EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10686/2021  
[…](2021) XXX  draft  
ANNEX 1  
 
ANNEX  
to the  
COMMISSION REGULATION (EU) .../...  
amending Annex II to Regulation (EC) No 1107/2009 as regards specific criteria for the 
approval of active substances that are micro -organisms    EN 1  EN ANNEX  
Annex II to Regulation (EC) No 1107/2009  is amended as follow s:  
(1) Point 3.1 (b) is replaced by the following:  
‘(b) reliably predict the residues in food and feed, including succeeding crops , on the 
basis of testing carried out in accordance with the data requirements for active 
substances ;’; 
(2) Point 3.4 is replaced by the following:  
‘3.4.  Composition of the active substance, safener or synergist  
3.4.1.  For c hemical active substances, safeners and synergists , the specification shall define 
the minimum degree of purity, the identity and maximum content of impurities and, 
where relevant, of isomers/ diastereo -isomers and additives, and the content of  
impurities of toxicological, ecotoxicological or environmental concern within 
acceptable limits.  
3.4.2.  For c hemical active substances, safeners and synergists , the specification shall be in 
compliance with the relevant Food and Agriculture Organisation s pecification as 
appropriate, where such specification exists. However, where necessary for reasons 
of protection of human or animal health or the environment, stricter specifications 
may be adopted.  
3.4.3. Active substances that are micro -organisms shall be deposited at an internationally 
recognised culture collection and shall have an accession number. The s pecies ’ name 
of the micro -organisms shall be identified unequivocally , based on the latest 
scientific information, and the micro -organisms  shall be na med at the strain level, 
including any other designation which may be relevant (e.g. isolate level, if relevant 
for viruses). It shall  be indicated whether or not the micro -organism s arewild type s, 
spontaneous or induced mutant s, or genetically modified or ganism s. 
3.4.4. For a ctive substances that are micro -organisms , the specification shall define the 
minimum and maximum content of the micro -organism, the identity and content of 
relevant contaminating micro -organisms, metabolites of concern and impurities of 
toxicological, ecotoxicological or environmental concern within acceptable limits .’; 
(3) Point 3.5  is replaced by the following:  EN 2  EN ‘3.5.  Methods of analysis  
3.5.1.  The methods of analysis of chemical  active substance s, safener s or synergist s as 
manufactured and of determination of impurities of toxicological, ecotoxicological or 
environmental concern or which are present in quantities greater than 1 g/kg in the 
active substance, safener or synergist as manufactured, shall have been validated and 
shown to be sufficiently specific, correctly calibrated, accurate and precise.  
3.5.2.  The methods of residue analysis for chemical  active substance s and relevant 
metabolites in plant, animal and environmental matrices and drinking water, as 
appropriat e, shall have been validated and shown to be sufficiently sensitive with 
respect to the levels of concern.  
3.5.3.  The evaluation shall have been carried out in accordance with the uniform principles 
for evaluation and authorisation of plant protection products referred to in 
Article  29(6).  
3.5.4. For a ctive substances that are micro -organisms , the methods of analysis to identify 
and quantify them , and relevant contaminating micro -organisms , shall have been 
validated and shown to be sufficiently specific, correctly calibrated, accurate and 
precise.  
3.5.5. For a ctive substances that are micro -organisms , the methods of determination of 
metabolites of concern and relevant impurities shall have been validated and shown 
to be sufficiently specific, correctly cal ibrated, accurate and precise. ’; 
(4) The following point 3.6.6 is added after point 3.6.5 : 
‘3.6.6.  Active substances that are micro -organisms  shall only be approved if, on the basis of 
the assessment carried out on the information provided in accordance with the data 
requirements , it is concluded that the strain of the micro -organism is not pathogenic 
to humans;  
In addition:  
(a) viruses shall only be approved  if, on the basis of the assessment carried out on 
the information provided in accordance with the data re quirements , it is 
concluded that the isolate of the virus is not infective to humans;  
(b) strains of bacteria  shall only be approved  if, on the basis of the assessment 
carried out on the information provided in accordance with the data 
requirements , it is conc luded that they do not have a ny known, functional and 
transferrable gene coding for resistance to relevant antimicrobial agents as 
defined in accordance with the data requirements .’; 
(5) Point 5.2 is replaced by the following:  
‘5.2. Micro -organisms  
5.2.1.  An active substance that is a bacteri um or a fung us shall  be considered a  low-risk 
active substance unless its susceptibility to at least two classes of antimicrobial 
agents has not been demonstrated . 
5.2.2.  An active substance that is a virus shall be con sidered a  low-risk active substance 
unless  either of the following applies :  
(a) It is a baculovirus with  demonstrated adverse effects on non -target insects ;  
(b) It has demonstrated adverse effects on  non-target plants .’.