Date: 2023-10-20Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2023/2194 of 19 October 2023 amending Regulation (EU) No 37/2010 as regards the classification of the substance ketoprofen with respect to its maximum residue limit in foodstuffs of animal origin
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2023/2194 amends Regulation (EU) No 37/2010 regarding the maximum residue limit (MRL) of ketoprofen in foodstuffs of animal origin. It establishes numerical MRLs for ketoprofen in chicken tissues and extends these to other poultry species, excluding poultry eggs. The regulation came into force on the twentieth day following its publication in the Official Journal of the European Union (20 October 2023).
Key Points / Main Content:
* **Ketoprofen Classification:**
* Updates the classification of ketoprofen regarding MRLs in foodstuffs of animal origin.
* Ketoprofen remains classified as "No MRL required" for bovine, porcine, and equidae species.
* **Poultry MRLs:**
* Establishes numerical MRLs for ketoprofen in poultry tissues (chicken and other poultry species excluding eggs):
* 10 μg/kg in muscle
* 30 μg/kg in skin and fat (in natural proportion)
* 10 μg/kg in liver
* 10 μg/kg in kidney
* Specifies that ketoprofen is not for use in poultry from which eggs are produced for human consumption.
* **Extrapolation of MRLs:**
* MRLs for ketoprofen are extrapolated from chicken tissues to tissues of other poultry species.
* Extrapolation does not apply to poultry eggs due to the absence of residue depletion data.
* **Regulatory Amendment:**
* Amends Table 1 of the Annex to Regulation (EU) No 37/2010 to reflect the new MRLs for ketoprofen in poultry.
* **Entry into Force:**
* The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Impact Analysis:
* **Poultry Farmers:**
* *Impact:* Can use ketoprofen in poultry farming, excluding animals producing eggs for human consumption, while adhering to the specified MRLs in meat and offal.
* *Action Required:* Ensure adherence to the established MRLs for ketoprofen in poultry tissues and refrain from using ketoprofen in poultry producing eggs for human consumption.
* **Veterinary Medicinal Product Manufacturers (Huvepharma nv):**
* *Impact:* Can market ketoprofen for use in poultry farming, provided it is not intended for poultry producing eggs for human consumption and aligns with the MRLs.
* *Action Required:* Ensure product labeling reflects the approved use in poultry, excluding animals producing eggs for human consumption, and aligns with MRL requirements.
* **European Medicines Agency (Agency):**
* *Impact:* Their recommendations regarding MRLs for ketoprofen in chicken tissues have been adopted and extended to other poultry species.
* *Action Required:* Continue to monitor and assess the safety and efficacy of ketoprofen use in animals, updating recommendations as necessary.
* **European Commission:**
* *Impact:* Accountable for ensuring the regulation is implemented and enforced across Member States.
* *Action Required:* Oversee implementation and compliance of the regulation by Member States.
* **Member States:**
* *Impact:* Responsible for enforcing the updated MRLs for ketoprofen in foodstuffs of animal origin within their territories.
* *Action Required:* Implement and enforce the new MRLs for ketoprofen in poultry tissues, ensuring compliance by poultry farmers and related industries.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day operations.
Regulation (EC) No 470/2009: A European Parliament and Council regulation laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin.
Commission Regulation (EU) No 37/2010: A European Union regulation on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin.
ketoprofen: A pharmacologically active substance (drug) whose maximum residue limit (MRL) in foodstuffs of animal origin is being regulated.
European Medicines Agency: A European Union agency responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
Committee for Veterinary Medicinal Products: A committee within the European Medicines Agency responsible for opinions on veterinary medicinal products.
Brussels: The de facto capital city of the European Union and the location where the regulation was adopted.
Official Journal EN
of the European Union L series
2023/2194 20.10.2023
COMMISSION IMPLEMENTING REGULATION (EU) 2023/2194
of 19 October 2023
amending Regulation (EU) No 37/2010 as regards the classification of the substance ketoprofen with
respect to its maximum residue limit in foodstuffs of animal origin
(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 2009laying 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 of the Council(1), and in
particular Article 14, in conjunction with Article 17, thereof,
Whereas:
(1) In accordance with Regulation (EC) No 470/2009, the Commission is to establish, by way of a regulation, maximum
residue limits (‘MRLs’) 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.
(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) The substance ketoprofen is already included in that table as an allowed substance for bovine, porcine and equidae
species. The existing entry has a ‘no MRL required’ classification.
(4) In accordance with Article 3 of Regulation (EC) No 470/2009, on 14 December 2020, Huvepharma nv submitted an
application to the European Medicines Agency (‘Agency’) for the extension of the existing entry for the substance
ketoprofen to chicken.
(5) On 12 May 2022, the Agency, through the opinion of the Committee for Veterinary Medicinal Products,
recommended the establishment of a ‘no MRL required’ classification for the substance ketoprofen in chicken.
(6) On 1 March 2023, the Commission requested the Agency to reconsider its opinion of 12 May 2022 to further
examine possible safety concerns with regard to some metabolites and, where appropriate, to recommend
numerical MRLs for ketoprofen in chicken tissues.
(7) On 16 May 2023, the Agency, based on the opinion of the Committee for Veterinary Medicinal Products, and having
considered the application of Huvepharma nv and the request from the Commission, recommended the
establishment of numerical MRLs for ketoprofen use in chicken, applicable to muscle, skin and fat in natural
proportion, liver and kidney, but not for use in animals from which eggs are produced for human consumption.
(8) In accordance with 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
(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).
ELI: http://data.europa.eu/eli/reg_impl/2023/2194/oj 1/3EN
OJ L, 20.10.2023
concluded that the extrapolation of the MRLs for ketoprofen from chicken tissues to the tissues of other poultry
species is appropriate, but not to poultry eggs as no residue depletion data for the substance ketoprofen in eggs
were provided.
(9) In view of the opinion of the Agency, the Commission considers it appropriate to establish the recommended MRL
for ketoprofen in chicken tissues and to extrapolate it to other poultry species, but not to poultry eggs.
(10) Regulation (EU) No 37/2010 should therefore be amended accordingly.
(11) 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, 19 October 2023.
For the Commission
The President
Ursula VON DER LEYEN
2/3 ELI: http://data.europa.eu/eli/reg_impl/2023/2194/ojELI:
http://data.europa.eu/eli/reg_impl/2023/2194/oj
3/3
ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance ‘ketoprofen’ is replaced by the following:
Other Provisions (according
Pharmacologically to Article 14(7) of Therapeutic
Marker residue Animal Species MRL Target Tissues
active Substance Regulation (EC) Classification
No 470/2009)
‘Ketoprofen NOT APPLICABLE Bovine, No MRL required NOT APPLICABLE NO ENTRY NO ENTRY
Porcine,
Equidae
Ketoprofen Poultry 10μg/kg Muscle Not for use in animals NO ENTRY’
from which eggs are
30μg/kg Skin and fat in natural proportion
produced for human
10μg/kg Liver consumption
10μg/kg Kidney
OJ
L,
20.10.2023
EN