European Union (EU) is a good bet for Nutraceuticals as the region is economically advanced. 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 labeling 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 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. The Novel Food Regulation 258/97 lays down detailed rules for the authorization of novel foods and novel food ingredients.
Despite adhering to EFSA’s regulations, country-specific requirements concerning linguistic diversities, approval pathways, etc., may slowdown the progress of approval in individual countries across EU.
Freyr, with thorough Regulatory knowledge about the EU regional authorities, and with dedicated delivery centers in UK & Germany, caters end-to-end Regulatory services for client requirements. Freyr’s experts provide professional assistance for classification, novel food registration, label & claims review and ingredient analysis.