Avis juridique important

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) Official Journal L 102 , 18/04/2002 P. 0019 - 0031

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(1), as last amended by Commission Directive 2000/41/EC(2), and in particular Article 8(2) thereof, After consulting the Scientific Committee on Cosmetic Products 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 radioactive 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(3). These Directives were repealed by Council Directive 96/29/Euratom(4), Article 6(5) thereof providing that Member States shall permit neither the deliberate addition of radioactive substances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 application. Therefore, entry 293 of Annex II should be amended accordingly. (2) On the basis of IFRA (International Fragrance Association) 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 ingredients. Accordingly, it is necessary to regulate their use for this purpose. Further safety assessment of these substances for other uses is being carried out by the SCCNFP. (3) The SCCNFP recommends that methyleugenol should not be intentionally added as a cosmetic ingredient. Therefore methyleugenol should be included in Annex II. As methyleugenol is however naturally present in essential oils that are used as components in cosmetic products, the SCCNFP has set specific maximum concentrations when present in cosmetic products. (4) 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 accordingly. (5) 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 III, Part 1. (6) 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 permanent 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 phenylendiamine 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 III. (7) 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 μg/kg/day. Therefore, until the risk assessment of this substance in the framework of Council Regulation (EEC) No 793/93(5) on the evaluation and control of the risks of existing substances is finalised, musk xylene should be included in Annex III, Part 2. (8) The SCCNFP recommends that musk ketone can be safely used in cosmetic products, excluding oral care products, up to a maximum daily theoretically absorbed dose of about 14 μg/kg/day. Therefore, until the risk assessment of this substance in the framework of Regulation (EEC) 793/93 is finalised, musk ketone should be included in Annex III, Part 2. (9) The SCCNFP has expressed the opinion that the UV-filter dimethicodiethylbenzalmalonate can be safely used in cosmetic products under certain restrictions. Therefore, dimethicodiethylbenzalmalonate should be included in Annex VII, Part 1. (10) The SCCNFP has expressed the opinion that titanium dioxide can be safely used as UV-filter in cosmetic products under certain restrictions. Therefore, titanium dioxide should be included in Annex VII, Part 1. (11) 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 indicated in the Annex to this Directive. Article 2 Member States shall take the necessary measures to ensure that cosmetic products containing the substances listed in Annexes II, III and VII to Directive 76/768/EEC, as set out in the Annex to this Directive, which are supplied to the final consumer after 15 April 2004, comply with the provisions of this Directive. Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 April 2003 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. Article 4 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States. Done at Brussels, 15 April 2002. For the Commission Erkki Liikanen Member of the Commission (1) OJ L 262, 27.9.1976, p. 169. (2) OJ L 145, 20.6.2000, p. 25. (3) OJ 11, 20.2.1959, p. 221/59. (4) OJ L 159, 29.6.1996, p. 1. (5) OJ L 84, 5.4.1993, p. 1. ANNEX Annexes II, III and VII to Directive 76/768/EEC are amended as follows: 1. In Annex II: (i) Reference No 293 and corresponding footnote 1 are replaced by the following: "293. Radioactive substances, as defined by Directive 96/29/Euratom(1) laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation." (ii) Reference Nos 423 to 451 are added as indicated below: "423. Alanroot oil (Inula helenium) (CAS No 97676-35-2), when used as a fragrance ingredient. 424. Benzyl cyanide (CAS No 140-29-4), when used as a fragrance ingredient. 425. Cyclamen alcohol (CAS No 4756-19-8), when used as a fragrance ingredient. 426. Diethyl maleate (CAS No 141-05-9), when used as a fragrance ingredient. 427. Dihydrocoumarine (CAS No 119-84-6), when used as a fragrance ingredient. 428. 2,4-Dihydroxy-3-methylbenzaldehyde (CAS No 6248-20-0), when used as a fragrance ingredient. 429. 3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol) (CAS No 40607-48-5), when used as a fragrance ingredient. 430. 4,6-Dimethyl-8-tert-butylcoumarin (CAS No 17874-34-9), when used as a fragrance ingredient. 431. Dimethyl citraconate (CAS No 617-54-9), when used as a fragrance ingredient. 432. 7,11-Dimethyl-4,6,10-dodecatrien-3-one (CAS No 26651-96-7), when used as a fragrance ingredient. 433. 6,10-Dimethyl-3,5,9-undecatrien-2-one (CAS No 141-10-6), when used as a fragrance ingredient. 434. Diphenylamine (CAS No 122-39-4), when used as a fragrance ingredient. 435. Ethyl acrylate (CAS No 140-88-5), when used as a fragrance ingredient. 436. Fig leaf absolute (Ficus carica) (CAS No 68916-52-9), when used as a fragrance ingredient. 437. trans-2-Heptenal (CAS No 18829-55-5), when used as a fragrance ingredient. 438. trans-2-Hexenal diethyl acetal (CAS No 67746-30-9), when used as a fragrance ingredient. 439. trans-2-Hexenal dimethyl acetal (CAS No 18318-83-7), when used as a fragrance ingredient. 440. Hydroabietyl alcohol (CAS No 13393-93-6), when used as a fragrance ingredient. 441. 6-Isopropyl-2-decahydronaphthalenol (CAS No 34131-99-2), when used as a fragrance ingredient. 442. 7-Methoxycoumarin (CAS No 531-59-9), when used as a fragrance ingredient. 443. 4-(4-Methoxyphenyl)-3-butene-2-one (CAS No 943-88-4), when used as a fragrance ingredient. 444. 1-(4-Methoxyphenyl)-1-penten-3-one (CAS No 104-27-8), when used as a fragrance ingredient. 445. Methyl trans-2-butenoate (CAS No 623-43-8), when used as a fragrance ingredient. 446. 7-Methylcoumarin (CAS No 2445-83-2), when used as a fragrance ingredient. 447. 5-Methyl-2,3-hexanedione (CAS No 13706-86-0), when used as a fragrance ingredient. 448. 2-Pentylidenecyclohexanone (CAS No 25677-40-1), when used as a fragrance ingredient. 449. 3,6,10-Trimethyl-3,5,9-undecatrien-2-one (CAS No 1117-41-5), when used as a fragrance ingredient. 450. Verbena oil (Lippia citriodora Kunth.) (CAS No 8024-12-2), when used as a fragrance ingredient. 451. Methyleugenol (CAS No 95-15-2) except for normal content in the natural essences used and provided that the concentration does not exceed: (a) 0,01 % in fine fragrance (b) 0,004 % in eau de toilette (c) 0,002 % in fragrance cream (d) 0,001 % in rinse-off products (e) 0,0002 % in other leave-on products and oral hygiene products.". 2. In Annex III, Part 1: (i) In reference No 8, column b is replaced by the following: "m- and p-Phenylenediamines, their N-substituted derivatives and their salts; N-substituted derivatives of o-Phenylenediamines(2), with the exception of those derivatives listed elsewhere in this Annex" (ii) Reference Nos 15b and 15c are replaced by the following: "" (iii) Reference No 16 is replaced by the following: >TABLE> (iv) Reference No 66 is inserted as shown in the following table: >TABLE> 3. In Annex III, Part 2: Reference Nos 1 to 62 are inserted as shown in the following table: >TABLE> 4. In Annex VII, Part 1 Reference Nos 26 and 27 are inserted as shown in the following table: >TABLE> (1) OJ L 159, 29.6.1996, p. 1. (2) These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1. (3) The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column d.

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(1), as last amended by Commission Directive 2000/41/EC(2), and in particular Article 8(2) thereof,

After consulting the Scientific Committee on Cosmetic Products 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 radioactive 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(3). These Directives were repealed by Council Directive 96/29/Euratom(4), 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 application. Therefore, entry 293 of Annex II should be amended accordingly.

(2) On the basis of IFRA (International Fragrance Association) 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 ingredients. Accordingly, it is necessary to regulate their use for this purpose. Further safety assessment of these substances for other uses is being carried out by the SCCNFP.

(3) The SCCNFP recommends that methyleugenol should not be intentionally added as a cosmetic ingredient. Therefore methyleugenol should be included in Annex II. As methyleugenol is however naturally present in essential oils that are used as components in cosmetic products, the SCCNFP has set specific maximum concentrations when present in cosmetic products.

(4) 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 accordingly.

(5) 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 III, Part 1.

(6) 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 permanent 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 phenylendiamine 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 III.

(7) 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 μg/kg/day. Therefore, until the risk assessment of this substance in the framework of Council Regulation (EEC) No 793/93(5) on the evaluation and control of the risks of existing substances is finalised, musk xylene should be included in Annex III, Part 2.

(8) The SCCNFP recommends that musk ketone can be safely used in cosmetic products, excluding oral care products, up to a maximum daily theoretically absorbed dose of about 14 μg/kg/day. Therefore, until the risk assessment of this substance in the framework of Regulation (EEC) 793/93 is finalised, musk ketone should be included in Annex III, Part 2.

(9) The SCCNFP has expressed the opinion that the UV-filter dimethicodiethylbenzalmalonate can be safely used in cosmetic products under certain restrictions. Therefore, dimethicodiethylbenzalmalonate should be included in Annex VII, Part 1.

(10) The SCCNFP has expressed the opinion that titanium dioxide can be safely used as UV-filter in cosmetic products under certain restrictions. Therefore, titanium dioxide should be included in Annex VII, Part 1.

(11) 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 indicated in the Annex to this Directive.

Article 2

Member States shall take the necessary measures to ensure that cosmetic products containing the substances listed in Annexes II, III and VII to Directive 76/768/EEC, as set out in the Annex to this Directive, which are supplied to the final consumer after 15 April 2004, comply with the provisions of this Directive.

Article 3

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 April 2003 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.

Article 4

This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 15 April 2002.

