The process for authorisation is set down in Regulation 1831/2003 and this requires:
- a scientific evaluation (risk assessment)
- feed additive authorisation concluded by the competent authority
This regulation sets out conditions of use for additives and provisions on the labelling of feed additives or premixtures of additives which must be adhered to. Please note that additives that are authorised in countries outside the EU are not automatically authorised for use in the UK or elsewhere in the EU.
Categories of feed additives
Additives may be put on the market and only used for the purpose stated within the authorisation.
The regulation covers the following feed additive categories:
- technological additives, eg preservatives
- sensory additives, eg flavourings and colourings
- nutritional additives, eg vitamins and minerals
- zootechnical additives, eg enzyme and micro-organisms used to affect favourably the performance of animals in good health
- coccidiostats and histomonostats (to control gut parasites)
The use of antibiotics as feed additives were previously permitted, but their use – other than coccidiostats and histomonostats – have since been prohibited.
All authorised feed additives are listed in Annex I of the Register of Feed Additives.
The Register of Feed Additives is a useful source of information about the status of feed additives. The register provides information on the authorised feed additive and its conditions for use, such as its purity, specific function and target animal species. Certain restrictions may be applied, including the setting maximum permitted levels or for its use in drinking water.
If you would like to seek authorisation for a feed additive you will need to submit:
- an application for authorisation to the Competent Authority
- a technical dossier for risk assessment
- three feed additive samples to the Reference Laboratory
Legal requirements for submitting a feed additive dossier are set out in Regulation (EC) 429/2008, whilst the European Food Safety Authority (EFSA) provides further guidance in the preparation of dossiers.
Under these regulations, feed additives are generally authorised for a ten-year period. Under previous legislation, some feed additives were authorised with no expiry date and a new authorisation was required to be submitted by 2010 for their continued use on the market.
Feed additives under withdrawal
Feed additives may be withdrawn from the market due to various reasons; such as no new application received, safety concerns raised or superseded by new innovative feed additives for example.
See Regulation 2017/1145 on most recent market withdrawals of certain authorised feed additives.
Feed additive withdrawals of particular importance
This was commonly used for the treatment of microbial contamination in animal feed, but its authorisation was denied in 2018 under Regulation 2018/183. Findings from the EFSA risk assessments could not conclude on safe levels of use for formaldehyde in target animal species.
In 2019, formaldehyde was also rejected when used as a processing aid in the detoxification process of Aflatoxin B1 (a mycotoxin) in peanuts. The Catalogue of feed materials currently allows the presence of aldehydes (including formaldehyde) when used as processing aids for rumen protection (entry #56) which is also anticipated to come under review.
This is another feed additive which has been used globally for many years as an antioxidant, where its use has now become suspended in animal feed under Regulation (EU) 2017/962. It is recognised that a risk assessment for ethoxyquin is still ongoing.
This has been on the market for many years as a gelling agent in animal feed. In 2019, the risk assessment identified a co-impurity (p-phenetidine) which may potentially be carcinogenic in the semi-purified feed-grade of cassia gum. As purified cassia gum is used in food with very low levels of this co-impurity; Regulation (EU) 2019/1947 now substitutes the purified cassia gum for use in animal feed, with the withdrawal of the semi-purified feed-grade being phased out from the market by December 2020.
Non-compliant feed additives within the Register of Feed Materials
The website for the Register of Feed Materials was significantly updated in 2019, which now includes a new function to access a list of rejected notifications. Rejected entries are based on a number of reasons (e.g. already captured within the Catalogue of feed materials but also includes entries which have been determined as being non-authorised feed additives. It is the responsibility of the Feed Business Owner to monitor the Register of Feed Materials to ensure that products of interest remain in the Register of Feed Materials as valid entries.