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Thirteenth Commission Directive 91/184/EEC of 12 March 1991 adapting to technical progress Annexes II, III, IV, V, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products Official Journal L 091 , 12/04/1991 P. 0059 - 0062 Finnish special edition: Chapter 13 Volume 20 P. 0067 Swedish special edition: Chapter 13 Volume 20 P. 0067

THIRTEENTH COMMISSION DIRECTIVE of 12 March 1991 adapting to technical progress Annexes II, III, IV, V, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (91/184/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 90/121/EEC (2), and in particular Article 8 (2) thereof, Whereas, on the basis of the available information, certain provisionally permitted colouring agents, substances and preservatives may be definitively permitted, while others must be definitively prohibited or be permitted for a further specified period; Whereas, in order to protect public health, it is necessary to prohibit the use of lidocaine and thiomersal; Whereas, on the basis of the latest scientific and technical research, the use of magnesium fluoride may be permitted subject to certain restrictions and obligatory inclusion on the label of health warnings; Whereas, on the basis of the latest scientific and technical research, 7-ethyl bicyclo-oxazolidine may be used as a preservative up to 31 December 1992 and 3,3-(1.4-phenylene dimethylidyne) bis (7,7-dimethyl-2-oxo-bicyclo-(2,2,1) heptane-1-methane sulphonic acid) and its salts may be used as an ultraviolet filter in cosmetic products subject to certain restrictions and conditions; Whereas 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: Article 1 Directive 76/768/EEC is hereby amended as follows: 1. Annex II (a) No 221, 'in Annexes V and VI, Part 1' is replaced by 'in Annex VI, Part 1'; (b) the following numbers are added: '395. hydroxy-8-quinoline and its sulphate, except for the uses provided for in No 51 in Annex III, Part 1 396. dithio-2,2-bispyridine-dioxide 1,1 (additive with trihydrated magnesium sulphate) - (pyrithione disulphide + magnesium sulphate) 397. Colouring agent CI 12075 and its lakes, pigments and salts 398. Colouring agent CI 45170 and CI 45170:1 399. Lidocaine' 2. In Annex III, Part 1, reference No 56 is added: a b c d e f '56 Magnesium fluoride Dental hygiene products 0,15 % calculated as F when mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % Contains magnesium fluoride' 3. Annex III, Part 2 (a) reference Nos 1 and 4 are deleted; (b) '31 December 1990' in the column 'Allowed until' is replaced by '31 December 1991' for the following number: 2. 1,1,1-Trichloroethane (methyl chloroform); 4. In Annex IV, Part 1, Nos 12075, 15585, 45170 and 45170:1 are deleted; 5. In Annex IV, Part 2: (a) '31 December 1990' in the column 'Allowed until' is replaced by '31 December 1991' for Nos 26 100 and 73 900; (b) the following colouring agent is added: 'Colour index No or denomination Colour Field of application Other limitations and requirements Allowed until 1 2 3 4 15 585 (3) Red × Maximum 3 % in the products intended to come into contact with mucous membranes 31. 12. 1991 (3) Lakes, pigments or salts of barium, strontium and zirconium insoluble in these colouring agents are also allowed. They must satisfy the insolubility test, which will be determined in accordance with the procedure provided for in Article 8'; 6. In Annex V, reference Nos 7 and 8 are deleted; 7. In Annex VI, Part 1, the following reference numbers are added: a b c d e '44 Alkyl (C12-C22) trimethyl ammonium, bromide and chloride (*) 0,1 % 45 4,4-dimethyl-1,3-oxazolidine 0,1 % The pH of the finished product must not be lower than 6.' 46 N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5- imidazolidinyl-4)-N-(hydroxymethyl) urea 0,5 % 8. Annex VI, Part 2: (a) '31. 12. 1990' in column (f) is replaced by '31. 12. 1991' for the following substances: 2. Ether p-chlorophenyl glycerol (Chlorphenesin) 15. Diisobutyl-phenoxy-ethoxy-ethyl dimethyl benzyl ammonium, chloride (+) (benzethonium chloride) 16. Alkyl (C8-C18) dimethylbenzyl ammonium chloride, bromide and saccharinate (+) (benzalkonium chloride, bromide and saccharinate) 20. 1,6-di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethioniate and p-hydroxybenzoate (+)) 21. Benzylmiformal 27. Decyloxy-3-hydroxy-2amino-1 propane hydrochlorate (Decominol (DCI)); (b) reference Nos 4, 6 and 17 are deleted; (c) the following reference number is added: a b c d e f '28 7-Ethylbicyclooxa- zolidine 0,3 % Prohibited in dental hygiene products and in products intended to come into contact with mucous membranes 31 12. 1992' 9. In Annex VII, Part 1, the following reference number is added: a b c d e '7 3,3-(1,4-Phenylenedimethylidyne) bis (7,7-dimethyl-2-oxo-bicyclo-(2,2,1) heptane-1-methane-sulphonic acid) and its salts 10 % (expressed in acid) Prohibited in aerosols (sprays)' Article 2 1. Regardless of the dates of admission mentioned in Article 1 (3) (b), (5) and (8) (a) and (c), Member States shall take all the necessary measures to ensure that as from 1 January 1992, for the substances mentioned in Article 1 (1), and as from 1 January 1993, for the substances mentioned in Article 1 (2) to (9), neither manufacturers nor importers established in the Community shall place on the market products which do not comply with the requirements of this Directive. 2. Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 containing the substances mentioned in Article 1 (1) shall no longer be sold or otherwise surrendered to the final consumer after 31 December 1992 and that the products containing the substances mentioned in Article 1 (2) to (9) shall no longer be sold or surrendered to the final consumer after 31 December 1994, if they do not comply with the requirements of this Directive. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions needed to comply with this Directive no later than 31 December 1991. They shall forthwith inform the Commission thereof. 2. When the Member States adopt these provisions these shall contain a reference 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 Member States. 3. Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive. Article 4 This Directive is addressed to the Member States. Done at Brussels, 12 March 1991. For the Commission Karel VAN MIERT Member of the Commission (1) OJ No L 262, 27. 9. 1976, p. 169. (2) OJ No L 71, 17. 3. 1990, p. 40.

THIRTEENTH COMMISSION DIRECTIVE of 12 March 1991 adapting to technical progress Annexes II, III, IV, V, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (91/184/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 90/121/EEC (2), and in particular Article 8 (2) thereof,

Whereas, on the basis of the available information, certain provisionally permitted colouring agents, substances and preservatives may be definitively permitted, while others must be definitively prohibited or be permitted for a further specified period;

Whereas, in order to protect public health, it is necessary to prohibit the use of lidocaine and thiomersal;

Whereas, on the basis of the latest scientific and technical research, the use of magnesium fluoride may be permitted subject to certain restrictions and obligatory inclusion on the label of health warnings;

Whereas, on the basis of the latest scientific and technical research, 7-ethyl bicyclo-oxazolidine may be used as a preservative up to 31 December 1992 and 3,3-(1.4-phenylene dimethylidyne) bis (7,7-dimethyl-2-oxo-bicyclo-(2,2,1) heptane-1-methane sulphonic acid) and its salts may be used as an ultraviolet filter in cosmetic products subject to certain restrictions and conditions;

Whereas 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: Article 1

Directive 76/768/EEC is hereby amended as follows:

1. Annex II

(a) No 221, 'in Annexes V and VI, Part 1' is replaced by 'in Annex VI, Part 1';

(b) the following numbers are added:

'395. hydroxy-8-quinoline and its sulphate, except for the uses provided for in No 51 in Annex III, Part 1 396. dithio-2,2-bispyridine-dioxide 1,1 (additive with trihydrated magnesium sulphate) - (pyrithione disulphide + magnesium sulphate) 397. Colouring agent CI 12075 and its lakes, pigments and salts 398. Colouring agent CI 45170 and CI 45170:1 399. Lidocaine'

2. In Annex III, Part 1, reference No 56 is added:

a b c d e f '56 Magnesium fluoride Dental hygiene

products 0,15 % calculated as F when mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % Contains magnesium

fluoride'

