EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12066/2020  
[…](2021) XXX  draft  
ANNEXES 1 to 2  
 
ANNEXES  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) .../...  
renewing the approval of the active substance abamectin 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 Im plementing Regulation (EU)  No 540/2011    
EN 2  EN ANNEX I  
Common Name,  
Identification 
Numbers  IUPAC Name  Purity1 Date of approval  Expiration of 
approval  Specific provisions  
Abamectin  
CAS No  71751 -41-2  
 
Avermectin  B1a 
CAS  No 65195 -55-3 
 
Avermectin  B1b  
CAS  No 65195 -56-4  
 
Abamectin  
CIPAC  No 495 
 Avermectin B1a  
(10E,14E,16E) -
(1R,4S,5′S,6S,6′R,8R,12S,13S,20
R,21R,24S) -6′-[(S)-sec-butyl] -
21,24 -dihydroxy -5′,11,13,22 -
tetramethyl -2-oxo-(3,7,19 -
trioxatetracyclo[15.6.1.14,8.020,2
4]pentacosa -10,14,16,22 -
tetraene) -6-spiro -2′-(5′,6′ -dihydro -
2′H-pyran) -12-yl 2,6 -dideoxy -4-
O-(2,6-dideoxy -3-O-methyl -α-L-
arabino -hexopyranosyl) -3-O-
methyl -α-L-arabino -
hexopyranoside  
 
Avermectin B1b   
(10E,14E,16E) -
(1R,4S,5′S,6S,6′R,8R,12S,13S,20
R,21R,24S) -21,24 -dihydroxy -6′-
isopropyl -5′,11,13,22 -tetramethyl -
2-oxo-(3,7,19 -
trioxatetracyclo[15.6.1.14,8.020,2
4]pentacosa -10,14,16,22 -
tetraene) -6-spiro -2′-(5′,6′ -dihydro -
2′H-pyran) -12-yl 2,6 -dideoxy -4-
O-(2,6-dideoxy -3-O-methyl -α-L-
arabino -hexopyranosyl) -3-O-
methyl -α-L-arabino -
hexopyranoside   ≥ 850 g/kg abamectin 
(sum of avermectin 
B1a and avermectin 
B1b), min. 800 g/kg 
avermectin B1a and 
max. 200 g/kg 
avermectin B1b  
 1 July 2021  31 May 2036  Only  uses in permane nt greenhouses  shall 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 renewal 
report on Abamectin , and in particular Appendices 
I and II thereto, shall  be taken into account.  
 
In this overall assessment Member States shall pay 
particular attention to:  
- the protection of operators  and workers , 
ensuring that conditions of use include the 
application of adequat e personal protective 
equipment  
- the significant effect of photolysis on the 
residue levels. Where appropriate, seasonal 
restrictions for the application/growing/harvest 
should be considered (cf. representative uses 
excluded application from November till 
February) and particular attention is required to  
ensure that available residue trials reflect the 
most critical residue situation of the envisaged 
uses, even under protected crop conditions . 
                                                 
1 Further details on the identity and the specification of the active substance are provided in the re newal  report .  
EN 3  EN ANNEX II 
The Annex to Commission Implementing Regulation (EU) No 540/2011  is amended as follows:  
(1) in Part A, entry 99 on Abamectin  is deleted;  
(2) in Part B, the following entry is added:  
No. Common Name,  
Identification 
Numbers  IUPAC Name  Purity2 Date of 
approval  Expiration of 
approval  Specific provisions  
‘XX  Abamectin  
CAS No  71751 -
41-2  
 
Avermectin  B1a 
CAS  No 65195 -
55-3 
 
Avermectin  B1b  
CAS  No 65195 -
56-4  
 
Abamectin  
CIPAC  No 495 
 Avermectin B1a  
(10E,14E,16E) -
(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,2
4S)-6′-[(S)-sec-butyl] -21,24 -dihydroxy -
5′,11,13,22 -tetramethyl -2-oxo-(3,7,19 -
trioxatetracyclo[15.6.1.14,8.020,24]penta
cosa-10,14,16,22 -tetraene) -6-spiro -2′-
(5′,6′ -dihydro -2′H-pyran) -12-yl 2,6 -
dideoxy -4-O-(2,6-dideoxy -3-O-methyl -α-
L-arabino -hexopyranosyl) -3-O-methyl -α-
L-arabino -hexopyranoside  
 
Avermectin B1b   
(10E,14E,16E) -
(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,2
4S)-21,24 -dihydroxy -6′-isopropyl -
5′,11,13,22 -tetramethyl -2-oxo-(3,7,19 -
trioxatetracyclo[15.6.1.14 ,8.020,24]penta
cosa-10,14,16,22 -tetraene) -6-spiro -2′-
(5′,6′ -dihydro -2′H-pyran) -12-yl 2,6 -
dideoxy -4-O-(2,6-dideoxy -3-O-methyl -α-
L-arabino -hexopyranosyl) -3-O-methyl -α-
L-arabino -hexopyranoside   ≥ 850 g/kg 
abamectin (sum 
of avermectin 
B1a and 
avermectin B1b), 
min. 800 g/kg 
avermectin B1a 
and max. 
200 g/kg 
avermectin B1b  
 1 July 2021  31 May 2036  Only uses in permanent greenhouses shall 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 renewal report on 
Abamectin, and in particular Appendices I and II 
thereto, shall be taken into account.  
 
In this overall assessment Member States shall pay 
particular attention to:  
- the protection of operators and workers, ensuring 
that conditions of use include the application of 
adequate personal protective equipment.  
- the significant effect of photolysis on the residue 
levels. Where appropriate, seasonal restrictions for 
the application/growing/harvest should be 
considered (cf. representative uses excluded 
application from November till February) and 
particular attention is required to ensure that 
available residue trials reflect the most critical 
residue situation of the envisaged uses, even under 
protected crop c onditions.’  
 
                                                 
2 Further details on the identity and the specification of the active substance are provided in the re newal  report .