classification of cosmetic raw materials and adjuncts · kenya standard ks 1474-3: 2011...

KENYA STANDARD KS 1474-3: 2011

Classification of cosmetic raw materials and adjuncts

List of substances which cosmetic products must not contain except subject to the restrictions and conditions laid down

© KEBS 2011 Third Edition 2011

ICS 71.100.70

Part 3:

KS 1474-3: 2011

TECHNICAL COMMITTEE REPRESENTATION

REVISION OF KENYA STANDARDS

©

© Kenya Bureau of Standards, 2011

Copyright: Users are reminded that by virtue of section 6 of the Copyright Act, Cap. 130 of the Laws of Kenya, copyright sists in all Kenya Standards and except as provided under section 7 of this Act, no Kenya Standard produced by Kenya Bureau of Standards may be reproduced, stored in a retrieval system in any for or transmitted by any means without prior permission in w i ting from the Managing Director.

KEBS 2011 — All rights reservedii

The following organizations were represented on the Technical Committee:

HACO Industries Ltd.Oasis Ltd.Orbit Chemical Industries Ltd.Rozeco Chemical IndustriesInterconsumer Products Ltd.Beiersdorf (E.A.) Ltd.PZ Cussons E.A. LtdColgate PalmoliveUnilever Kenya LtdHenkel Chemicals (E.A.) Ltd.Kenya Association of ManufacturersMinistry of Public Health and SanitationGovernment ChemistJKUATConsumer Information NetworkKenya Industrial Research and Development Institute Kenyatta National Hospital — Dermatology DepartmentPharmacy & Poisons BoardNational Quality Control LaboratoriesKenya Bureau of Standards — Secretariat

In order to keep abreast of progress in industry, Keny Standards shall be regularly reviewed. Suggestions for improvements to published standards, addressed to Director, Kenya Bureau of Standards, are welcome.

ISBN 9966-23-944-8

ICS 71.100.70




K E N Y A B U R E A U O F S T A N D A R D S ( K E B S )

Head Office:

Coast Regional Office Western Kenya Regional Office Rift Valley Regional Office

© KEBS 2011 — All rights reserved iii

Part 3:

P.O. Box 54974, Nairobi-00200, Tel.: (+254 020) 605490, 602350, Fax: (+254 020) 604031E-Mail: [email protected], Web:http://www.kebs.org

P.O. Box 99376, Mombasa-80100 P.O. Box 2949, Kisumu-40100 P.O. Box 8111, Eldoret-30100

Tel.: (+254 041) 229563, 230939/40 Tel.: (+254 057) 23549, 22396 Tel.: (+254 053) 33151, 63377Fax: (+254 041) 229448 Fax: (+254 057) 21814 Fax: (+254 053) 33150

KS 1474-3: 2011Foreword

Cosmetic Products

© KEBS 2011 — All rights reservediv

This Fourth Edition of KS 1474-3 has been prepared by the Technical Committee on Cosmetics and Related Products under the guidance of the Standards Projects mmittee, and it is in accordance with the procedures of the Kenya Bureau of Standards.

It is an adoption of the European Union Regulation (EC) No. 1223/2009. This standard is in six parts for easy reference as follows:

Part 1: Illustrative list by category of cosmetic products.

Part 2 List of substances which must not form part of the composition of cosmetic products.

Part 3: List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down.

Part 4: List of colouring agents allowed for use in cosmetic p oducts.

Part 6: List of preservatives which cosmetic products may cont in.

Part 7: List of UV filters which cosmetic products may contain.

This standard was first issued in 1998. In the Second on, reference numbers 1 and 65 were amended. Also, reference number 14 on hydroquinone was deleted ince it has been proven to be harmful to the user.

In the Third Edition (2004), lead acetate (previously reference number 55) has been deleted f om the standard.

In this fourth Edition (2011), the list has been updated as per the EC reference docu reaching a total of 256 compounds. The compounds whose numbers have been skipped are under review.

The ingredients included in this standard are on the b sis of information and data available to the Committee at the time of preparation of this classification. The list will be regularly reviewed and revised when necessary.

During the preparation of Part 3 of this Kenya Standard, reference was made to the following document:

Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of the European Union. (2009): (pg.128-175). Brussels.

Acknowledgement is hereby made for the assistance derived from the above source.




1 Scope

© KEBS 2011 — All rights reserved 1

Part 3:

This Part 3 of this Kenya Standard lists substances which cosmetic products must not contain except subject to the restrictions and conditions laid down.

