The looming deadline for the submission of scientific dossiers in support of nutrients not listed in the EU's Food Supplements Directive to the European Food Safety Authority (EFSA) has spurred US companies into action, according to Phil Harvey, PhD, chief science officer at the National Nutritional Foods Association (NNFA). He said the message is finally getting through to US ingredient suppliers and supplement manufacturers: now is the time to gather the necessary science and present it to EFSA if they want to continue to trade in products containing ingredients not currently on the Directive's positive list of permitted substances.
NNFA, together with the US-based Council for Responsible Nutrition (CRN), has been seeking to persuade companies to take action for many months. NNFA, which represents smaller companies, has circulated a document explaining EFSA's scientific requirements to clarify and speed up the science-gathering process.
Ten dossiers have already been sent to EFSA, he noted, with another 40 in process. A Web site is also being established to publicise which companies are working on which of the 271 ingredients not on the positive list.
"It is my understanding that there will not be much of a negotiation process once the dossiers have been submitted to EFSA, so it is important we make sure they contain the right information and are presented in the right format," he noted. "We are confident most of the dossiers that are required will be with EFSA by the deadline in mid-2005." Harvey said most dossiers would require only a month's preparation if the toxicology studies had been carried out.
John Hathcock, PhD, CRN's vice president of nutritional and regulatory science, said that while EFSA's requirements were clear, the manner in which those requirements would be interpreted by the Authority was less clear, especially in regard to upper safe limits. For this reason, it was vital to send off dossiers at the earliest possible juncture, he said.
Peter Berry Ottaway, a UK-based scientific consultant, noted that the vast majority of the non-listed ingredients originated in the US. He said the lack of science on many of these reflected the liberal nature of the US DSHEA legislation, which allows many products onto the market with minimal scientific backing. "You can blame DSHEA for taking the responsibility for safety away from the Food and Drug Administration and placing it with the manufacturer via a self-affirmation process," he said.
Many of the ingredients not on the positive list are unlikely to receive scientific support, he added, because the trade in them does not justify the cost of preparing a dossier, which could run to hundreds of thousands of dollars.
"The toxicity studies are simply too expensive for many companies to engage in," he said. "They'd rather concentrate on the US market than spend a load of money to get into Europe."