european union legislation on food additives, food · pdf fileeuropean union legislation on...

European Union legislation on Food additives, Food enzymes, Extractions solvents and Food

Health andConsumersHealth andConsumers

Extractions solvents and Food flavourings

European Commission, DG Health and Consumers,

Unit E3 Chemicals, contaminants and pesticides

Serbia-Screening meeting on Chapter 12 Food Safety Policy

European Union legislation on Food additives


on Food additives

Screening meeting on Chapter 12 Food Safety Policy

Table of Contents

1. Framework legislation including Annex II and III

2. Regulation (EC) No 231/2012 on specifications


2. Regulation (EC) No 231/2012 on specifications

3. Food additives database

4. Re-evaluation Programme

5. Common Authorisation Procedure

Screening meeting on Chapter 12

Food Safety Policy

1-Framework legislation on FA

�Regulation (EC) No 1333/2008 onfood additives


�Regulation (EC) No 1331/2008establishing a common authorisationprocedure for food additives, foodenzymes and flavourings.


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Framework Regulation (EC) No 1333/2008

��Annexes to specific Directives for 3 groups of additives applied until

1 June 2013

1-Food additivesFully harmonized sector


1 June 2013

�� Positive lists of additives + conditions of use

Dir. 94/36/EC, Article 2(1) to (6), (8), (9) (10) and Annexes I to V:

40 Colours

Dir. 94/35/EC, Article 2(1), (2), (4)

and the Annex:

17 sweeteners

Dir. 95/2/EC, Articles 2 and 4 and Annexes I to

VI : +/- 300 other

additives

��


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1-Regulation (EC) No 1333/2008 on food additives

It does not apply to:

� Processing aids

� Substances used for the protection of plant and


� Substances used for the protection of plant and plant products

� Substances added to foods as nutrients

� Substances used for the treatment of water for human consumption

� Flavourings

� Food enzymes-only Union list is adopted

Screening meeting on Chapter

12 Food Safety Policy

1-Regulation (EC) No 1333/2008 on food additives

It provides for:

a) Definitions


a) Definitions

b) Conditions of use

c) Union list of authorised food additives

d) Labelling requirements


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1a-Definitions

• ‘food additive’ means any substance:

1. not normally consumed as a food in itself,

2. not normally used as a characteristic ingredientof food,


2. not normally used as a characteristic ingredientof food,

3. intentionally added for a technological purposein the manufacture, processing, preparation,treatment, packaging, transport or storage offood,

4. that becomes directly or indirectly a componentof the food, including its by-products.


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1b-Conditions of use

� Do not pose a safety concern to the health ofthe consumer at the level of use proposed;

� Reasonable technological need for their use


� Reasonable technological need for their usewhich cannot be achieved by othereconomically and technologically practicablemeans;

� Do not mislead the consumer

� Advantages and benefits for the consumer


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1c-Union list of food additives

authorised in food

� Listed on the basis of the categories of food to which theymay be added.

� Food additives which are permitted for use in foods under


� Food additives which are permitted for use in foods underDirectives 94/35/EC, 94/36/EC and 95/2/EC and theirconditions of use have been transferred in Annex II toRegulation (EC) No 1333/2008.

� Established by Regulation (EU) No 1129/2012

� It is already applicable from 1 June 2013.

� 30 amendments including review of colours, aluminium andnew authorisations.


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1c-Food categorisation system

• 0 All foodstuffs• 1 Dairy• 2 Fats and Oils• 3 Edible Ice• 4 Fruit and Vegetables• 5 Confectionery• 6 Cereals and Cereal Products


• 6 Cereals and Cereal Products• 7 Bakery Wares• 8 Meat and Meat Products• 9 Fish and Fish Products• 10 Eggs and Egg Products• 11 Sugars and Table Top Sweeteners• 12 Salt, Spices, Seasonings, Sauces etc.• 13 PARNUTS• 14 Beverages• 15 Snacks• 16 Desserts• 17 Food Supplements • 18 Processed foodstuffs not belonging to 1 - 17


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1c-Union list of food additives authorised in Additives, Enzymes, Flavourings and

Nutrients

• Annex III to Regulation (EC) No 1333/2008,established by Regulation (EU) NO 1130/20121. Carriers in food additives


1. Carriers in food additives

2. Food additives other than carriers in food additives

3. Food additives including carriers in food enzymes

4. Food additives including carriers in food flavourings

5. Carriers in nutrients and other substances added for nutritional and/or for other physiological purposes

• Adopted on 11 November 2011

• Applicable from 2 December 2012


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2-Specifications of Food Additives

Commission Regulation (EU) No 231/2012adopted revised specifications in one single listand applies from 1 December 2012.


