Twenty-fourth Commission Directive 2000/6/EC of 29 February 2000 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 56/42 EN Official Journal of the European Communities 1. 3. 2000 TWENTY-FOURTH COMMISSION DIRECTIVE 2000/6/EC of 29 February 2000 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 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Commission Directive 98/62/EC (2), and in particular Article 8(2) thereof, After consulting the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, Whereas: (1) (2) (3) (4) (5) Tallow derivatives, such as fatty acids, glycerine, esters of fatty acids and soaps and fatty alcohols, fatty amines and fatty amides derived therefrom, are considered safe for use in the manufacture of cosmetic products with regard to the risk of contracting transmissible spongiform encephalopathies if they are prepared in strict accordance with specific physico-chemical processes in which tempera- ture is the decisive parameter on which the corresponding pressure conditions depend. Annex II to the abovementioned Directive should therefore be amended accordingly. Harmful secondary effects have been shown to arise following prolonged use of hydroquinone as skin-lightening cream. This particular use of hydroquinone must not therefore be authorised, meaning that Part I of Annex III to the abovementioned Directive needs to be amended. Studies also show that the concentration of hydroquinone used in hair dyes does not have harmful effects for health if it does not exceed 0,3 %. Part I of Annex III to the abovementioned Directive must be amended accordingly. On the basis of new scientific data, benzalkonium chloride, bromide and saccharinate have recently been added to the list of substances which may be used as preservatives in the manufacture of cosmetic products set out in Part 1 of Annex VI to the abovementioned Directive. In the light of experience, it is also acceptable for these benzalkonium salts to be used for other purposes in cosmetic products, according to the length of their carbon chain, provided that the maximum authorised concentrations are observed. These specific characteristics therefore justify their inclusion in the list Part 1 of Annex III. The cosmetics industry has supplied new scientific data based on studies of the percutaneous absorption of acqueous solutions of boric acid, borates and tetraborates at various pH numbers and at various concentrations showing that the requirement that pH should be neutral or slightly alkaline in order to minimise the percutaneous absorption of these boron derivatives is not justified. The list of substances which cosmetic products must not contain except subject to the restrictions and conditions laid down, set out in Part 1 of Annex III, should therefore be amended accordingly. In the concentrations in which it is normally used as a preservative in cosmetic products intended to be removed by rinsing, benzylhemiformal is not likely to cause harmful effects for human health. Therefore it should be removed from Part 2 of Annex VI to the abovementioned Directive which sets out the list of preservatives provisionally allowed in cosmetic products and included in Part 1 of Annex VI which contains the list of preservatives allowed in cosmetic products. (1) OJ L 262, 27. 9. 1976, p. 169. (2) OJ L 253, 15. 9. 1998, p. 20. 1. 3. 2000 EN Official Journal of the European Communities L 56/43 (6) (7) (8) In the concentrations in which it is normally used as a preservative in cosmetic products, 3-iodo-2- propynyl butylcarbamate is not likely to have harmful effects on human health. Therefore, it should be removed from the list in Part 2 of Annex VI and entered in the list in Part 1 of Annex VI. In the concentrations in which it is normally used as a UV filter for sunscreen cream, 4-dimethyl- amino-benzoate of ethyl-2-hexyl (octyl dimethyl PABA) is not likely to have harmful effects on the health of users. Therefore, it should be removed from Part 2 of Annex VII to the abovementioned Directive which sets out the list of UV filters that cosmetic products may provisionally contain and entered in Part 1 of Annex VII which contains the list of UV filters allowed in cosmetic products. In the concentrations in which it is normally used as a UV filter for sunscreen cream, 2-hydroxy-4- methoxybenzophenone-5-sulfonic acid (benzophenone-5) and its sodium salt is not likely to give rise to harmful effects for human health. Therefore, 2-hydroxy-4-methoxybenzophenone-5-sulfonic (benzophenone-5) and its sodium salt should be removed from Part 2 of Annex VII and entered in Part 1 of Annex VII. (9) 4-isopropyl-benzyl salicylate is no longer used as a UV filter for sunscreen products. Consequently, 4-isopropyl-benzyl salicylate must be removed from Part 2 of Annex VII. (10) Within the concentration limits and under the conditions adopted by the cosmetic industry for its use products, 2,2'-methylene-bis-6-(2H-benzotriazol-2-yl)-4-tetra- as methyl-butyl-1,1,3,3-phenol, is not likely to produce harmful effects for the health of users. Therefore, it may be included in the list in Part 1 of Annex VII. a UV filter sunscreen for (11) Within the concentration limits