EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11110/2019 Rev 1  
[…](2019) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substance metalaxyl -M, and restricting the use of 
seeds treated with plant protection products containing it, in accordance with 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council 
concerning the p lacing of plant protection products on the market, and amending the 
Annex to Commission Implementing 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 metalaxyl -M, and restricting the use of 
seeds treated with plant protection products containing it, 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 Impl ementing Regulation (EU) No 540/2011  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having 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)  and 49(2)  thereof,  
Whereas:  
(1) Commission Directive  2002/64/ EC2 included  metalaxyl -M 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 Imple menting Regulation (EU) No  540/20114. 
(3) The approval of the active substance metalaxyl -M, as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011, expires on 30  June 2020 . 
(4) An application for the renewal of the inclusion of metalaxyl -M in Annex I to Council 
Directive  91/414/EEC5 was submitted in accordance with Article 4 of Commission 
Regulation (E U) No 1141/20106 within the time period provided for in that Article.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2002/64/EC of 15 July 2002 amending Council Directive 91/414/EEC to include 
cinidon -ethyl, cyhalofop butyl, famoxadone, florasulam, metalaxyl -M and picolinafen as active 
substances (OJ L 189, 18.7.2002, p.  27). 
3 Council Directive 91/4 14/EEC of 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 the Council as regards the list of approved active 
substances (OJ L 153, 11.6.2011, p.  1). 
5 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on 
the market (OJ L 230, 19.8.1991, p.  1). 
6 Commission Regulation (EU) No 1141/2010  of 7 December 2010  laying down the procedure for the 
renewal of the inclusion of a second group of active substances in Annex I to Council 
Direc tive 91/414/EEC and establishing the list of those substances  (OJ L 322, 8.12.2010,  p. 10).   
EN 2  EN (5) The applicant submitted the supplementary dossiers  required in accordance  with 
Article  9 of Regulation (E U) No 1141/2010.  The application  was found to be complete 
by the rapporteur Member State . 
(6) The rapporteur Member State prepared a  renewal assessment report in consultation 
with the co -rapporteur Member State and submitted it to the European Foo d Safety 
Authority ( ‘the Aut hority’) and the Commission on 13  November  2013 .  
(7) The Authority communicated the renewal assessment report to the applicant and to the 
Member States for comments and forwarded the comments received to the 
Comm ission. The Authority also made the supplementary summary dossier available 
to the public.  
(8) On 30 January 2015 , the Authority communicated to the Commission its conclusion7 
on whether metalaxyl -M can be expected to meet the approval criteria provided for i n 
Article 4 of Regulation (EC) No 11 07/2009.  The Commission presented an initial draft 
review report for metalaxyl -M to the Standing Committee on Plant s, Animals, Food 
and Feed  on 14 July 2015 and  a revised version on 16  July 2019 . 
(9) The applicant was given the opportunity to submit comments on the draft review 
report.  
(10) It has been established with respect to one or more representative uses of at least one 
plant protection product containing metalaxyl -M that the approval criteria provided for 
in Article 4 of R egulation (EC) No 1107/2009 are satisfied.  
(11) It is therefore appropriate to renew the approval of metalaxyl -M. 
(12) 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 knowledge, it 
is, however, necessary to include certain conditions and restrictions .  
(13) Risks for birds and mammals from consumption of treated seeds have been identified  
by the Authority. Taking into consideration those risks , the use of seeds tre ated with 
plant protection products containing metalaxyl -M should be  restricted . It is therefore 
appropriate that seeds treated with plant protection produ cts containing metalaxyl -M 
should only be sown  in greenhouses.  
(14) The Commission considers that metalaxy l-M does not hav e endocrine disrupting 
properties based on the available scientific information summarised in the conclusion 
of the Authority . However , in order to increase the confidence in this conclusion, the 
applicant should provide an updated assessment , in accordance with point 2.2 (b) of 
Annex II to Regulation (EC) No 1107/2009, of the criteria laid down in points 
3.6.5  and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by 
Regulation (EU) 2018/605 , and in accordance with the gui dance for  the identification 
of endocrine disruptors8.   
(15) The risk assessment for the renewal of the approval of metalaxyl -M is based on a 
limited number of representative uses, which however do not restrict the uses for 
which plant protection products cont aining metalaxyl -M may be authorised. It is 
therefore appropriate not to maintain the restriction to uses as a fungicide.  
                                                 
7 EFSA (European Food Safety Authority), 2015. Conclusion on the peer review of the pesticide risk 
assessment of the active substance metalaxyl -M. EFSA Journal 2015;13(3):3999, 105 pp. 
doi:10.2903/j.efsa.2015.3999.  
8 Guidance for the identificati on of endocrine disruptors in the context of Regulations (EU) No 528/2012 
and (EC) No 1107/2009. https://efsa.onlinelibrarv.wilev.eom/doi/epdt710.2903/i.efsa.2018.5311 .  
EN 3  EN (16) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(17) Commission Implementing Regulation (EU) 2019/7079 extended the approval period  
of metalaxyl -M to 30 June 2020 in order to allow the renewal process to be completed 
before the expiry of that  approval period . However, g iven that a decision on renewal 
of the approval is taken ahead of the expiry of that extended approval period,  this 
Regulation shall apply as soon as possible.  
(18) The restriction  to the use of treated seeds should apply as of 1  November  2020 in order 
to allow for a sufficient period of transition . 
(19) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Renewal of the approval of the active substance  
The approval of the active substance metalaxyl -M 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 
Restriction to the  use of treated seeds  
Seeds treated with plant protection products containing metalaxyl -M shall only be sown  in 
greenhouses.  
Article 4 
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 April 2020 .  
However, Article 3 shall apply as of 1 November  2020.  
                                                 
9 Commission Implementing Regulation (EU) 2019/707 of 7 May 2019 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 
alpha -cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenaz ate, boscalid, bromoxynil, captan, 
cyazofamid, desmedipham, dimethoate, dimethomorph, diuron, ethephon, etoxazole, famoxadone, 
fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, metalaxyl -m, methiocarb, 
metribuzin, milbemectin, Pa ecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos -
methyl, propamocarb, prothioconazole, s -metolachlor and tebuconazole  (OJ L 120, 8.5.2019, p.  16).  
EN 4  EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Comm ission  
 The President  
 (Name to be added )