Commission Implementing Regulation (EU) 2018/523 of 28 March 2018 amending Regulation (EU) No 37/2010 to classify the substance fluazuron as regards its maximum residue limit (Text with EEA relevance. )
Date: 2018-03-28
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal product, cattle, consumer protection, fish, food safety, foodstuff, health legislation, veterinary legislation








L_2018088EN.01000101.xml










4.4.2018   


EN


Official Journal of the European Union


L 88/1








            COMMISSION IMPLEMENTING REGULATION (EU) 2018/523
of 28 March 2018
         
amending Regulation (EU) No 37/2010 to classify the substance fluazuron 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 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 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 Council (1), and in particular Article 14 in conjunction with Article 17 thereof,


Having regard 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 substances 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 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.












(3)


Fluazuron is already included in that table as an allowed substance for bovine species, applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption.












(4)


An application for the extension of the existing entry for fluazuron to fin fish has been submitted to the European Medicines Agency (‘EMA’).












(5)


The EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended the establishment of an MRL for fluazuron in fin fish.












(6)


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 one or more species for other species.












(7)


The EMA has considered that the extrapolation of the entry for fluazuron to tissues of all ruminants except ovine species and to bovine milk is appropriate.












(8)


Regulation (EU) No 37/2010 should therefore be amended accordingly.












(9)


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.












(10)


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 3 June 2018.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 March 2018.


For the Commission


The President

Jean-Claude JUNCKER
            





(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).




ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance ‘fluazuron’ is replaced by the following:












Pharmacologically active Substance


Marker residue


Animal Species


MRLs


Target Tissues


Other Provisions (according to Article 14(7) of Regulation (EC) No 470/2009)


Therapeutic Classification




‘Fluazuron


Fluazuron


All ruminants except bovine and ovine


200 μg/kg


Muscle


Not for use in animals from which milk is produced for human consumption


Antiparasitic agents/Agents (acting) against ectoparasites’




7 000  μg/kg


Fat




500 μg/kg


Liver




500 μg/kg


Kidney




 


Bovine


200 μg/kg


Muscle


NO ENTRY




7 000  μg/kg


Fat




500 μg/kg


Liver




500 μg/kg


Kidney




200 μg/kg


Milk




 


Fin fish


200 μg/kg


Muscle and skin in natural proportions


NO ENTRY