Additives are often processed in animal feed in order to improve the quality of the feed or the welfare of the animal. Vitamins, preservatives and probiotics are well-known examples of additives. An additive must be licensed for use by the European Union.
If you want to put animal feed on the market with an additive that has not (yet) been licensed, the additive has to be examined first before the licence can be applied for. You can apply for permission to carry out tests. You can also apply for an extension or change to the testing for the additive. No permission can be granted for antibiotics.
The Veterinary Medicinal Products Unit processes the application. After permission has been granted, the Food and Consumer Products Safety Authority (NVWA) are informed and they may carry out checks. These checks are intended to confirm that the tests are carried out in accordance with the conditions.
Application for permission to carry out testing
You can apply to the Veterinary Medicinal Products Unit for permission. To do so, you should submit an application accompanied by a number of appendices, according to the instructions. These appendices can be sent in a zip file.
You should send the application to infobd@cbg-meb.nl.
Procedure for processing the application
Applications for permission are processed according to a set procedure.
The Veterinary Medicinal Products Unit coordinates, prepares recommendations and grants permission on behalf of the Minister of Agriculture, Nature and Food Quality (LNV). In addition, the Veterinary Medicinal Products Unit checks that all the requested information has been provided. Incomplete applications will not be processed.
If the application turns out to be insufficient after assessment, you will be allowed to provide additional information. If the application remains insufficient, certain (stricter) requirements will be imposed on the granting of permission to test. It may be necessary for an expert opinion to be obtained at the applicant's expense in order to address particular aspects.
The Product Authorisation Advisory Committee (APR) issues recommendations on the application (preferably within thirty days of the completed application being accepted for processing). The following parties are represented on this committee:
- The Ministry of Agriculture, Nature and Food Quality (LNV)
- The Ministry of Health, Welfare and Sport (VWS)
- The Netherlands Food and Consumer Product Safety Authority (NVWA)
- Wageningen Food Safety Research
- The National Institute for Public Health and the Environment [Rijksinstituut voor Volksgezondheid en Milieu] (RIVM)
- The Veterinary Medicinal Products Unit
If the Product Authorisation Advisory Committee’s opinion is favourable, the head of the Veterinary Medicinal Products Unit will grant permission for testing to the applicant on behalf of the minister of Agriculture, Nature and Food Quality (LNV) as a written decision.
Tests described on the application form usually comprise a range of different activities carried out by several individuals, companies and/or institutions. As the applicant you are responsible for the entire array of tests described in the application form. You are therefore expected to inform all parties concerned clearly about all important aspects, and to come to appropriate agreements.
Costs
The applicant pays the Veterinary Medicinal Products Unit for processing an application for permission. This is stated in article 59( 1) of the Regeling diervoeders.
Legal basis
Permission to carry out tests with additives for animal feed is based on Article 3 paragraph 2 of EC Regulation no. 1831/2003.
In brief this states that the authorities can allow scientific tests to be carried out using unlicensed additives for animal feed as long as certain conditions are met and as long as supervision by the authorities is ensured. The animals used may only enter the food production chain if this does not have an adverse effect on animal health, human health or the environment (Article 5 paragraph 2.a of Regulation 1831/2003).
The conditions are detailed in the assessment of the European Commission's Regulation 429/2008.