additives for use in animal nutrition

The phrase "animal feed additive" is used as a generic term. There are various different types of products, i.e.:

  1. Additives for use in animal nutrition;
  2. Feedingstuffs intended for particular nutritional purposes, also known as dietetic feedingstuffs.

A brief description of the various product types is given below. They all have a different legal basis and undergo a different authorisation procedure.

Additives for use in animal nutrition
The term ‘feed additives’ means substances, micro-organisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to perform, in particular, one or more of the following functions:

a) favourably affect the characteristics of feed;
b) favourably affect the characteristics of animal products;
c) favourably affect the colour of ornamental fish and birds;
d) satisfy the nutritional needs of animals;
e) favourably affect the environmental consequences of animal production;
f) favourably affect animal production, performance or welfare, particularly by affecting the gastro-intestinal flora or digestibility of feedingstuffs, or
g) to have a coccidiostatic or histomonostatic effect (antibiotics, other than coccidiostats or histomonostats, shall not be authorised as feed additives).

The statutory basis for additives in animal feed is Regulation EC 1831/2003. A distinction is drawn between the following categories of additives:

  1. technological additives:
  2. sensory additives
  3. nutritional additives
  4. zootechnical additives
  5. coccidiostats and histomonostats
  6. others

Zootechnical additives, coccidiostats and histomonostats, as well as products containing genetically modified organisms (GMOs) are authorisations issued to the holder of authorisation. This does not apply to other products.

NB. Any products containing GMOs are also subject to legislation and regulations governing GMOs.

Authorisations are granted for periods of ten years, irrespective of whether or not they relate to a brand-specific authorisation. Applications for marketing authorisation may be submitted to the European Commission.

For further information, visit the website of the European Commission – Animal feed safety. This contains details of the guidelines you should follow whenth compiling your dossier, the costs of applying for marketing authorisation, the status of existing products and their future reassessment.

The register of existing animal feed additives can be found at Register of Feed Additives (Community Register of feed additive van de European Commission).

If you have any further questions after reading the above, contact the Veterinary Medicinal Products Unit for more information.  

Feedingstuffs intended for particular nutritional purposes (dietetic feedingstuffs)
Dietetic feeds are supplementary or complete feedingstuffs which, by virtue of their particular composition or method of manufacture, can be clearly distinguished from both ordinary feedingstuffs and medicated feedingstuffs. The statutory basis for dietetic feeds is Regulation (EC) No 767/2009.

The phrase particular nutritional purpose is taken to mean:

‘particular nutritional purpose’ means the purpose of meeting the specific nutritional needs of animals whose process of assimilation, absorption or metabolism is, or could be, temporarily or irreversibly impaired and who can therefore benefit from the ingestion of feed appropriate to their condition.

Authorised dietetic feedingstuffs must be included in the list referred to in  Regulation 2008/38/EC.

If you would like to apply for authorisation of a dietetic feedingstuff, please contact the  Veterinary Medicinal Products Unit.

If you have any further questions after reading the above, contact the  Veterinary Medicinal Products Unit for more information.

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