Feed regulatory services in the EU, UK and USA – product classification, registration and labelling

Registration of Feed Materials and Additives in the EU, UK and USA

When developing new feed materials or additives, it is essential to understand the regulatory requirements of each market. In the EU and UK, feed materials must be registered, but no prior authorisation is required, while feed additives must be authorised and re-authorised every 10 years. In the USA, both feed materials and additives require approval. Our feed team supports you at all stages of the process – including renewals of existing authorisations.

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.

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.

See also:

• UK-EU SPS Agreement: What could alignment with EU rules mean for GB market authorisations of food and feed products
• What’s on the horizon for feed additives regulatory affairs in the EU and UK
• Algiecel & Medfiles: Collaborating on EU Regulation for novel feed and cosmetic ingredients
• For novel food ingredients, the faster EU market access is to sell them first as feeds and cosmetics
• Importance of regulatory knowledge in transforming science to commercial food and feed products
• GRAS – the faster regulatory pathway to food and feed market
• Is the self-affirmed GRAS pathway coming to an end?
• Animal feed trends in the changing world
• Will the algae-based new foods feed Europe’s population?
• Meet our people: Expertise in food and feed toxicology, risk assessment and regulatory compliance