The European Union is a thriving market for food supplements and functional foods. However, navigating its Regulatory landscape, especially concerning novel food, can be complex. Compliance with national and EU-level regulations is vital for legal market access, product safety, and avoiding enforcement actions. Below is a complete overview of the novel food registration landscape, key definitions, processes, and how Freyr supports Food Business Operators (FBOs) in achieving compliance.
Understanding Food Supplements and Food Regulations EU
The EU regulates food supplements primarily at the national level under Directive 2002/46/EC. Merely labeling a product as a dietary supplement, nutraceutical, Natural Health Product (NHP), or complementary medicine in other markets does not qualify it as a food supplement in the EU.
Key Compliance Areas:
- Approved and banned substances
- Maximum usage levels
- Labeling and advertising requirements
- Health claim substantiation
Failure to meet these standards can result in penalties such as sanctions, product recalls, or market withdrawal.
National-Level Regulation and Competent Authorities
Each EU member state has a competent authority to interpret and enforce the directive. These authorities issue country-specific guidance for FBOs selling and promoting food supplements locally.
Botanicals and Probiotics in the EU:
- Botanicals (e.g., plants, mushrooms) are regulated nationally.
- Positive and negative plant lists define usage conditions.
- Most countries follow the EU on-hold claims list for botanicals, except Italy, which uses a proprietary list.
- Probiotic claims are not harmonized; regulations vary across countries.
Notification Procedure for Food Supplements EU
Businesses must complete a notification procedure with the relevant national authority before selling or importing food supplements in the EU—including on platforms like Amazon. This includes:
Post-Brexit Considerations and Legal Representation
Post-Brexit, or for companies outside the EU, it is mandatory to:
*This representative must appear on the label and liaise with national authorities.
Exceptions: Foods for Specific Groups (FSG)
Unlike food supplements, most food products do not require notification. However, exceptions apply for Foods for Specific Groups (FSG), such as:
- Infant formula and follow-on formula
- Foods for Special Medical Purposes (FSMP)
- Total diet replacement products
- Fortified foods, including sports nutrition bars
These products are tightly supervised and must meet both EU and national-level regulations.
What is a Novel Food?
Novel foods refer to ingredients or products not widely consumed in the EU before May 15, 1997. Common examples include:
- Chia seeds (before approval)
- Noni juice
- CBD-infused products
Regulatory Basis for Novel Food:
- Regulation (EU) 2015/2283 governs novel food approval.
- Came into effect on January 1, 2018.
Novel Food Registration Process in the EU
Registration involves a multi-stage process, including:
- Submission of a comprehensive dossier
- Toxicological and nutritional safety assessments
- Scientific review by the European Food Safety Authority (EFSA)
EFSA’s opinion forms the basis for approval decisions made by the European Commission.
European Food Safety Authority (EFSA): Role & Responsibility
EFSA is the independent agency overseeing food safety in the EU. Its primary responsibilities include:
- Evaluating novel food safety
- Advising EU policy makers and risk managers
- Supporting transparency in food-related communication to:
- Primary producers
- Consumer organizations
- Industry stakeholders
How Freyr Can Help
- 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/Food Supplements Registration Europe.
- EU Country-specific Regulatory Support.
- Regulatory Strategy for the EU.
- EU Legal Representation (LR)/ Local representative for EU supplement registration.
- Regulatory Intelligence (RI) Report.
- Product-specific updates on the Regulatory Guidelines/Standards.
- Novel Food Registration/ Novel Food Authorization Request/Traditional Food from a Third Country Registration.
- Consultation Processes for Determining a Food Ingredient's Status (novel/not novel).
- 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 EU Supplement 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).
Why Choose Freyr for EU Food Supplement Registration?
- End-to-end Regulatory consultation for food regulations in the EU
- 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.
Start your EU Food Supplement Registration journey today
Talk to an Expert on EU Compliance.
FAQs about EU Food Supplement Registration
1. What is considered a novel food in the EU?
A novel food is an ingredient not consumed significantly in the EU before May 15, 1997. Examples include non-traditional plants, insects, CBD, and some fermented products. These require pre-market authorization under Regulation (EU) 2015/2283.
2. Do all food supplements require notification in the EU?
Yes, most food supplements must be notified to the member state's competent authority before being marketed. This applies even when selling via e-commerce platforms like Amazon.
3. What are the key differences between food supplements and novel foods EU?
Food supplements contain vitamins, minerals, or botanicals with a history of safe use. Novel foods lack such a history in the EU and require EFSA safety evaluation and EU-level approval before market entry.
4. Who evaluates the safety of novel foods in the EU?
The European Food Safety Authority (EFSA) conducts scientific evaluations of novel food applications and provides safety opinions, which the European Commission reviews for Novel Food authorization.
5. What documentation is required for novel food registration?
Applicants must submit a comprehensive dossier including ingredient details, toxicological and nutritional safety data, proposed usage levels, and labeling information.
6. Is a legal representative required for non-EU companies?
Yes, companies outside the EU must appoint a Legal Representative (LR) or establish a legal entity in an EU member state. The LR is a liaison with the competent national authority and must be listed on the product label.
7. Are botanical ingredients regulated at the EU level?
No, botanicals are regulated at the national level. Countries maintain their positive and negative plant lists and interpret claims differently—Italy, for example, has its proprietary list.
8. What are the consequences of non-compliance with EU regulations?
Non-compliance can lead to product recall, fines, withdrawal from the market, or long-term bans. Proper classification, labeling, and notification are essential to avoid enforcement actions.
9. Are probiotic claims harmonized across EU member states?
No, the regulation of probiotics is not harmonized. Each EU country may have different interpretations and requirements for using probiotic-related claims on labels and advertising.
10. Do Foods for Specific Groups (FSG) require separate registration?
Yes, FSG products like infant formulas, FSMPs, and total diet replacements are exceptions. They are regulated under stricter EU and national requirements and may require additional notifications and approvals.