KS 1474-3: 2011

2 KEBS 2011 — All rights reserved

1a Boric acid, borates and tetra-borates

a) Talc

b) Products for oral hygiene

c) Other products (excluding bath products and hair waving products)

a) 5 % (by mass/mass as boric acid

b) 0.1 % (by mass/mass as boric acid)

c) 3 % (by mass/mass as boric acid)

a) 1. Not to be used in products for children under three years of age

2. Not to be used on peeling or irritated skin of the concentration of free soluble borates exceeds 1.5 % (by mass/mass as boric acid)

b) 1. Not to be used in products for children under 3 years of age

c) 1. Not to be used in products for children under 3 years of age

2. Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1.5 % (by mass/mass as boric acid

a) 1. Not to be used for Children under three years of age

2. Not to be used on peeling or irritated skin

b) 1. Not to be swallowed

2. Not to be used for children under years of age 3

c) 1. Not to be used for children underyears of age 3

2. Not to be used on peeling or irritated skin

1b Tetraboratesa) Bath products

b) Hair waving products

a) 18 % (by mass/mass as boric acid)

b) 8 % (by mass/mass as boric acid)

a) Not to be used in products for children under 3 years of age

a) Not to be used for bathing children under 3 years of age

b) Rinse well

©

SECTION 1

List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down

Reference number

SubstanceRestrictions

Conditions of use and warnings which must be printed on the labelField of application

and/or useMaximum authorized concentration in the

finished cosmetic product

Other limitations and requirements

a b c d e f

KS 1474-3: 2011

KEBS 2011 — All rights reserved 3

( )

2a Thioglycollic acid and its salts

a) Hair waving orstraightening products:

– general use

– professional

b) Depilatories

c) Other hair care products which are removed after application

– 8 % ready for use pH 7 – 9.5

– 11 % ready for use pH 7– 9.5

– 5 % ready for use pH 7 – 12.7

– 2 % ready for use pH 7– 9.5

a ) b ) c )

The directions for use drawn up in the national or official language(s) must obligatorily incorporate the following sentences:

– Avoid contact with eyes.

– In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice

– Wear suitable glovesa) and c) only

a) – Contains thioglycolate – Follow the instructions – Keep out of reach of children

– For professional use only

b) and c)

– Contains thioglycolate. – Follow the instructions.– Keep out of reach of children

©

Cont’dSECTION 1

Referencenumber Substance

Restrictions





a b c d e f

KS 1474-3: 2011


( )

2b Thioglycollic acid esters

Hair waving or Straightening products:

– general use

– professional use

Percentage calculated asthioglycollic

– 8 % ready for use pH 6-9.5 acid

– 11 % ready for use

pH 6-9.5

The directions for use drawn up in the national or official language(s) must obligatorilyincorporate the following sentences:

– May cause sensitization in the event of skin contact– Avoid contact with eyes– In the event of contact with eyes, rinse immediately with

plenty of water and seek medical advice

– Wear suitable gloves

– Contains thioglycollate– Follow the instructions– Keep out of reach of

children

– For professional use only

3 Oxilic acid, its esters and alkaline salts

Hair care products 5 % – For professional use only

4 Ammonia 6 % calculated as NH3 – Above 2 %: contains ammonia

©

Cont’dSECTION 1

Reference Number Substance

Restrictions

Conditions of use and warnings which must be printed on the

labelField of

applicationand/or use

Maximum authorized concentration in the finished cosmetic

product


a b c d e f

KS 1474-3: 2011


( )

5 Tosylchloramide sodium 0.2 %

6 Chlorates of alkali metals a) Toothpaste

b) Other uses

a) 5 %

b) 3 %

7 Dichloromethane 35 % (when mixed with1,1,1-trichloroethane, total concentration must not exceed 35 %)

0.2 % as maximumimpurity content

8 p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylene-diamine (1), with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II

a) Oxidizing colouring agents for hair dyeing

b) General use

6 % calculated as free base

a) – Can cause an allergic

reaction– Contains phenylenediamines– Do not use to dye eyelashes

or eyebrowsb)

– For professional use only– Contains phenylenediamines– Contains phenylenediamines– Can cause an allergic

reaction– Wear suitable gloves

1) These substances may be used singly in or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorized for each of them does not exc ed 1.