The revised Directives were:

• Directive 2008/60/EC - purity criteria forsweeteners in foodstuffs

• Directive 2008/84/EC - purity criteria for foodadditives other than colours and sweeteners.

• Directive 2008/128/EC - purity criteria forcolours used in foodstuffs

.Screening meeting on Chapter 12

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4-Re-evaluation programme.

• Established by Commission Regulation (EU) No257/2010

• All additives authorised before 20 January 2009


• All additives authorised before 20 January 2009

• Colours completed by 31.12.2015

• Sweeteners completed by 31.12.2020Exception: Aspartame. Opinion delivered Dec 2013

• All other additives completed by31.12.2018


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5-Common Authorisation Procedure

Reg 1331/2008 establishes a CAP for FA, FE and FF

� Applies to substances for which placing on themarket in the EU is authorised by an Union list(food additives, flavourings, food enzymes)

� Does not apply to smoke flavourings or extraction



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� Does not apply to smoke flavourings or extractionsolvents

Procedure for updating the Union list

� Adding the substance on the list

� Removing the substance from the list

� Addition, removing or changing of the conditions,specifications or restrictions which are associatedwith the presence of the substance on the list

5-Main stages of the CAP

�May be started either on the initiative of theCOM or following an application. Applicationsmay be made by a MS or by an interestedparty. Applications shall be sent to the COM.



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party. Applications shall be sent to the COM.

�Consultation of the EFSA except if theupdates in question are not liable to have aneffect on human health.

�Ends with the adoption by the COM of aregulation implementing the update.

5-Reg 234/2011-Implementing measures

It provides for

�The content, drafting and presentationof the application



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of the application

�The arrangements for checking thevalidity of applications

�The type of information that must beincluded in the opinion of EFSA

European Union legislation on Food Enzymes and


on Food Enzymes and Extraction Solvents


Table of Contents

1. Food enzyme legislation

2. Guidance on food enzymes

3. Submission of enzyme applications


3. Submission of enzyme applications

4. Extraction solvents legislation

5. Labelling of extraction solvents


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1-Food Enzymes Legislation

1. Regulation (EC) No 1332/2008 (enzymeRegulation) as amended by Comm. Reg. No1056/2012.


1056/2012.

2. Regulation (EC) No 1331/2008 establishing aCAP for FA, FE and FF.

3. Commission Regulation (EC) No 234/2011implementing CAP Reg. as amended byComm. Regulation (EC) No 562/2012.

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1- Reg 1332/2008

• The Regulation No 1332/2008 lays down rules onfood enzymes used in foods, including suchenzymes used as processing aids.


enzymes used as processing aids.

• Scope: Food enzymes that are added to food toperform a technological function in themanufacture, processing, preparation, treatment,packaging, transport or storage of food, includingenzymes used as processing aids.


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Definition of food enzyme

Product obtained from plants, animal or micro-organisms or products thereof including a productobtained by a fermentation process using micro-organisms:


organisms:

� Containing one or more enzymes capable ofcatalysing a specific biochemical reactions

� Added to food for a technological purpose at anystage of the manufacturing, processing,preparation, treatment, packaging, transport orstorage of foods.

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1-Food Enzymes Legislation

Reg 1332/2008 does not apply to

� Enzymes used exclusively in the productionof FAs and PAs.


of FAs and PAs.

� Enzymes intended for human consumption,such as enzymes for nutritional purposes.

�Microbial cultures that are traditionally usedin the production of food, such as cheese andwine, which may contain enzymes but arenot specifically used to produced them.


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1-Regulation 1332/2008 provides for

1a) A Union list of approved food enzymes

1b) Conditions of use of food enzymes in


1b) Conditions of use of food enzymes in foods.

1c) Rules on the labelling of food enzymes sold as such.


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1a)-Establishment of the Union list of Food Enzymes

�Union list in one single step. After EFSA hasdelivered its opinion (no deadline for EFSA)


delivered its opinion (no deadline for EFSA)on all the FE listed in the Register.

�Until the date of application of the Union list,national provisions in force on food enzymesshall continue to apply in the MS.

�There is no Union list yet


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1b-Conditions of use

� Do not pose a safety concern to thehealth of the consumer at the level ofuse proposed;


use proposed;

� Reasonable technological need fortheir use;

� Its use does not mislead theconsumer


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1-Regulation (EC) No 562/2012

This amendment provides for:

�Derogation from submitting toxicological


�Derogation from submitting toxicological data;

�Possibility of grouping dossiers

This amendment does not apply to:

� GMM derived enzymes


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1c-Labelling on enzymes

1) If food enzymes are sold as such to foodmanufacturers

2) If food enzymes are sold as such to finalconsumers


consumers

3) If food enzymes are present in foods intendedfor final consumers.

For options 1 (B2B) and 2 the legal provisions arelaid down in Art 10-12 of the enzyme Regulation.

For option 3: Dir 2000/13/EC (to be replaced byReg 1169/2011 as of 13 Dec 2014)Screening meeting on Chapter 12

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2-Guidance

1-Article 3 of Reg 234/2011-The applicant shall take intoaccount the practical guidance on the submission ofapplications made available by DG SANCO's websitehttp://ec.europa.eu/food/food/fAEF/index_en.htm


2-Article 5 of Reg 234/2011-The applicant shall take intoaccount the latest guidance documents adopted orendorsed by EFSA. Available at EFSA and SANCO website

� GMM-derived enzymeshttp://www.efsa.europa.eu/en/efsajournal/pub/2193.htm

� Conventional food enzymeshttp://www.efsa.europa.eu/en/efsajournal/pub/1305.htm


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3-Submission of Food EnzymeApplications

• WHEN:

• It started from 11 September 2011

• Deadline: 48 months after the date of


• Deadline: 48 months after the date ofapplication of Reg 234/2011 (11 March 2015 atmidnight).

• Validity check:

• COM together with EFSA

• WHY?: The COM shall submit the applicationsfor new authorisations to EFSA for its opinion(Art 17.3 of Reg 1332/2008)


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Update on the food enzyme dossiers

� First four opinions to be adopted by March/April2014.

� Expected No of dossiers: ~300


� Expected No of dossiers: ~300

� Bulk of the dossiers expected in 2014

� Few dossiers expected in the first trimester 2015


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4-Extraction Solvent Legislation

• Directive 2009/32/EC (Recast)

�Why a recast? Council Directive 88/344/EC hasbeen substantially amended several times.


been substantially amended several times.

�Scope: Extraction solvents used or intendedfor use in the productions of foodstuffs or foodingredients.

� It does not apply to: Extraction solvents usedin the production of food additives, vitaminsand other nutritional additives


Food Safety Policy

4-Extraction Solvent Legislation

It provides for:

� The establishment of a single list of extraction


� The establishment of a single list of extractionsolvents for the preparation of foodstuffs orfood ingredients,

� Conditions of use

� Where necessary, maximum residue limits

� General and specific purity criteria specified.


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5-Labelling of Extraction solvents

• Extraction solvents may not be marketed unlesstheir packaging, containers or labels carry thefollowing particulars:

Commercial name (e.g. propane, butane)


�Commercial name (e.g. propane, butane)

� Indication that the material is of qualitysuitable for use for the extraction of food orfood ingredients.

�Net quantity given as units of volume

�Batch, and name and address of the company


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European Union legislation


European Union legislation on food flavourings


Table of Contents

1.Framework legislation on flavourings


2.Smoke flavourings

3-Flavouring database


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1-Framework legislation

• Regulation (EC) No 1334/2008 on flavouringsand certain food ingredients with flavouringproperties for use in and on foods andamending Council Regulation (EEC) No



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amending Council Regulation (EEC) No1601/91, Regulations (EC) No 2232/96 and(EC) No 110/2008 and Directive 2000/13/EC

• It provides for:� Union list of flavourings and source materials� Conditions of use of flavourings and foodingredients with flavouring properties

� Labelling rules for flavourings

Scope of the Regulation 1334/2008

• It applies to:

1) Flavourings

2) Food ingredients with flavouring properties



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2) Food ingredients with flavouring properties

3) Food containing flavourings and/or foodingredients with flavourings properties

4) Source materials of flavourings and/or sourcematerials for food ingredients with flavouringproperties

Scope of the Regulation 1334/2008

It does not apply to:

1)Substances which have exclusively a sweet,sour or salty taste



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sour or salty taste

2)Raw foods

3)Non-compound foods and mixtures such as,but not exclusively, fresh, dried of frozenspices and/or herbs, mixtures of tea andmixtures for infusion as such as long as theyhave not been used as food ingredients.

Conditions of use

�do not pose a safety risk to the health ofthe consumer; and

�their use does not mislead the consumer.



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�their use does not mislead the consumer.