3. Annex III, Part 2

(a) reference Nos 1 and 4 are deleted;

(b) '31 December 1990' in the column 'Allowed until' is replaced by '31 December 1991' for the following number: 2. 1,1,1-Trichloroethane (methyl chloroform);

4. In Annex IV, Part 1, Nos 12075, 15585, 45170 and 45170:1 are deleted;

5. In Annex IV, Part 2:

(a) '31 December 1990' in the column 'Allowed until' is replaced by '31 December 1991' for Nos 26 100 and 73 900;

(b) the following colouring agent is added:

'Colour index No or denomination Colour Field of application Other limitations and requirements Allowed until 1 2 3 4 15 585 (3) Red × Maximum 3 % in the products intended to come into contact with mucous membranes 31. 12. 1991 (3) Lakes, pigments or salts of barium, strontium and zirconium insoluble in these colouring agents are also allowed. They must satisfy the insolubility test, which will be determined in accordance with the procedure provided for in Article 8';

6. In Annex V, reference Nos 7 and 8 are deleted;

7. In Annex VI, Part 1, the following reference numbers are added:

a b c d e '44 Alkyl (C12-C22) trimethyl ammonium, bromide and chloride (*) 0,1 % 45 4,4-dimethyl-1,3-oxazolidine 0,1 % The pH of the finished product must not be lower than 6.' 46 N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-

imidazolidinyl-4)-N-(hydroxymethyl) urea 0,5 %

8. Annex VI, Part 2:

(a) '31. 12. 1990' in column (f) is replaced by '31. 12. 1991' for the following substances:

2. Ether p-chlorophenyl glycerol (Chlorphenesin)

15. Diisobutyl-phenoxy-ethoxy-ethyl dimethyl benzyl ammonium, chloride (+) (benzethonium chloride)

16. Alkyl (C8-C18) dimethylbenzyl ammonium chloride, bromide and saccharinate (+) (benzalkonium chloride, bromide and saccharinate)

20. 1,6-di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethioniate and p-hydroxybenzoate (+))

21. Benzylmiformal

27. Decyloxy-3-hydroxy-2amino-1 propane hydrochlorate (Decominol (DCI));

(b) reference Nos 4, 6 and 17 are deleted;

(c) the following reference number is added:

a b c d e f '28 7-Ethylbicyclooxa-

zolidine 0,3 % Prohibited in dental hygiene products and in products intended to come into contact with mucous membranes 31 12. 1992'

9. In Annex VII, Part 1, the following reference number is added:

a b c d e '7 3,3-(1,4-Phenylenedimethylidyne) bis

(7,7-dimethyl-2-oxo-bicyclo-(2,2,1) heptane-1-methane-sulphonic acid) and its salts 10 %

(expressed

in acid) Prohibited in aerosols (sprays)'

Article 2 1. Regardless of the dates of admission mentioned in Article 1 (3) (b), (5) and (8) (a) and (c), Member States shall take all the necessary measures to ensure that as from 1 January 1992, for the substances mentioned in Article 1 (1), and as from 1 January 1993, for the substances mentioned in Article 1 (2) to (9), neither manufacturers nor importers established in the Community shall place on the market products which do not comply with the requirements of this Directive.

2. Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 containing the substances mentioned in Article 1 (1) shall no longer be sold or otherwise surrendered to the final consumer after 31 December 1992 and that the products containing the substances mentioned in Article 1 (2) to (9) shall no longer be sold or surrendered to the final consumer after 31 December 1994, if they do not comply with the requirements of this Directive. Article 3

1. Member States shall bring into force the laws, regulations and administrative provisions needed to comply with this Directive no later than 31 December 1991. They shall forthwith inform the Commission thereof.

2. When the Member States adopt these provisions these shall contain a reference 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 Member States.

3. Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive. Article 4

This Directive is addressed to the Member States. Done at Brussels, 12 March 1991. For the Commission

Karel VAN MIERT

Member of the Commission (1) OJ No L 262, 27. 9. 1976, p. 169. (2) OJ No L 71, 17. 3. 1990, p. 40.