H. whereas the RAC opinion does acknowledge the endocrine mode of action of DEHP but also recognises that it has been included in Annex XIV because of its reproductive toxicity classification (Article 57(c)) and not on the basis of endocrine disrupting properties (Article 57(f)); whereas, as a consequence, the current assessment of DEHP is limited to its reproductive toxicity;

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.

On 14 June 2013, the Member State Committee, referred to in Article 76(1)(e) of Regulation (EC) No 1907/2006, identified PFOA as a persistent, bioaccumulative and toxic substance (‘PBT’) in accordance with Article 57(d) of that Regulation.

On 29 November 2012, the Member State Committee, referred to in Article 76(1)(e) of Regulation (EC) No 1907/2006, identified decaBDE as a persistent, bioaccumulative and toxic substance (‘PBT’) and a very persistent and very bioaccumulative (‘vPvB’) substance in accordance with points (d) and (e) respectively of Article 57 of Regulation (EC) No 1907/2006.

Nevertheless, because the sources of exposure of the general public to boron are multiple, as expressed in the 2010 opinion of the RAC, and due to its reproductive toxicity it is desirable to reduce the exposure of the general public to boron.

(4) Whereas the Scientific Steering Committee (SSC) adopted an opinion on BSE risk on 27 March 1998; whereas in that opinion the SSC recognised three major issues in considering the risk of BSE: first, the risk of human exposure arising from the direct consumption of potentially infective material, secondly, the risk to man from ingesting or being exposed to processed, potentially infective material, and, thirdly, the risk of propagating the infection by recycling the infective material through animal feed; whereas the Code Commission of the International Office of Epizootics (OIE) also proposes that the assessment of the risk to human ...[+++] and animal health in countries, or regions within countries, be based on a combination of the spread of BSE and the application of measures to control the risk;