COMMISSION IMPLEMENTING REGUL ATION (EU) 2019/1881 
of 8 November 2019 
amending Regulation (EU) No 37/2010 to classify the subst ance diflubenzuron as regards its 
maximum residue limit 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng regar d to Regulation (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 phar macologically 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 Council (1), and in 
particular Article 14 in conjunction with Article 17 thereof, 
Havi ng regar d to the opinion of the European Medicines Agency formulate d by the Committ ee for Medicinal Products for 
Veterinar y Use, 
Whereas: 
(1) Article 17 of Regulation (EC) No 470/2009 requires that the maximum residue limit (‘MRL ’) for phar macologically 
active substances intended for use in the Union in veteri nary medicinal products for food-producing animals or in 
biocidal products used in animal husbandr y is established in a Regulation. 
(2) Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the phar macologically active 
substances and their classification regar ding MRLs in foodstuffs of animal origin. 
(3) Diflubenzuron is already included in that table as an allowed substance for salmonidae species, applicable to muscle 
and skin. 
(4) On 7 May 2014, the Commission requested the European Medicines Agen cy (‘EMA ’) to issue a new opinion on 
diflubenzuron in accordance with Article 11 of Regulation (EC) No 470/2009, taking into account the genot oxic 
poten tial of diflubenzuron’s metabolite 4-chloroaniline as well as the results of the more recent evaluations of 
diflubenzuron as a pesticide, under taken by the European Food Safe ty Author ity EFSA ) (3), and as a biocide, 
coordinat ed by the Joint Research Centre of the Commission (4). 
(5) In its opinion of 7 May 2015, the Committee for Medicinal Products for Veterinar y Use (‘CVMP’) concluded that the 
genoto xic metabolite has not been confir med to be present in fish muscle and adopt ed an opinion noting that 
further data on 4-chloroani line formation and depletion in fish muscle was required in order to fully character ise 
the risk, if any, to the consumer from exposure to diflubenzuron. Publicly available repor ts about phar macology of 
diflubenzuron indicated that in sheep, swine and chick en, 4-ch loroaniline has been found as a minor metabolite. 
Based on that opinion, EMA recommended to amend the existing entr y for diflubenzuron in salmonidae species in 
table 1 of the Annex to Commission Regulation (EU) No 37/2010 and to establish a provis ional MRL, pending 
provision of additional residue data. 
(1)OJ L 152, 16.6.2009, p. 11. 
(2)Commission Regulation (EU) No 37/2010 of 22 December 2009 on phar macologically active substances and their classif ication 
regar ding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1). 
(3)EFSA Jour nal 2012;10(9):2870. Conclusion on the peer review of the pesticide risk assessment of confir mat ory data submitt ed for the 
active substance Diflubenzuron 
(4)Diflubenzuron assessment repor t, avail able at http://dissemination.echa.europa.eu/Biocides/A ctiveSubstances/0062-18/0062- 
18_Assessment_Repor t.pdf EN Offi cial Jour nal of the European Union L 290/8                                                                                                                                         11.11.2019   (6) Havi ng considered the recommendation from EMA, the Commission clarified in March 2017 that Regulation (EC) 
No 470/2009 only allows the establishment of a provis ional MRL in cases where scientific data are incomplet e and 
where there are no grounds for supposing that residues of the substance at the level proposed constitut e a hazard to 
human health. In the case of diflubenzuron there is a possibility that the genot oxic metabolite 4-chlor oaniline is 
present in treated fish at levels that could be hazardous to human health, and consequently the establishment of a 
provisiona l MRL was not considered appropr iate, according to the Commission. The Commission also highlight ed 
the EFSA 2015 conclusion (5) relating to the use of diflubenzuron in plant protection products, indicating that the 
available data were not suffi cient 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 adop ted its revised opinion on the establishment of maximum residue limits for 
diflubenzuron (6). Based on that opinion, EMA has recommended that the existing entr y 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-ch loroaniline 
remains at an accepta ble level. 
(8) According to Article 5 of Regulation (EC) No 470/2009, EMA is to consider using MRLs established for a 
phar macologically active substance in a particular foodstuff for another foodstuff derived from the same species, or 
MRLs established for a phar macologically active substance in one or more species for other species. 
(9) EMA has considered that the extrapolation of the entr y for diflubenzuron to fin fish is not appropr iate at this time 
due to a lack of evidence that the metabolite 4-chlor oaniline is not formed in any relevant amount in ever y species 
concer ned. 
(10) Pursuant to the CVMP opinions and the EMA recommendation, it appears necessar y 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 theref ore be amended according ly. 
(12) It is appropr iate to grant the stak eholders concer ned a reasonable period of time to take measures that may be 
required to compl y with the new MRL for diflubenzuron. 
(13) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Veterinar y Medicinal Products, 
HAS ADOPTED THIS REGUL ATION: 
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 followi ng that of its publication in the Official Journal of the 
European Union. 
(5)EFSA Jour nal 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 summar y opinion Diflubenzuron 16 March 2018. EN Offi cial Jour nal of the European Union 11.11.2019                                                                                                                                         L 290/9   It shall apply from 10 Januar y 2020. 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, 8 November 2019.  
For the Commission 
The President 
Jean-Claude JUNCKER     EN Offi cial Jour nal of the European Union L 290/10                                                                                                                                       11.11.2019   ANNEX 
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entr y for the substance ‘diflubenzuron’ is replaced by the following:                                                                
Phar macologically active 
Substance Marke r residue Animal Species MRLs Target Tissues Other Prov isions (ac­
cording to Article 14(7) of 
Regulation (EC) No 
470/2009) Therapeutic Classif ication 
‘Diflubenzuron Diflubenzuron Salmonidae 10 µg/kg Muscle and skin in natural 
propor tions NO ENTR Y Antiparasitic agents/ 
Agen ts against ectopara­
sites’   EN Offi cial Jour nal of the European Union 11.11.2019                                                                                                                                       L 290/11