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Sixth Commission Directive 85/391/EEC of 16 July 1985 adapting to technical progress Annexes II, III, IV, V and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products Official Journal L 224 , 22/08/1985 P. 0040 - 0041 Spanish special edition: Chapter 15 Volume 6 P. 0026 Portuguese special edition Chapter 15 Volume 6 P. 0026 Finnish special edition: Chapter 13 Volume 14 P. 0187 Swedish special edition: Chapter 13 Volume 14 P. 0187

***** SIXTH COMMISSION DIRECTIVE of 16 July 1985 adapting to technical progress Annexes II, III, IV, V and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (85/391/EEC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic 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 Directive 84/415/EEC (2), and in particular Article 8 (2) thereof, Whereas with a view to safeguarding public health the use of certain hydroquinone ethers in cosmetic products should be prohibited; Whereas on the basis of the most recent scientific and technical research and subject to certain restrictions and conditions, the use of selenium disulphide in anti-dandruff shampoos may be permitted; whereas the use of certain aluminium zirconium complexes as antiperspirants may be definitively permitted; Whereas certain preservatives may release formaldehyde and consequently finished products containing them must be made subject to the labelling conditions laid down for formaldehyde; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for 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 follows: 1. In Annex II: - under reference No 167, 'Annex IV, Part 1' is replaced by 'Annex VII, Part 2'; - reference No 178 is replaced by: '178. 4-Benzyloxyphenol, 4-methoxyphenol and 4-ethoxyphenol'; - reference No 297 is replaced by: '297. Selenium and its compounds with the exception of selenium disulphide under the conditions set out under reference No 49 in Annex III, Part 1'; 2. In Annex III, Part 1, the following reference numbers are added: 1.2.3.4.5.6 // // // // // // // a // b // c // d // e // f // // // // // // // 49 // Selenium disulphide // Antidandruff shampoos // 1 % // // - Contains selenium disulphide - Avoid contact with eyes or damaged skin // // // // // // // 50 // Aluminium zirconium chloride hydroxide complexes AlxZr(OH)yClz and the aluminium zirconium chloride sydroxide glycine complexes // Antiperspirants // 20 % as anhydrous aluminium zirconium chloride hydroxide 5,4 % as zirconium // 1. The ratio of the number of aluminium atoms to that of zirconium atoms must be between two and 10 2. The ratio of the number of (Al+Zr) atoms to that of chlorine atoms must be between 0,9 and 2,1 3. Prohibited in aerosol dispensers (sprays) // Do not apply to irritated or damaged skin // // // // // // 3. In Annex IV, Part 1, No 7 is deleted. 4. In Annex V, No 6 is replaced b: '6. Zirconium and its compounds, with the exception of the complexes under reference No 50 in Annex III, Part 1, and of zirconium lakes, salts and pigments of colouring agents listed with reference (5) in Annex III, Part 2, and in Annex IV, Part 2'. 5. In Annex VI, - the following paragraph 5 is added to the preamble: '5. All finished products containing formaldehyde or substances in this Annex and which release formaldehyde must be labelled with the warning "contains formaldehyde" where the concentration of formaldehyde in the finished product exceeds 0,05 %.' - the warning 'contains formaldehyde' in column (e) is deleted for substance No 5 in Part 1 and substances 39, 44 and 50 in Part 2; - the maximum authorized concentrations in column (c) is deleted for substance No 5 in Part 1 and substances 39, 44 and 50 in Part 2; - the maximum authorized concentrations in column (c) for substances 39, 44 and 50 in Part 2 are replaced respectively by 1 % 0,15 % and 0,6 %; - footnote (2) in Part 1 and footnote (1) in Part 2 are deleted. Article 2 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1986. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States. Done at Brussels, 16 July 1985. For the Commission Stanley CLINTON DAVIS Member of the Commission (1) OJ No L 262, 27. 9. 1976, p. 169. (2) OJ No L 228, 25. 8. 1984, p. 31.

*****

SIXTH COMMISSION DIRECTIVE

of 16 July 1985

adapting to technical progress Annexes II, III, IV, V and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products

(85/391/EEC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic 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 Directive 84/415/EEC (2), and in particular Article 8 (2) thereof,

Whereas with a view to safeguarding public health the use of certain hydroquinone ethers in cosmetic products should be prohibited;

Whereas on the basis of the most recent scientific and technical research and subject to certain restrictions and conditions, the use of selenium disulphide in anti-dandruff shampoos may be permitted; whereas the use of certain aluminium zirconium complexes as antiperspirants may be definitively permitted;

Whereas certain preservatives may release formaldehyde and consequently finished products containing them must be made subject to the labelling conditions laid down for formaldehyde;

Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for 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 follows:

1. In Annex II:

- under reference No 167, 'Annex IV, Part 1' is replaced by 'Annex VII, Part 2';

- reference No 178 is replaced by:

'178. 4-Benzyloxyphenol, 4-methoxyphenol and 4-ethoxyphenol';

- reference No 297 is replaced by:

'297. Selenium and its compounds with the exception of selenium disulphide under the conditions set out under reference No 49 in Annex III, Part 1';

2. In Annex III, Part 1, the following reference numbers are added:

1.2.3.4.5.6 // // // // // // // a // b // c // d // e // f // // // // // // // 49 // Selenium disulphide // Antidandruff shampoos // 1 % // // - Contains selenium disulphide - Avoid contact with eyes or damaged skin // // // // // // // 50 // Aluminium zirconium chloride hydroxide complexes AlxZr(OH)yClz and the aluminium zirconium chloride sydroxide glycine complexes // Antiperspirants // 20 % as anhydrous aluminium zirconium chloride hydroxide 5,4 % as zirconium // 1. The ratio of the number of aluminium atoms to that of zirconium atoms must be between two and 10 2. The ratio of the number of (Al+Zr) atoms to that of chlorine atoms must be between 0,9 and 2,1 3. Prohibited in aerosol dispensers (sprays) // Do not apply to irritated or damaged skin // // // // // //

3. In Annex IV, Part 1, No 7 is deleted.

4. In Annex V, No 6 is replaced b:

'6. Zirconium and its compounds, with the exception of the complexes under reference No 50 in Annex III, Part 1, and of zirconium lakes, salts and pigments of colouring agents listed with reference (5) in Annex III, Part 2, and in Annex IV, Part 2'.

5. In Annex VI,

- the following paragraph 5 is added to the preamble:

'5. All finished products containing formaldehyde or substances in this Annex and which release formaldehyde must be labelled with the warning "contains formaldehyde" where the concentration of formaldehyde in the finished product exceeds 0,05 %.'

- the warning 'contains formaldehyde' in column (e) is deleted for substance No 5 in Part 1 and substances 39, 44 and 50 in Part 2;

- the maximum authorized concentrations in column (c) is deleted for substance No 5 in Part 1 and substances 39, 44 and 50 in Part 2;

- the maximum authorized concentrations in column (c) for substances 39, 44 and 50 in Part 2 are replaced respectively by 1 % 0,15 % and 0,6 %;

- footnote (2) in Part 1 and footnote (1) in Part 2 are deleted.

Article 2

The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1986.

They shall forthwith inform the Commission thereof.

Article 3

This Directive is addressed to the Member States.

Done at Brussels, 16 July 1985.

For the Commission

Stanley CLINTON DAVIS

Member of the Commission

(1) OJ No L 262, 27. 9. 1976, p. 169.

(2) OJ No L 228, 25. 8. 1984, p. 31.