Feed material and feed additive registration and authorisation in the EU, UK and USA

FEED MATERIAL AND ADDITIVE REGISTRATION AND AUTHORISATION

Once the target market and regulatory route have been established, Medfiles can support the registration or authorisation process from planning through submission.

Gap analysis, literature review and data collection

We perform gap analyses to assess whether your documentation is complete and compliant. This provides a clear overview of:

• which requirements are already met
• what additional data is needed
• what gaps remain to be filled

We prepare literature reviews and help collect the required data and studies. Through our extensive laboratory and research network, we can arrange compositional analyses, feeding trials in food-producing or companion animals, or studies required for occupational safety assessments.

Pre-submission consulting

We help define the data and studies required before writing and submitting the application. We also assist in early consultations with EFSA (EU), FSA (UK) or FDA (USA).

EFSA pre-notifications

For EU applications, EFSA requires early notification of studies – often before dossier preparation begins. Medfiles can manage these notifications on your behalf.

Safety Data Sheets (SDS)

When placing feed materials or additives on the EU or UK markets, a compliant Safety Data Sheet (SDS) is required. SDS documents are not only a legal obligation but also a key tool for ensuring safe handling, storage and use of products.

Medfiles provides SDS drafting or updates through our audited partners, ensuring compliance with current legislation.

EU Representative for Non-EU Feed Companies to submit the application

If your company is based outside the EU and wishes to market feed additives in the EU, legislation requires you to appoint an EU-based representative. Medfiles can act as an EU representative for applications, managing submissions and authority communications on your behalf to ensure compliance and smooth processing.

Registration of Feed Materials and Additives for Different Markets

We support the preparation of application dossiers and safety assessments for submissions in the EU, UK and USA, including all interactions with EFSA, the European Commission, FSA or FDA. See also feed registration services for US market (GRAS & FAP).

We ensure your dossier meets all requirements from the outset, preparing all sections: product details, background, exposure estimates for animals (and humans, where applicable), scientific evidence and a comprehensive safety assessment.

If your target markets include Asia (e.g. South Korea, China, Japan), Canada, South America or other countries, we work with our audited international partners to support registrations in these regions as well.