Feed regulatory services in the EU, UK and USA – product classification, registration and labelling
When developing or placing animal feed on the market – including innovative products based on side streams or cellular agriculture – regulatory expertise and professional support are essential. Medfiles helps ensure your feed products meet all requirements and are suitable for the target markets.
We support you from product development through to registration and labelling – or step in at the stage where you need expertise the most. Our services are tailored to your needs, taking into account the characteristics of your feed products and factors affecting marketing. In addition to feed regulatory services, we also provide regulatory affairs and pharmacovigilance services for veterinary medicines.
Feed Regulatory Services for Feed Materials, Additives and Products
Feed materials / additives
- Regulatory classification of feed materials and additives
- Gap analysis for safety assessment of feed materials/additives
- Feed material registration
- Feed additive applications
- Consulting support on safety assessments and registration dossiers
- Preparation of Safety Data Sheets (SDS) for feed materials/additives
Feed products
- Feed classification
- Ingredient compliance
- Feed labelling (Finland and Sweden only)
- Feed marketing claims (Finland and Sweden only)
- Raw material specification review
- Nutrient content calculations
- Outsourced regulatory expert for your company
Read more about our feed regulatory services
Feed Regulatory Classification, Consulting and Strategies
Regulatory classification of feed products, assessment of applicable requirements and development of market-entry strategies for feed materials, additives and borderline products.
Feed Material and Additive Registration in the EU, UK and USA
Regulatory support throughout feed material registration and feed additive authorisation processes, including dossier preparation, submissions, authority interactions and renewals.
Feed Materials and Additives in the USA: GRAS and FAP
Strategic assessment of US regulatory options for feed ingredients and additives, including the suitability of GRAS or FAP routes and support with the required documentation.
Feed Labelling and Marketing Materials in the Nordics
Regulatory review of feed labels, product claims and marketing materials to ensure compliance with EU requirements and national legislation in the Nordic countries.
Feed for Particular Nutritional Purposes (Dietetic Feed)
Regulatory classification, assessment of permitted claims and support with compliance requirements for dietetic feed, including new intended nutritional purposes.
In addition to above services, our experts can act as part- or full-time outsourced resources at your company in challenging situations. With the help of an outsourcing regulatory service, you can patch up your staff gap or get a replacement to fill in for example for a permanent employee during maternity leave or sick leave. Our experts can assist, for example, as product information or registration specialists.
insights into animal feed
Our expert team regularly writes blogs about feed. Topics include animal health and feed industry trends, as well as feed registration and labelling.
Feed Materials and Additives in the USA: GRAS and Food Additive Petitions (FAP)
US feed legislation differs significantly from EU rules. In the USA, new feed materials also require registration – unlike in the EU or UK. The key registration routes for feed materials and additives are GRAS (Generally Recognized As Safe) and FAP (Food Additive Petition). It is crucial to determine which route applies. FAP is required if the product does not qualify as GRAS, and it is a more demanding and lengthy process.
GRAS registration may be completed as self-affirmed GRAS or as FDA-notified GRAS. In both cases, evaluation by a GRAS Expert Panel is required. FAP applications must always be submitted to FDA. Medfiles supports you in both routes – from assembling the GRAS Expert Panel to managing submissions, and preparing FAP applications where required.
Explore our services on feed material and feed additive registration and authorisation in the EU, UK and USA.
See also:
Feed Labelling and Marketing Materials for the Nordics
Labelling of feed for pets and food-producing animals must comply with Regulation (EC) No 767/2009 and the local legislation of each target country. Correct labels are essential for compliance and for clear communication with both consumers and authorities.
Medfiles prepares, reviews and translates feed labels for the Nordic markets, covering:
- Compliance of claims and images used on packaging
- Classification of the feed (complete feed, complementary feed, mineral feed, dietetic feed)
- Mandatory labelling information and language requirements
- Product name and indication of target animal species
- Composition and nutrient content declarations
- Compliance of claims and images used on packaging
Marketing content
We also provide marketing content creation and review for feed products – from online product descriptions and blog posts to guides, social media campaigns and articles. All content is written and reviewed by experts, ensuring compliance with feed regulations and guidances. Content can be produced in Finnish, Swedish and English.
See also:
Feed for Particular Nutritional Purposes
Feed intended for particular nutritional purposes (dietetic feed) is strictly defined in legislation and must bear the label “dietetic feed”. Approved health-related claims may be used if authorised by legislation. Medfiles supports you in classification, claim assessment and in meeting the detailed requirements for new dietetic feeds, including new intended uses.
See also: Preparing a PARNUT application in the EU: what EFSA’s new guidance will mean for companies
Feed regulatory Team
Medfiles’ feed regulatory experts have more than 25 years of experience in feed safety regulation. Our extensive knowledge in feed legislation, registrations, market entry, and safety and risk assessment has been gained through work in national authorities, EFSA, the European Commission and the feed industry. Our dedicated team includes registration specialists, chemists, a toxicologist, a risk assessor, and other feed safety professionals.
This is how Medfiles’ clients describe the cooperation
The Medfiles regulatory specialists clearly knew what they were doing and were very organised. We felt that we could trust them and that they would be honest with us. They were also able to point out the regulatory pitfalls. We felt that if we needed to ask any further questions, we would choose Medfiles again. –Algiecel
We have received a thorough and professional service from Medfiles. Medfiles has shown excellent expertise and service spirit, even in complex matters. They have provided us with answers quickly and have been very helpful in moving things forward. -Orion
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You may also be interested in:
- Medfiles experts’ article on IAHJ: Bringing novel foods to market: a guide to the EU, UK and US regulatory pathways
- The proposed FDA GRAS rule is out for a 120-day comment period: what will change if the rule is adopted
- Preparing a PARNUT application in the EU: what EFSA’s new guidance will mean for companies
- 3 trends affecting the animal health industry in 2026
- UK-EU SPS Agreement: What could alignment with EU rules mean for GB market authorisations of food and feed products
- European Biotech Act: what it means for EU food and feed regulation
- What’s on the horizon for feed additives regulatory affairs in the EU and UK
- Food and feed innovation funding: key programmes and requirements
- Free webinar: Regulatory aspects of feed labelling in the EU – overview
- Orion & Medfiles: 15 years of cooperation in food supplements, cosmetics and animal feed
- Algiecel & Medfiles: Collaboration to shed light on the regulation of novel feed and cosmetic ingredients in the EU
- For novel food ingredients, the faster EU market access is to sell them first as feeds and cosmetics
- Will algae-based new foods soon feed Europe?
- Medfiles’ expert’s thoughts on animal feed trends in the changing world
- Generally Recognised As Safe (GRAS) – the faster regulatory pathway to food and feed market
- Is the self-affirmed GRAS pathway coming to an end?