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KENYA STANDARD KS 1474- 6: 2010

Specification for cosmetic raw materials and adjuncts — Classification

Part 6:

List of preservatives which cosmetic products may contain

No copying of this standard without KEBS permission except as permitted by copyright law

© KEBS 2010 First Revision 2010

ICS 71.100.70

KS 1474- 6: 2010

REVISION OF KENYA STANDARDS

ii © KEBS 2010 –– All rights reserved

TECHNICAL COMMITTEE REPRESENTATION

The following organizations were represented on the Technical Committee:

Haco Industries LtdOasis Ltd Ministry of Medical Services Government Chemist Jomo Kenyatta University of Agriculture & Technology (JKUAT)Rozeco Chemical Industries Interconsumer Products Ltd Consumer Information Network Kenya Industrial Research of Development Institute (KIRDI)Kenyatta National Hospital Pharmacy and Poisons Board Beiersdorf (EA) Ltd National Quality Control Labs Pz Cussons E.A Ltd. Kenya Association of ManufacturersCarson Products (PTY) Ltd.Colgate Palmolive Unilever Kenya Ltd. Henkel Chemical s (E.A.) Ltd. Intertek InternationalKenya 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 the ging Director, Kenya Bureau of Standards, are welcome.

© Kenya Bureau of Standards, 2010

Copyright. Users are reminded that by virtue of sec ion 6 of the Copyright Act, Cap. 130 of the Laws of Kenya, copyright subsists 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 form or transmitted by any means without prior permission in writing from the Managing Director.

Permission may be conditional on an appropriate royalty payment.

Care should be taken to ensure that material used is f current edition of the standard and that it is updated whenever the standard is amended or revised. The number and date of the standard should therefore be clearly identified.

The use of material in print or in electronic form to be used commercially with or without payment or in commercial contracts is subject to payment of a royalty.

KS 1474- 6: 2010


List of colouring agents allowed for use in cosmetic products

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 Region Lake Region Rift Valley Region

Fax: (+254 041) 229448 Fax: (+254 057) 21814

iv © KEBS 2010 –– All rights reserved

ICS 71.100.70

Part 4:

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 2138, Nakuru-20100

Tel.: (+254 041) 229563, 230939/40 Tel.: (+254 057) 23549, 22396 Tel.: (+254 051) 210553, 210555


PREFACE

© KEBS 2010 –– All rights reserved

This Part 6 of this Kenya Standard was adopted from the European Union Cosmetics Directive, Dir. 76/768 EEC, by the Technical Committee on Cosmetics and related products under the guidance of the Chemical Industry Standards Committee. Dir. 76/768 EEC was wri over several years but updated regularly. This standard is in seven 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 mu not contain except subject to restrictions and Conditions laid down.Part 4. List of colouring agents allowed for use in c smetic products.Part 6. List of preservatives which cosmetic products may contain.Part 7. List of UV filters which cosmetic products ma contain.

A positive list of raw materials which are generally recognized as safe for use in cosmetics will be included in this standard, and will form Part 8. In the absence o effective regulations or standards, cosmetics and toilet goods may constitute a potential health hazard to the onsumers. This Part 6 of this Kenya Standard has therefore been adopted to guard against harmful substances being used in the formulation of cosmetics and toilet goods.

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

In the preparation of this Part 6 of this Kenya Standard, reference was made to the following document:

Dir. 76/768 EEC Cosmetics directive, updated 1997.

The assistance obtained from this source is hereby acknowledged with thanks.

v


Part 4:

This Part 6 of this Kenya Standard lists preservatives which cosmetic products may contain.

1. Preservatives are substances which may be added to cosmetic products for the primary purpose of inhibiting the development of micro-organisms in such products.

2. The substances marked with the symbol (+) may also be added to cosmetic products in concentrations other than those laid down in this standard for other specific purposes apparent from the pre entation of the products, e.g. as deodorants in soaps or as anti-dandruff agents in shampoos.

3. Other substances used in the formulation of cosmetic products may also have anti-microbial properties and thus help in the preservation of the products, as, for instance, many essential oils and some alcohol. These substances are not included in this standard.