For the Commission

Erkki Liikanen

Member of the Commission

(1) OJ L 262, 27.9.1976, p. 169.

(2) OJ L 145, 20.6.2000, p. 25.

(3) OJ 11, 20.2.1959, p. 221/59.

(4) OJ L 159, 29.6.1996, p. 1.

(5) OJ L 84, 5.4.1993, p. 1.

ANNEX

Annexes II, III and VII to Directive 76/768/EEC are amended as follows:

1. In Annex II:

(i) Reference No 293 and corresponding footnote 1 are replaced by the following: "293. Radioactive substances, as defined by Directive 96/29/Euratom(1) laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation."

(ii) Reference Nos 423 to 451 are added as indicated below: "423. Alanroot oil (Inula helenium) (CAS No 97676-35-2), when used as a fragrance ingredient.

424. Benzyl cyanide (CAS No 140-29-4), when used as a fragrance ingredient.

425. Cyclamen alcohol (CAS No 4756-19-8), when used as a fragrance ingredient.

426. Diethyl maleate (CAS No 141-05-9), when used as a fragrance ingredient.

427. Dihydrocoumarine (CAS No 119-84-6), when used as a fragrance ingredient.

428. 2,4-Dihydroxy-3-methylbenzaldehyde (CAS No 6248-20-0), when used as a fragrance ingredient.

429. 3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol) (CAS No 40607-48-5), when used as a fragrance ingredient.

430. 4,6-Dimethyl-8-tert-butylcoumarin (CAS No 17874-34-9), when used as a fragrance ingredient.

431. Dimethyl citraconate (CAS No 617-54-9), when used as a fragrance ingredient.

432. 7,11-Dimethyl-4,6,10-dodecatrien-3-one (CAS No 26651-96-7), when used as a fragrance ingredient.

433. 6,10-Dimethyl-3,5,9-undecatrien-2-one (CAS No 141-10-6), when used as a fragrance ingredient.

434. Diphenylamine (CAS No 122-39-4), when used as a fragrance ingredient.

435. Ethyl acrylate (CAS No 140-88-5), when used as a fragrance ingredient.

436. Fig leaf absolute (Ficus carica) (CAS No 68916-52-9), when used as a fragrance ingredient.

437. trans-2-Heptenal (CAS No 18829-55-5), when used as a fragrance ingredient.

438. trans-2-Hexenal diethyl acetal (CAS No 67746-30-9), when used as a fragrance ingredient.

439. trans-2-Hexenal dimethyl acetal (CAS No 18318-83-7), when used as a fragrance ingredient.

440. Hydroabietyl alcohol (CAS No 13393-93-6), when used as a fragrance ingredient.

441. 6-Isopropyl-2-decahydronaphthalenol (CAS No 34131-99-2), when used as a fragrance ingredient.

442. 7-Methoxycoumarin (CAS No 531-59-9), when used as a fragrance ingredient.

443. 4-(4-Methoxyphenyl)-3-butene-2-one (CAS No 943-88-4), when used as a fragrance ingredient.

444. 1-(4-Methoxyphenyl)-1-penten-3-one (CAS No 104-27-8), when used as a fragrance ingredient.

445. Methyl trans-2-butenoate (CAS No 623-43-8), when used as a fragrance ingredient.

446. 7-Methylcoumarin (CAS No 2445-83-2), when used as a fragrance ingredient.

447. 5-Methyl-2,3-hexanedione (CAS No 13706-86-0), when used as a fragrance ingredient.

448. 2-Pentylidenecyclohexanone (CAS No 25677-40-1), when used as a fragrance ingredient.

449. 3,6,10-Trimethyl-3,5,9-undecatrien-2-one (CAS No 1117-41-5), when used as a fragrance ingredient.

450. Verbena oil (Lippia citriodora Kunth.) (CAS No 8024-12-2), when used as a fragrance ingredient.

451. Methyleugenol (CAS No 95-15-2) except for normal content in the natural essences used and provided that the concentration does not exceed:

(a) 0,01 % in fine fragrance

(b) 0,004 % in eau de toilette

(c) 0,002 % in fragrance cream

(d) 0,001 % in rinse-off products

(e) 0,0002 % in other leave-on products and oral hygiene products.".

2. In Annex III, Part 1:

(i) In reference No 8, column b is replaced by the following: "m- and p-Phenylenediamines, their N-substituted derivatives and their salts; N-substituted derivatives of o-Phenylenediamines(2), with the exception of those derivatives listed elsewhere in this Annex"

(ii) Reference Nos 15b and 15c are replaced by the following: ""

(iii) Reference No 16 is replaced by the following: >TABLE>

(iv) Reference No 66 is inserted as shown in the following table: >TABLE>

3. In Annex III, Part 2:

Reference Nos 1 to 62 are inserted as shown in the following table: >TABLE>

4. In Annex VII, Part 1

Reference Nos 26 and 27 are inserted as shown in the following table: >TABLE>

(1) OJ L 159, 29.6.1996, p. 1.

(2) These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.

(3) The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column d.