The Authorisation Process for Feed Additives
By Apheya Animal Nutrition www.apheya.com
We have worked with a number of clients helping them prepare documentation for new feed additives and advising them of the information required for the different types of feed additives. This information is in-depth and complex, and depends upon the type of additive being developed, but here is a brief insight into the work behind the products listed in Annex I of the EU Register of Feed Additives.
Feed additives are defined in Regulation EC 1831/2003 Article 2 as ‘substances, microorganisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to perform, one or more of the functions’:
- Favourably affect the characteristics of feed
- Favourably affect the characteristics of animal products
- Favourably affect the colour of ornamental fish and birds
- Satisfy the nutritional needs of animals
- Favourably affect the environmental consequences of animal production
- Favourably affect animal production, performance or welfare, particularly by affecting the
- gastro-intestinal flora or digestibility of feedingstuffs, or have a coccidiostatic or histomonostatic affect
Annex I of Regulation 1831/2003 lists the different groups of feed additives including:
1 Technological feed additives – preservatives, antioxidants, emulsifiers, stabilisers, thickeners,
gelling agents, binders, substances for control of radionucleide contamination, anticaking agents, acidity regulators, silage additives, denaturants
2 Sensory additives – colourings, flavouring compounds
3 Nutritional additives – vitamins, pro-vitamins and chemically well-defined substances, compounds of trace elements, amino acids, their salts and analogues, urea and its derivatives
4 Zootechnical additives – digestibility enhancers, gut flora stabilisers, substances which favourably effect the environment, coccidiostats and histomonostats This regulation states that in order to protect human health, animal health and the environment, all feed additives must undergo a safety assessment through a Community procedure before being placed on the market, used or processed within the Community. This safety assessment is done by the European Food Safety Authority (EFSA), in conjunction with the European Commission (EC) to whom the feed additive application is made, and the European Union Reference Laboratory (EURL) to whom reference samples of the feed additive are sent.
Applicants wishing to have a product approved or reapproved as a feed additive must submit a technical dossier to EFSA. This has four main sections and an example of the contents for technological additives includes:
- Identity, characterisation and conditions of use of the additive – identity, name, how the additive will be classified e.g. 1K is a silage additive, purity, batch to batch variation, impurities and contaminants e.g. lead, cadmium, aflatoxin, mycotoxins, salmonella, E. coli, dusting potential and particle size distribution, genotypic identification (microorganisms), toxins and virulence factors, the manufacturing process for the additive and active ingredient, stability in storage and water if applicable, proposed use and level of inclusion incomplete feedingstuffs or water
- Studies concerning the safety of the additive – tolerance studies for the target species, safety of use of the additive for consumers, safety of use of the additive for users / workers and safety of use of the additive for the environment.
- Studies concerning the efficacy of the additive – different feed additive categories (shown above) have different requirements relating to the claim being made, for example preservative should demonstrate inhibition of microbial growth, antioxidants should demonstrate protection against oxidative damage of key nutrients / components during feed processing and/or storage, and a silage additive should demonstrate improved production of silage, and if claimed, inhibition of undesirable microorganisms, reduction of effluents and improved aerobic stability.
- Post-market monitoring plan – only required for additives that are products consisting of containing or produced from GMOs
The additive dossier is reviewed over a period of time by EFSA’s feed additives panel and then a decision is made of whether the additive can be approved for use. If this is successful then EFSA notify the EC and the EC write new or update current legislation authorising the additive. This might involve updating the EU Register of Feed Additives and the most up to date version of Annex I of this list showing all additives authorised for use is available at:
https://ec.europa.eu/food/safety/animal-feed/feed-additives/eu-register_en
