and 76 of Regulation

(EU) No 1308/2013»; and

(b) in the third subparagraph, in point (e), for “Union” substitute

«Island».

(29) In Article 11(2), for “Member States”, in both places it occurs, substitute

«The appropriate authority».

(30) In Article 11(3) for “Member States” substitute «the appropriate

authority».

(31) In Article 12(1) for “Member States” substitute «The appropriate

authority».

(32) In Article 12(3)(a) for “Member States” substitute «appropriate

authority».

(33) In Article 12(4) for “Member State” substitute «appropriate authority».

(34) In Article 12(5) —

(a) omit the first subparagraph; and

(b) for “22 June 2011” substitute «exit day».

(35) In Article 13(1), for “the Member State may carry” substitute «that may

be carried».

(36) In Article 13(2), for “Member State concerned” substitute «appropriate

authority».

(37) In Article 14 —

(a) in paragraph 1 —

(i) for “Union”, in each place it occurs, substitute «Island»;

(ii) for “Commission” substitute «appropriate authority»;

and

(iii) for “it” substitute «the appropriate authority»;

(b) omit paragraphs 4 and 6; and

(c) after paragraph 6 insert —

«7. Notwithstanding paragraph 1, until 29 March 2021,

competent authorities in third countries may continue to use

certificates which conform to Article 14(1) of Commission


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Implementing Regulation (EU) No 543/20115, as it has effect in EU

law as amended from time to time.

8. If at any time until 29 March 2021 the appropriate authority

considers that the marketing standards that apply in the EU to

any products to which this Title applies are not at least equivalent

to the marketing standards that apply in the Island for like

products:

(a) the appropriate authority must publish a statement to that

effect, and

(b) paragraph 7 shall not apply in relation to the products set out

in such statement.».


(a) in the heading for “Union” substitute «Island»;

(b) in paragraph 1 —

(i) for “Commission” substitute «appropriate authority»;

(ii) for the words from “may, in accordance” to “approve”

substitute «may make regulations approving»; and

(iii) for “Union” substitute “«Island»;

(c) in paragraph 2, for “Union”, in each place it occurs, substitute

«Island»; and

(d) in paragraph 4 —


and

(ii) at the end insert «Whenever the appropriate authority

makes regulations under paragraph 1, those regulations

must include provision amending Annex IV to include the

third country or countries where conformity checks have

been approved under paragraph 1 and the products

concerned.».

(39) In Article 16, for “Commission” substitute «appropriate authority».

(40) In Article 17(1) for “Member States” substitute «The appropriate

authority».

(41) In Article 17(3) —

(a) omit the third subparagraph; and

(b) in the fifth subparagraph, for “Member States” substitute «the

appropriate authority».

5 OJ L 157, 15.6.2011, p.1, as last amended by Commission Implementing Regulation (EU) No

2017/1185 (OJ L 171, 4.7.2017, p.113).


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(a) omit paragraph 1;


(i) for “A Member State where” substitute «Where»;

(ii) after “from a third country” insert «listed in Annex IV»;

(iii) after “marketing standards” insert «, the appropriate

authority»; and

(iv) omit “the Commission, the Member States likely to be

concerned and”; and

(c) omit paragraphs 3 to 5.

(43) Before Article 149 insert —

«Article A149

Regulations

2. Regulations made by the appropriate authority under these

Regulations may contain —

(a) consequential, incidental, supplementary, transitional or

saving provision (including provision amending, repealing or

revoking enactments);

(b) provisions amending, repealing or revoking statutory

documents and retained direct EU legislation; or

(c) a combination of (a) and (b).

3. Tynwald procedure —

(a) for paragraph 1(a) – negative;

(b) for paragraph 1(b) or 1(c) – approval required.».

(44) In Article 149 omit the second paragraph.

(45) Omit Article 150.

(46) After Article 151 omit “This Regulation shall be binding in its entirety

and directly applicable in all Member States.”.

(47) In Annex I —

(a) in Part A —

(i) in point 4(A), in the second indent, for “Union” substitute

«Island or the United Kingdom (or, until 31 December

2020, within the Island, the United Kingdom or the EU)»;

and

(ii) in point 4(B) —


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(A) for “a Member State” substitute «the Island»; and

(B) for “the language of the country of origin”

substitute «English»;

(b) in Part B, for “Union”, in each place it occurs, substitute «Island

or the United Kingdom (or, until 31 December 2020, within the

Island, the United Kingdom or the EU)»; and

(c) in footnotes 14 and 15 for “European Union provision” substitute

«legislation».

(48) In the specimen label in Annex II —

(a) omit the European Union emblem;

(b) omit “European Union”; and

(c) for “Member State” substitute «Isle of Man or IM».

(49) In Annex III, for “European Union”, in each place it occurs (including the

heading), substitute «Isle of Man».

(50) In footnote 1 to Annex IV, for “The Commission’s approval” substitute

«Approval».

(51) In Annex V —

(a) in paragraph 2.3 for “Council Directive 89/396/EEC” substitute

«Directive 2011/91/EU of the European Parliament and of the

Council6»; and

(b) in paragraph 2.5 —

(i) for “pre-packed foodstuff” substitute «prepacked food»;

and

(ii) for “European Parliament and Council Directive

2000/13/EC” substitute «Article 2(2)(e) of Regulation (EU)

No 1169/2011».

(52) Omit Annexes Va and Vb.

(53) Omit Annex XX.

2 Regulation (EU) No 1308/2013 amended

(1) Regulation (EU) No 1308/2013 of the European Parliament and of the

Council of 17 December 2013 establishing a common organisation of the

markets in agricultural products and repealing Council Regulations

(EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No

1234/20077 is amended as follows.

6 OJ L 334, 16.12.2011, p. 1. 7 Paragraph 1(5) of the Schedule to the retention regulations.


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(2) In Article 1(1), for “Union legislative acts” substitute «retained EU

law».



(b) in paragraph 4, for the words from “Commission” to “Article 227”

substitute «appropriate authority may make regulations»; and

(c) in paragraph 5, after point (b) insert —

«(c) ‘appropriate authority’ means the Department of

Environment, Food and Agriculture; and

(d) a reference to another country or other countries is to be read

as including the British Overseas Territories.».

(4) Omit Article 7.

(5) In Article 8, in point (a) —

(a) for “competent authorities of the Member State” substitute

«appropriate authority»; and

(b) for “them” substitute “it”.

(6) In Article 9, for “Union”, in each place it occurs, substitute «Island».


(a) in the heading, omit “Union”;

(b) in the first subparagraph, omit “Union”; and

(c) in the second subparagraph —

(i) for “Member States” substitute «the appropriate

authority»; and

(ii) omit “Union”.


(a) for the words from “that” to “Article 20” substitute «prescribed

in legislation made pursuant to Articles 19 or 20»; and

(b) in points (d) and (e), for “Union” substitute «Island».

(9) For Articles 13 and 14 substitute —

«Article 13

Public intervention

1. The appropriate authority must buy in common wheat, butter and

skimmed milk powder during the periods referred to in Article 12 in

respect of those products.


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2. Subject to paragraphs 3 and 4, the appropriate authority may buy in

any other products listed in Article 12 under public intervention during

the periods referred to in respect of those products.

3. In the case of durum wheat, barley, maize and paddy rice (including

specific varieties or types of paddy rice), the appropriate authority may

only buy in products if the market situation so requires.

4. In the case of beef and veal, the appropriate authority may only buy

in products if, over the representative period determined pursuant to

point (c) of the first paragraph of Article 20, the average market price in

the Island, recorded on the basis of the scale for classification of

carcasses of bovine animals referred to in point A of Annex IV, is below

85% of the reference threshold laid down in point (d) of Article 7(1).

5. The appropriate authority may close the tendering procedure for the

beef and veal sector where, over the representative period determined

pursuant to point (c) of the first paragraph of Article 20, the conditions

provided for in paragraph 4 of this Article are no longer fulfilled.

Article 14

Buying-in at a fixed price or tendering

The appropriate authority may make regulations laying down measures

on:

(a) fixing buying-in prices for the products referred to in Article 11; and

(b) quantitative limitations where buying-in is carried out at a fixed

price.».

(10) For Article 15(2) substitute —

«2. The appropriate authority may make regulations fixing the level of

the public intervention price, including the amounts of increases and

reductions.».


(a) in paragraph 1, in point (c), for the words from “concluded” to

“TFEU” substitute «to which the Island is a party»;

(b) omit paragraph 2; and

(c) in paragraph 3, for “Commission” substitute «appropriate

authority».

(12) In Article 17, for the words from “to be” to “Article 20” substitute

«prescribed in legislation made pursuant to Articles 18, 19 or 20».


(a) in paragraph 1, for the words from “Commission” to “Article 227”

substitute «appropriate authority may make regulations»;


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(c) in paragraph 3 —

(i) for the words from “Commission” to “Article 227”

substitute «appropriate authority may make

regulations»; and

(ii) omit point (b);

(d) in paragraph 4, for the words from “Commission” to “Article 227”


(e) in paragraph 5 —



regulations»; and

(ii) in point (b), omit “Member States and”; and

(f) in paragraph 6 —



regulations»;

(ii) in point (a), omit “Union”;

(iii) in point (b), for “Union prices”, substitute «prices in the

Island»;

(iv) in point (c), for “which may be granted by Member States”

substitute «applying»; and

(v) for point (d) substitute —

«(d) providing for the grading scale for classification of

pig carcasses not to apply, providing for derogations from

the scale, or providing for assessment criteria to be used in

addition to weight and estimated lean-meat content.».


(a) for the words from “Commission” to “uniform” substitute

«appropriate authority may make regulations in relation to

the»;

(b) in point (h), for “territory of the Member State” substitute

«Island»;

(c) in point (i), omit the words from “, including”, in the first place it

occurs, to the end”;

(d) in point (j), for “Member States” substitute «the relevant

authority»;


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(e) in point (k), omit “of the Member State”;

(f) in point (o)(iii), omit the words from “ensuring” to the end;

(g) in point (p), omit “Union”;

(h) in point (r), omit “to be applied by Member States”;

(i) in point (s), for the words from “by” to “price” substitute «of the

weighted average price in the Island»;

(j) in point (t) —

(i) for the words from the beginning to “territory,” substitute

«provision»; and

(ii) in point (i), for “their territory” substitute «the Island»;

(k) omit point (u); and

(l) omit the second subparagraph.


(a) for the words from “The Commission” to “classification”

substitute «By way of derogation from point C.III of Annex IV,

the appropriate authority may make regulations providing for the

following criteria for classification of lambs of less than 13kg

carcass weight»; and

(b) omit the second subparagraph.

(16) In Article 22, for “competent authorities of Member States” substitute

«relevant authority».


(a) in paragraph 1, for “Union aid shall” substitute «Aid may»;


(i) for the words from “Member” to “shall” substitute «The

relevant authority may»; and

(ii) for “national circumstances” substitute «circumstances in

the Island»;

(c) in paragraph 4, for “their territory, Member States” substitute

«the Island, the relevant authority»;


(i) in the first subparagraph —

(A) for “Member States consider” substitute «the

relevant authority considers»; and

(B) for “they” substitute «it»; and


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(ii) in the second subparagraph, for “Union aid” substitute

«aid referred to in paragraph 1»;

(e) in paragraph 6, in the second subparagraph —

(A) for “any Member State” substitute «the relevant

authority»; and

(B) for the words from “obtaining” to “procedures”

substitute «consulting the public bodies

responsible for health and nutrition in the

constituent nation»;

(f) omit paragraph 7;

(g) in paragraph 8, in the first subparagraph, for the words from the

beginning to “level”, in the second place it occurs, substitute

«The relevant authority must ensure that there is a strategy in

place for the implementation of the scheme in the Island for any

period during which it intends to make payments under the

scheme. The strategy may cover a period of up to six years and

may be amended by the relevant authority at any time»;

(h) in paragraph 9 —

(i) for “Member States” substitute »The relevant authority»;

(ii) for “their strategies” substitute «its strategy»; and

(iii) for the second sentence substitute «In drawing up that

list, the relevant authority must consult, where

appropriate, the public bodies responsible for health and

nutrition in the Island.»;

(i) in paragraph 10, for “Member States” substitute «The relevant

authority»; and

(j) in paragraph 11 —


(A) for “Member States”, in both places it occurs,

substitute «The relevant authority»; and

(B) for “Union” substitute «Island»; and

(ii) in the second subparagraph —

(A) for “Member States” substitute «The relevant

authority»; and

(B) for “their strategies” substitute «its strategy».

(18) In Article 23a —

(a) in the heading, for “Financing” substitute «Publicity»;

(b) omit paragraphs 1 to 7; and


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SD No.2019/0212 c


(i) for the first sentence substitute «During any period that

the relevant authority is making payments under the

school scheme in accordance with Article 23, the relevant

authority must publicise the school scheme, at school

premises or other relevant places.»;

(ii) for “Member States”, in the second and third places it

occurs, substitute «The relevant authority»; and

(iii) omit “Union” in the second place it occurs.





regulations»; and

(ii) in point (b), omit “by Member States”;

(b) for paragraph 2 substitute —

«2. In order to ensure proper management of public funds and to

facilitate the implementation of the school scheme, the

appropriate authority may make regulations laying down:

(a) costs and measures eligible for funding;

(b) provisions for monitoring and evaluating the effectiveness of

the school scheme.»;


(i) for the words from “Commission”, in the first place it

occurs, to “Article 227”, in the first place it occurs,


regulations»;

(ii) for the words from “Commission”, in the second place it

occurs, to “Article 227”, in the second place it occurs,


regulations»; and

(iii) omit “by Member States”;

(d) in paragraph 4, the words before point (a) —

(i) for the words from “and” to “scheme”, in the last place it

occurs, substitute «appropriate authority may make

regulations requiring the school scheme to be publicised»;

(e) in paragraph 5, for the words from “Commission” to “Article 227”



c SD No.2019/0212

(f) omit paragraph 6.


(a) for the words from “Commission” to “adopt” substitute

«appropriate authority may make regulations laying down»;

(b) in point (a), for “Member States’ strategies” substitute «the

strategy referred to in Article 23(8)»;

(c) for point (d) substitute —

«(d) the format and content of monitoring and evaluation

reports»;

(d) omit point (e); and

(e) omit the second subparagraph.

(21) Omit Articles 29 to 31.


(a) in paragraph 1, in point (b) —

(i) omit “Union”;

(ii) after “assistance” insert «under Article 34»; and

(iii) for the words from “to be” to “Article 38” substitute

«specified in legislation made pursuant to Article 37 or

38»; and

(b) in paragraph 2, for “Member States” substitute “the relevant

authority”.



(i) in point (f), omit the words from “including” to the end;

and

(ii) in the second subparagraph, for “Member States for their

approval” substitute «relevant authority for its

approval»;

(b) in paragraph 2, in the second subparagraph, for “Member States”

substitute «relevant authority»;


(i) omit point (a);

(ii) in point (d), omit “and financial contributions to replenish

mutual funds”;

(iii) omit points (e) to (g);

(iv) omit point(i); and


Regulations 2019

SD No.2019/0212 c

(v) in the fifth subparagraph, omit “Union”;

(d) omit paragraph 4; and

(e) in paragraphs 5 and 6, for “Member States” substitute «The

relevant authority».


(a) in the heading and in paragraphs 1 and 2, omit “Union”;

(b) in paragraph 3, omit points (a) and (g); and

(c) omit paragraph 4.

(25) For Article 35 substitute —

«Article 35

Additional financial assistance

1. The appropriate authority may make regulations allowing for the

payment to producer organisations of additional financial assistance in

regions where the degree of organisation of producers in the fruit and

vegetable sector is particularly low.

2. Regulations under paragraph 1 must provide for the additional

financial assistance payable to be:

(a) additional to the operational fund;

(b) no more than 80% of the financial contribution referred to in point

(a) of Article 32(1).».


(a) in the heading, for “National framework and national” substitute

«Framework and»;


(i) in the first subparagraph, for “Member States shall

establish a national framework” substitute «The relevant

authority must ensure that there is a framework in place»;

and

(ii) omit the second subparagraph;


(i) in the first subparagraph, for the first sentence substitute

«The relevant authority must ensure that there is a

strategy in place for sustainable operational programmes

in the fruit and vegetable market.»; and

(ii) in the second subparagraph, omit “national” in both places

it occurs; and

(d) omit paragraph 3.


c SD No.2019/0212


(a) for the words from “Commission” to “Article 227” substitute

«appropriate authority may make regulations»;

(b) in point (a)(ii), for “the additional requirements to be determined

by Member States” substitute «any additional requirements»;

(c) in point (c), omit “Union” in both places it occurs;

(d) in point (d) —

(i) in point (i), for “Member States” substitute «the relevant

authority»;

(ii) in point (ii), for “(a), (b), (c) and (i)” substitute “(b) and (c)”;

and

(iii) omit points (iii) to (vii), (x) and (xiii); and

(e) in point (e) —

(i) in the words before point (i), for “national” substitute

«additional»; and

(ii) omit point (iii).


(a) for “Commission may adopt implementing acts” substitute


(b) in point (b) —

(i) omit “national” in both places it occurs; and

(ii) for “Member States”, in both places it occurs, substitute

«the relevant authority»;

(c) in point (d), omit “national”;

(d) omit points (f) to (h);

(e) in point (i), for “training and coaching” substitute «and

training»;

(f) in point (j), omit the words from “withdrawal” to “and”;

(g) omit point (k); and

(h) omit the second subparagraph.



(a) in the heading, for “National programmes” substitute

«Programmes»;



Regulations 2019

SD No.2019/0212 c


authority»; and

(ii) for “national programmes for the apiculture sector”

substitute «programmes for the apiculture sector»;

(c) omit paragraph 2;


(i) for the words from the beginning to “shall” substitute

«Before drawing up a programme under paragraph 1, the

appropriate authority must»; and

(ii) for “their territory” substitute «the Island»; and

(e) in paragraph 4, in point (e), omit “in the Union”.


(a) for paragraph 1 substitute —

«1. In order to ensure the efficient and effective use of aid for

apiculture, the appropriate authority may make regulations on

the avoidance of double funding between apiculture programmes

and rural development programmes.»; and


(i) for “the Union” substitute «any»;

(ii) for the words from “Commission” to “Article 227”


regulations»;

(iii) omit “Member States”;

(iv) omit “national”; and

(v) for “the delegated act” substitute «those provisions».


«Article 57

Regulations relating to apiculture

The appropriate authority may make regulations relating to the content

of apiculture programmes and the content of the studies under Article

55(3).».


(34) In Article 65, omit “referred to in Article 95”.

(35) In Article 74, for “Union” substitute «Island».



c SD No.2019/0212






regulations»;

(ii) for “delegated acts”, in the second place it occurs,

substitute «regulations»; and

(iii) omit the words from “and shall” to the end.


(a) in paragraph 3, for Union” substitute «Island»; and


substitute «appropriate authority may make regulations».


(a) in paragraph 1, for “Union” substitute «Island».

(b) in paragraph 4, at the end insert the following subparagraphs —

«Products of the hops sector imported from the European Union

before 29 March 2021 may be marketed or exported if covered by

a certificate issued in accordance with Article 77 of Regulation

(EU) No 1308/2013, as it has effect in EU law as amended from

time to time, provided that the appropriate authority considers

that the quality standards adopted in EU law for any hops or hop

products are at least equivalent to the quality standards adopted

for like products harvested within the Island or made from such

products.

If, before 29 March 2021, the appropriate authority considers the

EU quality standards referred to in the third subparagraph are not

at least equivalent to the quality standards in the Island, the

appropriate authority must publish a statement to that effect.»;

and

(c) in paragraph 5, for the words from “Commission” to “from”

substitute «appropriate authority may make regulations making

exceptions to».


(a) in paragraph 2, for “Union” substitute «Island»;




regulations»; and


Regulations 2019

SD No.2019/0212 c

(ii) for “delegated acts”, in the second place it occurs,

substitute «regulations»;


(i) omit “and Member States”; and

(ii) for the words from “Commission” to “Article 227”


regulations»; and

(d) in paragraph 5, for the words from “Commission” to “Article 227”






(i) for “adopting the acts referred to in” substitute «making

regulations under»; and

(ii) for “Commission” substitute «appropriate authority».


(a) in paragraph 1, for “Union”, in both places it occurs, substitute

«Island»;



(A) for “Union”, in the first place it occurs, substitute

«Island»;

(B) omit point (a); and

(C) in point (b), omit “national”;

(ii) in the second subparagraph, for “Member States”

substitute «the appropriate authority»;

(c) in paragraph 3, for “Commission” substitute «appropriate

authority»;


(i) for the words from “Commission” to Article 227”


regulations»; and

(ii) omit “national”; and



c SD No.2019/0212

(i) for “Commission shall, where necessary, adopt

implementing acts” substitute «appropriate authority

may make regulations»; and

(ii) omit the words from “in view” to the end.




(i) omit the first subparagraph;

(ii) in the second subparagraph, for “classified by Member

States” substitute «planted, replanted or grafted for the

purposes of wine production»; and

(iii) omit the third subparagraph;

(c) for paragraph 3 substitute —

«3. If wine production in the Island exceeds 50,000 hectolitres per

wine year, calculated on the basis of the average production

during the last five wine years, the appropriate authority shall

classify which wine grape varieties meeting the conditions in

paragraph 2 may be planted, replanted or grafted in the Island for

the purposes of wine production.»; and

(d) for paragraph 4 substitute —

«4. By way of derogation from paragraphs 2 and 3, the planting,

replanting or grafting of wine grape varieties which do not

comply with those paragraphs is allowed for scientific research

and experimental purposes.».


(a) in the heading, omit “National”;


(i) for “Member States may adopt or maintain national”

substitute «nothing in this Regulation prevents the

appropriate authority from adopting or maintaining»;

and


(c) in paragraph 2, for the words from the beginning to “territory”

substitute «Nothing in this Regulation prevents the appropriate

authority from limiting or prohibiting the use of certain

oenological practices or providing for more stringent rules for

wine production»;


Regulations 2019

SD No.2019/0212 c

(d) in paragraph 3, for “Member States” substitute «The appropriate

authority»;

(e) for paragraph 4 substitute —

«4. In order to ensure the correct and transparent application of

this Article:

(a) the appropriate authority may make regulations laying down

the conditions for the application of paragraph 1 of this Article;

(b) the appropriate authority may make regulations laying down

the conditions for the application of paragraphs 2 and 3 of this

Article, as well as the conditions for the holding, circulation and

use of the products obtained from the experimental practices

referred to in paragraph 3 of this Article.». and


(44) In Article 86, for the words from “Commission” to “Article 227”




(i) in point (c), omit “in several Member States”;

(ii) in point (d), omit “Directive 2000/13/EC of the European

Parliament and of the Council or”; and

(iii) for “Commission” substitute «appropriate authority»;

and




(a) omit paragraph 2; and




(a) for “concluded in accordance with the TFEU”, in both places it

occurs, substitute «to which the Island is a party»;

(b) in paragraph 1, for “Union” substitute «Island»;

(c) in paragraph 2, omit “by the Union”;

(d) after paragraph 2 insert —

«2A. By way of derogation from paragraph 2, products referred

to in paragraph 1:


c SD No.2019/0212

(a) which are produced before exit day, or which are still in the

finishing process immediately before exit day, may be placed or

remain on the market until stocks are exhausted provided that

they are produced in accordance with oenological practices

authorised pursuant to this Regulation as it had effect

immediately before exit day;

(b) other than products falling within point (a), which are

imported into the Island on or before 31 December 2020, may be

produced in accordance with oenological practices authorised

pursuant to this Regulation as it had effect immediately before

exit day.»; and



and

(ii) at the end insert —

«; or

(c) a certificate and an analysis report which comply with

points (a) and (b) as they had effect immediately before

exit day.».




(b) in point (a), omit the words from “on the basis” to the end; and

(c) omit the second subparagraph.



(i) for “third” substitute «other»; and

(ii) for “Union” substitute «Island»; and

(b) in paragraph 5, omit “Member State or third”.

(50) In Article 94, omit paragraphs 1 and 3.


(52) In Article 101(1) —

(a) in the second subparagraph, omit “in the Union”;

(b) in the third subparagraph —

(i) in point (a), omit “in the Union”;

(ii) in point (b), omit “Union or national”.



Regulations 2019

SD No.2019/0212 c

(a) in paragraph 1, in point (a), after “Commission” insert «or

United Kingdom appropriate authority»;


(i) for “territory of the Union” substitute «Island»;

(ii) for the words from “Directive” to the end substitute «the

Trade Marks Act 1994, as applied to the Island».

(54) In Article 103(3), for “Union” substitute «Island».


«Article 104

Register

The appropriate authority shall provide direction to an electronic

register of protected designations of origin and protected geographical

indications for wine.».

(56) Omit Articles 105 and 106.


(a) for the heading substitute «Protection of established protected

designations of origin etc.»; and

(b) for paragraphs 1 to 4 substitute —

«1. The register that the appropriate authority provides direction

to (as provided for in Article 104 of this Regulation) must list the

names of established protected designations of origin, established

protected geographical indications, and established traditional

terms.

2. For the purposes of paragraph 1:

(a) ‘established protected designation of origin’ means a

designation of origin shown as a registered United Kingdom

designation of origin on the register maintained by the

Commission pursuant to Article 104 as it had effect immediately

before exit day, including a protection granted via the conclusion

of a bilateral trade agreement as that register stood immediately

before exit day;

(b) ‘established protected geographical indication’ means a

geographical indication shown as a United Kingdom registered

geographical indication on the register maintained by the

Commission pursuant to Article 104 as it had effect immediately

before exit day, including a protection granted via the conclusion

of a bilateral trade agreement as that register stood immediately

before exit day;


c SD No.2019/0212

(c) ‘established traditional term’ means a traditional term shown

as a United Kingdom registered traditional term on the register

maintained by the Commission pursuant to Article 104 as it had

effect immediately before exit day, including a protected

traditional term granted via the conclusion of a bilateral trade

agreement as that register stood immediately before exit day.».



(a) omit “in Member States”; and

(b) in point (a), for “under Union or national law” substitute «and is

included in the register established under Article 104».



(a) for the first paragraph substitute —

«Save as otherwise provided for in this Regulation, the Food

Labelling Regulations 20048, the Food Information Regulations

20149, the Weights and Measures (Intoxicating Liquor) Order

200110, the Weights and Measures (Foods) Order 200511, The Trade

Marks Act 1994 (as applied to the Island by the Trade Marks (Isle

of Man) Order 201312 and the Trade Marks (Isle of Man)

(Amendment) Order 201813) and Regulation (EU) No 1169/201114

apply to labelling and presentation.»; and

(b) in the second subparagraph, omit “Directive 2000/13/EC or”.

(62) In Article 119(1) —

(a) in paragraph 1, for “Union” substitute «Island»; and

(b) after paragraph 3 insert —

«4. By way of derogation, products referred to in paragraph 1:

(a) which are produced before exit day, or which are still in the

finishing process immediately before exit day, may be placed or

remain on the market until stocks are exhausted, provided that

the labelling and presentation of those products complies with

this Regulation as it had effect immediately before exit day;

8 SD 453/04 9 SD 2014/0377 10 SD 164/01 11 SD 98/2005 12 SI 2013/2601 13 SI 2018/1157 14 SD 2019/0037


Regulations 2019

SD No.2019/0212 c

(b) other than those falling within point (a), which are imported

into the Island on or before 31 December 2020, may be marketed if

the labelling and presentation of those products complies with

this Regulation as it had effect immediately before exit day.».


(a) in paragraph 1, in point (e), for “the Union symbol” substitute

«any symbol established by the appropriate authority under

Article 12 of Regulation (EU) No 1151/2012»; and


«2. In the case of wines without a protected designation or origin

or a protected geographical indication, the information referred to

in points (a) and (b) of paragraph 1 must be verified in accordance

with guidance issued by the appropriate authority.».


(a) for “one or more official language of the Union”, in both places it

occurs, substitute «English, and may also appear in another

language»; and

(b) after paragraph 2, insert —

«3. Paragraph 1 does not apply to any products imported into

the Island prior to 31 December 2020 if they comply with the

requirements of this Article as it had effect immediately before

exit day.».



(a) in paragraph 1, for “Union”, in both places it occurs, substitute

«Island»; and

(b) in paragraph 2, for the words from “authorities” to the end

substitute «authority».


(a) in the first paragraph —

(i) for “Commission may adopt implementing acts” substitute

«appropriate authority may make regulations»; and

(ii) omit the second sentence; and

(b) in the third paragraph, for “Commission” substitute

«appropriate authority».





c SD No.2019/0212

(i) for “Member States”, in both places it occurs, substitute

«the appropriate authority»; and

(ii) omit “Union”; and


«2. The appropriate authority shall publish the names and

addresses of the authorities and laboratories referred to in

paragraph 1 and shall update them periodically.».



(b) in paragraph 3, for the words from “Member States” to “Article

227” substitute «competent authorities, the appropriate authority

may make regulations»;



(A) in the words before point (a), for “Commission may

adopt implementing acts” substitute «appropriate

authority may make regulations»; and

(B) in point (b), omit “measures requiring Member

States to determine”; and

(ii) omit the second subparagraph.



(i) for “a Member State”, in both places it occurs, substitute


(ii) in the second subparagraph, for “it” substitute «the


(b) in paragraph 1a, for “Member States do” substitute «the

appropriate authority does»;




(ii) for “it”, in both places it occurs, substitute «the

appropriate authority»; and





Regulations 2019

SD No.2019/0212 c

(i) in point (c) —

(A) omit point (i); and

(B) in points (ii) and (iii), for the words from “any” to

“that Member State” substitute «the Island does

not exceed 33% of total production in the Island»;

(ii) in point (d), for “Member States” substitute «the


(iii) in point (f), for the words from “competent” to “operates”

substitute «Office of Fair Trading»;

(b) omit paragraph 3;



(i) in the first subparagraph, for the words from

“competition” to “paragraph”, in the third place it occurs,

substitute «Office of Fair Trading»; and


(e) in paragraph 7, omit point (a); and




(a) in the first paragraph, for “competent national authority”

substitute «appropriate authority»; and

(b) omit the third paragraph.


(a) in paragraph 1, for “Member States” substitute «The appropriate

authority»;

(b) in paragraph 1a —

(i) in the first subparagraph, for “Article 101(1) TFEU”

substitute «section 8 of the Fair Trading Act 1996»;

(ii) in the second subparagraph, in point (a), omit from “,

thus” to the end; and

(iii) in the third subparagraph, for the words from “Member”

to “subparagraph”, substitute «nothing in this Regulation

prevents the appropriate authority from providing that the

condition set out in point (d) of the second subparagraph

does not apply»;

(c) in paragraph 1c —


c SD No.2019/0212

(i) in the first subparagraph, for the words from “national” to

“1/2003”, substitute «Office of Fair Trading»; and

(ii) omit the second and third subparagraphs; and

(d) in paragraph 2, for “Union support” substitute «public

funding».

(76) In Article 153, in paragraph 1, in point (b), for the words from “Member”

to “condition” substitute «nothing in this Regulation prevents the

appropriate authority from providing that this condition does not

apply».



(i) for “a Member State” substitute «the appropriate

authority»; and

(ii) in point (b), for the words from “to” to “concerned”

substitute «as laid down by the appropriate authority»;

(b) in paragraph 1a, for “Member States” substitute «The



«2. A producer organisation is deemed to be recognised

pursuant to Article 152 if the appropriate authority made a

decision to deem such recognition prior to exit day.».

(d) omit paragraph 3; and



authority»;

(ii) in point (a), omit the words from “this” to the end; and

(iii) omit point (d).


(a) for “Member States” substitute «The appropriate authority»;

and

(b) omit “by the Commission”.


(a) in paragraph 1, in the first subparagraph, for “Member States”

substitute «The appropriate authority»; and


(i) for “Member States” substitute «appropriate authority»;

and


Regulations 2019

SD No.2019/0212 c

(ii) for “Member State concerned” substitute «appropriate

authority».




authority»; and

(ii) in point (c)(v), omit “, compatible with Union rules,”;

(b) in paragraph 1a, for “Member States” substitute «The


(c) omit paragraph 2; and



authority»; and

(ii) in point (c) —

(A) omit the words from “in” to “Union”; and

(B) in point (v), omit “compatible with Union rules”.




authority»; and

(ii) in point (b), for “one or more regions of the territory

concerned” substitute «the Island»;

(b) omit paragraphs 2 to 4; and



authority»;

(ii) in point (a), omit the words from “this” to the end;

(iii) in point (c), for “the applicable penalties they have laid

down” substitute «any applicable penalties»; and

(iv) omit point (e).

(82) In Article 159, for “Member States” substitute “the Secretary of State”.




authority»; and


c SD No.2019/0212

(ii) in point (b), for the words from “to” to “concerned”

substitute «as laid down by the appropriate authority»;




authority»;

(ii) in point (a), omit the words from “this” to the end; and

(iii) omit point (d).





authority»;

(ii) in point (b), for “one or more regions in the territory

concerned” substitute «the Island»;



(i) in the introductory words —

(A) for “Member States make” substitute «the

appropriate authority makes»; and

(B) for “they shall” substitute «it must»;

(ii) in point (a), omit from “this” to the end; and

(iii) omit point (e).




(i) for the words from the beginning to “lay” substitute

«Nothing in this Regulation prevents the appropriate

authority from laying”;

(ii) At the end of the first subparagraph, insert «Any such

rules must be made with a view to improving and

stabilising the operation of the market in wines, including

the grapes, musts and wines from which they derive.»;

and

(iii) in point (d), omit “national and Union”; and

(b) omit paragraphs 2 and 3.


Regulations 2019

SD No.2019/0212 c



(i) for “a Member State” substitute «the appropriate

authority»; and

(ii) for “its territory”, in both places it occurs, substitute «the

Island»;

(b) in paragraph 1a, for “Member States do” substitute «appropriate

authority does»;



(A) for “Member State” substitute «appropriate

authority»; and

(B) for “it” substitute «the appropriate authority»;

and

(ii) in the second subparagraph, for the words from the

beginning to “adopt” substitute «The appropriate

authority must ensure that any provisions made»;

(d) in paragraph 3, for “Member State” substitute “Secretary of

State”;

(e) in paragraph 6, in the second subparagraph —


«the appropriate authority»;

(ii) for “it”, in both places it occurs, substitute «the


(iii) for “internal market”, in both places it occurs, substitute

«market in the Island»; and

(f) for paragraph 7 substitute —

«7. The appropriate authority must ensure that any provisions

made to implement the options referred to in this Article do not

impair the proper functioning of the market in the Island.».







c SD No.2019/0212

«2. Without prejudice to the application of Articles 177, 178 and

179 of this Regulation, the appropriate authority must issue

licences to any applicant established in the Island.»; and

(c) in paragraph 3, for “Union” substitute «Island».





regulations»; and

(ii) for “third” substitute «other»; and


(i) for “a third”, in both places it occurs, substitute

«another»; and

(ii) for the words from “concluded” to “States” substitute «to

which the Island is a party, the appropriate authority may

make regulations laying down the circumstances in which

the competent authority is required».





(i) omit “import or”; and

(ii) omit point (iii);

(c) omit points (e) and (f); and

(d) omit the last sentence.


(a) in paragraph 1, for “Commission” substitute «appropriate

authority»; and



authority»; and

(ii) for “Commission” substitute «appropriate authority».



(i) for “third” substitute «other»; and



Regulations 2019

SD No.2019/0212 c

(b) in paragraph 2, ), at the end insert the following subparagraph —

«Products of the hops sector imported from the European Union

before 29 March 2021 shall be considered to be of the standard

referred to in paragraph 1 if they are accompanied by a certificate

issued in accordance with Article 77 of Regulation (EU) No

1308/201315 as it has effect in EU law, as amended from time to

time, provided that the appropriate authority has not published a

statement under Article 77(4) in respect of those products.».


(97) In Article 196(1) —

(a) for “concluded in accordance with the TFEU” substitute «to

which the Island is a party»;

(b) for “Union” substitute «Island»; and

(c) in point (b) for “Council Regulation (EC) No 1216/2009” substitute


(98) In Article 197, in point (a), for “Union” substitute «Island».

(99) In Article 198(1) —

(a) for “Union” substitute «of the Island»; and

(b) for the words from “concluded” to “TFEU” substitute «to which

the Island is a party».

(100) In Article 199(3), for point (a) substitute —

«(a) the products have been exported from the Island in accordance

with the applicable export provisions, as construed in accordance with

section 35(2) of the Taxation (Cross-border) Trade Act 2018, as it has

effect in the Island16;».

(101) In Article 200, for “Union” substitute «retained EU».

(102) In Article 201, for “concluded in accordance with the TFEU” substitute

«to which the Island is a party».


(a) in the heading, omit “Commission guidelines on”;

(b) for the first paragraph substitute —

«Save as otherwise provided in this Regulation and subject, in

particular, to Articles 207 to 210 of this Regulation, the Fair

Trading Act 1996 shall apply to all agreements, decisions and

15 OJ L 347, 20.12.2013, p.671, as last amended by Regulation (EU) No 2017/2393 of the European

Parliament and of the Council (OJ L 350, 29.12.2017, p.15). 16 The Taxation (Cross-border Trade) Act 2018, as applied in the Island by SD 2019/0080.


c SD No.2019/0212

practices referred to in Part 2 of that Act which relate to the

production of, or trade in, agricultural products.»; and

(c) omit the second and third paragraphs.


(a) in the heading, for “of the CAP” substitute «set out in Article 39

TFEU»;

(b) in paragraph 1, in the first and second subparagraphs, for “Article

101(1) TFEU” substitute «Part 2 of the Fair Trading Act 1996»;

and


(i) in the second subparagraph, for “Commission” substitute

«Office of Fair Trading»;

(ii) in the third subparagraph —

(A) for “Commission”, in both places it occurs,

substitute «Office of Fair Trading»; and

(B) omit the words from “, at its” to “State,”; and

(iii) in the fourth subparagraph —

(A) omit “national or Union”;

(B) for “Article 101 TFEU” substitute «part 2 of the

Fair Trading Act 1996»; and

(C) for “Article 101(1) TFEU” substitute «part 2 of the

Fair Trading Act 1996».


(a) in paragraph 1, for “Article 101(1) TFEU” substitute «Part 2 of

the Fair Trading Act 1996»;


(i) in point (a), for “Commission” substitute «Office of Fair

Trading»;

(ii) in point (b) —

(A) for “Commission” substitute «Office of Fair

Trading»; and

(B) for “Union rules” substitute «any applicable

legislation»; and

(iii) in the second subparagraph —


Trading»;


Regulations 2019

SD No.2019/0212 c

(B) for “Union rules” substitute «any applicable

legislation»; and

(C) omit the words from “without” to the end;


(i) in the introductory words, for “Union rules” substitute

«any applicable legislation»;

(ii) in point (a), for “Union” substitute «Island»; and

(iii) in point (c), for “of the CAP” substitute «set out in Article

39 TFEU which are»;




Trading»;

(B) omit from “, without” to “(3),”; and

(C) for “Article 101(1) TFEU” substitute «part 2 of the

Fair Trading Act 1996»;

(ii) in the second subparagraph, for “That Commission

decision” substitute «That decision of the Office of Fair

Trading»;


(i) for “Commission” substitute «Office of Fair Trading»;

and

(ii) omit from “, on” to “State,”; and



(a) in paragraphs 1 and 2, for “Articles 107 to 109” substitute

«Articles 107(1), (2) and (3) and Article 108(3)»;


(i) omit “by Member States”;

(ii) in point (a), for the words from “which” to “Union”

substitute «, with the exception of payments made under

Article 35»; and

(iii) omit point (b); and


«3. In this Article —


c SD No.2019/0212

(a) a reference to Article 107(1) or 108(3) of TFEU is a reference to

that Article as it has effect in domestic law by virtue of section 8 of

the European Union and Trade Act 2019 and regulation 3(1) and

(2) of the state aid regulations;

(b) a reference to Article 107(2) or (3) of TFEU is to be read in

accordance with regulation 3(3)(b) of the state aid regulations;

(c) “the state aid regulations” means the State Aid (EU Exit)

Regulations 2019.».

