EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/2311  
[…](2022) XXX  draft v3  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes III and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for phosmet in or on 
certain products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes III and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for phosmet in or on 
certain products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty o n 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 18(1) , point (b), thereof,  
Whereas:  
(1) For phosmet , maximum residue levels ( ‘MRLs ’) were set in  Part A of  Annex I II 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 phosmet  in accordance with Article 12(1) of 
Regulation (EC) No 396/20052. It proposed to change the residue definition  for 
enforcement  from “phosmet and phosmet oxon expressed as phosmet ” to “phosmet ”. 
The Commission considers this new residue definition to be appropriate  in the context 
of Regulation (EC) 396 /2005 . 
(3) In its  reasoned opinion on the review of the existing MRLs for phosmet in accordance 
with Article 12(1) of Regulation (EC) No 396/2005 , the Authority  identified a risk for 
consumers  concerning the MRLs for grapefruits, oranges, lemons, limes, mandarins, 
coconuts, apples, pears, quinc es, medlars, loquats, apricots, peaches, table grapes, 
wine grapes, blueberries, cranberries, kumquats and potatoes. In addition, i n the 
context of a decision on non -renewal  of the approval  of the activ e substance phosmet3, 
the Authority published a conclusion4 on the peer review  of the pesticide risk 
assessment of the active substance phosmet  explaining that the consumer dietary risk 
assessment  for phosmet  could not be finalised because  data including the toxicological 
profile and genotoxicity potential of the metabo lite phosmet -oxon  was incomplete . In 
 
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 phosmet  according to Article 12 of Regulation (E C) No 396/2005. EFSA Journal 
2022;20(7):7448 . 
3 Commission Implementing Regulation (EU) 2022/94 of 24 January 2022 concerning the non -renewal 
of the approval of the active substance phosmet, 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 am ending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 
16, 25.1.2022, p. 33).  
4 European Food Safety Authority ;  Conclusion on the peer review of the pesticide risk assessment of the 
active substance phosmet , EFSA Journal 2021;19 (3):6237 . EN 2  EN view of the data gaps, the Authority could not rule out harmful effects on human 
health with the existing MRLs for phosmet  in all products. Therefore, none of the 
existing MRLs  for phosmet , including those based on Codex maximum residue limits 
(CXLs), could be confirmed as being safe for consumers. It is therefore appropriate to 
delete the MRLs for phosmet in Part A of  Annex II I to Regulation (EC) No 396/2005 
in accordance with Article 17 o f Regulation (EC) No 396/2005 in conjunction with 
Article  14(1) point (a) thereof.  MRLs for  phosmet in  all products should be set at the 
limits of determination (‘ LOD s’), specific to each product , which should be set in 
Annex V to Regulation (EC) No 396/20 05 in accordance with Article 18(1) , point (b) 
of that Regulation . 
(4) Additionally, the Authority and a Member State identified that the default value of 
0.01* mg/kg for oranges , potatoes , apples, pears, pineapples, melons, watermelons , 
sugar beet roots , and milk (cattle), does not provide a sufficient level of protection for 
the consumer . Therefore,  the LOD s for these products should be set at the lower and 
achievable level of 0.005*  mg/kg . 
(5) The Commission consulted the European Union ref erence laboratories for residues of 
pesticides as regards the need to adapt certain LODs. 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) A reasonable period should be allowed to elapse before the new MRLs for phosmet  
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 .  
(9) The measures provided for in this Regulation are in accordance with the opinion of  the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes III and V to Regulation (EC) No  396/2005 are amended in accordance with the 
Annex to this Regulation.  
Article 2 
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 … [ 3 months after the date of entry into force 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  EN 3  EN  Ursula VON DER LEYEN  