Key data
| Regulation | Commission Implementing Regulation (EU) 2026/1115 of 26 May 2026 |
|---|---|
| Modified regulation | Regulation (EC) No 429/2008 |
| Publication | 27 May 2026 |
| Entry into force | 26 May 2026 |
| Affected parties | Manufacturers and applicants for authorization of feed additives for farm animals in the EU |
| Category | Agriculture and Fisheries |
| National transposition | Not required — direct application in all Member States |
If your company manufactures or intends to market feed additives in the European Union, the authorization procedure has just changed. The Implementing Regulation (EU) 2026/1115, in force since 26 May 2026, amends Regulation (EC) No 429/2008 and updates the official form that applicants must submit to EFSA and the European Commission.
The change does not alter the substantive requirements for obtaining authorization, but rather the format and structure in which files are submitted. Using the incorrect form can cause delays or rejection of the application.
What does this regulation establish?
Regulation (EC) No 429/2008 regulates the procedures for applying for authorization of feed additives in the EU. The new Implementing Regulation (EU) 2026/1115 introduces the following specific modifications:
| Modified element | Before (Regulation EC 429/2008) | Now (Regulation EU 2026/1115) |
|---|---|---|
| Official application form | Previous format without updates | New structure and updated fields |
| Designation of target animal species | Previous fields | Revised and harmonized fields |
| Categories of target animals | Previous categories | Updated categories in the form |
| Scope of application | All EU Member States | All EU Member States (without transposition) |
The stated objective of the amendment is to achieve greater clarity and harmonization in files submitted to EFSA (European Food Safety Authority) and the European Commission. As an Implementing Regulation, its application is direct in all Member States without the need for national transposition.
Economic and operational impact
The direct economic impact of this regulation does not translate into new fees or specific penalties published in the regulation. The real cost for companies is operational and opportunity-based:
- Review of ongoing files: Authorization applications that are in preparation must be adapted to the new form before submission. If they were already advanced with the old format, they will need to be reformatted.
- Risk of authorization delays: Submitting the application with the incorrect form may cause EFSA or the European Commission to reject it or request corrections, delaying the authorization process and, therefore, the product's market launch.
- Cost of internal adaptation: Regulatory and scientific affairs teams will need to update their work templates and internal file submission procedures.
- No published transition period: The regulation entered into force on 26 May 2026, the same day it was signed, which means immediate application.
Who does it affect?
- Manufacturers of feed additives for farm animals that operate or wish to operate in the EU market.
- Companies applying for authorization of new feed additives before EFSA and the European Commission.
- Regulatory and scientific affairs departments of companies in the animal nutrition sector.
- Specialized consulting and advisory firms in registration and authorization of feed additives in the EU.
- Companies that market feed and are in the process of expanding their portfolio with new authorized additives.
The regulation affects all operators that submit or will submit authorization applications in any EU Member State, as the regulation applies directly throughout the Union.
Practical example
A Spanish company manufacturing poultry feed additives had prepared an authorization application file for a new additive, with the form based on Regulation (EC) No 429/2008 in its previous version.
Following the publication of Regulation (EU) 2026/1115 on 27 May 2026, the regulatory team must:
- Download the new official form updated in accordance with Regulation (EU) 2026/1115.
- Review the fields relating to the designation of the target animal species (in this case, poultry) and the category of animals, as these are the specifically modified fields.
- Transfer the information from the prepared file to the new format before submitting it to EFSA.
If the company had submitted the file with the old form, EFSA could have returned it for correction, delaying the evaluation process and, consequently, the date of market launch for the new additive.
What should companies do now?
- Identify files in preparation: Review whether there are feed additive authorization applications in progress or in preparation phase that have not yet been submitted to EFSA or the European Commission.
- Obtain the new official form: Access the text of Implementing Regulation (EU) 2026/1115 on EUR-Lex to download the updated form with the new structure and revised animal species and categories fields.
- Adapt files to the new format: Transfer the information already prepared to the new template, paying special attention to the fields for designation of target animal species and categories of animals.
- Update internal procedures: Modify the regulatory department's internal templates and guides so that all future applications are prepared directly with the new form.
- Inform external consultants: If working with external advisors specialized in additive registration, communicate the change so they can update their work tools.
- Do not submit applications in the old format: Since the regulation applies immediately from 26 May 2026, any application submitted from that date must use the new form.
Frequently asked questions
When is it mandatory to use the new feed additive authorization application form?
Implementing Regulation (EU) 2026/1115 entered into force on 26 May 2026, the same day it was signed. There is no published transition period, so the new form is mandatory from that date for any application submitted to EFSA or the European Commission.
What happens if I submit a feed additive application with the old form?
The previous form corresponds to Regulation (EC) No 429/2008 in its previous version. Submitting an application in that format may result in EFSA or the European Commission returning it for correction or rejecting it, which would delay the authorization process and, consequently, the marketing of the additive.
What specific fields change in the new feed additive form?
Regulation (EU) 2026/1115 specifically modifies the overall form structure and the fields relating to the designation of target animal species and the categories of target animals. These are the sections that must be reviewed most carefully when adapting files.
Does Spain need to transpose this regulation into its national legislation?
No. As an Implementing Regulation of the EU, its application is direct in all Member States without the need for national transposition. It is mandatory in Spain from 26 May 2026.
Where can I find the new official feed additive authorization application form?
The new form is found in the text of Implementing Regulation (EU) 2026/1115, published in the Official Journal of the European Union on 27 May 2026 and accessible through EUR-Lex (CELEX:32026R1115).
Official source
View complete regulation in official source — Implementing Regulation (EU) 2026/1115 on EUR-Lex
Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=CELEX:32026R1115