A Food supplement is defined under European Union (EU) legislation as ‘foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders’.
Food supplements that are marketed in a EU Member State have to comply with all relevant aspects of
EU food legislation and any specific EU Member State national legislation in terms of their composition,
manufacture and control.
As food supplements are designed to supply nutrients, particularly micronutrients, and other nutritional or physiologically active substances in predetermined amounts, specialist skills and equipment are generally used in the manufacture of the majority of such products.
The aim of this document is to produce guidelines which address the specific needs of the food supplement industry in relation to good manufacturing practice, with special attention paid to the requirements of EU food legislation. It covers the complete cycle of production and quality control of a food supplement, from the acquisition of all materials through all stages of subsequent processing, packaging and storage to the distribution or release of the finished product. As such, relevant sections of the document apply also to food supplement companies whose products are contract manufactured and also to those who are solely distributors of products.
All businesses along the food supplement supply chain should ensure that the relevant sections are
complied with. For example, distributors should undertake audits on the manufacturers to ensure
compliance with good manufacturing practice.
Manufacturers and distributors of food supplements should comply with all relevant EU and specific national legislation in their home country and also that of any EU countries to which they export their products. The EU legal requirements on food hygiene apply also to food supplements that are manufactured in a EU Member State for direct export to countries outside of the EU.
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