Feed additives: Implementing Regulation (EU) 2026/1115 changes the application form, target species terminology and minimum duration of efficacy studies (e.g. laying hens and salmonids 84 days) — from 16 December 2026
Commission Implementing Regulation (EU) 2026/1115 of 26 May 2026, published on 27 May, amends Regulation (EC) No 429/2008 on the preparation and assessment of applications for feed additive authorisation. The application form will be generated from electronically submitted documents, Annex IV will cover all animal species and categories farmed or kept in the Union, and the minimum duration of long-term efficacy studies has been aligned with EFSA’s 2024 guidance.
- Since 2021 applications have been submitted only through the Commission’s electronic system; once submitted, the applicant, the Commission, EFSA and the Member States have access to the Annex I form, which the system generates automatically from the documents uploaded. The content of the form has been simplified.
- New definitions: “major species” (points 1–4 of the new Annex V) and “minor species”; rabbits and horses not used for food belong to the Leporidae and Equidae rather than to pets. Annex III of the Regulation contains a correspondence table between the old and new names of animal categories, for applications to modify or renew authorisations.
- The minimum duration of long-term efficacy studies in the new Annex IV includes: chickens for fattening 35 days; laying hens, turkeys for fattening, veal calves, cattle for fattening and salmonids 84 days; lambs and kids 56 days; pigs for fattening until slaughter but at least 70 days; honey bees, dogs, cats and other pets 28 days. A recital notes that EFSA recommended shorter studies for laying hens and for salmon and trout, among others.
- For species with no value in Annex IV, the duration for the physiologically related major species applies, otherwise 42 days for growing animals and 56 days for adults; the observation period may not be shorter than 28 days. The Regulation also replaces the tables on the duration of tolerance trials — e.g. laying hens 56 days, salmon and trout 90 days (Annex II, point 3.1.1.2, Tables 2 and 5). The Regulation applies from 16 December 2026.