Europe may ban 120 food nutrients
backing 120 nutrient sources for ongoing use within the European
Union because they were deemed "not to be adequate".
While this may lead to the removal of nutrients including forms of boron, selenium, magnesium and calcium from supplements and foods, industry sources said they were unconcerned by EFSA's rulings.
No surprise "There is nothing surprising in this," said the UK Health Food Manufacturers' Association technical advisor, Michael Evans, referring to the fact many hastily conceived dossiers were submitted to the European Commission before a 2005 deadline so that nutrients that hadn't made the original Food Supplements Directive positive list, could remain on market via national derogation.
The dossiers, some of which consisted of little more than a single sheet of paper with a product or nutrients' name inscribed on it, served their purpose in that derogations were granted in member states, but now EFSA has ruled the dossiers do not demonstrate safety, their future status becomes unclear.
"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," EFSA said.
"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 AFC panel is EFSA's Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food which performed the assessments.
Melanie Hickie, regulatory affairs manager at UK-based supplements manufacturer and retailer, Holland & Barrett, agreed with Evans that the verdicts were hardly shocking.
Indeed, several of the company's own dossiers were among those rejected by EFSA along with submissions from the likes of Gee Lawson, Metabolics, BioCare, Solgar and the UK National Association of Health Stores.
"The fact is these one-page dossiers were a stop-gap measure to keep products on market when the deadline passed in 2005," Hickie told NutraIngredients.com.
"But for most of these sources there are other options so reformulating won't be a huge issue if the UK decides they should be removed from the market.
Rejection of these dossiers is not going to have a major effect on retail shelves."
She said a greater priority was the debate over nutrient upper safe levels in food supplements, due to be resolved next year.
"If levels there are set low that is when you are really going to see an outcry from the UK industry and a reformulation frenzy.
We're doing everything we can to ensure levels are maintained at current levels."
The verdict In its current verdict AFC said it had, "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."
It added: "This has remained the situation, despite repeated requests at national level, since 2005, for complete technical dossiers to be provided by food supplements manufacturers."
AFC noted that while in some cases additional dossiers had been submitted by other petitioners, the evidence presented, " 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."
EFSA noted that repeated requests for additional safety data had gone unheeded.
Of more than 500 dossiers passed to EFSA, 170 have been withdrawn in addition to the 120 EFSA has presently rejected.
A further 30 informed nine other opinions, meaning EFSA has roughly 180 "full" dossiers to process.