Do you meet European requirements?
may need to act quickly to ensure their products are included in
new EU regulations coming into force in July 2005. CRN's John
Hathcock and James Roza of Now Foods are urging companies to
respond to the legislation.
Companies marketing ingredients for dietary supplements in Europe may need to act quickly to ensure their products are included in new EU regulations coming into force in July 2005.
The European Food Supplements Directive, passed in July last year, aims to remove trade barriers within Europe by establishing a single set of market requirements for food supplements in the European Union.
However the list of permitted ingredients compiled for the legislation leaves out many health ingredients currently available in European markets. John Hathcock of the trade association Council for Responsible Nutrition (CRN) and James Roza of supplement maker Now Foods write this week that it is "imperative that companies interested in retaining the unlisted ingredients for use in food supplements respond to the opportunity to submit dossiers".
Currently, there are approximately 300 nutrients and/or nutrient forms usedin the manufacture of food supplements in the United Kingdom that have beenexcluded from the list, according to the Hathcock and Roza. All forms of vanadium, boron, silica, choline and inositol as well as numerous forms of vitamins and minerals are absent, and ingredients such as dibencozide, d-gamma-tocopherol, and pantethine would be precluded from use in vitamin and mineral preparations.
Unless manufacturers and suppliers submit a dossier for these ingredients' biological and toxicological properties, they will be removed from the EU marketplace. Currently, only 17 dossiers are actively being compiled, say the authors, and the deadline for submitting dossiers (July 2005) is approaching.
Individual EU member states can allow a derogation period of four years while the EC's Scientific Committee on Food (SCF) evaluates dossiers for acceptance. If rejected, these nutrients would not be available in a food supplement after December 31, 2009. However if the derogation is not allowed, the ingredient would be removed from the market by July 2005.
Hathcock and Roza also refer to the recent report from the UK's Expert Committee on Vitamins and Minerals (EVM) which advised on maximum supplement levels of vitamins and minerals. The SCF will consider these recommendations, commissioned by the UK's Food Standards Agency,as well as those of the other national governments, in the establishment ofmaximum limits of nutrients used in supplements, also part of the new Food Supplements Directive.
"Unfortunately, both the UK EVM and the EC SCF have reached safety conclusions that are unnecessarily restrictive - far beyond that needed to assure the safety of supplements," say Hathcock and Roza in their statement.
It is certainly clear that the EVM levels differ, considerably in some cases such as niacin, from those set by the National Academy of Sciences or the Food and Nutrition Board (FNB). This may result in "there-formulation of countless food supplements currently sold in the EU. Thiswill have a significant impact on food supplements sold abroad by limitingthe potencies and composition of these products", according to the authors.
CRN and the NNFA/AHPA International Committee is lobbying the EU for 'higher, science-based standards'. Hathcock and Roza are encouraging companies to participate. CRN and NNFA can also be contacted for advice on submitting dossiers to the Commission.
