# Commission Implementing Regulation (EU) No 438/2014Show full title

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)         

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U.K.

# 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,

HAS ADOPTED THIS REGULATION:

# Article 1U.K.

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.                  

# Article 2U.K.

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.

Done at Brussels, 29 April 2014.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEXU.K.

1

OJ L 167, 27.6.2012, p. 1.                           

2

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in                              Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products                              on the market (OJ L 325, 11.12.2007, p. 3).                           

3

Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products                              on the market (OJ L 123, 24.4.1998, p. 1).                           

4

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling                              and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation                              (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).