Guidance for trials using feed additives not authorised
Guidance summary for trials using feed additives not authorised
This guidance is intended to support individuals interested in conducting a field trial, including the application submission process.
Purpose of the guidance
This guidance is intended to support individuals interested in conducting a field trial, including the application submission process.
Only feed additives which are authorised may be placed on the market, processed or used. A definition of feed additives is available.
Feed additives which are not authorised may be used for a scientific trial only following the approval of an application made to either the Food Standards Agency (FSA) or Food Standards Scotland (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), as amended, please initially direct your query to the Veterinary Medicines Directorate (VMD: postmaster@vmd.gov.uk). To conduct a clinical field trial of a veterinary medicine in animals in GB and/or NI, i.e., under normal conditions of animal husbandry or as part of routine veterinary practice, applicants must first be granted an Animal Test Certificate (ATC) by the VMD.
The applicant will need to consider whether a Home Office licence is required to undertake the feed trial, in addition to an agreement from the FSA; for example, if blood or rumen sampling is proposed during the trial. Please refer to the Home Office guidance on animal testing and research for more information about the licences required under the Animals (Scientific Procedures) Act (ASPA) 1986 to conduct ‘regulated’ scientific procedures in animals.
Legal status of the guidance
Regulatory Compliance: This Guidance is in compliance with all relevant assimilated EC regulations refrenced in the 'purpose' section of this page.
Who is this publication for?
- farmers and growers
- manufacturers and processors
- other (individuals or organisations intending to submit feed additive trial applications)
Which UK countries does this guidance apply to?
- England
- Wales
- Northern Ireland
Review date
We will review this guidance by April 2027.
Key words
- meat and livestock
- products (for example: eggs or milk from animals fed the additive)