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Navigating updates in EU feed additives regulations: Three new guidance documents

Navigating updates in EU feed additives regulations: Three new guidance documents

We are eager to inform you about significant regulatory updates in the animal feed industry.

Regulation (EC) No. 1831/2003 establishes the rules for registering feed additives for use in animal nutrition, and Regulation (EC) No. 429/2008 provides instructions for the preparation of feed additive registration applications. To complement the regulations, the European Food Safety Authority (EFSA) has adopted a series of guidance documents to aid applicants in preparing and submitting technical dossiers, some of which are currently undergoing an update process.

Efficacy of feed additives

The guidance on the assessment of the efficacy of feed additives is being updated to stimulate innovation and sustainability, in particular for additives that are beneficial for the environment and animal welfare, as outlined in the Green Deal.

The draft version is published and is under public consultation until the 9th February 2024. Be sure to check out what is new:

  • More detailed evaluation criteria for feed additives belonging to new functional groups, such as hygiene condition enhancers or physiological condition stabilisers
  • A new requirement for providing a certification of compliance of animal studies with the EU welfare legislation as part of animal trial reporting

Other critical updates include:

  • A more detailed explanation of the requirements to demonstrate efficacy for nutritional additives, silage additives, substances which favourably affect the environment, coccidiostats and histomonostats
  • Higher flexibility in the experimental design of in vivo trials
  • A refinement and reduction of the number of required animal studies, especially when an application involves multiple target species
  • A description of the efficacy requirements for new species such as insects
  • The definition of an independent study

User safety

Updated guidance on user safety, taking into consideration recent scientific developments and experience, will be put into effect on the 15th February 2024. Be sure to consider the final version for any upcoming applications.

Characterisation of microorganisms

The guidance on the characterisation of microorganisms used as feed additives or as production organisms, and the EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain, will also be updated in the first half of 2024, considering the fast developments in this field.

Stay tuned for more important updates coming up!

Please contact us if you have any comments you would like us to share with authorities on your behalf, questions about the interpretation, or require assistance navigating these updates. Our experienced team is happy to provide support.

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