EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/12068/2017 CIS 
(POOL/E4/2017/12068/12068 -EN 
CIS.doc)  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving acetamiprid as an existing active substance for use in biocidal products of 
product -type 18  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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 
products1, and in particular the third subparagraph of Article  89(1) thereof,  
Wherea s: 
(1) Commission Delegated Regulation (EU) No 1062/20142 establishes a list of existing 
active substances to be evaluated for their possible approv al for use in biocidal 
products. That list includes acetamiprid . 
(2) Acetamiprid  has been evaluated for use in  produ cts of product -type 18, insecticides, 
acaricides and products to control other arthropods, a s describ ed 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 Product s Committee , having regard to the conclusions of the evaluating 
competent authority3.  
(5) According to th at 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 com pliance 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 
                                                 
1 OJ L  167, 27.6.2012, p.  1. 
2 Commission Delegated Regula tion (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 refe rred 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/1 85/2017, Adopted on 14 December 2017 .  
EN 2  EN Annex XIII to Regulation (EC) No 1907/2006 of the Europea n Parliament and of the 
Council4. 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 Re gulation (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  
Anne x 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 Product s, 
HAS ADOPTED THIS REGULATIO N: 
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,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER  
                                                 
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) .