EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) No 37/2010 to classify the substance diflubenzuron as 
regards its maximum residue limit  
(Text with EEA relevance)   EN 2  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) No 37/2010 to classify the substance diflubenzuron as 
regards its maximum residue limit  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regu lation (EC) No  470/2009 of the European Parliament and of the 
Council of 6  May 2009 laying down Community procedures for the establishment of residue 
limits of pharmacologically active substances in foodstuffs of animal origin, repealing 
Council Regulation  (EEC) No 2377/90 and amending Directive 2001/82/EC of the European 
Parliament and of the Council and Regulation (EC) No  726/2004 of the European Parliament 
and the Council1, and in particular Article  14 in conjunction with Article  17 thereof,  
Having regar d to the opinion of the European Medicines Agency formulated by the 
Committee for Medicinal Products for Veterinary Use,  
Whereas:   
(1) Article  17 of Regulation (EC) No  470/2009 requires that the maximum residue limit 
('MRL ') for pharmacologically active substa nces intended for use in the Union in 
veterinary medicinal products for food -producing animals or in biocidal products used 
in animal husbandry is established in a Regulation.  
(2) Table 1 of the Annex to Commission Regulation (EU) No 37/20102 sets out the 
pharmacologically active substances and their classification regarding MRLs in 
foodstuffs of animal origin.  
(3) Diflubenzuron  is already included in that table  as an allowed substance for salmonidae  
species , applic able t o muscle  and skin . 
(4) On 7 May 2014, t he Commission requested the European Medicines Agency ('EMA') 
to issue a new opinion  on diflubenzuron in accordance with Article 11 of Regulation 
(EC) No 470/2009, taking into account  the genotoxic potential  of diflubenzuron’s 
metabolite 4 -chlor oaniline  as well as the results of the more recent evaluations of 
diflubenzuron as a pesticide, undertaken by the European Food Safety Authority 
                                                 
1 OJ L  152, 16.6.2009, p.  11. 
2 Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active 
substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ 
L 15, 20.1.2010, p. 1).  EN 3  EN EFSA)3, and as a biocide, coordinated by the Joint Research Centre  of the 
Commission4.  
(5) In its opinion of 7 May  2015, t he Committee for Medicinal Products for Veterinary 
Use ('CVMP') concluded that the genotoxic metabolite has not been confirmed to be 
present in fish muscle and adopted an opinion noting that further data on 4 -
chloroaniline formatio n and depletion in fish muscle wa s required in order to fully 
characterise the risk, if any, to the consumer fr om exposure to  diflubenzuron . Publicly 
available reports about pharmacology of diflubenzuron indicated that in sheep, swine 
and chicken, 4 -chloroaniline has been  found as a minor metabolite.  Based on th at 
opinion , EMA recommended to amend the existing entry for diflubenzuron in 
salmonidae species in table 1 of the Annex to Commission Regulation (EU) No 
37/2010 and to establish a provisional MRL, pending provision of additional residue 
data.   
(6) Having considered the recommendation  from EMA , the Commission clarified in 
March 2017 that Regulation (EC) No 470/2009 only allows the establishment of a 
provisional MRL in cases where scientific data are incomplete and where t here are no 
grounds for supposing that residues of the substance at the level proposed constitute a 
hazard to human health. In the case of diflubenzuron there is a possibility that the 
genotoxic metabolite 4 -chloroaniline is present in treated fish at leve ls that could be 
hazardous to human health, and consequently the establishment of a provisional MRL 
was not considered appropriate , according to the Commission . The Commission also 
highlighted the EFSA 2015 conclusion5 relating to the use of diflubenzuron in plant 
protection products, indicating that the available  data were not sufficient to 
demonstrate that the representative uses were safe for consumers. For those reasons, 
the Commission invited the CVMP to revise its  opinion of 7 May 2015.   
(7) On 15 March 2018, CVMP adopted its revised opinion on the establishment of 
maximum residue limits for diflubenzuron6. Based on that opionion, EMA  has 
recommended that the existing entry  for diflubenzuron in salmonidae species  in table 1 
of the Annex to Commission Regulation (EU) No 37/2010  be amended so that the 
MRL is reduced . The MRL value  is set at 10 µg/kg  in order to ensure that consumer 
exposure to 4 -chloroaniline remains at an acceptable level .  
(8) According to Article  5 of Regulation (EC) No 470/2009, EMA is to consider using 
MRLs established for a pharmacologically active substance in a particular foodstuff 
for another foodstuff derived from the same species, or MRLs established for a 
pharmacologically active substance in o ne or more species for other species.  
(9) EMA has considered that the extrapolation of the entry for diflubenzuron  to fin fish  is 
not appropriate at this time due to a lack of evidence  that the metabolite 4-
chloroaniline is not formed in any relevant amount in every species concerned.  
                                                 
3 EFSA Journal 2012;10(9):2870. Conclusion on the peer review of the pesticide risk assessment of 
confirmatory data submi tted for the active substance Diflubenzuron  
4 Diflubenzuron assessment report, available at  
http://dissemination.echa.europa.eu/Biocides/Act iveSubstances/0062 -18/0062 -
18_Assessment_Report.pdf   
5 EFSA Journal 2015;13(12):4222.Peer review on the review of the approval of the active substance 
diflubenzuron regarding the metabolite  PCA   
6 EMA/CVMP/153976/2018 MRL summary opinion Diflubenzuron 16 March 2018  EN 4  EN (10) Pursuant to the CVMP opinions and the EMA recommendation, it appears necessary 
for the protection of human health to reduce the MRL for diflubenzuron from 1 000 
μg/kg to 10 μg/kg.  
(11) Regulation (EU) No 37/2010 should therefore be am ended accordingly.  
(12) It is appropriate to grant the stakeholders concerned a reasonable period of  time to take 
measures that may be required to comply with the new MRL for  diflubenzuron . 
(13) The measures provided for in this Regulation are in accordance with the  opinion of the 
Standing Committee on Veterinary Medicinal Products,  
 
HAS ADOPTED THIS REGULATION:  
Article  1 
The Annex to Regulation (EU) No  37/2010 is amended as set out in 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 … [the date corresponding to 60 days  after the date of publication  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