Whenever new substances are proposed for use as sources of nutrients in food supplements, foods for the general population or foods for specific groups, EFSA is requested by the European Commission to perform an assessment of their safety and of the bioavailability of the nutrient from the proposed source. The chemical substances used as sources which may be added to food, including food supplements and foods for specific groups, should be safe and also bioavailable, a property which is described, in the relevant legislation, as "available to be used by the body".

The use of chemical substances as "sources" of vitamins and minerals in food is regulated in the European Union (EU) by the establishment of positive lists of substances, annexed to the relevant sectorial legislation. In the next Table 2.2.5 is presented the new guidance document proposed by EFSA which refers to the data needed for the assessment of sources of nutrients proposed for use in the manufacture of foods.

Table 2.2.5. Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources

Scientific data required to allow an evaluation of the safety of the source within the established framework for risk assessment and the bioavailability of the nutrient from this source.

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For the safety assessment of the source, data requirements which should be covered in all applications relate to the description of the source, manufacturing process (including possible residuals or contaminants), technical specifications, proposed uses and use levels, and anticipated intake of the source and the corresponding intake of the nutrient. There are described the:

• Technical data aimed at characterizing the proposed source and at identifying potential hazards resulting from its manufacture and stability in food;
• Existing authorizations and evaluation, providing an overview of previous assessments on the proposed source and their conclusions;
• Proposed uses and exposure assessment section, allowing an estimate of the dietary exposure to the source and the nutrient based on the proposed uses and use levels;
• Toxicological data, describing approaches which can be used to identify (in conjunction with data on manufacture and composition) and to characterize hazards of the source and any relevant breakdown products.
• Bioavailability focuses on determining the extent to which the nutrient from the proposed source is available for use by the body in comparison with one or more forms of the same nutrient that are already permitted for use on the positive lists.