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.
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