Brussels, Belgium—The European Federation of Health Product Manufacturers (EHPM) has called for a deadline extension for companies to provide scientific dossiers to the Scientific Committee for Food (SCF), which sets maximum safety levels for vitamins and minerals in Europe.
In an unusual move, EHPM issued a statement criticising the 18-month timeframe for the provision of scientific dossiers as too short and said it would continue lobbying for an extension of this submission period.
It also questioned the volume of evidence required by the SCF, especially for substances that are a part of the daily diet and proven to be safe.
Pedro Vicente Azua, EHPM's regulatory affairs director, says smaller companies are likely to suffer the most if the present draft is not amended.
"The big companies may be able to meet the guidelines and develop extensive dossiers, but the burden for smaller companies is too great," he says. "Our priority must be to make the European Commission listen to the smaller companies."
The move follows concern in Sweden, the Netherlands and the UK, in particular, where the industry has been dissatisfied with the final text in the Directive.
Sue Croft, director of UK-based Consumers for Health Choice, warns the Directive would limit consumer choice and could be disastrous for the UK supplements industry, which operates under Europe's most liberal regulatory infrastructure.
"What concerns me is that every country in Europe will benefit from this Directive except the UK," she says. "We are concerned that the Directive will attach to the legislation a list of permitted ingredients and when you compare that list with all the products that are on the shelves here, there are about 300 missing. We want every country across Europe to enjoy the freedoms we have."
The 'positive list' of permitted supplement ingredients contained in the current draft of the Directive has provoked widespread concern over the criteria needed for inclusion. EHPM says the list is partial at best and threatens the existence of a number of products.
Chris Downes, Secretary General of the European Responsible Nutrition Alliance (ERNA), which represents larger supplement manufacturers, said companies whose nutrients had been omitted from the positive list draft (Article 4) had submitted or were preparing scientific dossiers.
But Joseph Hasslberger, member of Italian consumer advocacy group La Leva Di Archimede, says the text of the Directive is not explicit. He claims the ambiguity is thwarting the industry's best efforts to present the required scientific evidence.
"It's not known what kind of evidence is needed to put something on the positive list," says Hasslberger. However, Downes notes that no ERNA members have raised concerns about the SCF's scientific criteria.