Feed additives authorisation guidance

Feed additives are products authorised for specific purposes in animal feed, for example:

• in meeting the animals’ nutritional requirements
• to improve the quality of feed and the quality of food from animal origin (i.e. meat, fish, milk, eggs)
• to improve the animals’ performance and health

Feed additives must be authorised before they are placed on the market in Great Britain (GB) and may only be used for the purpose stated in the authorisation.  If a feed additive is intended to perform more than one function, a separate authorisation is required for each function. They are generally authorised for ten years.

Register of feed additives

The register of feed additives sets out a list of feed additives permitted for use in Great Britain and provides reference to the individual feed additive legislation. The register does not replace assimilated Regulation (EC) 1831/2003 which is the legal basis for the placing on the market and use of individual feed additives.

Feed additive legislation

Assimilated Regulation (EC) 1831/2003 and assimilated Commission Regulation (EC) No 429/2008, outline the authorisation procedure for these substances, and explain the:

• rules on feed additive authorisations
• conditions of use for additives
• provisions on the labelling of feed additives and their premixtures which must be adhered to
• detailed requirements for submitting an application

The authorisation process includes an evaluation of the analytical method provided by the applicant. For applications submitted within GB, the evaluation is completed by the Reference Laboratory (LGC Ltd). Further information on the evaluation can be found on the Authorisation of Feed Additives for Great Britain (GB) page of the LGC Group website.

Tasks assigned to the reference laboratory are set out in assimilated Commission Regulation (EC) No 378/2005.

Application process

To apply for an authorisation of a feed additive in GB:

1. Use our regulated products application service to complete the application form. You will be asked to upload all the documents to support your application, taking into account the requirements in assimilated law and following the EFSA guidance as appropriate.
2. You should also upload documentation on the analytical method and any relevant information needed for the Reference Laboratory to undertake an evaluation of the method. If relevant, submit the EU No Fee Acknowledgement Letter or make reference to any evaluation which may have already been undertaken by the EU Reference Laboratory on the feed additive in question. Make it clear in your application if you consider that Article 5(4) of assimilated Commission Regulation (EC) No 378/2005 applies and that the conditions for placing the feed additive on the market fall within the scope of a previously evaluated method.
3. If the method requires a full evaluation, the Reference Laboratory (LGC) will contact you to agree and set out the process for payment of any fees. If applicable, LGC will also provide details on how to send the three samples (and standards) to the Reference Laboratory.

Detailed application guidance

The European Food Safety Authority (EFSA) has previously developed technical guidance on the requirements of application dossiers. This guidance generally remains relevant as our approach is based on EU processes. You should follow the parts that relate to the development of dossiers only and not the application process:

• EFSA guidance for feed additive applicants
• (applicable to applications submitted until 26 March 2021)

Existing authorisations

If your feed additive was authorised by the European Commission (EC) and the Regulation entered into force before 1 January 2021 and the necessary legislation is in place, that authorisation will remain valid in Great Britain.

Re-authorisation of feed additives

Ongoing applications submitted to EU for existing feed additives under Article 10 of Regulation 1831/2003 will still need to be submitted to us but there are no immediate deadlines for doing this. We will review these feed additives and provide further information on submission requirements and deadlines in due course.

All other feed additive applications

Similarly, applications for renewal previously submitted to the EU before 1 January 2021 for which the assessment process was not completed do not need to be submitted until requested.  Applications after 1 January 2021 should be submitted to us using our regulated products application service.

These include:

• new authorisations (Article 4 of Regulation 1831/2003)
• modification to authorisation (Article 13)
• renewal of authorisations (Article 14)- to be submitted at least one year prior to the authorisation expiry date. 

When completing the application, you will be asked to provide your EFSA question number where applicable.

Urgent authorisations

Urgent authorisation for feed additives may be progressed to ensure the protection of animal welfare. Urgent authorisations may be granted for a maximum period of five years.

How long will my application take? 

The legislation includes deadlines for key steps in the process. In most cases, applications will take at least a year.  

The quality of the dossier, and the information provided will significantly affect the time needed for assessment and authorisation. We encourage applicants to follow the guidance and provide all the required information to ensure we can process your request as efficiently as possible.

Getting help

If you have any questions about the authorisation procedure or application requirements, you can contact us at regulatedproducts@food.gov.uk

Apply for authorisation

You can now use our online service to make a regulated product application.