European Union (EU) is a good bet for Nutraceuticals or Food Supplements. Better standards and awareness towards health foods has led to consistent demand for dietary supplements in the region. Though there is no requirement to register imported foods/ food supplements except for the introduction of novel foods, the EU has taken steps to harmonize the regulation of nutritional supplements, health foods, and herbal medicines. The European Food Safety Authority (EFSA), the agency responsible to regulate the Nutraceuticals in the region, has laid out separate regulations for:
- Food Supplements - The Food Supplements Directive (FSD) Directive 2002/46/EC establishes a list of allowable vitamins and minerals (others not covered under this directive) and sets labelling requirements for these food supplements along with the dosage limits.
- 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 to be allowed on the EU market, an application for authorization must be submitted to the competent authorities for Novel Food registration. The Novel Food Regulation 258/97 lays down detailed rules for the authorization of novel foods and novel food ingredients.
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
- Label and Claims Review
- Claims Consultation and Substantiation
- NHCR Claims Application (EU Register on Nutrition and Health Claims)
- Dossier Gap Analysis
- Dossier Compilation and Submission
- Product Registration
- EU Country-specific Regulatory Support
- Regulatory Strategy for EU
- Legal Representation
- Regulatory Intelligence Report
- Product-specific Updates on the Regulatory Guidelines/Standards
- Novel Food Registration
- Food products / Food Supplements Import Guidance
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