(107) Omit Articles 212 to 214a.



(b) for “Member States” substitute «The relevant authority»; and

(c) omit “national”.




(b) for “Member States”, in each place it occurs, substitute «The

relevant authority»; and

(c) omit “national”.




(i) for “Member States” substitute «The relevant authority»;

and

(ii) omit “national”;


«2. The appropriate authority may not make payments under

paragraph 1 in respect of more than 100 hectares per year.»;



and

(ii) omit “national”.




Regulations 2019

SD No.2019/0212 c



regulations»;

(ii) omit “concluded in accordance with the TFEU”; and

(iii) omit the second and third subparagraphs;

(b) in paragraph 2, for the second subparagraph substitute —

«However, the appropriate authority may make regulations

applying the measures referred to in paragraph 1 to one or more

of the products listed in Section 2 of Part XXIV of Annex I.»; and


«3. The appropriate authority may make regulations laying

down necessary procedural rules and technical criteria for the

application of measures referred to in paragraph 1 of this

Article.».





(ii) for “intra-Union and third-country” substitute «trade

within the Island and international»; and

(iii) omit the second subparagraph;

(b) in paragraph 2, in the third subparagraph, for the words from

“Commission” to “Article 228” substitute «appropriate authority



(d) in paragraph 4, for the words from “the Member” to “quickly”

substitute «health and veterinary measures have been taken»;

and

(e) omit paragraphs 5 and 6.



(i) for “Commission shall adopt implementing acts”


regulations»; and

(ii) omit the last sentence;



c SD No.2019/0212

(i) for “To” substitute «The appropriate authority may make

regulations to»; and

(ii) omit the words from “, the Commission” to the end;


(i) for “Commission shall adopt measures” substitute


(ii) omit “or 2”;


«4. Regulations made under paragraph 1 or 2 may remain in

force for a period not exceeding 12 months.

If it appears to the appropriate authority that the specific

problems which led to the making of the regulations under

paragraph 1 or 2 will persist beyond the period for which they are

in force, the appropriate authority may make further regulations

to address the problems. Such regulations may only remain in

force for a period not exceeding 12 months.

The power to make further regulations under the second

subparagraph may not be exercised more than twice.»; and

(e) omit paragraph 5.



(i) for the words from “Commission” to “TFEU” substitute

«appropriate authority may make regulations to the effect

that part 2 of the Fair Trading Act 1996»;

(ii) for “the internal market” substitute «trade within the

Island»;

(iii) in point (f), for “Union”, in both places it occurs, substitute

«Island»; and

(iv) for the second and third subparagraph substitute —

«Regulations made under this paragraph must specify the

substantive and geographic scope of the derogation and

the period for which the derogation applies.»; and




(ii) omit the last sentence.



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SD No.2019/0212 c


«1. Personal data collected for the purposes set out in Article

223(1) must not be processed in a way which is incompatible with

those purposes.»;


(i) for “Directive 95/46/EC and Regulation (EC) No 45/2001”,

substitute «the GDPR and LED Implementing

Regulations 201817 and the Data Protection Act 2018»; and

(ii) for the words from “the minimum” to the end, substitute

«any statutory minimum retention periods»; and



(ii) for “by national and Union bodies”, substitute «by Isle of

Man bodies»; and

(iii) for the words from “Directive” to the end, substitute «the

GDPR and LED Implementing Regulations 2018 and the

Data Protection Act 2018».


(a) in the heading, for “Commission” substitute «appropriate

authority»;

(b) for the words from “Commission” to “Council”, substitute

«appropriate authority may publish a report»;

(c) in point (a), for “and for the first time by 21 December 2016”

substitute «on»; and

(d) omit points (b), (c), (d) and (f).


(119) In the heading of Part 6, for “Delegations of power, implementing

provisions” substitute «Regulations».

(120) For the heading of Part 6, Chapter 1 substitute «Regulations».



«Article 227

Regulations

1. Regulations made by the Department under these Regulations may

contain —

17 2018/0145


c SD No.2019/0212


saving provisions;





(a) for paragraph 1(a) – negative; or

(b) for paragraphs 1(b) or 1(c) – approval required.».

(123) Omit Articles 228 and 229


(125) After Article 232, omit the words from “This Regulation” to “States”.

(126) In Annex 2, in Part 2, —

(a) in Section A, in paragraph 6(a), for “Member State concerned”


(b) omit Section B.

(127) In Annex 4 —


(b) in Section A —

(i) in the heading, omit “Union”;

(ii) in part 3 (Classification), in paragraph 2, in the second

subparagraph, for “Member States are authorised to”

substitute «The relevant authority may»; and

(iii) in part 5 (Classification and identification) —

(A) in the first paragraph, omit “Union”; and

(B) in the second paragraph, for “Member States”

substitute «the relevant authority»;

(c) in Section B —


(ii) in part 4 (Lean-meat content), in paragraph 1, for

“Commission” substitute «relevant authority»; and

(iii) in part 5 (Identification of carcasses) —

(A) for “by the Commission” substitute «in retained

EU law»; and

(B) omit “Union”; and

(d) in Section C —


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SD No.2019/0212 c


(ii) in part 4 (Presentation), in the second paragraph, for

“Member States are authorised to” substitute «The

relevant authority may»; and

(iii) in part 5 (Identification of carcasses), omit “Union”.

(128) Omit Annex 6.

(129) Annex 7 is amended in accordance with subparagraphs (130) to (138).

(130) In the introductory wording, omit the words from “under” to “name”, in

the second place it occurs;

(131) In Part 1 —

(a) in point 3 (Sales descriptions) —

(i) in paragraph 1 —

(A) for “Member States” substitute «Island»;

(B) omit “laid down for each Member State”; and

(C) in points A and B —

i. omit all entries except for the entry for the

United Kingdom; and

ii. after “United Kingdom” insert «and the Isle

of Man»; and

(ii) in paragraph 3, in the second subparagraph, for the words

from “terms” to “teletina” substitute «term “veal”»;

(b) in point 4 (Compulsory indication on the label) —

(i) in paragraph 1, omit “Directive 2000/13/EC”; and

(ii) in paragraph 2, for the words from “Member” to the end

substitute «the information referred to in paragraph 1

must be indicated in accordance with the legislation

applying in the Island»; and

(c) in point 6 (Official checks) —

(i) omit paragraph 1;

(ii) in paragraph 2, after “authorities” insert «designated by

the appropriate authority»;

(iii) for paragraph 3 substitute —

«3. The competent authorities shall carry out on the spot

checks to ensure that the provisions of this Annex are

being implemented. Where required, those checks shall be

carried out jointly with the relevant authority’s experts.»;


c SD No.2019/0212

(iv) omit paragraph 4; and

(v) in paragraph 5, for “third” in both places where it occurs

substitute «other».

(132) In Part 2 —

(a) in point (1) —

(i) in the second subparagraph —

(A) in point (a), omit the words from “provided” to the

end;

(B) in point (c), in the first indent, for the words from

“certain” to “pursuant to” substitute «wine

growing areas specified under»; and

(C) in point (d), for the words from “which” to

“pursuant to” substitute «provided for under»;

(ii) omit the third and fourth subparagraphs; and

(iii) in the fifth subparagraph, for “Member States” substitute

«the appropriate authority»;

(b) in point (3) —

(i) in point (b), for the words from “a list” to “acts” substitute

«any list drawn up»;

(ii) in point (c), in the fourth indent, from “to be” to “pursuant

to” substitute «specified under»; and

(iii) in points (d) and (f), for the words from “a list” to “acts”

substitute «any list drawn up»;

(c) in point (6)(a) —

(i) for the words from “a list” to “acts” substitute «any list

drawn up»; and

(ii) for the words from “shall” to “pursuant to in” substitute

«are as specified under»;

(d) in point (12), for the words from “certain” to “acts” substitute

«wines specified»; and

(e) in point (16), omit the second subparagraph.

(133) In Part 3 —

(a) in paragraph 2 (b), omit “Article 5 of Directive 2000/13/EC or”;

and

(b) in paragraph 6, in the second subparagraph, omit “Directive

2000/13/EC or”.

(134) In Part 4 —


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SD No.2019/0212 c

(a) in point 2 (Delivery or sale to the final consumer), in paragraph 3,

for the words from the beginning to “consumers of” substitute

«The appropriate authority must ensure there is information

available to consumers regarding»; and

(b) in point 3 (Drinking milk) —

(i) in paragraph 1(b)(i), for “Member States may provide”

substitute «nothing in this Regulation prevents the

appropriate authority from providing»; and

(ii) in paragraph 2, in the third subparagraph, for “Member

States may” substitute «nothing in this Regulation

prevents the appropriate authority from using any power

the authority has to».

(135) In Part 5 —

(a) in point 1, for “union” substitute «Island»; and

(b) in point 2 —

(i) in paragraph (2), for “Member States may” substitute

«nothing in this Regulation prevents the appropriate

authority from using any power the authority has to»;

and

(ii) in paragraph (6), in the second subparagraph, for “Member

States may” substitute «nothing in this Regulation

prevents the appropriate authority from using any power

the authority has to»;

(136) In Part 6 —

(a) in point 1 (Scope) —


(A) for “Union”, in each place it occurs, substitute

«Island»; and

(B) for “third” substitute “other”; and

(ii) in paragraph 2 —

(A) in the first subparagraph, for “Member States may”

substitute «Nothing in this Regulation prevents the

appropriate authority from using any power the

authority has to»;

(B) in point (b), omit “of the Member State concerned”;

and

(C) omit the third subparagraph; and

(b) in point 3 (Marking of eggs) —


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(i) in paragraph 1, for the third subparagraph substitute —


authority from using any power the authority has to

exempt Class B eggs from this requirement where those

eggs are marketed exclusively in the Island.»; and


(A) in the first subparagraph, omit “of the Member State

concerned”; and

(B) in the second subparagraph, for “Member States

may” substitute «nothing in this Regulation

prevents the appropriate authority from using any

power the authority has to».

(137) In Part 7, in point 2 (Terminology), in paragraph 3, in the first

subparagraph —

(a) for the words from “By” to “addition,” substitute «Nothing in

this Regulation prevents»; and

(b) for “may be” substitute «being».

(138) In Part 8 —

(a) in the introductory wording —

(i) for “Union” substitute «Island»; and

(ii) for “third” substitute «other»; and

(b) omit “by the Commission” in each place it occurs.

(139) Omit Appendix 1.

(140) In Appendix 2, omit the footnotes to the table.

(141) Annex 8 is amended in accordance with subparagraphs (142) and (143).

(142) In Part 1 —

(a) in Section A —

(i) in paragraph 1, for the words from “in certain” to

“concerned”, substitute «, the appropriate authority»;

(ii) in paragraph 2, for the words from “the following” to the

end substitute «3% volume»; and

(iii) in paragraph 3 —

(A) for the words “Member States”, in the first place it

occurs, substitute «appropriate authority»; and

(B) omit the second sentence;

(b) in Section B —


Regulations 2019

SD No.2019/0212 c

(i) in paragraph 3, omit the words from “and only” to the end;

(ii) in paragraph 4, omit the words from “ in wine-growing

zone A” to the end;

(iii) in paragraph 6, for “wine”, in the second place it occurs, to

the end substitute «wine to more than 11.5% volume»;

and

(iv) in paragraph 7 —

(A) for the words from “By way of” to “may” substitute

«Nothing in this Regulation prevents the

appropriate authority from»;

(B) for “raise”, in both places it occurs, substitute

«raising»;

(C) in point (a), omit the words from “in wine-growing

zone A” to the end; and

(D) in point (b), for “Member States” substitute «the


(c) in Section C —

(i) in paragraph 1, for the words from “subject to” to the end,

substitute «subject to deacidification»;


(A) for “Member States” substitute «the appropriate

authority»; and

(B) omit “in wine-growing zones A and B”; and

(iii) in paragraph 7, for the words from “except” to “pursuant

to” substitute «subject to any exceptions made under»;

and

(d) in Section D —

(i) in paragraph 1, for the words from “to be” to “pursuant

to” substitute «prescribed under»;

(ii) in paragraph 2, for the words from “wine-growing” to the

end substitute «Island»;

(iii) in paragraph 3, omit “and in the wine-growing zone”;

(iv) in paragraph 4, for the words from “to be” to “pursuant

to” substitute «prescribed under»; and

(v) in paragraph 6 —

(A) omit point (a); and

(B) in point (b), omit “in wine-growing zones A and B”.


c SD No.2019/0212

(143) In Part II —

(a) in Section B —

(i) in paragraph 1, omit the second sentence;

(ii) in paragraph 2, for “territory of the Union” substitute

«Island»;

(iii) in paragraph 3 —

(A) omit “, Ireland, Poland and”;

(B) for “Member States” substitute «the appropriate

authority»;

(iv) omit paragraph 4; and

(v) in paragraph 5 —

(A) (aa) for “third” substitute “other”; and

(B) (bb) for “territory of the Union” substitute

«Island»;

(b) in Section C —

(i) for “a third” substitute «another»;

(ii) for “Union”, in both places it occurs, substitute «Island»;

and

(iii) for “third”, in the second place it occurs, substitute

«other»; and

(c) in Section D —

(i) in paragraph 1, for “Member States” —

(A) in the first place it occurs, substitute «The


(B) in the second place it occurs, substitute «the


(ii) in paragraph 2, omit the second sentence;

(iii) in paragraph 4, for “Member State concerned” substitute


(iv) in paragraph 5 —

(A) for the words from “Without” to “any” substitute

«Any»; and

(B) for the words from “to be” to “pursuant to”

substitute «prescribed under».

(144) In Annex 10 —


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SD No.2019/0212 c

(a) in Point 7, in point (c), for “Member State” substitute


(b) in Point 11 —

(i) in paragraph 2, for “Union rules” substitute «any

applicable legislation»; and

(ii) in paragraph 3, for “Union” substitute «national».

(145) Omit Annexes 11 to 13.



Council of 16 April 2014 laying down the trade arrangements applicable

to certain goods resulting from the processing of agricultural products

and repealing Council Regulations (EC) No 1216/2009 and (EC) No

614/200918 is amended as follows.


(a) in paragraph 1, after “circulation” insert «in the Island»;


(i) for “Member States” substitute «the Department of

Environment, Food and Agriculture»;


(iii) omit the words from “, irrespective” to the end;

(c) in paragraph 3, for “Union” substitute «Island»; and


(i) after “circulation” insert «in the Island»; and

(ii) for “third” substitute «another».

(3) In Article 22(2), for “accordance with Article 29 TFEU”, in each place it

occurs, substitute «the Island».

(4) Article 23(1), for “authorities of the Member State” substitute

«authority».


(a) for the words from “concluded” to “TFEU” substitute «to which

the Island is a party»; and

(b) for “authorities of the Member State” substitute «authority».


18 Paragraph (1(6) of the Schedule to the retention regualtions.


c SD No.2019/0212

(a) for “Member States” substitute «The Department of

Environment, Food and Agriculture»; and

(b) for the words from “Union”, in the first place it occurs, to the end

substitute «United Kingdom».

(7) In Article 30(1), for “authorities of the Member State concerned”

substitute «Island».


(9) In Article 40(1), for “legal acts adopted” substitute «regulations made».

(10) Omit Article 46 and the sentence which follows it.

4 Commission Delegated Regulation (EU) 2016/1238 amended

(1) Commission Delegated Regulation (EU) 2016/1238 of 18 May 2016

supplementing Regulation (EU) No 1308/2013 of the European

Parliament and of the Council with regard to public intervention and aid

for private storage19 is amended as follows.

(2) After Article 1 insert —

«Article 1A

Definitions

In this Regulation —

“appropriate authority” means the Department of Environment Food

and Agriculture.».


(4) In Article 4(a), omit the words from “, or the disposal” to the end.

(5) For Article 5(7), substitute —

«7. In the case of sale of intervention products, except in cases of force

majeure, the security shall be forfeit in respect of quantities for which

payment has not been made in accordance with Article 35 of

Implementing Regulation (EU) 2016/1240 and the sale shall be cancelled

in respect of those quantities.».


(a) in the fourth paragraph, for “Member State exercising jurisdiction

over the paying agency” substitute «Island»; and

(b) omit the last subparagraph.

(7) In Article 8, in paragraphs 3 and 4, for the words “Implementing

Regulation” to the end, substitute «tendering procedure or the



Regulations 2019

SD No.2019/0212 c

Regulations fixing the amount of aid in advance, referred to in Article 39

of Implementing Regulation (EU) 2016/124020.».

(8) Omit Article 9.

(9) After Article 11, omit the words from “This Regulation” to “Member

States”.

(10) In Annex 1, Part 1 —

(a) in point 1(d) for “Union” substitute «retained EU»; and

(b) in point 3 for “Member States” substitute «The appropriate

authority».

(11) In Annex 2, point 1(e), for “Union” substitute «retained EU».

(12) In Annex 3 —

(a) in Part 1, point 2(b), for “Commission Regulation (EC) No

1249/2008” substitute «Commission Delegated Regulation (EU)

2017/118221»; and

(b) for Part 2 substitute —

«Classification of products

For the purpose of this Part, category Z refers only to male

animals as described in point 1(c) of Part I.

I. ISLE OF MAN

Carcases, half-carcases:

Category C, class U3

Category C, class U4

Category C, class R3

Category C, class R4

Category C, class O3

Category C, class O4

Category A, class U2

Category A, class U3

Category A, class R2

Category A, class R3

Category A, class O2

Category A, class O3

20 OJ L 206, 30.7.2016, p. 71. 21 Paragraph 24(2) of the Schedule to the retention regulations.


c SD No.2019/0212

Category Z, class U2

Category Z, class U3

Category Z, class R2

Category Z, class R3

Category Z, class O2

Category Z, class O3».

(13) In Annex 4 —

(a) in Part 1 —

(i) in paragraph 2, for “Commission” substitute «appropriate

authority»;

(ii) in paragraph 3, for “Union” substitute «retained EU»;

and

(iii) omit paragraphs 5 and 6; and

(b) in Part 3 —

(i) in paragraph 1(b), omit “of each Member State”;

(ii) in paragraph 1(d), for “Member State” substitute


(iii) in paragraph 3, in the third subparagraph, for “Member

State” substitute «appropriate authority».

(14) In Annex 5 —

(a) in Part 1 —


(A) in subparagraph 2, for ”Union” substitute

«Island»; and

(B) in subparagraph 3 for “Commission” substitute

«appropriate authority»;

(ii) in paragraph 3, for “Union” substitute «retained EU»;

and

(iii) omit paragraphs 5 and 6;

(b) in Part 3 —

(i) in paragraph 1(b), omit “of each Member State”;

(ii) in paragraph 1(d), for “Member State” substitute


(iii) in paragraph 3, for “Member State” substitute



Regulations 2019

SD No.2019/0212 c

(15) In Annex 6 —

(a) in the first paragraph, for “Union” substitute «retained EU»;

(b) under heading 1 (sugar), omit the last sentence;

(c) under heading 2 (flax fibre), in point (a), omit “and the Member

State”;

(d) under heading 3 (meat) —

(i) in paragraph (a) —

(A) omit “Union”; and

(B) for “Regulation (EC) No 1249/2008, and identified in

accordance with Article 6(3)” substitute

«Regulation (EU) No 2017/1182, and identified in

accordance with Article 8(2)(a)»; and

(ii) in paragraph (c), in each place it occurs, for “Union”

substitute «Island»;

(e) under heading 4 (butter) —

(i) in the third paragraph, omit “of the Member State of

production”; and

(ii) omit the fourth paragraph;

(f) under the heading 5 (cheese), for point (b) substitute —

«(b) it is stored as a whole cheese in the Island; and»; and

(g) under the heading 6 (skimmed milk powder) —»

(i) in the third paragraph, omit “of the Member State of

production; and

(ii) omit the fourth paragraph.

(16) In Annex 7 —

(a) omit point (a); and

(b) in points (b) and (c) —

(i) for “the requirements”, in both places those words occur,

substitute «any statutory requirements»; and

(ii) omit “by the Member State concerned” in both places those

words occur.


c SD No.2019/0212

PART 2

COMMON AGRICULTURAL POLICY REGULATIONS

5 Commission Regulation (EC) No 2004/2002 amended

(1) Commission Regulation (EC) No 2004/2002 of 8 November 2002 relating

to the procedure for determining the meat and fat content of certain

pigmeat products22 is amended as follows.

(2) After Article 3 omit “This Regulation shall be binding in its entirety and

directly applicable in all Member States.”.

PART 3

CEREALS REGULATIONS

6 Commission Implementing Regulation (EC) No 1312/2008 amended

(1) Commission Implementing Regulation (EC) No 1312/2008 of 19

December 2008 fixing the conversion rates, the processing costs and the

value of the by-products for the various stages of rice processing23 is

amended as follows.

(2) Omit Article 7.

(3) In the sentence following Article 8, omit the words from “This

Regulation” to “Member States”.

(4) Omit Annexes 1 and 2.

PART 4

QUALITY SCHEMES AND PROTECTED DESIGNATION OF ORIGIN

REGULATIONS



Council of 21 November 2012 on quality schemes for agricultural

products and foodstuffs24 is amended as follows.


22 Paragraph 2(2) of the Schedule to the retention regulations. 23 Paragraph 3(12) of the Schedule to the retention regulations. 24 Paragraph 6(1) of the Schedule to the retention regulations.


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SD No.2019/0212 c

(a) at the end of point (b) insert “and”;

(b) at the end of point (c) omit “and”; and

(c) omit point (d).


(a) in paragraph 1, in the second subparagraph, for the words from

“Commission” to “Article 56,” substitute «competent authority


(b) in paragraph 2, for “Annex XIb to Regulation (EC) No 1234/2007”

substitute «Part 2 of Annex 7 to Regulation 1308/2013»;


(i) for “Union provisions” substitute «provisions in retained

EU law»; and

(ii) for “the single common organisation of the markets, and”

substitute «provisions in, or under, Regulation 1308/2013

and provisions relating»; and



(a) in point (6), for “Union” substitute «Isle of Man»; and

(b) after point (8) insert —

«(9) ‘EU Regulation 1151/2012’ means Regulation (EU) No

1151/2012 of the European Parliament and of the Council on

quality schemes for agricultural products and foodstuffs as it had

effect in EU law immediately before exit day;

(10) ‘Regulation 1308/2013’ means Regulation (EU) No 1308/2013

of the European Parliament and of the Council establishing a

common organisation of the markets in agricultural products;

(11) ‘Regulation 664/2014’ means Commission Delegated

Regulation (EU) No 664/2014 supplementing Regulation (EU) No

1151/2012 of the European Parliament and of the Council with

regard to the establishment of the Union symbols for protected

designations of origin, protected geographical indications and

traditional specialities guaranteed and with regard to certain rules

on sourcing, certain procedural rules and certain additional

transitional rules;

(12) ‘the competent authority’ means the Department of

Environment, Food and Agriculture;

(13) ‘the designated authority’ means:


c SD No.2019/0212

(a) unless point (b) applies, the Department of Environment, Food

and Agriculture;

(b) in a case where an official control has been delegated to a

control body in accordance with Article 39, the control body to

which the function has been delegated;

(14) ‘enactment’ includes:

(a) statutory documents, and

(b) except in Article 28, retained direct EU legislation;

(15) ‘established protected designation of origin’ means a

designation of origin shown as a United Kingdom registered

designation of origin on the register maintained by the European

Commission pursuant to Article 11 of EU Regulation 1151/2012 as

that register stood immediately before exit day as amended

further to any application submitted under Article 49 from a

person or body based on the Island;

(16) ‘established protected geographical indication’ means a

geographical indication shown as a registered United Kingdom

geographical indication on the register maintained by the

European Commission pursuant to Article 11 of EU Regulation

1151/2012 as that register stood immediately before exit day as

amended further to any application submitted under Article 49

from a person or body based on the Island;

(17) ‘established protected traditional speciality guaranteed’

means a traditional speciality guaranteed shown as a registered

United Kingdom traditional speciality guaranteed on the register

maintained by the European Commission pursuant to Article 22

of EU Regulation 1151/2012 as that register stood immediately

before exit day as amended further to any application submitted

under Article 49 from a person or body based on the Island;

(18) ‘third country’ means a country other than the Isle of Man.».

(5) In Article 4(b), for “Union” substitute «Isle of Man».


(a) in the first subparagraph, for the words from “Commission” to

“Article 56,” substitute «competent authority may make

regulations»; and

(b) in the second subparagraph, for the words from “Commission” to

“Article 56,” substitute «competent authority may make

regulations».



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SD No.2019/0212 c

(a) in paragraph 1(e) omit the words from “, taking into account” to

the end of that point; and



“Commission” to “Article 56,” substitute «competent



(A) for “Commission may adopt implementing acts”

substitute «competent authority may make

regulations»; and

(B) omit the second sentence.

(8) Omit Article 8.

(9) Omit Article 9.



(a) in paragraph 1, for the words from “Commission” to

“maintaining” substitute «competent authority must provide

direction to»; and

(b) omit paragraphs 2 to 4.


(a) in paragraph 2 omit “Union”;

(b) in paragraph 4, for “Member State” substitute «Isle of Man or

third country, as relevant, in which that geographical area of

origin is located»;

(c) in paragraph 5, for the words from “Directive 2000/13/EC” to

“Directive 2008/95/EC” substitute «Regulation (EU) No

1169/2011 of the European Parliament and of the Council on the

provision of food information to consumers, the collective

geographical marks registered under the Trade Marks Act 1994

(of Parliament) (as applied to the Island by the Trade Marks (Isle

of Man) Order 201325 and the Trade Marks (Isle of Man)

(Amendment) Order 201826)»;

(d) in paragraph 6 omit “Union”; and



25 SI 2013/2601 26 SD 2018/1157


c SD No.2019/0212

(A) for the words from “Commission” to “Article 56,”


regulations»; and





regulations»;


(C) omit the second sentence.

(13) In Article 13(3) —


(i) for “Member States” substitute «The designated

authority»; and

(ii) for “that Member State” substitute «the Island»; and





(b) in paragraph 4, for “Union legislation” substitute «retained EU

law»; and

(c) in paragraph 5, for the words from “Commission” to “Article 56,”

substitute «competent authority may make regulations».


(a) in paragraph 1(a) omit “, in the appropriate language versions”;

and



“Commission” to “Article 56,” substitute «competent





regulations»; and




Regulations 2019

SD No.2019/0212 c


(a) in paragraph 1, for the words from “Commission” to

“maintaining” substitute «competent authority must provide

direction to»; and



«competent authority may make regulations»; and

(ii) omit the second sentence.


(a) in paragraph 2 omit “Union”;



(A) for the words from “Commission” to “Article 56,”


regulations»; and





regulations»;


(C) omit the words from “, including” to the end.



(i) for “Member States” substitute «The designated

authority»; and

(ii) for “at national level” substitute «in the Island»; and






(22) In Article 27, for “internal market” substitute «Island».


«Article 28


c SD No.2019/0212

Existing enactments

1. Nothing in this Regulation prevents the maintenance of enactments

on optional quality terms that are not covered by this Regulation and

are in force immediately before exit day, provided that they comply

with retained EU law.

2. In paragraph 1, ‘maintenance’ includes repeal and replacement, and

revocation and replacement, without, in both cases, any substantive

modification.».


(a) in paragraph 1(c), for “European” substitute «Island»;

(b) in paragraph 4, for the words from “Commission” to “Article 56,”

substitute «competent authority may make regulations»;






(i) for “adopting delegated and implementing acts” substitute

«making regulations»; and

(ii) for “Commission” substitute «competent authority».


(a) in paragraph 1, for the words from “Commission” to “Article 56,”

substitute «competent authority may make regulations»; and

(b) in paragraph 2, for the words from “Commission” to “Article 56,”




(i) for “Union” substitute «Island»;

(ii) for “Article 18(1) of Regulation (EC) No 1257/1999”, in the

first place it occurs, substitute «Article 32 of Regulation

(EU) No 1305/2013 of the European Parliament and of the

Council on support for rural development by the European

Agricultural Fund for Rural Development (EAFRD)27»;

and

(iii) for “Article 18(1) of Regulation (EC) No 1257/1999”, in the

second place it occurs, substitute «Article 32 of Regulation

27 OJ L 347, 20.12.2013, p. 487.


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SD No.2019/0212 c

(EU) No 1305/2013 of the European Parliament and of the

Council»;


(i) for the words from “Commission”, in the first place it

occurs, to “Article 56,” substitute «competent authority


(ii) for the words from “Commission”, in the second place it

occurs, to “delegated act” substitute «competent authority





(28) In Article 33(2) —



(b) omit the second sentence.

(29) In Article 34, for “Member States” substitute «The designated

authority».


(a) for the heading substitute —

«Official controls»;

(b) in paragraph 1 omit the first subparagraph; and

(c) in paragraph 2 omit “referred to in paragraph 1”.




(A) in the words before point (a), for “Union” substitute

«Island»; and

(B) in point (a), for the words from the beginning to

“Regulation” substitute «the competent

authority»; and

(ii) in the second subparagraph, for “Member States”

substitute «competent authority»;


(i) in the first subparagraph, for “Member States” substitute

«The competent authority»;


c SD No.2019/0212

(ii) in the second subparagraph, for “Commission” substitute

«the competent authority»; and

(iii) after the second subparagraph insert —

«The competent authority may make the information

specified in the first and second subparagraphs public, and

update that information periodically, in such manner as

appears appropriate to the competent authority from time

to time.»; and



(a) omit the first paragraph; and

(b) in the second paragraph —

(i) for “Member States”, in the first place it occurs, substitute

«The designated authority»; and

(ii) for “Member States”, in the second place it occurs,

substitute «that authority».

(33) In Article 39(3), in both points (a) and (b), for “Union” substitute

«Island».

(34) In Article 40(1), for “Member States” substitute «The competent

authority».


(a) in paragraph 1, for “Union” substitute «Isle of Man»;

(b) for paragraph 2(b) substitute —

«(b) any relevant enactment.»; and



(36) In Article 42(2), for the words from “Commission” to “Article 56,”



(a) for “Union rules or to those of Member States” substitute

«retained EU law and any other enactments»; and

(b) for “those rules” substitute «such law and those enactments».





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SD No.2019/0212 c

(i) for “Commission shall adopt implementing acts”

substitute «competent authority may make regulations»;

and




(i) in the words before point (a), for “Regulation (EC) No

1234/2007” substitute «Regulation 1308/2013»; and

(ii) in point (a), for the words from “competent authorities” to

“other competent” substitute «the competent authority or

any designated»; and


(i) for “Member States”, in the first place it occurs, substitute

«The «competent authority»;

(ii) for “on their territories” substitute «in the Island»; and

(iii) for the second and third sentences substitute —

«The competent authority must publish the names and

addresses of the groups referred to in Article 3(2) in such

manner as appears appropriate to the competent authority

from time to time.».


(a) in paragraph 1, for “Member States” substitute «The competent

authority»; and

(b) in paragraph 3, for “Member States” substitute «The competent

authority».


(42) For Article 49 —

«Article 49

Application for registration of names

1. Applications for registration of names under the quality schemes

referred to in Article 48 may be submitted to the European Union.».


(44) In Title 6 omit Chapter 1.


«Article 56

Regulations


c SD No.2019/0212


contain —


saving provisions;





(a) for paragraph 1(a) – negative; or;



(47) In Article 58(1) omit the second subparagraph.


(49) After Article 59 omit the words from “This Regulation” to “Member

States.”.

8 Commission Delegated Regulation (EU) No 664/2014 amended

(1) Commission Delegated Regulation (EU) No 664/2014 of 18 December

2013 supplementing Regulation (EU) No 1151/2012 of the European

Parliament and of the Council with regard to the establishment of the

Union symbols for protected designations of origin, protected

geographical indications and traditional specialities guaranteed and with

regard to certain rules on sourcing, certain procedural rules and certain

additional transitional rules28 is amended as follows.


«Article A1

Definition of ‘third country‘

In this Regulation ‘third country’ means any country, other than the

British Islands.».




States.”.



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9 Commission Delegated Regulation (EU) No 665/2014 amended

(1) Commission Delegated Regulation (EU) No 665/2014 of 11 March 2014


Parliament and of the Council with regard to conditions of use of the

optional quality term ‘mountain product’29 is amended as follows.



States.”.



c SD No.2019/0212

SCHEDULE 2

[Regulation 5(b)]

RETAINED DIRECT EU LEGISLATION CONCERNING ANIMAL DISEASES

AMENDED

PART 1

TRANSMISSIBLE ANIMAL DISEASES REGULATIONS

1 Commission Decision 97/794/EC amended

(1) Commission Decision of 12 November 1997 laying down certain detailed

rules for the application of Council Directive 91/496/EEC as regards

veterinary checks on live animals to be imported from third countries

(97/794/EC)30 is amended as follows.

(2) In Article 1, at the end, insert as a new subparagraph—

«In this Decision:

“the appropriate authority” means the Department of Environment,

Food and Agriculture

“third country” means any country other than a member State or the

British Islands.».

(3) In Article 3, in paragraph 3, for “Community rules”, substitute “retained

EU law”.

(4) In Article 4—

(a) in paragraph 1—

(i) for the words from “the physical check” to “equidae”,

substitute «a physical check»; and

(ii) at the end insert, as a new subparagraph—

«The physical check must include a clinical examination

of the animals to ensure that they conform to the

information provided in the accompanying documents and

are clinically healthy as well as any laboratory tests

thought necessary.»;

(b) in paragraph 6, for “Member States”, substitute “The appropriate

authority”; and

(c) for paragraph 7, substitute—



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SD No.2019/0212 c

«7. The results of the checks, together with the information

referred to in paragraph 4, shall be communicated to the

appropriate authority on a routine basis at intervals of every six

months together with copies of the relevant veterinary certificates.

However, in the case of positive sampling results, or in any other

circumstances where the official veterinarian or other inspector

considers justified, the results of the tests shall be communicated

to the appropriate authority immediately and copies of the

relevant veterinary certificates shall be sent to the appropriate

authority as soon as possible thereafter.».

(5) In Article 6—

(a) in each of paragraphs 1 and 2, for “certificate as laid down in

Decision 92/527/EEC”, substitute «Common Veterinary Entry

Document (CVED)»;

(b) in paragraph 3, in the seventh indent, for “Member State”,

substitute «place»;

(c) in paragraph 4, for “Article 2(c) of Council Directive 90/426/EEC”,

substitute «Article 2(c) of Council Directive 2009/156/EC»;

(d) in paragraph 5, for “certificate as laid down in Decision

92/527/EEC”, substitute «CVED»;

(e) in paragraph 7, omit «as laid down in Decision 92/527/EEC»;

and

(f) after paragraph 7, insert—

«8. In this Decision, “Common Veterinary Entry Document

(CVED)” means a document published by the appropriate

authority from time to time based on national requirements but

which is otherwise equivalent to the model for the certificate

referred to in Article 7(1) of Council Directive 91/496/EEC.».


(7) In Annex 1—


(i) in point (a), for “at least one of the official languages of the

Member States of the border inspection post and of the

final destination”, substitute «English, whether or not it

also appears in other languages»; and

(ii) in points (b) and (f), for “Community, substitute «Isle of

Man» in each place; and

(b) in paragraph 2—


c SD No.2019/0212

(i) for the first sentence, substitute «The competent authority

must check the transport documentation required by

Article 4 of Regulation (EC) No 1/2005.»;

(ii) in the second sentence, for “written undertaking and route

plan”, substitute «transport documentation»; and

(iii) for “at least one of the official languages of the Member

States of the border inspection post and of the final

destination”, substitute «English and may also appear in

other languages».

(8) In Annex 2, in paragraph 1, in the second subparagraph, for “Directive

91/628/EEC”, substitute «Regulation (EC) No 1/2005».


(1) Commission Decision of 20 June 2003 on certain protection measures

with regard to monkey pox virus (2003/459/EC)31 is amended as follows.

(2) In Article 1—

(a) for “Member States, substitute “The appropriate authority”;

(b) after the text, insert—

«“the appropriate authority” means the Department of

Environment, Food and Agriculture.»

(3) In Article 2, for “Member States”, substitute «The appropriate

authority».

(4) In Article 3, for “competent authorities of a Member State”, substitute


(5) In Article 4—

(a) for “The Member States”, substitute «The appropriate

authority»;

(b) omit the last sentence.

(6) Omit Article 6.

3 Commission Implementing Decision 2013/652/EU amended

(1) Commission Implementing Decision 2013/652/EU on the monitoring and

reporting of antimicrobial resistance in zoonotic and commensal

bacteria32 is amended as follows.


31 Paragraph 13(3) of the Schedule to the retention regulations. 32 Paragraph 20(2) of the Schedule to the retention regulations, as amended by SD 2019/0122.


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SD No.2019/0212 c

(a) in the heading, after “Subject matter” insert «, definitions»;

(b) in paragraph 1, in the first subparagraph —

(i) omit “harmonised”; and

(ii) omit the words from “to be” to the end;

(c) in paragraph 2, omit “harmonised”; and

(d) after paragraph 2, insert —

«3. In this Decision, ‘appropriate authority’ means the

Department of Environment, Food and Agriculture.».


(a) in the heading, omit “by Member States”;

(b) in paragraphs 1 and 2, for “Member States shall”, substitute «The

appropriate authority must»; and

(c) in paragraph 3, for “Member States” substitute «The appropriate

authority».


(a) in the words before point (a), for “a Member State” substitute

«the Island»; and

(b) in point (a), omit “national”.


(a) for “Member States shall” substitute «The appropriate authority

must»; and

(b) for the words from “include” to the end, substitute «publish an

annual report on that assessment».


(7) The Annex is amended as follows.

(8) Part A is amended in accordance with paragraphs (9) to (18).

(9) In point 1 —


(i) in the words before point (a), for “Member States shall”

substitute «The appropriate authority must»;

(ii) in point (a) —

(A) in point (i), omit “national”;

(B) in point (iv), for “Member State” substitute

«Island»;


c SD No.2019/0212

(iii) in points (b) to (d), for “Member State”, in each place it

occurs, substitute «Island»;

(iv) in point (e), for “a Member State” substitute «the


(v) in point (f) —

(A) in the words before point (i), for “a Member State”


(B) in points (i) and (ii), for “Member State” substitute

«Island»;

(b) in the second paragraph, for “Member State” substitute


(10) In point 2.1, for “Member States shall” substitute «The appropriate

authority must».

(11) In point 2.2 —


(i) for “Member States shall”, substitute «The appropriate

authority must»;

(ii) for “in Member States with”, substitute «if there is»;

(iii) after “per year”, in the second place where it occurs, insert

«in the Island»;

(iv) for “they” substitute «its»;

(b) in the second and third paragraphs, for “In those Member States

where” substitute «If»;

(c) in the fourth paragraph —

(i) for “Member States shall”, in both places it occurs,

substitute «the appropriate authority must»;

(ii) for “in Member States with”, substitute «if there is»;

(iii) after “per year”, in the third place where it occurs, insert

«in the Island».

(12) In point 2.3, in the third paragraph, for “Member State” substitute

«Island».

