Home > SPS > SPS Notification > CEEC’s SPS Notification

SPS Notification: Commission Implementing Regulation (EU) amending Regulation (EU) No 37/2010 as regards the classification of the substance fluralaner with respect to its maximum residue limit in foodstuffs of animal origin G/SPS/N/EU/847

Issue Date:2025-04-30 Source:WTO/TBT-SPS National Notification and Enquiry of China

 

 

NOTIFICATION

1.

Notifying Member: EUROPEAN UNION

If applicable, name of local government involved:

2.

Agency responsible: European Commission, Health and Food Safety Directorate-General

3.

Products covered (provide tariff item number(s) as specified in national schedules deposited with the WTO; ICS numbers should be provided in addition, where applicable): Foodstuffs of animal origin

4.

Regions or countries likely to be affected, to the extent relevant or practicable:

[X]    All trading partners

[ ]      Specific regions or countries:

5.

Title of the notified document: Commission Implementing Regulation (EU) amending Regulation (EU) No 37/2010 as regards the classification of the substance fluralaner with respect to its maximum residue limit in foodstuffs of animal origin. Language(s): English. Number of pages: 4

https://members.wto.org/crnattachments/2025/SPS/EEC/25_03105_00_e.pdf

https://members.wto.org/crnattachments/2025/SPS/EEC/25_03105_01_e.pdf

6.

Description of content: This draft legislation will establish a maximum residue limit (MRL) in the Union for the pharmacologically active substance fluralaner, intended for use in veterinary medicinal products for food-producing animals.

This draft legislation will amend the existing entry for fluralaner in Table 1 of the Annex of Commission Regulation (EU) No 37/2010 on pharmacologically active substances and its classification regarding maximum residue limits in foodstuffs of animal origin.

7.

Objective and rationale: [X] food safety, [X] animal health, [ ] plant protection, [ ] protect humans from animal/plant pest or disease, [ ] protect territory from other damage from pests.

8.

Is there a relevant international standard? If so, identify the standard:

[ ]        Codex Alimentarius Commission (e.g. title or serial number of Codex standard or related text):

[ ]        World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic Animal Health Code, chapter number):

[ ]        International Plant Protection Convention (e.g. ISPM number):

[X]      None

Does this proposed regulation conform to the relevant international standard?

[ ] Yes   [ ] No

If no, describe, whenever possible, how and why it deviates from the international standard:

9.

Other relevant documents and language(s) in which these are available:

10.

Proposed date of adoption (dd/mm/yy): July 2025

Proposed date of publication (dd/mm/yy): August 2025

11.

Proposed date of entry into force: [ ] Six months from date of publication, and/or(dd/mm/yy): This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

[ ]      Trade facilitating measure

12.

Final date for comments: [X] Sixty days from the date of circulation of the notification and/or (dd/mm/yy): 28 June 2025

Agency or authority designated to handle comments: [X] National Notification Authority, [X] National Enquiry Point. Address, fax number and e-mail address (if available) of other body:

European Commission

DG Health and Food Safety, Unit A4-Multilateral International Relations

Rue Froissart 101

B-1049 Brussels

Tel: +(32 2) 29 54263

E-mail: sps@ec.europa.eu

13.

Text(s) available from: [X] National Notification Authority, [X] National Enquiry Point. Address, fax number and e-mail address (if available) of other body:

European Commission

DG Health and Food Safety, Unit A4-Multilateral International Relations

Rue Froissart 101

B-1049 Brussels

Tel: +(32 2) 29 54263

E-mail: sps@ec.europa.eu