30.4.2014 EN Official Journal of the European Union L 128/68
COMMISSION IMPLEMENTING REGULATION (EU) No 438/2014
of 29 April 2014
approving cyproconazole as an existing active substance for use in biocidal products for product-type 8
(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 products (1), and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1) Commission Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes cyproconazole.
(2) Cyproconazole has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to that Directive, which corresponds to product-type 8 as defined in Annex V to Regulation (EU) No 528/2012.
(3) Ireland was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 30 May 2012 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
(4) The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated in an assessment report reviewed within the Standing Committee on Biocidal Products on 13 March 2014.
(5) According to that assessment report, biocidal products used for product-type 8 and containing cyproconazole may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC provided that certain specifications and conditions relating to its use are satisfied.
(6) It is therefore appropriate to approve cyproconazole for use in biocidal products for product-type 8 subject to compliance with such specifications and conditions.
(7) Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.
(8) The report concludes that cyproconazole meets the criteria for being classified as toxic for reproduction category 1B in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (4), and for being very persistent (vP) and toxic (T) according to Annex XIII to Regulation (EC) No 1907/2006. Notwithstanding the fact that the existing harmonised classification of cyproconazole should be revised pursuant to Article 37 of Regulation (EC) No 1272/2008, those intrinsic properties should be taken into account for the purpose of determining the period of approval.
(9) Since the conditions of the first subparagraph of Article 90(2) of Regulation (EU) No 528/2012 are not met, the current practice under Directive 98/8/EC should be followed. The period of approval should therefore be five years.
(10) However, for the purpose of authorising products in accordance with Article 23 of Regulation (EU) No 528/2012, cyproconazole shall be considered as a candidate for substitution pursuant to Article 10(1)(a) and (d) of that Regulation.
(11) 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 laid down.
(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
Cyproconazole shall be approved as an active substance for use in biocidal products for product-type 8, subject to the specifications and conditions set out in the Annex.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.