EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/145  rev.3  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II, IV and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for (Z) -13-hexadecen -
11-yn-1-yl acetate, (Z,Z,Z,Z) -7,13,16,19 -docosatetraen -1-yl isobutyrate, acrinathrin, 
azimsulf uron, famoxadone, methyl nonyl ketone, prochloraz and sodium hypochlorite in 
or on certain products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II, IV and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for (Z) -13-hexadecen -
11-yn-1-yl acetate, (Z,Z,Z,Z) -7,13,16,19 -docosatetraen -1-yl isobutyrate, acrinathrin, 
azimsulf uron, famoxadone, methyl nonyl ketone, prochloraz and sodium hypochlorite 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), Article 18(1) , point (b), and 49(2)  thereof,  
Whereas:  
(1) For acrinathrin, azimsulfuron, famoxadone  and prochloraz  maximum residue levels 
(‘MRLs ’) were set in Annex  II to Regulation (EC) No  396/2005.  Methyl nonyl ketone 
is temporary included in Annex IV to tha t Regulation. For (Z)-13-hexadecen -11-yn-1-
yl acetate, (Z,Z,Z,Z) -7,13,16,19 -docosatetraen -1-yl isobu tyrate  and sodium 
hypochlorite  no specific MRLs are set in Regulation (EC) No 396/2005 . As these 
active substances are not included in Annex IV to that Regulation, the default value of 
0,01 mg/kg laid down in Article 18(1), point (b), of that Regulation applies . 
(2) The approval of the active substance s (Z)-13-hexadecen -11-yn-1-yl acetate and 
(Z,Z,Z,Z) -7,13,16,19 -docosatetraen -1-yl isobu tyrate  expired on 13 May 2016 . The 
Commission withdrew the approval of those  active substances by Commission 
Implementing Regulations  (EU)  2016/6382 and (EU) 2016/6363 as the applicant s did 
not submit the confirmatory information by the deadline . The approval of the active 
substance sodium hypochlorite expired on 31 August  2019 as no application for its 
renewal  had been submitted . For those active substances, the default value of 
0,01 mg/kg laid down in Article 18(1), p oint (b), of Regulation (EC) No 396/2005 
applies . MRLs for all products of those active substances  because of  the specific 
analytical methods applicable should be set at the product specific limit of 
determination (‘LOD’) in Annex V to that Regulation .  
 
1 OJ L 70, 16.3.2005, p. 1.  
2 Commission Implementing Regulation (EU) 2016/638 of 22 April 2016 withdrawing the approval of 
the active substance Z -13-hexadecen -11-yn-1-yl acetate, in acc ordance with Regulation (EC) 
No 1107/2009 of the European Parliament and of the Council, and amending Commission 
Implementing Regulation (EU) No 540/2011  (OJ L 108, 23.4.2016, p.  28). 
3 Commission Implemen ting Regulation (EU) 2016/636 of 22 April 2016 withdrawing the approval of 
the active substance Z,Z,Z,Z -7,13,16,19 -docosatetraen -1-yl isobutyrate, in accordance with Regulation 
(EC) No 1107/2009 of the European Parliament and of the Council, and amending C ommission 
Implementing Regulation (EU) No 540/2011  (OJ L 108, 23.4.2016, p.  22). EN 2  EN (3) The approval of the active subs tance acrinathrin expired on 31 December  2021 as the 
applicant withdrew the application for its renewal . All existing authorisations for plant 
protection products containing that active substance have been revoked. No MRLs 
based on Codex maximum residue limits (‘CXLs’)  or import tolerance  requests  exist 
for acrinathrin . It is therefore appropriate to delete  the MRLs set out for that active 
substance in Annex II to Regulation (EC) No 396/2005 in accordance with Article 17 
of Regulation (EC) No 396/2005 in conjunction with Article 14(1) , point (a) , thereof. 
MRLs for all products should be set at  the product sp ecific LOD in Annex V to that 
Regulation.  Additionally, for the avoidance of doubt, the footnotes indicating lack of 
information on residue trials should be deleted.  
(4) The approval of the active substance azimsulfuron  expired on 3 1 December  2021 as no 
applic ation for its renewal  had been submitted . All existing authorisations for plant 
protection products containing that active substance have been revoked. No MRLs 
based on CXLs or import tolerance  request s exist for azimsulfuron. It is therefore 
appropriate to delete the MRLs set out for that active substance in Annex II to 
Regulation (EC) No 396/2005 in accordance with A rticle 17 of Regulation (EC) 
No 396/2005 in conjunction with Article 14(1) , point (a) , thereof. MRLs for all 
products should be set at the  product specific  LOD in Annex  V to that Regulation.  
(5) The approval of the active substance famoxadone  expired on 9 September  2021 as the 
Commission did not renew the approval . All existing authorisations for plant 
protection produc ts containing that active substance have been revoked . No MRLs 
based on import tolerance requests  exist. MRLs based on CXLs exist. T he European 
Food Safety Authority ( ‘the Authority ’) published on 30 March 2023 a statement on 
the targeted risk assessment f or famoxadone4. In the statement , the Authority assessed  
the CXLs in the light of the lowered toxicological reference values that were 
established after the non -renewal of approval of the active substance famoxadone  by 
Commission Implementing Regulation (EU) 2021/13795. The Authority recommended 
lowering the MRL of famoxadone in or on table grapes as  it could not be excluded that  
the acute reference dose  would be exceeded . MRLs for wine grapes, potatoes, 
tomatoes, cucumbers, courgettes, barely, wheat, swine (muscle, fat, live, kidney, 
edible offal  (other than liver and kidney )), bovine (muscle, fat, live r, kidney, edible 
offal ( other than liver and kidney )), sheep (muscle, fat, live r, kidney, edible offal  
(other than liver and kidney) ), goat (muscle, fat, live r, kidney, edible offal  (other than 
liver and kidney) ), equine  (muscle, fat, live r, kidney, edible offal (other than liver and 
kidney)), other farm ed terrestrial  animals (muscle, fat, live r, kidney, edible offal (other 
than liver and kidney)), milk and birds eggs were based on CXLs that the Authority 
had confirmed are safe for consumers. Those MRLs should be  maintained  at the 
exist ing levels  according to Article  3(2), point (g) , and Article 14 (2), points (a), (c ) 
and (e) , of Regulation (EC) No  396/2005.  For aubergines/eggplants , gherkins, melons, 
broccoli, cauliflowers, leeks, oat and herbal infusions from flowers  for which the 
MRLs were base d on uses in the EU are no longer authorized,   it is therefore 
appropriate to lower  the existing MRLs set out for famoxadone  in Annex II to 
Regulation (EC) No 396/2005  to the product specific LOD  in accordance with Article 
 
4 European Food Safety Authority; Statement on the targeted risk assessment for famoxadone. EFSA 
Journal 2023;21(3):7932 . 
5 Commission Implementing Regulation (EU) 2021/1379 of 19 August 2021 concerning the non -renewal 
of approval of the active substance famoxadone, 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 Commission Implementing Regulation (EU) No 540/2011  (OJ L 297, 20.8.2021, 
p. 32). EN 3  EN 17 of that Regulation, in conjunc tion with Article  14(1), point  (a) and (2) thereof. 
Additionally, for the avoidance of doubt, the footnote indicating lack of information 
on analytical methods should be deleted.  
(6) The approval of the active substance  methyl  nonyl ketone expired on 26  May 2017. 
The Commission withdrew the approval of that active substance  by Commission 
Implementing Regulation  (EU) 2017/7816 as the applicant did not submit the 
confirmatory information by the deadline . It is therefore appropriate to delete this 
active substance in Annex I V to Regulation (EC) No  396/2005 and to set MRLs for all 
products at the  product specific LOD in Annex  V to that Regulation  in accordance 
with Article 18(1), point (b), of that Regulati on.  
(7) The approval of the active substance prochloraz expired on 31 December 2021 as no 
application for its renewal  had been submitted . All existing authorisations for plant 
protection products containing that active substance have been revoked. No MRLs 
based on import tolerance request s exist . MRLs based on CXLs exist but the residue 
definition differs from the one established by the Co dex Alimentarius  and 
confirmatory data has not been submitted to support those MRLs. It is therefore 
appropriate to delete the MRLs set out for that active substance in Annex II to 
Regulation (EC) No 396/2005 in accordance with Article 17 of Regulation (EC ) No 
396/2005 in conjunction with Article 14(1) , point (a) , thereof. MRLs for all products 
should be set at the product specific LOD in Annex  V to that Regulation  in accordance 
with Article 18(1), point (b), of that Regulation . Additionally, for the avoidance of 
doubt, the footnotes indicating lack of information on residue trials should be deleted.  
(8) The Commission consulted the European Union reference laboratories  for residues of 
pesticides as regards the need to adapt certain LODs . For all the active substances 
covered by this Regulation t hose laboratories proposed product specific LODs that are 
analytically achievable . 
(9) Through the World Trade Organisation, the tr ading partners of the Union were 
consulted on the modified  MRLs and their comments have been taken into account.  
(10) Regulation (EC) No 396/2005 should therefore be amended accordingly.  
(11) 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 modified MRLs become applicable  and for which 
information shows that a high level of consumer protection is maintained . This is the 
case for all products except  for famoxadone in  or on  table grapes  and for prochloraz in 
or on all products . 
(12) A reasonable period should be allowed to elapse before the modified  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 . 
(13) The measures provided for in this Regulation are in accordance with  the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
 
6 Commission Implementing Regulation (EU) 2017/781 of 5 May 2017 withdrawing the approval of the 
active substance methyl nonyl ketone, 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 Commission Implementing Regulation (EU) No 540/2011 ( OJ L 1 18, 6.5.2017, 
p. 1). EN 4  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes II , IV and V to Regulation (EC) No  396/2005 are amended in accordance with the 
Annex to this Regulation.  
Article 2  
Regulation (EC) No 3 96/2005 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  … [Publications  Office , please insert date  6 months after the date of  entry  into force of 
this Regulation ], except for famoxadone in or on table grapes  and prochloraz in  or on  all 
products.  
 
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the Europ ean Union . 
It shall apply from  … [Publications  Office , please insert date  6 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  
 Ursula VON DER LEYEN