EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12040/2020  
[…](2021) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) No 283/2013 as regards the information to be submitted for 
active substances and the specific data requirements for micro -organisms   
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) No 283/2013 as regards the information to be submitted for 
active substances and the specific data requirements for 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 the 
Council of 21 October 2009 concerning the placing of plant protection products on the market 
and repealing Council Directiv es 79/117/EEC and 91/414/ EEC1, and in parti cular 
Article  78(1)(b) t hereof,  
Whereas:  
(1) Commission Regulation (EU) No 283/20132 lays down data requirements for active 
substances . For active substances that are chemicals , these are laid down  in Part A  of 
the Annex  to that Regulation , and for active substances that are  micro -organisms , 
these are laid down  in Part B  of that Annex , with common requirements set out in the 
introductory part of that Annex . 
(2) The Farm to Fork Strategy  for a fair, healthy and environmentally -friendly food 
system3 aims at reducing dependency  on and use of chemical plant protection 
products, including through facilitat ing the placing  on the market of biological active 
substances  such as micro -organisms. In order to reach those objectives, it is necessary 
to specify  the data requirements related to micro -organisms  taking into account the 
most up -to-date scientific and technical knowledge , which has evolved significantly.  
(3) The currently available scientific knowledge concerning metabolites produced by 
micro -organisms allows for a better understanding of the role those metabolites play in 
the mode of action of micro -organisms  producing them . Taking into consideration that 
metabolites produced by micro -organisms are chemical substances, their possible 
contribution to the mode of action may lead to legal uncertainty on whether 
applications are to comply with the requirements provided for in Part A of that Annex 
concerning chemic al active substances, or in Part  B thereof, concerning micro -
organisms . It is therefore appropriate to amend the introduction of the Annex to 
Regulation (EU) No  283/2013 , in order to better specify, based on the properties of the 
                                                 
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 283/2013 of 1 March 2013 setting out t he data requirements for active 
substances, 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). 
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 f ood system (COM/2020/381 final, https://eur -lex.europa.eu/legal -
content/en/TXT/?qid=1590404602495&uri=CELEX:52020DC0381 ). EN 2  EN active substances , and in particular of the metabolites produced by micro -organisms , 
when applications are to comply with the requirements provided for in Part A of that 
Annex, or in Part  B thereof .   
(4) Since  micro -organisms are living organisms, a specific approach is needed compare d 
to chemical substances , in order to also take  into account the new scientific knowledge 
that has emerged on the biology of micro -organisms . That scientific knowledge  
consists in new information on key characteristics of micro -organisms, such as their 
pathogenicity and infectivity, the possible production of metabolite(s) of concern and 
the capacity to transfer antimicrobial resistance genes to other micro -organisms which 
are pathogenic and occurring  in European environments, potentially affecting the 
effectiveness of antimicrobials used in human and veterinary medicine .  
(5) The current  state of scientific knowledge  on micro -organisms  allows for a better and 
more specific approach for their assessment,  which is based on  their mode of action 
and the ecological characteristics of the respective species and, where applicable , the 
respective strains  of micro -organisms . As it allows for a more targeted risk 
assessment, such scientific knowledge should be taken into account when assessing 
the risks posed by active subs tances that are micro -organisms . 
(6) In order to better  reflect the latest scientific developments and the specific  biological 
properties of mi cro-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 data requirements accordingly . 
(7) In general, micro -organis ms used for plant protection are active a gainst a specific 
group of pests , and t heir specific mode s of action may intrinsically not be of relevance 
as regards effects on  human and animal health. They may well produce metabolites 
that would require specific exposure and risk assessment . Their host-specificity may 
well limit the risk of persistent effects on non -target organisms, compared to chemical 
substances , reducing also the relevance of animal testing to establish their pathogenic 
profile . All these specific characteristics  of micro -organi sms are important to 
differentiate the way to conduct the  risk assessment  for micro -organisms compared to 
the way it is being done for chemical substances . It is therefore appropriate to amend 
Part B of the Annex to Regulation (EU) No 283/2013 in order to update the data 
requirements to the latest scientific developments and adapt them to the  specific 
biological properties of micro -organisms.  
(8) The current title of Part B of the Annex to Regulation (EU) No 283 /2013 refers to 
micro -organisms including viruses.  However, Article 3 , point (15) of Regulation (EC) 
1107/2009 already defines viruses as belonging to the group of micro -organisms. It is 
therefore appropriate to adapt  that title to be consistent with Article 3 , point (15) of 
that Regulation .  
(9) It is approp riate to introduce a definition of ‘Microbial Active Substance as 
Manufactured’ (‘MASAM’) because certain tests are required to be performed using  a 
sample of the MASAM, rather than using the active substance or the other components 
of the MASAM after purification . It is indeed more appropriate  to refer, with one 
unique term, to the micro -organism as manufactured and to those components  
included in the manufacturing batch which might be of  relevan ce for the risk 
assessment, such as relevant contaminating mi cro-organisms and relevant impurities.   
(10) New scientific knowledge has emerged on the capacity of micro -organisms to transfer 
antimicrobial resistance genes to other micro -organisms which are pathogenic and EN 3  EN occurring in European environments, potentially affecting the effectiveness of 
antimicrobials used in human and veterinary medicine . This new scientific knowledge  
allows for a better and more specific approach for the assessment  of which genes 
encoding for antimicrobial resistance are likely to be trans ferred to other micro -
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 specific ation is needed  on the d ata requirements to 
implement the most up -to-date scientific and technical knowledge  on transferability of 
antimicrobial resistance , and allow 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.  
(11) A reasonable period should be allowed to elapse before the amended  data 
requirements become applicable in order to permit  applicants to prepare themselves to 
meet those requirements.  
(12) In order to permit Member States and interested parties to prepare themselves to fulfil  
the new requirements, it is appropriate to lay down transitional measures concerning 
data submitted for applications for the approval, renewal of approval or amendment to 
the conditions of approval of active substances that are micro -organisms and data 
submitted for applications for authorisation, renewal of authorisation and amendment 
to the authorisation of plant protection products  containing active substances that are 
micro -organisms . 
(13) The measures provided for in this Regulation are in accordance with t he opinion of 
the Standing Committee,  on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Amendments to Regulation (EU) No 283/2013  
The Annex to Regulation (EU) No 283/2013 is amended as follows:  
(1) the Introduction  is replaced by the text set out in Annex I to this Regulation ; 
(2) Part B is replaced by the text set out in Annex II to this Regulation . 
Article 2 
Transitional measures as regards  certain  procedures concerning active substances  that 
are micro -organisms  
1. Applicants may submit data in accordance with Part B of the Annex to Regulation 
(EU) No 283/2013  as it stood before being amended by this Regulation in the 
following cases:   
(a) procedures concerning the approval of an active substance that is a micro -
organism or an amendment to the approval of such a substance for which the 
dossiers provided for in Article 8(1) and (2)  of Regulation (EC) No 1107/2009 
are submitted before  … [one y ear after the day of entry into force of this 
Regulation] ;  
(b) procedures concerning the renewal of approval of an active substance that is a 
micro -organism where the application for renewal referred to in Article 5 of EN 4  EN Commission Implementing Regulation (EU) 2020/17404 is submitted before 
[one year after the date of entry into force of this Regulation ]. 
2. Where a pplicants choose to apply the option  provided for in paragraph 1 , they  shall 
specify that choice  in writing when submitting the application  concerned. S uch 
choice shall be irrevocable for the procedure concerned.  
Article 3  
Transitional measures as regards certain procedures concerning plant protection 
products  contain ing active substance s that are micro -organisms  
1. For authorisation of plant protection products, within the meaning of Regulation 
(EC) No  1107/2009, containing one or more active substances that are micro -
organisms, where  the dossiers have been submitted in accordance with Article 2 of 
this Regulation or a decision on the renewal of the app roval has not been taken in 
accordance with Article  20 of Regulation (EC) No  1107/2009  on the basis of Part B 
of the Annex to this Regulation , applicants:  
(a)  shall submit data in accordance with Part B of the Annex to Regulation (EU) 
No 283/2013 as it stood before being amended by this Regulation, unless they 
act in accordance with point (b) of this paragraph;  
(b)  may choose, from … [ 6 months after the date of entry into force of this 
Regulation ] to submit data in accordance with Part B of the Annex to 
Regulati on (EU) No 283/2013 as amended by this Regulation.  
2. Where applicants choose to apply the option provided for in paragraph 1(b), they 
shall specify that choice in writing when submitting the application concerned. Such 
choice shall be irrevocable for the pr ocedure concerned.  
Article 4 
Entry into force and 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  … [ 6 months after the date of entry into force  of this Regulation] . 
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  
                                                 
4 Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 setting out the provisions  
necessary for the implementation of the renewal procedure for active substances, as provided for in 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and rep ealing 
Commission Implementing Regulation (EU) No 844/2012  (OJ L 392, 23.11.2020, p.  20).