(Høringsutkast) Kommisjonsforordning om fastsettelse av vitenskapelige kriterier for bestemmelse av hormonforstyrrende stoffer i henhold til forordning (EF) nr. 528/2012
(Consultation draft) Commission Regulation setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012
Utkast til kommisjonsforordning lagt ut på høring av Kommisjonen 30.6.2016
BAKGRUNN (fra Kommisjonens høringsutkast, engelsk utgave)
(1) Scientific criteria for the determination of endocrine disrupting properties pursuant to Regulation (EU) No 528/2012 should be developed taking into account the purpose of that Regulation to improve the free movement of biocidal products within the Union while ensuring a high level of protection of both human and animal health and the environment.
(2) In 2002, the World Health Organisation (WHO) through its International Programme for Chemical Safety, proposed a definition for endocrine disruptors and in 2009 a definition of adverse effects. Those definitions have by now reached the widest consensus among scientists. The European Food Safety Authority ('the Authority') endorsed those definitions in its Scientific Opinion on endocrine disruptors adopted on 28 February 2013 (hereinafter “The Scientific Opinion of the Authority"). It is also the view of the Scientific Committee on Consumer Safety. It is therefore appropriate to base the criteria for the determination of endocrine disrupting properties on those WHO definitions.
(3) In order to implement those criteria, weight of evidence should be applied following in particular the methodology provided for in Regulation (EU) No 528/2012 and in Regulation (EC) No 1272/2008 of the European Parliament and Council on the weight of evidence. Previous experience with the application of the Guidance document on standardised test guidelines for evaluating chemicals for endocrine disruption of OECD should be also considered. In addition, the implementation of the criteria should be based on all relevant scientific evidence, in particular studies based on international agreed study protocols.
(4) The criteria for the determination of endocrine disrupting properties reflect the current state of scientific and technical knowledge and allow identifying active substances having endocrine disrupting properties more accurately. Without prejudice to Article 90(2) of Regulation (EU) No 528/2012, the new criteria should therefore apply as soon as possible, except where the relevant Committee has voted on the draft Regulation presented to it without that Regulation having been adopted by the Commission by [date of IEF of this Regulation]. The Commission will consider on a case-by-case basis the implications for each pending procedure and, where necessary, take appropriate measures with due respect for the rights of the applicants. This may include a request for a revised opinion from the Agency and comments from the applicants.
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