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), and in particular Article 8(2) thereof,
After consulting the Scientific Committee on Consumer Products,
Whereas:
(1) Annex VI to Directive 76/768/EEC establishes a list of preservatives allowed in cosmetic products. The substances listed in Annex VI marked with the symbol (*) may be used in concentrations other than those fixed in that Annex for non-preservative purposes, if the specific purpose is apparent from the presentation of the product. Nevertheless, the use of these substances may be restricted in other Annexes to that Directive.
(2) The substances listed in Annex VI without the symbol (*) may not be used in concentrations other than those listed in that Annex and the other restrictions set out therein also apply when those substances are used for other specific purposes.
(3) The Scientific Committee on Consumer Products, hereinafter ‘the SCCP’, has issued an opinion stating that the restrictions for usage level and warnings in Annex VI should also apply if the preservatives marked with the symbol (*) are used for other specific purposes.
(4) The Commission therefore called upon the industry to submit safety files for substances listed with the symbol (*) when used in higher concentrations for other specific purposes.
(5) On the basis of those safety-files, the SCCP concluded that the use of several of the preservative substances in Annex VI for other specific purposes in higher concentrations is safe.
(6) The safe concentration limits for those preservative substances when used for other specific purposes should be included in Annex III to Directive 76/768/EEC. For the sake of clarity, it should be indicated for the relevant entries in Annex III that the same substance is listed in Annex VI to that Directive.
(7) Substances that were not considered to be safe by the SCCP when used in concentrations other than those laid down in Annex VI for other specific purposes should be subject to the restrictions laid down in that Annex for use as preservatives. The symbol (*) should therefore be deleted from those substances in Annex VI.
(8) In order to ensure a coherent approach, all substances listed in Annex VI which may also be added to cosmetic products, for other specific purposes, in higher concentrations than those laid down in that Annex should be marked with the symbol (*).
(9) Moreover, the SCCP considered it safe to increase the maximum concentration of benzoic acid and its sodium salt in rinse-off products and oral-care products and to increase the maximum concentration of zinc pyrithione in rinse-off hair products for preservative use. It is therefore appropriate to amend reference numbers 1 and 8 of Annex VI to Directive 76/768/EEC accordingly.
(10) The SCCP is also of the opinion that methyldibromo glutaronitrile should not be present in any cosmetic products, as no safe use-levels in cosmetic leave-on and rinse-off products have been established. It is therefore necessary to delete that substance from reference number 36 of Annex VI to Directive 76/768/EEC.
(11) Directive 76/768/EEC should therefore be amended accordingly.
(12) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,
HAS ADOPTED THIS DIRECTIVE:
Annexes III and VI to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.
Member States shall take all necessary measures to ensure that from 23 March 2008 no cosmetic products which fail to comply with this Directive are placed on the market by Community manufacturers or by importers established within the Community.
Member States shall take all necessary measures to ensure that those products are not sold or disposed of to the final consumer after 23 June 2008.
1.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 23 September 2007 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
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.
2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Directive is addressed to the Member States.
Done at Brussels, 22 March 2007.
For the Commission
Günter Verheugen
Vice-President
Directive 76/768/EEC is amended as follows:
Annex III, Part 1, is amended as follows:
Reference numbers 98 to 101 are added as indicated below:
| a As a preservative, see Annex VI, Part 1, No 3. | |||||
| b Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin. | |||||
| c As a preservative, see Annex VI, Part 1, No 9. | |||||
| d As a preservative, See Annex VI, Part 1, No 23. | |||||
| e As a preservative, see Annex VI, Part 1, No 8.’ | |||||
| Reference No | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | ||
|---|---|---|---|---|---|
| Field of application and/or use | Maximum authorised concentration in the finished cosmetic product | Other limitations and requirements | |||
| a | b | c | d | e | f |
| ‘98 | Salicylic acida (CAS No 69-72-7) | a)Rinse-off hair productsb)Other products | a)3,0 %b)2,0 % | Not to be used in preparations for children under three years of age, except for shampoos. For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product. | Not to be used for children under three years of ageb |
| 99 | Inorganic sulfites and bisulfitesc | a)Oxidative hair dye productsb)Hair straightening productsc)Self tanning products for the faced)Other self tanning products | a)0,67 % expressed as free SO2b)6,7 % expressed as free SO2c)0,45 % expressed as free SO2d)0,40 % expressed as free SO2 | For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product. | |
| 100 | Triclocarband (CAS No 101-20-2) | Rinse-off products | 1,5 % | Purity criteria:
For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product. | |
| 101 | Zinc pyrithionee (CAS No 13463-41-7) | Leave-on hair products | 0,1 % | For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product. | |
Annex VI, Part 1, is amended as follows:
In column b, the symbol ‘(*)’ is deleted for the reference numbers 1, 2, 4, 7, 12, 14, 18, 19, 21, 22, 24, 25, 26, 27, 28, 29, 30, 32, 33, 35, 37, 42 and 47.
In column b, the symbol ‘(*)’ is added for the reference numbers 5 and 43.
Reference number 1 is replaced by the following:
| Reference No | Substance | Maximum authorised concentration | Limitations and requirements | Conditions of use and warnings which must be printed on the label |
|---|---|---|---|---|
| a | b | c | d | e |
| ‘1 | Benzoic acid (CAS No 65-85-0) and its sodium salt (CAS No 532-32-1) | Rinse-off products, except oral care products: 2,5 % (acid) Oral care products: 1,7 % (acid) Leave-on products: 0,5 % (acid) | ||
| 1a | Salts of benzoic acid other than that listed under reference number 1 and esters of benzoic acid | 0,5 % (acid)’ |
Reference number 8 is replaced by the following:
| Reference No | Substance | Maximum authorised concentration | Limitations and requirements | Conditions of use and warnings which must be printed on the label |
|---|---|---|---|---|
| a | b | c | d | e |
| ‘8 | Zinc pyrithione (*) (CAS No 13463-41-7) | Hair products: 1,0 % Other products: 0,5 % | Rinse-off products only. No use in products for oral hygiene.’ |
Reference number 36 is deleted.
OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2007/1/EC (OJ L 25, 1.2.2007. p. 9).