©

Cont’dSECTION 1


Restrictions

Conditions of use and warningswhich must be printed on the label

Field of application And/or use


product


a b c d e f

KS 1474-3: 2011


)

9 Methylphenylenediamines, their N-substituted derivatives and their salts 1)

with the exception of substance N° 364 in Part 2

Oxidizing colouring agents for hair dyeing

a) General use

b) Professional use


a)– Can cause an allergic

reaction– Contains phenylenediamines– Do not use to dye

eyelashes or eyebrows

b) – For professional use only– Contains phenylenediamines– Can cause an allergic


10 Diaminophenols1) Oxidizing colouring agents forhair dyeing

a) General use

b) Professional use


a)– Can cause an allergic

reaction.– Contains diaminophenols– Do not use to dye

eyelashes or eyebrows

b) – For professional use only– Contains diaminophenols– Can cause an allergic


11 Dichlorophen 0.5 % – Contains dichlorophen


©

Cont’dSECTION 1 (


Restrictions

Conditions of use and warningswhich must be printed on the

label

Field of application and/or use

Maximum authorizedconcentration in thefinished cosmetic

product

Other limitationsAnd requirements

a b c d e f

KS 1474-3: 2011


( )

12 Hydrogen peroxide, and

other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide

a) Hair-care preparations

b) Skin-care preparations

c) Nail hardening preparations

d) Oral hygiene products

12 % H2O2 (40 volumes)present or released4 % of H2O2 present or released2 % of H2O2 present or released

1 % of H2O2 present or 0. 2 % released

a ) b ) c ) – Contains hydrogen

peroxide– Avoid contact with eyes– Rinse eyes immediately if product comes into

contact with them.– Wear suitable gloves

13 Formaldehyde Nail hardeners 5 % calculated as formaldehyde

– Protect cuticles with grease or oil.

– Contains formaldehyde1)

14. Hydroquinone (4) (a) Oxidising colouring agent for hair dyeing

0.3% General useNot to be used on eyebrows

Professional use

Do not use to dye eyelashes or eyebrowsRinse eyes immediately if the product comes into contact with themContains Hydroquinone

For professional use onlyContains hydroquinoneRinse eyes immediately if product comes into contact with them

1) Only if the concentration exceeds 0.05 %

©

Cont’dSECTION 1

Referencenumber

Substance

RestrictionsConditions of use and

warningswhich must be printed on the

label


Maximum authorized concentration in thefinished cosmetic product

Other limitationsand requirements

a b c d e f

KS 1474-3: 2011


( )

15a Potassium or sodium hydroxide

a) Nail cuticle solvent

b) Hair straightener

1. professional use

c) pH adjust-depilatories

d) Other uses as pH adjuster

a) 5 % by weight 2)

b)

1. 2.5 % by weight 2)

c) Up to pH 12.7

d) Up to pH 11

a) – Contains alkali– Avoid contact with eyes– Can cause blindness– Keep out of reach of

children

b)1.– For professional use only– Contains alkali– Follow the instructions– Wear suitable gloves– Keep out of reach of

children– Avoid contact with eyes– Can cause blindness– In the event of contact with

eyes, rinse immediately with plenty of water and seek medical advice.

c)– Keep out of reach of

children – Avoid contact with eyes

15b Lithium hydroxide a) Hair straightener1. Professional use 1)

a) 1. 2.5 % by weight 1)

a) 1. As in a) 1 above


2) The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in Column d.

©

Cont’dSECTION 1

Reference number

Substance

Restrictions


label


Maximum and authorized

concentration in the finished cosmetic

product


a b c d e f

KS 1474-3: 2011


(

15c Calcium hydroxide a) Hair straighteners containing two components: calcium hydroxide and a guanidine

salt

a) 7 % by weight calcium hydroxide

a) As in b) 1 above

16 1-Naphthol and its salts

Oxidising colouring agents for hair dyeing

0.2 %In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Can cause an allergic reaction

–

17 Sodium nitrite Rust inhibitor 0.2 % Do not use with secondary and /or tertiary amines or other substances forming nitrosamines

18 Nitromethane Rust inhibitor 0.3 %

18Moved or deleted

19Moved or deleted

©

Cont’dSECTION 1 )

Referencenumber

Substance

Restrictions

Conditions of use and warningswhich must be printed on the

labelField of application

and/or use

Maximum authorized concentration in the finished

cosmetic product


a b c d e f

KS 1474-3: 2011


( )

21 Cinchonan-9-ol, 6’-methoxy-, (8.alpha., 9R)-and its salts

(a) Hair rinse-off products

(b) Hair leave-on products

(a) 0,5 % (as quinine base)

(b) 0,2 % (as quinine base)

22 Resorcinol (4)

(a) Oxidising colouring agent for hair dyeing

(b) Hair lotions and shampoos

5 %

0,5 %

General useNot to be used on eyebrows

Professional use

Contains resorcinolRinse hair well after applicationDo not use to dye eyelashes or eyebrowsRinse eyes immediately if product comes into contact with them

For professional use onlyContains resorcinolRinse eyes immediately if product comes into contact with them

Contains resorcinol

23 a) Alkali sulphides

b) Alkaline earth sulphides

a) Depilatories

b) Depilatories

a) 2 % calculated as sulphur pH up to 12.7 a)– Keep out of reach of

children– Avoid contact with eyes

©

cont’dSECTION 1

Reference number

Substance

Restrictions


label

Field of applicationand/or use


product

Other limitations and

requirements

a b c d e f

KS 1474-3: 2011


( )

b) 6 % calculated as sulphurpH up to 12.7

b)– Keep out of reach of children– Avoid contact with thee yes

24 Water-soluble zinc salts with the exception of zinc-4-hydroxy-benzenesulphonate and zinc pyrithione

1 % calculated as Zinc

25 Zinc 4-hydroxybenzene Deodorants, antiperspirants and astringent lotions

6 % calculated as % anhydrous substance

– Avoid contact with eyes

1) These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorized for each of them does not exc ed 2.26 Ammonium

monofluorophosphateOral hygiene products 0.15 % calculated as F when

mixed with other fluorine compounds permitted in this standard, total F concentration must not exceed 0.15 %

Contains ammonium monofluorophosphateFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

27 Disodium Oral 0,15 % (as F). When Contains potassium

©

Cont’dSECTION 1

Reference number

Substance

Restrictions


and/or use


product


a b c d e f

KS 1474-3: 2011


fluorophosphate products mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

monofluorophosphateFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

28 Dipotassium fluorophosphate

Oral products

0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains potassium monofluorophosphateFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

29Calcium fluorophosphate

Oralproducts


Contains potassium monofluorophosphateFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

30 Calcium fluoride

Oral products

0,15 % (as F). When mixed with other fluorine compounds

Contains calcium fluorideFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for

©

KS 1474-3: 2011


permitted under this Annex, total F concentration must not exceed 0,15 %

adult use only’) the following labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

31 Sodium fluoride

Oral products


Contains sodium fluorideFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

32 Potassium fluoride

Oral products


Contains potassium fluorideFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

33 Ammonium fluoride

Oral products

0,15 % (as F). When mixedwith other fluorine compounds permitted

Contains ammonium fluorideFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult

©

KS 1474-3: 2011


under this Annex, total F concentration must not exceed 0,15 %

use only’) the following labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

34 Aluminium fluoride

Oral products


Contains aluminium-fluorideFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

35 Tin difluoride

Oral products


Contains stannous fluorideFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

©

KS 1474-3: 2011


)

36 Hexadecyl ammonium fluoride

Oral products


Contains Cetylamine hydrofluorideFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

37 3-(N-Hexadecyl-N-2-hydroxyethyl-ammonio) propylbis (2-hydroxyethyl) ammonium dihydrofluoride

Oral products


Contains 3-( -Hexadecyl- -2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluorideFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:‘Children of 6 years and younger: Use a pea sizedamount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

©

cont’d

N N

SECTION 1 (

Reference number


Conditions of use and warnings which must be printed on the labelField of

application and/or use

Maximum authorized concentration in the

finished product


requirements a b c d e f

KS 1474-3: 2011


38 NN’N’Tris(polyoxythylene)-N-bexa decylpropylene diamine dihydrofluoride

Oral products


Contains ’-Tris(polyoxyethylene)- -hexadecylpropylenediamine dihydrofluorideFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory: ‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor

39 9-Octadecenamine, hydrofluoride

Oral products


Contains octadecenyl-ammonium fluorideFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or

©

N,N’,NN

Reference number





finished product


requirements

KS 1474-3: 2011


doctor’40 Disodium

hexafluorosilicateOral products


Contains sodium fluorosilicate

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

41 Dipotassium hexafluorosilicate

Oral products 0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains potassium fluorosilicateFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

42 Ammonium fluorosilicate

Oral products 0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total

Contains potassium fluorosilicateFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following

©

Reference number





finished product


requirements

KS 1474-3: 2011


F concentration must not exceed 0,15 %

labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

43 Magnesium fluorosilicate

Oral products 0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, totalF concentration must not exceed 0,15 %

Contains magnesium fluorosilicateFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

