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1. This Regulation shall enter into force on the thirtieth day following that of its publication in the Official Journal of the European Union.

2. Article 7 shall apply from 26 July 2008. Article 8 shall apply from 26 January 2009. Articles 30 and 31 shall apply from 26 July 2007. This Regulation shall be binding in its entirety and directly applicable in all Member States. COMMISSION STATEMENT In view of the risks of carcinogens, mutagens and substances toxic to reproduction, the Commission will request the Committee for Medicinal Products for Human Use of the European Medicines Agency to draw up an opinion on the use of these categories of substances as excipients of medicinal products for human use, on the basis of Articles 5(3) and 57(1)(p) of Regulation (EC) No 726/2004 of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. The Commission will transmit the opinion of the Committee for Medicinal Products for Human Use to the European Parliament and the Council.

Within six months of the opinion of the Committee for Medicinal Products for Human Use, the Commission will inform the European Parliament and the Council of any necessary action it intends to take to follow-up on this opinion.