(13) In point 2.3.2 —

(a) in the heading, omit “national”;

(b) in the second paragraph, for “Member State”, in both places it

occurs, substitute «Island».

(14) In point 2.3.3, for “Member States shall” substitute «The appropriate

authority must».


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SD No.2019/0212 c

(15) In point 3, in the first paragraph before Table 1, for “Member States

shall” substitute «The appropriate authority must».

(16) In point 4.1 —

(a) in the third paragraph, for “Member State” substitute


(b) in the fourth paragraph, for “Member States” substitute «The


(17) In point 4.3, in the first paragraph, for the words from the beginning to

“point 4.1,” substitute «The appropriate authority».

(18) In point 5, in the first paragraph —

(a) omit “harmonised” in both places it occurs;

(b) for “either at national or Union level” substitute «at national

level».

(19) In Part B, in point 2, omit the second paragraph.

4 Commission Implementing Decision (EU) 2018/320 amended

(1) Commission Implementing Decision (EU) 2018/320 of 28 February 2018

on certain animal health protection measures for intra-Union trade in

salamanders and the introduction into the Union of such animals in

relation to the fungus Batrachochytrium salamandrivorans33 is amended as

follows.

(2) In Article 1—

(a) omit “intra-Union”; and

(b) for “Union”, in the second place where it appears, substitute

«Isle of Man from third countries».

(3) In Article 2—

(a) in point (f)—

(i) omit “before being dispatched to another Member State

or”; and

(ii) for “Union”, substitute «Isle of Man from a third

country»;

(b) in point (h)—

(i) for “Union”, substitute «Isle of Man from a third

country»; and

(ii) omit the words from “and drawn up” to the end; and



c SD No.2019/0212

(c) after point (i), insert—

«(j) “the appropriate authority” means the Department of


(k) “third country” means any country other than the Isle of Man,

a member State or the British Islands.».

(4) In Article 3—

(a) in the heading, omit “intra-Union”;


(i) for the words before (a), substitute—

«1. The appropriate authority shall prohibit the import

into the Isle of Man of consignments of salamanders from

outside the United Kingdom except:»,

(ii) in point (a), for “set out in Part A of Annex I”, substitute

«as published by the appropriate authority from time to

time»,

(iii) in point (b), for “Member State of destination”, substitute

«Isle of Man»;

(c) in paragraph 2—

(i) for the words before point (a), substitute—

«2. Where consignments of salamanders from member

States which have originated from a third country have

already undergone quarantine in the appropriate

establishment of destination in accordance with Article 6,

the appropriate authority may only authorise the

acceptance of such consignments into the Isle of Man

where they comply with the following conditions:»;

(ii) in point (b)—

(A) for “Union”, substitute «Isle of Man»,

(B) for “set out in Part A of Annex I”, substitute «as

published by the appropriate authority from time to

time».

(5) In Article 4—

(a) in the heading, for “Union”, substitute «Isle of Man»;

(b) in the words before point (a)—

(i) for “Member States”, substitute «The appropriate

authority»;

(c) for “Union”, substitute «Isle of Man»;


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SD No.2019/0212 c

(d) in point (a)(i), for “Decision 2004/211/EC”, substitute

«Commission Implementing Regulation (EU) 2018/659»; and

(e) in point (b), for “set out in Part B of Annex I”, substitute «as

published by the appropriate authority from time to time»;

(f) in point (c), for “Union”, substitute “Isle of Man”.

(6) In Article 5, for the words before point (a), substitute—

«The appropriate authority shall ensure that border inspection posts

do not accept the entry into the Isle of Man of any consignments of

salamanders unless importers or their agents have provided a written

attestation in English (other languages may also appear), signed by the

person responsible for the appropriate establishment of destination,

stating:».

(7) In Article 6—

(a) in the heading, for “Union”, substitute «Isle of Man»;


(i) in the words before point (a), for “Member States”,


(ii) for “Union”, substitute «Isle of Man».

(8) In Article 7, in paragraph 1, in the words before point (a), for “Member

States”, substitute «The appropriate authority».


authority».

(10) In Article 9, for the words before point (a), substitute—

«At the latest by 30 June each year, starting from 2019, where the

appropriate authority has authorised the handling of consignments of

salamanders in the previous year at a border inspection post in the Isle

of Man, the competent authority at the border inspection post shall

notify the appropriate authority of the following information related to

the introduction of salamander consignments into the Isle of Man:».


(12) Omit Annex 1.


c SD No.2019/0212

PART 2

SALMONELLA REGULATIONS

5 Regulation (EC) No 2160/2003 amended

(1) Regulation (EC) No 2160/2003 of the European Parliament and of the

Council of 17 November 2003 on the control of salmonella and other

specified food-borne zoonotic agents34 is amended as follows.

(2) In Article 2, in paragraph 3, after point (b), insert —

«(c) ‘the Department’ means the Department of Environment, Food

and Agriculture;

(d)’competent authority’ means a person or body designated under

Article 3; and

(e) ‘third country’ means a country other than the Island, the United

Kingdom or a member State.».

(3) In Article 3, in paragraph 2(b), omit “national”.


(a) in the heading omit “National”;


(i) for the first sentence substitute —

«To achieve a target set in accordance with Article 4, the

Department must establish a control programme.»; and

(ii) in the second sentence, omit “National”;

(c) in paragraphs 2, 3 and 4, omit “National”; and

(d) in paragraph 5, omit “National”, in the first place it occurs.


(a) in paragraph 1, after “establish” insert «operator»;


(i) in the first sentence —

(A) after “their”, in both places it occurs, insert

«operator»; and

(B) omit “national”; and


(i) after “approve” insert «operator»;

34 Paragraph 19 of the Schedule to the retention regulations.


Regulations 2019

SD No.2019/0212 c

(ii) after “satisfied that the” insert «operator»; and

(iii) for “national control programme” substitute «control

programme established under Article 5»;

(d) in paragraph 4, in the first sentence, after “approved” insert

«operator»; and

(e) in paragraph 5, after “their” in the second place it occurs, insert

«operator».

(6) In Article 8, in paragraph 2, for “paragraph 1(a), (b) and (c) shall”

substitute «paragraphs 1(a) and 1A do».

(7) In Article 9, in paragraph 3, omit the words from “as if” to the end.


(a) in paragraph 4, in the second sentence, omit the words from “, or,

if necessary” to “Article 14(2)”;


«4A. The Department may by regulations specify additional

zoonoses or zoonotic agents which, for the purposes of paragraph

4, are to be treated as if they are listed in Annex 1, column 1.

4B. The Department may not make regulations under paragraph

4A unless satisfied it is necessary to do so in order to achieve the

objective of equivalent guarantees laid down in paragraph 1.»;

and


(9) In Article 11, in paragraph 3, in the first sentence, omit “national”.

(10) In Annex 2 —

(a) in part A —

(i) in the heading omit “national”; and

(ii) in point 1.10, omit “national”; and

(b) in part D —

(i) in point 1, omit “national”; and

(ii) in point 4, in the first paragraph, in point (b), in the words

before point (i), omit “national”.

(11) In Annex 3, in point 1, for “through EC” substitute «by the

Department’s».


c SD No.2019/0212

SCHEDULE 3

[Regulation 5(c)]

RETAINED DIRECT EU LEGISLATION CONCERNING ANIMAL BY-PRODUCTS

AND ANIMAL SLAUGHTER AMENDED

PART 1

CARCASE CLASSIFICATION REGULATIONS

Commission Delegated Regulation (EU) 2017/1182 amended

(12) Commission Delegated Regulation (EU) 2017/1182 of 20 April 2017


Parliament and of the Council as regards the Union scales for the

classification of beef, pig and sheep carcasses and as regards the

reporting of market prices of certain categories of carcasses and live

animals35 is amended as follows.

(13) In the heading of Chapter I omit “Union”.


«Article A1

Definitions

1. For the purposes of this Regulation, the following definitions shall

apply:

(a) ‘relevant authority’ means the Department of Environment, Food

and Agriculture;

(b) ‘appropriate authority’ means the Department of Environment, Food

and Agriculture.».

(15) In Article 1 for “each Member State” substitute «the Island».


(a) for “Member States may decide” substitute «Nothing in this

Regulation prevents the appropriate authorities from deciding»;

and

(b) for “Member States may determine” substitute «Nothing in this

Regulation prevents the appropriate authorities from

determining».

(17) In Article 2(2) for “Member States may decide” substitute «Nothing in

this Regulation prevents the appropriate authorities from deciding».



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SD No.2019/0212 c


(a) for “Member States” substitute «Nothing in this Regulation

prevents the appropriate authorities»; and

(b) for “may decide” substitute «from deciding».


(20) In Article 4 for “Member States may decide” substitute «Nothing in this

Regulation prevents the appropriate authorities from deciding».


(a) for “Member States may further subdivide” substitute «Nothing

in this Regulation prevents the appropriate authorities from

further subdividing»; and

(b) for “Member States may authorise” substitute «Nothing in this

Regulation prevents the appropriate authorities from

authorising».


(a) for “For” substitute «Nothing in this Regulation prevents the

appropriate authorities, for»

(b) for “Member States may allow” substitute «from allowing»;

(c) for “Member States”, in the second place it occurs, substitute

«The appropriate authorities»; and

(d) omit “national”.


(a) for “Commission” substitute «appropriate authority»; and

(b) for “Member State” substitute «constituent nation».


(a) in the words before point (a), omit “of the Member State

concerned”; and

(b) in point (b), for “Member State concerned” substitute


(25) In Article 8(6) for “Member States may lay” substitute «Nothing in this

Regulation prevents the appropriate authorities from laying».


(a) for “Member States may lay” substitute «Nothing in this

Regulation prevents the appropriate authorities from laying»;

and

(b) omit “national”.


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(a) for “Member States”, in both places it occurs, substitute «The

relevant authorities»; and

(b) for “Member State” substitute «appropriate authority».

(28) In Article 10(1) —


and

(b) for “their territory” substitute «the Island».


(30) In Article 10(4) —

(a) in the first sentence, for “Member States” substitute «The




«(6) The appropriate authority may authorise beef and sheep

automated grading methods without organising an authorisation test,

provided that the same grading methods were authorised before exit

day for application in a member State on the basis of an authorisation

test where the sample of carcasses is sufficiently representative for the

bovine or sheep population in the Island.».

(32) In Article 10(7) omit the second paragraph.

(33) Omit Article 11(3) and (4).

(34) In Article 11(5) omit “Commission”.


«(6) The appropriate authority may authorise a grading method

without an authorisation test, provided that the same grading method

was authorised before exit day for application in a member State on the

basis of an authorisation test where the sample of carcasses is

sufficiently representative of the pig population in the Island.».

(36) In Article 12(2)(b) omit “of the Member State concerned”.

(37) In Article 13 for “15” substitute «14».

(38) In Article 15(1) —

(a) for “average of the prices” substitute «price»; and

(b) omit the words from “, and weighted” to the end.



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(40) In Article 17(1) for the words from the beginning to “of the Member

State” substitute «The appropriate authority».

(41) In Article 17(2) —

(a) for “Member States” substitute «the appropriate authority»;

and

(b) for “a Member State” substitute «the appropriate authority».

(42) In the heading of Chapter 3 for “UNION” substitute «ISLAND».

(43) In the heading of Section 1 of Chapter 3 for “union” substitute

«Island».

(44) In the heading of Article 18 for “Union” substitute «Island».

(45) In Article 18(1) —

(a) in point (a) —

(i) for “Union”, in the first place it occurs, substitute

«Island»;

(ii) omit “weighted”;

(iii) omit “national”; and

(iv) omit the second sentence;

(b) in point (b) for “Union”, in each place it occurs, substitute

«Island»; and

(c) in point (c) for “Union”, in each place it occurs, substitute

«Island».

(46) In Article 18(2) for “Union”, in both places it occurs, substitute

«Island».


(a) for “Union”, in each place it occurs (including the heading),


(b) omit “weighted”;

(c) omit “national”; and

(d) omit the second sentence.



substitute «Island»; and

(b) omit the words from “That average” to the end.



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(b) omit the words from “That average” to the end.

(50) In the heading of Section 2 of Chapter 3 for “Union” substitute

«Island».




(b) omit paragraph 2.









(54) Omit Chapter 4.



(56) In Annex 4 —

(a) in paragraph 1 of Part A —

(i) for “Member State concerned”, in both places it occurs,


(ii) omit the second, third and fifth sentences;

(b) omit Part B; and

(c) omit Part C.

(57) In Annex 5 —

(a) in Part A —

(i) n point 1(c) for “Member State” substitute «appropriate

authority»; and

(ii) in point 1(f) for “Commission” substitute «appropriate

authority»; and

(b) omit Part B.


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6 Commission Implementing Regulation (EU) 2017/1184 amended

(1) Commission Implementing Regulation (EU) 2017/1184 laying down rules

for the application of Regulation (EU) No 1308/2013 of the European

Parliament and of the Council as regards the Union scales for the

classification of beef, pig and sheep carcasses and as regards the

reporting of market prices of certain categories of carcasses and live

animals36 is amended as follows.


«Article A1

Definitions

1. For the purposes of this Regulation ‘appropriate authority’ means the


(3) In Article 1(1)(c) —

(a) for “within the territory or a region of the Member State

concerned” substitute «the Island»; and

(b) for “national” substitute «Island’s».

(4) In Article 1(2) for “Member States may require” substitute «Nothing in

this Regulation prevents the appropriate authorities from requiring».

(5) In Article 2(2) omit “of a Member State”.

(6) In Article 3(1) omit “in a Member State”.


(a) in the words before point (a) omit “in a Member State”; and

(b) in point (c) for “Member States” substitute «The appropriate

authority».

(8) In Article 5(1) for “Member States” substitute «appropriate authority».

(9) In Article 5(2) for “territory of a Member State” substitute «Island».


(11) In Article 7 omit “Union”.

(12) In Article 8(1) for “Member State”, in both places it occurs, substitute



(a) for “Member State”, in the first place it occurs, substitute «The


(b) for “that Member State”, in both places it occurs, substitute «the


36 Paragraph 24(3) of the Schedule to the retention regulations, as amended by 2019/0122.


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(14) In Article 9 omit “Union”.

(15) In Article 10 for “Member State”, in both places it occurs, substitute






(18) In Article 13(1) —

(a) omit “in the Member State concerned”;

(b) for “a Member State” substitute «the appropriate authority»;

and

(c) for “that Member State” substitute «the appropriate authority».


«The appropriate authority may decide not to take the prices for flat-

rate purchases of carcasses of bovine animals aged eight months or

more into account in the calculations of prices. In such cases a

representative price for each class shall be calculated by the appropriate

authority, taking into account the factors referred to in Article 14 of

Delegated Regulation (EU) 2017/1182 and in Article 5 of this

Regulation.».








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SD No.2019/0212 c

SCHEDULE 4

[Regulation 5(d)]

RETAINED DIRECT EU LEGISLATION CONCERNING ANIMAL MOVEMENTS

AND ANIMAL WELFARE AMENDED

PART 1

TRADE AND IMPORTATION OF ANIMALS, ANIMAL EMBRYOS, ANIMAL

SEMEN AND ANIMAL OVA

Commission Regulation (EC) No 599/2004 amended

(24) Commission Regulation (EC) No 599/2004 concerning the adoption of a

harmonised model certificate and inspection report linked to intra-

Community trade in animals and products of animal origin37 is amended

as follows.


(a) for the first unnumbered paragraph substitute —

«1. Health certificates required to be used for imports from the

European Union, with the exception of health certificates for

registered equidae, must be presented on the basis of the standard

model certificates published by the appropriate authority from

time to time.

2. In paragraph 1 “the appropriate authority” means the

Department of Environment, Food and Agriculture.»;

(b) in the second unnumbered paragraph, for “These model

certificates” substitute —

«3. Health certificates must».

(26) Omit Article 2 and the Annex.

37 Paragraph 28(21) of the Schedule to the retention regulations, as amended by SD 2019/0122.


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PART 2

VETERINARY MEDICINAL PRODUCTS

7 Commission Implementing Decision 2011/630/EU amended

(1) Commission Implementing Decision of 20 September 2011 on imports

into the Union of semen of domestic animals of the bovine species

(2011/630/EU)38 is amended as follows.

(2) In Annex 1 —

(a) in the title of the Table, for “Member States are to authorise

imports of semen of domestic animals of the bovine species”

substitute «imports of semen of domestic animals of the bovine

species are to be authorised under Article 2»;

(b) in footnote 1, for “is set out in” substitute «shall be based, subject

to any changes that may be appropriate, on»;

(c) in footnote 2 —

(i) for “are set out in” substitute «shall be based, subject to

any changes that may be appropriate, on»; and

(ii) for “with”, in the first place that it occurs, substitute «as

modified by»; and

(d) in footnote 3, for the words from “a Member State “ to “Directive

64/432/EEC” substitute «the Island as being an ‘officially

tuberculosis-free bovine herd’ as described in paragraphs 1(a) to

(c) of Annex A to Council Directive 64/432/EEC».



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SCHEDULE 5

[Regulation 5(e)]

RETAINED DIRECT EU LEGISLATION CONCERNING AQUACULTURE

AMENDED

Council Regulation (EC) No 708/2007 amended

(1) Council Regulation (EC) No 708/2007 of 11 June 2007 concerning use of

alien and locally absent species in aquaculture39 is amended as follows.



(b) in paragraph 2, for “Member States” substitute «the Island»;

(c) in paragraph 3, for “jurisdiction of Member States” substitute

«the Island»;

(d) omit paragraph 4, for the words from “Article 6” to the end

substitute «Article 4 of Regulation 1251/200840»;


(i) for “Member States wish” substitute «the appropriate

authority wishes»; and

(ii) for “their territory” substitute «the Island»;

(f) in paragraph 6, for “Member States wish” substitute «the

appropriate authority wishes»; and

(g) in paragraph 7, in the second subparagraph —


authority»;

(ii) for “their territory” substitute «the Island»; and

(iii) omit the last sentence.



«1. “aquaculture” means the rearing or cultivation of aquatic

organisms using techniques designed to increase the production

of the organisms in question beyond the natural capacity of the

environment, where the organisms remain the property of a

natural or legal person throughout the rearing and culture stage,

up to and including harvesting;»;

39 Paragraph 30(1) of the Schedule to the retention regulation. 40 OJ L 337, 16.12.2008, p. 41.


c SD No.2019/0212

(b) in paragraph 8, before “Directive 2006/88/EC”, insert «retained

EU law»; and


«18. “the appropriate authority” means the Department.»;

and


(4) In the heading to Chapter 2, omit “of the Member States”.


(a) in paragraph 1, for “Member States” substitute «The appropriate

authority»; and

(b) in paragraph 2, for “authorities in the Member States” substitute

«authority».



and

(b) for “a Member State” substitute «the appropriate authority».

(7) In Article 6, omit “of the receiving Member State”.

(8) In Article 10, in paragraph 2, for “Member States which are signatories to

ICES” substitute «If the Isle of Man is a signatory to ICES, it».




(b) in point (a), before “Directive”, insert «retained EU law which

transposed»; and

(c) in point (b), before “Council Directive”, insert «retained EU law

which transposed».


(a) in paragraph 2, for “territory of the Union” substitute «Island»;


(c) in paragraph 4, omit «of the receiving Member State».


(a) in the heading, omit “Union”; and

(b) in paragraphs (a) and (b), before “Directive”, in each place where

it appears, insert «retained EU law which transposed».


(a) for “receiving Member State” substitute «competent authority»;


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SD No.2019/0212 c

(b) omit “and subject to approval by the Commission”; and

(c) omit from “The request” to the end.


(a) For the title “Register” substitute “Records”;

(b) in the first paragraph, for “Member States shall keep a register”

substitute «The appropriate authority shall keep records»; and




«1. The appropriate authority may, by regulations —

(a) amend Annex 1, 2 or 3 in order to adapt them to technical and

scientific progress; and

(b) amend Annex 4 so as to add a species.»;



(i) for the words from “In order” to “have” substitute

«Regulations under paragraph 1(b) may only be made

where the appropriate authority is satisfied that the aquatic

organism has»; and

(ii) for “certain parts of the Union” substitute «the Island»;


«3A. In paragraph 3, “long time (with reference to its life cycle)”

and “adverse effect” have the meanings given in Article 2 of

Commission Regulation (EC) No 535/2008.»; and

(e) omit paragraphs 4 to 6.

(3) Omit Articles 24a to 24c.


«Article 24d

Regulations


contain —

(a) consequential, incidental, supplementary, transitional or saving

provisions;

(b) provisions amending, repealing or revoking statutory documents

and retained direct EU legislation; or



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States”.

(18) In Annex 3 —

(a) omit “in the Member State of its location”;

(b) for “of the receiving Member State” substitute «in the Island»;

(c) for “Member State” substitute «Island»; and

(d) in the second paragraph under the heading “Mortalities and

disposal”, for “and Member States” substitute «which».


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SCHEDULE 6

[Regulation 5(f)]

RETAINED DIRECT EU LEGISLATION CONCERNING DAIRY PRODUCTS

AMENDED

Commission Regulation (EU) No 605/2010 amended

(5) Commission Regulation (EU) No 605/2010 laying down animal and

public health and veterinary certification conditions for the introduction

into the European Union of raw milk, dairy products, colostrum and

colostrum-based products intended for human consumption, is amended

as follows.


(a) number the text as paragraph 1;


(i) in the first subparagraph, in points (a) and (b), for

“European Union”, substitute «Island» in each place;

and

(ii) in the second subparagraph, for “Union acts or in

agreements concluded by the Union with third countries”,

substitute «Isle of Man agreements with a third

country»; and

(c) after paragraph 1, insert —

«2. In this Regulation:

“the appropriate authority” means the Department of


“third country” means any country other than a member State or

the British Islands.».


authority».

(8) In Article 3, in the words before point (a), for “Member States”,

substitute «The appropriate authority».


(a) in paragraph 1, in the words before point (a), for “Member

States”, substitute «The appropriate authority»; and

(b) in paragraph 2, in the words before point (a), for “Member

States”, substitute «The appropriate authority».



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(a) for the first subparagraph, substitute —

«Consignments authorised for importation in accordance with

Articles 2, 3 and 4 must be accompanied by a health certificate as

published by the appropriate authority from time to time for the

commodity concerned and completed in accordance with any

accompanying explanatory notes.»;

(b) omit “agreed” and “harmonised at European Union level”.


(a) in the words before point (a) —

(i) for “European Union”, substitute «Isle of Man» in each

place; and

(ii) for “the Union”, substitute «Isle of Man»;


(i) for “European Union”, substitute «Isle of Man»; and

(ii) for “point II.1 of the relevant model health certificate set

out in Part 2 of Annex II”, substitute «in the health

certificate as published by the appropriate authority from

time to time»;

(c) in point (c), for the words “drawn up” to the end, substitute

«completed in accordance with any accompanying explanatory

notes»; and

(d) in point (d), for “Union”, substitute «Isle of Man».

(12) Omit Articles 7 and 7a.


(a) for “European Union” in each place, substitute «Isle of Man»;

and

(b) for “Articles 2, 3, 4, 6 or 7”, substitute «Articles 2, 3, 4 and 6».

(14) Omit Article 10 and the final paragraph of Article 11.

(15) In Annex 1, in the heading to the table and in footnote 1 to the table, for

“European Union” in each place, substitute «Isle of Man».

(16) Omit Annex 2.


Regulations 2019

SD No.2019/0212 c

SCHEDULE 7

[Regulation 5(g)]

RETAINED DIRECT EU LEGISLATION CONCERNING FISHERIES AMENDED


(1) Commission Delegated Regulation (EU) 2018/2034 establishing a discard

plan for certain demersal fisheries in North-Western waters for the

period 2019-202141 is amended as follows.

(2) In Article 1 for “Union” substitute «Isle of Man».



«“2. If the fisheries administration has a direct management

interest in relation to the exemption provided for in paragraph 1 it

must annually assess the appropriateness of the exemption on the

basis of the best available scientific information.»; and

(b) in paragraph 3 for the words from “Member States” to the end,

substitute —

«If the fisheries administration has a direct management interest

in relation to this aspect of the exemption it must, as soon as

possible after exit day, assess its appropriateness on the basis of

the best available scientific information.».

(4) In Article 6(2), for the second and third sentences, substitute —

«If the fisheries administration has a direct management interest in

relation to these exemptions it must, as soon as possible after exit day,

assess their appropriateness on the basis of the best available scientific

information.».

(5) In Article 7 for “Union” substitute “Isle of Man”.

(6) In Article 8(2) for the second and third sentences, substitute —

«If the fisheries administration that has a direct management interest in

relation to these exemptions it must, as soon as possible after exit day,

assess their appropriateness on the basis of the best available scientific

information.».

(7) In Article 9(5) for “the STECF” substitute «the fisheries

administration».

(8) In Article 10(5) for “the STECF” substitute «a fisheries administration».




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«Article 11

Application

This Regulation applies until 31 December 2021.».

9 Council Regulation (EU) 2018/2025 amended

(1) Council Regulation (EU) 2018/2025 fixing for 2019 and 2020 the fishing

opportunities for Union fishing vessels for certain deep-sea fish stocks42

is amended as follows.

(2) Omit Article 1.



(i) omit point (a);

(ii) for point (b) substitute —

«(b) ‘catch quota’ means the maximum quantity of sea

fish that may be caught by Isle of Man fishing vessels as

determined by the United Kingdom Secretary of State;»;

(iii) in point (c) for “State” substitute «state or country»; and

(iv) omit point (d); and

(b) in paragraph 2 omit point (b).



«Article 6

Conditions for landing catches and bycatches

Where an Isle of Man fishing vessel makes a catch that is —

(a) not subject to the landing obligation established under Article 15 of

Regulation (EU) No 1380/2013; and

(b) subject to catch quota,

that catch may only be retained on board or landed if the fishing vessel

has been allocated a proportion of the relevant catch quota and that

allocation has not been exhausted.».


(a) in paragraph 1 for “Union” in both places it occurs, substitute

«Isle of Man»; and




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(i) for “Union” in each place it occurs, substitute «Isle of

Man»; and

(ii) omit the words from “, with the exception of cases” to the

end.


(8) In the Annex —

(a) in Part 1, omit paragraph 1 and the table immediately following it;

and

(b) omit Part 2.

10 Council Regulation (EU) 2019/124 amended

(1) Council Regulation (EU) 2019/124 fixing for 2019 the fishing

opportunities for certain fish stocks and groups of fish stocks, applicable

in Union waters and, for Union fishing vessels, in certain non-Union

waters43 is amended as follows.

(2) Omit Article 1.


(a) in point (a) for “Union” substitute «Isle of Man»; and

(b) in point (b) for “Union” substitute «Isle of Man».


(a) in point (c) for “State” substitute «any country or state»;

(b) for point (e) substitute —

«(e) ‘catch quota’ means the maximum quantity of sea fish that

may be caught by Isle of Man fishing vessels as determined by the

United Kingdom Secretary of State;»; and

(c) omit points (f) and (h).


(a) omit points (b) to (l); and

(b) omit points (p) to (u).

(6) In the heading to Title 2 for “Union” substitute «Isle of Man».


(8) In Article 7 for paragraph 1 substitute —

«1. Where an Isle of Man fishing vessel makes a catch that is —



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(a) not subject to the landing obligation established under Article 15 of

Regulation (EU) No 1380/2013; and

(b) subject to catch quota,

that catch may only be retained on board or landed if the fishing vessel

has been allocated a proportion of the relevant catch quota and that

allocation has not been exhausted.».



(a) in paragraph 1 for “Union” substitute «Isle of Man»;


(i) in the wording before point (a) for “Union” substitute


(ii) in the final subparagraph —

(A) for “Union” in the first two places it occurs,

substitute «Isle of Man»;

(B) for “Member States may” substitute “the fisheries

administration must”;

(C) omit “Union” in the final place it occurs;

(D) after “fishing vessels” in the final place it occurs,

insert «in its fleet»;

(E) for “their” substitute «its»; and

(F) for “do” substitute «does»;


(i) for “Union” substitute «Isle of Man»; and

(ii) omit the final sentence; and




(13) In Article 13(2) for “Union” substitute «United Kingdom».

(14) In Article 14(1) —

(a) in the words before point (a), for “Union” substitute «Isle of

Man»;

(b) in points (a), (c), (d), (f), (g), (i), (o) and (q) for “Union” substitute

«United Kingdom»;


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(c) in points (h), (j), (k), (p), (t), (u) and (v) for “Union” substitute


(d) in point (w) for “Union” substitute «United Kingdom and Isle of

Man».


(16) Omit Chapter 2 of Title 2.

(17) Omit Section 1 of Chapter 3 of Title 2.

(18) In Article 18(7) for “Union” substitute «Isle of Man».


(a) for paragraphs 1 and 2 substitute —

«1. No Isle of Man fishing vessels may fish for tropical tunas in

the IOTC Area of Competence.

2. The maximum number of Isle of Man fishing vessels fishing for

swordfish (Xiphias gladius) and albacore (Thunnas alalunga) in

the IOTC Area of Competence and the corresponding capacity in

gross tonnage are as determined by the United Kingdom

Secretary of State.»;



(i) for “Member States shall” substitute «The fisheries

administration must»; and

(ii) for “their” substitute «its»; and


(i) for “Member States” substitute «The fisheries

administration with agreement of the United Kingdom

Secretary of State»; and

(ii) for “their” substitute «its».



(i) omit “, all flying the flag of the same Member State”, and

(ii) for “Member States” substitute «the fisheries

administration»;


(c) in paragraph 4 for “the Union shall” substitute «the fisheries

administration must».

(21) In Article 26(2) —


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(a) for “Member State whose flag they fly” substitute «Isle of

Man»; and

(b) for “local” substitute «Isle of Man».

(22) Omit Sections 5 to 11 of Title 2.

(23) Omit Titles 3 and 4.

(24) In the List of Annexes —

(a) for the description of Annex 1 substitute «Non-target species»;

(b) omit the entries for Annexes 1A to 1C;

(c) omit the entries for Annexes 1F to 1J;

(d) omit the entries for Annexes 1L – 3; and

(e) omit the entries for Annexes 6, 7 and 8.

(25) In Annex 1 —


«NON-TARGET SPECIES»;

(b) for the first paragraph substitute —

«The table identifies the stocks of non-target species within safe

biological limits referred to in Article 15(8) of Regulation (EU)

1380/2013 for the purposes of the derogation from the obligation

to count catches against the relevant quotas provided for in that

Article.»; and


(26) Omit Annexes 1A to 1C.

(27) Omit Annexes 1F to 1J.

(28) Omit Annexes 1L to 3.

(29) Omit Annexes 6, 7 and 8.


Regulations 2019

SD No.2019/0212 c

SCHEDULE 8

[Regulation 5(h)]

RETAINED DIRECT EU LEGISLATION CONCERNING FOOD LABELLING

AMENDED

PART 1

BEEF AND VEAL LABELLING


(1) Commission Regulation (EC) No 1825/2000 of 25 August 2000 laying

down detailed rules for the application of Regulation (EC) No 1760/2000

of the European Parliament and of the Council as regards the labelling of

beef and beef products44 is amended as follows.


(a) in the first paragraph, for “the third indent of Article 12”

substitute «Article 12(3)»; and

(b) in the second paragraph, for “Articles 13(1) and 16(2)” substitute

«Article 13(1)».

(3) In Article 1a, at the end insert —

«(i) third country’ means any country or territory other than:

(i) the United Kingdom;

(ii) the Bailiwick of Jersey;

(iii) the Bailiwick of Guernsey;

(iv) the Isle of Man.».


(a) in point (a) for “Article 10(1) of Council Directive 64/433/EEC”

substitute «Article 3(3) of Regulation (EC) No 854/2004»; and



(a) omit point (a); and


(i) for “Community” substitute «Island from a third

country»; and



c SD No.2019/0212

(ii) for “EC” substitute «IM».


«3. By way of derogation from paragraph 2(b), meat:

(a) derived from animals that are, before exit day, imported live into the

United Kingdom or the Island from a third country, and

(b) labelled in accordance with paragraph 2(b), as it had effect

immediately before exit day,

may be placed on the market until 31 December 2020, and may remain

on the market until stocks are exhausted.

4. Meat:

(a) derived from animals imported live into the EU (provided that such

animals are not subsequently imported live into the United Kingdom or

the Island on or after exit day), and

(b) labelled in accordance with paragraph 2(b), as it had effect

immediately before exit day,

may be placed on the market until 31 December 2020, and may remain

on the market until stocks are exhausted.».


(a) omit “Member State or third”, in each place it occurs; and

(b) omit “Member States or third”.


(a) in point (a) omit “as from 1 September 2000,”;

(b) omit point (b);and

(c) in point (c) omit “as from 1 January 2002,”.

(9) In Article 5a omit “Member State or third”, in each place it occurs.

(10) In Article 5b omit “Member State or third”, in both places it occurs.



(a) omit “the experts of the Commission,”; and

(b) omit the words from “and the relevant” to “Regulation (EC) No

1760/2000,”.


(a) omit the words from “and, in the case” to “control body”; and

(b) omit the words from “which” to “concerned”.



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(15) In Article 7(4) for “, organisations and independent control bodies”

substitute «and organisations».







(1) Commission Regulation (EC) No 566/2008 of 18 June 2008 laying down

detailed rules for the application of Council Regulation (EC) No

1234/2007 as regards the marketing of the meat of bovine animals aged

12 months or less45 is amended as follows.

(2) In Article 1 for “Article 113b of Regulation (EC) No 1234/2007” substitute

«Article 78(1)(a) of, and Part I of Annex VII to, Regulation (EU) No

1308/2013».

(3) For Article 2, substitute —

«Article 2

Definitions

1. For the purposes of this Regulation, the following definitions shall

apply:

(a) ‘competent authority’ means any authority appointed by the

appropriate authority competent for the organisation of official checks

referred to in point VI of Part I of Annex VII to Regulation (EU) No

1308/2013; it shall also include, where appropriate, the corresponding

authority of a third country;

(b) ‘relevant authority’ means the Department of Environment, Food

and Agriculture;

(c) ‘third country’ means any country or territory other than:

(i) the United Kingdom;

(ii) the Bailiwick of Jersey;

(iii) the Bailiwick of Guernsey;

(iv) the Isle of Man.».


«Article 2a



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Definition of appropriate authority

1. For the purposes of this Regulation, ‘appropriate authority’ means the


(5) In Article 3 for “point II of Annex XIa to Regulation (EC) No 1234/2007”

substitute «point II of Part I of Annex VII to Regulation (EU) No

1308/2013».

(6) In Article 4(1)— —

(a) for “point IV of Annex XIa to Regulation (EC) No 1234/2007”

substitute “point IV of Part I of Annex VII of Regulation (EU) No

1308/2013”;

(b) for “point II of Annex XIa to that Regulation” substitute «point II

of Part I of Annex VII to that Regulation»; and

(c) for the fifth subparagraph substitute —

«However, nothing in this Regulation prevents the appropriate

authority from determining other positions on each quarter.».

(7) In Article 4(2) for “point IV of Annex XIa to Regulation (EC) No

1234/2007” substitute «point IV of Part I of Annex VII of Regulation

(EU) No 1308/2013».



(a) for “point VI of Annex XIa to Regulation (EC) No 1234/2007”

substitute «point V of Part I of Annex VII of Regulation (EU) No

1308/2013»; and

(b) for “point I of Annex XIa to that Regulation” substitute “point I of

Part I of Annex VII to that Regulation”.


(a) for “point VII of Annex XIa to Regulation (EC) No 1234/2007”

substitute “point VI of Part I of Annex VII of Regulation (EU) No

1308/2013”; and

(b) for “point II of Annex XIa to that Regulation” substitute «point II

of Part I of Annex VII to that Regulation».

(11) In Article 6(2) for the words from “European Standard EN 45011” to the

end substitute «ISO/IEC 17065 (Requirements for bodies certifying

products, processes and services)».


(a) for “Commission”, in the first place it occurs, substitute «the

relevant authority»; and



Regulations 2019

SD No.2019/0212 c


(a) for “Regulation (EC) No 1234/2007” substitute «Regulation (EU)

No 1308/2013»; and

(b) omit “the experts of the Commission,”.

(14) Article 7 is amended in accordance with subparagraphs (15) to (19).

(15) In paragraph 1 —

(a) for “point VIII of Annex XIa to Regulation (EC) No 1234/2007”

substitute «paragraph 5 of point VI of Part I of Annex VII to

Regulation (EU) No 1308/2013»; and

(b) for “point VIII of Annex XIa to that Regulation”, in both places it

occurs, substitute «point VI of Part I of Annex VII to that

Regulation».


(a) for “point VIII of Annex XIa to Regulation (EC) No 1234/2007”

substitute «paragraph 5 of point VI of Part I of Annex VII to


(b) for the words from “European Standard EN 45011” to the end

substitute «ISO/IEC 17065 (Requirements for bodies certifying

products, processes and services)».


(a) for “Commission”, in both places it occurs, substitute


(b) for “Community”, substitute «Island»;

(c) at the end of the second subparagraph insert —

«Notifications made before exit day to the Commission of the

European Union under this paragraph, as it had effect

immediately before exit day, are deemed to have been made to

the Department of Environment, Food and Agriculture.»;

(d) omit the third subparagraph; and

(e) at the end insert —

«By way of derogation from the second subparagraph, in

relation to a member State, the notification referred to in the first

subparagraph shall be made on or before 30 June 2019 or before

the first consignment of meat of each individual operator is

imported into the Island after exit day (whichever is later) and

thereafter within one month after any changes in the information

to be notified.».



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(i) for the words from “Upon request” to “initiative, the

Commission” substitute «The appropriate authority»;

and

(ii) for “Regulation (EC) No 1234/2007” substitute


(b) in the second subparagraph, for “Commission”, in both places it

occurs, substitute «appropriate authority»;


(a) for “Regulation (EC) No 1234/2007”, in the first and third places it

occurs, substitute «Regulation (EU) No 1308/2013»;

(b) for “Commission”, substitute «appropriate authority»; and

(c) omit “, in accordance with the procedure referred to in Article

195(2) of Regulation (EC) No 1234/2007,”.

(20) For the heading of Article 8 substitute «Follow-up measures».




«3. Where an appropriate authority has evidence that meat referred to

in point I of Part I of Annex VII to Regulation (EU) No 1308/2013 and

imported from a third country as referred to in paragraph 5 of point VI

of Part I of Annex VII to that Regulation does not comply with

requirements laid down in either Regulation (EU) No 1308/2013 or this

Regulation, the appropriate authority shall take whatever measures and

action are required to solve the non-compliance.

In particular, the appropriate authority shall require the removal of the

meat concerned from the market until it is re-labelled in conformity

with Regulation (EU) No 1308/2013 and this Regulation.».





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PART 2

FOOD INFORMATION REGULATIONS



Council of 25 October 2011 on the provision of food information to

consumers, amending Regulations (EC) No 1924/2006 and (EC) No

1925/2006 of the European Parliament and of the Council, and repealing

Commission Directive 87/250/EEC, Council Directive 90/496/EEC,

Commission Directive 1999/10/EC, Directive 2000/13/EC of the European

Parliament and of the Council, Commission Directives 2002/67/EC and

2008/5/EC and Commission Regulation (EC) No 608/200446 is amended as

follows.


(a) in paragraph 1 omit the words from “whilst” to the end;

(b) in paragraph 3, in the second subparagraph, for the words from

“on the territories” to the end substitute «from the Island»; and

(c) in paragraph 4, for “Union provisions” substitute «provisions in

retained EU law and retained direct EU legislation».