44 1,3 Bis (hydroxymethyl) imidazolidine-2-thione

a) Hair care preparations

b) Nail care preparations

a) 2 %

b) 2 %

a) Prohibited in dispensers (sprays)

b) pH < 4

Contains Dimethylol ethylene thiourea

©

Reference number





finished product


requirements

KS 1474-3: 2011


( )

45 Benzyl alcohol Solvents, perfumes and flavourings

For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product

46 6-methylcoumarin Oral hygiene products 0.003 %47 3-

Pyridinemethanol, hydrofluoride

Oral products 0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains nicomethanol hydrofluorideFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

©

cont’dSECTION 1

Reference number Substance

Restrictions

Conditions of use and warnings which must be printed on the label



finished product

Other limitations

and requirements

a b c d e f

KS 1474-3: 2011


( )

48 Silver nitrate Only for colouring eyelashes and eyebrows

4 % Contains silver nitrateRinse eyes immediately if product comes into contact with them

49 Selenium disulphide Anti-dandruff shampoos 1 %Contains selenium disulphideAvoid contact with eyes or damaged skin

50 Aluminium zirconium chloride hydroxide

Complexes AlxZr(OH)yClzand the aluminium zirconium chloride hydroxide glycine complexes

Anti-perspirants 20 % as anhydrous aluminium zirconium chloride hydroxide5.4 % as zirconium

1. The ratio of the number of aluminium atoms to that of zirconium atoms must be between 2 and 10

2. The ratio of the number of (Al+ Zr) atoms to that of chlorine atoms must be between 0.9 and

2.1

3. Not to be used in aerosol dispensers (sprays)

Do not apply to irritated or damaged skin

©

cont’dSECTION 1


Restrictions


labelField of application

and/or use


finished product


a b c d e f

KS 1474-3: 2011


( )

51 Quinolin-8-ol and bis (8-hydroxyquinolinium) sulphate

Stabilizer for hydrogen peroxide in rinse-off hair-care preparations.

Stabilizer for hydrogen peroxide in non-rinse-off hair-care preparations

0.3 % calculated as base

0.03 % calculated as base

52 Methanol Denaturant for ethanol and isopropyl alcohol

5 % calculated as a % of ethanol and isopropyl alcohol

53 (I-hydroxy-ethylidene diphosphoric acid and its salts)

a) Hair-care

b) Soap

1,5 % (as etidronic acid)

0,2 % (as etidronic acid)

54 1-Phenoxypropan-2-01 – Rinse-off products only– Prohibited in oral hygiene

products

2 % For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product

55 Moved or deleted56 Magnesium fluoride Oral

products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration

Contains magnesium fluorideFor any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the

©

cont’dSECTION 1

Reference number

Substance

Restrictions



finished product


a b c d e f

KS 1474-3: 2011


must not exceed 0,15 %

following labelling is obligatory:‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

57 Strontium chloride hexahydrate

(a) Oral products

(b) Shampoo and face products

3.5 % calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3.5 %

2,1 % (as strontium). When mixed with other permitted strontium compounds the total strontium content must not exceed 2,1 %

Contains strontium chloride

Frequent use by children is not advisable

58 Strontium acetate hemihydrate

Oral products 3.5 % calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3.5 %

Contains strontium acetate

Frequent use by children is not advisable

59 Talc: Hydrated magnesium silicate

a) Powdery products intended to be used by children under three years of age

b) Other products

Keep powder away from children’s nose and mouth

©

Reference number

Substance

Restrictions



finished product


KS 1474-3: 2011


( )

60 Fatty acid dialkanolamides

Maximum secondary amine content:

content:0.5%

– Do not use with nitrosating system

– Maximum dialkanolamine content: 5 % (concerns raw materials)

– Maximum N-nitroso-dialkanolamine content:

50 g/kg– Keep in nitrite-free containers

61 Monoalkylamines, monoalkanolamines and their salts

Maximum secondary amine

content:0.5 %

– Do not use with nitrosating system

– Minimum purity: 99 %– Maximum secondary

alkanolamine content:0.5 % (concerns raw materials)

– Maximum N-nitroso-dialkanolamine content: 50 g/kg

– Keep in nitrite-free containers

©

cont’dSECTION 1

Reference number

Substance

RestrictionsConditions of use and

warnings which must be printed on the labelField of application

and/or use


finished product


a b c d e f

µ

µ

KS 1474-3: 2011


( )

62Trialkylamines, and their salts

Trialkanolamines

a) Rinse-off products

b) Leave-on products

a) 2.5 % a) b):– Do not use with nitrosating

system– Minimum purity: 99%– Maximum secondary

alkanolamine content: 0.5 % (concerns raw materials)