4. For the purposes of this list

- ‘Salts’ is taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines; salts of the anions chloride, bromide, sulphate, acetate.

‘Esters’ is taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl.

5. All finished products containing formaldehyde or substances in this standard and which release formaldehyde must be labelled with the warning ‘contai formaldehyde’ where the concentration of formaldehyde in the finished product exceeds 0.05 per cent.

1



List of colouring agents allowed for use in cosmetic products 1. SCOPE

PART 6

LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN

Preamble

KS 1474- 6: 2010


Ref. No

Sunstance identification Conditions Wording of conditions of use and warnings

Chemical name /INN/XAN Product type, body part Maximum concentration for use preparation

Other

1. Benzoic acid and its salts Rinse off products, except oral products

Oral products

Leave on products

2.5% (acid)

1.7% (acid)

0.5% (acid)1a Salts of benzoic acid other than that listed

under reference number 1 and esters of benzoic acid

Ammonium benzoate, calcium benzoate, potassium benzoate, magnesium benzoate, MEA- benzoate, methyl benzoate, ethyl benzoate, propyl benzoate, butyl benzoate. Isobutyl benzoate, phenyl benzoate

0.5%

2. Propionic acid and its salts 2 % (acid)3. Salicylic acid (1) and its salts 0,5 % (acid) Not to be usedin

products forchildren under3 years of age,except forshampoos

Not to be usedfor childrenunder 3 years ofage (2)

4. Hexa-2,4-dienoic acid and its salts 0,6 % (acid)5. Formal-dehyde, paraformaldehyde (3) Oral products

Other products

0,1 % (free formaldehyde)

0,2 % (free

Not to be used in aerosol dispensers (sprays

2

SECTION 1

LIST OF PRESERVATIVES ALLOWED


formaldehyde)6. Moved or deleted7.

Biphenyl-2-ol, and its salts0,2 % (as phenol)

8. Pyrithione zinc (4) Oral products

Other products

1,0 %

0,5 %

Only in rinse-off products

Not to be used in oral products

9. Inorganic sulphites and hydrogen- sulphites (5)

0,2 % (as free SO2)

10.11. Chlorobutanol 0,5 % Not to be used in

aerosol dispensers (sprays)

Contains Chlorobutanol

12. 4-Hydroxybenzoic acid and its salts and esters

0,4 % (as acid) for single ester,0,8 % (as acid) for mixtures of esters

13. 3-Acetyl-6-methylpyran-2,4 (3H)-dione and its salts

0,6 % (as acid) Not to be used in aerosol dispensers (sprays)

14. Formic acid and its sodium salt 0,5 % (as acid) 15. 3,3’-Dibromo-4,4’-hexamethylenedioxydi-

benzamidine and its salts (including isethionate)

0,1 %

16. Thiomersal Eye products 0,007 % (of Hg)

If mixed with other mercurial compounds authorised by thisRegulation, the maximum concentration of Hg remains fixed at 0,007 %

Contains Thiomersal

17. Phenylmercuric salts (including borate) Eye products 0,007 % (of Hg)

If mixed with other

Contains Phenylmercuric compounds

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KS 1474- 6: 2010


mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0,007 %

18. Undec-10-enoic acid and its salts 0,2 % (as acid)19. 5- Pyrimidinamine, 1,3-bis (2-ethylhexyl)

hexahydro-5-methyl-0,1 %

20. 5-Bromo-5-nitro-1,3-dioxane Rinse-off products 0,1 % Avoid formation of nitrosamines

21. Bronopol 0,1 % Avoid formation of nitrosamines

22. 2,4-Dichlorobenzyl alcohol 0,15 %23.

