Legalize / European Union / Implementing Regulation

Commission Implementing Regulation (EU) 2025/1102 of 3 June 2025 amending Regulation (EU) No 37/2010 as regards chemical-unlike biological substances

Type Implementing Regulation

Publication 2025-06-04

State In force

Text As published

Department European Commission, SANTE

Source EUR-Lex

articles 2

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

Reform history JSON API


Image omitted; see official source	Official Journal of the European Union	EN L series

---	---	---
	2025/1102	4.6.2025

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 [^ntr4-L_202501102EN.000101-E0004]: (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

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

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).

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).

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.

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).

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)

Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.

This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence. EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.