– Maximum N nitrosodialkanolamine content: 50 g/kg

– Keep in nitrite-free containers

63 Strontium hydroxide pH-regulator in depilatory products

3.5 calculated as strontium, max. pH of 12.7

– Keep out of reach of children

– Avoid contact with the eyes

©

cont’dSECTION 1


Restrictions

Conditions of use and warnings which must be

printed on the label




Other limitations andrequirements

a b c d e f

µ

KS 1474-3: 2011


( )

64 Strontium peroxide Rinse-off hair care preparations professional use

4.5 % calculated as strontium in the ready-for-use preparation

All products must meet the hydrogen peroxides release requirements

– Avoid contact with eyes– Rinse eyes immediately if

product comes into contact with them

– For professional use only– wear suitable gloves

65 Benzalkonium chloride, bromide and saccharinate

a) Rinse-off hair (head) care products

b) Other products

a) 3 % (as benzalkonium chloride)

b) 0.1 % (as benzalkoniumchloride)

a) In the final products the concentrations of benzalkonium chloride bromide, and saccharinate with an alkyl chain of C14 or less must not exceed 0.1 %

( 2,5 benzalkonium chloride)

a) Avoid contact with the eyes

b) Avoid contact with the eyes

66 Polyacrylamides

(a) Body-leave-on products

(b) Other products

(a) Maximum residual acrylamidecontent 0,1 mg/kg

(b) Maximum residual acrylamide content 0,5 mg/kg

©

cont’dSECTION 1


RestrictionsConditions of use and warnings

which must be printed on the label





a b c d e f

KS 1474-3: 2011


67 2-Benzylideneheptanal

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:—0,001 % in leave-on products —0,01 % in rinse-off products

68 Benzyl alcohol


69 Cinnamyl alcohol


70 3,7-Dimethyl-2,6-octadienal

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration

©








KS 1474-3: 2011


exceeds:—0,001 % in leave-on products —0,01 % in rinse-off products

71 Phenol, 2-methoxy-4-(2-propenyl)


72 7-Hydroxycitronellal


73

Phenol, 2-methoxy-4-(1-propenyl)-

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:—0,001 % in leave-on products —

©








KS 1474-3: 2011


0,01 % in rinse-off products

74 2-Pentyl-3-phenylprop-2-en-1-ol


75 Benzyl salicylate

The presence of the substance must be

©








SECTION 2

LIST OF SUBSTANCES PROVISIONALLY ALLOWED

Reference number

Substance

Restrictions


and/or useMaximum authorized

concentration in the finished cosmetic product


a b c d e f

KS 1474-3: 2011


indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:—0,001 % in leave-on products —0,01 % in rinse-off products

76 2-Propenal, 3-phenyl-


77 2H-1-Benzopyran-2-one


©


Restrictions





KS 1474-3: 2011


78 2,6-Octadien-1-ol, 3,7-dimethyl-, (2E)-


79 3 and 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde


80 4-Methoxybenzyl alcohol

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:—0,001 % in leave-on

©


Restrictions





KS 1474-3: 2011


products —0,01 % in rinse-off products

81 2-Propenoic acid, 3-phenyl-, phenylmethyl ester


82 2,6,10-Dodecatrien-1-ol, 3,7,11-trimethyl-


83 2-(4-tert-Butylbenzyl) propionaldehyde

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration

©


Restrictions





KS 1474-3: 2011


exceeds:—0,001 % in leave-on products —0,01 % in rinse-off products

84 1,6-Octadien-3-ol, 3,7-dimethyl


85 Benzyl benzoate


86 Citronellol/(±) -3,7-dimethyloct-6-en-1-ol

The presence of the substance must be indicated in the list of ingredients referred

©


Restrictions





KS 1474-3: 2011


to in Article 19(1)(g) when its concentration exceeds:—0,001 % in leave-on products —0,01 % in rinse-off products

87 2-Benzylideneoctanal


88 (4R)-1-Methyl-4-(1-methylethenyl)cyclohexene


89 Methyl heptin carbonate

The presence of the substance must be indicated in the list of

©


Restrictions





KS 1474-3: 2011


ingredients referred to in Article 19(1)(g) when its concentration exceeds:—0,001 % in leave-on products —0,01 % in rinse-off products

90 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one


91 Oak moss extract


©


Restrictions





KS 1474-3: 2011


92 Treemoss extract


93 2,4-Pyrimidinediamine, 3-oxide

Hair products 1,5 %

94 Dibenzoyl peroxide

Artificial nail systems0,7 % (after mixing for use)

Professional use For professional use onlyAvoid skin contactRead directions for use carefully


95 Hydroquinone methylether/Mequinol

Artificial nail systems

0,02 % (after mixing for use)


96 5-tert-Butyl-2,4,6-trinitro-m-xylene

All cosmetic products, with the exception of oral products

(a) 1,0 % in fine fragrance(b) 0,4 % in eau de toilette(c) 0,03 % in other products

97 4’-tert-Butyl-2’,6’-dimethyl-

All cosmetic products, with

(a) 1,4 % in fine fragrance

©


Restrictions





KS 1474-3: 2011


3’,5’-dinitroacetophenone

the exception of oral products

(b) 0,56 % in eau de toilette(c) 0,042 % in other products

98 Benzoic acid, 2-hydroxy-(10)

(a) Rinse-off hair products(b) Other products

(a) 3,0 %(b) 2,0 %

Not to be used in preparations for children under 3 years of age, except for shampoosFor purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product

Not to be used for childrenunder 3 years of age (11)

99 Inorganic sulfites and bisulfites (12)

(a) Oxidative hair dye products

(b) Hair straightening products

(c) Self-tanning products for the face

(d) Other self-tanning products

(a) 0,67 % (as free SO2)

(b) 6,7 % (as free SO2)

(c) 0,45 % (as free SO2)

(d) 0,40 % (as free SO2)

For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product

100 1-(4-Chlorophenyl)

Rinse-off products

1.5% Purity criteria:3,3’,4,4’-

©


Restrictions





KS 1474-3: 2011


-3-(3,4-dichlorophenyl) urea (13)

Tetrachloroazobenzene = 1 ppm3,3’,4,4’-Tetrachloroazoxybenzene = 1 ppmFor purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product

101 Pyrithione zinc (14)

Leave-on hair products

0.1 % For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product

102 1,2-Dimethoxy-4-(2-propenyl)-benzene

Fine fragrance

Eau de toilette

Fragrance cream

Other leave-on productsand oral products

0,01 %

0,004 %

0,002 %

0,0002 %

0,001 %

©


Restrictions





KS 1474-3: 2011


Rinse-off products

215 4-Amino-3-nitrophenol and its salts

(a) Oxidising colouring agents for hair dyeing

(b) Non-oxidising colouring agents for hair dyeing

(a) 3,0 %

(b) 3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %Not to be used after31.12.2009

(a) (b) Can cause allergic reaction

216 2,7-Naphthalenediol and its salts


1,0 % In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 %Not to be used after31.12.2009

217 m-Aminophenol and its salts


2,0 %In combination with hydrogen peroxide the maximum use concentration upon

Can cause allergic reaction

©


Restrictions





KS 1474-3: 2011


application is 1,0 %Not to be used after31.12.2009

218 2,6-Dihydroxy-3,4-dimethylpyridine and its salts



2191-Hydroxy-3-nitro-4-(3-hydroxypro pylamino)benzene and its salts



(a) 5,2 %

(b) 2,6 %



220 1-[(2’-Methoxyethyl) amino]-2-nitro-4-[di-(2’-hydroxyethyl) amino]benzene and its salts



(a) 3,0 %

(b) 2,0 %



221 1-Methyl-3-nitro-4-(.beta.-hydroxyethyl) aminobenzene and its salts


(b) Non-

(a) 2,0 %

(b) 1,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is


©


Restrictions





KS 1474-3: 2011


oxidising colouring agents for hair dyeing

1,0 %Not to be used after31.12.2009

222 1-Hydroxy-2-.beta.-hydroxyethylamino-4,6-dinitrobenzene and its salts



(a) 3,0 %

(b) 2,0 %



223 4-Methylaminophenol and its salts

Oxidising colouring agent for hair dyeing

3,0 % In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

Not to be used after31.12.2009


224 1-(3-Hydroxy-propylamino)-2-nitro-4-bis(2-hydroxyethylamino) benzene and its salts

Non-oxidising colouring agent for hair dyeing

2,0 % Not to be used after31.12.2009

225 1-(.beta.-Hydroxyethyl) amino-2-nitro-4-N-ethyl-N-(.beta.-hydroxyethyl)


(b) Non-oxidising

(a) 1,5 %

(b) 1,5 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,75 %


©


Restrictions





KS 1474-3: 2011


aminobenzene and its salts

colouring agents for hair dyeing


226 4,4’-[1,3-Propanediylbis (oxy)]bis-, benzene-1,3-diamine and its salts





227 3-Amino-2,4-dichlorophenol and its salts





228 3-Methyl-1-phenyl-5-pyrazolone and its salts




229 5-[(2-Hydroxyethyl) amino]-o-cresol and its salts




©


Restrictions





KS 1474-3: 2011



230 3,4-Dihydro-2H-1,4-benzoxazin-6-ol and its salts





231 1,5-bis(.beta.-Hydroxyethyl) amino-2-nitro-4-chlorobenzene and its salts

Non-oxidising colouring agents for hair dyeing


232 3,5-Diamino-2,6-dimethoxypyridine and its salts


0,5 %

1,0 %


233 1-(2-Aminoethyl) amino-4-(2-hydroxyethyl)oxy-2-nitrobenzene and its salts


1,0 %Not to be used after31.12.2009

234 Ethanol, 2-[(4-amino-2-methyl-5-nitrophenyl)


(b) Non-oxidising

(a) 0,5 %

(b) 0,5 %

In combination with hydrogen peroxide the maximum use concentration upon

©


Restrictions





KS 1474-3: 2011


amino]-and its salts

colouring agents for hair dyeing

application is 0,25 %


235 2-[3-(Methylamino)-4-nitrophenoxy] ethanol and its salts



236 2-[(2-Methoxy-4-nitrophenyl)amino]ethanol and its salts



237 2,2’-[(4-Amino-3-nitrophenyl)imino]bisethanol hydrochloride and other salts



(a) 2,5 %

(b) 2,5 %



238 Naphthalene-1,5-diol and its salts



239 Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) and its salts




240 o-Aminophenol and its salts

Oxidising colouring agents for

3,0 % In combination with hydrogen peroxide the maximum use

©


Restrictions





KS 1474-3: 2011


hair dyeing concentration upon application is 1,5 %


241 2,4-Diaminophenoxyethanol and its salts



242 5-Amino-o-cresol and its salts




243 1,3-Benzenediol, 2-methyl-, and its salts -




244 4-Amino-m-cresol and its salts



©


Restrictions





KS 1474-3: 2011



245 2-[(3-amino-4-methoxyphenyl)amino]ethanol and its salts




246 Hydroxyethyl-3,4-methylenedioxyaniline 2-(1,3-benzodioxol-5-ylamino)ethanol hydrochloride and other salts




247 2,2’-[[4-[(2-Hydroxyethyl) amino]-3-nitrophenylimino] ]bisethanol. and its salts



247 4-[(2-Hydroxyethyl) amino]-3-nitrophenol and its salts



(a) 6,0 %

(b) 6,0 %


©


Restrictions





KS 1474-3: 2011


248 1-(.beta.-Ureidoethyl)amino-4-nitrobenzene and its salts



(a) 0,5 %

(b) 0,5 %



249 1-amino-2-nitro-4-(2’,3’-dihydroxypropyl) amino-5-chlorobenzene and 1,4-bis-(2’,3’-dihydroxypropyl) amino-2-nitro-5-chlorobenzene and its salts



(a) 2,0 %

(b) 1,0 %



250 Phenol, 2-chloro-6-(ethylamino)-4-nitro-and its salts



(a) 3,0 %

(b) 3,0 %



251 2-Amino-6-chloro-4-nitrophenol and its salts


(b) Non-oxidising colouring agents

(a) 2,0 %

(b) 2,0 %



©


Restrictions





KS 1474-3: 2011


for hair dyeing

252 [4-[[4-Anilino-1-naphthyl][4-(dimethylamino) phenyl]methylene] cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride (CI 44045) and other salts



(a) 0,5 %

(b) 0,5 %



2253 Disodium 5-amino-4-hydroxy-3-(phenylazo) naphthalene-2,7-disulphonate (CI 17200) and other salts



254 Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl) azo]-4-hydroxynaphthalene-1-sulphonate (CI 14700) and other salts



255 Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl) azo]-4-hydroxynapht



©


Restrictions





KS 1474-3: 2011


halene-1-sulphonate (CI 14700) and other salts

256 (4-(4-Aminophenyl) (4-iminocyclohexa-2,5-dienylidene) methyl)-2-methylaniline hydrochloride (CI 42510) and other salts



(a) 0,3 %

(b) 0,3 %



NOTE No substance is listed in this section for the present time

©


Restrictions





classification of cosmetic raw materials and adjuncts · kenya standard ks 1474-3: 2011...

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