Avis juridique important

Seventeenth Commission Directive 94/32/EC of 29 June 1994 adapting to technical progress Annexes II, III, V, VI and VII of Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products Official Journal L 181 , 15/07/1994 P. 0031 - 0034 Finnish special edition: Chapter 13 Volume 26 P. 0122 Swedish special edition: Chapter 13 Volume 26 P. 0122

SEVENTEENTH COMMISSION DIRECTIVE 94/32/EC of 29 June 1994 adapting to technical progress Annexes II, III, V, VI and VII of Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products 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 93/47/EEC (2), and in particular Article 8 (2) thereof, After consultation of the Scientific Committee on Cosmetology, Whereas, on the basis of the latest scientific and technical research, certain provisionally permitted substances, preservatives and ultraviolet filters may be definitively permitted, whilst 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 2-Methyl-m-phenylenediamine; Whereas, on the basis of the latest scientific and technical research, the use of strontium hydroxide may be permitted subject to certain restrictions and conditions and the obligatory inclusion of health warnings on the label; Whereas, on the basis of the latest scientific and technical research, Polymer of N-{(2 and 4)-[2-oxoborn-3ylidene)methyl]benzyl}acrylamide may be used as ultraviolet filter in cosmetic products up to 30 June 1995 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. In Annex II, the following reference number is added: '413. 2-Methyl-m-phenylenediamine'; 2. In Annex III, Part 1: (a) reference number 59 is replaced by the following: "" ID="1">'59> ID="2">Talc: Hydrated magnesium silicate> ID="3">(a) Powdery products intended to be used for children under three years of age> ID="6">Keep powder away from children's nose and mouth'"> ID="3">(b) other products"> (b) the following reference numbers are added: "" ID="1">'63> ID="2">Strontium hydroxide> ID="3">pH-regulator in depilatory products> ID="4">3,5 % calculated as strontium, max. pH of 12,7> ID="6">- Keep out of reach of children"> ID="6">- Avoid contact with the eyes"> ID="1">64> ID="2">Strontium peroxide> ID="3">Rinse-off hair care preparations professional use> ID="4">4,5 % calculated as strontium in the ready-for-use preparation> ID="5">All products must meet the hydrogen peroxide release requirements> ID="6">- Avoid contact with eyes"> ID="6">- Rinse eyes immediately if product comes into contact with them"> ID="6">- For professional use only"> ID="6">- Wear suitable gloves'"> 3. In Annex III, Part 2: (a) reference number 1 is deleted; (b) '30. 6. 1994' in reference number 3 is replaced by '30. 6. 1995'. 4. In Annex V, reference number 5 is replaced by the following number: '5. Strontium and its compounds, with the exception of strontium lactate, strontium nitrate and strontium polycarboxylate listed in Annex II, strontium sulphide, strontium chloride, strontium acetate, strontium hydroxide, strontium peroxide, under the conditions laid down in Annex III, Part 1 and of strontium lakes, pigments and salts of the colouring agents listed with the reference (3) in Annex IV, Part 1.' 5. In Annex VI, Part 1: (a) reference number 14 is replaced by the following number: "" ID="1">'14> ID="2">Formic acid and its sodium salt (+)> ID="3">0,5 % (expressed as acid)'"> (b) the following reference numbers are added: "" ID="1">'48> ID="2">Glutaraldehyde (Pentane-1,5-dial)> ID="3">0,1 %> ID="4">Prohibited in aerosols (sprays)> ID="5">Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0,05 %)"> ID="1">49> ID="2">5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane> ID="3">0,3 %> ID="4">Prohibited in oral hygiene products and in products intended to come into contact with mucous membranes'"> 6. In Annex VI, Part 2: (a) reference numbers 26, 27 and 28 are deleted; (b) reference number 21 is replaced by the following number: "" ID="1">'21> ID="2">Benzylhemiformal> ID="3">0,03 %> ID="4">For rinse-off products only> ID="6">30. 6. 1995'"> (c) '30. 6. 1994' in reference numbers 2, 15, 16, 29 and 30 is replaced by '30. 6. 1995'. 7. In Annex VII, Part 1: (a) reference number 7 is replaced by the following number: "" ID="1">'7> ID="2">3,3& prime;-(1,4-Phenylenedimethylene) bis (7,7-dimethyl-2-oxobicyclo-[2,2,1]hept1-ylmethanesulfonic acid) and its salts> ID="3">10 % (expressed as acid)'"> (b) the following reference number is added: "" ID="1">'9> ID="2">alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its salts> ID="3">6 % (expressed as acid)'"> 8. In Annex VII, Part 2: (a) reference numbers 24 and 28 are deleted; (b) the following reference number is added: "" ID="1">'34> ID="2">Polymer of N-{(2 and 4)-[2-oxoborn-3- ylidene)methyl] benzyl}acrylamide-> ID="3">6 %> ID="6">30. 6. 1995'"> (c) '30. 6. 1994' in reference numbers 2, 5, 6, 12, 13, 17, 25, 26, 29, 32 and 33 is replaced by '30. 6. 1995'. Article 2 1. The Member States shall take all the necessary measures to ensure that as from 1 July 1995 for the substances mentioned in Article 1, 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 shall not be sold or otherwise supplied to the final consumer after 30 June 1996 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 30 June 1995. They shall forthwith inform the Commission thereof. When 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. 2. 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 shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Done at Brussels, 29 June 1994. For the Commission Christiane SCRIVENER Member of the Commission (1) OJ No L 262, 27. 9. 1976, p. 169. (2) OJ No L 203, 13. 8. 1993, p. 24.

SEVENTEENTH COMMISSION DIRECTIVE 94/32/EC of 29 June 1994 adapting to technical progress Annexes II, III, V, VI and VII of Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products

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 93/47/EEC (2), and in particular Article 8 (2) thereof,

After consultation of the Scientific Committee on Cosmetology,

Whereas, on the basis of the latest scientific and technical research, certain provisionally permitted substances, preservatives and ultraviolet filters may be definitively permitted, whilst 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 2-Methyl-m-phenylenediamine;

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

Whereas, on the basis of the latest scientific and technical research, Polymer of N-{(2 and 4)-[2-oxoborn-3ylidene)methyl]benzyl}acrylamide may be used as ultraviolet filter in cosmetic products up to 30 June 1995 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:

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

1. In Annex II, the following reference number is added:

'413. 2-Methyl-m-phenylenediamine';

2. In Annex III, Part 1:

(a) reference number 59 is replaced by the following:

"" ID="1">'59> ID="2">Talc: Hydrated magnesium silicate> ID="3">(a) Powdery products intended to be used for children under three years of age> ID="6">Keep powder away from children's nose and mouth'"> ID="3">(b) other products">

(b) the following reference numbers are added:

"" ID="1">'63> ID="2">Strontium hydroxide> ID="3">pH-regulator in depilatory products> ID="4">3,5 % calculated as strontium, max. pH of 12,7> ID="6">- Keep out of reach of children"> ID="6">- Avoid contact with the eyes"> ID="1">64> ID="2">Strontium peroxide> ID="3">Rinse-off hair care preparations professional use> ID="4">4,5 % calculated as strontium in the ready-for-use preparation> ID="5">All products must meet the hydrogen peroxide release requirements> ID="6">- Avoid contact with eyes"> ID="6">- Rinse eyes immediately if product comes into contact with them"> ID="6">- For professional use only"> ID="6">- Wear suitable gloves'">

3. In Annex III, Part 2:

(a) reference number 1 is deleted;

(b) '30. 6. 1994' in reference number 3 is replaced by '30. 6. 1995'.

4. In Annex V, reference number 5 is replaced by the following number:

'5. Strontium and its compounds, with the exception of strontium lactate, strontium nitrate and strontium polycarboxylate listed in Annex II, strontium sulphide, strontium chloride, strontium acetate, strontium hydroxide, strontium peroxide, under the conditions laid down in Annex III, Part 1 and of strontium lakes, pigments and salts of the colouring agents listed with the reference (3) in Annex IV, Part 1.'

5. In Annex VI, Part 1:

(a) reference number 14 is replaced by the following number:

"" ID="1">'14> ID="2">Formic acid and its sodium salt (+)> ID="3">0,5 % (expressed as acid)'">

(b) the following reference numbers are added:

"" ID="1">'48> ID="2">Glutaraldehyde (Pentane-1,5-dial)> ID="3">0,1 %> ID="4">Prohibited in aerosols (sprays)> ID="5">Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0,05 %)"> ID="1">49> ID="2">5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane> ID="3">0,3 %> ID="4">Prohibited in oral hygiene products and in products intended to come into contact with mucous membranes'">

6. In Annex VI, Part 2:

(a) reference numbers 26, 27 and 28 are deleted;

(b) reference number 21 is replaced by the following number:

"" ID="1">'21> ID="2">Benzylhemiformal> ID="3">0,03 %> ID="4">For rinse-off products only> ID="6">30. 6. 1995'">

(c) '30. 6. 1994' in reference numbers 2, 15, 16, 29 and 30 is replaced by '30. 6. 1995'.

7. In Annex VII, Part 1:

(a) reference number 7 is replaced by the following number:

"" ID="1">'7> ID="2">3,3& prime;-(1,4-Phenylenedimethylene) bis (7,7-dimethyl-2-oxobicyclo-[2,2,1]hept1-ylmethanesulfonic acid) and its salts> ID="3">10 % (expressed as acid)'">

(b) the following reference number is added:

"" ID="1">'9> ID="2">alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its salts> ID="3">6 % (expressed as acid)'">

8. In Annex VII, Part 2:

(a) reference numbers 24 and 28 are deleted;

(b) the following reference number is added:

"" ID="1">'34> ID="2">Polymer of N-{(2 and 4)-[2-oxoborn-3- ylidene)methyl] benzyl}acrylamide-> ID="3">6 %> ID="6">30. 6. 1995'">

(c) '30. 6. 1994' in reference numbers 2, 5, 6, 12, 13, 17, 25, 26, 29, 32 and 33 is replaced by '30. 6. 1995'.

Article 2

1. The Member States shall take all the necessary measures to ensure that as from 1 July 1995 for the substances mentioned in Article 1, 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 shall not be sold or otherwise supplied to the final consumer after 30 June 1996 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 30 June 1995. They shall forthwith inform the Commission thereof.

When 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.

2. 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 shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.

Done at Brussels, 29 June 1994.

For the Commission

Christiane SCRIVENER

Member of the Commission

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

(2) OJ No L 203, 13. 8. 1993, p. 24.