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 products, and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1)
Commission Delegated Regulation (EU) No 1062/2014 establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes Bacillus subtilis.
(2)
As a result of the evaluation of the active substance originally notified, it became apparent that it belonged in fact to the species Bacillus amyloliquefaciens strain ISB06. The evaluation did not allow for conclusions to be drawn regarding any other substance complying with the definition of Bacillus subtilis in the abovementioned list of active substances in Delegated Regulation (EU) No 1062/2014. Therefore, only Bacillus amyloliquefaciens strain ISB06 should be covered by this approval.
(3)
Bacillus amyloliquefaciens strain ISB06 has been evaluated for use in products of product-type 3, veterinary hygiene as described in Annex V to Regulation (EU) No 528/2012.
(4)
Germany was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 22 September 2014.
(5)
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 10 December 2015 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
(6)
According to that opinion, biocidal products of product-type 3 and containing Bacillus amyloliquefaciens strain ISB06 may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.
(7)
It is therefore appropriate to approve Bacillus amyloliquefaciens strain ISB06 for use in biocidal products of product-type 3, subject to compliance with certain specifications and conditions.
(8)
A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.
(9)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS REGULATION: