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.
(2)
That list includes N,N-Methylenebismorpholine, to be renamed formaldehyde released from N,N-Methylenebismorpholine (hereafter referred to as ‘MBM’), as the result of its evaluation.
(3)
MBM has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council for use in product-type 6, in-can preservatives, and product-type 13, metalworking-fluid preservatives, as defined in Annex V to that Directive, which correspond respectively to product-types 6 and 13 as defined in Annex V to Regulation (EU) No 528/2012.
(4)
Austria was designated as evaluating competent authority and submitted the assessment reports, together with its recommendations, to the Commission on 25 July 2013 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/2007.
(5)
In accordance with Article 7(1)(b) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 3 October 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority.
(6)
According to those opinions, biocidal products used for product-types 6 and 13 and containing MBM may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC provided that certain conditions concerning its use are complied with.
(7)
It is therefore appropriate to approve MBM for use in biocidal products for product-types 6 and 13 subject to compliance with the specific conditions in the Annex.
(8)
The opinions conclude that MBM meets the criteria for classification as carcinogenic category 1B in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council.
(9)
Since pursuant to Article 90(2) of Regulation (EU) No 528/2012, substances for which the Member States' evaluation has been completed by 1 September 2013 should be approved in accordance with Directive 98/8/EC, the period of approval should be 5 years in accordance with the practice established under that Directive.
(10)
For the purposes of Article 23 of Regulation (EU) No 528/2012 however, MBM meets the conditions of Article 10(1)(a) of that Regulation and should therefore be considered a candidate for substitution.
(11)
Furthermore, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the competent authorities should also evaluate whether the conditions of Article 5(2) can be satisfied to decide if a biocidal product containing MBM can be authorised or not.
(12)
Since MBM meets the criteria for classification as carcinogenic category 1B, and as skin sensitiser category 1 as defined in Annex I to Regulation (EC) No 1272/2008, treated articles treated with or incorporating MBM should be appropriately labelled when placed on the market.
(13)
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.
(14)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS REGULATION: