Novel Food Registration - Overview
The European Union (EU) is a thriving market for food supplements, attracting companies in the industry. However, the EU’s food supplement regulations are implemented at the national level, following Directive 2002/46/EC. Merely classifying a product as a food supplement, dietary supplement, nutraceutical, Natural Health Product (NHP), complementary medicine, health food, or health supplement in other markets is insufficient for EU classification. Compliance with substance usage, maximum levels, and banned substances is crucial. It is essential to adhere to proper food labeling, advertising, and health claims to ensure safety, avoid sanctions, and prevent product withdrawal and recall.
Each EU member state has its own competent authority, which has published guidelines and opinions providing valuable guidance to Food Business Operators (FBOs) on selling and advertising food supplements in the EU. Botanicals (plants and fungi, like mushrooms) are regulated nationally, and authorities have developed positive and negative lists of plants with specific usage conditions. Most EU countries accept claims on botanicals from the on-hold health claims list, except Italy, which has its own list. Compliance with claim conditions and applicable EU regulations is the responsibility of the FBO. Health claims on vitamins and minerals are harmonized across the EU, and maximum levels may be established at the national level. Additionally, some countries have positive lists for other substances with nutritional and physiological effects. Competent authorities have provided guidance on the use of probiotics. To sell or import food supplements in the EU, including online platforms like Amazon and other e-commerce marketplaces, the product generally needs to undergo a notification procedure with the national authority of a member state. Upon completion, the product is included in a specific list with a unique registration code, verifying formula and label compliance. Nutrients used in food must have a History of Safe Use (HoSU) within the EU to be considered for use. Otherwise, they may be classified as "novel foods" requiring prior authorization at the EU level. After Brexit or for non-EU registered companies, establishing a legal entity in an EU member state or appointing a third-party Legal Representative (LR) is necessary. The representative will be mentioned on the label and act as the point of contact for the national authority.
Unlike food supplements, most food products do not require notification in the EU. However, there are exceptions for Foods for Specific Groups (FSG), such as infant formulas, follow-on formulas, Foods for Special Medical Purposes (FSMP), total diet replacement products for weight control, and fortified foods, which may include sports nutrition products and bars. These products are supervised by competent national authorities, and compliance with EU and national regulations regarding composition and labeling is essential.
Novel Food Registration in EU
Novel foods are defined as food products or ingredients that have not been consumed to a significant degree within the EU before May 15, 1997. Novel food registration in Europe is governed by Regulation (EU) 2015/2283, which came into effect on January 1, 2018. The regulation outlines the steps and prerequisites for novel food approval and marketing inside the EU.
The European Food Safety Authority (EFSA) plays a key role in the novel food registration process. EFSA conducts a thorough evaluation of the novel food's safety and potential risks to human health before providing its scientific opinion.
European Food Safety Authority (EFSA) – Food Safety
The European Food Safety Authority (EFSA) is an independent agency responsible for ensuring the safety of the food chain within the European Union (EU). It also advises on food-related risks, offering scientific and technical support to the EU risk managers and policy makers. Furthermore, the agency takes on the task of effectively communicating advice related to European food safety to the public and relevant stakeholders in the food chain, which includes primary producers and consumer organizations.
The EU food market is dynamic, requiring companies to stay updated with regulations. Freyr, with an operational center in Europe, assists Food Business Operators FBOs with end-to-end Regulatory procedures, including formula and ingredient assessment, health claims, food labeling, advertising, product notification, EU Legal Representation (LR), Regulatory updates, surveillance, and vigilance.
Novel Food Registration - Freyr Expertise
- Food Product Classification/Food Supplement Classification.
- Formula Review/Ingredients Assessment.
- Safety Assessment of Finished Products/Food Ingredients.
- Label and Claims Review.
- Nutritional and Health Claims Consultation and Substantiation.
- NHCR Claims Application (EU Register on Nutrition and Health Claims).
- Environmental Labeling/Recycling Labeling Review and Review of Green Claims.
- Packaging Material Requirements.
- Dossier Gap Analysis.
- Dossier Compilation and Submission.
- Product Compliance.
- Product Notification/Registration.
- EU Country-specific Regulatory Support.
- Regulatory Strategy for the EU.
- EU Legal Representation (LR).
- Regulatory Intelligence (RI) Report.
- Product-specific updates on the Regulatory Guidelines/Standards.
- Novel Food Registration/ Authorization Request/Traditional Food from a Third Country Registration.
- Consultation Processes for Determining the Status (novel/not novel) of a Food Ingredient.
- Regulatory Guidance on Food Products/Food Supplements Import Services in the EU.
- Translation Support.
- Review of Advertising Promotional Material.
- Food Surveillance and Vigilance.
- Post-notification/Post-marketing Follow-up.
- Management of Alerts and Authorities’ Remarks.
- FBO Registration Support.
- Communication with Health Authorities (HAs).
- Product Compliance for European Economic Area Countries Outside the EU (Switzerland, Norway, and Iceland).
- End-to-end Services for Fortified Foods, Food for Special Medical Purposes (FSMP), Infant Formula, Follow-on Formula, and other Foods for Specific Groups (FSG).
Novel Food Registration - Freyr Advantages
End-to-end Regulatory consultation.
Market-specific Regulatory consulting and advice.
Harmonized compliance, local labeling, and local market support.
Qualified team of experts with hands-on experience across all categories of foods.
Support for region-specific Regulatory activities.
Extensive partner network across the globe.
A strong relationship with various Health Authorities.