18.4.2002 Official Journal of the European Communities L 102/19 TWENTY-SIXTH COMMISSION DIRECTIVE 2002/34/EC of 15 April 2002 adapting to technical progress Annexes II, III 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 July 1976 on the approximation of the laws of the Member States relating to cosmetic products ('), as last amended by Commis- sion Directive 2000/41/EC (3, and in particular Article 8(2) thereof, After consulting the Scientific Committee on Cosmetic Prod- ucts and Non-Food Products intended for consumers (SCCNFP), Whereas: 1) Entry 293 of Annex II includes radioactive substances among the substances prohibited in cosmetic products. However, footnote 1 to entry 293 allows, under the conditions set out therein, the presence of natural radio- active substances and of radioactive substances caused by artificial contamination from the environment by making reference to Directives of 2 February 1959 laying down the basic standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation (}). These Direct- ives were repealed by Council Directive 96/29/ Euratom (%), Article 6(5) thereof providing that Member States shall permit neither the deliberate addition of radioactive substances in the production of cosmetic products nor the import and export of such goods. Directive 96/29/Euratom also provides for the definition of radioactive substances for the purpose of its applica- tion. Therefore, entry 293 of Annex II should be amended accordingly. On the basis of IFRA (International Fragrance Associa- tion) Code of Practice, the SCCNFP has listed 36 substances that must not form part of fragrance compounds used in cosmetic products. Of these 36 fragrance ingredients, seven are already included in Annex II and one (6-methylcoumarin) under reference No 46 in Annex III, Part 1, which already restricts its use to oral hygiene products. Therefore the 28 remaining fragrance ingredients should be included in the list of Annex II. The safety of these substances has only been assessed by the SCCNFP for their use as fragrance ingre- dients. Accordingly, it is necessary to regulate their use for this purpose. Further safety assessment of these L 262, 27.9.1976, p. 169. L 145, 20.6.2000, p. 25. 11, 20.2.1959, p. 221/59. L 159, 29.6.1996, p. 1. substances for other uses is being carried out by the SCCNFP. The SCCNFP recommends that methyleugenol should not be intentionally added as a cosmetic ingredient. Therefore methyleugenol should be included in Annex . As methyleugenol is however naturally present in essential oils that are used as components in cosmetic products, the SCCNFP has set specific maximum concen- trations when present in cosmetic products. On the basis of information on the use in cosmetic products of lithium hydroxide and calcium hydroxide and their safety evaluation, the SCCNFP recommends that their use should be restricted. Therefore entries 15b and 15c of Annex III, Part 1, should be amended accord- ingly. On the basis of a toxicological evaluation, the SCCNFP recommends that the maximum residual acrylamide content needs to be restricted in the finished product. Therefore, polyacrylamide should be included in Annex I, Part 1. The SCCNFP has made toxicological evaluations of 61 hair dyes, including recommendations on their field of application, maximum concentration levels and specific warnings. One is already included under reference No 16 in Annex III, Part 1, which shall therefore be amended. More information on the safety of some hair dyes is still needed, in particular in order to investigate a potential link between long term regular use of perma- nent hair dyes and an increased risk for bladder cancer, as requested by the SCCNFP. Therefore the 60 remaining hair dyes should be included in Annex III, Part 2. Entry 8 of Annex III, Part 1, covers a group of phenylendia- mine derivatives used as hair dyes. In order to avoid double entries, the text in column b should be amended to except those derivatives listed elsewhere in Annex IIL The SCCNFP recommends that musk xylene can be safely used in cosmetic products, excluding oral care products, up to a maximum daily theoretically absorbed dose of about 10 pg/kg/day. Therefore, until the risk assessment of this substance in the framework of Council Regulation (EEC) No 793/93 (°) on the evalu- ation and control of the risks of existing substances is finalised, musk xylene should be included in Annex III, Part 2. () O] L 84, 5.4.1993, p. 1.