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. Additives must be authorised for use by the European Union.
If you want to put animal feed on the market with an additive that has not yet been authorised, the safety and efficacy of the additive has to be examined first before the authorisation can be applied for. Permission is required for such research. No permission whatsoever can be granted for antibiotics.
The use of other substances that have not been authorised (such as inert substances) falls outside the scope of applications to carry out testing. You will need to apply for a licence for the use of veterinary medicinal products, animal feed or other substances in a test based on Section 2.1(1) of the Veterinary Medicinal Products Decree 2022 for this. This licence application should be submitted to the Netherlands Food and Consumer Product Safety Authority via erkenningen@nvwa.nl.
Application for permission to carry out testing
You can apply for permission from the MEB Agency, Veterinary Medicinal Products Unit (VMPU) using the Application for permission to carry out tests involving additives for animal feed form. Carefully read through the instructions before completing the application form. You must also submit various appendices with the application.
Procedure for processing the application
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, Fisheries, Food Security and Nature (LVVN). 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 to be insufficient following assessment, you will be given the opportunity to provide additional information. If the application remains insufficient, certain (stricter) requirements will be imposed on the granting of permission to test, or this permission will not be granted.
The Product Authorisation Advisory Committee (APR) will provide an opinion on the application. The following parties are represented in this committee:
- Ministry of Agriculture, Fisheries, Food Security and Nature (LVVN);
- Ministry of Health, Welfare and Sport (VWS);
- Netherlands Food and Consumer Product Safety Authority (NVWA);
- Wageningen Food Safety Research (WFSR);
- National Institute for Public Health and the Environment (RIVM);
- MEB Agency, Veterinary Medicinal Products Unit (VMPU).
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, Fisheries, Food Security and Nature. Applicants who do not agree with the decision can lodge an objection within six weeks. After permission has been granted, the Food and Consumer Products Safety Authority (NVWA) is informed and may carry out checks. These checks are intended to confirm that the tests are carried out in accordance with the conditions. You can start carrying out tests on the date indicated. You do not need to wait for any checks.
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. Applicants are therefore expected to clearly inform all parties concerned about all important aspects and to come to appropriate agreements.
Deadlines for handling applications
The Veterinary Medicinal Products Unit aims to process applications within eight weeks of the complete application having been submitted. If necessary, the decision period can be extended once by a reasonable period (this is usually six weeks). In this case, we will inform you of this decision to extend this period within the initial decision period. It is therefore important to submit your application some time before you intend to start testing.
As soon as an application is submitted, the Veterinary Medicinal Products Unit first checks whether the application is complete. We call this the validation phase. If the application is not yet complete, we will first ask you to complete it. Once we have received the additional information, we will forward the application to the APR. The APR may also request additional information. In this case, the decision period will be suspended (clock stop). Once this information has been submitted as well, the substantive assessment of the application will begin (the assessment phase).
The intention is to inform you of whether the application is complete within 14 days of submission of the application. You will then receive a message stating that the substantive assessment of the application (assessment phase) has begun, or you will be requested to provide additional information. The APR may ask additional substantive questions during the assessment phase. In this case, the decision period will again be suspended (clock stop). Once these questions have also been answered, a decision will follow, of which you, as the applicant, will be informed in writing. Applicants who do not agree with the decision can lodge an objection within six weeks.
Withdrawing the application
If you are unable to provide all necessary information, or if you would like to withdraw the application for a different reason, you can submit a request to withdraw your application to diervoeders@cbg-meb.nl. We will then cease handling of your application. This way, you can avoid extra costs being charged for further handling of your application. Any assessment costs already incurred will still be charged.
Costs
The applicant pays the Veterinary Medicinal Products Unit for handling the application for permission. This is stipulated in Section 59(1) of the Animal Feed Regulation. This concerns an hourly rate. You should therefore take care to submit an application that is as complete as possible, since a clear and complete application can be processed more swiftly.
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 guidelines of Commission Regulation (EC) 429/2008.
More information
If you have any other questions, please contact the Veterinary Medicinal Products Unit by sending an email to diervoeders@cbg-meb.nl.