Regulatory classification and strategy for feed products, materials and additives
When developing a new feed product or ingredient, one of the first questions is how the product is regulated. Depending on its characteristics, composition and intended use, a product may be considered a feed material, feed additive, complete or complementary feed, food ingredient or, in some cases, a medicinal product.
Correct regulatory classification provides the basis for product development and market entry. Medfiles supports companies in determining the regulatory status of feed products and ingredients, identifying applicable requirements and defining a suitable regulatory strategy – with 25+ years of experience.
Medfiles team also provides classification and registration services for veterinary medicinal products.
Feed Regulatory GO/NO-GO Assessment
Is your feed product or ingredient concept feasible from a regulatory perspective?
Before investing further in product development, studies or market entry, it can be useful to identify potential regulatory barriers and determine whether the concept is worth taking forward. Our fixed-fee Feed Regulatory GO/NO-GO Assessment provides an early regulatory view of your product or ingredient and the key issues that should be considered before further investment.
Choose the level of support:
- High-level GO/NO-GO Assessment: a first regulatory assessment for early-stage decision-making. Suitable when the main question is whether the product concept appears feasible and worth investigating further.
- Detailed GO/NO-GO Assessment: a more comprehensive assessment when greater regulatory certainty is needed before proceeding with product development or market-entry activities.
What’s included?
- Preliminary or detailed regulatory classification
- Assessment of whether the product is a feed material, feed additive or borderline product
- Identification of key regulatory gaps, red flags and potential blockers
- Initial assessment of applicable regulatory requirements
- Considerations related to intended use, claims and labelling
- Assessment of potential authorisation or registration requirements
- Recommended next steps
Interested to know more? Book a free 30-minute meeting to discuss your plans and assessment scope, package options and pricing.
Feed Regulatory classification and positioning
Medfiles supports the classification and regulatory positioning of feed products and ingredients, including:
- Determination of the regulatory status of a product or ingredient
- Assessment and positioning of borderline products
- Classification as a feed material or feed additive
- Classification of feed products, such as complete, complementary or dietetic feed
- Feed additive classification and identification of the applicable functional group
- Planning of regulatory strategy and pathway
Regulatory classification can be provided as an individual expert assessment or as part of broader regulatory support.
Evaluation of feed products and ingredients
We can also assess the regulatory compliance of product formulations and raw materials, including:
- Ingredient compliance
- Raw material and recipe reviews
- Nutritional content and nutrient calculations
- Raw material specifications, quality and safety
- Intended use
- Relevant regulatory requirements
Support can be provided for individual regulatory questions as well as broader product development projects.
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FEED MATERIAL AND FEED ADDITIVE REGISTRATION AND AUTHORISATION
Once the regulatory status is established, Medfiles can help determine what regulatory steps, documentation and data are needed to proceed. Support can include planning the regulatory pathway, identifying data requirements and determining whether registration or authorisation is required.
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
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.
Contact us
You may also be interested in:
- For novel food ingredients, the faster EU market access is to sell them first as feeds and cosmetics
- Generally Recognised As Safe (GRAS) – the faster regulatory pathway to food and feed market
- Algiecel & Medfiles: Collaboration to shed light on the regulation of novel feed and cosmetic ingredients in the EU
- Orion & Medfiles: 15 years of cooperation in food supplements, cosmetics and animal feed
- Importance of regulatory knowledge in transforming science to commercial food and feed products
- Food and feed innovation funding: key programmes and requirements
- Medfiles’ expert’s thoughts on animal feed trends in the changing world
- 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