(a) in point (b), for “the Union provisions” substitute «retained EU

law or retained direct EU legislation»;

(b) in point (c), for “Union provisions” substitute «retained EU law

or retained direct EU legislation»;

(c) for point (n) substitute —

«(n) ‘legal name’, in relation to a food, means the name

prescribed for it in retained EU law or retained direct EU

legislation or, in the absence of such legislation, any other

enactment;»;

(d) in point (o), for “Member State in which that food is sold”

substitute «British Islands»; and

(e) after point (u) insert —

«(v) ‘the appropriate authority’ means the Department of Environment,

Food and Agriculture;

(w) ‘enactment’ includes enactments of the type specified in section 16 of

the Interpretation Act 2015 but not retained direct EU legislation.».



c SD No.2019/0212


(a) in paragraph 2, for the words from the beginning to “taking”

substitute «Regulations must take»;

(b) in paragraph 3, for “food information law establishes” substitute

«regulations establish»; and

(c) in paragraph 4, after “consultation” insert «(so far as not already

required by Article 9 of Regulation (EC) No 178/2002)».

(5) Omit Article 5.

(6) In Article 7(3), for “Union law” substitute «retained EU law or retained

direct EU legislation».



(i) in the first subparagraph, for the words from “the

Commission” to “referred to in” substitute «regulations

are made under»; and


(A) for “, the Commission, taking into account”

substitute «and»; and

(B) for the words from “, may establish” to “Article 51,”

substitute «is taken into account, regulations may

be made to establish»; and


(i) for “the Commission may adopt implementing acts”

substitute «regulations may be made»; and


(8) In Article 8, in each of paragraphs 2, 3 and 5, for “relevant national

provisions” substitute «any other relevant enactment».


(a) in the first subparagraph, for the words from “the Commission”

to the end substitute «regulations may amend Annex 3.»; and




(i) for “, the Commission, taking into account” substitute

«and»; and


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SD No.2019/0212 c

(ii) for the words from “, may establish” to “Article 51,”

substitute «is taken into account, regulations may

establish»; and


(i) for “the Commission may adopt implementing acts”



(11) In Article 11, for “Union provisions” substitute «provisions in retained

EU law or retained direct EU legislation».


(a) in paragraph 1, for “the national measures adopted under Article

44(2)” substitute «enactments referred to in Article 44(2) relating

to the presentation of mandatory particulars for food to which

that Article applies»;

(b) in paragraph 2, for “Union provisions” substitute «provisions in

retained EU law or retained direct EU legislation»; and


(i) in the first subparagraph, for the words from “the

Commission” to “Article 51,” substitute «regulations may

be made to»; and

(ii) in the second subparagraph, for the words from “the

Commission” to “Article 51,” substitute «regulations may

be made to».


(a) in paragraph 1, for the words from “a language” to the end

substitute «English»;


(c) in paragraph 3, for “Paragraphs 1 and 2” substitute “«Paragraph

1».


(a) in paragraph 3, for “Union provisions” substitute «provisions in

retained EU law or retained direct EU legislation»; and


(i) in the first subparagraph, for “Union provisions”

substitute «provisions in retained EU law or retained

direct EU legislation»; and

(ii) omit the second and third subparagraphs.

(15) Omit Article 17(2) and (3).


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(16) In Article 21(1), for “the rules adopted under Article 44(2)” substitute

«enactments referred to in Article 44(2) relating to the presentation of

mandatory particulars for food to which Article 44 applies».

(17) In Article 19(2), for the words from “the Commission” to “Article 51,”

substitute «regulations may be made, in exceptional cases, to».

(18) In Article 21(2) —

(a) in the first subparagraph, for the words from “Commission” to

the end substitute «appropriate authority must systematically re-

examine the list in Annex 2. Where considered necessary by the

appropriate authority, that list must be updated by regulations»;

and


(19) In Article 23(2) —

(a) for “the Commission may” substitute «regulations may be made

to»; and

(b) omit the words from “, by means” to “Article 51,”.

(20) In Article 24(3) —

(a) for “the Commission may adopt implementing acts” substitute

«regulations may be made»; and



(a) in paragraph 1, for the words from “Union provisions” to the end

substitute «provisions in retained EU law or retained direct EU

legislation, in particular Regulation (EU) No 1151/2012 of the

European Parliament and of the Council on quality schemes for

agricultural products and foodstuffs»;

(b) in paragraph 2(b), for the words from “shall be” to the end

substitute «is subject to Commission Implementing Regulation

(EU) No 1337/2013 laying down rules for the application of

Regulation (EU) No 1169/2011 of the European Parliament and of

the Council as regards the indication of the country of origin or

place of provenance for fresh, chilled and frozen meat of swine,

sheep, goats and poultry and any regulations made under

paragraph 8»;

(c) in paragraph 3, for the second subparagraph substitute —

«The application of the first subparagraph is subject to any

regulations made under paragraph 8 concerning the application

of that subparagraph.»;

(d) omit paragraphs 4 to 7;


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SD No.2019/0212 c


«8. Regulations may be made:

(a) concerning the application of paragraphs 2(b) and 3;

(b) to revoke Regulation (EU) No 1337/2013.» and


(22) In Article 27(2) —

(a) for “The Commission may adopt implementing acts” substitute

«Regulations may be made»; and


(23) In Article 28(1), for “Union provisions” substitute «provisions in

retained EU law or retained direct EU legislation».


(a) in paragraph 1, for points (a) and (b) substitute —

«(a) the Food Supplements Regulations 200847;

(b) the Natural Mineral Water, Spring Water and Bottled Drinking

Water Regulations 200948.»; and



(a) in paragraph 6, for the words from “the Commission” to “Article

51,” substitute «regulations may»; and




(i) for the words from the beginning to “conversion factors”

substitute «Regulations may amend Annex 14 to require

specified conversion factors to be used»; and


(b) in paragraph 4, in the second subparagraph —

(i) for “The Commission may adopt implementing acts

setting” substitute «Regulations may set»; and


(27) In Article 33(5), for the words from “the Commission” to the end

substitute «regulations may regulate the way in which per portion and

47 SD 898/08 48 SD 405/09


c SD No.2019/0212

per consumption unit indications are to be expressed for specific

categories of food. The actual consumption behaviour of consumers as

well as dietary recommendations must be taken into account when

making such regulations».


(a) in paragraph 5, in the second subparagraph —

(i) for “the Commission may adopt implementing acts

regarding” substitute «regulations may be made relating

to»; and



(i) for “the Commission may adopt implementing acts

setting” substitute «regulations may set»; and




(i) in the first sentence, for “Member States” substitute «The


(ii) omit the second sentence;


(i) in the first subparagraph, for “Member States shall ensure

an appropriate monitoring” substitute «The appropriate

authority may monitor the use»; and


(A) at the beginning insert «Nothing in this Regulation

prevents the appropriate authority from making

regulations, so as»;

(B) for “Member States may require” substitute

«requiring»;

(C) omit “in their territory”; and

(D) after “competent authority” insert «specified in

those regulations»;

(c) omit paragraphs 4 and 5; and


(i) for “the Commission shall adopt implementing acts”




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SD No.2019/0212 c



(i) in the first subparagraph, in the words before point (a), for

“The Commission shall adopt implementing acts”

substitute «Regulations may be made»; and

(ii) omit the second subparagraph; and

(b) in paragraph 4, for the words from “the Commission” to “Article

51,” substitute «regulations may».


«Article 38

Subordinate legislation

Any provision in this Regulation that relates to any specific matter has

the effect on and after exit day of preventing the making of any

enactment in subordinate legislation (within the meaning of the

Interpretation Act 2015) relating to the same matter unless the making of

such an enactment is authorised by this Regulation or by other retained

direct EU legislation.».


(a) in paragraph 1, in the words before point (a), for the words from

“Member States” to “measures” substitute «nothing in this

Regulation prevents the appropriate authority from making

regulations»; and


(i) for “paragraph 1, Member States” substitute «regulations

referred to in paragraph 1, the appropriate authority»;

and

(ii) for the second sentence substitute—

«It is a condition of making such regulations that the

appropriate authority considers that the majority of

consumers in the territory to which the measures would

apply attach significant value to the provision of that

information.».


(a) renumber the unnumbered paragraph as paragraph 1;

(b) in paragraph 1, as renumbered, for the words from the beginning

to “Article 10(1)” substitute «Nothing in this Regulation prevents

the appropriate authority from making regulations derogating

from any of the provisions specified in paragraph 2»; and


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(c) for the second unnumbered paragraph substitute —

«2. The specified provisions are:

(a) Article 9(1), except for Article 9(1)(e), and

(b) Article 10(1).

3. Nothing in this Regulation prevents the appropriate authority

from making regulations derogating from Article 9(1)(e) in the

case of milk and milk products presented in glass bottles intended

for reuse.».




(i) for “Union provisions referred to in” substitute «any

regulations made under»; and

(ii) for the words from “Member States” to the end substitute

«the measures in the legislation specified in the second

paragraph concerning the expression of net quantity for

specified foods in a different manner to that provided for

in Article 23(1) may be maintained»;

(b) after the first paragraph insert —

«The specified legislation is the Weights and Measures (Foods)

Order 200549.»; and

(c) omit the last paragraph.


(a) in the first paragraph, for the words from “adoption” to

“measures” substitute «making of regulations under Article

36(3)(c), nothing in this Regulation prevents the appropriate

authority from making regulations»; and

(b) omit the second paragraph.


(a) in paragraph 1, for point (b) substitute —

«(b) the provision of the particulars specified in Articles 9(1)(e) is

not mandatory but nothing in this Regulation prevents

regulations from being made to make the provision of those

particulars mandatory;

(c) the provision of the other particulars specified in Articles 9(1)

and 10 is not mandatory but nothing in this Regulation prevents

49 SD 98/2005


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SD No.2019/0212 c

regulations from being made to make the provision of those

particulars, or some of those particulars, mandatory.»;

(b) in paragraph 2, for “Member States may adopt national

measures” substitute «Nothing in this Regulation prevents the

appropriate authority from making regulations»; and



(39) In Article 46, for the words from “the Commission” to “Article 51,”

substitute «regulations may».



«Article 51

Regulations

1. The power to make regulations is exercisable by the appropriate

authority.

2. Regulations made by the appropriate authority under these

Regulations may contain —


saving provision (including provision amending, repealing or

revoking enactments);





(a) for paragraph 1(a) – negative;

(b) for paragraph 1(b) or 1(c) – approval required.».



States.”.

(44) In Annex 6 —

(a) in Part A —

(i) in point 3, for the words from “one of the” to the end

substitute «the indication ‘irradiated’ or ‘treated with

ionising radiation’»; and

(ii) in point 7, for the words from “in Bulgarian” to the end

substitute «‘formed meat’ and ‘formed fish’»; and


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(b) in Part B, for point 3 substitute —

«3. Minced meat that does not comply with the criteria laid down in

point 1 of this Part may be placed on the market if either mark in Part 1

of Schedule 2 to the Food Information Regulations 201450 is used to

identify the minced meat in accordance with regulation 5 of those

Regulations».

(45) In Annex 7 —

(a) in Part B, in the table, in entry 16, for “Annex XIb to Regulation

(EC) No 1234/2007” substitute «Part 2 of Annex 7 to Regulation

(EU) No 1308/2013 of the European Parliament and of the Council

establishing a common organisation of the markets in agricultural

products»; and

(b) in Part E, in point 2 —

(i) in point (a), for “current Union provisions” substitute

«retained EU law in force or retained direct EU legislation

in force»; and

(ii) in point (c), for “Union provisions” substitute «retained

EU law in force or retained direct EU legislation in force».

(46) In Annex 8, in point 1 —

(a) in point (a) —

(i) in point (ii), for “Union provisions” substitute «retained

EU law or retained direct EU legislation»; and

(ii) in point (iv), omit “in the country of marketing”; and

(b) in point (b), for “Union provisions stipulate” substitute «retained

EU law or retained direct EU legislation stipulates».

(47) In Annex 9, in point 2, for the words from “Union” to “national

provisions” substitute «retained EU law or retained direct EU

legislation or, where there is none, another enactment».

(48) In Annex 10, in point 1(d), in the words before the first indent, for

“Union provisions” substitute «provisions in retained EU law or

retained direct EU legislation».

50 SD 2014/0377


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PART 3

ORGANIC PRODUCTS

14 Council Regulation (EC) No 834/2007 amended

(1) Council Regulation (EC) No 834/2007 of 28 June 2007 on organic

production and labelling of organic products and repealing Regulation

(EEC) No 2092/9151 is amended as follows.


(a) in the second subparagraph of paragraph 3 —

(i) for the words “Member States” to “thereof” substitute

«The relevant authority may apply, in the absence of

legislation,»;

(ii) omit the words “,in so far” to the end;


(i) omit “community provisions or national”;

(ii) for “Community law” substitute «retained EU law».


(a) in point (l), for the words from “Article” to the end substitute

«Article 2(2)(e) of Regulation (EU) No 1169/2011»;

(b) in point (n), for “a Member State” substitute «the Island»;

(c) in point (o), for “a Member State” substitute «the Island»;

(d) in point (r), for “Article 6(4) of Directive 2000/13/EC” substitute

«Article 2(2)(f) of Regulation (EU) No 1169/2011»;

(e) in point (s), for the words from “Council” to the end of the

paragraph substitute «Regulation (EC) No 1107/2009»;

(f) after point (aa) insert —

«(bb) ‘third country’ means any country or territory other than:

(i) the United Kingdom,

(ii) the Bailiwick of Guernsey,

(iii) the Bailiwick of Jersey, or

(iv) the Isle of Man;

(cc) ‘relevant authority’ means the Department of Environment,




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(dd) ‘appropriate authority’ has the meaning given in Article

38a.».


(a) in point (o) omit the words from “of fisheries as” to “Fisheries

Policy”;

(b) after point (o) insert —

«In this paragraph, “sustainable exploitation” means the

exploitation of a stock in such a way that does not prejudice the

future exploitation of the stock and does not have a negative

impact on marine eco-systems».


(a) at the end of paragraph 2 insert as a new subparagraph —

«For the purposes of this paragraph, requirements in Directive

2001/18/EC52 imposed on Member States are to be read as imposing

requirements on the appropriate authority»; and


(i) for “Commission shall decide on” substitute «appropriate

authority may by regulations impose»; and

(ii) omit the words from “in accordance” to the end.

(6) In Article 11, in the second subparagraph, omit the words from “in

accordance” to “Article 37(2),”.

(7) In Article 12(3), for the words from “shall be” to the end substitute

«may be adopted by the appropriate authority by regulations».

(8) In Article 13(3), for the words from “shall be” to the end substitute




(i) in subparagraph (b)(iii) for “Community legislation”

substitute «retained EU law»; and

(ii) in subparagraph (e)(iv) for “Community legislation”


(b) in paragraph 2, for the words from “shall be” to the end substitute



(a) in paragraph 1(f)(iv), for “Community legislation” substitute

«retained EU law»; and

52 OJ No L 106, 17.4.2001, p. 1.


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SD No.2019/0212 c

(b) in paragraph 2, for the words from “shall be” to the end substitute




(i) in the first subparagraph, for the words from “Commission

shall” to “Article 37(2)” substitute «appropriate authority

may, by regulations»; and

(ii) in the second subparagraph, for the words from “Member

States concerned” to the end substitute «Island»;


(i) in point (a), for the words from “Commission may” to

“Article 37(2)” substitute «appropriate authority may, by

regulations»;

(ii) omit point (b); and

(iii) in point (c), for the last sentence substitute «The

appropriate authority may, by regulations, withdraw such

products or substances.»; and


(i) for “Member States may regulate, within their territory,”


relevant authority from using any power the authority has

to regulate»; and

(ii) omit the words from “, and in so far” to the end.

(12) In Article 17(2), for the words from “in accordance” to the end substitute

«by the appropriate authority, by regulations».


«by the appropriate authority by regulations».


(a) in paragraph 2(c) omit “by a Member State”; and


(i) omit “by Member States”; and

(ii) for the words from “in accordance” to the end substitute






c SD No.2019/0212

(a) in paragraph 1 (ii), for “the Community legislation” substitute

«retained EU law»; and




may, by regulations»;

(ii) omit the second and third subparagraphs; and

(iii) in the fourth subparagraph, for the words “Commission

may” to the end of the paragraph substitute «appropriate

authority may, by regulations, withdraw such products or

substances.».


(a) in paragraph 1, for the words from “Commission may” to “Article

37(2) and” substitute «appropriate authority may, by regulations

and in accordance with»;

(b) in paragraph 2(h), for “Community law or national law”


(c) in paragraph 3, for the words from “Commission may” to “Article

37(2)” substitute «appropriate authority may, by regulations,».


(a) in paragraph 1 omit the words from “throughout” to “language”;

(b) in paragraph 2 omit the words from “anywhere” to “language”;

(c) in paragraph 3, for “Community provisions” substitute «retained

EU law»; and

(d) omit paragraphs 5 and 6.

(19) In Article 24(3), for the words from “Commission shall” to “Article 37(2)”

substitute «appropriate authority may, by regulations».

(20) In Article 25(3) —

(a) for the words from “Commission shall” to “Article 37(2)”

substitute «appropriate authority may, by regulations»; and

(b) for “the Community logo” substitute “any organic production

logo”.

(21) In Article 26, for the words from “Commission shall” to “Article 37(2)”

substitute «appropriate authority may, by regulations».


(a) in paragraph 1, for “Member States shall set up” substitute «The

relevant authority must maintain»;


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SD No.2019/0212 c

(b) in paragraph 2, for the words from “shall comprise” to the end

substitute «must apply such precautionary and control measures

as the appropriate authority may specify in regulations»;

(c) in paragraph 4(b), for “Member States” substitute «relevant

authority»;

(d) in paragraph 5(c) —

(i) for “notified” substitute «published»;

(ii) for the words from “, by” to “45011 or” substitute «of»;

and

(iii) for “authorities” substitute «authority»;

(e) in paragraph 7(b), for “Commission” substitute «appropriate

authority»;

(f) in paragraph 10, for “Member States” substitute «The relevant

authority»; and

(g) in paragraph 13, for the words from “Member States” to “allows

for” substitute «The control system as set up must ensure».


(a) in paragraph 1(a), for the words from “authorities” to the end

substitute «authority»;

(b) in paragraph 2, for “Member States may exempt” substitute

«Nothing in this Regulation prevents the relevant authority from

using any power the authority has to exempt»;

(c) in paragraph 3, for “Member States” substitute «The relevant

authority»;

(d) in paragraph 4, for “Member States” substitute «The relevant

authority»; and

(e) in paragraph 6, for the words from “Commission, in” to

“implementing” substitute «appropriate authority may, by

regulations, prescribe».


«(3) The form of documentary evidence referred to in paragraph 1 may

be drawn up or amended by the relevant authority, taking into account

the advantages of electronic certification.».


(a) in paragraph 1, in the second subparagraph omit “of the Member

State”; and



c SD No.2019/0212

(i) in the first subparagraph, for the words from “, competent

authorities” to the end substitute «and the competent

authority»; and

(ii) in the third subparagraph, for the words from

“Commission may” to “Article 37(2),” substitute

«appropriate authority may, by regulations».


(a) in paragraph 1, for “Community” substitute «Island»; and




must, by regulations»;


(A) for “notified” substitute «published»; and

(B) for the words “, by” to “45011 or” substitute «of»;

(iii) in the third subparagraph, for “Commission” substitute

«appropriate authority», in both places it appears; and

(iv) in the fifth subparagraph, for “Commission assisted by the

Member States” substitute «appropriate authority».



(i) the first subparagraph, for “Community” substitute

«Island»; and

(ii) at the end insert —

«The requirement set out in point (d) applies to organic

products entering the Island from the European Union, an

EEA state or Switzerland only on and after 1st January

2021.»;



may” to “Article 37(2)” substitute «appropriate authority

may, by regulations»;


«appropriate authority», in both places it appears;




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SD No.2019/0212 c

(iv) in the fourth subparagraph, for “Commission assisted by

the Member States” substitute “«appropriate authority»;

and

(v) at the end insert —

«The requirement in this paragraph to provide a concise

annual report applies to the European Union, an EEA state

and Switzerland only on and after 1st January 2021.»; and



(A) for the words from “Commission may” to “Article

37(2)” substitute «appropriate authority may, by

regulations”; and

(B) for “establish” substitute «maintain»;




«appropriate authority», in both places it appears; and

(28) in the fifth subparagraph, for “Commission assisted by the Member

States” substitute «appropriate authority».



(a) for the first sentence substitute —

«In relation to points (a) to (c) below, the appropriate authority

may, by regulations, lay down detailed rules for the application of

this Regulation.».

(b) after the first sentence insert —

«In relation to point (d) below, the appropriate authority may, by

regulations, lay down detailed rules for the application of this

Regulation. The regulations laid down by the appropriate

authority are subject to the objectives and principles laid down in

Title 2.».

(c) omit point (e).


«Article 38a

Regulations

1. This Article applies in relation to any power conferred by this

Regulation on the appropriate authority to make provision by

regulations.


c SD No.2019/0212

2. The appropriate authority is the Department of Environment, Food

and Agriculture.

Article 38b

Regulations procedure


contain —


provisions;









(a) for the heading substitute «Miscellaneous application»;

(b) omit the first subparagraph;

(c) in the second subparagraph omit the second sentence;

(d) omit the third and fourth subparagraphs.


States”.

(35) In the Annex omit the listed terms other than “EN: organic”.


(1) Commission Regulation (EC) No 889/2008 of 5 September 2008 laying

down detailed rules for the implementation of Council Regulation (EC)

No 834/2007 on organic production and labelling of organic products

with regard to organic production, labelling and control53 is amended as

follows.


(a) in point (c) —

(i) omit “within the community”; and

(ii) for “Community” substitute «Island»;



Regulations 2019

SD No.2019/0212 c

(b) in point (s), for “authorities of the Member State” substitute

«authority»; and

(c) after point (u), insert —

«(v) ‘relevant authority’ means the Department of Environment,


(w) ‘third country’ has the same meaning as in Article 2 of

Council Regulation (EC) No 834/2007.».

(3) In Article 6b —



(A) for “Member State authorities may” substitute

«Nothing in this Regulation prevents the relevant

authority from using any power the authority has

to»; and

(B) for “and may also” substitute «or»; and


(b) in paragraph 3, for “Council Directive 85/337/EEC” substitute

«Directive 2011/92/EU54«.

(4) In Article 9(3) omit the words from “This provision” to the end.


(a) in paragraph 3, for “Article 3(3) of Council Directive 91/629/EEC”

substitute «Article 3 of Council Directive 2008/119/EC55»; and

(b) in paragraph 4, for “91/630/EEC” substitute «2008/120/EC».

(6) In Article 12(5), in the second subparagraph omit the words from “or

draw” to the end.


(a) in paragraph 1, for the words from “Article 36” to “1257/1999”

substitute «Title 3 of Regulation (EU) No 1305/201356»; and

(b) in paragraph 2, for “The Member States may” substitute

«Nothing in this Regulation prevents the relevant authority from

using any power the authority has to».

(8) In Article 14(7), for “Community legislation” substitute «retained EU

law».

54 OJ L 026, 28.1.2012, p. 1. 55 OJ L 010, 15.1.2009, p. 7. 56 OJ L 347, 20.12.2013, p. 487.


c SD No.2019/0212

(9) In Article 15(2), for “national provisions adopted pursuant to Directive

91/676/EEC” substitute «retained EU law on nitrates».

(10) In Article 17(3) (b), for the words from “Article 36” to the end substitute

«Title 3 of Regulation (EU) No 1305/2013».

(11) In Article 23(5), for “Member States” substitute «The relevant

authority».

(12) In Article 24(5), for “Article 11 of Directive 2001/82/EC” substitute

«paragraph 2 of Schedule 4 to the Veterinary Medicines Regulations

201957».

(13) In Article 25(5), for the words from “Member State” to the end substitute

«Island in accordance with any relevant retained EU law».

(14) In Article 25o(1) omit the third subparagraph.

(15) In Article 25t —

(a) in paragraph 3, for “by Member States” substitute «in the

Island»; and

(b) in paragraph 4, for “Article 11 of Directive 2001/82/EC” substitute

«paragraph 2 of Schedule 4 to the Veterinary Medicines

Regulations 2019».



(i) for point (c) substitute —

«(c) substances and products as defined in Articles 3(2)(b)

to (d) of Regulation (EC) No 1334/2008 labelled as natural

flavouring substances or natural flavouring preparations,

according to Articles 15(1)(e) and 16 of that Regulation;»;

and

(ii) in point (d), for the words from “, respectively, Article

2(8)” to the end substitute «Article 17 and Annex 2 of

Regulation (EC) No 1333/2008»;



(i) for “may comprise” substitute «must not allow the use

of»; and

(ii) omit the words from “until 31” to the end.


(a) in the heading omit “by Member State”;

57 S.D. 2019/0028.


Regulations 2019

SD No.2019/0212 c


(i) in point (a) —

(A) omit “of the Member State”;

(B) for “Community” substitute «Island, United

Kingdom or Channel Islands»;


(A) omit “of the Member State”; and

(B) omit “in the Community”; and

(iii) for the second subparagraph, substitute —

«Nothing in this Regulation prevents the relevant

authority from using any power the authority has to

prolong the authorisation provided for in point (b) for a

period of 12 months on a maximum of three occasions.»;

and


(18) In Article 29c(2), for “Regulation (EC) No 1234/2007” substitute


(19) In Article 29d —

(a) in paragraph 1, for the words from “Article 120c” to “1234/2007”

substitute «Articles 80 and 83(2) of Regulation (EU) No

1308/2013»;

(b) in paragraph 2, point (a), for “Annex XVa to Regulation (EC) No

1234/2007” substitute «Part 1 of Annex 8 to Regulation (EU) No

1308/2013»;


(d) in paragraph 5, for “Regulation (EC) No 1234/2007” substitute


(20) At the end of Article 34 insert —

«The requirement to provide a certificate of inspection for import

applies to organic products entering the Island from the European

Union, an EEA state or Switzerland only on and after 1st January

2021.».


(a) omit paragraph 2(a); and




c SD No.2019/0212

(A) for “Member State” substitute «relevant

authority»;

(B) in point (a) omit “of the Member State”; and

(C) in point (b) omit “of the Member State”; and

(ii) omit the third subparagraph.

(22) In Article 40(1)(b), for “Member States’ competent authorities” substitute

«competent authority».


(a) in paragraph 1(b), for “Member States may” substitute «nothing

in this Regulation prevents the relevant authority from using any

power the authority has to»;


(i) for “Council Directive 2000/29/EC” substitute «the Plant

Health Order 201158»; and

(ii) omit “of the Member State”;

(c) in paragraph 3, in the first subparagraph omit “in all parts of the

Community”;


(i) for “Member States may” substitute «Nothing in this

Regulation prevents the relevant authority from using any

power the authority has to»; and

(ii) omit the words from “to another” to “supervision or”;

(e) in paragraph 5(d), for the words from “agreed” to the end

substitute «as agreed by the competent authority»; and

(f) in paragraph 8, for the words from “By way of” to “general

authorisation” substitute «Nothing in this Regulation prevents

the relevant authority from using any power the authority has to

grant all users, by way of a derogation from paragraph 7, a

general authorisation».

(24) In Article 46a, omit the second subparagraph.


(a) in the first subparagraph, for the words “The competent authority

may” substitute «Nothing in this Regulation prevents the

relevant authority from using any power the authority has to»;

(b) in the second subparagraph, omit the second sentence.


58 S.D. 0385/11.


Regulations 2019

SD No.2019/0212 c


(i) for “Each Member State shall ensure that” substitute «The

relevant authority shall use»; and

(ii) for “on its territory” substitute «in the Island»;


(i) omit “of the Member State”;

(ii) for “the Member State” substitute «the relevant

authority»; and

(iii) for “Member States” substitute «The relevant authority»;

and


(27) In Article 49(3), for “Each Member State” substitute «The relevant

authority».

(28) In Article 50(2) omit “of the Member State”.

(29) For Article 51(1)(d) substitute —

«(d) the country or region in which the variety is tested and approved

for the purposes of either the United Kingdom national list as defined in

the Seed Marketing Regulations 201659 or the common catalogues of

varieties of agricultural plant species and vegetable species60.

Varieties listed on the common catalogues may only be used for a

period of two years beginning at exit day.».


(a) in paragraph 1, for “Member States” substitute «The relevant

authority»; and

(b) in paragraph 2, for “Member States” substitute «relevant

authority».

(31) In Article 53 omit “of the Member State”.

(32) In Article 54, paragraph 1 omit “of the Member State”.


(34) In Title 3, after “Chapter 1” in the heading omit “of the European

Union”.


(36) In Article 58(1) —

59 S.D. 2016/0313. 60 OJ L 193, 20.7.2002, p. 1; OJ L 193, 20.7.2002, p. 33.


c SD No.2019/0212

(a) in point (a), for “the Member State or the third country” substitute

«the product as originating from the United Kingdom or the

third country”;

(b) in point (c) —

(i) omit “the Commission or by”;

(ii) omit “of the Member States”; and

(iii) omit “and”; and

(c) omit point (d).

(37) In Article 60(1) omit “and the Organic logo of the EU”.

(38) In Article 61(1) —

(a) in point (a), for the words from “Article 5” to the end substitute

«Article 11 of Regulation (EC) No 767/2009»; and

(b) in point (b), for the words from “Article 5(1)(a)” to the end

substitute «Regulation (EC) No 767/2009».


(a) in paragraph 2(d) omit the words from “in accordance” to

“concerned”; and

(b) in paragraph 3(f), for the words from “the Member” to the end

substitute «that body is approved in accordance with the control

system».

(40) In Article 82(1) —

(a) in the first subparagraph, for “Community” substitute «Island»;

(b) in the second subparagraph, for the words from “when” to the

end substitute «when these storage facilities are situated outside

of the Island or the United Kingdom, by a control body or

authority approved by the Secretary of State for control in that

country.».

(41) In Article 83, in the second paragraph, for “Community” substitute

«Island».


(a) in the first paragraph, for “Community” substitute «Island»;

(b) in the third paragraph, for the words from “Trade Control” to the

end substitute «import control system operated in the United

Kingdom.».

(43) In Article 88(1)(d), for “Article 5(1)(a) of Directive 79/373/EEC” substitute

«Regulation (EC) No 767/2009».



Regulations 2019

SD No.2019/0212 c


(i) for “a control authority” substitute «the control

authority»;

(ii) for “production method, this control” substitute

«production method, the control»; and

(iii) for “set by that control authority” substitute «set by the

control authority»; and


(45) In Article 92— —

(a) in paragraph 4, omit the words from “of the” to “approved it”;

(b) in paragraph 5, for “Member States” substitute «The relevant

authority»; and

(c) in paragraph 6, for “Member States” substitute «The relevant

authority».

(46) Omit Article 92a.


(a) for “Member States” substitute «The relevant authority»;

(b) for “The Member States” substitute «The relevant authority»;

and

(c) for the words from “Directive” to the end substitute «the Data

Protection Act 2018».

(48) In Article 92c(3), for “Union rules” substitute «retained EU law».

(49) In Article 92e (c)(vi) —

(a) omit “Member States where that”;

(b) omit “operates”; and

(c) for “Directive 95/46/EC” substitute «the Data Protection Act

2018».

(50) In Article 92f, for “Member States” substitute «The relevant authority»

in both places it occurs.

(51) In the heading to Title 5 omit “TRANSMISSION OF INFORMATION TO

THE COMMISSION,”.

(52) Omit the Chapter 1 title and its heading;


(54) Omit the Chapter 2 title and its heading.



c SD No.2019/0212

(a) omit paragraphs 1 to 4;

(b) in paragraph 5, for “Member States” substitute «relevant

authority»; and




States”.

(58) In Annex 1, in the fifth row of column 3, omit “, accepted by the Member

State”.

(59) In Annex 2, in paragraph 3, the second column of the fourth row, in the

second subparagraph for the words “For perennial” to “provide that the”

substitute «Nothing in this Regulation prevents the relevant authority

from using any power the authority has to provide by way of derogation

from the previous paragraph, in respect of perennial crops, that the».

(60) In Annex 6, in paragraph 3(a), in the third column of the first row of the

table, in the third indent, for “Member States” substitute «relevant

authority».

(61) In Annex 7 —

(a) in paragraph 2.1 —

(i) for “Union and national provisions” substitute «retained

EU law»; and

(ii) omit the eighth indent which begins “copper sulphate”;

and

(b) in paragraph 2.2, for “Union and national provisions” substitute

«retained EU law».

(62) In Annex 11 —

(a) omit Part A;

(b) in Part B —

(i) in paragraph 2, for “Commission or each Member State”



(A) in point (a), for “each Member State’s” substitute

«the»; and

(B) in point (b), for “Commission” substitute «relevant

authority»;

(C) omit point (c); and


Regulations 2019

SD No.2019/0212 c

(c) in the final paragraph, for “Commission” substitute «relevant

authority».

(63) In Annex 12b, omit every indent other than the eighth indent which

begins “In English”.

(64) Omit Annex 13c.


(1) Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying

down detailed rules for implementation of Council Regulation (EC) No

834/2007 as regards the arrangements for imports of organic products

from third countries61 is amended as follows.



(i) omit “relevant Member State’s”;

(ii) for “Union” substitute «Isle of Man»;


«6. ‘competent authority’ means the customs authority or other

authorities designated by the relevant authority pursuant to Article 27(1)

of Regulation (EC) No 834/2007 responsible for the verification of the

consignments and the endorsement of the certificates of inspection»;

(c) in paragraph 7, for “a relevant” substitute «the»;

(d) in paragraph 11, after “circulation” insert «in the Island»;

(e) after paragraph 11 insert —

«12. ‘third country’ has the same meaning as in Council

Regulation (EC) No 834/2007;

13. ‘relevant authority’ means the Department of Environment,


14. ‘customs authority’ means the Treasury.».



(i) for “Commission” substitute «relevant authority»;

(ii) omit the second sentence;

(b) in paragraph 2, omit “Community”.




c SD No.2019/0212


(i) for “The Commission” substitute «The relevant

authority»;

(ii) omit “by the Commission”;

(iii) omit the second sentence;

(b) in paragraph 2, for “Community” substitute «Island»;


(i) in the words before point (a) —

(A) for “Commission to ensure” substitute «relevant

authority to ensure»;

(B) for “Community” substitute «Island»;

(ii) in point (a), for “Community” substitute «Island»;

(iii) in point (g), for “Commission” substitute «relevant

authority»;

(d) in paragraph 4, for “Commission”, in both places it occurs,



(i) for “Commission” substitute «relevant authority»;

(ii) for the final sentence substitute «The decision must be

taken by the relevant authority by regulations.».



(i) in point (a), for “Commission”, in both places it occurs,


(ii) in point (b), for “Commission” substitute «relevant

authority»;

(iii) in point (c), for “Commission”, in both places it occurs,


(iv) in point (d), for “Commission” substitute «relevant

authority»;



(A) for “Commission”, in both places it occurs,


(B) for the words from “that control” to the end

substitute «the relevant authority may, by


Regulations 2019

SD No.2019/0212 c

regulations, withdraw that control body or control

authority from the list of control bodies and control

authorities.»;


«relevant authority».

(6) In Article 6(3), for “Commission” substitute «relevant authority».


(a) in paragraph 1, for “Commission” substitute «relevant

authority»;


(i) in the words before point (a), for “Community market”

substitute «market in the Island»;

(ii) in point (f), for “Union” substitute «Island».




(i) for “Commission”, in each place it occurs, substitute

«relevant authority»;

(ii) for “request for inclusion which” substitute «request from

a third country for inclusion on the list provided for in

Article 7 if it»;

(iii) for “Community”, in each place it occurs, substitute

«Island»;

(c) in paragraph 4, for the second subparagraph substitute —

«The decisions referred to in the first subparagraph must be made by

the relevant authority by regulations.».


(a) for “Commission”, in each place it occurs, substitute «relevant

authority»;

(b) in paragraph 1(a) omit the words from “via the” to the end;

(c) in paragraph 2, for the words from “that third” to the end

substitute «the relevant authority may, by regulations, withdraw

that third country from the list.».


(a) in paragraph 1, for “Commission shall draw up” substitute

«relevant authority must provide direction to»;

(b) in paragraph 2, omit “Community”.


c SD No.2019/0212



authority»;

(b) in paragraph 2, for “Community” substitute «Island»;

(c) in paragraph 3, for “Community”, in each place it occurs,


(d) in paragraph 5, for the final sentence substitute «The decision

must be made by the relevant authority by regulations.».



authority»;


(i) for the words before point (a) substitute —

«2. The relevant authority may request that the UK relevant authority

withdraws from the list referred to in Article 10 a control body or a

control authority, or a reference to a specific product category or a

specific third country in relation to that control body or control authority,

in the following cases:»;


(A) for the words from “the Commission shall

withdraw” to “834/2007” substitute «the relevant

authority must, by regulations, withdraw it from

the list without delay»;




(i) in the first subparagraph, for “Union” substitute

«Island»;

(ii) in points (a) and (b), omit “relevant Member State’s”;

(iii) in point (c), for the words “Article 158(1)” to the end

substitute «paragraph 17(4) of Schedule 1 to the Taxation

(Cross-border) Trade Act 2018, as it has effect in the

Island62.»;

(iv) in the second subparagraph, for the words from “relevant

Member” to the end substitute «competent authority.»;

(v) omit the third subparagraph;

62 The Taxation (Cross-border Trade) Act 2018, as applied in the Island by SD 2019/0080.


Regulations 2019

SD No.2019/0212 c


«The requirements in this Article relating to certificates of inspection

apply to organic products entering the Island from the European Union,

an EEA state or Switzerland only on and after 1st January 2021.»;



(A) omit “relevant Member State’s”;

(B) for the words from “electronic Trade” to the end

substitute «United Kingdom’s import control

system.»;

(ii) in the second subparagraph for “TRACES”, in both places

it occurs, substitute «the United Kingdom’s import

control system»;

(iii) in the third subparagraph —

(A) for “TRACES”, in both places it occurs, substitute

«the United Kingdom’s import control system»;

(B) omit “relevant Member State’s”;


(i) in the second subparagraph, for “Union” substitute

«Island»;

(ii) in the fourth subparagraph, for the words from

“Commission or” to “State” substitute «relevant

authority»;

(e) in paragraph 6, omit “relevant Member State’s”;

(f) after paragraph 7 insert —

«8. During the transition period a certificate of inspection issued by a

control body which appears on both Annex 4 of this Regulation and

Annex 4 of Regulation (EC) No 1235/2008(a) as it had effect in EU law

immediately before exit day must be accepted for the purposes of

satisfying the requirements, including those in paragraph 1, for import

into the Island notwithstanding that the certificate of inspection certifies

compliance with requirements in Regulation (EC) No 834/2007(b) as it

has effect in EU law from time to time.

9. During the transition period a certificate of inspection issued by a

control body which appears on both Annex 4 of this Regulation and

Annex 4 of Regulation (EC) No 1235/2008 as it had effect in EU law

immediately before exit day must not be accepted for the purposes of

satisfying the requirements, including those in paragraph 1, for import

into the Island where it certifies compliance with Regulation (EC) No


c SD No.2019/0212

834/2007 as it has effect in the Island unless the competent authority has

approved the control body to certify products to the Island standards,

following a notification in accordance with Article 12(1).

10. The transition period referred to in paragraphs 8 and 9 is a period

which begins on exit day and ends on 31st December 2020.».



