European Union (EU) is a steadily growing market for Food Supplements. Better standards and awareness of Healthy Foods have led to consistent demand for Food Supplements in the region. The European Food Safety Authority (EFSA), the agency responsible for advising on the Food Supplements Regulation in the region, has set out higher standards for Consumer Protection.
All Food Supplements sold in the EU must comply with the EU Harmonized Regulation and the country-specific local regulations as applicable, for which it requires a compliance check to ensure the product complies with the Quality Requirements, Labeling Parameters along with the Product Composition in terms of Active ingredients, Additives, and their limits as per the EU regulations and the EFSA safety provisions.
Directive 2002/46/EC mentions that the EU Member States require the manufacturer or the person placing Food Supplements on the market needs to notify the competent authority. Most Member States, except a few, currently have a Notification/Registration procedure in place for Food supplements. The registration process and documents required in every nation may vary.
Novel Foods – Food Supplements also need to comply with the EU Novel Foods Regulation, which lays down rules for novel foods that were not used in the EU before 1997. For Food and Food Supplements containing Novel Ingredients, an application for authorization must be submitted to the competent authorities for Novel Food registration to be allowed on the EU market after a safety evaluation by the European Food Safety Authority (EFSA).
The new Regulation (EU) 2015/2283 on Novel foods came into force on January 01, 2018, signalling the start of a new system operated by the European Commission and the European Food Safety Authority (EFSA).
Freyr, with an operational and delivery centre in Europe, assists Manufacturers with end-to-end Regulatory procedures.
- 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
- Regulatory Intelligence Report
- Product-specific Updates on the Regulatory Guidelines/Standards
- Novel Food 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
- 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, and other Foods for Specific Groups (FSG)
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 like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc.
Support for region-specific Regulatory activities
Extensive partner network across the globe
A strong relationship with various Health Authorities