The UK's Food Standards Agency (FSA) said yesterday that it has received dossiers of safety and technical data on 14 ingredients, several from US firms, allowing them to remain in supplement products after August this year, the enforcement date for the 2002 directive.
The directive lists of nutrients and their sources that can be included in supplements on the EU market excludes six minerals (tin, silicon, nickel, boron, cobalt, and vanadium) currently available in products in the UK and numerous other vitamin and mineral sources, estimated by industry bodies to fall just short of 300 missing ingredients in total.
Supplement makers using these ingredients have been required to look at alternative sources and invest in reformulation of their products to ensure that they will meet the legal requirements after August.
Health retailer Boots, which has a third of the UK's vitamins market, says it has already changed some of the products on sale in its stores, removing both boron and vanadium from vitamin supplements.
Other brands, particularly those supplying the independent sector, have followed a riskier course of action in a bid to hold onto the nutrient sources that they consider superior and key to the quality of their products.
"Rather than switch immediately to those ingredients on the annexed lists, which would have been the safest course of action, we have gone to an intermediate stage of looking at the dossiers actually being prepared and following this process," said Paul Chamberlain, director of technical and regulatory affairs at Solgar's UK division.
"We are making our lives very difficult but we couldn't bring ourselves to switch to such poorly absorbed minerals [those forms that are included on the lists]," he told NutraIngredients.com.
The ingredients that have gained derogation so far include several mineral chelates made by US-based Albion (calcium amino acid chelate, magnesium amino acid chelate, iron amino acid, manganese amino acid chelate, zinc amino acid chelate, copper amino acid chelate and chromium amino acid chelate), boric acid supported by a dossier from Solgar UK, sodium borate backed by a Wassen dossier and US-based Zila's calcium ascorbate/threonate.
Also, InterHealth Nutraceuticals has completed a dossier on chromium polynicotinate and zinc monomethionine, while Wassen UK, Lallemand and Lesaffre France teamed up to fund a dossier on selenium-enriched yeast. The Health Food Manufacturers' Association has also cleared the ground for calcium sulphate.
"It's a relief to know that these ingredients are now registered by the FSA and will go to EFSA," said Chamberlain.
However risk does not end with the acceptance of a dossier by a member state. If EFSA finds the evidence submitted by ingredient firms to be insufficient, the ingredient can be thrown out.
"We have some multivitamins with up to 10 ingredients under derogation. If EFSA reviews these all at different times, we could be reformulating up to 10 times," explained Chamberlain.
An assessment of the directive's impact by the FSA in 2002 suggested that reformulation would cost manufacturers up to £3,000 (€4,372) per product. Companies also face relabelling costs of between £300-£500 for all products to comply with new labelling requirements under the law.
David Adams, director of the HFMA, noted that "specialist manufacturers would ideally like to see permanent derogation for these ingredients in member states. But failing that we would like to get as many derogations as possible."
The HFMA says a further 23 dossiers are under preparation, including one for selenium methionine, an important ingredient for several manufacturers including Solgar.
However the UK industry is still counting on more fundamental changes to the directive. A hearing at the European Court of Justice in January this year argued that the directive is unfair, disproportionate and infringes the principle of subsidiarity. The verdict is due in June.
Meanwhile a Conservative MEP John Bowis has tabled an amendment to the nutrition and health claims regulation currently being discussed by members of the European parliament.
The amendment adds two new clauses to the regulation to allow member states to permit trade in their territory of supplements containing vitamins and minerals not listed in annex I or II the directive, provided that they comply with the claims regulation.