European Union (EU) is a good bet for Food Supplements. Better standards and awareness towards healthy foods have led to consistent demand for Food Supplements in the region. The European Food Safety Authority (EFSA), the agency responsible for regulating the Food Supplements in the region, has laid out regulations as below:
- All Food Supplements sold in the EU must comply with the European Food Safety Authority (EFSA), 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 actives, additives, and their limits as per EFSA regulations.
- Directive 2002/46/EC mentions that the EU Member States require the manufacturer or the person placing Food Supplements on the market in their territory 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 with every nation may vary.
Novel Foods – Food Supplements also need to comply with the EU Novel Foods Regulation, which lays down rules in European Food Safety Authority (EFSA) for novel foods that were not used before 1997. For food and 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.
The new Regulation (EC) 2015/2283 on novel foods came into force on January 1, 2018, signaling the start of a new system operated by the European Commission and the European Food Safety Authority (EFSA).
Freyr, with an operational and delivery center in Europe, assists manufacturers with end-to-end Regulatory procedures.
- Food Product Classification/Food Supplement Classification
- Formula Review/Ingredients Assessment
- Label and Claims Review
- Nutritional and Health Claims Consultation and Substantiation
- NHCR Claims Application (EU Register on Nutrition and Health Claims)
- Dossier Gap Analysis
- Dossier Compilation and Submission
- Product Compliance
- Product Notification/Registration
- EU Country-specific Regulatory Support
- Regulatory Strategy for EU
- EU Legal Representation
- Regulatory Intelligence Report
- Product-Specific Updates on the Regulatory Guidelines/Standards
- Novel Food Registration
- Regulatory Guidance on Food products/Food Supplements Import Services in the EU
- Translation Support
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
Strong relationship with different Health Authorities