Commission Implementing Regulation (EU) 2020/1712
of 16 November 2020
amending Regulation (EU) No 37/2010 to classify the substance lidocaine 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 Council1, and in particular Article 14, in conjunction with Article 17 thereof,
Having regard to the opinions of the European Medicines Agency formulated on 16 July 2020 by the Committee for Medicinal Products for Veterinary Use,
Whereas:
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.
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.
Lidocaine is already included in that table as an allowed substance for equidae, for local-regional anaesthetic use only. The existing entry has a ‘no MRL required’ classification.
An application for the extension of the existing entry for lidocaine to porcine species, for cutaneous and epilesional use only in piglets up to 7 days of age, has been submitted to the European Medicines Agency (‘Agency’).
An application for the extension of the existing entry for lidocaine to bovine species, applicable to muscle, fat, liver, kidney and milk, has also been submitted to the Agency.
The Agency, based on the opinions of the Committee for Medicinal Products for Veterinary Use, has recommended the establishment of an MRL for lidocaine in bovine species, but has concluded that the establishment of an MRL for lidocaine in porcine species, of certain age and for certain use, is not necessary for the protection of human health.
According to Article 5 of Regulation (EC) No 470/2009, the Agency 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.
The Agency has considered that the extrapolation of the entry for lidocaine in porcine and bovine to other food-producing species is not appropriate at this time due to insufficient data.
Regulation (EU) No 37/2010 should therefore be amended accordingly.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 November 2020.
For the Commission
The President
Ursula von der Leyen
ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance ‘lidocaine’ 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
‘Lidocaine
NOT APPLICABLE
Equidae
No MRL required
NOT APPLICABLE
For local/regional anaesthesia only.
Local anaesthetic’
Porcine
For use in piglets up to 7 days of age only.
For cutaneous and epilesional use only.
Lidocaine
Bovine
150 μg/kg
200 μg/kg
1 μg/kg
200 μg/kg
30 μg/kg
Muscle
Fat
Liver
Kidney
Milk
NOT APPLICABLE