EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/897_Rev1  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of 
the Council as regards maximum residue levels for haloxyfop in or on certain products  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of 
the Council as regards maximum residue levels for haloxyfop 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)(a) and Article 49 (2) thereof , 
Whereas:  
(1) For the active substance haloxyfop , maximum residue levels ( ‘MRLs ’) were set in 
Annex  II to Regulation (EC) No  396/2005.  
(2) In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 , an 
application for import tolerance was submitted for haloxyfop use d in Australia on 
linseeds  and rapeseeds /canola seeds . The applicant claims that the authorised uses of 
that substance on such crop in Australia lead s to residues exceeding the MRL 
contained in Regulation (EC) No  396/2005 for linseeds , and that a higher MR L is 
necessary to avoid trade barriers for the importation of linseeds and rapeseeds . 
(3) In accordance with Article 8 of Regulation (EC) No 396/2005, the application was 
evaluated by the Member State concerned and in accordance with Article 9 of that 
Regulation, the evaluation report was forwarded to the Commission.  
(4) The European Food Safety Authority ( ‘the Authority ’) assessed the application and the 
evaluation report, examining in particular the risks to consumer s and, where relevant, 
to animals and gave a reasoned opinion on the proposed MRL2. It forwarded th at 
opinion to the applicant, the Commission and the Member States , and made it 
available to the public.  
(5) The Authority concluded that all requirements with res pect to data were met and that 
the modification to the MRL requested by the applicant was acceptable with regard to 
consumer safety on the basis of a consumer exposure assessment for 27  specific 
European consumer groups. It took into account the consu mption data and the 
information on the toxicological properties of the substance  valid at that time . The 
Authority concluded that n either the lifetime exposure to the substance via 
consumption of all food products that may contain it, nor the short -term exposur e due 
to high consumption of those products  showed that there is a ny risk that the acceptable 
daily intake or the acute reference dose is exceeded.  
 
1 OJ L 70, 16.3.2005, p. 1.  
2 European Food Safety Authority reasoned opinion on the setting of import tolerances for haloxyfop -P 
in linseed and rapeseed . EFSA Journal 2018;16 (11):5470.   
EN 2  EN (6) Such an application was  previuosly  implemented in Commission Regulation (EU) 
2017/171 for the MRLs of haloxy fop in soyabeans3 since the Authority concluded that 
the proposed MRL was safe for consumers4.   
(7) In 2020, according to Commission Implementing Regulation (EU) 2020/16435, the 
approval of the active substance  haloxyfop  was not renewed due to the decision , of the 
applicant for renewal,  to no longer support that application for renewal of approval .  
(8) All authorisations for plant protection products containing haloxyfop have been 
revoked. It is therefore appropriate to delete the existing MRLs set for that active 
substance in Annex II of Regulation (EC) No 396/2005 in accordance with Article  17 
of that Regulation in conjunction with Article  14(1)(a) thereof .  
(9) In accordanc e with Article 43 of Regulation (EC) No  396/2005, the Commission 
requested the Authority to provide a reasoned opinion, assessing the risks that the 
current MRLs  based on import tolerances and CXLs  for haloxyfop may pose to 
consumers  considering the most recent consu mption data available  and the presence or 
absence of submission of the required confirmatory to address the data gaps identified 
during the MRL review in accordance to the Article 12 of Regulation (EC) 
No 396/20056.  
(10) The authority concluded that the data gap previously identified for onions and 
sunflower seeds, for which CXLs also exist, was not addressed . It is appropriate to 
lower the respective MRLs set out for haloxyfop in Annex II to Regulation (EC) 
No 396/2005 to the  product specific limit of determination (‘LOD’)  in accordance 
with Article  14(1)(a) of Regulation (EC) No  396/2005, in conjunction with Article  17 
of that Regulation. The Authority  concluded  that the existing MRLs for  haloxyfop in  
soya beans , as well as  the proposed import tolerances for that active substance in 
linseed and rapeseed/canola seeds are not expected to pose a risk to consumers. 
However , considering the most recent consumption data and data requirements, for 
soya beans  some information  was no t available  and further consideration by risk 
managers was therefore required7. Since  the MRL  for haloxyfop in soya beans  is 
considered safe and the missing information was identified during the risk assessment 
performed by the Authority only in 202 2, it is appropriate  to provide the applicant 
time to submit the requested data. Th at MRL will therefore be review ed taking into 
account the information available within  two years from the publication of this 
Regulation. As there is no risk for consumers, it is appropriate to set the MRLs for 
 
3  Commission Regulation (EU) 2017/171 of 30 January 2017  amending Annexes II, III and IV to 
Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum 
residue levels for aminopyral id, azoxystrobin, cyantraniliprole, cyflufenamid, cyproconazole, 
diethofencarb, dithiocarbamates, fluazifop -P, fluopyram, haloxyfop, isofetamid, metalaxyl, 
prohexadione, propaquizafop, pyrimethanil, Trichoderma atroviride strain SC1 and zoxamide in or on 
certain products  (OJ L 30, 3.2.2017, p. 45 –111).  
4  European Food Safety Authority reasoned opinion on the setting of import tolerance for haloxyfop -P in 
soya beans. EFSA Journal 2016;14(7):4551 [15 pp.].  
5 Commission Implementing Regulation (EU) 2020/1643 of 5 November 2020 amending Implementing 
Regulation (EU) No 540/2011 as regards the approval periods of the active substances calcium 
phosphide, denathonium benzoate, haloxyfop -P, imidacloprid, pencycuron and zeta -cypermethrin ( OJ L 
370, 6.11.202 0, p. 18 ). 
6  Commission Regulation (EU) 2015/2075  of 18 November 2015  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 abamectin, desmedipham, dichlorprop -P, hal oxyfop -P, oryzalin and phenmedipham in 
or on certain products  (OJ L 302, 19.11.2015, p. 15 –50) 
7 European Food Safety Authority reasoned opinion on the t argeted review of maximum residues levels 
(MRLs) for  haloxyfop -P. EFSA Journal 2022;20(11):7658 .  
EN 3  EN soya beans, linseed and rapeseed/canola seeds in Annex  II to Regulation (EC) 
No 396/2005 at the level s identified by the Authority.  For all other products, it is 
appropriate to lower the respective MRLs set out for haloxyfop in Annex II to 
Regulation (EC) No  396/2005 to the  product specific  LOD  in accor dance with 
Article  14(1)( a) of Regulation (EC) No  396/2005 , in conjunction with Arti cle 17 of 
that Regulation.  
(11) The Commission consulted the European Union reference laboratories for residues of 
haloxyfop  as regards the need to adapt certain LODs . Those laboratories proposed 
product specific LODs that are  analytically achievable for all p roducts .  
(12) 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.  
(13) Annex II to Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(14) 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 protect ion is maintained.  
(15) 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 prepare themselves to meet the new requirements which will result from 
the modification of the MRLs.   
(16) 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  
Annex  II to Regulation (EC) No  396/2005 is 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 Publication s: 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 Europea n Union . 
It shall apply from [ Office of Publication s: please insert date 6 months after the date of entry 
into force  of this regulation ].  
EN 4  EN 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