Guidance for trials using feed additives not authorised

Guidance for trials using feed additives not authorised

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Application process Trial Information required Contact details

Overview

Only feed additives which are authorised may be placed on the market, processed or used. Read our information on the legislation which applies to feed additives. A definition of feed additives is available on the Food Standards Agency (FSA) website.

Feed additives which are not authorised may be used for a scientific trial only following the approval of an application made to either the FSA or FSS.

Prior to EU exit, the FSA was the competent authority carrying out animal feed trial authorisations on behalf of UK. Following EU exit, the decision to approve trials in GB transferred and now rests with respective Ministers. In accordance with Regulation (EC) 1831/2003) Article 3 (2) ‘For experiments for scientific purposes, the appropriate authority (i.e. Ministers) may authorise the use, as additives, of substances which are not authorised, with the exception of antiobiotics, provided that the experiments are carried out in accordance with the principles and conditions laid down in Regulation 767/2009 or the guidance set out in in Article 7(4) of this Regulation and provided that there is adequate official supervision. The animals concerned may be used for food production only if the authorities (i.e.  FSA/FSS and Ministers) establish that this will have no adverse effect on animal health, human health or the environment’. Therefore, the final decision as to whether to authorise a trial and whether animals from the trial can enter the food chain lies with the Minister. The decision to approve trials in Northern Ireland (NI) is the FSA’s responsibility.

These trials are specific to feed additives, and do not apply to other feedstuffs such as feed materials, which do not require authorisation before market use.

For coccidiostats and histomonostats, or any other substance that could be considered a veterinary medicine under The Veterinary Medicines Regulations 2013, please refer to relevant websites at the end of this guidance

Application process

The process for GB is set out in legislation (Article 3(2)) in Regulation (EC) 1831/2003 on additives for use in animal nutrition. Regulation (EC) 1831/2003 sets out the requirements for trials in NI. These regulations allow for the use of feed additives not authorised in trials.

Annexes II and III of assimilated Commission Regulation (EC) 429/2008 and for NI Regulation (EC) 429/2008 can be used as a guide as to what information might be submitted.

FSA/FSS requests that feed additive trial applications are submitted at the earliest opportunity. If information required for the safety evaluation of the trial is not provided in the original submission, supplementary information will be requested and the application will be paused until supplementary information is received.

The FSA/FSS application process is expected to take 12 weeks, although timescales may vary depending on whether additional information is required.

The application process consists of an FSA/FSS review of the safety of the feed additive itself, and an appraisal of the trial design undertaken by an expert third party organisation in confidence.

The information provided by applicants will only be shared with those involved in the authorisation process.  FSA/FSS complies with UK Privacy Laws, including the application of  UK General Data Protection Regulation (GDPR) and Data Protection Act 2018.

Information required

  • FSA/FSS Feed additive Trial Application Form Applicants must complete the trial application form and return to the FSA/FSS.

  • The trial (experimental) protocol. Applicants must supply the full trial protocol when submitting an application.

  • Risk assessment of the animal feed trial. A risk assessment should be undertaken by the applicant and should include consideration of safety for humans, animals and the environment. Supporting data may be required, for example characterisation information of the additive. Justification should be provided if any of these are not submitted. If further information is required, the applicant will be contacted by the FSA/FSS.

Any changes to the trial will require an updated FSA/FSS trial protocol, to be sent to FSA/FSS.

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Form

FSA and FSS feed additive trial application form

Related

Risk assessment for UK feed trial application for feed additives not authorised