The Cosmetic Products (Safety) Regulations 1996

Explanatory Note

(This note is not part of the Regulations)

These Regulations consolidate with amendments the Cosmetic Products (Safety) Regulations 1989 as amended. They implement Council Directive 76/768/EEC (O.J. No. L262, 27.9.1976, p.169) on the approximation of the laws of the member States relating to cosmetic products, as amended (“the Cosmetics Directive”). They implement for the first time the amendments made to the Cosmetics Directive by Council Directive 93/35/EEC (O.J. No. L151, 23.6.1993, p.32) and Commission Directive 96/41/EC (O.J. No. L198, 8.8.1996, p.36). They also implement Commission Directives 95/32/EC (O.J. No. L178, 28.7.1995, p.20) and 96/45/EC (O.J. No. L213, 2.7.1996, p.8) relating to methods of analysis necessary for checking the composition of cosmetic products. Further, they implement Commission Directive 95/17/EC (O.J. No. L140, 23.6.1995, p.26) laying down detailed rules for the application of the Cosmetics Directive as regards the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic products.

These Regulations give effect to Council Directive 93/35/EEC and Commission Directive 96/41/EC as follows—

1. they contain an amended definition of “cosmetic product”(regulation 2(1));

2. they contain an expanded general safety requirement for cosmetic products (regulation 3(1));

3. they prohibit the use of urocanic acid and its ethyl ester in cosmetic products (regulation 4(2)(a) and Schedule 1, entry numbers 342, 405 and 751);

4. they permit the use in certain cosmetic products of potassium hydroxide, sodium hydroxide, lithium hydroxide and calcium hydroxide, subject to restrictions (regulation 4(2)(b) and Schedule 2, Part I, entry numbers 15a, 15b and 15c);

5. they permit the use as preservatives in cosmetic products of chlorphenesin, sodium hydroxymethylglycinate and silver chloride deposited on titanium dioxide, subject to restrictions (regulations 4(2)(e)(i) and 4(2)(f) and Schedule 4, Part I, entry numbers 50, 51 and 52);

6. they permit, subject to restrictions, the use in cosmetic products until 30 June 1997 of three preservatives listed as entry numbers 16, 21 and 29 in Schedule 4, Part II (regulation 4(2)(e)(ii) and Schedule 4, Part II);

7. they permit the use as a UV filter in cosmetic products of polymer N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl}acrylamide, subject to a restriction (regulation 4(2)(h)(i) and 4(2)(i) and Schedule 5, Part I, entry number 11);

8. they permit the use in cosmetic products until 30 June 1997 of 10 UV filters listed as entry numbers 2, 5, 6, 12, 13, 17, 25, 26, 29 and 32 in Schedule 5, Part II, subject to restrictions (regulation 4(2)(h)(ii) and Schedule 5, Part II);

9. they prohibit the use in cosmetic products of any ingredients which have been tested on animals after 1st January 1998 (regulation 4(3));

10. they provide that any reference to testing on animals in the labelling, putting up for sale or advertising of a cosmetic product must state clearly whether the tests carried out involved the cosmetic product itself or its ingredients (regulation 4(4) and (5));

11. they require cosmetic products to be labelled with information about their function, unless this is clear from their presentation (regulation 6(2)(h));

12. they require cosmetic products to be labelled with details of their ingredients, identified by their common names as provided for in the common ingredients nomenclature (an inventory of ingredients compiled by the Commission and contained in Commission Decision 96/335/EC (O.J. No. L132, 1.6.1996, p.1), and they make provision for the manner of labelling required and for cases where ingredients are not listed in the common ingredients nomenclature (regulation 6(1), (5)(b) and (9) to (12));

13. they require manufacturers, their agents, persons to whose order cosmetic products are manufactured and (in certain circumstances) persons responsible for supplying cosmetic products for the first time in the Community to keep for control purposes detailed information (which must be readily accessible to a United Kingdom competent authority) bearing on the composition, ingredients, method of manufacture, safety and effect of the cosmetic products in question (regulation 8);

14. they require manufacturers, their agents, persons to whose order cosmetic products are manufactured and (in certain circumstances) persons responsible for supplying cosmetic products for the first time in the Community to notify a United Kingdom competent authority of the address of the place of manufacture or initial importation into the Community of a type of cosmetic product before that type of product is first supplied in the Community, where the place of manufacture or initial importation is within the United Kingdom (regulation 9); and

15. they enable United Kingdom competent authorities to require that any holder of information on substances used in cosmetic products must make that information available where this may overcome or ease any difficulties encountered in providing prompt and appropriate medical treatment (regulation 10).

These Regulations give effect to the requirements of Commission Directives 95/32/EC and 96/45/EC by introducing procedures for the identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid, propionic acid, hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether, hydroquinone monobenzylether (monobenzone), 2-phenoxyethanol, 1-phenoxypropan-2-ol, and methyl, ethyl, propyl, butyl and benzyl 4-hydrozybenzoate in cosmetic products (regulation 14 and Schedule 8, paragraph 6(39), (40) and (41)).

Finally, these Regulations give effect to the requirements of Commission Directive 95/17/EEC by providing that manufacturers, their agents, persons to whose order cosmetic products are manufactured and (in certain circumstances) persons responsible for supplying cosmetic products for the first time in the Community may, if for reasons of trade secrecy they do not wish to include a particular cosmetic ingredient in the list of cosmetic ingredients required for labelling purposes, apply to a competent authority for approval to use a reference number in that list rather than the ingredient’s name. Provision is made for the particulars which must accompany such an application and for the procedures which apply to applications and to the withdrawal of any approval (regulation 11 and Schedule 7).

The Colour Index referred to in these Regulations may be obtained from the Society of Dyers and Colourists, PO Box No. 244, 82 Grattan Road, Bradford BD1 2JB.

The International Cosmetic Ingredient Dictionary referred to in these Regulations may be obtained from Micelle Press, 12 Ullswater Crescent, Weymouth, Dorset DT3 5HE.

A Compliance Cost Assessment is available, copies of which have been placed in the libraries of both Houses of Parliament. Copies are also available from the Consumer Affairs and Competition Policy Directorate of the Department of Trade and Industry, Room 4.D.2, 1 Victoria Street, London SW1H 0ET.