(i) for “TRACES”, in both places it occurs, substitute «the

United Kingdom’s electronic import control system»;

(ii) for “2, 3 and 4” substitute «2 and 3»;

(iii) for “Commission” substitute «relevant authority»;


(i) in the first subparagraph, for “TRACES” substitute «the

United Kingdom’s electronic import control system»;

(ii) in the first subparagraph, for “one of the official languages

of the Union” substitute «English, and may also appear in

other languages,»;

(iii) omit the second subparagraph;

(c) in paragraph 3, for “TRACES” substitute «the United Kingdom’s

import control system»;



(a) for “Article 158(1) of Regulation (EU) No 952/2013” substitute

«section 3 of the Taxation (Cross-border) Trade Act 2018 (of

Parliament)»;

(b) at the end insert —

«The requirements of this Article apply to organic products entering the

Island from the European Union, an EEA state or Switzerland only on

and after 1st January 2021.».

(16) Omit Article 13c.

(17) In Article 13d, for “TRACES” substitute “The import control system

adopted by the relevant authority”.



(i) for “Regulation (EU) No 952/2013” substitute «the

Taxation (Cross-border Trade) Act 2018, as it has effect in

the Island»;


Regulations 2019

SD No.2019/0212 c

(ii) omit “relevant Member State’s”;

(iii) after “circulation” insert «in the Island»;

(iv) at the end insert —

«The requirements in this Article in respect of a certificate of inspection

apply to organic products entering the Island from the European Union,

an EEA state or Switzerland only on and after 1st January 2021.».


(i) in the first subparagraph, for “suspensive customs”

substitute «special»;

(ii) in the first subparagraph, for “Regulation (EU) No

2913/92” substitute «the Taxation (Cross-border) Trade

Act 2018, as it has effect in the Island»;

(iii) in the first subparagraph, for the words from “submitted

in” to “splitting” substitute «split»;

(iv) in the second subparagraph —

(A) for “TRACES” substitute «the United Kingdom’s

import control system»;

(B) omit “relevant Member State’s”, in each place it

occurs;

(C) after “circulation” insert «in the Island»;

(D) omit the final sentence.




(A) for “Union” substitute «Island»;

(B) after “834/2007”, in the second place it occurs, insert

«, or in relation to products to which paragraph 8

of Article 13 applies, Regulation (EC) No 834/2007

on organic production and labelling of organic

products as it has effect in EU law from time to

time,»;

(ii) omit the second and third subparagraphs;


(i) for “of the Member States concerned and of the” substitute

«of both the Island and the»;

(ii) omit “and, where appropriate, the Commission”;



c SD No.2019/0212

(i) for “a Member State” substitute «the Island»;

(ii) for “Member States concerned” substitute «Island»;

(iii) omit “and the Commission”;


(i) for the words from “Commission after” to “informing it”


(ii) for the words from “Commission and” to “initial

communication” substitute «relevant authority»;

(iii) omit “by the Commission”;

(iv) omit the second subparagraph;





(A) for “Commission” substitute «relevant

authority»;

(B) omit the words from “with the” to “of procedure”;



authority»;

(B) for “Commission shall” substitute «relevant

authority may»;




(i) omit “to the Commission or the Member States”;

(ii) omit “by the Commission or the Member States”;

(iii) omit the final sentence;


(i) in the first sentence, for “Commission” substitute

«relevant authority»;

(ii) in the second sentence —


authority»;


Regulations 2019

SD No.2019/0212 c

(B) for the words from “Member States” to “countries”

substitute «appropriate authorities»;

(c) in paragraph 4, for “Commission and the Member States”


(d) in paragraph 5, omit the words from “in accordance” to the end.


«Article 17a

Regulations


contain —


saving provisions;







(23) Omit Title 5.


States”.

(25) In Annex 3, at the appropriate place insert —

«EUROPEAN UNION AND EEA STATES

1. Product categories

Category of products Designation of category as in

Annex IV

Limitations

Unprocessed plant products A

Live animals or unprocessed

animal products

B

Unprocessed aquaculture

products and algae

C

Processed agricultural

products for use of food

D

Processed agricultural

products for use of feed

E

Vegetative propagating

material and seeds for

cultivation

F

2. Origin: products of categories A, B, C and F and organically grown

ingredients in products of category D and E that —


c SD No.2019/0212

(a) have been grown in the European Union or an EEA state, or

(b) have been imported into the European Union or an EEA state and

processed or packaged in the European Union or an EEA state in

accordance with EU regulations.

3. Production Standards: Regulation (EC) No 834/2007, Regulation (EC)

No 889/200863 and Regulation (EC) No 1235/2008, as those Regulations

have effect in EU law, as amended from time to time.

4. Competent authority: the competent authority as appointed by each

Member State in accordance with Regulation (EC) No 834/2007, as that

Regulation has effect in EU law, as amended from time to time.

5. Control bodies:

Code number Name Internet address Comments

Austria Control Bodies

AT-BIO-004 GfRS Gesellschaft fur

Ressourcenschutz mbH

www.grfs.de

AT-BIO-301 Austria Bio Garantie GmbH www.abg.at

AT-BIO-401 BIOS —

Biokontrollservice

Osterreich

www.bios.kontrolle.at

AT-BIO-402 LACON GmbH www.lacon-institut.at

AT-BIO-501 SLK GesmbH www.slk.at

AT-BIO-701 Kontrollservice BIKO

Tirol

www.biko.at

AT-BIO-901 LVA GmbH www.lva.at

AT-BIO-902 SGS Austria Controll —

Co. Ges.m.b.H

www.as.sgs.com

AT-BIO-903 LKV Austrai

Gemeinnutzige GmbH

www.lkv-austria.at

BELGIUM Control Bodies

BE-BIO-01 CERTISYS www.certisys.eu

BE-BIO-02 TUV NORD INTERGA

bvba

www.tuv-nord-

integra.com

BE-BIO-03 QUALITY PARTNER www.quality-partner.be

BE-BIO-05 Comite du Lait www.comitedulait.be/inde

x. php/page/production-

biologique

BULGARIA Control Bodies

BG-BIO-02 BALKAN BIOCERT Ltd www.balkanbiocert.com

BG-BIO-03 Q CERTIFICATION S.P.A. www.qcertification.bg

BG-BIO-04 CERES-CERtification of

Environmental Standards Ltd

www.ceres-cert.com

BG-BIO-05 LACON – Private Institute for

Quality Assurance and

Certification of organically

www.lacon-

institut.com;www.lacon-

bg.com



Regulations 2019

SD No.2019/0212 c

produced food products LTD

BG-BIO-07 Control Union Certifications

B.V.

www.controlunion.com

BG-BIO-10 Inspection Institute for Organic

products S.A. (BIO HELLAS)

www.bio-hellas.gr

BG-BIO-12 ECOGRUPPO ITALIA S.R.L.

with branch office in Bulgaria –

ECOGRUPPO ITALIA –

BULGARIA BRANCH UNIT

www.ecogruppoitalia.it

BG-BIO-13 BIOAGRICERT ITALIA

BULGARIA Ltd

www.bioagricert.bg

BG-BIO-14 SGS BULGARIA Ltd

BG-BIO-15 BULGARKONTROLA S.A. www.bulgarkontrola.bg

BG-BIO-16 “Austria Bio Grantie” GMBH

with branch office in Bulgaria

“AUSTRIA BIO GRANTIE

BULGARIA BRANCH UNIT”

www.abg.at;www.bg-

abgcert.com

BG-BIO-17 “Agency for organic

certification” Ltd

www.abcbg.net

BG-BIO-18 ‘COSMOCERT’ www.cosmocert.bg

BG-BIO-19 MAKOM CERTIFICATION www.makom.bg

BG-BIO-20 ‘Agro Organic Control’ Ltd www.agro-organic.com

BG-BIO-21 Bio Certification www.biocertification.eu

BG-BIO-22 Nutramed nm.nutramedbg.com

CROATIA Control Bodies

HR-EKO-01 BIOINSPEKT d.o.o. www.bioinspekt.com;http:

//www.bioinspekt.hr

HR-EKO-02 PRVA EKOLOSKA STANICA

d.o.o.

www.prvaekoloska.hr

HR-EKO-03 ZADRUGA AGRIBIOCERT www.agribiocert.hr

HR-EKO-04 BIOTECHNICON d.o.o. www.biotechnicon.hr

HR-EKO-05 HRVATSKE SUME d.o.o. www.hrsume.hr

HR-EKO-06 TRGO-INVEST d.o.o. www.binarnet.hr/trgo-

invest

HR-EKO-07 AUSTRIA BIO GARANTIE

d.o.o.

hr.abg-cert.com/

HR-EKO-08 BUREAU VERITAS d.o.o. www.bureauveritas.si

HR-EKO-09 Eurotalus j.d.o.o. www.eurotalus.hr

HR-EKO-10 EKO RAZVOJ d.o.o. www.ekorazvoj.hr

CYPRUS Control Bodies

CY-BIO-001 LACON LTD www.lacon-institut.com

CY-BIO-002 BIOCERT (CYPRUS) LTD N/A

CY-BIO-003 Eurocert ʹΕυρϖггαΐкη

Εταιρεία Ελέγχϖѵ кαι

Пιогоггоιήоεϖѵ ᾺΕ

N/A

CY-BIO-004 TUV AUSTRIA HELLAS MOV

E.П.Ε.

http://www.tuvaustriacypr

us.com.cy

CZECH

REPUBLIC

Control Bodies


c SD No.2019/0212

CZ-BIO-001 KEZ o.p.s. www.kez.cz

CZ-BIO-002 CZ-BIO-002 ABCERT AG www.abcert.cz

CZ-BIO-003 BIOKONT CZ, s.r.o. www.biokont.cz

CZ-BIO-004 BUREAU VERITAS CZECH

REPUBLIC, spol. s.r.o.

www.bureauveritas.cz

CZ-BIO-005 State Veterinary

Administration

En.svscr.cz/ In the Czech

Republic we

have system A

with four

approved

control bodies.

However State

Veterinary

Administration

and other two

state control

authorities are

mentioned too.

They perform

organic official

controls

similarly to the

private control

bodies except

they do not do

certification.

CZ-BIO-006 Czech Agriculture and Food

Inspection Authority

www.szpi.gov.cz/en In the Czech

Republic we

have system A

with four

approved

control bodies.

However State

Veterinary

Administration

and other two

state control

authorities are

mentioned too.

They perform

organic official

controls

similarly to the

private control

bodies except

they do not do

certification.

CZ-BIO-007 Central Institute for

Supervising and Testing in

Agriculture

Eagei.cz/public/web/en/uk

zuz/portal

In the Czech

Republic we

have system A


Regulations 2019

SD No.2019/0212 c

with four

approved

control bodies.

However State

Veterinary

Administration

and other two

state control

authorities are

mentioned too.

They perform

organic official

controls

similarly to the

private control

bodies except

they do not do

certification.

Denmark Control

Authorities

DK-OKO-

050

Landbrugsstyrelsen (The

Danish Agricultural Agency)

www.lbst.dk

DK-OKO-

100

Fodevarestyrelsen (The Danish

Veterinary and Food

Administration)

www.fvst.dk

Estonia Control

Authorities

EE-OKO-01 Agricultural Board www.pma.agri.ee

EE-OKO-02 Veterinary and Food Board www.vet.agri.ee

Finland Control

Authorities

FI-EKO-101 Uudenmaan elinkeino-liikenne-

ja ymparistokeskus

N/A

FI-EKO-102 Varsinais-Suomen elinkeino-

liikenne-ja ymparistokeskus

N/A

FI-EKO-103 Satakunnan elinkeino-liikenne-

ja ymparistokeskus

N/A

FI-ELO-104 Hameen elinkeino-liikenne-ja

ymparistokeskus

N/A

FI-EKO-105 Pirkanmann elinkeino-liikenne-

ja ymparistokeskus

N/A

FI-EKO-106 Kaakkois-Suomen elinkeino-

liikenne-ja myparistokeskus

N/A

FI-EKO-107 Etela-Savon elinkeino-liikenne-

ja ymparistokeskus

N/A

FI-EKO-108 Pohjois-Savon elinkeino-


N/A

FI-EKO-109 Pohjois-Karjalan elinkeino-


N/A

FI-EKO-110 Keski-Suomen elinkeino- N/A


c SD No.2019/0212

liikenne-ja myparistokeskus

FI-EKO-111 Etela-Pohjanmaan elinkeino-

liikenne-jas ymparistokeskus

N/A

FI-EKO-112 Pohjanmaan elinkeino-liikenne-

ja ymparistokeskus

N/A

FI-EKO-113 Pohjois-ja Keski-Pohjanmaan

elinkeion-liikenne-ja

ymparistokeskus

N/A

FI-EKO-114 Kainuun elinkeino-liikenne-ja

ymparistokeskus

N/A

FI-EKO-115 Lapin elinkeino-liikenne-jas

ymparistokeskus

N/A

FI-EKO-201 Elintarviketurvallisuusvirasto

Evira (The Finnish Food Safety

Authority Evira)

www.evira.fi The Finnish

Food Safety

Authority Evira

is the Central

Control

Authority for

organic

products.

Operates also

the databases of

operators

(including

organic seeds)

FI-EKO-301 Sosiaali-ja terveysalan lupa-ja

valvontavirasto Valvira

(National Supervisory

Authority for Welfare and

Health)

www.valvira.fi

FI-EKO-401 Alands landskapsregering www.regeringen.ax Operates on

Aland

France Control Bodies

FR-BIO-01 ECOCERT FRACE www.ecocert.fr

FR-BIO-07 AGROCERT www.agrocert.fr

FR-BIO-09 CERTIPAQ BIO www.certipaqbio.com

FR-BIO-10 BUREAU VERITAS

CERTIFICATION FRANCE

www.bureauveritas.com

FR-BIO-12 Certisud www.certisud.fr

FR-BIO-13 CERTIS www.certis.com.fr

FR-BIO-15 BUREAU ALPES CONTROLES www.certification-bio.fr/

FR-BIO-16 QUALISUD www.qualisud.fr

FR-BIO-17 BIOTEK AGRICULTURE www.biotek-agriculture.fr

FR-BIO-18 EUROFINS CERTIFICATION www.eurofins.fr/certificati

on

Germany Control Bodies

DE-OKO-

001

Kiwa BCS Oko-Garantie Gmbh www.kiwabcs.de

DE-OKO- Lacon GmbH Deutschland www.lacon-institut.com


Regulations 2019

SD No.2019/0212 c

003

DE-OKO-

005

Ecocert IMO GmbH www.imo.ch

DE-OKO-

006

ABCERT AG www.abcert.de

DE-OKO-

007

PRUFVEREIN

VERARBEITUNG okologische

Landbauprodukte e.V

www.pruefverein.de

DE-OKO-

009

LC Landwirtschafts-Consulting

GmbH

www.lc-sh.de

DE-OKO-

012

AGRECO R.F. GODERZ GmbH www.agrocogmbh.com

DE-OKO-

013

QC&I Gesellschaft fur

Kontrolle und Zertifizerung

von Qualitatssicherungssyteme

n GmbH

www.qci.de

DE-OKO-

021

Grunstempel®-Okopurfstelle

e.V

www.grunstempel.de

DE-OKO-

022

Kontrollverein okologischer

Landbau e.V.

www.kontrollverein.de

DE-OKO-

034

Fachgesellschaft OKO-

Kontrolle mbH

www.fgs-kontrolle.de

DE-OKO-

037

OkoP Zertifizierungs GmbH www.oekop.de

DE-OKO-

039

GfRS-Gesellschaft fur

Ressourcenschutz mbH

www.gfrs.de

DE-OKO-

044

ARS PROBATA GmbH www.ars-probata.com

DE-OKO-

060

QAL GmbH Gesellschaft fur

Qualiatssicherung in der Agrar

– und Lebensmittelwirtschaft

www.gal-gmbh.de

DE-OKO-

064

ABC Gmbh Agrar-Beratungs

und Coltroll GmbH

www.abcg-alsfeld.de

DE-OKO-

070

Peterson CU Deutschland

GmbH

www.pcu-deutschland.de

Greece Control Bodies

GR-BIO-01 DIO-inspection and

Certification Organisation of

Organic Products

www.dionet.gr

GR-BIO-02 PHYSIOLOGIKE

INSPECTIONS

CERTIFICATIONS OF

ORGANIC PRODUCTS-

PROMOTION

www.physiologike.gr;

www.pyhsiologike.org

GR-BIO-03 BIO HELLAS www.bio-hellas.gr

GR-BIO-05 A CERT SA www.a-cert.org

GR-BIO-06 IRIS www.irisbio.gr

GR-BIO-07 GREEN CONTROL www.greencontrol.gr

GR-BIO-08 GEOTECHNICAL www.bio-geolab.gr;


c SD No.2019/0212

LABORATORY S.A. www.geolab.gr

GR-BIO-10 GMCert www.gmcert.gr

GR-BIO-12 Q-CERT www.qmcert.com

GR-BIO-13 TUV HELLAS S.A. www.tuvhellas.gr

GR-BIO-14 OXYGONO-HELLENIC

CERTIFICATION BODY

www.oxygencert.gr

GR-BIO-15 TUV AUSTRIA-HELLAS-LTD www.tuvaustriahellas.gr

GR-BIO-16 Q-check P.C. or Q-check

PRIVATE COMPANY

www.qcheck-cert.gr

GR-BIO-17 EUROCERT SA www.eurocert.gr

GR-BIO-18 COSMOCERT www.cosmocert.gr

HUNGRAY Control Bodies

HU-OKO-01 Biokontroll Hungaria

Nonprofit Kft

www.biokontroll.hu

HU-OKO-02 Hungaria Oko Garancia Kft www.okogarancia.hu

IRELAND Control Bodies

IE-ORG-02 Irish Organic Association www.irishorganicassociati

on.ie

IE-ORG-03 Organic Trust Ltd www.organic-trust.org

IE-ORG-04 Global Trust Certification Ltd www.gtcert.com

IE-ORG-05 BDA Certification www.biodynamic.org.uk

Italy Control Bodies

IT-BIO-001-

BZ

BIKO – Tirol www.biko.at CERTIFIED

PRODUCTION

S:

Vegetable

Wine

Zootechnics

IT-BIO-002 CODEX Srl www.codexsrl.it CERTIFIED

PRODUCTION

S:

Vegetable

Wine

Zootechnics

Preparation

Import

IT-BIO-003-

BZ

QC&I GmbH www.qci.de CERTIFIED

PRODUCTION

S:

Vegetable

Zootechnics

Preparation

IT-BIO-004 SUOLO & SALUTE Srl www.suoloesalute.it CERTIFIED

PRODUCTION

S:

Vegetable

Wine

Zootechnics

Preparation


Regulations 2019

SD No.2019/0212 c

Not authorised

for control of

import activity

OPERATIVE

OFFICE:

Via Galliera, 93

40121 Bologna

(BO) +39 051

6751265

IT-BIO-005 BIOS Srl www.certbios.it CERTIFIED

PRODUCTION

S:

Vegetable

Wine

Zootechnics

Aquaculture

Preparation

Import

IT-BIO-006 ICEA Srl www.icea.info CERTIFIED

PRODUCTION

S:

Vegetable

Wine

Zootechnics

Aquaculture

Preparation

Import

IT-BIO-007 Bioagricert Srl www.biocert.org CERTIFIED

PRODUCTION

S:

Vegetable

Wine

Zootechnics

Aquaculture

Preparation

Import

IT-BIO-008 ECOGRUPPO ITALIA Srl www.ecogruppoitalia.it CERTIFIED

PRODUCTION

S:

Vegetable

Wine

Zootechnics

Preparation

Import

IT-BIO-009 CCPB Srl www.ccpb.it CERTIFIED

PRODUCTION

S:

Vegetable

Wine

Zootechnics


c SD No.2019/0212

Aquaculture

Preparation

Import

IT-BIO-012 Sidel Spa www.sideitalia.it CERTIFIED

PRODUCTION

S:

Vegetable

Wine

Zootechnics

Preparation

Import

IT-BIO-013 ABCERT Srl www.abcert.it CERTIFIED

PRODUCTION

S:

Vegetable

Wine

Zootechnics

Preparation

Import

IT-BIO-014 QCertificazioni Srl www.qcsrl.it CERTIFIED

PRODUCTION

S:

Vegetable

Wine

Zootechnics

Aquaculture

Preparation

Import

IT-BIO-015 Valoritalia Srl www.valoritalia.it CERTIFIED

PRODUCTION

S:

Vegetable

Wine

Zootechnics

Preparation

Import

OPERATIVE

OFFICE:

Piazza Roma, 10

14100 Asti (AT)

+39 0141 436915

IT-BIO-016 Siquria www.siquria.it CERTIFIED

PRODUCTION

S:

Vegetable

Wine

Zootechnics

Preparation

Import

IT-BIO-017 CEVIQ srl www.ceviq.it CERTIFIED


Regulations 2019

SD No.2019/0212 c

PRODUCTION

S:

Vegetable

Wine

Zootechnics

Preparation

Import

IT-BIO-018 Agroqualitia S.p.a. www.agroqualita.it CERTIFIED

PRODUCTION

S:

Vegetable

Zootechnics

Preparation

Import

IT-BIO-019 Instituto Nord Ovest Qualita

Soc. Coop.

www.inoq.it CERTIFIED

PRODUCTION

S:

Vegetable

Zootechnics

Preparation

Import

IT-BIO-020 Dipartimento di Qualita

Agroalimentare Srl

www.dqacertificazioni.it Vegetable

Zootechnics

Preparation

Import

LATVIA Control Bodies

LV-BIO-01 Biedriba ‘Vides kvalitãte’ www.videskvalitate.lv

LV-BIO-02 Valsts SIA ‘Sertifikãcijas

untestesanas ‘centrs

www.stc.lv

LUTHUANI

A

Control Bodies

LT-EKO-01 Ekoagros www.ekoagros.lt

LUXEMBOU

RG

Control Bodies

and Control

Authorities

LU-BIO-01 Administration des Services

techniques de l’Agriculture

(autorité compétente) Service

de la protection des végétaux

www.asta.etat.lu

LU-BIO-04 Prüfverein Verarbeitung

Okologische Landbauprodukte

e.V.(DE-ÖKO-007)

www.pruefverein.de

LU-BIO-05 Kontrollverein Ökologischer

Landbau e.V. (DE-ÖKO-022)

www.kontrollverein.de

LU-BIO-06 CERTISYS (BE-BIO-01) www.certisys.eu

LU-BIO-07 GfRS Gesellschaft

fürRessourcenschutz mbH (DE-

ÖKO-039)

www.gfrs.de

LU-BIO-08 Quality Partner S.A. (BE-BIO-

03)

www.quality-partner.be/


c SD No.2019/0212

MALTA Control

Authorities

MT-ORG-01 Malta Competition and

Consumer Affairs

mccaa.org.mt/

NETHERLA

NDS

Control

Authorities

NL-BIO-01 Stichting Skal Biocontrole www.skal.nl

POLAND Control Bodies

and Control

Authorities

PL-EKO-01 EKOGWARANCJA PTRE Sp.

z.o.o

www.ekogwarancja.pl

PL-EKO-02 PNG Sp. z o.o. www.certyfikacja.co

PL-EKO-03 COBICO Sp. z o.o. www.cobico.pl Not accredited

for aquaculture

animal

production and

seaweed

PL-EKO-04 Bioekspert Sp. z o.o. www.bioekspert.pl Not accredited

for aquaculture

animal

production and

seaweed. Not

accredited for

beekeeping

PL-EKO-05 BIOCERT MALOPOLSKA Sp.z

o.o.

www.biocert.pl

PL-EKO-06 POLSKIE CENTRUM BADAN

I CERTYFIKACJI S.A.

www.pcbc.gov.pl

PL-EKO-7 AGRO BIO TEST Sp. z o.o. www.agrobiotest.pl Not accredited

for the

collection of

wild plants and

parts thereof,

growing

naturally in

natural areas,

forests and

agricultural

areas. Not

accredited for

aquaculture

animal

production and

seaweed.

PL-EKO-08 TÜV RHEINLAND POLSKA

Sp. z o.o.

www.tuv.pl

PL-EKO-09 CENTRUM JAKOŠCI

AGROEKO Sp. z o.o.

www.agroeko.com.pl

PL-EKO-10 SGS POLSKA Sp. z o.o. www.pl.sgs.com Not accredited


Regulations 2019

SD No.2019/0212 c

for:

- aquaculture

animal

production and

seaweed

- bees

production.

PL-EKO-11 DQS Polska Sp. z o.o. dqs.pl Not accredited

for aquaculture

animal

production and

seaweed. Not

accredited for

bees

production.

PL-EKO-12 Bureau Veritas Polska Sp. z.o.o. www.bureauveritas.pl Not authorized

for:

- aquaculture

animal

production and

seaweed,

- collection of

wild plants and

parts thereof,

growing

naturally in

natural areas,

forests and

agricultural

areas,

- bees

production.

Control Body

was authorized

to control and

certify organic

production 5th

March

PORTUGAL Control Bodies

PT-BIO-11 APCER – Associação

Portuguesa de Certificacão

www.apcer.pt

PT-BIO-10 Naturalfa - control e

certificação, Lda

www.naturalfa.pt

PT-BIO-01 IVDP - Instituto dos vinhos do

Douro e do

Porto

www.ivdp.pt

PT-BIO-02 ECOCERT PORTUGAL,

Unipessoal Lda

www.ecocert.pt

PT-BIO-03 SATIVA, Desenvolvimento

Rural, Lda

www.sativa.pt


c SD No.2019/0212

PT-BIO-04 CERTIPLANTET - Certificação

da Agricultura, Florestas e

Pescas, Unipessoal, Lda

www.certiplanet.pt

PT-BIO-05 CERTIS, Controlo e

Certificação, Lda

www.certis.pt

PT-BIO-06 AGRICERT - Certificação de

Produtos Alimentares, Lda

www.agricert.pt

PT-BIO-07 TRADIÇÃO E QUALIDADE [email protected]

PT-BIO-08 CODIMACO - Certificação e

Qualidade, Lda

www.codimaco.pt

PT-BIO-09 SGS Portugal - Sociedade Geral

de Superintendência, S. A.

www.pt.sgs.com

ROMANIA Control Bodies

RO-ECO-007 S.C ECOCERT S.R.L www.ecocert.com Approved by

CA for:

- unprocessed

plants products

- live and

unprocessed

animal products

- processed

agricultural

products for use

as food

- processed

agricultural

products for use

as feed

- vegetative

propagating

material and

seeds for

cultivation

RO-ECO-008 S.C. ECOINSPECT S.R.L www.ecoinspect.ro Approved by

CA for:

- unprocessed

plants products

- live and

unprocessed

animal products

-aquaculture

products

- processed

agricultural

products for use

as food

- processed

agricultural

products for use

as feed


Regulations 2019

SD No.2019/0212 c

- vegetative

propagating

material and

seeds for

cultivation

RO-ECO-009 BIOS S.R. L. ITALIA -

SUCURSALA ROMÃNIA

www.certbios.ro Approved by

CA for:

-unprocessed

plants products

- live and

unprocessed

animal products

- aquaculture

products

- processed

agricultural

products for use

as food

- processed

agricultural

products for use

as feed

- vegetative

propagating

material and

seeds for

cultivation

RO-ECO-015 AGRECO R.F. GÖDERZ

GMBH GERMANI -

SUCURSALA ROMÃNIA

www.agrecogmbh.de Approved by

CA for:

- unprocessed

plants products

- live and

unprocessed

animal products

- processed

agricultural

products for use

as food

- vegetative

propagating

material and

seeds for

cultivation

RO-ECO-016 BIOAGRICERT ITALI SRL -

SUCURSALA ROMÃNIA

www.bioagricert.org Approved by

CA for:

- unprocessed

plants products

- live and

unprocessed

animal products


c SD No.2019/0212

- processed

agricultural

products for use

as food

- processed

agricultural

products for use

as feed

RO-ECO-018 AUSTRIA BIO GARANTIE

GmbH ENZERSFELD

SUCURSALA BUCURESTI

ro.abg-cert.com/ Approved by

CA for

- unprocessed

plants products

- live and

unprocessed

animal products

- aquaculture

products

- processed

agricultural

products for use

as food

- processed

agricultural

products for us

as feed

- vegetative

propagating

material and

seeds for

cultivation

RO-ECO-021 CERTROM SRL www.certrom.ro Approved by

CA for:

- unprocessed

plants products

- live and

unprocessed

animal products

- aquaculture

products

- processed

agricultural

products for use

as food

- processed

agricultural

products for use

as feed

- vegetative

propagating

material and


Regulations 2019

SD No.2019/0212 c

seeds for

cultivation

RO-ECO-022 S.C. ECOROISCERT SRL www.ecoroiscert.ro Approved by

CA for:

- unprocessed

agricultural

products

RO-ECO-023 MISCAREA ROMÃNÃ

PENTRU CALITATE

www.mrco.ro Approved by

CA for:

- unprocessed

plants products

- live and

unprocessed

animal products

RO-ECO-024 CERES ORGANIC VCERT SRL www.ceres-cert.com Approved by

CA for:

- unprocessed

plants products

- live and

unprocessed

animal products

- processed

agricultural

products for use

as food

- processed

agricultural

products for use

as feed

RO-ECO-025 BIO CERT TRADITIONAL SRL biocerttraditional.ro Approved by

CA for:

- unprocessed

plants products

- live and

unprocessed

animal products

- processed

agricultural

products for use

as food

RO-ECO-026 SC SRAC CERT SRL N/A Approved by

CA for:

-. Agricultural

unprocessed

products

- live or

unprocessed

agricultural

products

- processed


c SD No.2019/0212

agricultural

products for us

as food

RO-ECO-027 SC TUV AUSTRIA ROMÃNIA

SRL

N/A Approved by

CA for: —

- unprocessed

plants products

- live and

unprocessed

animal products

- processed

agricultural

products for use

as food

- processed

agricultural

products for

used as feed

SLOVAKIA Control Bodies

SK-BIO-002 Naturalis SK, s.r.o www.naturalis.sk

SK-BIO-003 Biokont CZ, s.r.o. www.biokont.sk Mgr. Ján Kútnit

is designated

representative

in Slovak

republic

SK-BIO-004 EKO-CONTROL SK s.r.o, www.eo.control.sk

SI-EKO-001 Institute for Inspection and

Certification in Agriculture and

in Silviculture Maribor

(Institute KON - CERT

Maribor)

www.kon-cert.si Control body

does not have

the scope of

accreditation

for feed

SLOVENIA Control Bodies

SI-EKO-002 Institute for Inspection and

Certification of University of

Maribor (IKCUM)

www.ikc-um.si

SI-EKO-003 Bureau Veritas d.o.o www.bureauveritas.si

SI-EKO-004 TUV SUD Sava d.o.o www.tuv-sud.si/sava-si

SPAIN Control Bodies

and Control

Authorities

ES-ECO-001-

AN

SERVICIO DE

CERTIFICACIÓN CAAE,

S.L.U.

Andalusia

www.caae.es

ES-ECO-001-

AR

SERVICIO DE

CERTIFICACIÓN CAAE, S.L.

Aragon

www.caae.es

ES-ECO-001-

CL

SERVICIO DE


Castile-y-Léon

www.caae.es


Regulations 2019

SD No.2019/0212 c

ES-ECO-001-

CM

SERVICIO DE


Castile-La Mancha

www.caae.es

ES-ECO-002-

AN

SOHISCERT S.A.

Andalusia

www.sohiscert.com

ES-ECO-002-

AR

SOHISCERT S.A.

Aragon

www.sohiscert.com

ES-ECO-002-

CL

SOHISCERT S.A.

Castile-y-Léon

www.sohiscer.com

ES-ECO-002-

CM

SOHISCERT, S.A.

Castile-La Mancha

www.sohiscert.com

ES-ECO-003-

AN

AGROCOLOR, S.L.

Andalusia

www.agrocolor.es

ES-ECO-004-

AN

LGAI TECHNOLOGICAL

CENTER, S.A.

Andalusia

N/A

ES-ECO-005-

AN

CERES Certification of

Environmental Standard

GMBH

Andalusia

www.ceres-cert.com

ES-ECO-006-

AR

COMITÉ ARAGONES DE

AGRICULTURE ECOLÓGICA

Aragon

www.caaearagon.com

ES-ECO-010-

AN

ECOCERT S.A.

Andalusia

www.ecocert.com/es/

ES-ECO-010-

AR

ECOCERT S.A.

Aragon

www.ecocert.com

ES-ECO-011-

AN

KIWA ESPAÑA S.L.U.

Andalusia

www.kiwa.es

ES-ECO-011-

AR

KIWA ESPAÑA S.L.U. -

Aragón

Aragón

www.kiwa.es

ES-ECO-001-

CL

KIWA ESPAÑA, S.L.U.

Castile-y-Léon

www.kiwa.es

ES-ECO-011-

CM

KIWA ESPAÑA S.L.U.

Castile-La Mancha

www.kiwa.es

ES-ECO-012-

AS

CONSEJO DE LA

PRODUCCIÓN AGRARIA

ECOÓGICA DEL

PRINCIPADO DE ASTURIAS

Asturias

www.copaeastur.or

ES-ECO-013-

IB

Consell Balear de la Producció

Agrària Ecològica (CBPAE)

Balearic Islands

www.cbpae.org

ES-ECO-014-

IC

INSTITUTO CANARIO DE

CALIDAD

AGROALIMENTARIA (ICCA)

Canary Islands

www.gobiernodecanarias.

org/agricultura/i

Public Control

Authority

ES-ECO-015- OFICINA DE CALIDAD www.alimentosdecantabri Public Control


c SD No.2019/0212

CN ALIMENTARIA

Cantabria

a.com Authority

ES-ECO-016-

CL

CAECYL - CONSEEJO DE

AGRCULTURA ECOLÓGICA

DE CASTILLA Y LEÓN

Castile-y-Léon

www.caecyl.es Public Control

Authority

ES-ECO-019-

CT

CONSELL CATALÀ DE LA

PRODUCCIÓ

AGRÀRAI ECOLÒGICA -

CONSEJO

CATALÁN DE LA

PRODUCCIÓN AGRARIA

ECOLÓGICA

Catalonia

www.ccpae.org Public Control

Authority

ES-ECO-020-

CV

COMITÉ DE AGRICULTURA

ECOLÓGICA DE LA

COMUNIDAD VALENCIANA

(CAECV)

Valencia

www.caecv.com Public Control

Authority

ES-ECO-021-

EX

DIRECCIÓN GTENERAL DE

AGRICULTURA Y

GANADERÍA

Extremadura

N/A Public Control

Authority

ES-ECO-022-

GA

CONSEJO REGULADOR DE

AGRICULTURA ECOLÓGICA

DE GALICIA (CRAEGA)

Galicia

www.craega.es Public Control

Authority

ES-ECO-023-

MA

COMITÉ DE AGRICULTURA

ECOLÓGICA DE LA

COMUNIDAD DE MADRID

Madrid

www.caem.es Public Control

Authority

ES-ECO--

024-MU

CONSEJO DE AGRICULTURA

ECOLÓGICA DE LA REGIÓN

DE MURCIA

Murcia

www.caernrcia.com Public Control

Authority

ES-ECO-025-

NA

CONSEJO DE LA

PRODUCCIÓN AGRARIA

ECOLÓGICA DE NAVARRA

(CPAEN) —

Nafarroako Nekazal Produkzio

Ekologikoarean kontseilua

(NNPEK)

Navarre

www.cpaen.org Public Control

Authority

ES-ECO-026-

VAS

ENEEK - CONSEJO DE

AGRICULTURA Y

ALIMENTACIÓN

ECOLÓGICA DE EUSKADI/

Euskadiko Nekazaritza Eta

Elikadura

Ekologikoaren kontseilua

www.eneek.eus Public Control

Authority


Regulations 2019

SD No.2019/0212 c

Basque Country

ES-ECO-027-

RI

DIRECCIÓN GENERAL DE

AGRICULTURA Y

GANADERÍA CONSEJERÍA

DE AGRICULTURA,

CANADERÍA Y MEDIO

AMBIENTE

Rioja

www.larioja.org/agricultur

a/agriculturaecologica

Public Control

Authority

ES-ECO-028-

AN

CERTIFOOD S.L.

Andalusia

www.certifood.org Private Control

Body

ES-ECO-028-

AR

CERTIFOOD S.L.

Aragon


Body

ES-ECO-028-

CL

CERTIFOOD S.L.

Castile-y-Léon


Body

ES-ECO-028-

CM

CERTIFOOD S.L.

Castile-La Mancha


Body

ES-ECO-029-

AN

UREAU VERITAS IBERIA S.L.

Andalusia

www.bureauveritas.es Private Control

Body

ES-ECO-029-

CL

BUREAU VERITAS IBERIA

S.L.

Castile-y-Léon


Body

ES-ECO-029-

CM

BUREAU VERITAS IBERIA

S.L.

Castile-La Mancha


Body

ES-ECO-30-

CM

CENTRO DE INNOVACIÓN

TECNOLÓGICO

AGROALIMENTARIO, S.A.

(CITAGRO, S.A.)

Castile-La Mancha

citagro.es/ Private Control

Body

ES-ECO-031-

CL

CCL CERTIFICACIÓN, S.L.

Castile-y-Léon

www.cclalimentaria.es Private Control

Body

ES-ECO-032-

CL

SAI GLOBAL ASSURANCE

SERVICES - OFICINA DE

REPRESENTACION EN

ESPAÑA, LTD

Castile-y-Léon

www.saigblobal.com Private Control

Body

ES-ECO-033-

CM

QUALITAS NATURA

CERTIFICACIÓN S.L.

Castile-La Mancha

www.qualitasnatura.es Private Control

Body

ES-ECO-034-

CM

OCE GLOBAL, S.L.U.

Castile-La Mancha

www.oce-global.com Private Control

Body

SWEDEN Control bodies

SE-EKO-01 KIWA Sverige AB www.kiwa.com All scope

SE-EKO-03 Smak Certifiering AB www.smak.se All scope

SE-EKO-04 HS Certifiering AB www.hscertifiering.se All scope

SE-EKO-05 Valiguard AB www.valiguard.com Processed

agricultural

products for use

as food


c SD No.2019/0212

SE-EKO-06 ControlCert Scandinavia AB www.controlcert.se Processed

agricultural

products for use

as food

SE-EKO-07 ProSanitas Certifiering AB www.bmgprosanitas.se Processed

agricultural

products for use

as food.

Mushroom

production

(limited

delegation of

crop

production)

SE-EKO-08 Intertek Certification AB www.intertek.se Processed

agricultural

products for use

as food Feed

vegetative

propagating

material and

seeds for

cultivation

ICELAND

(EEA state)

Control Bodies

IS-LIF-01 Vottunarstofa Tun www.tun.is

NORWAY

(EEA state)

Control Bodies

NO-ØKO-01 Debio www.debio.no

SWITZERLA

ND AND

LIECHTENS

TEIN (EEA

state)

No updated

information

submitted

6. Certificate issuing bodies: as at point 5.

7. Duration of the inclusion: 31st December 2020.».

(26) In Annex 5 —

(a) in the heading, for “EUROPEAN UNION” substitute «ISLE OF

MAN»;

(b) for box 2 substitute —

«2. Council Regulation (EC) No 834/2007, as it has effect in the Isle of Man:

- Article 33(2) or

- Article 33(3)

Council Regulation (EC) No 834/2007, as it has effect in the European Union:

- Article 33(2) or

- Article 33(3) »;


Regulations 2019

SD No.2019/0212 c

(c) in the Notes —

(i) in the entry relating to box 2, after “834/2007” insert «, as

it has effect in the Island or Regulation (EC) No 834/2007,

as it has effect in the European Union,»;

(ii) in the entry relating to box 3, for “electronic Trade Control

and Expert System (TRACES)” substitute «United

Kingdom’s import control system»;

(iii) in the entry relating to box 4 —

(A) after “834/2007” insert «, as it has effect in the

Island, or Article 2(i) of Regulation (EC) No

834/2007, as it has effect in the European Union,»;

(B) after “889/2008” insert «, as it has effect in the

Island or Article 34 of Regulation (EC) 889/2008, as

it has effect in the European Union.»;

(iv) in the entry relating to box 8, after “834/2007” insert «, as

it has effect in the Island, or Article 2(i) of Regulation (EC)

No 834/2007, as it has effect in the European Union,»;

(v) in the entry relating to box 9, for the words from “country

in” to the end substitute «Isle of Man»;

(vi) in the entry relating to box 10, for the words from “the

country” to the end substitute «the Isle of Man»;

(vii) in the entry relating to box 11 —

(A) for “European Union” substitute «Isle of Man»;

(B) omit “into the Union”;

(viii) in the entry relating to box 12, for “European Union”


(ix) in the entry relating to box 19, omit “relevant Member

State’s”;

(x) in the entry relating to box 20, omit “relevant Member

State’s”.

