Evaluation of nutrient sources in food supplements and food – an update

During 2005 EFSA received approximately 500 dossiers relating to nutrient substances added to food supplements and foods currently on the market in the European Union (EU). Under current EU legislation[1], a scientific opinion from EFSA on the safety of such nutrient sources is required prior to any approval of their continued use in food supplements and/or fortified foods and/or foods for particular nutritional purposes.

Where dossiers were submitted before 12 July 2005, products can continue to be used in food, via derogation, until 31 December 2009 (or until EFSA’s risk assessment is completed). During 2005 dossiers were submitted to Member States by food supplements manufacturers and traders and forwarded to EFSA. Guidelines had been produced to assist companies in understanding the kind of scientific data needed on their products in order to facilitate a risk assessment. EFSA’s AFC Panel[2] endorsed these guidelines in 2003 and provided clarification on the requirements for toxicological studies[3].

EFSA undertook an initial evaluation of all the dossiers received in 2005. Approximately 200 of these dossiers provided adequate information for EFSA to begin its work. In many cases the dossiers related to the same or similar substance, but they were filed by different companies or intended for different uses. For some of these dossiers further information has been requested from the applicant, in other cases opinions have already been delivered.

Approximately 300 dossiers were basic one page submissions. In most cases only the name of the substance was provided together with a statement about how it had been sold for several years without any apparent side effects. EFSA is unable to work towards issuing an opinion on these substances on the basis of the limited information provided.

Companies who have submitted these dossiers were informed by the UK Food Standards Agency (FSA) in 2005, the national authority from which all the limited dossiers were received, that a full dossier was required by EFSA to undertake a scientific risk assessment of the safety and bioavailability of these substances. However, until now very limited additional data for these limited dossiers have been submitted to EFSA and until EFSA receives such data it is unable to progress this work any further.

EFSA informed the European Commission on 25 September 2007 that if additional data on substances for which limited dossiers were provided are not forthcoming by 31 December 2007[4] its expert scientific committee, the AFC Panel, will, in order to protect the consumer, adopt opinions on these substances stating that the safety of the nutrient source and bioavailability of the nutrient cannot be assessed on the basis of the data submitted. At the request of the Commission, EFSA has subsequently informed the UK FSA of this urgent need for additional data, with a copy of the letter forwarded to the companies in question[5].

[1] Food Supplements Directive 2002/46/EC
[2] Panel on additives, flavourings, processing aids and materials in contact with food (AFC)
[3] See https://www.efsa.europa.eu/en/events/event/afc030709 .  
[4] Or at least a commitment to send a dossier in accordance with the guidelines within a 3-month period.
[5] See https://www.food.gov.uk/