 
EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/2195  
[…](2023) XXX  draft  
ANNEXES 1 to 3  
 
ANNEXES  
to the  
COMMISSION REGULATION (EU) …/…  
 
defining data requirements for the approval of safeners and synergists and establishing 
a work programme for the gradual review of safeners and synergists on the market, in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council    
EN 1  EN ANNEX I  
 
List of safeners and synergists included in the work programme for gradual review as 
referred to in Article 6(3)  
 
 
Safeners  RMS  Co-RMS  
     
     
     
     
     
     
    
 Synergists  RMS  Co-RMS  
    
    
    
    
    
    
 
 
 
 
 
  
EN 2  EN ANNEX II 
Content of notification of interest to apply for the approval of a safener or synergist as 
referred to in Article 4(1) 
1. Identification data on the notifying party:  
1.1. manufacturer of the substance (name, address, including location of plant);  
1.2. notifying company  (name, address, etc.) (if different from 1.1):  
1.2.1.  acting as sole representative designated by the manufacturer?:  Yes / No;  
1.3. Identification of the contact person responsible for the notification and further 
engagements:  
1.3.1.  Name;  
1.3.1.1.  Postal address;  
1.3.1.2.  Email;  
1.3.1.3.  Primary ph one number;  
1.3.1.4.  Alternative phone number.  
2. Identification of the safener or synergist:  
2.1. name of the safener or synergist;  
2.2. CAS number safener or synergist;  
2.3. EC number safener or synergist.  
 
 
ANNEX III  
Supplementary data requirements for submission of applications for the approval of 
safeners and synergists  as referred to in Article 9(1), points ( a) and ( b) 
1. A description of the intended purpose of the use of the safener or synergist and the 
dose and manner of their use or proposed use.  
2. An evaluation of the nature and extent of benefits that accrue from the presence of 
the safener or synergist following use of the plant protection product, in comparison 
to an untreated control and in comparison to the use of the same plant protection 
product not containing the safener or synergist .  
3. Reports in summary form of preliminary tests, including glasshouse and field studies, 
used to assess the activity or dose range finding of the safeners or synergists 
contained in a plant protection product,  when requested by the competent authority. 
These reports must provide additional information for the competent authority in 
order to justify the recommended dose of the safener or synergist, and when several 
are used their ratio.  
4. sufficient information to per mit an evaluation of the level, duration and consistency 
of control or protection or other intended effects of the plant protection product.  
4.1. In case of safeners, the following three types of studies:   
EN 3  EN (a) an investigation of the effects of a treatment on a rep resentative use with a 
plant protection product containing the relevant safener in relation to the 
control of the target organism and effect on the treated plants or plant products;  
(b) an investigation of the effects of a treatment on a representative use with the 
same plant protection product without the relevant safener in relation to the 
control of the target organism and effect on the treated plants or plant products 
in order to prove that the safener eliminates or reduces phytotoxic effects of the 
plant protection product;  
(c) an investigation of the effects of a treatment on a representative use with the 
same plant protection product containing the relevant safener but no active 
substance in order to prove that the safener has no efficacy on its own.  
4.2. In ca se of synergists, the following three types of studies:  
(a) an investigation of the effects of a treatment on a representative use with a 
plant protection product containing the relevant synergist in relation to the 
control of the target organism and effect on  the treated plants or plant products;  
(b) an investigation of the effects of a treatment on a representative use with the 
same plant protection product without the relevant synergist in relation to the 
control of the target organism and effect on the treated plants or plant products 
in order to prove that the synergist increases the efficacy of the product against 
the treated pests;  
(c) an investigation of the effects of a treatment on a representative use with the 
same plant protection product containing the rele vant synergist but no active 
substance in order to prove that the synergist has no efficacy on its own.  