EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10686/2021  
[…](2021) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 1107/2009 as regards specific criteria for the 
approval of active substances that are micro -organisms  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 1107/2009 as regards specific criteria for the 
approval of active substances that are 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 O ctober 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  22(3) and 78(1)(a) thereof,  
Whereas:  
(1) Regulation (EC) No 1107/2009 lays down , among others,  rules for the procedure and 
criteria for the approval of active substances, safeners and synergists.  
(2) The Farm to Fork Strategy for a fair, healthy and environmentally friendly food 
system of the Commission2 aims at reduc ing dependenc y on 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 approval criteria related to micro -organisms taking into account  the most 
up-to-date scientific and technical knowledge , which has evolved significantly.   
(3) The existing procedures and criteria for the approval set out in Annex II to Regulation 
(EC) 1107/2009,  which are used to assess whether active substances may have 
harmful effects on human health, animal health, or unacceptable effects on the 
environment, are referring to the properties of micro -organisms. Since  micro -
organisms are living organisms, a specific approach is needed compar ed to chemical 
substances , in order to also take   into account the currently available  scientific 
knowledge that has been gather ed on the biology of micro -organisms, such as on their 
pathogenicity and infectivity, the possible production of metabolite(s) of concern and 
the capacity to transfer anti -microbial 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.  
(4) The current state of scientific knowledge  on micro -organisms allows for a better and 
more specific approach for the ir assessment, which  is based on the biological and 
ecological characteristics of the respective species and, where applicable, 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 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 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 substances that are micro -organisms and plant protection 
products containing thes e substances . 
(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 accordi ngly the  
criteria  in Annex II to Regulation (EC) No 1107/2009 . 
(6) Point 3.1(b) of Annex II to Regulation (EC) No 1107/2009 provides for  the 
information to be submitted by the applicant in the dossier in order  to reliably  predict 
residues in food and feed. Based on the available  scientific knowledge, it is now 
known that  residues for which an assessment is required in the case of micro -
organisms are different than those needed to assess chemical active substances : the 
presence of  micro -organisms that are non-pathogenic to humans and animal s onto or 
into edible parts of treated crops does not constitute per-se a hazard  and only residues 
of chemical substances which  are relevant for human and animal health  may constitute 
a hazard or risk, i.e. the  toxic metabo lites possibly  produced by the micro -organisms . 
For the sake of clarity , it is therefore appropriate to provide  for this differentiation, so 
that it is possible to reliably predict relevant residues in relation to micro -organisms . 
(7) Point 3.4 of Annex II to Regulation (EC) No 1107/2009 refers to the composition of 
active substances, safeners or synergists . However, the current provisions do not apply 
for micro -organisms due to their different nature compared to chemicals. Indeed, the 
concepts of isomers and d iastereo -isomers mentioned in the current provision are only 
relevant for chemical substances and not for any living organism, including micro -
organisms. Moreover, it is necessary to specify the appropriate information required to 
define the composition of  an active substance that is a micro -organism, such as the 
taxonomical identification, the deposition of the micro -organism strain at an 
internationally recognised culture collection including its accession number, and the 
content of the active substance i n units which used in microbiology.  It is therefore 
appropriate to specify this suitable information for micro -organisms.  
(8) Point 3.5 of Annex II to Regulation (EC) No 1107/2009 refers to methods of analysis 
of active substances and other components occurrin g in the manufactu ring batch . 
Currently available  scientific knowledge inludes knowledge regarding the risk 
assessment of  relevant impurities and contaminating micro -organisms occurring 
during manufacturing of micro -organisms, and on metabolites  produced by them. In 
addition,  due to the different nature of active substances which are micro -organisms 
compared to chemicals, manufacturing batches and processes are different, and a 
specific approach is needed for micro -organisms compared to chemicals . Taking into 
consideration  this scientific knowledge and these differences between actives 
substances which are micro -organisms and chemicals, i t is therefore appropriate to 
specify methods of analysis used for micro -organisms .  
(9) Point 3.6 of Annex II to Regulation (EC) No 1107/2009 refers to  the assessment of the 
impact  of active substances , safeners and synergists  on human health . As regards 
active substances that are micro -organisms, currently available scientific knowledge 
includes knowledge regarding  the assessment of pathogenicity of micro -organisms to 
humans and infectivity of viruses  and the capacity of bacteria to transfer anti -microbial 
resistance genes to other micro -organisms, potentially affecting the effectiveness of 
antimicrobials used in huma n and veterinary medicine  has been collected . This EN 3  EN scientific knowledge  show s that further specific ation is needed  regarding  the approval 
criteria laid down in Article 4 of Regulation  (EC) No 1107/2009 , implementing the 
most up -to-date scientific and technical knowledge  in the risk assessment of micro -
organisms . It is therefore appropriate to specify the approval criteria applying for 
micro -organisms.  
