Commission Delegated Regulation (EU) No 837/2013
of 25 June 2013
amending Annex III to Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the information requirements for authorisation of biocidal products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products1, and in particular Article 85 thereof,
Whereas:
Pursuant to Article 19(1) of Regulation (EU) No 528/2012 a biocidal product may be authorised if the active substances in the product have been approved in accordance with Article 9 of that Regulation.
A biocidal product may be authorised even if one or more of the active substances contained therein has been manufactured in a different location or according to a different process, including from different starting materials, than those of the substance evaluated for approval pursuant to Article 9 of Regulation (EU) No 528/2012.
In such cases, for the purpose of ensuring that the active substance contained in a biocidal product does not have significantly more hazardous properties than the substance which has been evaluated for the purpose of approval, it is necessary to establish technical equivalence pursuant to Article 54 of Regulation (EU) No 528/2012.
It is therefore appropriate to include proof of establishment of technical equivalence in the information requirements for authorisation of biocidal products listed in Annex III to Regulation (EU) No 528/2012,
HAS ADOPTED THIS REGULATION: