Products containing nutrients that don’t appear on the EU Food Supplements Directive (FSD) positive lists are now officially illegal and can be stripped from store shelves after the derogation period expired on December 31, 2009.
While this is not a problem for most companies that have engaged in reformulation where necessary to ensure their products are in line with the FSD, there remains a question mark over products that may remain on-market, and the manner in which the regulation will be enforced across the 27 member states of the European Union bloc.
Several member state trade associations have highlighted the issue, with concerned companies wondering what actions need to be taken in regard to unsold stock.
According to the European Federation of Associations of Health Product Manufacturers (EHPM) regulatory affairs director, Lorène Courrège, it is difficult to tell exactly how the regulation will be enforced.
“It is up to the enforcement agencies in each member state now,” she said. “It is difficult to say what actions will be taken , if any, but I suspect there is going to be a pragmatic approach.”
Asking for trouble
But she said companies were asking for trouble if they allowed products to remain on-shelf containing prohibited ingredients.
“This deadline has not come as a surprise – there has a lot of warning about it and prudent manufacturers will remove products otherwise there is a danger products could be removed from shelves.”
A European Commission spokesperson said the Commission left it to member state enforcement bodies to get on with policing the regulation, unless it received a corporate or consumer complaint directly that may prompt it into action.
“There are instances where we can deal with on a case-by-case basis but usually it is up to the member states to enforce the rule,” she said.
Trade groups in Poland, Lithuania, the UK, the Czech Republic, Belgium and Hungary have registered concern about how the regulation is going to be enforced and what kind of advice they should be giving their members.
The Polish Council for Supplements and Nutritional Foods (KRSiO) had lobbied for an extended transition period to 2014, but this failed. It called the imposition of the Directive into Polish law a “flawed transposition”.
Edvinas Butkus, executive director of the Lithuanian Self-medication Industry Association (LSIA), said its members had highlighted as potentially problematic products containing ingredients such as chromium nicotinate and nickel sulfate.
Butkus said he was aware of about 10 ingredients that were raising potential red flags for its members.
“We hope extra time will be given to allow some of these products, for which there are no safety concerns, to be sold through.”
Aušra Aleknavičiūtė, products and registration specialist at supplier Walmark in Lithuania, said a sell-through period should be allowed because nutrients not on the positive list did not necessarily possess safety concerns.
In many cases the European Food Safety Authority (EFSA) did not, “have enough data for their evaluation.”
“Those substances have been on the EU market for a long time and there is no serious reason for immediate withdrawal of these substances from the market. For such substances, there is no reason not to allow a reasonable sell-out period on the national level.”
Information about the FSD, including the full text and the annexes, can be found here .
EFSA processed 533 applications relating to 344 nutrients and identified safety concerns with 39 of them.