23rd Commission Directive 98/62/EC of 3 September 1998 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance)
L 253/20 EN Official Journal of the European Communities 15. 9. 98 23rd COMMISSION DIRECTIVE 98/62/EC of 3 September 1998 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/768/EEC of 27 the July 1976 on the approximation of Member States relating to cosmetic products (1), as last amended by Commission Directive 98/16/EC (2) and in particular Article 8(2) thereof, the laws of After consulting the Scientific Committee on Cos- metology, as regards long-term toxicity, Whereas, in the absence of fresh scientific data, in par- ticular the Scientific Committee on Cosmetology recommends that the use of moskene and musk tibetene should be prohibited in cosmetic products as they may present a risk to the health of consumers; Whereas a further toxicological evaluation of strontium chloride, based on new data submitted by industry, shows that the use of this substance may be extended, without any safety risk, to shampoos and face care products provided a maximum concentration is not exceeded; Whereas, on the basis of the latest scientific data, the use may be permitted of benzalkonium chloride, bromide and saccharinate as preservatives in cosmetic products subject to the requirements of the Directive; Whereas, on the basis of the latest scientific research and data, 3-iodo-2-propynyl butylcarbamate (iodopropynyl butylcarbamate) may be provisionally used as a preserva- tive in cosmetic products subject to certain conditions on concentrations and use; Whereas, on the basis of the latest scientific data, phenol 2-(2H-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1,3,3,3- tetramethyl-1-(trimethylsilyl)oxy)-disiloxanyl)propyl) may be used as a UV filter in cosmetic products subject to the requirements of the Directive; (1) OJ L 262, 27. 9. 1976, p. 169. (2) OJ L 77, 14. 3. 1998, p. 44. Whereas, on the basis of the latest scientific data, benzoic acid,4,4-((6-(((1,1-dimethylethyl)amino)carbonyl)phenyl) amino) 1,3,5-triazine-2,4-diyl)diamino)bis-,bis(2-ethylhexyl) ester may be used as a UV filter in cosmetic products; ethoxylated ethyl-4-aminobenzoate, Whereas, on the basis of the latest scientific research and data, isopentyl-4- 2,4,6-trianilino-(p-carbo-2Y-ethyl- methoxycinnamate, hexyl-1Yoxy)-1,3,5-triazine salicylate may be used as UV filters in cosmetic products subject to the requirements of the Directive; and 2-Ethylhexyl Whereas, on the basis of the latest scientific research and data, 3-(4Y-methylbenzylidene)-d-1camphor and 3-benzyl- idene camphor may be used as UV filters in cosmetic products; Whereas the measures laid down in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 76/768/EEC is hereby amended as shown in the Annex. Article 2 1. Member States shall take the necessary measures to ensure that, as from 1 July 1999, for the substances set out in the Annex, neither manufacturers nor importers established in the Community place on the market prod- ucts which do not comply with the requirements of this Directive. 2. Member States shall take the necessary measures to the products referred to in paragraph 1 ensure that containing the substances set out in the Annex are not sold or otherwise supplied to the final consumer after 30 June 2000. 15. 9. 98 EN Official Journal of the European Communities L 253/21 Article 3 Article 4 1. Member States shall bring into force the laws, regula- tions and administrative provisions necessary to comply with this Directive no later than 30 June 1999. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a refer- ence to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. 2. Member States shall communicate to the Commis- sion the provisions of national law which they adopt in the field covered by this Directive. This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States. Done at Brussels, 3 September 1998. For the Commission Martin BANGEMANN Member of the Commission L 253/22 EN Official Journal of the European Communities 15. 9. 98 ANNEX The Annexes to Directive 76/768/EEC are amended as follows: 1. In Annex II The following reference numbers are added: ‘421. 1,1,3,3,5,-Pentamethyl-4,6-dinitroindane (moskene) 422. 5-tert-Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (musk tibetene)'. 2. In Annex III Reference number 57 is amended as follows: ‘57 Strontium chloride hexahydrate (a) Toothpaste (b) Shampoo and face care products 3. In Annex VI (a) P a r t o n e The following reference number is added as 3,5 % calculated strontium. When mixed with other permitted strontium compounds total strontium content must not exceed 3,5 %. the Contains strontium Frequent chloride. use by children is not advisable. ' as 2,1 % calculated strontium. When mixed with other permitted strontium compounds total strontium content must not exceed 2,1 %. the a ‘54 b c d e Benzalkonium chloride, bromide and saccharinate (+) 0,1 % calculated as benzalkonium chloride Avoid contact with the eyes' (b) P a r t t w o Reference number 16 is deleted. ‘30. 6. 1998' is replaced by ‘30. 6. 1999' for reference number 21 and 29. Reference number 29 is also modified: a ‘29 b c d e 3-Iodo-2-propynyl butylcarbamate (iodopropynyl butylcarbamate) 0,05 % Not for oral hygiene and lip products' 15. 9. 98 EN Official Journal of the European Communities L 253/23 4. In Annex VII (a) P a r t o n e The following reference numbers are added a b c d e ‘13 Ethoxylated Ethyl-4-Aminobenzoate (PEG-25 PABA) Isopentyl-4-methoxycinnamate (Isoamyl p-Methoxycinnamate) 10 % 10 % 2,4,6-Trianilino-(p-Carbo-2’-Ethylhexyl-1’Oxy)-1,3,5-Triazine (Octyl Triazone) 5 % Phenol,2-(2H-Benzotriazol-2-yl)-4-Methyl-6-(2-Methyl-3-(1,3,3,3-Tetramethyl-l- (Trimethylsilyl)Oxy)-Disiloxanyl)Propyl) (Drometrizole Trisiloxane) Benzoic 1,3,5-triazine-2,4-diyl)diimino)bis-,bis(2-ethylhexyl)ester) 4,4-((6-(((1,1-dimethylethyl)amino)carbonyl)phenyl)amino) acid, 3-(4’-Methylbenzylidene)-d-l camphor (4-Methylbenzylidene Camphor) 3-Benzylidene camphor (3-Benzylidene Camphor) 2-Ethylhexyl salicylate (Octyl-salicylate) 15 % 10 % 4 % 2 % 5 %' 14 15 16 17 18 19 20 (b) P a r t t w o Reference numbers 2, 6, 12, 25, 26 and 32 are deleted. ‘30. 6. 1998' is replaced by ‘30. 6. 1999' for reference numbers 5, 17 and 29