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Nov 30, 2019

The Italian Ministry of Health has made a guidance available summarizing the available rules and guidelines regarding quality standards for food supplement ingredients.

European rules do not foresee specific standards on the quality of food supplement ingredients. In the absence of harmonized EU standards, Member States may determine such rules at national level. However, in most cases EU countries also do not have specific standards.

At present, the EU Directive on Food Supplements (Directive 2002/46/EC) does not provide for any guidelines for the purity of substances other than vitamins and minerals that are used in food supplements. The Italian guidance therefore makes reference to Regulation 2013/609 on foods for specific groups which holds that purity of ingredients, including substances other than vitamins and minerals, should observe generally acceptable purity criteria as recommended by international bodies until the establishment of such criteria. More in particular, the recommendations of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and European Pharmacopoeia are to be applied.

Regardless of the absence of specific purity criteria for the ingredients used in food supplements, the general EU food safety rules require that food business operators guarantee the foods they place on the market are safe. For that purpose, food business operators are obliged to have good manufacturing practices and good hygiene practices in place based on the HACCP principles. The Italian Ministry of Health has a more extensive Guidance on GMP for food supplements that is available in English (

Lastly, the recent Italian guidance indicates that for certain ingredients, such as novel food ingredients, an authorization procedure needs to be completed in order for the ingredient to be incorporated in foods and food supplements.

Ministero della Salute (10 September 2019) – Integratori alimentari: Standard di qualita delle materie prime e buone practice di fabbricazione (GMP) - link

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