and under the conditions adopted by the cosmetic industry for its use the monosodium salt of 2-2'-bis-(1,4- phenylene)1H-benzimidazole-4,6-disulfonic acid is not likely to have harmful effects on the health of users. Therefore, it may be included in the list in Part 1 of Annex VII. sunscreen products, a UV filter for as (12) Within the concentration limits and under the conditions adopted by the cosmetic industry for its use (1,3,5)-triazine-2,4-bis-((4-(2-ethyl-hexy- sunscreen products, loxy)-2-hydroxy)-phenyl)-6-(4-methoxyphenyl) is not likely to have harmful effects on the health of users. Therefore, it may be included in the list in Part 1 of Annex VII. a UV filter for as (13) The measures provided for 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: Directive 76/768/EEC is hereby amended as indicated in the Annex to this Directive. Article 1 Article 2 Member States shall adopt the necessary measures to ensure that cosmetic products containing the substances listed in Annexes II, III, VI and VII to Directive 76/768/EEC, as set out in the Annex to this Directive, which are supplied to the final consumer after 1 January 2001, comply with the provisions of this Directive. L 56/44 EN Official Journal of the European Communities 1. 3. 2000 Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 2000 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States. Article 5 Done at Brussels, 29 February 2000. For the Commission Erkki LIIKANEN Member of the Commission 1. 3. 2000 EN Official Journal of the European Communities L 56/45 The Annexes to Directive 76/768/EEC are hereby amended as follows: ANNEX 1. In Annex II The first indent of paragraph (b) of reference number 419 reads as follows: ‘— transesterification or hydrolysis at at least 200 °C and at an appropriate corresponding pressure, for 20 minutes (glycerol, fatty acids and fatty acid esters),’ 2. In Part 1 of Annex III (i) Reference number 1 is amended as shown in the following table: a ‘1a b c d e f Boric acid, borates and tetra- borates (a) Talc (a) 5 % (by mass/mass as (a) 1. Not to be used in (a) 1. Not to be used for boric acid) products for children under 3 years of age children under 3 years of age 2. Not to be used on peeling or irritated skin 2. Not to be used on peeling or irritated skin if the concentra- tion of free soluble borates exceeds 1,5 % (by mass/mass as boric acid) (b) Products for all hygiène (b) 0,1 % (by mass/mass as (b) 1. Not to be used in (b) 1. Not to be swallowed boric acid) products for children under 3 years of age 2. Not to be used for children under 3 years of age (c) Other products (c) 3 % (by mass/mass as (c) 1. Not to be used in (c) 1. Not to be used for (excluding bath products and hair waving prod- ucts) boric acid) products for children under 3 years of age children under 3 years of age 2. Not to be used on peeling or irritated skin 2. Not to be used on peeling or irritated skin if the concentra- tion of free soluble borates exceeds 1,5 % (by mass/mass as boric acid) 1b Tetraborates (a) Bath products (a) 18 % (by mass/mass as boric acid) (a) Not to be used in prod- ucts for children under 3 years of age (a) Not to be used of bathing children under 3 years of age (b) Hair waving products (b) 8 % (by mass/mass as (b) Rinse well’ boric acid) (ii) Reference number 14 is hereby amended as follows: — the second occurrence of ‘Hydroquinone’ in column b, item ‘(b)’ in column c, the second occurrence of ‘2 %’ in column (d) and item ‘(b)’ in column f are deleted, — ‘2 %’ in column d is replaced by ‘0,3 %’. L 56/46 EN Official Journal of the European Communities 1. 3. 2000 a ‘65 (iii) Reference number 65 is added in accordance with the following table: b c d e f Benzalkonium Chloride, bromide and saccharinate (a) Rinse-off hair (head) (a) 3 % (as benzalkonium (a) care products chloride) (a) Avoid contact with the eyes In the final products the concentrations of benzalkonium chloride, bromide and sacchari- nate with an alkyl chain of C , or less must not exceed 0,1 % (as benzalkonium chloride) 14 (b) Other products (b) 0,1 % (as benzalkonium chloride) (b) Avoid contact with the eyes’ 3. In Annex VI (i) The following reference numbers are added in Part 1: a b ‘55 Benzylhemiformal c 0,15 % d e Only for products to be removed by rinsing 56 3-Iodo-2-propynylbutylcarba- mate 0,05 % 1. Not to be used for oral hygiene and lipcare products 2. If the concentration in prod- ucts intended to remain on the skin exceeds 0,02 % add the phrase: Contains iodine Contains iodine’ (ii) Reference numbers 21 and 29 in Part 2 are deleted. 4. In Annex VII (i) The following reference numbers are added in Part 1: a ‘21 22 23 b 4-Dimethyl-amino-benzoate of ethyl-2-hexyl (octyl dimethyl PABA) d e c 8 % 2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid (Benzophenone-5) and its sodium salt 5 % (of acid) 2,2'-Methylene-bis-6-(2H-benzotriazol- 2yl)-4-(tetramethyl-butyl)-1,1,3,3-phenol 10 % 24 Monosodium salt of 2-2'-bis-(1,4- 10 % (of acid) phenylene)1H-benzimidazole-4,6-disulphonic acid) 25 (1,3,5)-Triazine-2,4-bis((4-(2-ethyl-hexyloxy)- 2-hydroxy)-phenyl)-6-(4-methoxyphenyl) 10 %’ (ii) Reference numbers 5, 17 and 29 in Part 2 are deleted