DefinitionsFlavourings shall mean products:

�not intended to be consumed as such, which areadded to food in order to impart or modifyodour and/or taste;



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odour and/or taste;

�made or consisting of the following categories:�flavouring substances�flavouring preparations�thermal process flavourings�smoke flavourings�flavour precursors�or other flavourings or mixtures thereof;

Definitions• Food ingredient with flavouring properties = afood ingredient other than flavourings which may beadded to food for the main purpose of adding flavour toit or modifying its flavour and which contributessignificantly to the presence in food of certain naturally

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significantly to the presence in food of certain naturallyoccurring undesirable substances;

• Source material = material of vegetable, animal,microbiological or mineral origin from which flavouringsor food ingredients with flavouring properties areproduced; it may be:

� (i) food or;

� (ii) source material other than food;

Flavourings and food ingredients with flavourings properties for which

evaluation and approval are not required

Article 8� flavouring preparations obtained from food



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� flavouring preparations obtained from food

� thermal process flavourings obtained fromfood which comply with the conditions for theproduction of thermal process flavourings andmaximum levels for certain substances in thermalprocess flavourings set out in Annex V

� flavour precursors obtained from food

� food ingredients with flavouring properties

Flavourings and source materials for which evaluation and approval are

required

Article 9� flavouring substances� flavouring preparations, thermal process



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� flavouring preparations, thermal process flavourings, flavour precursors obtained from non-food

� thermal process flavourings obtained from food but which do not comply with the criteria in Annex V

� smoke flavourings� other flavourings� source materials other than food

Labelling� Labelling of flavourings not intended for sale to the final

consumer

� Labelling of flavourings intended for sale to the finalconsumer

� Designation of flavourings in the list of ingredients(amendment to Directive 2000/13)



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(amendment to Directive 2000/13)

� flavourings or a more specific name or description ofthe flavouring, if the flavouring component containsflavourings defined in flavourings Regulation

� smoke flavouring(s) or smoke flavouring(s)produced from ‘food(s) or food category orsource(s)’ (e.g. smoke flavouring produced frombeech), if the flavouring component contains smokeflavourings and imparts a smoky flavour to the food.

� Specific requirements for use of the term "natural"

Annex I - Union list of flavourings and source materials

• Part A Flavouring substances� Commission Implementing Regulation (EU) No 872/2012

– lays down the list of flavouring substances

� Around 2100 authorised flavouring substances



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� Around 2100 authorised flavouring substances

� Around 300 flavouring substances under evaluation which may continue to be placed on the market (footnotes)

� All other substances are not permitted

� New flavouring substances to follow the CAP

Union List Part A Table 1


48

Annex I

• Part B to F - Other categories of flavourings and non-food source materials



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� Commission Regulation (EU) No 873/2012 of 1October 2012 on transitional measures concerningthe Union list of flavourings and source materialsset out in Annex I to Regulation (EC) No 1334/2008of the European Parliament and of the Council

� Deadline for submitting applications: October 2015

•

Annexes II to V• II: List of traditional food preparation processes

• III: Presence of certain substances

� Part A: Substances which shall not be added as such (directly) to food e.g. capsaicin, hypercine, coumarin

� Part B: Maximum levels of certain substances,



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� Part B: Maximum levels of certain substances,naturally present in flavourings and foodingredients with flavouring properties, in certaincompound food as consumed to which flavouringsand/or food ingredients with flavouring propertieshave been added

• IV: List of source materials to which restrictions apply fortheir use in the production of flavourings and foodingredients with flavouring properties

• V: Conditions for the production of thermal processflavourings and maximum levels for certain substances inthermal process flavourings

• Regulation (EC) No 2065/2003 of theEuropean Parliament and the Council of 10November 2003 on smoke flavourings used orintended for use in or on food.

Smoke Flavourings Regulation



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intended for use in or on food.

• It applies to :� Smoke flavourings used or intended for use in orfoods

� Food in or on which smoke flavourings arepresent

General use and safety requirements

� Sufficiently demonstrated that the smokeflavouring does not present risks to human

Smoke Flavourings Regulation



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flavouring does not present risks to humanhealth

� The use does not mislead the consumer

Union list of authorised primary products

� Exclusion of all others for use as such in or onfoods and/or for the production of derivedsmoke flavourings

Union List of smoke flavourings

• Commission Regulation 1321/2013, justpublished last December 2013

• Contains 10 primary products


• Contains 10 primary products

• Authorised for defined food categories and withmaximum limits

• Products can be mixed in formulationsrespecting the individual limits


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Contents of Union List of smoke flavourings

• Unique code

• Name of the product

• Name and address of authorization holder


• Name and address of authorization holder

• Description and characterisation of the product

• Conditions of its use

• Date from which it is authorised

• Date until it is authorised (10 years)


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