28 April 2008 - EFSA has completed its consideration of 120 dossiers relating to nutrient sources in food supplements which were found not to be adequate for scientific assessment.
In a statement adopted at its April meeting, EFSA’s AFC Panel has concluded that the safe use of a number of nutrient sources and the bioavailability of the nutrients from these substances cannot be assessed on the basis of these dossiers.
EFSA was asked by the European Commission for scientific opinions on the safety and bioavailability of these nutrient sources prior to any approval of their continued use for nutritional purposes in food supplements. EFSA has been unable to complete scientific opinions on these nutrient sources due to the limited information that has been supplied. It was not possible to undertake a risk assessment on which to base a scientific opinion when, for example, only a product name was provided or a clear chemical description was not given. This has remained the situation, despite repeated requests at national level, since 2005, for complete technical dossiers to be provided by food supplements manufacturers.
None of the dossiers listed in the Annex to the AFC Panel’s statement provided enough information to complete a risk assessment of the nutrient source and assess the bioavailability of the nutrient from the source. In some cases, separate dossiers submitted by other petitioners provided additional information on nutrient sources of the same name (see table 2 of the statement). However even that information did not allow the Panel to reach a view on these dossiers when, for example, confirmation of the identity or specification of the substances was not given.
Up to now, these food supplements have remained on the market in Europe, through specific derogation, as a result of the submission of these limited dossiers. It will now be for the European Commission and Member States to consider the implications of the AFC Panel’s statement on the future status of these products currently marketed in the EU.
The conclusions on these dossiers are part of EFSA’s on-going work in relation to over 500 dossiers relating to nutrient substances added to food supplements and foods currently on the market in the European Union originally received during 2005. Over 170 were subsequently withdrawn, 9 opinions have been issued in relation to some substances relating to 30 dossiers and in other cases the work is still on-going.