(10) Specifically on anti-microbial resistance , the current state of scientific knowledge on 
the capacity of micro -organisms to transfer antimicrobial resistance genes 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 micro -organisms, and 
which antimicrobi als 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 data requirements to implement the 
most up -to-date scie ntific and technical knowledge  on transferability of antimicrobial 
resistance , and to allow 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) Point 5.2.1 of Annex II to Regulation (EC) No 1107/2009 sets out the  criteri a for 
considering  active substance s that are  micro -organism s as low -risk active substances 
and currently refers to  the possible occurrence of multiple resistance to antimicrobials . 
Without any reference to the possibility of this resistance to be transferred, th ese 
criteri a refer to the number of treatment options with antimicrobials which are 
effective  against  the active substance that is a micro -organism . Indeed, although  
micro-organisms can only be approved if not pathogenic, no t infective under the 
recommended conditions of  use, and not infective to humans under  any circumstances 
if they are viruses, it is necessary to ensur e that a certain number of treatment option s 
with effective antimicrobials are available in order to  maintain a high level of 
protection of human health  in the unlikely event of an opportunist ic infection , 
especially  in vulnerable groups of the population . However , the possible occurrence of 
multiple  resistance to a certain number of antimicrobials as currently outlined in point 
5.2.1 does not clarif y the number of effective  treatment options based on 
antimicrobials  which are available . It is therefore appropriate to specify the low -risk 
criteria applying for bacteria and fungi.  For the sake of clarity and legal certainty, i t is 
therefore  appropriate to further specify  the criter ia to consider an active substance  that 
is a micro -organism  as low-risk active substance , by referring to the number of 
antimicrobial agents against which the micro -organism is demonstrated susceptible. In 
addition, it is appropriate to specify that such criteri a apply only for  bacteria and fungi  
and not for viruses, since viruses are usually provided by a narrow host range, and 
viruses which are infective to humans would be excluded from approval . 
(12) Point 5.2.2 of Annex II to Regulation (EC) No 1107/2009 sets out the criteri a to 
consider baculoviruses  as low -risk active substances . However, new applications for 
approval concerning  viruses belonging to species other than the baculovirus species, 
and used as active substances in plant protection products  have been submit ted. It is 
therefore  appropriate to include low -risk criteri a which are applicable also to other 
species of viruses.  In addition, the currently available  scientific knowledge on viruses 
used as active substances in plant protection products , in particular for those  viruses 
which are non -virulent variants of plant pathogens  makes it possible  to identify those 
active substances  which  may be approved only where, under the proposed conditions 
of use, the likelihood of regaining virulence and causing adverse eff ects in target and EN 4  EN non-target plants through mutation is negligible. In light of this concern, it is 
appropriate to provide that viruses which are non -virulent variants of plant pathogens 
are not to be considered as low -risk active substances when the like lihood of regaining 
virulence and causing adverse effects in target and non -target plants  could not  be 
entirely excluded, i.e. through further genomic analysis . It is therefore appropriate to 
specify the low -risk criteria applying to these viruses other than baculovirus . 
(13) As the amended criteria reflect the current state of scientific and technical knowledge 
and clarify the existing criteria , the new criteria should apply as soon as possible  
however in for legal certainty a transitional regime needs to be provided for in this 
Regulation.  
(14) 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  
Amendment to Regulation (EC) No 1107/2009  
Regulation (EC) No 1107/2009 is amended in accordance with the Annex to this Regulation.  
Article 2 
Transitional measures  
Regulation (EC) No 1107/2009 in the version applicable on [date prior to the date of 
application of this act] shall continue to apply 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 substances for which the dossiers  
provided for in Article 8(1) and (2) of Regulation (EC) No 1107/2009 were  
submitted before [the date of application of this act] ; 
(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 Commission 
Regulation (EU) 2020/1740 was submitted before [the date of application of this act] . 
Article 3 
Entry into force and application  
This Regulation shall enter into force on the twentieth day following that of its publi cation in 
the Official Journal of the European Union . 
It shall apply  from [Office of publications: please insert 6 months after the entry into force ]. 
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