Regulation (EC) No 1223/2009 of the European Parliament and of the Council seeks to comprehensively harmonise the rules in the Community in order to achieve an internal market for cosmetic products while ensuring a high level of protection of human health (Recital 4) and to distinguish cosmetics from medicinal products, medical devices and biocidal products (Recital 6). The regulation also covers the manufacture of cosmetic products (Article 8) and lists depilatories as a type of cosmetic (Recital 7). It will enter into force on 11 July 2013 (Article 40). The transitional provisions set out in Article 39 stipulate that, by way of derogation from Directive 76/768/EEC, cosmetic products which comply with the regulation may be placed on the market before that date. In Spain, cosmetics are regulated by Royal Decree No 1599/1997 of 17 October 1997, Article 1 of which defines them as medical products.
The decree defines cosmetic products, establishes the technical and medical criteria they must fulfil, the checks to which they are subject, the requirements to be met by premises where they are manufactured or imported from third countries, and lays down provisions relating to labelling, advertising, inspections, infringements and penalties. Article 18 of the decree states that cosmetic products must be approved by the Spanish Agency for Medicines and Medical Products (Agencia Española de Medicamentos y Productos Sanitarios) and lays down the requirements that must be met in order to gain such approval.
In the light of the above and of the list of categories of cosmetic products contained in Annex I to Royal Decree No 1599/1997:
Does the Commission think that there is a contradiction between Regulation (EC) No 1223/2009 and Royal Decree 1599/1997 with regard to whether cosmetics, and depilatories in particular, are medical or non-medical products?
In the light of the forthcoming entry into force of Regulation (EC) No 1223/2009, do the provisions of Royal Decree No 1599/1997, in particular Article 18 on manufacturing and import approval and requirements, still apply to cosmetics manufactured in Spain?
May cosmetic products, with specific reference to depilatories, be manufactured in Spain prior to 11 July 2013 under the transitional provisions set out in the regulation?