1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl) urea (6)

0,2 % Purity criteria:3,3’,4,4’-Tetrachloroazobenzene < 1 ppm

3,3’,4,4’-Tetrachloroazoxybenzene < 1 ppm

24. Chlorocresol Not to be used in products applied on mucuous membranes

0,2 %

25. 5-Chloro-2- (2,4- dichlorophenoxy) phenol 0,3 %26. Chloro-xylenol 0,5 %27. N,N?-methylenebis[N'-[3-(hydroxymethyl)-

2,5-dioxoimidazolidin-4-yl]urea]0,6 %

28. Poly(methylene),.alpha.,.omega.-bis[[[(aminoiminomethyl)amino]iminomethyl] amino]-, dihydrochloride

0,3 %

29. 2-Phenoxyethanol 1,0 %30. Methenamine 0,15 % 31. Methenamine 3-chloroallylochloride 0,2 %32. 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-

dimethylbutan-2-one0,5 %

2


33. 1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione

0,6 %

34. 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt

Oral products

Other products

1,0 %

0,5 % 35. Benzyl alcohol (7) 1,0 %36. Moved or deleted37. 2,2’-methylenebis(6-bromo-4-chlorophenol) 0,1 %38. 4-Isopropyl-m-cresol 0,1 %39. Mixture of 5-Chloro-2-methyl-isothiazol-

3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate

0,0015 % (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one

40. 2-Benzyl-4-chlorophenol 0,2 %41. 2-Chloroacetamide 0,3 % Contains

chloroacetamide 42. N,N?-bis(4-chlorophenyl)-3,12-diimino-

2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochloride

0,3 % (as chlorhexidine)

43. 1-Phenoxypropan-2-ol (8) Only for rinse-off products

1,0 %

44. Alkyl (C 12-22) trimethyl ammonium bromide and chloride

0,1 %

45. 4,4-Dimethyl-1,3-oxazolidine 0,1 % pH > 646. N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-

dioxo-2,5-imidazolidinyl-4)-N’-(hydroxymethyl) urea

0,5 %

47. Benzenecarboximidamide, 4,4’-(1,6-hexanediylbis (oxy))bis- and its salts (including isethionate and p-hydroxybenzoate)

0,1 %

48. Glutaraldehyde (Pentane-1,5-dial) 0,1 % Not to be used in aerosols (sprays)

Contains glutaral (9)

49. 5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane

0,3 % Not to be used in oral products and in

3

KS 1474- 6: 2010


products applied on mucous membranes

50. 3-(p-Chlorophenoxy)-propane-1,2 diol 0,3 %51. Sodium hydroxymethylamino acetate 0,5 %52. Silver chloride deposited on titanium

dioxide0,004 % (as AgCl) 20 % AgCl (w/w) on

TiO2. Not to be used in products for children under 3 years of age, in oral products and in eye and lip products

53. Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3,-tetramethylbutyl)phenoxy] ethoxy] ethyl]-, chloride

(a) Rinse-off products

(b) Leave-on products other than oral products

0,1 %

54. Benzalkonium chloride, bromide and saccharinate (10)

0,1 % (as benzalkonium chloride)

Avoid contact with eyes

55. Methanol, (phenylmethoxy-) Rinse-off products0,15 %

56. 3-Iodo-2-propynylbutylcarbamate

(a) Rinse-off products

(b) Leave-on products

(c) Deo-dorants/anti-perspirants

(a) 0,02 %

(b) 0,01 %,

(c) 0,0075 %

Not to be used in oral and lip products(a) Not to be used in products for children under 3 years of age, except in bath products/ shower gels and shampoo(b) Not to be used in body lotion and body cream (13)(b) and (c) Not to be used in products for children under 3 years of age

(a) Not to be used for children under 3 years of age (11)(b) and (c) Not to be used for children under 3 years of age (12)

57. 2-Methyl-2H-isothiazol-3-one 0,01 %

2


LIST OF PRESERVATIVES PROVISIONALLY ALLOWED

Colipa number

Reference number

Substance Maximum authorized concentration

Limitations and Requirements

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

Allowed until

P71 16 Alkyl (C8-C18) dimethyl benzyl ammonium chloride, bromide and saccharinate (+) (Benzalkonium chloride, bromide and saccharinate)

0.1 per cent 30.06.1998

P21 21 Benzylhemiformal 0.03 per cent For rinse-off products only

30.06.1998

P91 29 3-Iodo-2-propynylbutyl carbamate 0.1 per cent 30.06.1998

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SECTION 2

a b c d e f

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