EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10716/2021  
[…](2021) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) No 546/2011 as regards specific uniform principles for 
evaluation and authorisation of plant protection products containing micro -organisms  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) No 546/2011 as regards specific uniform principles for 
evaluation and authorisation of plant protection products containing micro -organisms  
(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 th e 
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  29(6) and Article 78(1)(c)  thereof,  
Whereas:  
(1) Commission Regulation  (EU) No  546/20112 provides for  uniform principles for 
evaluation and authorisati on of plant protection products.  Part I and Part II of the 
Annex  to Regulation (EU) No 546/2011  lay down, for plant protection products 
containing chemical substances and micro -organisms respectively , the  existing 
uniform principles for assessing whether the plant protection products  may have 
harmful effects on human health, animal health or unacceptable effects on the 
environment  in view of their authorisation . 
(2) The Farm to  Fork Strategy for a fair, healthy and environmentally  friendly food 
system  of the Commission3 aims at reducing dependency on and use of chemical plant 
protection products, including through facilitating the placing on the market of 
biological active subst ances such as micro -organisms.  In order to reach these 
objectives, it is necessary to specify the uniform principles related to plant protection 
products containing  micro -organisms  taking into account  the most up -to-date scientific 
and technical knowledge , which has evolved significantly.  
(3) Since  micro -organisms are living organisms, a specific approach is needed compared 
to chemical substances , in order to also take  into account the current state of Science 
regarding  the biology of micro -organisms, which are living organisms. That scientific 
knowledge  consists of information on key characteristics of micro -organisms, such as 
their pathogenicity and infectivity, the possible production of metabolite(s) of concern 
and t he capacity to transfer  antimicrobial resistance  genes to other micro -organisms 
                                                 
1 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/EEC (OJ L 309, 24.11.2009, p. 1 ). 
2 Commi ssion Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 
1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation 
and authorisation of plant protection products  (OJ L 155, 11.6.2011, p. 1 27). 
3 Communication from the Commission to the European Parliament, the Council, the Economic and 
Social Committee and the Committee of the Regions A Farm to Fork Strategy for a fair, healthy and 
environmentally -friendly food system (COM/2020/381 final, https://eur -lex.europa.eu/legal -
content/en/TXT/?qid=1590404602495&uri=CELEX:52020DC0381 ). EN 2  EN which are pathogenic and occurring in European environments, potentially affecting 
the effectiveness of antimicrobials used in human and veterinary medicine .  
(4) The currently available  scientific knowledge  on plant protection products containing 
micro -organisms allows for a better and more specific approach for their assessment , 
which is based on the mode of action and the ecological characteristics of the 
respective species and, where applicable, the respective strains  of micro -organisms . As 
it allows a more targeted  risk assessment , such scientific knowledge should be taken 
into account when assessing the risks posed by plant protection products containing 
micro -organisms .  
(5) In order to better reflect the latest scientific developments and the specificities of 
micro -organisms , while maintaining a high level of protection of human and animal 
health and of the environment, it is therefore necessary to adapt the existing uniform 
principles  accordingly . 
(6) Currently available  scientific knowledge about  the capacity of micro -organisms to 
transfer antimicrobial resistance genes to other micro -organisms which are pathogenic 
and occurring in European environments, hence potentially affecting the effectiveness 
of antimicrobials used in human and veterinary medicine allows for a better and more 
specific approach for the assessment of which genes encoding for antimicrobial 
resistance are likely to be transferred to other mic ro-organisms, and which 
antimicrobials are those relevant for human and veterinary medicines. In addition, the 
EU Farm to Fork Strategy has set antimicrobial resistance -related targets. Therefore, 
further specification is needed on the data requirements to  implement the most updated 
scientific and technical knowledge on transferability of antimicrobial resistance, and 
ensure for  an assessment to be made on whether the active substance  may have 
harmful effects on human or animal health, as indicated in the approval criteria laid 
down in Article 4 of Regulation (EC) No 1107/2009 concerning effects on human and 
animal health . 
(7) For the sake of clarity of the uniform principles , various points that currently appear in 
sections  A, B and C  of both Part I and Part  II of the Annex regarding uniform 
principles should be consolidated  in a general introduction.  
(8) The current Annex to Regulation (EU) No 546/2011  contains references to 
Commission Regulation s (EU) No  544/20114 and (EU) No  545/20115, which are no 
longer in f orce. It is therefore appropriate to update these reference s and refer to 
Commission Regulation (EU) No  283/20136 and Commission Regulation (EU) 
No 284/20137, respectively , which replaced  Regulations  (EU) No  544/2011 and (EU) 
No 545/2011 . 
                                                 
4 Commission Regulation (EU) No 544/2011 of 10 June 2011 implem enting Regulation (EC) 
No 1107/2009 of the European Parliament and of the Council as regards the data requirements for 
active substances  (OJ L 155, 11.6.2011, p. 1 ). 
5 Commission Regulation (EU) No 545/2011 of 10 June 2011 implementing Regulation (E C) 
No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant 
protection products  (OJ L 155, 11.6.2011, p. 67 ). 
6 Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active 
substa nces, 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  (OJ L 93, 3.4.2013, p.  1). 
7 Commission Regulation (EU) No 284/2013 of 1 March 2013 settin g out the data requirements for plant 
protection products, 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  (OJ L 93, 3.4.2013, 
p. 85). EN 3  EN (9) The uniform principles for evaluation and authorisation of plant protection products 
aim to ensure that evaluations and decisions with regard to authorisation of plant 
protection products by Member States result in a high level of protection of human and 
animal health and the environment as required by Regulation (EC) No 1107/2009. The 
uniform principles also give some explanations on how the Member States are to  
assess data submitted by applicants in accordance with the data requirements as set out 
in the relevant legislation. Considering that the legislation setting out the data 
requirements is being amended by XXX [ Office of Publications  please insert the 
reference to the Regulation amending the Regulation 284/2013 ] it is necessary to 
ensure consistency in the application of new rules, so that new applications are 
submitted according to the amended data requirements.  
(10) Part A of the Annexe s to Regulation (EU) No  283/2013 and Regulation (EU) 
No 284/2013 sets out the requir ements for the  data to be assessed i n accordance with 
the uniform principles,  and refer s to chemical active substances and plant protection 
products  containing them , respectively . For the sake of legal certainty, clarity and 
consistency with Regulation (EU) No 283/2013 and Regulation (EU) No  284/2013, 
Part I of the Annex to Regulation (EU) No  546/2011 should be  renamed as ‘Part A’. 
(11) Part B of the Annexes to Regulation (EU) No 283/2013 and Regulation  (EU) 
No 284/2013 set s out the requirements for the data to be assessed in accordance with 
the uniform principles,  and refer s to active substances that are micro -organisms and 
plant protection products containing them, respectively. For the sake of  legal certainty,  
clarity and consistency with Regulation (EU) No 283/2013 and Regulation (EU) No 
284/2013, Part  II of the Annex to Regulation (EU) No  546/2011 should be  renamed as 
‘Part  B’. 
(12) 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 
The Annex to Regulation (EU) No 546/2011 is replaced by the text set out in the Annex to 
this Regulation.  
Article 2  
Regulation (EU) No 546/2011  as it stood p rior to being amended by this Regulation shall 
continue to apply to applications for authorisation of plant protection products, within the 
meaning of Regulation (EC) No 1107/2009, for which data is submitted in accordance with 
Commission Regulation (EU) N o 284/2013  in the version applicable before [Office of 
Publications: please insert date of application of Regulation (…) amending Regulation (EU) 
No 284/2013 ]. 
Article 3 
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  (…) [Office of Publications: please insert the date of application  of 
Regulation (…) amending Regulation (EU) No  284/2013 ] EN 4  EN This Regulation shall be bi nding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN