EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/2637 v2  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for pyriproxyfen in or 
on certain products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for pyriproxyfen in or 
on certain products  
(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  396/2005 of the European Parliament and of the 
Council of 23  February 2005 on maximum residue levels of pesticides in or on food and feed 
of plant and animal origin and amending Council Directive 91/414/EEC1, and in particular 
Article  14(1) , point (a), and Article 49(2) thereof,  
Whereas:  
(1) Maximum residue levels ( ‘MRLs ’) for pyriproxyfen were set in  Part A of  Annex  III to 
Regulation (EC) No  396/2005.  
(2) The European Food Safety Authority (‘the Authority ’) submitted a reasoned opinion 
on the review of the existing MRLs for pyriproxyfen  in accordance wi th Article 12(1) 
of Regulation (EC) No 396/20052. The Authority recommended to lower  the existing 
MRLs for pyriproxyfen  on swine/bovine/goat/horse muscle , fat, liver and kidney, as 
well as cattle/horse milk to the limit of determination (‘LOD ’) in line with the 
principle of setting MRLs at levels as low as reasonably achievable and based on 
sufficient supporting data for the current good agricultural pract ices (‘GAPs’). As 
there is no risk for consumers, it is appropriate to set the MRL for pyriproxyfen  on 
these products in Annex  II to Regulation (EC) No 396/2005 at the level identified by 
the Authority . 
(3) The Authority further concluded that the MRLs for pyriproxyfen  on almonds, 
chestnuts, hazelnuts, pecans, pistachios, walnuts, pine nuts kernels, pome fruits, 
grapes, table olives, kaki/Japanese persimmons, pineapples, tomatoes, sweet peppers, 
aubergines, cucurbits with edible peel, and watermelons  should be lowered in line with 
the principle of setting MRLs at levels as low as reasonably achievable and based on 
the current GAPs and Codex maximum residue limits  (‘CXLs ’), which are confirmed 
as being safe for consumers3. It also concluded that the MRLs for pyriproxyfen  on 
apricots, peaches, plums, strawberries, mangoes , papayas, melons, cotton seeds and 
tea should be maintained based on the current GAPs and CXLs , which are confirmed 
 
1 OJ L 70, 16.3.2005, p. 1.  
2 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for pyriproxyfen according to Article 12 of Regulation (E C) No 396/2005 ; EFSA Journal 
2022;20(1 1):7617 . 
3 European Food Safety Authority; Scientific support for preparing an EU position in the 51st Session of 
the Codex Committee on Pesticide Residues (CCPR) ; EFSA Journal 2019;17(7):5797 . EN 2  EN as being safe for consumers3,4. In addition, th e Authority  concluded that the MRLs for 
pyriproxyfen  on citrus fruits , cherries  and kumquats  should be raised based on the 
current GAPs  and CXL s, which are confirmed as being  safe for consumers . As the 
Authority confirmed in a n earlier  reasoned opinion5 that the MRL for pyriproxyfen  on 
banana is safe for consumers , that MRL  can be maintained . However, as some 
information was not available, further consideration by risk managers was required. 
Therefore, while the MRLs for almonds, chestnuts, hazelnuts, pecans, pistachios, 
walnuts, pine nuts kernels, pome fruits, grapes, table olives, kaki/Japanese 
persimmons, pineapples, tomatoes, sweet peppers, aubergines, cucurbits with edible 
peel, watermelons, apricots, peaches, plums, strawberries, mangoes , papayas, melons, 
cotton seeds , tea, citrus fruits , cherries , kumquats and bananas  are considered safe, 
they will be reviewed. The review will take into account the information available 
within two years from the publication of this R egulation. As there is no risk for 
consumers, it is appropriate to set the MRLs for pyriproxyfen  on those products in 
Annex  II to Regulation (EC) No  396/2005 at the levels identified by the Authority.  
(4) As the  Authority identified that no residue trials were  available to derive MRL values 
for pyriproxyfen  on macadamias, avocados, granate apples/ pomegranates, cherimoyas, 
potatoes, sweet potatoes and yams, other root and tuber vegetables except sugar beets, 
bulb vegetables, okra /lady’s fingers , pumpkins, brassi ca vegetables (excluding 
brassica roots and brassica baby leaf crops) , lettuces and salad plants, spinaches and 
similar leaves, watercresses, witloofs/Belgian endives, herbs and edible flowers, 
legume vegetables , stem vegetables , beans (dry), and soyabeans , further consideration 
by risk managers was required. In the absence of such trials, which are necessary to 
derive a MRL value, the Commission considers that it is appropriate to set the MRLs 
for those products at the product specific LODs set ou t in Annex II to Regulation (EC) 
No 396/2005 . 
(5) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain LODs. For pyriproxyfen , those 
laboratories proposed product  specific LODs that are analytically  achievable.   
(6) Through the World Trade Organisation, the trading partners of the Union were 
consulted on the new MRLs  and their comments have been taken into account.  
(7) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(8) To allow for the normal marketing, processing and consumption of products, this 
Regulation should not apply to products which have been produced in  the Union  or 
imported into the Union before the new MRLs become applicable and for which a 
high level of consumer protection is maintained.  This is the case for all products.  
(9) A reasonable period should be allowed to elapse before the new MRLs become 
applicable , in order to permit Member States, third countries and food business 
operators to adapt themselves to the requirements which result  from the modification 
of the MRLs .  
(10) The measures provided for in this Regulation are in accordance with the opinion of the 
Stand ing Committee on Plants, Animals, Food and Feed,  
 
 
4 European Food Safety Authority; Scientific support for preparing an EU position in the 5 2nd Session of 
the Codex Committee on Pesticide Residues (CCPR) ; EFSA Journal 2021;19(8):6766 . 
5 European Food Safety Authority; Reasoned Opinion on the modification of the existing maximum 
residue levels  for pyriproxyfen in bananas ; EFSA Journal 2016;14(2):438.  EN 3  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes II and III to Regulation (EC) No  396/2005 are amended in accordance with the 
Annex to this Regulation.  
Article 2  
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall 
continue to apply to products which were produced in the Union or imported into the Union 
before … [ Office of Publications: please insert date 6  months after the date of entry into force 
of this Regulation ].  
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union .  
It shall apply from … [ Office of publications: please insert date  6 months after the date of 
entry into f orce of this Regulation ]. 
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  