The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2000

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the Cosmetic Products (Safety) Regulations 1996 (S.I. 1996/2925) (“the principal Regulations”).

Commission Directive 2000/11/EC amends for the twenty-fifth time Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. In line with the judgement of the European Court of Justice of 25th January 1994, C-212/91 Angelopharm GmbH v Freie Hanseadt Hamburg, it removes from Annex II to Council Directive 76/768/EEC substances which had been improperly added to Annex II by Commission Directives 82/107/EEC, 84/415/EEC, 86/179/EEC, 87/137/EEC, 88/233/EEC and 90/121/EEC. The substances were added without proper consultation with the Scientific Committee on Cosmetic Products and Non-Food Products. Commission Directive 2000/11/EC then re-inserts these substances, with the exception of Tyrothricin (INN) back in Annex II to Council Directive 76/768/EEC with immediate effect.

The Regulations implement Commission Directive 2000/6/EC (which amended Council Directive 76/768/EEC for the twenty-fourth time) and 2000/11/EC by amending the principal Regulations to—

1.  Permit subject to restrictions, the use of boric acid, borates, and tetraborates in talcum powder, oral hygiene products and other products (excluding bath products and hair waving products), and impose labelling requirements (in respect of products intended to be used for children under 3 years old and in respect of use on peeling or irritated skin). Also to permit, subject to restrictions the use of tetraborates in bath products and hair waving products and imposing labelling requirements in respect of products intended to be used for children under three years old (regulation 2(c)(i)).

2.  Prohibit the use of hydroquinone as a skin lightener and reduce the level of hydroquinone in oxidation hair dyes (regulation 2(c)(ii)).

3.  Permit, subject to restrictions, the use of Benzalkonium chloride, bromide and saccharinate in hair care products and other products and impose labelling requirements (regulation 2(c)(iii)).

4.  Permit the use, subject to restrictions, of benzylhemiformal as a preservative in products which are rinsed off after use. Also to permit the use, subject to restrictions of 3-iodoprop-2-ynyl butylcarbamate [Iodopropynyl butylcarbamate] as a preservative though not to be used in oral hygiene and lip products (regulation 2(d)).

5.  Permit, subject to restrictions, the use of 2-Ethylhexyl 4-dimethylaminobenzoate [Octyl dimethyl PABA]; 2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid [Benzophenone-4] and its sodium salt [Benzophenone-5] (Sulisobenzone (INN) and Sulisobenzone sodium (INNM)); 2,2'-Methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol]; diSodium 2,2'-(1,4-phenylene)bis(1H-benzimidazole-4,6-disulfonate); and 5,5'-bis(2-ethylhexyloxy)-2,2'-(6-p-methoxyphenyl-1,3,5-triazine-2,4-diyl)diphenol as UV filters in cosmetic products (regulation 2(f)).

6.  Amending the methods by which tallow derivatives may be manufactured (regulation 2(h)).

7.  Provide that as from the date of coming into force of the Regulations the following entries in Schedule 1 shall continue to have effect in relation to the supply of cosmetics on or after 17th March (the date Commission Directive 2000/11/EC came into force) but shall cease to have effect in relation to any supply of cosmetic products occurring prior to that date (regulation 3(1))—

• 2; 9; 55; 62; 208; 341; 399; 485; 587; 596; 688; 697; 727; 728; 766.

8.  Delete entry number 749 (Tyrothricin (INN)) from the list of prohibited substances in Schedule 1 (regulation 3(2)). However the use of Tyrothricin (which is an antibiotic) in cosmetics will continue to be prohibited by entry number 56 which prohibits the use of antibiotics.

• The Regulations also remove laurel oil of unspecified origin from Schedule 1 which had been incorrectly added (regulation 2(b)).

• The Regulations come into force on 31st October 2000 except as provided by Regulation 1(2) and (3).