The compounds containing fluorine are currently regulated under reference numbers 26 to 43, and reference numbers 47 and 56 in Part 1 of Annex III to Directive 76/768/EEC. Their maximum authorised concentration in toothpastes refers to the content of elemental fluorine (0,15 % calculated as F, i.e. 1 500 ppm).

The Scientific Committee on Consumer Products replaced by the Scientific Committee on Consumer Safety (hereinafter ‘SCCS’)2 stated in its opinion SCCP/0882/08 that the maximum permitted concentration of 0,15 % (1 500 F^- ppm) fluoride does not pose a safety concern when used by children under the age of six years, based on the available scientific evidence. The data used were generated from studies primarily on sodium fluoride.

Based on the scientific conclusions of the SCCS, Commission Directive 2007/53/EC of 29 August 2007 amending Council Directive 76/768/EEC concerning cosmetic products for the purposes of adapting Annex III thereto to technical progress3 introduced for the regulated compounds containing fluorine a requirement for warning which must be printed on the label of toothpastes containing fluoride. This requirement refers to the content of fluoride instead of elemental fluorine. As a result, not all fluorine containing compounds listed in Part 1 of Annex III to Directive 76/768/EEC were covered by the introduced labelling requirement.

Upon request of the Commission, the SCCS clarified that in opinions SCCNFP/0653/03 and SCCP/0882/05, it was pointed out that an extrapolation to other compounds containing fluorine listed in Part 1 of Annex III to Directive 76/768/EEC could only be made with respect to fluorosis. However, for the purpose of the reference to compounds containing fluorine in Part 1 of Annex III to Directive 76/768/EEC, introduced by Directive 2007/53/EC, the SCCS considered that the terms ‘fluorine’ and ‘fluoride’ were equivalent and interchangeable.

To ensure legal certainty, it is necessary to clarify that the labelling requirement refers to all 20 compounds containing fluorine listed in Part 1 of Annex III to Directive 76/768/EEC, and not only to those containing fluoride.

Therefore, the condition for labelling which must be printed on the label of toothpastes containing fluorine compounds listed in Part 1 of Annex III to Directive 76/768/EEC should refer to the content of fluorine instead of fluoride. Directive 76/768/EEC should therefore be amended accordingly.

In view of a smooth transition, Member States should not prohibit the marketing of products complying with this Directive before its date of application.

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,