Commission Directive 2007/17/EC
of 22 March 2007
amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes III and VI thereto to technical progress
(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 products1, and in particular Article 8(2) thereof,
After consulting the Scientific Committee on Consumer Products,
Whereas:
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.
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.
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.
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.
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.
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.
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.
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 (*).
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.
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.
Directive 76/768/EEC should therefore be amended accordingly.
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,
HAS ADOPTED THIS DIRECTIVE: