Commission Implementing Regulation (EU) 2018/1129 of 13 August 2018 approving acetamiprid as an existing active substance for use in biocidal products of product-type 18 (Text with EEA relevance.)
Date: 2018-08-13
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: chemical product, insecticide, market approval, plant health control, plant health treatment








L_2018205EN.01000401.xml










14.8.2018   


EN


Official Journal of the European Union


L 205/4








            COMMISSION IMPLEMENTING REGULATION (EU) 2018/1129
of 13 August 2018
         
approving acetamiprid as an existing active substance for use in biocidal products of product-type 18
(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 Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes acetamiprid.












(2)


Acetamiprid has been evaluated for use in products of product-type 18, insecticides, acaricides and products to control other arthropods, as described in Annex V to Regulation (EU) No 528/2012.












(3)


Belgium was designated as rapporteur Member State and its evaluating competent authority submitted the assessment report together with its recommendations on 27 July 2015.












(4)


In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 14 December 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority (3).












(5)


According to that opinion, biocidal products of product-type 18 containing acetamiprid 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.












(6)


It is therefore appropriate to approve acetamiprid for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.












(7)


The opinion of the European Chemicals Agency concludes that acetamiprid meets the criteria for being a very persistent (vP) and toxic (T) substance in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4). Acetamiprid therefore meets the conditions set out in point (d) of Article 10(1) of Regulation (EU) No 528/2012 and should be considered a candidate for substitution.












(8)


Pursuant to Article 10(4) of Regulation (EU) No 528/2012, the approval of an active substance that is considered as a candidate for substitution should be for a period not exceeding seven years.












(9)


Since acetamiprid meets the criteria for being very persistent (vP) in accordance with Annex XIII to Regulation (EC) No 1907/2006, treated articles treated with or incorporating acetamiprid should be appropriately labelled when placed on the market.












(10)


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.












(11)


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 1
Acetamiprid is approved as an active substance for use in biocidal products of product-type 18, subject to the specifications and conditions set out in the Annex.


Article 2
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, 13 August 2018.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 167, 27.6.2012, p. 1.

(2)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

(3)  Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance Acetamiprid, Product type: 18, ECHA/BPC/185/2017, Adopted on 14 December 2017.

(4)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).




ANNEX











Common Name


IUPAC Name
Identification Numbers


Minimum degree of purity of the active substance (1)



Date of approval


Expiry date of approval


Product type


Specific conditions




Acetamiprid


IUPAC Name:
(E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamide
EC No: None
CAS No: 135410-20-7


99,0 % w/w


1 February 2020


31 January 2027


18


Acetamiprid is considered a candidate for substitution in accordance with point (d) of Article 10(1) of Regulation (EU) No 528/2012.
The authorisations of biocidal products are subject to the following conditions:






1.


The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.










2.


In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:






(a)


professional users;










(b)


infants and toddlers following secondary exposure when the product is sprayed by professionals;










(c)


surface water, sediment, soil, groundwater for products applied by spray or brush in stables;










(d)


surface water, sediment, soil, groundwater for products applied by spray outdoors.














3.


For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (2) or Regulation (EC) No 396/2005 of the European Parliament and of the Council (3) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.




The placing on the market of treated articles is subject to the following condition:
The person responsible for the placing on the market of a treated article treated with or incorporating acetamiprid shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.






(1)  The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.

(2)  Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

(3)  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).