Commission Implementing Regulation (EU) 2025/1102 of 3 June 2025 amending Regulation (EU) No 37/2010 as regards chemical-unlike biological substances
Date: 2025-06-03
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Medicines Agency, animal product, classification, drug residue, food inspection, food safety, foodstuff, health control, health risk, veterinary medicinal product








L_202501102EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/1102


4.6.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/1102
of 3 June 2025
         
amending Regulation (EU) No 37/2010 as regards chemical-unlike biological substances
(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 of the Council (1), and in particular Article 14 thereof,

Whereas:







(1)


Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding maximum residue limits (‘MRLs’) in foodstuffs of animal origin.












(2)


Commission Regulation (EU) 2018/782 (3) provides that chemical-unlike biological substances for which it is concluded that a standard MRL evaluation is not required are to be published by the European Medicines Agency (‘Agency’) in a list of such substances.












(3)


The following five chemical-unlike biological substances were included in the list published by the Agency (4): (i) bovine casein hydrolysate (bCNH), produced from sodium caseinate hydrolysed with trypsin, heat treated, for intramammary use in cows, (ii) probiotic components including bacteria and yeasts, (iii) recombinant bovine IL-8 (His-tag) for intrauterine use in cattle at a dose of up to 1 000 μg per animal, (iv) stem cells and (v) varroa destructor calmodulin gene-specific double-stranded interfering RNA EP15 (naked unmodified dsRNA).












(4)


Regulation (EU) 2018/782 was amended by Commission Regulation (EU) 2025/1101 (5) providing that chemical-unlike biological substances are to be evaluated by the Agency in order to determine whether a ‘no MRL required’ classification is appropriate.












(5)


On 13 September 2024, the Commission requested the Agency to provide scientific advice on whether, a classification as ‘no MRL required’ is appropriate for the five chemical-unlike biological substances included by the Agency in the list of chemical-unlike biological substances considered as not requiring an MRL evaluation.












(6)


On 15 January 2025, the Agency (6), based on the opinion of the Committee for Veterinary Medicinal Products, concluded that the five chemical-unlike biological substances do not pose a risk to public health and that the classification thereof as ‘no MRL required’ is appropriate.












(7)


Those substances should therefore be included in table 1 of the Annex to Regulation (EU) No 37/2010.












(8)


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












(9)


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, 3 June 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 152, 16.6.2009, p. 11, ELI: http://data.europa.eu/eli/reg/2009/470/oj.

(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/2010/37(1)/oj).

(3)  Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (OJ L 132, 30.5.2018, p. 5, ELI: http://data.europa.eu/eli/reg/2018/782/oj).

(4)  Chemical-unlike biological substances considered as not requiring an MRL evaluation as per Regulation (EU) 2018/782, with regard to residues of veterinary medicinal products in foodstuffs of animal origin of 20 November 2023, EMA/CVMP/572629/2019–Rev.2, Committee for Veterinary Medicinal Products of European Medicines Agency.

(5)  Commission Regulation (EU) 2025/1101 of 3 June 2025 amending Regulation (EU) 2018/782 concerning the assessment by the European Medicines Agency of maximum residue limits for chemical-unlike biological substances (OJ L 2025/1101, 4.6.2025, ELI: http://data.europa.eu/eli/ reg/2025/1101/oj).

(6)  Scientific advice on MRL classification of chemical-unlike biological substances considered as not requiring an MRL evaluation according to Regulation (EU) 2018/782. EMA/CVMP/375793/2024.




ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the following entry is inserted in alphabetical order:












Pharmacologically active Substance


Marker residue


Animal Species


MRL


Target Tissues


Other Provisions

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



Therapeutic Classification




‘Bovine casein hydrolysate (bCNH), produced from sodium caseinate hydrolysed with trypsin, heat treated – chemical-unlike biological substance


NOT APPLICABLE


Bovine


No MRL required


NOT APPLICABLE


For intramammary use only


NO ENTRY




Probiotic components including bacteria and yeasts – chemical-unlike biological substance


NOT APPLICABLE


All food producing species


No MRL required


NOT APPLICABLE


NO ENTRY


NO ENTRY




Recombinant bovine IL-8 (His-tag) – chemical-unlike biological substance


NOT APPLICABLE


Bovine


No MRL required


NOT APPLICABLE


For intrauterine use only at a dose of up to 1 000  μg per animal


NO ENTRY




Stem cells – chemical-unlike biological substance


NOT APPLICABLE


All food producing species


No MRL required


NOT APPLICABLE


NO ENTRY


NO ENTRY




Varroa destructor calmodulin gene-specific double-stranded interfering RNA EP15 (naked unmodified dsRNA) – chemical-unlike biological substance


NOT APPLICABLE


Bees


No MRL required


NOT APPLICABLE


NO ENTRY


NO ENTRY’








ELI: http://data.europa.eu/eli/reg_impl/2025/1102/oj
ISSN 1977-0677 (electronic edition)