EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12042/2020  
[…](2021) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) No 284/2013 as regards the information to be submitted for 
plant protection products and the specific data requirements for plant protection 
products containing micro -organisms  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) No 284/2013 as regards the information to be submitted for 
plant protection products and the specific data requirements for 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 1107/20 09 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  78(1) , point (b), thereof,  
Whereas:  
(1) Commission Regulation (EU) No 284/20132 lays down  the data requirements for plant 
protection products containing active substances . For plant protection products 
containing active substances that  are chemicals , these are laid down  in Part A of the 
Annex  to that Regulation , and for plant protection products containing active 
substances that are  micro -organism s, 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 facilitating 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 plant protection products containing  micro -
organisms  taking into account  the most up -to-date scientific and technical knowledge 
which has evolved significantly.  
(3) Currently available  scientific knowledge on plant protection products containing 
micro -organisms , in particular concerning effectiveness, efficacy, relevance of 
impurities, and toxicity of certain chemical substances which may be present in these 
plant  protection products , triggers the need  to better specify  certain definitions which 
                                                 
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  284/2013 of 1  March 2013 setting 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 prod ucts on the market Text ( OJ L 93, 
3.4.2013, p.  85). 
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 
environmenta lly-friendly food system (COM/2020/381 final, https://eur -lex.europa.eu/legal -
content/en/TXT/?qid=1590404602495&uri=CELEX:52020DC0381 ). EN 2  EN apply for Part B  of the Annex to Regulation (EU) No  284/2013 . Taking into 
consideration that these definitions apply also to Part A  of that Annex , concerning 
plant protection p roducts containing chemical active substances,  it is appropriate to 
amend  the introduction of the Annex to Regulation (EU) No  284/2013 . 
(4) Since micro -organisms are living organisms, a specific approach is needed compared 
to chemical substances , in order to also take  into account the n ew 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 possib le 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 hu man and veterinary medicine .  
(5) The current  state of  scientific knowledge on plant protection products containing 
micro -organisms allows for a better and more specific approach for the ir assessment,  
which is based on  the mode of action and ecological charact eristics 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 plant protection  products containing  micro -
organisms .  
(6) In order to better reflect the latest scientific developments and the specific  biological 
properties of plant protection products containing micro -organisms, while maintaining 
a high level of protection of human and a nimal health and of the environment , it is 
therefore necessary to adapt accordingly the existing data requirements . 
(7) It is appropriate to amend Part B of the Annex to Reg ulation  (EU) No 284/2013, in 
order to update the data requirements to the latest scient ific 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 284/2013  refers to 
plant protection products containing  micro -organisms including viruses. However, 
Article 3 , point (15), of Regulation (EC)  No 1107/2009 already defines viruses as 
belonging to the group of micro -organisms. It is appropriate to be consistent with 
Article 3, point (15), of that Regulation , and therefore there is no need to refer to 
virus es separately . 
(9) It is appropriate 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 compone nts 
of the MASAM after purification. It is indeed more appropriate to refer, with a unique 
term, to the micro -organism as manufactured and to those components included in the 
manufacturing batch which might be of relevance for the risk assessment, such as 
relevant contaminating micro -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 
occurring in European envi ronments, potentially affecting the effectiveness of 
antimicrobials used in human and veterinary medicine . This new scientific knowledge  
allows a better and more specific approach for the assessment  of which genes 
encoding for antimicrobial resistance are likely to be transferred to other micro -
organisms, and which antimicrobials are those relevant for human and veterinary 
medicine. In addition, the Farm to Fork Strategy has set antimicrobial resista nce-EN 3  EN related targets. Therefore, further specification is needed on the data requirements to 
implement the most up -to-date scientific and technical knowledge on transferability of 
antimicrobial resistance, and allow an assessment to be made on whether the a ctive 
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 . 
(11) A reasonable period should be allowed to elapse before the amended  data 
requirements become ap plicable 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 meet 
the amended  requirements, it is appropriate to lay down transitional measures 
concerning 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 , and concerning data submitted on the 
representative u ses of plant protection products submitted in the context of 
applications for the approval, renewal of approval or amendment to the conditions of 
approval of active substances that are micro -organisms.  
(13) The measures provided for in this Regulation are in ac cordance with the opinion of the  
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Amendments to Regulation (EU) No 284/2013  
The Annex to Regulation (EU) No 284 /2013 is amended as follows:  
(a) the Introduction  is replaced by the text set out in Annex I to this Regulation ; 
(b) Part B is replaced by the text set out in Annex II to this Regulation.  
Article 2 
Transitional measures  as regards certain procedures concerning plant protection 
products contain ing active subs tances that are micro -organisms  
1. Applicants shall  submit data , in the context of  applications 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 , in accordance with Part B of 
the Annex to Regulation (EU) No 284 /2013 as it stood before being amended by this 
Regulation in the following cases:  
(a) the application for authorisation is submitted by … [2 years and 6 months after the 
date of entry into force of this Regulation];  
(b) the dossiers for all the active substances contained in the plant protection product 
concerned have been submitted in accorda nce with Regulation (EU) No 283/2013  as 
it stood before being amended by Commission  Regulation  XXX4 [PO: please, insert 
number for Implementing Regulation amending Regulation (EU) No 283/2013 and a 
footnote with reference].  
                                                 
4 Commission Reg ulation  …. (OJ L…, p. …).  EN 4  EN 2. As a derogation from paragraph 1, applicants  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 Regulation (EU) No 284/2013 as amended by this Regulation.  
3. Where applicants make the choice provided fo r in paragraph 2, they shall specify that 
choice in writing when submitting the application concerned. Such choice shall be 
irrevocable for the procedure concerned.  
Article 3 
Transitional measures as regards certain procedures concerning active substances  that 
are micro -organisms  and are contained in plant protection products  
Regulation (EU) No  284/2013 as it stood before being amended by this Regulation shall 
continue to apply as regards data  required on one or more representative uses of a plant 
protection product, submitted before …  [6 months after the date of entry into force  of this 
Regulation ] to fulfil  the requirements of one of the following provisions:  
(a) Article 8(1) , point (a), of Regulation (EC) No 1107/2009 ;  
(b) Article  7(1), point (c), of Commission Implementing Regulation (EU) No  844/20125;  
(c) Article 6(2) , point (c), of Commission Impleme nting Regulation (EU) 2020/17406.   
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 the Member 
States in accordance with the Treaties.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN  
                                                 
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 active 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).  
6 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 repealing 
Commission Implementing Regulation (EU) No 844/2012 (OJ L 392, 23.11.2020, p. 20 ).