(27) In Annex 6 —

(a) in the heading, for “EUROPEAN UNION” substitute «ISLE OF

MAN»;

(b) for box 2 substitute —

«2. Council Regulation (EC) No 834/2007, as it has effect in the Isle of Man:

- Article 33(2) or

- Article 33(3)

Council Regulation (EC) No 834/2007, as it has effect in the European Union:

- Article 33(2) or


c SD No.2019/0212

- Article 33(3) »;

(c) in the Notes —

(i) in the entry relating to box 2, after “834/2007” insert «, as

it has effect in the Island or Regulation (EC) No 834/2007,

as it has effect in the European Union,»;

(ii) in the entry relating to box 3, for “electronic Trade Control

and Expert System (TRACES)” substitute «United

Kingdom’s import control system»;

(iii) in the entry relating to box 9, for the words from “country

in” to the end substitute «Isle of Man»;

(iv) in the entry relating to box 10, for the words from “the

country” to the end substitute «the Isle of Man»;

(v) in the entry relating to box 11, for “European Union”


(vi) in the entry relating to box 13, omit “relevant Member

State’s”.

(28) Omit Annex 7.

PART 4

SPIRIT DRINK REGULATIONS


(1) Commission Regulation (EC) No 2870/2000 of 19 December 2000 laying

down Community reference methods for the analysis of spirits drinks64 is

amended as follows.

(2) In Article 1, in the words before the first indent —

(a) omit “Community”; and

(b) for the words from “Regulation (EEC) No 1576/89” to “1014/90”

substitute «Regulation 110/2008».


(a) in the words before point (a) —

(i) omit “Community”; and

(ii) after “down” insert «in retained EU law»;



Regulations 2019

SD No.2019/0212 c

(b) in point (a), for “the Annex to Directive 85/591/EEC” substitute

«Annex 3 to Regulation (EC) No 882/2004 of the European

Parliament and of the Council»;

(c) in point (d), in the first indent —

(i) at the beginning insert «in relation to an official

control,»; and

(ii) for “Member State concerned” substitute «appropriate

authority, by administrative decision, on a case by case

basis»; and

(d) after the existing paragraph insert —

«In this Article ‘the appropriate authority’ means the


(4) In Article 4, after point (c) insert —

«(d) ‘Regulation 110/2008’: means Regulation (EC) No 110/2008 of the

European Parliament and of the Council.».


States.”.


(a) in Part 3(1) (general remarks relating to the determination of

volatile substances and methanol of spirit drinks) —

(i) in point 1, in the words before point 1, for “Regulation

(EEC) No 1576/89” substitute «Regulation 110/2008»;

and

(ii) in point 2, in the second subparagraph, for “Regulation

(EEC) No 1576/89” substitute «Regulation 110/2008»;

(b) in Part 6 (determination of glycyrrhizic acid using high

performance liquid chromatography), in point 1, for “Regulation

(EEC) No 1576/89” substitute «Regulation 110/2008»; and

(c) in Part 7 (high-performance liquid chromatography method for

verifying the presence of chalcones in pastis), in point 1, in the

second subparagraph, for Regulation (EEC) No 1576/89”

substitute «Regulation 110/2008».

18 Regulation (EC) No 110/2008 amended


Council of 15 January 2008 on the definition, description, presentation,

labelling and the protection of geographical indications of spirit drinks


c SD No.2019/0212

and repealing Council Regulation (EEC) No 1576/8965 is amended as

follows.



(i) in the first sentence, for “Community”, in each place it

occurs, substitute «Island»; and

(ii) for “third” substitute «other»;


(i) omit “third”; and

(ii) for the words from “the regulatory” to the end substitute

«paragraphs 4 to 6»; and


«4. A derogation may be granted:

(a) by regulations, or

(b) on application, by administrative decision, where regulations

have not been made or where regulations have been made but do

not apply in a particular case.

5. An application of the type referred to in the paragraph 4(b) in

relation to an operator intending to export a consignment of a

spirit drink to a relevant third country from the Island, may be

made to the Department of Environment, Food and Agriculture.

6. An application of the type referred to in paragraph 4(b) must be

made in relation to one type of spirit drink and on a consignment

by consignment basis.

7. In this Regulation ‘consignment’ means a quantity of one type

of spirit drink covered by a single document required for customs

formalities and may be composed of more than one lot.».


(a) in point (f)(i), for the words from “Council Directive 98/83/EC” to

“Council” substitute «relevant water quality legislation»; and

(b) at the end insert, as a separate paragraph —

«In this Article “relevant water quality legislation” means, in relation to

spirit drinks marketed in the Isle of Man, the Natural Mineral Water,

Spring Water and Bottled Drinking Water Regulations 200966 and the

Water Supply Byelaws 200267.».

65 Paragraph 49(2) of the Schedule to the retention regulations. 66 [S.D. 405/09.] 67 [S.D. 222/02.]


Regulations 2019

SD No.2019/0212 c


«Article 2a

Other definitions

In this Regulation:

‘enactment’ includes statutory documents;

‘third country’ means a country, other than the British Islands;

‘Department’ means the Department of Environment, Food and

Agriculture.».


(a) in paragraph 1)(e), for the words from “shall be decided” to the

end substitute «may be specified in regulations»; and

(b) in paragraph 2)(e), omit the words from “and taking” to the end.



«Stricter rules»;


(i) for the words from “and in” to “down” substitute «,

nothing in this Regulation prevents the making of

regulations imposing»;

(ii) after “labelling” insert «in relation to a category of spirit

drink in Annex 2»; and

(iii) for “Community” substitute «retained EU»; and


«2. In paragraph 1, ‘regulations’ means any regulations made by

the Department under the Food Act 1996 using an enabling power

in that Act that confers power on the Department to make

regulations imposing such stricter rules.».

(7) In Article 8, for “Article 5 of Directive 2000/13/EC” substitute «Article 17

of Regulation (EU) No 1169/2011 of the European Parliament and of the

Council on the provision of food information to consumers».


(a) in paragraph 6(a), for the words from “established” to “Article 20”

substitute —

«any of the following geographical indications:

(i) Irish Cream;

(ii) Irish Whiskey, Irish Whisky, Uisce Beatha Eireannach;


c SD No.2019/0212

(iii) Scotch Whisky;»; and

(b) in paragraph 9, for “Directive 2000/13/EC” substitute



(a) in paragraph 1, for “Directive 2000/13/EC” substitute


(b) in paragraph 4 omit “in the Community”.

(10) In Article 11(4), in the first subparagraph, for “Directive 2000/13/EC”

substitute «Regulation (EU) No 1169/2011».

(11) In Article 12(3) —

(a) omit the words from the beginning to “Article 25(3)”; and

(b) at the end insert as a new sentence —

«Regulations may specify derogations in respect of this

requirement.».

(12) In Article 14(4), for “Community” substitute «Island».

(13) In Article 15(3), in the third subparagraph, for “Community” substitute

«Island, the United Kingdom or the Channel Islands».



(i) for “Commission” substitute «United Kingdom Secretary

of State»; and

(ii) omit from “in one of the official” until the end; and





(18) In Article 22(1) —

(a) in the first subparagraph, in the words before the first indent, for

“Community” substitute «Island»; and

(b) for the first indent (but not the final “and/or”) substitute —

«— the authority designated as the authority responsible for

carrying out such verification by regulation 5 of the Spirit Drinks

Regulations 200868,».


68 SI 2008/3206


Regulations 2019

SD No.2019/0212 c


(i) omit “With due regard to Community law,”;

(ii) omit the words from “ if that” to “concerned,”;

(iii) for “territory of the Community” substitute «Island»;

and

(iv) for the words from “as specified” to the end substitute

«in, or under, the Trade Marks Act 1994 (of Parliament),

as applied to the Island»; and

(b) in paragraph 3, for “Community” substitute «Island, the United

Kingdom or the Channel Islands».



«Article 25

Regulations


contain —


provisions;









(i) for the words before point (a) substitute «Regulations

may be made»;

(ii) omit point (a); and

(iii) in point (c) omit “Community”;


(i) for the words from the beginning to “adopted” substitute

«Regulations may be made»; and

(ii) omit “Community”; and



c SD No.2019/0212

(i) omit the first sentence; and

(ii) in the second sentence, for “prior to 20 February 2008 or

until” substitute «as it had effect in the Island

immediately before».


States.”.

(24) In Annex 1 —

(a) in point (6) —

(i) in the first paragraph, for the words from “Council

Directive 80/777/EEC” to “consumption” substitute “any

relevant water quality legislation”; and

(ii) after the second paragraph insert —

«In this point ‘relevant water quality legislation’ means,

in relation to spirit drinks marketed in the Island, the

Water Act 1991 and the Natural Mineral Water, Spring

Water and Bottled Drinking Water Regulations 200969.»;

and

(b) in point (10), for the words from “colorants” to the end substitute

«colours, as defined in entry 2 of Annex 1 to Regulation (EC) No

1333/2008 of the European Parliament and of the Council on food

additives».

(25) In Annex 2 —

(a) in category 1 —

(i) in point (a)(ii) omit the second sentence; and

(ii) omit point (f);

(b) in category 9, in point (f), in the first subparagraph, omit the

second sentence;

(c) in category 15, in point (d), for “13(2) of Directive 2000/13/EC”

substitute «13(1) of Regulation (EU) No 1169/2011»;

(d) in point (c) of each of categories 25, 26, 27, 28 and 29, for “1(2)(b)(i)

and Article 1(2)(c) of Directive 88/388/EEC” substitute «3(2)(c)

and (d) of Regulation (EC) No 1334/2008»;

(e) in category 32, in point (d), in the first paragraph, in the words

before the first indent omit “produced in the Community”;

(f) in category 37, in point (c), for “1(2)(b)(i) and Article 1(2)(c) of

Directive 88/388/EEC” substitute «3(2)(c) and (d) of Regulation

(EC) No 1334/2008»;

69 S.D. 405/09.


Regulations 2019

SD No.2019/0212 c

(g) in category 37a, in the second paragraph omit “Member State or

third”;

(h) in categories 42(c), 43(c), 45(c) and 46(c), for “1(2)(b)(i) and Article

1(2)(c) of Directive 88/388/EEC” substitute «3(2)(c) and (d) of

Regulation (EC) No 1334/2008»; and

(i) in the section headed “Other spirit drinks” —

(i) in point 1, in the final sentence omit the words from

“Where” to “market,”; and

(ii) in point 2, in the third sentence omit the words from “If

this” to “Community,”.

(26) For Annex 3 substitute —

«ANNEX 3

GEOGRAPHICAL INDICATIONS

Product category Geographical indication Country of origin (the

precise geographical origin

is described in the technical

file)

Whisky/Whiskey

Scotch Whisky United Kingdom

(Scotland)

Irish Whiskey/ Irish

Whisky/ Uisce Beatha

Eireannach (1)

Ireland

Cider spirit and perry

spirit

Somerset Cider Brandy (2) United Kingdom

Liqueur

Irish Cream (3) Ireland

Other spirit drinks

Irish Poteen/Irish Poitín Ireland (4) (1) The geographical indications ‘Irish Whiskey’, ‘Irish Whisky’ and ‘Uisce Beatha

Eireannach’ cover whisky/whiskey produced in Ireland and Northern Ireland.

(2) The geographical indication ‘Somerset Cider Brandy’ must be accompanied by

the sales denomination ‘cider spirit’.

(3) The geographical indication ‘Irish Cream’ covers the corresponding liqueur

produced in Ireland and Northern Ireland.

(4) The geographical indication ‘Irish Poteen/Irish Poitín’ covers the corresponding

spirit drink produced in Ireland and Northern Ireland.»


c SD No.2019/0212

19 Commission Implementing Regulation (EU) No 716/2013 amended

(1) Commission Implementing Regulation (EU) No 716/2013 of 25 July 2013

laying down rules for the application of Regulation (EC) No 110/2008 of

the European Parliament and of the Council on the definition,

description, presentation, labelling and the protection of geographical

indications of spirit drinks70 is amended as follows.

(2) In Article 1(b) omit “Union”.

(3) In Article 2, after point (d) insert —

«(e) ‘third country’ means any country, other than the British Islands;

(f) ‘Department’ means the Department of Environment, Food and

Agriculture.».


(a) in the words before point (a), for “Commission” substitute «the

United Kingdom Secretary of State»; and

(b) omit “and consist of” until the end of the Article.



States.”.



(1) Commission Regulation (EC) No 936/2009 applying the agreements

between the European Union and third countries on the mutual

recognition of certain spirit drinks71 is amended as follows.



(i) for “third countries referred to therein” substitute

«United States of America»; and

(ii) for “third countries concerned” substitute «United States

of America»; and

(b) in paragraph 2, for the words from “referred to” to the end

substitute «contained in the Spirit Drinks Regulations 200872

under the conditions laid down in the Agreement between the

United Kingdom of Great Britain and Northern Ireland and the

United States of America on the mutual recognition of certain

70 Paragraph 49(3) of the Schedule to the retention regulations. 71 Paragraph 49(4) of the Schedule to the retention regulations, as amended by SD 2019/0122. 72 SI 2008/3206, as amended.


Regulations 2019

SD No.2019/0212 c

distilled spirits/spirit drinks as if the product descriptions were

registered Annex 3 geographical indications (as defined in those

Regulations)».


States.”.

(4) In Annex 1, in the table omit the last two rows (relating to tequila and

mescal).

PART 5

WINE REGULATIONS


(1) Commission Regulation (EC) No 606/2009 of 10 July 2009 laying down

certain detailed rules for implementing Council Regulation (EC) No

479/2008 as regards the categories of grapevine products, oenological

practices and the applicable restrictions73 is amended as follows.


«Article 1

Purpose

This Regulation lays down detailed rules for the application of the

following provisions of Regulation (EU) No 1308/2013 of the European

Parliament and of the Council establishing a common organisation of

the markets in agricultural products:

(a) Articles 75, 80, 83 and 90;

(b) Part 2 of Annex 7;

(c) Annex 8.».


«Article 1a

Definitions

In this Regulation:

‘the appropriate authority’ means the Department of Environment,


‘relevant legislation’, in relation to the making of regulations referred to

in a provision, means regulations made under the Food Act 1996 using

an enabling power in that Act that confers power on the appropriate



c SD No.2019/0212

authority to make regulations about the matter specified in the

provision in question.»

(4) Omit Article 2.

(5) In Article 3(1), for the words from “Regulation” to “thereof,” substitute

“Part 2 of Annex 7 to Regulation (EU) No 1308/2013”.


(a) in paragraph 1, in the first subparagraph —

(i) in the words before point (a), for the words from “Article

29(2)” to “use” substitute «Article 83(3) of Regulation

(EU) No 1308/2013, the appropriate authority may, on

application, authorise, by administrative decision, the use

by the applicant»;

(ii) in point (a), for the words from “Articles” to the end

substitute «the third subparagraph of Article 80(1), and

Article 80(3)(b) to (e), of Regulation (EU) No 1308/2013»;

and

(iii) omit point (c);





(a) for the words from “point (b)” to “of Regulation (EC) No

479/2008” substitute «points (4), (5) and (6) of Part 2 of Annex 7

to Regulation (EU) No 1308/2013»; and

(b) for “in Regulation (EC) No 479/2008” substitute «in Regulation

(EU) No 1308/2013».


(a) for the words from “point (c)” to “of Regulation (EC) No

479/2008” substitute «point (3) of Part 2 of Annex 7 to Regulation

(EU) No 1308/2013»; and

(b) for “in Regulation (EC) No 479/2008” substitute «in Regulation

(EU) No 1308/2013».

(9) In Article 7(1), for the words from “point (d)” to “479/2008” substitute

«Article 75(3)(h) of Regulation (EC) No 1308/2013».


(a) in the first subparagraph, for “Regulation (EC) No 479/2008”

substitute «Regulation (EU) No 1308/2013»; and


Regulations 2019

SD No.2019/0212 c

(b) in the third subparagraph, for “Annex I to Regulation (EC) No

479/2008” substitute «point 12 of Part 4 of Annex 2 to Regulation

(EU) No 1308/2013».


(a) for “Commission Directive 2008/84/EC” substitute «Commission

Regulation (EU) No 231/2012 laying down specifications for food

additives listed in Annexes II and III to Regulation (EC) No

1333/2008 of the European Parliament and of the Council»; and

(b) for the words from “point (e)” to “479/2008” substitute «Article

75(3)(f) of Regulation (EU) No 1308/2013».


(a) in the heading, for the words from “Chapter II” to “479/2008”

substitute «Article 80 of Regulation (EU) No 1308/2013»;


(i) for the words from “Chapter II” to “479/2008” substitute

«Article 80 of Regulation (EU) No 1308/2013»;

(ii) for “Member States may authorise” substitute «nothing in

this Regulation prevents the appropriate authority from

making regulations under the relevant legislation

authorising»; and

(iii) for “they shall determine” substitute «are specified in the

regulations»;


«3. Nothing in this Regulation prevents the appropriate

authority from making regulations under the relevant legislation:

(a) requiring denaturing agents or indicators to be added to wines

referred to in the first sentence of paragraph 1 in order to make

them more easily identifiable;

(b) where the appropriate authority is of the opinion that it is

justified, prohibiting the uses provided for in the second sentence

of paragraph 1 and requiring relevant products to be disposed

of.»; and

(d) in paragraph 4, for “Community or national rules in force”

substitute «law that was in force in the Island immediately».


(a) in the first sentence, for “Annex V to Regulation (EC) No

479/2008” substitute «Annex 8 to Regulation (EU) No

1308/2013»;


c SD No.2019/0212

(b) in the second sentence, for “Member States may permit”

substitute «nothing in this Regulation prevents the appropriate

authority from making regulations under the relevant legislation

authorising»; and

(c) in the final sentence, for “Annex V to Regulation (EC) No

479/2008” substitute «Annex 8 to Regulation (EU) No

1308/2013».

(14) Omit Article 12a.




(i) for “Member States shall” substitute «the appropriate

authority must, by regulations made under the relevant

legislation,»; and

(ii) for “Member States may” substitute «The appropriate

authority may, by regulations made under the relevant

legislation,»;

(b) in paragraph 2, for “by Member States” substitute «in

regulations made by the appropriate authority»; and

(c) in paragraph 3, for the words from “in the different” to the end

substitute «is 8.0%».


(a) in paragraph 1, for “competent authorities of the Member States”

substitute «appropriate authority»;

(b) in paragraph 2, for “Union legislation” substitute «retained EU

law»; and

(c) in paragraph 4, for “a competent authority of the Member State”

substitute «the appropriate authority».


(a) in the heading omit “Community”;


(i) for the words from “the second paragraph” to “479/2008”

substitute «Article 80(5) of Regulation (EU) No 1308/2013,

as read with Article 75(5)(d) of that Regulation,»; and

(ii) for “at Community level” substitute «in retained EU

law»; and



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SD No.2019/0212 c


States.”.

(20) In Annex 1 A —

(a) in the table —

(i) in paragraphs 12 and 13, in the column numbered 2, for the

words from “points” to “479/2008” substitute «Sections C

and D of Part 1 of Annex 8 to Regulation (EU) No

1308/2013»;

(ii) in paragraph 21, in the column numbered 2, for the words

from “paragraphs” to the end substitute «points (1), (3) to

(9), (15) and (16) of Part 2 of Annex 7 to Regulation (EC) No

1308/2013»;

(iii) in paragraph 23, in the column numbered 2, for the words

from “paragraphs” to the end substitute «points (1), (7)

and (9) of Part 2 of Annex 7 to Regulation (EC) No

1308/2013»;

(iv) in paragraphs 24 to 31, in the column numbered 2, for the

words from “paragraphs” to the end substitute «points

(1), (3) to (9), (15) and (16) of Part 2 of Annex 7 to


(v) in paragraph 32, in the column numbered 1, for the words

from “Directive” to “foodstuffs” substitute «point 2 of

Annex 1 to Regulation (EC) No 1333/2008»;

(vi) omit paragraph 33;

(vii) in paragraphs 34 to 37 and 43, in the column numbered 2,

for the words from “paragraphs” to “479/2008” substitute

«points (1), (3) to (9), (15) and (16) of Part 2 of Annex 7 to


(viii) in paragraphs 46 and 48, in the column numbered 2, for the

words from “points” to “1234/2007” substitute «Sections

C and D of Part 1 of Annex 8 to Regulation (EC) No

1308/2013»;

(ix) in paragraph 49, in the column numbered 2, for the words

from “point” to “1234/2007” substitute «point 10 of Part 2

of Annex 7 to Regulation (EC) No 1308/2013»;

(x) in paragraph 50, in the column numbered 2, for the words

from “points” to “1234/2007” substitute «Sections C and D

of Part 1 of Annex 8 to Regulation (EU) No 1308/2013»;

and


c SD No.2019/0212

(xi) in paragraph 52, in the column numbered 2, for the words

from “paragraphs” to “1234/2007” substitute «points (1),

(3) to (9), (15) and (16) of Part 2 of Annex 7 to Regulation

(EC) No 1308/2013»;

(b) in Appendix 2, in paragraph 2, for “Directive 2008/84/EC”

substitute «Regulation (EU) No 231/2012»;

(c) in Appendix 4 —

(i) in the first paragraph, for the words from “Community” to

“thereof” substitute «retained EU law»; and

(ii) in the second paragraph —

(A) for “authorities of the Member States” substitute


(B) after “authorities shall” insert «, by regulations

made under the relevant legislation,»;

(d) in Appendix 5 —

(i) for the first paragraph substitute —

«Potassium ferrocyanide or calcium phytate, the use of

which is provided for in paragraph 26 of Annex 1 A, or DL

tartaric acid, the use of which is provided for in paragraph

29 of Annex 1 A, may be used only under the supervision

of an oenologist or technician officially approved by the

appropriate authority in whose territory the process is

carried out. Where the appropriate authority considers it

necessary to fix the responsibilities of such oenologists and

technicians, nothing in this Regulation prevents the

authority from making regulations under the relevant

legislation for that purpose.»; and

(ii) for the third paragraph substitute —

«The appropriate authority must make regulations under

the relevant legislation regulating the supervision of the

use of the product referred to in the first paragraph.»;

(e) in Appendix 6, in the part headed “REQUIREMENTS” —

(i) in the second indent, for “Directive 2008/84/EC” substitute


(ii) in the third indent, for “Article 185c(2) of Regulation (EC)

No 1234/2007” substitute «Article 147(2) of Regulation

(EU) No 1308/2013»;

(f) in Appendix 7 —


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SD No.2019/0212 c

(i) in the part headed “1. MEMBRANE REQUIREMENTS”, in

paragraph 1.4, in the first subparagraph —

(A) in the first indent, for “Annex II to Commission

Directive 2002/72/EC” substitute «Annex 1 to

Commission Regulation (EU) No 10/2011 on plastic

materials and articles intended to come into contact

with food»; and

(B) in the third indent, for “Directive 2002/72/EC”


(ii) in the part headed “2. MEMBRANE UTILISATION

REQUIREMENTS”, in the second paragraph, for “Article

112(2) of Regulation (EC) No 479/2008” substitute «Article

147(2) of Regulation (EU) No 1308/2013»;

(g) in Appendix 9, in the part headed “PURITY”, in the second

paragraph, for “Article 112(2) of Regulation (EC) No 479/2008”

substitute «Article 147(2) of Regulation (EU) No 1308/2013»;

(h) in Appendix 10, in the part headed “Requirements:” —

(i) in point (3), for “Annex XVa to Regulation (EC) No

1234/2007” substitute «Part 1 of Annex 8 to Regulation

(EU) No 1308/2013»;

(ii) in point (4), for the words from “subparagraph (a)” to the

end substitute «point (a) of the second paragraph of point

(1) of Part 2 of Annex 7 to Regulation (EU) No 1308/2013»;

(iii) in point (6), for “Article 185c(2) of Regulation (EC) No

1234/2007” substitute «Article 147(2) of Regulation (EU)

No 1308/2013»; and

(iv) in point (7), for “The Member States may require”


appropriate authority from making regulations under the

relevant legislation requiring»;

(i) in Appendix 12, in the part headed “Requirements” —

(i) in paragraph 3, for “Article 112(2) of Regulation (EC) No

479/2008” substitute «Article 147(2) of Regulation (EU) No

1308/2013»; and

(ii) in paragraph 4, for “Community and national provisions

adopted thereunder” substitute «retained EU law

adopted under that Regulation, national provisions

implementing Regulation (EC) No 1935/2004»;


c SD No.2019/0212

(j) in Appendix 14, in the third indent, for “Article 185c(2) of

Regulation (EC) No 1234/2007” substitute «Article 147(2) of

Regulation (EU) No 1308/2013»;

(k) in Appendix 15, in the part headed “Requirements:” —

(i) in point (6), for “Article 185c(2) of Regulation (EC) No


No 1308/2013»; and

(ii) in point (7), for “EU and national provisions adopted

thereunder” substitute «retained EU law adopted under

that Regulation, national provisions implementing


(l) in Appendix 16, in the part headed “Requirements:” —

(i) in point (4), for “Annex XVa to Regulation (EC) No

1234/2007” substitute «Part 1 of Annex 8 to Regulation

(EU) No 1308/2013»; and

(ii) in point (9), for “adopted” substitute «made»;

(m) in Appendix 17, in the part headed “Requirements:” —



No 1308/2013»; and

(ii) in point (7), for “adopted” substitute «made»;

(n) in Appendix 18, in the part headed “REQUIREMENTS” —



No 1308/2013»; and

(ii) in point (4), for “adopted” substitute «made»; and

(o) in Appendix 19, in the part headed “Requirements:”, in point (3),

for “adopted” substitute «made».

(21) In Annex 1 C —


(i) in point (a), for “Community” substitute «Island»;


(A) for “third countries” substitute «countries other

than the British Islands and the European Union»;

and

(B) for “Community” substitute «Island»; and



Regulations 2019

SD No.2019/0212 c

(i) in the first subparagraph, for the words before point (a),

substitute —


authority from making regulations under the relevant

legislation derogating from paragraph 1:»; and


(22) In Annex 1 D —

(a) in paragraph 2, for “Community”, in both places it occurs,


(b) in paragraph 3, in the first subparagraph, in the words before

point (a), for “a Member State” substitute «on a case by case

basis, by the appropriate authority, by administrative decision»;

and


(i) in point (a), omit “of the Member State on whose territory

the operation is to take place”; and

(ii) in point (c), for “Member States may” substitute «the

appropriate authority may, by administrative decision,».

(23) In Annex 2 —

(a) in point A —

(i) in paragraph 3, for “Regulation (EC) No 479/2008”


(ii) in paragraph 8, for “Regulation (EC) No 479/2008”

substitute «Regulation (EU) No 1308/2013»;

(b) in point B, omit paragraph 2; and

(c) in point C, in paragraph 5, for the words from “paragraph 5(c)” to

“479/2008” substitute «point 5(c) of Part 2 of Annex 7 to

Regulation (EU) No 1308/2013».

(24) In Annex 3, in Part A —

(a) in point 1 —

(i) for “paragraph 3(c) of Annex IV to Regulation (EC) No

479/2008” substitute «point (3)(c) of Part 2 of Annex 7 to


(ii) for “in Regulation (EC) No 479/2008” substitute «in

Regulation (EU) No 1308/2013»;

(b) for point 3 substitute —

«3. Unless otherwise prohibited by law, the oenological practices

referred to in Regulation (EC) No 1308/2013 and in this Regulation


c SD No.2019/0212

are authorised for liqueur wines and liqueur wines with a

protected designation of origin or a protected geographical

indication.»;

(c) in point 4(b), for the words from “paragraphs 3(e)” to “479/2008”

substitute «points (3)(e) and (f) of Part 2 of Annex 7 to


(d) in point 5 —

(i) for the words from “paragraph 3(c)” to “to Regulation (EC)

No 479/2008” substitute «point (3)(c) of Part 2 of Annex 7

to Regulation (EU) No 1308/2013»; and

(ii) for “Article 24(1) of Regulation (EC) No 479/2008”

substitute «Article 81(2) of Regulation (EC) No

1308/2013».



Council of 26 February 2014 on the definition, description, presentation,

labelling and the protection of geographical indications of aromatised

wine products and repealing Council Regulation (EEC) No 1601/9174 is

amended as follows.


(a) for “Union”, in both places it occurs, substitute «Island»; and

(b) for “Member States” substitute «Island, United Kingdom».


(a) renumber the unnumbered paragraph as paragraph 1;

(b) in paragraph 1 as renumbered, after point (3), insert —

«(4) ‘enactment’ includes statutory documents;

(5) ‘register’ means the register established and maintained

pursuant to Article 21;

(6) ‘third country’ means any country, other than the British

Islands.»; and

(c) after paragraph 1 as renumbered insert —

«2. In this Regulation, a reference to a competent authority is to

be interpreted as a reference to the Department of Environment,

Food and Agriculture.

3. ‘Department’ means the Department of Environment, Food and

Agriculture.».



Regulations 2019

SD No.2019/0212 c




“Commission” to “Article 33” substitute «Department



«Department»; and



(A) for the words from “Commission” to “acts,”

substitute «Department may, by regulations,

specify the»; and

(B) omit the third sentence; and




(b) in paragraph 5 omit “Without prejudice to Article 26,”.

(6) In Article 7 omit “Member State or third”.

(7) Omit Article 9.



(b) in paragraph 2(f) —

(i) omit the words from “laid down” to “indication”; and

(ii) for “Union”, in the second place it occurs, substitute

«retained EU»; and


«3. In paragraph 2(f), ‘applicable requirements’ means:

(a) requirements laid down in law relating to the use of the

geographical indication in the country in which the relevant

geographical area is located, including, where the geographical

area is located in, or partly within, the Island, requirements

contained in any enactment, and

(b) where they must be complied with in the country in which the

relevant geographical area is located, requirements laid down by

an organisation that manages the protected geographical

indication.».


c SD No.2019/0212




«Article 13a

Application for protection relating to a geographical area in the Island

An application for the protection of a geographical indication for an

aromatised wine product originating in the Island must be submitted to

the United Kingdom Secretary of State.».


(13) In Article 18(1) —

(a) in the second subparagraph, for “Union” substitute «Island, the

United Kingdom or the Channel Islands»; and

(b) in the third subparagraph —

(i) in point (a), for “Union” substitute «Island, the United

Kingdom or the Channel Islands»; and

(ii) for point (b) substitute «any relevant enactment or

retained direct EU legislation».


(a) in paragraph 1, in the first subparagraph, for “Commission”

substitute «United Kingdom Secretary of State»; and

(b) in paragraph 2, in the first subparagraph —

(i) for the words from “, if that possibility” to “Union”

substitute «in the Island»;

(ii) for “Commission” substitute «United Kingdom Secretary

of State»; and

(iii) for the words from “Directive” to the end substitute

«Consumer Protection (Trade Descriptions) Act 1970 or

the Trade Marks Act 1994 (of Parliament)».





«Article 21

Register

The Department must provide publicly accessible direction to an

electronic register of geographical indications for aromatised wine


Regulations 2019

SD No.2019/0212 c

products protected under Regulation (EU) No 251/2014 of the European

Parliament and the Council75, as it applies in the United Kingdom under

the European Union (Withdrawal) Act 2018 (of Parliament).


(18) In Articles 23 to 27



«Power to make regulations»;

(b) in paragraph 1, in the words before point (a), for the words from

“Commission” to “Article 33” substitute «Department may make

regulations»;



(i) in the words before point (a), for the words from

“Commission” to “Article 33” substitute «Department


(ii) in point (c), for “Commission” substitute «Department»;

and

(iii) omit point (g); and

(e) in paragraph 4, for the words from “Commission” to “Article 33”

substitute «Department may make regulations».



«Further power to make regulations»;



(A) in the words before point (a), for the words from

“Commission” to “measures” substitute

«Department may make regulations»;

(B) in point (b), omit “referred to in Article 16”; and

(C) in point (d), for “Member States” substitute

«authorities specified in those regulations»; and



75 OJ L 084, 20.3.2014, p.14.


c SD No.2019/0212


“Commission” to “adopt” substitute «Department may,

by regulations, make provision for»; and







(A) for the words from “Commission” to “rules”

substitute «Department may make regulations»;

(B) omit “by the Member States”; and

(C) after “application of” insert «Chapter 2 of».


(iii) insert as the last subparagraphs —

«The Department may make regulations concerning the

administrative and physical checks to be conducted with

regard to the respect of obligations resulting from the

application of Chapter 3 of this Regulation.».


(a) in paragraph 1, for “Member States and the Commission”

substitute «The authorities specified in paragraph 4»;

(b) in paragraph 2, in the words before point (a), for the words from

“Commission” to “lay” substitute «Department may make

regulations laying»;



(A) for the words before point (a) substitute —

«The Department may, by regulations, make»;

and

(B) in point (c), for “Member States, the competent

authorities” substitute «competent authorities in

the British Islands and»; and


(d) after paragraph 3 insert—

«4. The specified authority is the Department.».


Regulations 2019

SD No.2019/0212 c


«Article 33

Provisions relating to regulations


contain —


saving provisions;











(i) for “have been” substitute «were»; and

(ii) after “Regulation (EEC) No 1601/91(a)” insert «as it had

effect in the Island immediately»; and


(i) for “have been” substitute «were»; and

(ii) after “Regulation (EEC) No 1601/91” insert «, as that

Regulation had effect in the Island immediately before it

was repealed,».



States.”.

(29) In Annex 1, in point (5) —

(a) in the second subparagraph, for the words from “Directive

2009/54/EC” to “Directive 98/83/EC” substitute «any relevant

water quality legislation»; and

(b) after the third subparagraph insert —

«In this point, ‘relevant water quality legislation’ means, in

relation to aromatised wine products marketed in the Island, the


c SD No.2019/0212

Water Act 1991 and the Natural Mineral Water, Spring Water and

Bottled Drinking Water Regulations 200976.»

(30) In Annex 2 —

(a) in Part A, in point (5) omit the second and third paragraphs; and

(b) in Part B —

(i) in point (3), in the second paragraph —

(A) for “other Member States” substitute «another

country»; and

(B) for “Member State” substitute «country»;

(ii) in point (4), in the second paragraph —


country»; and

(B) for “Member State” substitute «country»; and

(iii) in point (13), in the second paragraph —


country»; and

(B) for “Member States” substitute «country».


(1) Commission Delegated Regulation (EU) 2019/33 supplementing

Regulation (EU) No 1308/2013 of the European Parliament and of the

Council as regards applications for protection of designations of origin,

geographical indications and traditional terms in the wine sector, the

objection procedure, restrictions of use, amendments to product

specifications, cancellation of protection, and labelling and presentation77

is amended as follows.


«Article 1a

Definitions

In this Regulation:

‘the appropriate authority’ means the Department of Environment,


‘the Article 25 Register’ means the register referred to in Article 25 of

Implementing Regulation (EU) 2019/34;

76 S.D. 405/09. 77 Paragraph 50(6) of the Schedule to the retention regulations, as amended by SD 2019/0122.


Regulations 2019

SD No.2019/0212 c

‘third country‘ means any country, other than the British Islands;

‘relevant legislation’, in relation to the making of regulations referred to

in a provision, means regulations made under the Food Safety Act 1996

using an enabling power in that Act that confers power on the

appropriate authority to make regulations about the matter, or for the

purpose, specified in the provision in question.».

(3) In Article 4(2) omit the words from “, taking” to the end.

(4) In Article 5(1)(c) omit the words from “Member States”, in the first place

it occurs, to “third”.





(A) for “Commission may adopt implementing acts

granting” substitute «appropriate authority may,

by regulations, grant»; and

(B) for “a Member State” substitute «the Island»; and


(A) in the words before point (a) omit “Article 96(3) or”;

and

(B) in point (b), after “market” insert «in the Island»;

and


(i) in the words before point (a), for “Commission may adopt

implementing acts extending” substitute «appropriate

authority may, by regulations, extend»; and

(ii) in point (a), for “Commission” substitute «appropriate

authority».


(a) for “Commission” substitute «appropriate authority»;

(b) for “it shall publish the application for a Union” substitute «the

appropriate authority must publish, in such manner as appears

appropriate to the appropriate authority, the application for a

non-standard»;

(c) omit the words from “in the Official” to “series”; and

(d) for the second sentence substitute «The appropriate authority,

taking into account any admissible objection that has been lodged,

must decide whether to approve or reject the application.».


c SD No.2019/0212


(9) In Article 24(1) omit “Member State or third”.





(i) for “Member States may” substitute «the appropriate

authority may, by administrative decision,»; and

(ii) for “Union labelling and presentation rules in force”

substitute «labelling and presentation rules in retained

EU law».



(i) in the words before point (a), for “Union” substitute

«Island»; and


(A) omit the first subparagraph; and

(B) in the second subparagraph, for the words from

“Member States” to “Regulation (EU) No

1308/2013” substitute «wines produced in the

Island»; and

(b) in paragraph 2, in the second subparagraph omit the words from

“and the equivalent” to “languages”.



(i) in the words before point (a), for the words from “Member

States” to “‘varietal wine’” substitute «nothing in this

Regulation prevents the appropriate authority from

making regulations under the relevant legislation

permitting the use of the term ‘varietal wine’ on grapevine

products produced in the Island,»; and

(ii) in point (a), for “of the Member State(s) concerned”

substitute «‘Isle of Man’»;

(b) in the third paragraph, for the words from “name(s)” to the end

substitute «name ‘Isle of Man’ or the name of a third country»;

and

(c) in the fourth paragraph, for “of the Member State” substitute

«‘United Kingdom’».


Regulations 2019

SD No.2019/0212 c


(a) in paragraph 4, for “by the Member States or” substitute «in

relation to the Island, by law, or, in relation to a third country,

are»; and


«5. For the purpose of paragraph 4, in relation to the Island, ‘by

law’ includes regulations made under the relevant legislation.».

(15) In Article 53(2), in the first subparagraph omit “Member States and”.

(16) In Article 55(2) —

(a) in the first subparagraph omit the second sentence; and

(b) omit the third subparagraph.


(a) in paragraph 1, in the first subparagraph, in the words before

point (a), and in the second subparagraph, for “Union” substitute

«Island»; and

(b) in paragraph 2, for “Member States may decide” substitute

«nothing in this Regulation prevents regulations from being

made under the relevant legislation to provide».


(a) in the heading omit “laid down by the producing Member

States”;


(c) in paragraph 2, for “Member States may” substitute «Nothing in

this Regulation prevents regulations from being made under the

relevant legislation to»;


(i) for “Member State may decide” substitute «nothing in

this Regulation prevents regulations from being made

under the relevant legislation»; and

(ii) at the end insert «where those grapevine products do not

bear a protected designation of origin or geographical

indication»; and


«4. For control purposes, nothing in this Regulation prevents

regulations from being made under the relevant legislation to

apply Articles 118, 119(1) (other than point (b)) and 120(1) (other

than point (d)) to products to which paragraph 5 applies.


c SD No.2019/0212

5. This paragraph applies to grapevine products bottled in the

territory of the appropriate authority that do not bear a protected

designation of origin or geographical indication and have not

been placed on the market.».


«Article 61

Transitional provisions

1. Products to which paragraph 2 applies may be marketed until stocks

are exhausted.

2. This paragraph applies to grapevine products:

(a) placed on the market, or labelled without being placed on the

market, in the Island before 14th January 2019,

(b) that do not comply with the requirements in force under this

Regulation, and

(c) that comply with the requirements of Regulation 607/2009 as those

requirements had effect immediately before Regulation 607/2009 was

repealed by this Regulation78 as it stood before its incorporation into

domestic law by the European Union and Trade Act 2019 (Retained

Direct EU Legislation) (DEFA and OFT) Regulations 201979.

3. Products to which paragraph 4 applies may be marketed:

(a) before the relevant day, and

(b) in relation to stocks of such products in existence immediately before

the relevant day, on and after the relevant day until stocks are

exhausted.

4. This paragraph applies to grapevine products:

(a) placed on the market, or labelled without being placed on the

market, in the Island, before the relevant day,

(b) that do not comply with the requirements in force under this

Regulation, and

(c) that comply with the requirements of this Regulation as it stood

before its incorporation into domestic law by the European Union and

Trade Act 2019 (Retained Direct EU Legislation) (DEFA and OFT)

Regulations 2019.

5. In this Article:

‘Regulation 607/2009’ means Commission Regulation (EC) No 607/2009

laying down certain detailed rules for the implementation of Council

78 OJ L 009, 11.1.2019, p. 2. 79 SD 2019/0037, as amended by SD 2019/0122.


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SD No.2019/0212 c

Regulation (EC) No 479/2008 as regards protected designations of origin

and geographical indications, traditional terms, labelling and

presentation of certain wine sector products80;

‘the relevant day’ means the day that falls 21 months after the day on

which exit day falls.».


States.”.

(21) In Annex 1, for Part A substitute —

«PART A

Terms referred to in Article 41(1)

Terms concerning sulphites/sulfites:

‘sulphites’ or ‘sulfites’

‘sulphur dioxide’ or ‘sulfur dioxide’

Terms concerning eggs and egg-based products:

‘egg’

‘egg protein’

‘egg product’

‘egg lysozyme’

‘egg albumin’

Terms concerning milk and milk-based products:

‘milk’

‘milk products’

‘milk casein’ or ‘milk protein’».

(22) For Annexes 2 and 3 substitute —

«ANNEX 2

Words referred to in point (b) of the second subparagraph of Article 46(3)

Words authorised instead of ‘producer’: ‘processor’ or ‘winemaker’

Words authorised instead of ‘produced by’: ‘processed by’ or ‘made by’

ANNEX 3

Indication of the sugar content

PART A

80 OJ L 193, 24.7.2009, p. 60, 0, repealed by Commission Delegated Regulation (EU) 2019/33 (OJ L

9, 11.1.2019, p. 2) and as last amended, before its repeal, by Commission Delegated Regulation

(EU) 2018/273 (OJ L 058, 28.2.2018, p. 1).


c SD No.2019/0212

List of terms referred to in Article 47(1), to be used for sparkling wine,

aerated sparkling wine, quality sparkling wine or quality aromatic

sparkling wine

Terms Conditions of use

extra dry If its sugar content is between 12 and 17 grams

per litre.

dry If its sugar content is between 17 and 32 grams

per litre.

medium dry If its sugar content is between 32 and 50 grams

per litre.

mild, sweet If its sugar content is greater than 50 grams

per litre.

PART B

List of terms referred to in Article 52(1), to be used for used for products

other than those listed in Part A

Terms Conditions of use

dry If its sugar content does not exceed:

— 4 grams per litre, or

— 9 grams per litre, provided that the total

acidity expressed as grams of tartaric acid per

litre is not more than 2 grams below the

residual sugar content.

medium dry If its sugar content exceeds the maximum

permitted but does not exceed:

— 12 grams per litre, or

— 18 grams per litre, provided that the total

acidity expressed as grams of tartaric acid per

litre is not more than 10 grams below the

residual sugar content.

medium, medium sweet If its sugar content exceeds the maximum

permitted but does not exceed 45 grams per

litre.

sweet If its sugar content is at least 45 grams per

litre.».

24 Commission Implementing Regulation (EU) 2019/34 amended

(1) Commission Implementing Regulation (EU) 2019/34 laying down rules

for the application of Regulation (EU) No 1308/2013 of the European

Parliament and of the Council as regards applications for protection of

designations of origin, geographical indications and traditional terms in

the wine sector, the objection procedure, amendments to product

specifications, the register of protected names, cancellation of protection


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and use of symbols, and of Regulation (EU) No 1306/2013 of the

European Parliament and of the Council as regards an appropriate

system of checks81 is amended as follows.

(2) In Article 1(f) omit “Union”.


«Article 1a

Definition of ‘third country’

In this Regulation, ‘third country‘ means any country, other than the

British Islands.».

(4) Omit Article 2.



«Names and addresses of competent authorities etc.»;

(b) omit the first sentence; and

(c) in the second sentence —

(i) for “Commission shall make public” substitute

«appropriate authority must make public, in such manner

as appears appropriate to the appropriate authority from

time to time,»; and

(ii) at the end insert «responsible for carrying out checks

relating to the use of protected designations of origin and

protected geographical indications in the Island».


(a) in the heading, for “Commission” substitute «appropriate

authority»; and

(b) in the words before point (a), for “Commission, at its” substitute

«appropriate authority, at the appropriate authority’s”.



(i) in the second subparagraph, in the words before point (a)

omit the words from “in the” to “place”;

(ii) in the third subparagraph —

(A) omit “Member States opt to conduct”; and

(B) for “, they” substitute «are carried out, the

competent authority or the control body»; and

81 Paragraph 50(7) of the Schedule to the retention regulations, as amended by SD 2019/0122.


c SD No.2019/0212

(iii) in the fourth subparagraph —

(A) omit “Member States opt to conduct”; and

(B) for “, they” substitute «is carried out, the

competent authority or control authority»;


(c) in paragraph 6, for “5” substitute «4»; and

(d) omit paragraphs 7 and 8.


(a) in point (b)(ii), for “Member States legislation or product

specifications of” substitute «any other enactment relating to, or

in the product specification of, the»; and

(b) after the existing paragraph insert —

«In this Article, ‘enactment’ includes:

(a) statutory documents, and

(b) retained direct EU legislation.».


(a) for “Commission”, in the first place it occurs, substitute


(b) for the words from “through” to the end substitute «in such

manner as appears appropriate to the appropriate authority from

time to time».


States.”.

(11) Omit Annex 12.


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SD No.2019/0212 c

SCHEDULE 9

[Regulation 5(i)]

RETAINED DIRECT EU LEGISLATION CONCERNING FOOD SAFETY

AMENDED

PART 1

FOOD HYGIENE AND OFFICIAL CONTROLS FOR FEED AND FOOD

REGULATIONS

25 Commission Implementing Regulation (EU) No 636/2014 amended

(1) Commission Implementing Regulation (EU) No 636/2014 of 13 June 2014

on a model certificate for the trade of unskinned large wild game82 is

amended as follows.


(a) for “Member States”, substitute «the Island from outside the

British Islands»;

(b) for “in the Annex”, substitute «in a model certificate as

published by the appropriate authority from time to time»;

(c) after the second subparagraph, insert —

«In this Article, “the appropriate authority” means the


(3) Omit the sentence following Article 2.

(4) Omit the Annex.

PART 2

NATURAL MINERAL WATER, SPRING WATER AND BOTTLED DRINKING

WATER REGULATIONS

26 Commission Regulation (EU) No 115/2010 amended

(1) Commission Regulation (EU) No 115/2010 of 9 February 2010 laying

down the conditions for use of activated alumina for the removal of

fluoride from natural mineral waters and spring waters83 is amended as

follows.

82 Paragraph 54(13A) of the Schedule to the retention regulations, as amended by SD 2019/0122. 83 Paragraph 59 of the Schedule to the retention regulations.


c SD No.2019/0212


States.”.

(3) In the Annex, in point 4, for “in accordance with the Council Directive”

substitute «(in relation to the use of activated alumina to remove

fluoride from natural mineral water or spring water) in accordance with

regulation 17 of the Natural Mineral Water, Spring Water and Bottled

Drinking Water Regulations 200984».

84 SD 405/09


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SCHEDULE 10

[Regulation 5(j)]

RETAINED DIRECT EU LEGISLATION CONCERNING IMPORTATION OF

PRODUCTS FROM THIRD COUNTRIES AMENDED


(1) Commission Decision of 8 September 2000 laying down the animal and

public health and veterinary certification conditions for imports of meat

preparations into the Community from third countries (2000/572/EC)85 is

amended as follows.


(a) number the existing text as paragraph 1; and

(b) after paragraph 1, insert —

«2. In this Decision:



“meat preparations” means fresh meat, including meat that has

been reduced to fragments, which has had foodstuffs, seasonings

or additives added to it or which has undergone processes

insufficient to modify the internal muscle fibre structure of the

meat and thus to eliminate the characteristics of fresh meat;


the British Islands.

3. For the purposes of this Decision, Articles 12(4) and 13 of

Directive 1997/78 are to be read as if:

(a) any reference to ‘Community’ were replaced by a reference to

‘national’;

(b) in Article 12(4)(b), in the second indent, as if the words from

“or” to the end were omitted;

(c) in Article 13(2)(b), ‘Member State from which the products are

delivered’ were replaced by ‘the Island’;

(d) in Article 13(4), ‘Member State from which the products are

supplied’ were replaced by ‘the Island’;

(e) Article 13(6):

(i) enabled the appropriate authority to publish from time to time

detailed rules for the application of Article 13, including the



c SD No.2019/0212

checking procedures to be carried out on departure and during

transport and delivery of the products due to be delivered directly

on board means of sea transport, including proof that such

products have reached their legal destination, and

(ii) did not include the reference to the procedure laid down in

Article 29;

(f) any duty to provide information to the Commission or to

Member States (other than the Member State of destination) were

omitted.».


(a) in paragraph 2, for “and conforming to the model laid down in

Annex II” substitute «in accordance with a certificate as

published by the appropriate authority from time to time»; and

(b) in paragraph 3, for “at least one of the official languages of the

Member State of introduction into the Community” substitute

«English and may also appear in other languages».


(a) for the words before point (a) substitute —

«The appropriate authority must ensure that consignments of

meat preparations for human consumption which are introduced

onto their territory and are destined for a third country by transit,

either immediately or after storage in accordance with Articles

12(4) or 13 of Directive 97/78/EC, and which are not intended for

importation into the Island, comply with the following

requirements:»;

(b) for point (a) substitute —

«(a) they shall come from the territory of a third country, or part

of a third country, listed in Annex II, Part 1 to Regulation (EC) No

206/2010 for the import of fresh meat of those species or which is

listed in Annex I, Part 1 to Regulation (EC) No 798/2008 for the

import of fresh poultry meat or listed in Annex I, Part 1 to

Regulation (EC) No 119/2009 for the import of rabbit and game

meat;»;

(c) in point (b), for the words from “one of the corresponding” to the

end substitute «the animal health certificate for the import of

fresh meat of a specified species, poultry meat, or rabbit and game

meat as published by the appropriate authority from time to

time»; and

(d) in point (c), for “established in accordance with the model laid

down in Annex III” substitute «for transit and storage of meat


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preparations as published by the appropriate authority from time

to time».

(5) Omit Articles 4b and 7.



(1) Commission Decision of 21 November 2001 laying down the

requirements for the approval of border inspection posts responsible for

veterinary checks on products introduced into the Community from

third countries (2001/812/EC)86 is amended as follows.


«Article Z1

In this Decision, “the appropriate authority” means the Department of

Environment, Food and Agriculture.».

(3) In Article 1, paragraph 2, for “Community” substitute «Island».

(4) In Article 2, paragraph 1, omit “, in order to be approved and listed in the

Official Journal and to maintain approval,”.



«1. The appropriate authority may approve a border inspection

post for the inspection of all products or of certain categories of

products only. Where a border inspection post is approved for

certain categories of products only, the appropriate authority

must be satisfied that the border inspection post has the necessary

facilities, personnel and equipment to carry out the inspection of

those categories of products.»;

(b) in paragraph 2, for “In the Official Journal, border inspection

posts will be listed showing them” substitute «The appropriate

authority must maintain a list of border inspection posts in the

Island showing them as approved»; and


«5. A border inspection post operator must notify the

appropriate authority of any change in the infrastructure or

operation of a border inspection post, or of an inspection centre

within that post, that has any bearing on its approval. Additions

to the categorisation of any border inspection post may be

proposed by the appropriate authority, after the appropriate



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authority has checked that the facilities comply with this

Decision.».


(a) in paragraph 1, for “Community legislation” substitute «national

legislation»;


(i) in point (a), for “an Animo system terminal” substitute

«access to the United Kingdom’s system for import

control notifications»; and

(ii) in point (c), for the words from “the derogation” to

“apply” substitute «Article 2 of Decision 93/352/EEC

applies»; and

(c) in paragraph 5, omit the last sentence.



(i) for the words from “Member States” to “competent

authority” substitute «the appropriate authority after the


(ii) omit “, for listing in the Official Journal”; and

(b) in paragraph 3, for “an Animo system terminal” substitute

«access to the United Kingdom’s system for import control

notifications».


(a) for the words before the first indent substitute —

«In the circumstances referred to in Article 6.2(b) of Directive

97/78/EC, the reasonable time intervals to comply with the

recommendations made pursuant to inspection reports, before the

appropriate authority withdraws the border inspection post from

the approved list in full or in part, in the latter case with regard to

the product categories and/or inspection centres concerned by the

recommendations, taken from the date of receipt of the final

report, are as follows:»;

(b) in the first indent, omit “between the Member State and the

Commission”.

(9) Omit Article 8.




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SD No.2019/0212 c

(i) in the second subparagraph, in the words before point 1,

for “Pending the implementation of the Shift system, the

official veterinarian” substitute «The official

veterinarian»;

(ii) in point 1, for “Community or, where applicable, to certain

Member States” substitute «Island»;

(iii) for point 2 substitute —

«2. copies of relevant retained EU law specifying a

specimen health certificate, or any other document which

must accompany products from third countries;»;

(iv) in point 3, for “Community” substitute «Island»;

(v) in point 4, omit “to the Community”;

(vi) in point 6, for “in all Member States” substitute «the

Island»;

(vii) in point 7, omit the words “for that Member State” to the

end; and

(viii) in point 8, for “EC” substitute «national»; and


(i) in the words before point 1, for “TRACES” substitute «the

United Kingdom’s system for import control

notifications»; and

(ii) for point 1 substitute —

«1. up-to-date information on consignments of products

for which import or entry into the Island has been refused

and which have been re-dispatched which must be

communicated to each border inspection post by the

central competent authority;».


(1) Commission Decision of 31 October 2003 laying down animal health

requirements and the veterinary certification for the import of animal

casings from third countries (2003/779/EC)87 is amended as follows.


«Article 1

1. The appropriate authority must authorise the importation of animal

casings from any third country accompanied by a health certificate as



c SD No.2019/0212

published by the appropriate authority from time to time which must

consist of one sheet.

2. In this Decision:

“the appropriate authority” means the Department of Environment,


“third country” means any country other than a member State or the

British Islands.».

(3) For Article 1a substitute —

«Article 1a

1. The appropriate authority must ensure that consignments of animal

casings for human consumption which are introduced into the Island

and are destined for a third country by transit, either immediately or

after storage in accordance with Articles 12(4) or 13 of Directive

97/78/EC, and which are not intended for importation into the Island,

the United Kingdom or the Channel Islands, comply with the following

requirements:

(a) they must meet the specific animal health conditions set out in the

health certificate;

(b) they must be accompanied by the health certificate as published by

the appropriate authority from time to time, signed by an official

veterinarian of the competent veterinary services of the third country

concerned;

(c) they are certified as acceptable for transit or storage (as appropriate)

on the Common Veterinary Entry Document by the official veterinarian

of the Border Inspection Post of introduction.

2. For the purposes of paragraph 1, Articles 12(4) and 13 of Directive

97/78/EC are to be read as follows:

(a) any reference to “Community” is to be construed as a reference to

“national”;

(b) “Member State” from which the products are delivered” is to be

construed as a reference to the Island;

(c) “Member State from which the products are supplied” is to be

construed as a reference to the Island;

(d) Article 13 is to be treated as if paragraphs 5 and 6 were omitted.».

(4) Omit Articles 1b, 2 and 3.

(5) Omit Annexes 1A, 1B, 2 and 3.


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30 Commission Decision 2007/777 amended

(1) Commission Decision of 29 November 2007 laying down the animal and

public health conditions and model certificates for imports of certain

meat products and treated stomachs, bladders and intestines for human

consumption from third countries and repealing Decision 2005/432/EC

(2007/777/EC)88 is amended as follows.


(a) in paragraph 1, in the words before point (a), for “Community”

substitute «Island» in both places;

(b) in paragraph 2, for “Decision 2004/432/EC” substitute «Decision

2011/163/EU»; and

(c) after paragraph 2, insert —

«3. In this Decision:





(3) In Article 2, in the words before point (a) —


and

(b) for “Community” substitute «Island».

(4) In Article 3, in the words before point (a) —


and

(b) for “Community” substitute «Island».


(a) in the heading, for “Community” substitute «Island»;

(b) in the words before point (a), for “Member States” substitute

«The appropriate authority»;

(c) in point (a) —

(i) omit “the Community” where it first appears; and

(ii) for “Community” where it appears for the second time,




c SD No.2019/0212

(d) in point (b), for “set out in Annex 3 are imported into the

Community” substitute «as published by the appropriate

authority from time to time are so imported».



(b) (in the words before point (a) —


authority»;

(ii) for the first reference to “Community” substitute

«Island»; and

(iii) for the second reference to “Community” substitute

«Island»;

(c) in point (b), for “in Annex 3” substitute «as published by the

appropriate authority from time to time»;

(d) in point (c), for “set out in Annex 4” substitute «as published by

the appropriate authority from time to time»; and

(e) in point (d), for “Community” substitute «Island».

(7) Omit Articles 6, 6a, 7, and 10.

(8) In Annex 1 —

(a) in paragraph 1, in point (a), for “Community” substitute

«Island»; and


(i) in the second subparagraph, omit “Community” in both

places;

(ii) for “Decision 79/542” substitute «Regulation (EU) No

206/2010«; and

(iii) in the third subparagraph —

(A) for the first reference to “Community” substitute

«Island»; and

(B) omit the second reference to “Community”.



(1) Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down

a list of third countries, territories, zones or compartments from which

poultry and poultry products may be imported into and transit through


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SD No.2019/0212 c

the Community and the veterinary certification requirements89 is

amended as follows.



(i) in the words before point (a), for “Community” substitute

«Island»; and

(ii) in the words after point (b), for “Community” substitute

«Island»; and

(b) in paragraph 3, for “Community agreements with” substitute

«agreements between the United Kingdom and».

(3) In Article 2, after the definition in numbered point (20), insert —

«(21) ‘the appropriate authority’ means the Department of


(22) ‘third country’ means any country other than a member State or the

British Islands.».


(a) in the heading for “Community” substitute «Island»; and

(b) in the text, for “Community” substitute «Island».



(i) for “Community” substitute «Island»;

(ii) for the words from “as referred to in column 4” to “Annex

I” substitute «as published by the appropriate authority

from time to time»; and

(iii) for the words from “completed in accordance” to the end

substitute «completed in accordance with any notes in

relation to that certificate as published from time to time by

the appropriate authority»;


(i) for “as set out in Annex II” substitute «as published by

the appropriate authority from time to time»; and

(ii) for the words from “completed in accordance” to the end

substitute «completed in accordance with any relevant

explanatory notes published by the appropriate authority

from time to time»;




c SD No.2019/0212

(i) in the words before point (a), for “Community” substitute

«Island»; and

(ii) in point (a), for “EC” substitute “United Kingdom”;


(i) for “Community” substitute «Island»; and

(ii) for “set out in Annex XI” substitute «as published by the

appropriate authority from time to time»; and


«5. For the purposes of this Regulation, transit may include

storage during transit in accordance with Articles 12 and 13 of

Directive 97/78/EC, read as if:

(a) ‘Community’, in each place where it appears, were replaced by

‘national’;

(b) ‘A Member State’ in Article 12(6) were replaced by ‘The

appropriate authority’;

(c) Article 12(10) were omitted;

(d) in the first sentence of Article 12(11), “1 to 10” were replaced

by “1 to 9”;

(e) in Article 12(11):

(i) in the first subparagraph, for the words from “, the competent

authority” to the end of that subparagraph, there were substituted

“, the appropriate authority shall suspend or withdraw its

approval as referred to in paragraph 4(b); The relevant competent

authority must inform the other appropriate authorities of any

such withdrawal”, and

(ii) in the second subparagraph, for “national law of the member

State concerned”, there were substituted “national law”;

(f) Article 12(12) were omitted;

(g) ‘Member State from which the products are delivered’ in

Article 13 were replaced by ‘the Island’;

(h) ‘Member State from which the products are supplied’ in

Article 13 were replaced by ‘the Island’;

(i) Article 13(6) were omitted;

(j) any duty in Article 13 to provide information to the

Commission or to Member States (other than the Member State of

destination) were omitted.».

(6) In Article 5, in paragraph 1 —


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(a) in the words before point (a), for “Union” substitute «Island»;

and

(b) in point (e), for “Member State of destination” substitute

«Island».


(a) for “Community” substitute «Island» in each place; and

(b) for “Member State of destination” substitute «Island».


(a) in the words before point (a), for “Community” substitute

«Island»;

(b) in point (a), for “Commission” substitute «appropriate

authority»;

(c) in point (b) —

(i) for “the Community reference laboratory” substitute «a

laboratory which has been approved by the appropriate

authority as a national reference laboratory,»; and

(ii) for “Community is” substitute «Island is»; and

(d) in point (c), for “Commission” substitute «the appropriate

authority».

(9) In Article 8, in the words before paragraph 1 point (a), for “Community”

substitute «Island».

(10) In Article 9, in paragraph 1, for “Community” substitute, «Island».


(a) in the words before point (a), for “Community” substitute «the

Island»; and

(b) in point (b), for “Commission” substitute «appropriate

authority».



«Island»; and

(b) in point (b), for “Commission” substitute «appropriate

authority».

(13) In Article 12, in paragraph 1, in the words before point (a), for

Community” substitute «Island».

(14) In Article 13, in paragraph 2, for “Community” substitute «Island».

(15) In Article 15, in the words before point (a) and in point (c), for

“Community” substitute «Island» in each place.


c SD No.2019/0212



«Island»; and

(b) in point (b), for “Community” substitute «Island» in each place.

(17) In Article 17, for “Community” substitute «Island».

(18) Omit Articles 18, 18a and 20 and the final paragraph of Article 21.

(19) In Annex 1 —

(a) in Part 1, in footnotes 1 and 2 to the table, for “Union” in each

place substitute «Island»;

(b) in Part 2 —

(i) omit the heading “Model Veterinary Certificates” and all

the text below ending with “model veterinary certificate

for egg products”;

(ii) in the section headed “Additional Guarantees (AG)”, omit

point 10;

(iii) in the section headed “Salmonella control programme” —

(A) for “Community”, in each place it occurs, substitute

«Island»;

(B) for “Commission”, in each place it occurs, substitute


(C) for “Union”, in each place it occurs, substitute

«Island»;

(iv) in the section headed “Specific Conditions” —

(A) in the first and second paragraphs, for “transit

trough the Community” substitute «transit

through the Island»; and

(B) in the third paragraph, for “Union” in each place it

occurs, substitute «Island»; and

(v) in the section headed “Notes”, omit the general notes and

the additional notes for day old chicks; and

(c) omit the model certificates.

(20) Omit Annex 2.

(21) In Annex 3 —

(a) in the heading “for Community Acts” substitute «Island

legislative requirements»;

(b) in Part 1 —


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SD No.2019/0212 c

(i) in the heading, for “Community” substitute «Island»;

(ii) in point 8.2, in the words before point (a), for “Union”


(iii) in point 8.3(a) and (b), for “Union” substitute «Island» in

each place; and

(iv) in point 8.4, for “Union” substitute «Island»; and

(c) in Part 2, in the heading, for “Community” substitute «Island».

(22) In Annex 4, in Part 1, point 11, for “avian influenza national reference

laboratory, OIE or Community reference laboratory for avian influenza”

substitute «a laboratory which has been approved by the appropriate

authority as a national reference laboratory for avian influenza or OIE».

(23) In Annex 7, Part 1, points 1(a), (b) and (d), for “Community” substitute

«Island» in each place.

(24) In Annex 8 —

(a) in Part 1 —

(i) in point 1, for “Community” substitute «Island»; and

(ii) in point 3 —

(A) for “Community”, where it first appears, substitute

«Island»; and

(B) for “in one of the official languages of the

Community” substitute «in English, whether or

not it also appears in other languages»; and

(b) in Part 2, in paragraph 2, for “Member State” substitute

«member State».

(25) In Annex 9 —

(a) in Part 2 —

(i) in paragraph 1, for “in accordance with” substitute «set

out in»; and

(ii) in paragraph 3, for the second subparagraph substitute —

«Where day old chicks of ratites are not reared in the

Island or United Kingdom, they must be transported

directly to the final destination (as specified in the health

certificate as published by the appropriate authority from

time to time) and kept there for at least three weeks from

the day of hatching.»;

(b) in the heading to Part 3, for “Community” substitute «Island»;

and

(c) in Part 4, for point (c) substitute —


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«(c) where ratites are to be sent to the Island, a serological test

must be carried out on each ratite, in addition to the virus

isolation test provided for in point (b) of this Part, where the

status of the Island has been established in accordance with

Article 12(2) of Directive 2009/158/EC;».

(26) In Annex 10, in Part 1, for “Community” substitute «Island» in each

place.

(27) Omit Annex 11.


(1) Commission Regulation (EC) No 119/2009 of 9 February 2009 laying

down a list of third countries or parts thereof, for imports into, or transit

through, the Community of meat of wild leporidae, of certain wild land

mammals and of farmed rabbits and the veterinary certification

requirements90 is amended as follows.


(a) in paragraph 1, in point (a), for “Community” substitute

«Island»;

(b) in paragraph 3, in point (i), for “Community agreements with”

substitute «agreements between the United Kingdom and».



(b) for the text substitute —

«The commodities that may be imported into, or transited

through, the Island from a third country are confined to those

from a third country or parts thereof listed in Part 1 of Annex I;

and in this Regulation “third country” means a country other than

a member State or the British Islands,».




(ii) for “set out in Annex II” substitute «as published by the


(iii) omit the words from “completed” to the end;



90 Paragraph 66(12A) of the Schedule to the retention regulations, as amended by Schedule 1 to

these regulations.


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SD No.2019/0212 c

(ii) for “set out in Annex III” substitute «as published by the


(c) in paragraph 3, for the words from “for a certain” to “Part 3 of

Annex I” substitute «by the Island»;

(d) in paragraph 4 omit “agreed” and “harmonised at Community

level”;

(e) after paragraph (4), insert —

«5. In this Article, “the appropriate authority” means the

Department of Environment, Food and Agriculture».

(5) Omit Article 5, the second sentence of Article 6, Article 7 and the final

paragraph of Article 8.

(6) Omit Parts 2, 3 and 4 of Annex 1.

(7) Omit Annexes 2, 3 and 4.


(1) Commission Regulation (EC) No 206/2009 of 5 March 2009 on the

introduction into the Community of personal consignments of products

of animal origin and amending Regulation (EC) No 136/200491 is

amended as follows.


(a) in paragraph 1, for “into the Community” substitute «into the

Island»;

(b) in paragraph 2, before “Andorra”, insert «a member State,»;

(c) in paragraph 3, for “Community” substitute «national»; and


«5. In this Regulation:






(a) in the heading, for “Community”, substitute «Island»; and


(i) for “Article 16(1)(a), (b) and (d)” substitute «Article

16(1)(a) (read as if “a Member State or” were omitted and



c SD No.2019/0212

as if “Community” were replaced by “national”), 16(1)(b)

(read as if both “paragraph 3” and “Community rules”

were replaced by “national rules”) and 16(1)(d) (read as if

“paragraph 3” were replaced by “national rules”)»; and

(ii) omit “, and in 16(4)”.


(a) in the heading omit “by Member States”;


«1. The appropriate authority must ensure that the veterinary

conditions applicable to personal consignments introduced into

the Island are brought to the attention of travellers arriving from a

third country.»;


«2. The information provided to travellers pursuant to paragraph

1, which must include information relevant to keeping animal

disease out of the Island, must be displayed by prominent notices

placed in easily visible locations.»;


(i) in the words before point (a), for “Member States”,


(ii) for point (a) substitute —

«(a) information published by the appropriate authority

regarding the procedures for the introduction of certain

listed animal products into the Island, and what constitutes

the small quantities that are acceptable as small personal

consignments;»; and


(i) for point (a) substitute «English»;


(A) for “a second language”, substitute «one or more

languages»;

(B) for “that second language”, substitute «those other

languages»;

(C) omit “the language used in the neighbouring

country or,”; and

(D) for “the language which is”, substitute «any of the

languages which are»; and

(iii) in the final subparagraph —


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SD No.2019/0212 c

(A) for “Member States”, substitute «The appropriate

authority»; and

(B) omit “into the Community”.

(5) In Article 4, omit the words from “, in particular” to the end.


(a) in paragraph 1, for “Community”, substitute «Island»; and

(b) in paragraph 3, omit “of the Member State”.

(7) In Article 6, in paragraph 3, for “Member States”, substitute «The


(8) Omit Article 10 and the final paragraph of Article 11.

(9) Omit Annexes 3, 4, 5 and 6.


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SCHEDULE 11

[Regulation 5(k)]

RETAINED DIRECT EU LEGISLATION CONCERNING PLANT HEALTH AND

PLANT PROTECTION AMENDED

Regulation (EC) No 1107/2009 amended


Council of 21 October 2009 concerning the placing of plant protection

products on the market and repealing Council Directives 79/117/EEC and

91/414/EEC92 is amended as follows.


(a) in paragraph 1, for “Community” substitute «Island»;

(b) in paragraph 3, omit “internal”; and

(c) in paragraph 4, in the second sentence, for “Members States”

substitute «the competent authority».

(12) In Article 2(1)(c), for “special Community” substitute «retained EU

law».


(a) for the heading substitute «Definitions: general»;

(b) in paragraph 4, in the definition of “substance of concern”, in the

second subparagraph —

(i) for “dangerous” substitute «hazardous»; and

(ii) for “Article 3 of Directive 1999/45/EC” substitute «that

Regulation»;

(c) in paragraph 9, in the definition of “placing on the market” —

(i) in the first sentence, for “Community” substitute

«Island»; and

(ii) in the second sentence, for “into the territory of the

Community” substitute «in the Island».

(d) in paragraph 10, in the definition of “authorisation of a plant

protection product” —

(i) for “the competent” substitute «a UK competent»; and

(ii) omit “of a Member State”; and

(iii) omit “in its territory”;



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(e) in paragraph 16, at the end insert «, as last amended by Directive

(EU) 2015/412 of the European Parliament and of the Council93»;

(f) omit paragraphs 17 and 22;

(g) in paragraph 25, in the definition of “professional user”, after

“Directive 2009/128/EC(c)” insert «, and for these purposes,

Directive 2009/128/EC is to be read as if Article 3(10)(b) were

omitted»;

(h) in paragraph 26, in the definition of “minor use” —

(i) in the words before point (a), omit “in a particular Member

State”; and

(ii) in point (a), for “that Member State” substitute «the

Island»;

(i) omit paragraph 30; and

(j) after paragraph 31 insert —

«31A. “the Department” means the Department of Environment,


31B. ‘approvals register’ means the register maintained in

accordance with Article 27A;

31C. ‘unacceptable co-formulants register’ means the register

maintained in accordance with Article 27B;

31D. ‘retained EU law’ has the meaning given by Schedule 1 of

the European Union and Trade Act 2019;».


«Article 3A

Definitions: competent authority and appropriate authority

1. The Department is the competent authority.

2. In this Regulation, “the appropriate authority” means the

Department.»;

3. “A UK competent authority” is —

(a) in relation to England, the Secretary of State;

(b) in relation to Wales, the Welsh Ministers;

(c) in relation to Scotland, the Scottish Ministers;

(d) in relation to Northern Ireland, the Department of

Agriculture, Environment and Rural Affairs.


93 OJ No L 68, 13.3.2015, p 1, as corrected by a Corrigendum (OJ No L 82, 26.3.2018, p 17).


c SD No.2019/0212



«1. An application for the approval of an active substance may

be submitted by the producer of the active substance to a UK

competent authority.

1A. An application for an amendment to the conditions of an

approval may be submitted by the producer of the active

substance to a UK competent authority.

1B. A joint application may be submitted under paragraph 1 or 1A

by an association of producers designated by the producers for

the purpose of compliance with this Regulation.»;





(a) the existing first paragraph becomes paragraph 1;

(b) in that paragraph 1 —

(i) in the first sentence, for “The Commission” substitute

«The competent authority»; and

(ii) in the second sentence, for “Member States, the

Commission and the Authority” substitute «competent

authority»;

(c) the existing second paragraph becomes paragraph 2;

(d) in that paragraph 2, omit point (f); and

(e) after that paragraph 2, insert —

«3. The competent authority may vary or withdraw a work

programme established by it.

4. The competent authority must publish the work programme

and notice of any variation or withdrawal of a work programme

in such manner as the competent authority thinks appropriate.».



(a) omit paragraphs 2 and 3;




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«5. The appropriate authority may, by regulations, make

provision necessary for the implementation of this Article.».

(21) After Section 3, insert —

«SECTION 4

Registers

Article 27A

Approvals register

The competent authority must provide direction to the United Kingdom

approvals register of active substances, safeners, synergists, low-risk

active substances, basic substances and candidates for substitution

approved in accordance with Regulation (EC) No 1107/2009 as it forms

part of the law of England and Wales, Scotland and Northern Ireland by

virtue of section 3 of the European Union (Withdrawal) Act 2018 (of

Parliament) as amended from time to time by that law.

Article 27B

Unacceptable co-formulants register

1. The competent authority must provide direction to the United

Kingdom register of coformulants which are not acceptable for inclusion

in a plant protection product in accordance with Regulation (EC) No

1107/2009 as it forms part of the law of England and Wales, Scotland

and Northern Ireland by virtue of section 3 of the European Union

(Withdrawal) Act 2018 (of Parliament) as amended from time to time by

that law.».


(a) in paragraph 1, for “in the Member State concerned” substitute

«in the United Kingdom»; and


(i) omit point (b);

(ii) in point (c) —

(A) for “another Member State” substitute «the United

Kingdom»; and

(B) for the words from “in that Member State” to the

end substitute «for use in the United Kingdom»;

(iii) in point (d) —

(A) for “in a third country” substitute «outside the

Island and the United Kingdom»;


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(B) for the words from “the Member State” to

“inspection requirements” substitute «there are

inspection requirements in place»; and

(C) for “its territory” substitute «the Island and the

United Kingdom»; and

(iv) in point (e), for “has been granted” substitute «is in

force».




(i) for “Member States” substitute «The competent

authority»; and

(ii) for “in at least one Member State” substitute «in the

United Kingdom»;


«2. The appropriate authority may, by regulations, implement

measures to restrict or prohibit the use or sale of treated seeds as

referred to in paragraph 1 where the appropriate authority has

substantial concerns that —

(a) the treated seeds are likely to constitute a serious risk to

human or animal health or to the environment, and

(b) such risk cannot be contained satisfactorily by measures taken

by the competent authority.

2A. Before making regulations in accordance with paragraph 2,

the appropriate authority may obtain independent scientific

advice where the appropriate authority considers it appropriate to

do so.»;



(i) for “Community legislation” substitute «retained EU

law»; and

(ii) for “Directive 1999/45/EC” substitute «Regulation (EC)

No 1272/2008 of the European Parliament and of the

Council».



(a) omit paragraphs 1 to 4;

(b) before paragraph 5 insert —


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SD No.2019/0212 c

«4A. This Article applies to a parallel trade permit issued before

exit day by the United Kingdom as the Member State of

introduction in accordance with this Article as it had effect

immediately before exit day, where immediately before exit day

the validity of that permit had not expired.»;

(c) in paragraph 5, in the second sentence —

(i) for “the Commission shall” substitute «the appropriate

authority may»;

(ii) for “a Regulation” substitute «regulations»; and

(iii) for “Article 68” substitute «Article 68(3)»; and

(d) omit paragraphs 6 to 11.



(i) in the first subparagraph, for “a Member State” substitute

«the competent authority»; and


(b) omit paragraphs 2 and 3; and


(i) for “Paragraphs 1 to 3” substitute «Paragraph 1»; and

(ii) for “Directive 2001/18/EC” substitute «the Genetically

Modified Organisms Act 2001».



(a) the existing first and second paragraphs become paragraphs 1 and

2;

(b) in that paragraph 2, omit the words from “, which shall apply” to

the end; and

(c) after that paragraph 2 insert —

«3. For the purposes of this Article, Article 14 of Directive

2009/128/EC is to be read as if —

(a) obligations on Member States were obligations on the

competent authorities;

(b) paragraph 3 were omitted.».




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(i) in the first subparagraph, for “Member States” substitute

«competent authority»; and

(ii) in the fourth subparagraph, for “third” substitute

«other»;

(b) in paragraph 2, for “set out in Article 29” substitute «of the UK

competent authorities to grant an authorisation for a plant

protection product»;


(d) in paragraph 4, omit “of the Member States”.



«Article 58

Placing on the market and use of adjuvants

1. An adjuvant must not be placed on the market unless it has been

authorised for use in the United Kingdom.

2. The appropriate authority may, by regulations, make provision

regarding the authorisation of adjuvants including (but not limited to)

data requirements, notification, evaluation, assessment and decision

making procedures.»


(34) In Article 64(3) —

(a) for “Article 9 of Directive 1999/45/EC” substitute «Article 35 of

Regulation (EC) No 1272/2008 of the European Parliament and of

the Council»; and

(b) for “Directive” in the second place it occurs substitute

«Regulation».



«1. The labelling of plant protection products must include —

(a) the classification, labelling and packaging requirements of

Regulation (EC) No 1272/2008 of the European Parliament and of

the Council, and

(b) any requirements contained in regulations made under

paragraph 1A which apply in the Island.

1A. The appropriate authority may, by regulations, specify

additional requirements for the labelling of plant protection

products, including (but not limited to) standard phrases for

special risks and safety precautions which supplement the


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SD No.2019/0212 c

phrases provided for in Regulation (EC) No 1272/2008 of the

European Parliament and of the Council.»;

(b) in paragraph 2, for “Member States” substitute «The competent

authority»; and


(36) In Article 66(3) —

(a) for “Member States” substitute «The competent authority»; and

(b) for “Community” substitute «retained EU».



(i) in the third subparagraph, omit “or Community”; and

(ii) omit the fourth subparagraph

(b) in paragraph 2, in the first sentence, for “authorities”, in both

places it occurs, substitute «authority»;


(i) for “authorities of the Member States” substitute

«authority»; and

(ii) for the words from “in accordance” to the end substitute

«for the purposes of establishing and maintaining risk

indicators in accordance with Annex 4 to Directive

2009/128/EC»; and



(a) the existing first paragraph becomes paragraph 1;

(b) in that paragraph 1 —

(i) in the first sentence, for “Member States” substitute «The

competent authority»; and

(ii) in the second sentence —

(A) for “They shall finalise and transmit to the

Commission” substitute «The competent authority

must publish»; and

(B) after “controls” insert «in relation to the Island, in

a manner which the competent authority considers

appropriate,»;

(c) omit the second paragraph; and

(d) for the third paragraph substitute —


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«3. The appropriate authority may, by regulations, make

provision in respect of the official controls to be carried out in

accordance with this Article, in particular concerning —

(a) the production, packaging, labelling, storage, transport,

marketing, formulation, parallel trade and use of plant protection

products;

(b) the collection of information and reporting on suspected

poisonings.».




(42) In Article 73, for “Member States” substitute «Island».




(b) in paragraph 3, for “Member States shall ensure that competent

authorities have” substitute «The competent authority must

ensure that it has»; and

(c) omit paragraphs 4 and 5.

(45) For Articles 77 and 78 substitute —

«Article 77

Guidance documents

1. The competent authority may issue, amend or withdraw technical

and other guidance documents relating to the implementation of this

Regulation, including.

2. The competent authority must publish any guidance document issued

or amended, or a notice specifying any guidance document withdrawn,

under paragraph 1 in a manner which that competent authority

considers appropriate.

3. Before issuing, amending or withdrawing a guidance document

under paragraph 1 the competent authority may obtain independent

scientific advice, where the competent authority considers it appropriate

to do so.

4. In complying with any obligation under this Regulation, a person or

competent authority must have regard to any guidance issued in

accordance with paragraph 1.

Article 78

Amendments and implementing measures


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The appropriate authority may by regulations —

(a) amend the Annexes to take account of current scientific and technical

knowledge;

(b) make further provision as necessary for the implementation of this

Regulation.

Article 78A

Regulations


contain —


saving provisions;













(i) omit “Without prejudice to Article 80,”;

(ii) omit “by the Acts listed in Annex V”; and

(iii) omit the words from “, without prejudice” to the end; and

(b) in the second paragraph, omit “in other Community legislation,

such as Regulation (EC) No 1782/2003,”.


(52) After Article 84, omit the words from “This Regulation” to “all Member

States”.

(53) Omit Annexes 1.

(54) Omit Annex 2.



c SD No.2019/0212

SCHEDULE 12

[Regulation 5(l)]

RETAINED DIRECT EU LEGISLATION CONCERNING RESIDUES AMENDED

34 Specific modifications to Regulation (EC) No 396/2005


Council of 23 February 2005 on maximum residue levels of pesticides in

or on food and feed of plant and animal origin and amending Council

Directive 91/414/EEC94 is amended as follows.

(2) In Article 1, omit “and harmonised Community provisions”.


(a) in paragraphs 1, 2 and 3, for “covered by Annex I” substitute

«listed in Part 1 of the UK MRLs register»;


(i) omit “to third countries”; and

(ii) omit “third” in the second place it occurs; and



(a) for the heading substitute «Definitions: general»;

(b) in paragraph 1, for “Article 2, points 1 and 4 of Directive

91/414/EEC(a)” substitute «Article 2(1) and (2) of Regulation (EC)

No 1107/2009»; and


(i) before point (a) insert —

«(za) ‘Regulation (EC) No 1107/2009’ means Regulation

(EC) No 1107/200995 of the European Parliament and of the

Council concerning the placing of plant protection

products on the market;

(zb) ‘UK MRLs register’ means the register maintained by

the competent authorities of the United Kingdom in

accordance with Article 46A of Regulation (EC) No

396/200596 as it forms part of the law of England and Wales,

Scotland and Northern Ireland by virtue of section 3 of the

94 Paragraph 72(4) of the Schedule to the retention regulations 95 OJ L 309, 24.11.2009, p. 1. 96 OJ L 070, 16.3.2005, p. 1.


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European Union (Withdrawal) Act 2018 (of Parliament) as

amended from time to time; and

(zc) ‘the competent authority’ is the Department of

Environment Food and Agriculture;»;

(ii) in point (a), in the second sentence —

(A) for the words from “, in conformity with” to “in a

given climate zone” substitute —

«of the principles of integrated pest management

referred to in Article 14 of and Annex 3 to Directive

2009/128/EC of the European Parliament and of the

Council establishing a framework for Community

action to achieve the sustainable use of pesticides»;

and

(B) at the end, insert —

«, and for these purposes Article 14 of Directive

2009/128/EC is to be read as if —

(i) obligations on Member States were obligations

on the competent authority; and

(ii) paragraph 3 were omitted.»;

(iii) in point (a) omit the words “and setting MRLs/temporary

MRLs at the lowest level”;

(iv) omit point b;

(v) in point (c) —

(A) omit “as defined in Article 2, point 1 of Directive

91/414/EEC”; and

(B) for “covered by Annex I to this Regulation”

substitute «listed in Part 1 of the UK MRLs

register»;

(vi) omit point (e) to (g); and

(vii) omit points (i) and (j).


(a) in the heading, omit “harmonised”;


(i) in the first sentence, for the words from “harmonised

MRLs” to the end substitute «MRLs apply appear in a list

in Part 1 of the UK MRLs register»;


(iii) omit the third sentence; and


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«Article 5

Active substances for which no MRLs are required

1. MRLs are not required for active substances evaluated under

Regulation (EC) No 1107/2009 appearing in the list in Part 4 of the UK

MRLs register.

(7) Omit Chapter 2 (Articles 6 to 17).



«1. A product listed in Part 1 of the UK MRLs register must not

contain, from the time it is placed on the market as food or feed,

or fed to animals, any pesticide residue exceeding —

(a) the MRL for that product listed in Part 2 or 3 of the UK MRLs

register;

(b) the level described in paragraphs 1A or 1B, where there is no

MRL.

1A. Where there is no MRL for a product listed in Part 2 or 3 of

the UK MRLs register, the level is the default value for an active

substance as listed in Part 5 of the UK MRLs register (see Article

18A).

1B. Where —

(a) there is no MRL for the product in Part 2 or 3 of the UK MRLs

register,

(b) there is no default value for an active substance listed in Part 5

of the UK MRLs register, and

(c) the active substance is not listed in Part 4 of the UK MRLs

register,

the level applicable is 0.01mg/kg.»



(A) for “Member States” substitute “The competent

authority”;

(B) omit “their territories” and

(C) for “covered by Annex I” substitute “listed in Part 1

of the UK MRLs register”; and


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SD No.2019/0212 c

(ii) in point (b), for “Annex IV” substitute “Part 4 of the UK

MRLs register”;



(A) for the words before point (a) substitute —

«By way of derogation from paragraph 1, the

competent authority may authorise, further to a

post-harvest treatment with a fumigant, residue

levels for an active substance which exceed the

limits specified in Part 2 or 3 of the UK MRLs

register where the active substance/product

combinations are listed in Part 7 of the MRLs,

provided that — »;

(B) in point (b), for “Annexes II or III” substitute «Part

2 or 3 of the UK MRLs register»; and

(C) omit point (c); and



(i) in the first sentence —

(A) for “Article 8(4) of Directive 91/414/EEC” substitute

«Article 53 of Regulation (EC) No 1107/2009»;

(B) after “set out in” insert «the retained direct EU

legislation»;

(C) for “a Member State” substitute «the competent

authority»; and

(D) for “within its territory” substitute «in the

Island»; and

(ii) omit the second, third and fourth sentences; and

(e) after paragraph 4 insert —

«5. Where the competent authority grants an authorisation in

accordance with paragraph 4, the competent authority must, as

soon as reasonably practicable, undertake an appropriate risk

assessment and take any other necessary measures in relation to

the products to which the authorisation relates.».

(9) In Article 19 for “covered by Annex I” substitute «listed in Part 1 of the

UK MRLs register».




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(i) for “Annexes II or III” substitute “Part 2 or 3 of the UK

MRLs register”; and

(ii) for “covered by Annex I” substitute “listed in Part 1 of the

UK MRLs register”; and


«2. The competent authority may —

(a) specify concentration factors or dilution factors for —

(i) specified processing or mixing operations, or

(ii) specified processed or composite products;

(b) modify or withdraw any such factors.».

(11) Omit Articles 21 to 25

(12) In Article 26(1) —

(a) for “Without prejudice to Directive 96/23/EC(a), Member States”

substitute «The competent authority»; and

(b) for “Community” substitute «retained EU».


(a) in paragraph 1, in the first sentence, for “Each Member State”

substitute “The competent authority”; and


«2. Sampling for the purposes of paragraph 1 must be carried out

in accordance with the methods described in the Annex to

Commission Directive 2002/63/EC .

3. In paragraph 2, the “Annex to Commission Directive

2002/63/EC” means the Annex to Commission Directive

2002/63/EC establishing Community methods of sampling for

the official control of pesticide residues in and on products of

plant and animal origin, read as if —

(a) in Section 1, in the second paragraph, in the first sentence, for

the words from “the Annexes” to “Community” there were

substituted “accordance with Regulation (EC) No 396/2005 and, in

the absence of such”;

(b) in Section 2, in the first paragraph, “Community” were

omitted;

(c) in Section 4.3, in Tables 3, 4 and 5, for table footnote (1) there

were substituted- “(1) Classification of foods: Part 1 of the UK

MRLs register.”.».



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(a) in paragraph 1, for “Community” substitute “retained EU”;



«3. All laboratories analysing samples for the official controls on

pesticide residues must —

(a) have regard to any relevant guidance issued under Article

46(1);

(b) participate in any proficiency tests for pesticides organised by

the competent authority.».

(15) Omit Section 2.

(16) In the heading of Section 3, for “National control programmes”

substitute «National control programme».


(a) in the heading, for “National control programmes” substitute

«National control programme»;


(i) for the first subparagraph substitute —

«The competent authority must establish a multiannual

control programme for pesticide residues, and must

update its multiannual programme every year.»; and

(ii) omit point (d)(iv);



(18) In the heading of Section 4, for “Member States” substitute «competent

authorities».


Article 31

Information by the competent authority

1. The competent authority must submit, by 31 August each year, such

of the following information concerning the previous calendar as is

required by the competent authorities of the United Kingdom in order

for the Isle of Man to comply with the United Kingdom’s control

programme:

(a) the results of the official controls provided for in Article 26(1), and

the results of the analysis of samples tested in accordance with the

competent authority’s control programme and any United Kingdom

control programme);


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(b) the LODs applied in the competent authority’s control programme

referred to in Article 30 and under any United Kingdom control

programme referred to in Article 29;

(c) details of the participation of the analytical laboratories in the

proficiency tests referred to in Article 28(3) and other proficiency tests

relevant to the pesticide-product combinations sampled in the

competent authority’s control programme;

(d) details of the accreditation status of the analytical laboratories

involved in the controls referred to in point (a);

(e) where permitted by national legislation, details of enforcement

measures taken.

4. In submitting information in accordance with paragraph 1, a

competent authority must have regard to any guidance issued jointly by

the competent authorities of the United Kingdom.


(a) in paragraph 1 for “On the basis of the information provided by

Member States under Article 31(1) the Authority” substitute

«The competent authority»;


(i) in the words before point (a), for “Authority shall”

substitute «the competent authority must”;

(ii) in point (b), for “the” in the second place it occurs

substitute “any”; and

(iii) in point (d), omit “, including reports submitted under

Directive 96/23/EC”;

(c) omit paragraphs 3 to 6; and


«7. The competent authority must publish the Annual Report

by the 31st October of the second year following the year to which

the information in the Annual Report relates.».


(22) Omit Section 5.




«Article 43

Scientific advice


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1. In fulfilling any obligation or performing any function under this

Regulation, the competent authority may obtain independent scientific

advice, where the competent authority considers it appropriate to do so.

2. Where independent scientific advice is obtained in accordance with

paragraph 1, the competent authority must take that advice into account

when fulfilling the obligation or performing the function.».




«Article 46A

Regulations


contain —


provisions;







(29) Omit Article 47 to 50.


35 Specific modifications to Regulation (EU) 2018/555

(1) Commission Implementing Regulation (EU) 2018/555 of 9 April 2018

concerning a coordinated multiannual control programme of the Union

for 2019, 2020 and 2021 to ensure compliance with maximum residue

levels of pesticides and to assess the consumer exposure to pesticide

residues in and on food of plant and animal origin97 is amended as

follows.


«Article 1

The competent authority shall, during the years 2019, 2020 and 2021,

take and analyse samples for the pesticide/product combinations, such

as are required by the competent authorities of the United Kingdom in



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order for the Isle of Man to comply with the United Kingdom’s control

programme.

The number of samples of each product, including foods for infants and

young children and products originating from organic farming shall be

as determined by the competent authorities of the United Kingdom.».


(a) in paragraph 1, in the second subparagraph, for “Directive

2002/63/EC” substitute «the Annex to Commission Directive

2002/63/EC, as read in accordance with Article 27(3) of Regulation

(EC) No 396/2005»; and


«4. For the purposes of paragraph 3 —

(a) Directive 2006/125/EC(a) is to be read as if, in Article 2(c) the

reference to point 1 of Article 2 of Directive 91/414/EC were a

reference to Article 2(1) of Regulation (EC) No 1107/2009 of the

European Parliament and of the Council concerning the placing of

plant protection products on the market;

(b) Directive 2006/141/EC(b) is to be read as if, in Article 2(e) the

reference to point 1 of Article 2 of Directive 91/414/EC were a

reference to Article 2(1) of Regulation (EC) No 1107/2009.».


(a) in the first paragraph, for “Member States” substitute «The

competent authority»; and

(b) in the second paragraph, for “Member States” substitute «the

competent authority».



States”.

(7) Omit Annex 1.

(8) Omit Annex 2.


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SD No.2019/0212 c

SCHEDULE 13

[Regulation 5(m)]

RETAINED DIRECT EU LEGISLATION CONCERNING ZOOTECHNICAL

AMENDED

36 Specific modifications to Regulation (EU) 2016/1012

(1) Regulation (EU) 2016/1012 of the European Parliament and of the

Council of 8 June 2016 on zootechnical and genealogical conditions for

the breeding, trade in and entry into the Union of purebred breeding

animals, hybrid breeding pigs and the germinal products thereof and

amending Regulation (EU) No 652/2014, Council Directives 89/608/EEC

and 90/425/EEC and repealing certain acts in the area of animal breeding

(‘Animal Breeding Regulation’)98 is amended as follows.



(i) in point (a), for “Union” substitute «Island»;

(ii) in point (h), omit “and rules for enforcement by Member

States”; and

(iii) omit point (i); and



(c) at the end of point (1) insert —

«(1A) ‘appropriate authority’ means the Department of

Environment Food and Agriculture;»;

(d) in points (5) and (6), in each place it occurs, after “by the

competent authority of” insert «the Island, a constituent territory

of the United Kingdom or of»;

(e) in point (7) for “Union” substitute «Island»;

(f) in point (8) —


(A) after “the authorities of” insert «the Island, a

constituent territory of the United Kingdom or of»;

and

(B) after “this Regulation” insert «or, in the United

Kingdom or a member State, the EU Regulation»;

and



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(ii) in point (c) for “other” substitute «competent authorities

in the United Kingdom,»;

(g) after point (8), insert —

«(8A) ‘the EU Regulation’ means Regulation (EU) 2016/1012 of

the European Parliament and of the Council on zootechnical and

genealogical conditions for the breeding, trade in and entry in the

Union of purebred breeding animals, hybrid breeding pigs and

the germinal products thereof, as it has effect in EU law, as

amended from time to time or in respect of the United Kingdom

as it has effect in UK law;

(8B) ‘third country’ means a country, other than the Island and the

United Kingdom, which is not a member State;»;

(h) for point (21) substitute —

«(21) ‘entering the Island’ or ‘entry into the Island’ means the

action of bringing breeding animals or their germinal products

into the Island;»;

(i) in point (22), for the words from “Union” to the end substitute

«Island»;

(j) in point (24), for the words from “a Member State” to “that

Member State” substitute «the appropriate authority to be

endangered, genetically adapted to one or more traditional

productions systems or environments in the Island»; and

(k) at the end of point (26), insert —

«(27) ‘constituent territory of the United Kingdom’ means

England, Wales, Scotland, or Northern Ireland.».

(4) In Article 3, in the heading and in paragraph 1, in each place it occurs, for

“Union” substitute «Island».

(5) In Chapter 2, in the heading, omit “in Member States”.


(a) in the words before point (a) for “competent authorities”

substitute «competent authority»; and

(b) in point (a) for “territory of the Member State where the

competent authority is located” substitute «Island».

(7) In Article 5(2), omit from “At the same time” to the end.


(l) in paragraph 1 —

(i) for “Member States”, in each place it occurs, substitute

«The competent authority»; and


Regulations 2019

SD No.2019/0212 c

(ii) for “their competent authorities have” substitute «it

has»;

(m) in paragraph 2(b), omit point (ii);

(n) for paragraph 3 substitute —

«3. Where the competent authority itself carries out a breeding

programme, this must be included in the list provided for in

paragraph 1.»; and

(o) in paragraph 4, in each place it occurs, for “Member States”

substitute «the competent authority».

(9) For Article 7(5) substitute—

«The competent authority may lay down, and publish on a website,

model forms for the presentation of the information to be included in

the list of recognised breed societies and breeding operations provided

for in paragraph 1.».




(i) in the words before point (a), for “that Member State”

substitute «the Island»; and

(ii) in point (c)(ii), for “one or more territories of the Union”

substitute «the Island»; and


(i) in point (a), for “that Member State” substitute «the

Island»; and

(ii) in point (c) for “other Member States” substitute «the

United Kingdom or Member States».


«Article 12

Notification and approval of breeding programmes carried out in the

Island by breed societies or breeding operations approved in the

United Kingdom or a member State

1. Where a breed society or breeding operation, approved in accordance

with Article 8(3) of the EU Regulation by a competent authority in the

United Kingdom or a member State, intends to carry out a breeding

programme on animals kept in the Island, that breed society or breeding

operation must notify the competent authority of the Island where the

animals are to be kept.

2. The notification provided for in paragraph 1 must —


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(a) be sent to the competent authority at least 90 days before the

intended commencement date of the breeding programme in the Island;

(b) be provided in English.

3. The competent authority of the Island may, within 90 days from the

date of receipt of the notification referred to in of paragraph 2(a), refuse

to approve the carrying out on its territory of the breeding programme,

where an approved breeding programme is already being carried out in

the Island on purebred breeding animals of the same breed.

4. The competent authority of the Island must inform the competent

authority which has recognised the breed society or breeding operation

in accordance with Article 4(3) of the EU Regulation about the result of

the notification provided for in paragraph 1 of this Article and, where it

refuses to approve the carrying out on its territory of the breeding

programme, must provide a reasoned explanation for the refusal.

5. Failure by the competent authority of the Island to reply to the

notification referred to in paragraph 2(a) within 90 days from the date of

receipt of that notification shall constitute approval.

6. Where the competent authority of the Island refuses to approve the

breeding programme in accordance with paragraph 3, the competent

authority, on an application by the breed society or breeding operation,

must reconsider the refusal to approve the breeding programme, taking

into account any new information provided.

7. The competent authority of the Island may withdraw its approval of

the breeding programme provided for under this Article where, for at

least 12 months, no breeder in the Island participates in that breeding

programme.».

(13) In Article 13(1)(a), for “within the geographical territory of that breeding

programme” substitute «in the Island».



(i) for “exists in any” substitute «exists in the Island, a

constituent territory of the United Kingdom,»; and

(ii) after “Article 34” insert «of this Regulation or of the EU

Regulation»;

(b) in paragraph 2, for “a Member State” substitute «the appropriate

authority»; and

(c) in paragraph 5, for “Member States” substitute «the appropriate

authority».




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SD No.2019/0212 c

(i) after “Article 12,” insert «of this Regulation or of the EU

Regulation»; and

(ii) for “same or another Member State” substitute «the

Island, the United Kingdom or in a member State»;

(b) in paragraph 5, after “approved” insert «by the competent

authority in accordance with animal health law in force in the

Island, by a competent authority of a constituent territory of the

United Kingdom, or approved»; and


(16) For Article 22(3) substitute—

«3. The appropriate authority may by regulations prescribe methods to

be used for the verification of the identity of breeding animals.

4. Regulations under paragraph 3 may include (but are not limited to)

provision for implementation of recommendations made by national or

European Union reference centres, the International Committee for

Animal Recording (‘ICAR’) or the International Society for Animal

Genetics.».

(17) In Article 23(2), for “in the same or in another Member State” substitute

«of this Regulation in the Island or of the EU Regulation in the United

Kingdom or a member State».


(a) in paragraph 2, for “same or another Member State” substitute

«Island, the United Kingdom or in a member State»;

(b) in paragraph 3, after “approved” insert «by the competent

authority in accordance with animal health law in force in the

Island, by a competent authority of a constituent territory of the

United Kingdom, or approved»; and


(19) For Article 26 substitute—

“Article 26

Requirements for performance testing and genetic evaluation

1. The appropriate authority may by regulations amend Annex 3 in

order to take account of—

(a) scientific advances;

(b) technical developments;

(c) the need to preserve valuable genetic resources.


c SD No.2019/0212

2. The appropriate authority may by regulations prescribe requirements

for the performance testing and genetic evaluation of purebred breeding

animals of the bovine, ovine and caprine species.

3. Regulations under paragraph 2 may include (but are not limited to)—

(a) methods for the interpretation of the results of performance testing

and genetic evaluation;

(b) provision for implementation of recommendations of United

Kingdom reference centres (‘reference centres’) or European Union

reference centres, or of the principles agreed by ICAR.”.

(20) In the heading to Chapter 6, for “European Union” substitute “United

Kingdom”.




(i) in the first place where it occurs, for “a Member State”

substitute «the appropriate authority»; and

(ii) for the words from “which is authorised” to “referred to in

paragraph 2” substitute «designated in accordance with

paragraph 1(b)»; and


(i) in the first subparagraph, for the words from “or

authorised” to “Article 29”, substitute «may commit

themselves to comply with the rules and standards

established by ICAR or by reference centres referred to in

Article 29»; and

(ii) in the second subparagraph, omit “, authorising those third

parties”.

(22) In Article 29—

(a) in the heading, for “European Union” substitute «United

Kingdom»;

(b) in paragraph 1, for the words from “Commission” to “centres”

substitute «appropriate authority may by regulations designate

Kingdom reference centres (‘reference centres’)»;

(c) in paragraph 2, for the words from “Member States” to the end,

substitute «Island for the preservation of endangered breeds or

the preservation of genetic diversity existing within those breeds,

the appropriate authority may by regulations designate reference

centres responsible for scientific and technical contribution to the

establishment or harmonisation of those methods»;


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SD No.2019/0212 c

(d) omit paragraph 3;

(e) in paragraph 4—

(i) in each place it occurs, omit “European Union”; and

(ii) omit the words from “if those tasks” to the end;

(f) after paragraph 4 insert—

«4A. Regulations under paragraph 1 or 2 may also make

provision for reference centres to be responsible for tasks set out

in Annex 4, point 4.»;

(g) in paragraph 5—

(i) in the first subparagraph—

(A) in the words before point (a), for the words from

“Commission” to “amending:” substitute

«appropriate authority may by regulations

amend:»; and

(B) in points (a) and (b), omit “European Union”; and

(ii) in the second subparagraph, in the words before point (a),

for “The delegated acts provided for in this paragraph”

substitute «Regulations made under this paragraph»;

and

(h) omit paragraph 6.


(a) in paragraphs 1 and 2(a) after “Article 12” insert «of this

Regulation or of the EU Regulation»; and


(i) in point (b), after “Article 12(2)(a)”, insert «of this


(ii) in point (c), after “Article 34” insert «of this Regulation or

of the EU Regulation»;


(i) after “Article 34”, in each place it occurs, insert «of this


(ii) for “Union” substitute «Island»;


(i) in point (a), for “Annex V” substitute «Annex 5 to this

Regulation or to the EU Regulation»; and

(ii) in point (b), for the words from “the implementing acts

adopted pursuant to paragraph 10” substitute


c SD No.2019/0212

«regulations made under paragraph 9 or in implementing

acts adopted pursuant to Article 30(10) of the EU

Regulation;»; and

(e) for paragraphs 9 and 10 substitute—

«9. The appropriate authority may by regulations—

(a) amend the contents of the zootechnical certificates set out in

Annex 5, in order to take account of—

(i) scientific advances;

(ii) technical developments;

(iii) the need to preserve valuable genetic resources;

(b) prescribe model forms to be used for zootechnical certificates

for breeding animals and their germinal products.».

(24) In Article 31(1), after “approved” insert «by the competent authority in

accordance with animal health law in force in the Island, by a competent

authority of a constituent territory of the United Kingdom, or».









(a) in the heading, for “Union” substitute «Island»; and

(b) in paragraph 1, after “approved” insert

«for entry into the Island by the competent authority in

accordance with animal health law in force in the Island, for entry

into the United Kingdom by a competent authority in the United

Kingdom in accordance with animal health law in force in the

constituent territory of the United Kingdom, or»; and

(27) In Chapter 8, in the heading, for “Union” substitute «Island».


(a) in paragraph 1, for “Commission shall” substitute «appropriate

authority must»;

(b) in paragraph 2, for the words before point (a) substitute —

«Third country breeding bodies may only be included in the list

provided for in paragraph 1 where the appropriate authority is


Regulations 2019

SD No.2019/0212 c

satisfied that the breeding body meets the following

requirements:»; and

(c) for paragraphs 3 and 4, substitute —

«3. Where the appropriate authority is satisfied that a breeding

body in a third country has in place measures which are

recognised as equivalent in accordance with provision made

under Article 35, that breeding body may be included in the list

provided for in paragraph 1.

4. In a case where the appropriate authority is not satisfied that a

breeding body fulfils at least one of the requirements referred to

in paragraph 2, that breeding body must be removed from the list

provided for in paragraph 1.».





(ii) omit the words after point (g);


(c) in paragraph 3—

(i) for the words before point (a) substitute—

«Regulations under paragraph 1 may set out detailed

arrangements governing the entry of breeding animals and

their germinal products into the Island from a third

country and may include:»; and

(ii) in points (b) and (c), in each place where it occurs, for

“Union” substitute «Island»; and



(a) in the heading and in paragraph 1, in each place it occurs, for

“Union” substitute «Island from a third country»; and


«2. The entry into the Island of breeding animals and their

germinal products must not be prohibited, restricted or impeded

on zootechnical or genealogical grounds where those breeding

animals or the donors of the germinal products are entered in a

breeding book or registered in a breeding register maintained by a

breeding body included in the list of breeding bodies established

in accordance with Article 34 of this Regulation or Article 34 of

the EU Regulation.».


c SD No.2019/0212




(i) in the words before point (a), omit “in a Member State or

on a territory”;

(ii) after “operates” insert «in the Island»; and

(iii) in point (a), for “Member State or territory where that

competent authority operates”, substitute «Island»; and

(b) in paragraph 4(e), after “in accordance with” insert «animal

health law in the Island, the United Kingdom, or».

(33) In the heading to Chapter 10, omit “by Member States”.


(a) in paragraph 1, for “Member States”, substitute «The appropriate

authority»;


(i) in the words before point (a), for “Each Member State

shall” substitute «The appropriate authority must»;


(A) in point (i), after “Article 12” insert «of this


(B) in point (ii), after “Articles 48 and 49” insert «of

this Regulation or of the EU Regulation»; and

(iii) in point (c), omit “and notify that website to the

Commission”; and


(35) In Article 40, for “Member States”, substitute «the appropriate

authority».

(36) In Article 42(1), for “Union law or national law”, substitute «the law in

force in the Island».


«5. Competent authorities must perform official controls in the same

manner irrespective of whether the breeding animals or the germinal

products of the breeding animals originate in the Island or are entering

the Island from the United Kingdom, a member State or a third

country.».




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«1. Where non-compliance originates in, spreads to, or affects

countries other than the Island, competent authorities in the

Island must —

(a) cooperate with one another and with the competent authorities

of the United Kingdom, member States and third countries;

(b) provide administrative assistance to those competent

authorities, in order to ensure the correct application of the rules

provided for in this Regulation or in the EU Regulation.».


(i) in point (a) —

(A) after “request by a competent authority” insert “of a

constituent territory of the United Kingdom or”;

and

(B) for “a competent authority of another Member

State” substitute «another competent authority of

the Island or a competent authority of the United

Kingdom or a Member State»;

(ii) for point (b) substitute —

«(b) in the case of a non-compliance which might have

implications for the United Kingdom or for member States,

the notification of the competent authorities of the United

Kingdom or of member States by the competent authority

aware of the non-compliance;»;

(iii) in point (d)(ii), after “this Regulation”, insert «or of the

EU Regulation»; and

(iv) for point (e) substitute —

«(e) by agreement between the competent authorities

concerned, participation by a competent authority of the

Island in on-the-spot official controls performed by the

competent authorities of the United Kingdom or of a

member State.»;


«3. Where official controls performed on breeding animals or

their germinal products originating in a member State or the

United Kingdom show repeated instances of non-compliance with

the rules provided for in this Regulation or in the EU Regulation,

the competent authority which has performed those official

controls may inform the appropriate authority in the United


c SD No.2019/0212

Kingdom or Commission and competent authorities of member

States.».


(a) in the heading, after “Notification of”, insert «other competent

authorities in the Island, competent authorities in the United

Kingdom,»;


(i) in the words before point (a), after “this Regulation”, insert

«or in the EU Regulation»; and

(ii) in point (a), for “competent authorities of the other

Member States”, substitute «other competent authorities

of the Island, competent authorities of the United Kingdom

and of member States»; and


(i) in the words before point (a), after “this Regulation”, insert

«or the EU Regulation»; and

(ii) in point (b), omit “Union and national”.

(41) Omit Articles 50, 51 and 52.

(42) For the headings to Chapter 11, Section 1 and Article 53 substitute —

«Cooperation with the United Kingdom, Commission and member

States».


«Competent authorities in the Island may assist and cooperate with the

United Kingdom, the Commission and member States experts in

investigating and collecting information on problems concerning the

application of the rules provided for in this Regulation or in the EU

Regulation.».

(44) Omit Articles 54, 55, 56, 57, 58 and 59.

(45) For the heading to Chapter 11, Section 2 (Commission controls in third

countries), substitute —

«Controls on entry into the Island of breeding animals and their

germinal products».

(46) In the heading to Article 60, for “Union” substitute «Island».

(47) In Article 60(1) —

(a) in the words before point (a), for “Commission shall adopt

implementing acts” substitute «appropriate authority may make

regulations«;

(b) in point (a), for “Union”, substitute «Island».


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SD No.2019/0212 c

(c) in the second subparagraph, for the words from “Those

implementing acts shall” to “Commission” substitute «In

addition to, or instead of making regulations under paragraph 1,

the appropriate authority»; and

(d) omit paragraphs 2, 3 and 4.


«Article 61

Regulations


contain —


provisions;





(a) for paragraph 1(a) – negative; or





«6. Where operators referred to in paragraph 4 have been

approved or recognised under the repealed acts referred to in

paragraph 1 by a competent authority in the Island, the United

Kingdom or a member State and already carry out breeding

programmes in the Island, those operators (if they have not

already done so) must inform a competent authority in the Island

about those activities.»; and

(b) in paragraph 7, for “another” substitute «the United Kingdom, a

member State».

(51) Omit Articles 66, 67 and 68.


States.”.

(53) In Annex 1, in Part 1, in point A —

(a) in point 1, for “Member State where the application for

recognition is made” substitute «Island»; and

(b) in point 4, omit the words from “within” to the end.


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(54) In Annex 1, in Part 2 —

(a) in point 1 —

(i) omit point (e); and

(ii) in point (f), for “Union” substitute «Island»; and

(b) in point 2, omit the words from “within” to the end.


(a) in point 1, in the second subparagraph, for “a Member State”


(b) in point 3(a)(ii), for “same or another” substitute «the Island, the

United Kingdom, a»;

(c) in point 4 —

(i) omit point (a);


(A) for “neither a breed society in a Member State nor a

breeding body in a third country” substitute «no

breed society or breeding body in the Island, the

United Kingdom, a member State or a third

country»; and

(B) for “the competent authority in a Member State”

substitute «a competent authority in the Island».


(a) in Chapter 1 —

(i) in point 1 —

(A) in point (c), after “identified in accordance with”

insert «animal health law in force in the Island or

the United Kingdom or»; and

(B) in points (d) and (e), in each place it occurs, for


(ii) in point 3, for “Regulation 2016/429” substitute —

«Regulation (EU) 2016/429, as it has effect in EU law, as

amended from time to time, or under Article 7 of

Commission Implementing Regulation 2015/262 laying

down rules pursuant to Council Directives 90/427/EEC and

2009/156/EC as regards the methods for the identification

of equidae,»; and

(b) in Chapter 2, in point 1(a), after “identified in accordance with”

insert «Island, United Kingdom or»; and


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SD No.2019/0212 c

(c) in Chapter 3, in point 2 —

(i) in the words before point (a), in each place it occurs, for “a

Member State” substitute «an appropriate authority»;

and

(ii) in the final subparagraph, for “Member States” substitute

«A competent authority».


(a) in point (a), for “European Union reference centres provided for

in Article 29(1)” substitute «Island or United Kingdom reference

centres provided for in Article 29(1) of this Regulation or the

relevant European Union reference centres provided for in Article

29(1) of the EU Regulation»; and

(b) in point (b), omit “in the absence of those rules and standards,”.

(58) In Annex 4 —

(a) in the heading and in point 1, in each place it occurs, for

“European Union” substitute «Island»;

(b) in point 1(a)(iii), omit “, Union”.

(c) in point 2 —

(i) in the heading and in the words before point (a), in each

place it occurs, for “European Union” substitute

«Island»;

(ii) omit point (e);

(iii) in point (g), for “Member States” substitute “the Island”;

and

(iv) omit point (i); and

(d) in point 3 —

(i) in the heading and in the words before point (a), in each

place it occurs, for “European Union” substitute

«Island»;

(ii) in point (a), for “Member States” substitute “Island, United

Kingdom and of member States”; and

(iii) omit point (c); and

(e) after point 3 insert —

«Tasks referred to in Article 29(4) for United Kingdom reference

centres designated in accordance with Article 29(1) or (2).

4. Reference centres designated in accordance with Article 29(1) or

(2) may provide assistance in the development or harmonisation

of methods of performance testing and genetic evaluation of


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purebred breeding animals used in the Island, the United

Kingdom and member States, in particular by —

(a) developing control protocols for performance testing and

genetic evaluation of purebred breeding animals carried out in the

Island to improve the comparability of the results and the

effectiveness of breeding programmes;

(b) carrying out an international assessment of livestock on the

basis of the combined results of performance testing and genetic

evaluation of purebred breeding animals carried out in the Island,

the United Kingdom, member States and third countries;

(c) disseminating the results of those international assessments;

(d) publishing the conversion formulae and the related

information according to which the conversion formulae were

established;

(e) developing or harmonising methods used for the in situ and ex

situ conservation of endangered breeds or the preservation of the

genetic diversity within those breeds, or providing assistance in

such development or harmonisation;

(f) developing methods used for the characterisation of the status

of endangered breeds with regard to their genetic diversity or

their danger of being lost to farming, or providing assistance in

such development;

(g) providing training to support breed societies or third parties

designated by those breed societies in accordance with Article

27(1)(b), competent authorities and other authorities in the

preservation of endangered breeds and the preservation of genetic

diversity within those breeds;

(h) cooperating, within the scope of their tasks, with European

and internationally recognised organisations;

(i) providing, within the scope of their tasks, technical assistance

to an appropriate authority or competent authority;

(j) recommending calculation methods to be used for the

performance testing and genetic evaluation of purebred breeding

animals.».

(59) In Annex 5 —

(a) in Part 1, point (c), for “Union” substitute «Island»;

(b) in Part 2 —

(i) in Chapter 1, in point 1 —

(A) in points (a), (g)(iii) and (o), in each place it occurs,

for “Union” substitute «Island»; and


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SD No.2019/0212 c

(B) in point (g)(i) and (ii), in each place it occurs, for

“Union” substitute «United Kingdom or Union»;

and

(ii) in Chapters 2, 3 and 4, in point (d) of each Chapter, for


(c) in Part 3 —

(i) in Chapter 1, in point 1 —

(A) in points (a), (f)(iii) and (n), in each place it occurs,

for “Union” substitute «Island»; and

(B) in point (f)(i) and (ii), in each place it occurs, for

“Union” substitute «Island, United Kingdom or

Union»; and

(ii) in Chapters 2, 3 and 4, in point (d) of each Chapter, for

“Union” substitute «Island».

(60) Omit Annex 6.

37 Specific modifications to Commission Implementing Regulation (EU)

2017/716

(19) Commission Implementing Regulation (EU) 2017/716 of 10 April 2017

laying down rules for the application of Regulation (EU) 2016/1012 of the

European Parliament and of the Council with regard to the model forms

to be used for the information to be included in the lists of recognised

breed societies and breeding operations99 is amended as follows.

(20) After Article 2, omit the words “This Regulation shall be binding in its

entirety and directly applicable in all Member States”.

(21) In Annex 1, in each of the tables at points 1(a) to (e) and in the table at

point 2, in the first row, first column, in each place it occurs, after

“Member State” insert «, Isle of Man or constituent nation of the United

Kingdom».


European Union and Trade Act 2019 (Deficiencies) (DEFA) (No. 5) Regulations 2019 Explanatory Note

c SD No.2019/0212

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations modify the retained direct EU legislation prescribed in the European

Union and Trade Act 2019 (Retained Direct EU Legislation) (DEFA and OFT)

Regulations 2019 [SD 2019/0037] (the “retention regulations”).

These modifications to retained direct EU are organised in the Schedules to these

Regulations as follows –

Schedule 1 to these Regulations specifies the modifications to retained direct EU

legislation prescribed in Part 1 (agricultural trade) of the Schedule to the retention

regulations;


legislation prescribed in Part 2 (animal diseases) of the Schedule to the retention

regulations;


legislation prescribed in Part 3 (animal by-products and animal slaughter) of the

Schedule to the retention regulations;


legislation prescribed in Part 5 (animal movements and animal welfare) of the

Schedule to the retention regulations;


legislation prescribed in Part 6 (aquaculture) of the Schedule to the retention

regulations;


legislation prescribed in Part 7 (dairy products) of the Schedule to the retention

regulations;


legislation prescribed in Part 8 (fisheries) of the Schedule to the retention

regulations;


legislation prescribed in Part 9 (food labelling) of the Schedule to the retention

regulations;


legislation prescribed in Part 10 (food safety) of the Schedule to the retention

regulations;


legislation prescribed in Part 12 (importation of products from third countries) of

the Schedule to the retention regulations;

Explanatory Note European Union and Trade Act 2019 (Deficiencies) (DEFA) (No. 5)

Regulations 2019

SD No.2019/0212 c


legislation prescribed in Part 13 (plant health and plant protection) of the Schedule

to the retention regulations;


legislation prescribed in Part 15 (residues) of the Schedule to the retention

regulations; and


legislation prescribed in Part 17 (zootechnical) of the Schedule to the retention

regulations.

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