Feed additives authorisations: application process
- Feed additives
Summary
The European Commission proposes to improve the process of preparing and managing applications for the authorisation of feed additives (set out in Regulation 429/2008). This includes:
- simplifying the form to reflect the transition from physical to electronic submissions
- clarifying definitions of animal categories to ensure they cover all possible animal species, and to better distinguish between “major species” and “minor species”
- shortening the required minimum duration of efficacy studies for certain animals.
The Commission has notified the proposal to World Trade Organization Sanitary and Phytosanitary Measures (WTO SPS) Committee (G/SPS/N/EU/898).
EU to update and simplify the application form for feed additive authorisations
Draft Regulation amending Regulation (EC) No 429/2008 as regards the application form for authorisations of feed additives and the designation of target animal species and categories
Draft Annex
Update
The European Commission proposes to improve the process of preparing and managing applications for the authorisation of feed additives (set out in Regulation 429/2008). This includes:
- simplifying the form to reflect the transition from physical to electronic submissions
- clarifying definitions of animal categories to ensure they cover all possible animal species, and to better distinguish between “major species” and “minor species”
- shortening the required minimum duration of efficacy studies for certain animals.
The Commission has notified the proposal to World Trade Organization Sanitary and Phytosanitary Measures (WTO SPS) Committee (G/SPS/N/EU/898).
Impacted Products
Feed additives
What is changing?
The European Commission is proposing the following changes to Regulation 249/2008 to improve the process of preparing and presenting applications for the authorisation of feed additives:
- simplification of the application form (replacing the current Annex I)
- shortening of the required minimum duration of long-term efficacy studies for certain animal species/categories (e.g. laying hens, salmon, trout) (amending the current Annex II, point 4.4)
- a clearer distinction between “major species” and “minor species”, with definitions of each animal species (set out in a new Annex V).
These new Annexes to Regulation 249/2008, including the revised application form, can be found in the draft Annex to the proposal.
Why?
Since 2021, all applications for feed additives must be submitted via the Commission’s electronic submission system. The current application form, designed in 2008, does not reflect this evolution and needs to be updated to facilitate the management of applications. Experience in handling applications has also shown the need for greater clarity in defining the categories of animals.
Timeline
The Regulation is expected to be published in March 2026, and to apply from September 2026.
Recommended Actions
Competent authorities of countries that are members of the WTO can submit comments on the EU’s proposal by emailing the EU SPS Enquiry Point until 24 January 2026.
Background
Regulation (EC) 429/2008 sets out detailed rules for the implementation of Regulation 1831/2003 regarding applications for the authorisation of feed additives and their assessment. Annex I to Regulation (EC) 429/2008 contains the form that must be used to submit an application for the authorisation of a feed additive. Annex IV to that Regulation lists target animal categories and their respective definitions, and indicates the minimum duration of related efficacy studies.
Resources
Commission Regulation (EC) 429/2008 as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives
Regulation (EC) 1831/2003 on additives for use in animal nutrition
Sources
Draft Regulation as regards the application form for authorisations of feed additives and the designation of target animal species and categories
Draft Annex
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EU to update and simplify the application form for feed additive authorisations
Draft Regulation as regards the application form for authorisations of feed additives and the designation of target animal species and categories
Draft Annex
What is changing and why?
The European Union (EU) proposes to improve the process of preparing and presenting applications for the authorisation of feed additives by:
- simplifying the application form
- clarifying definitions of animal categories to ensure they cover all possible animal species, and to better distinguish between “major species” and “minor species”
- reducing the minimum duration of efficacy studies required for certain species (e.g. laying hens, salmon, trout).
The current application form, designed in 2008, does not reflect the move from physical to electronic submissions, and so needs to be updated. Experience of the European Commission in handling applications has also shown the need for greater clarity in defining the categories of animals.
Actions
Competent authorities of countries that are members of the World Trade Organization (WTO) can submit comments on the EU’s proposal by emailing the EU SPS Enquiry Point until 24 January 2026.
Timeline
The Regulation is expected to be published in March 2026, and to apply from September 2026.
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.