EFSA issues dossier warning to industry

By Alex McNally

- Last updated on GMT

Related tags: European union, Efsa

Three hundred dossiers relating to nutrient substances in
supplements and foods in the EU may not be assessed due to a lack
of information submitted to the European Food Safety Authority.

Under the Food Supplements Directive 2002 a scientific opinion from EFSA on the safety of nutrient sources is needed prior to any approval of their continued use in food supplements or fortified foods. In 2005 some 500 dossiers were handed to EFSA which has completed its initial evaluation and said some 300 of these did not have enough details for an assessment to be carried out. EFSA has issued a stern warning to industry, that if further information does not come forward by the end of the year these 300 nutrients will not be assessed. Should this happen businesses could be dealt a massive financial blow. Approximately 200 of these dossiers provided "adequate information"​ for EFSA to begin its work. A spokesperson said: "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." ​ The 300 dossiers under dispute contained 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 provide,"​ a spokesperson said.​ All the limited dossiers were from the UK, and the country's regulator was told full dossiers were needed for 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 without such data EFSA will be unable to progress any further. The authority has now told the European Commission that if further details do not come forward by the end of the year the authority's scientific panel will "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."

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