Permission to carry out tests with additives for animal feed

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 requested. 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 whatsoever can be granted for antibiotics.

The Veterinary Medicinal Products Unit handles the request. 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 for confirming that the tests are being 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 submit a request accompanied by a number of appendices, according to the instructions. These appendices can be sent in a zip file.

Send the application to infobd@cbg-meb.nl.

Procedure for handling the request

Applications for permission are handled 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 considered.

If the application turns out after assessment to be insufficient, 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 sought to address particular aspects; this will be at the applicant's expense.

The Product Authorisation Advisory Committee (APR) gives recommendations about the request (preferably within thirty days of the completed application being accepted for handling). The following parties are represented in this committee:

  • The Ministry of Agriculture, Nature and Food Quality (LNV)
  • The Ministry of Health, Welfare and Sport (VWS)
  • Netherlands Food and Consumer Product Safety Authority (NVWA)
  • RIKILT Wageningen University & Research
  • National Institute for Public Health and the Environment (RIVM)
  • Veterinary Medicinal Products Unit

If the Product Authorisation Advisory Committee’s opinion is favourable, the head of the Veterinary Medicinal Products Unit grants permission for testing to the applicant on behalf of the minister of Agriculture, Nature and Food Quality (LNV) as a written decision.

Tests as 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 granting test permission. This is stated in Article 19 of the Rules issued by the State Secretary of Economic Affairs on 20 February 2014, no. WJZ/14033284, concerning the determination of fees for activities of the NVWA (Netherlands Food and Consumer Product Safety Authority - fees arrangement).

This arrangement also determines the rates for the Veterinary Medicinal Products Unit for issuing the test permission.

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 have been detailed in the assessment guidelines of Regulation 429/2008 issued by the European Commission.

Legal basis

The MEB Agency, Veterinary Medicinal Products Unit performs these tasks at the request of the Ministry of Economic Affairs. This unit is the competent authority for issuing authorisation in the form of written decisions on behalf of the State Secretary of Economic Affairs.

Authorisation can be issued according to Regulation (EC) No 1831/2003.

Note: a separate permit is required for genetically modified organisms
If the product contains a genetically modified organism (GMO), a separate permit may be required to allow animal testing, based on the GMO Decree. The company can request such a permit from the GMO Desk of the Ministry of Infrastructure and the Environment.

For authorisation to carry out tests with a GMO or with a product derived from one, it must be demonstrated that the product is safe.