EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12066/2020  
[…](2021) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substance abamectin in accordance with Regulation 
(EC) No 1107/2009 of the European Parliament and of the Council concerning the 
placing of plant protection products on the market, and amending the Annex to 
Commission Im plementing Regulation (EU)  No 540/2011  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substance abamectin in accordance with Regulation 
(EC) No 1107/2009 of the European Parliament and of the Council concerning the 
placing of plant protection products on the market, and amending the Annex to 
Commission Implementing Regulation (EU)  No 540/2011  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Havi ng regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council of 21 October 2009 concerning the placing of plant protection products on the market 
and repealing  Council Directives  79/117/EEC and 91/414/EEC1, and in particular 
Article  20(1) thereof , 
Whereas:  
(1) Commission Directive 2008/107/EC2 included abamectin as an active substance in 
Annex I to Council Directive 91/414/EEC3. 
(2) Active substances included in Annex I  to Directive 91/414/EEC are deemed to have 
been approved under Regulation (EC) No 1107/2009 and are listed in Part  A of the 
Annex to Commission Implementing Regulation (EU) No  540/20114. 
(3) The approval of the active substance abamectin , as set out in Part A  of the Annex to 
Implementing Regulation (EU) No 540/2011 , expires on 30 April  2022. 
(4) An application for the  renewal of the approval of  the active substance abamectin was 
submitted in accordance with Article 1 of Commission Implementing Regulation (E U) 
No 844/20125 within the time period provided for in that Article.  
(5) The applicant submitted the supplementary dossiers required in accordance with 
Article  6 of Implementing Regulation (EU) No 844/2012. The application was found 
to be complete by the rapporteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.   
2 Commission Directive 2008/107/EC of 25 November 2008 amending Council Directive 91/414/EEC to 
include abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim as active substances 
(OJ L 316, 26.11.2008, p.  4). 
3 Council Directive 91/414/EEC o f 15 July 1991 concerning the placing of plant protection products on 
the market (OJ L 230, 19.8.1991, p.  1). 
4 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation 
(EC) No 1107/2009 of the European Parliament and of t he Council as regards the list of approved active 
substances (OJ L 153, 11.6.2011, p.  1). 
5 Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the 
provisions necessary for the implementation of the renewal procedure for ac tive substances, as provided 
for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the 
placing of plant protection products on the market  (OJ L 252, 19.9.2012, p.  26). EN 2  EN (6) The rapporteur Member State prepared a  draft renewal assessment report in 
consultation with the co -rapporteur Member State and submitted it to the European 
Food Safety Authority ( ‘the Aut hority’) and the Commission on 17 April  2019.  
(7) The Autho rity made the supplementary summary dossier available to the public. The 
Authority also circulated the draft renewal assessment report to the applicant and to 
the Member States for comments and launched a public consultation on it. The 
Authority forwarded the comments received to the Commission.  
(8) On 15 July 2020, t he Authority communicated  to the Commission its conclusion6 on 
whether abamectin can be expected to meet the approval criteria provided for in 
Article 4 of Regulation (EC) No 1107/2009. The Commiss ion presented a renewal 
report and the draft Regulation for abamectin  to the Standing Committee on Plant s, 
Animals, Food and Feed , on 25 March  2021 . 
(9) As regards the criteria to identify endocrine disrupting properties introduced by 
Commission Regulation (EU) 2018/6057, the conclusion  of the Authority indicates  
that, based on the scientific evidence, it is highly unlikely that abamectin  is an 
endocrine disrupter  via the estrogenic, androgenic and thyroidogenic modalities. 
Furthermore, the available evidenc e indicates that abamectin is unlikely to be an 
endocrine disruptor via the steroidogenic  modality.  Thus, the Commission concludes  
that abamectin  is not to be considered as having endocrine disrupting properties.  
(10) The Commission invited the applicant to sub mit its comments on the conclusion of the 
Authority and, in accordance with the third paragraph of Article 14(1) of 
Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant 
submitted its comments  on both versions of the renewal report , which have been  
carefully examined . 
(11) It has been established with respect to one or more representative uses of at least one 
plant protection product containing abamectin that the approval criteria provided for in 
Article 4 of Regulation (EC) No  1107/2009  are satisfied.  
(12) The risk assessment for the renewal of the approval of the active substance 
abamectin  is ba sed on representative uses as  insecticide and acaricide  in protected 
crops . While it is not necessary , in the light of this risk assessment,  to maintain the 
restriction to use only as insecticide and acaricide, it is necessary to provide , in 
accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with 
Article 6 thereof and in the light of current scientific and technical k nowledge, for 
certain conditions and restrictions. It is, in particular, appropriate to restrict the use of 
plant protection products containing abamectin to  use in permanent greenhouses , as 
defined in Article 3(27) of Regulation  (EC) No 1107/2009 , in orde r to mitigate the 
high risk identified to aquatic organisms and wild terrestrial non -target organisms .  
(13) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly . 
(14) Implementing Regulation (EU) 2021/XXX8 extended the approval period of  
abamectin to 30  April  2022  in order to allow the renewal process to be completed 
before the expiry of the approval period of that active substance . However, given that 
                                                 
6 EFSA Journal 2020;18(8):6227 . Available online:  www.efsa.europa.eu.  
7 Commission Regulation (EU) 2018/605 of 19 April 2018 amending  Annex II to Regulation (EC) 
No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties  
(OJ L 101, 20.4.2018, p.  33). 
8 OJ L XX.XX.X.XXXX. p.).  EN 3  EN a decision on renewal has been taken ahead of that extended expiry date, this 
Regulatio n shall apply from 1 July 2021.  
(15) The measures provided for in this Regulation are in accordance with the opinion of the  
Standing Committee on Plant s, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Renewal of the approval of the active substance  
The approval of the active substance  abamectin  is renewed as set out in Annex I.  
Article 2  
Amendments to Implementing Regulation (EU) No 540/2011  
The Annex to Implementing Regulation (EU) No 540/2011 is  amended in accordance with 
Annex II to this  Regulation.  
Article 3  
Entry into force and date of application  
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from  1 July 2021 . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN  