EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10590/2021 Rev. 0  
[…](2021) XXX  draft  
ANNEXES 1 to 2  
 
ANNEXES  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) .../...  
renewing the approval of the active substance cypermethrin as a candidate for 
substitution 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, and amending the Annex to Commission Implementing Regulation (EU) 
No 540/2011    
EN 1  EN ANNEX I 
Common Name,  
Identification 
Numbers  IUPAC Name  Purity1 Date of approval  Expiration of 
approval  Specific provisions  
Cypermethrin  
CAS No 52315 -07-8 
CIPAC No 332   (RS) -α-cyano -3-
phenoxybenzyl 
(1RS,3RS;1RS,3SR)
-3-(2,2-
dichlorovinyl) -2,2-
dimethylcyclopropan
ecarboxylate  
or 
 (RS) -α-
cyano -3-
phenoxybenzyl -
(1RS) -cis-trans -3-
(2,2-dichlorovinyl) -
2,2-
dimethylcyclopropan
ecarboxylate  920 g/kg  
cis:trans  : 
40/60 to 
60/40  
 
 
The 
following 
impurities 
are of 
toxicologic
al concern 
and must 
not exceed 
the 
following 
levels in the 
technical 
material:  
 
hexane :  
5g/kg  1 February 2022  31 January   2029 Authorisations sh all be limited to professional users.  
 
When authorising plant protection products containing cypermethrin for spray 
applications outdoors, in order to ensure the protection of non -target organisms, 
in particular aquatic organisms and non -target arthropods, including bees:  
 risk mitigation measures ac hieving reduction of drift shall be required that 
lead to exposure ≤5.8 mg as.s/ha in off -crop areas and, in addition, for 
spring applications to concentrations in water bodies ≤ 0.0038 µg a.s./L,  
 only uses outside flowering of the crop and when no flower ing weeds are 
present may be authorised.  
 
For the implementation of the uniform principles, as referred to in Article  29(6) 
of Regulation (EC) No  1107/2009, the conclusions of the re newal  report on 
cypermethrin , and in parti cular Appendices I and II there to, shall be taken into 
account.  Member States shall pay particular attention to:  
- the protection of aquatic organisms, non -target arthropods, including bees;  
- the consumer risk assessment;  
- the technical specification of the active substance used in plant p rotection 
products.  
Where considered appropriate, Member States shall  set monitoring requirements 
when granting authorisations in accordance with Article 6(i) of the Regulation 
(EC) No  1107/2009 , in order to complement the monitoring under Directive 
2000/ 60/EC  and Directive 2009/128/EC.  
 
The applicant shall submit to the Commission, the Member States and the 
Authority confirmatory information as regards:  
1. the toxicological profile of the metabolites bearing the 3 -phenoxybenzoyl 
moiety;  
                                                 
1 Further details on the identity and the specification of the active substance are provided in the re newal  report .  
EN 2  EN Common Name,  
Identification 
Numbers  IUPAC Name  Purity1 Date of approval  Expiration of 
approval  Specific provisions  
2. the relative toxicity of individual cypermethrin isomers, in particular the 
enantiomer (1S cis αR);  
3. the effect of water treatment processes on the nature of residues present in 
surface and groundwater, when surface water or groundwater is abstracted 
for drinking wat er. 
4. Points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as 
amended by Regulation (EU) 2018/605 . 
 
The applicant shall submit:  
- the information referred to in point 1 by [ publication office, please insert 
date corresponding to 1 year from t he date of entry into force of this 
Regulation ]; 
- the information referred to in point 2 by [ publication office, insert date 
corresponding to 2 years from the date of entry into force of this 
Regulation ]; and  
- the information referred to in point 3 within two years from the date of 
publication, by the Commission, of a guidance document on evaluation of 
the effect of water treatment processes on the nature of residues present in 
surface and groundwater.  
 
As regards Points 3.6.5 and 3.8.2 of Annex II to Regul ation (EC) No 1107/2009, 
as amended by Regulation (EU) 2018/605  an updated assessment of the 
information already submitted and, where relevant, further information to 
confirm the absence of endocrine activity shall be submitted by [publication 
office, inse rt date corresponding to two years from the date of entry into force of 
this Regulation ]  
EN 3  EN ANNEX II 
The Annex to Commission Implementing Regulation (EU) No 540/2011  is amended as follows:  
(1) in Part A, entry 103 on cypermethrin  is deleted;  
(2) in Part E, the following entry is added:  
No. Common Name,  
Identification 
Numbers  IUPAC Name  Purity1 Date of approval  Expiration of 
approval  Specific provisions  
‘XX Cypermethrin  
CAS No 52315 -07-8 
CIPAC No 332   (RS) -α-cyano -3-
phenoxybenzyl 
(1RS,3RS;1RS,3SR)
-3-(2,2-
dichlorovinyl) -2,2-
dimethylcyclopropan
ecarboxylate  
or 
 (RS) -α-
cyano -3-
phenoxybenzyl -
(1RS) -cis-trans -3-
(2,2-dichlorovinyl) -
2,2-
dimethylcyclopropan
ecarboxylate  920 g/kg  
cis:trans : 40/60 
to 60/40  
 
 
The following 
impurities are of 
toxicological 
concern and 
must not exceed 
the following 
levels in the 
technical 
material:  
 
hexane :  5g/kg  1 February 2022  31 January  2029 Authorisations shall  be limited to professional users.  
 
When authorising plant protection products containing 
cypermethrin for spray applications outdoors, in order to ensure the 
protection of non -target organisms, in particular aquatic organisms 
and non -target arthropods, including bees:  
 risk mitigation measures achieving redu ction of drift shall be 
required that lead to exposure ≤5.8 mg as.s/ha in off -crop areas 
and, in addition, for spring applications to concentrations in 
water bodies ≤ 0.0038 µg a.s./L,  
 only uses outside flowering of the crop and when no flowering 
weeds ar e present may be authorised.  
 
For the implementation of the uniform principles, as referred to in 
Article 29(6) of Regulation (EC) No  1107/2009, the conclusions of 
the re newal  report on cypermethrin , and in parti cular Appendices I 
and II thereto , shall be  taken into account.  Member States shall pay 
particular attention to:  
- the protection of aquatic organisms, non -target arthropods, 
including bees;  
- consumer risk assessment;  
- the technical specification of the active substance used in plant 
protection produc ts. 
Where considered appropriate, Member States shall set monitoring  
requirements when granting authorisations in accordance with 
Article 6(i) of the Regulation (EC) No  1107/2009 , in order to 
complement the monitoring under Directive 2000/60/EC  and 
Directive 2009/128/EC.  
                                                 
1 Further details on the identity and the specification of the active substance are provided in the re newal  report .  
EN 4  EN No. Common Name,  
Identification 
Numbers  IUPAC Name  Purity1 Date of approval  Expiration of 
approval  Specific provisions  
The applicant shall submit to the Commission, the Member States 
and the Authority confirmatory information as regards:  
 
1. the toxicological profile of the metabolites bearing the 
3-phenoxybenzoyl moiety;  
2. the relative toxic ity of individual cypermethrin isomers, in 
particular the enantiomer (1S cis αR);  
3. the effect of water treatment processes on the nature of residues 
present in surface and groundwater, when surface water or 
groundwater is abstracted for drinking water . 
4. Points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) 
No 1107/2009, as amended by Regulation (EU) 2018/605   
 
The applicant shall submit : 
- the information referred to in point 1 by [ publication office, 
please insert date corresponding to 1 year from the date of 
entry into force of this Regulation ];  
- the information referred to in point 2 by [ publication office, 
insert date corresponding to 2 years from the date of entry into 
force of this Regulation ]; and  
- the information referred to in point 3 within two years from the 
date of publication, by the Commission, of a guidance 
document on evaluation of the effect of water treatment 
processes on the nature of residues present in surface and 
groundwater.  
 
As regar ds Points 3.6.5 and 3.8.2 of Annex II toRegulation (EC) 
No 1107/2009, as amended by Regulation (EU) 2018/605  an 
updated assessment of the information already submitted and, 
where relevant, further information to confirm the absence of 
endocrine activity shall be submitted by  [publication office, insert 
date corresponding to two years from the date of entry into force of 
this Regulation ]’