Companies remain reluctant to invest in the science needed to ensure continued availability of many ingredients in Europe because the research can't be protected from competitors. That was the conclusion of a heated debate at the recent Natural Products Expo Europe trade show in Amsterdam, where representatives of US and European ingredient suppliers questioned the value of forking out up to $400,000 to compile a scientific dossier in defense of a nutrient not listed on the Food Supplements Directive's positive list.
Even if the evidence was accepted by the European Food Safety Authority (EFSA), their competitors could then cash in on the ongoing availability of the nutrient without investing anything to keep it on the market, they argued.
As it stands, more than 300 nutrient sources freely available in liberal European markets, such as the UK, the Netherlands and Sweden, will be prohibited after 31 July, 2005, unless dossiers are submitted to EFSA.
The UK-based Health Food Manufacturers' Association (HFMA) estimates dossiers for 24 nutrients are being compiled, including a variety of calcium and chromium forms, selenium yeast, zinc picolinate and manganese amino acid chelate.
Suzanne Tenn, director of export at supplements manufacturer Nature's Plus, said that even though the New York-based company's exports will be affected if the positive list is not expanded, the dossier-submission process gives little incentive for companies to conduct and compile the necessary data to illustrate a nutrient's safety.
"The current system offers no protection for those who shell out the cash on a dossier," she said. "Ideally, suppliers of similar raw materials would band together to prepare the required dossiers, but only a handful of suppliers are doing this. Companies are looking to see what difficulties their competitors experience before attempting to submit a dossier themselves," she noted.
Those that did the dossier work should be compensated, she suggested. "Other suppliers of the same material should have to pay this company a fee if they would like to sell their raw materials to manufacturers in the European Union."
Sharon Flynn, regulatory affairs manager at UK-based health store chain, Holland and Barrett (owned by NBTY), said the loss of 300 nutrients would stifle innovation and deal a massive blow to the industry. "If you can't use a wide range of substances, everyone ends up making exactly the same products," she stated. "So it is a definite curb on product development. Virtually every vitamin and mineral complex we carry will have to be reformulated. We are canvassing our suppliers but a lot of them have a 'wait-and-see' attitude."
Holland and Barrett, and groups like the HFMA, are lobbying for a simplified dossier procedure. "We think there should be more credence given to history-of-safe-use evidence, as is the case with the Herbal Directive," Flynn observed. "If EFSA accepts a simplified dossier that doesn't require a bioavailability study and will permit history-of-use data, then it will be easier for these ingredients to make it onto the list."
Newly appointed director of the HFMA, David Adams, said: "Even if the dossier process is simplified, there is still a lot of data to gather, so no one should hang back."
For information about compiling a dossier, visit www.hfma.co.uk/dossier_home_page.htm.