Groups like the European Federation of Associations of Health Products Manufacturers (EHPM) and the European Botanical Forum (EBF) praised the pragmatism of the Commission’s decision.
“In taking the decision the Commission has removed the distortion of the market batch publication would have caused and we are pleased about this,” EHPM chairman Peter van Doorn told NutraIngredients today.
“But the more fundamental questions about the way in which science is being interpreted under the regulation remain on the table.”
EFSA spokesperson Lucia de Luca affirmed that botanical opinions adopted over the summer would be published in its third article 13.1 batch – due the week beginning October 11, little more than two weeks away. But it would not publish any other article 13.1 botanical opinions until it received further direction from the Commission.
Impacts
As it hinted at in recent months, the Commission confirmed it would publish all article 13.1 opinions in one single uber-batch – likely now at some point after June, 2011, when the European Food Safety Authority (EFSA) is due to publish the last of the article 13.1 opinions.
In theory that task just became easier as the Commission’s resolution to extract botanicals from the regulation – if only in the short term – potentially freeing up precious EFSA resources to process the remaining dossiers.
But de Luca there would be no immediate impact on the agency’s health claims work.
It is unclear just how many of the 3000+ dossiers are for herbal products but one industry pundit suggested it may be as many as half.
Van Doorn said the EC move may prompt it to withdraw its complaint to the European Ombudsman that had been lodged due to what it views as the economically distorting effect of the batch system.
EBF secretary general Patrick Coppens said the EC move to take out herbals acknowledged a developing absurd situation where botanicals authorised under the Traditional Herbal Medicinal Products Directive (THMPD) could make claims with little proof other than traditional usage, while food supplements could not.
“This is a difficult issue and highlights the difficulty EFSA has had in dealing with botanicals where the kind of randomised clinical trials they seek often do not exist,” he said.
The new batch approach was in fact a return to its initial position when the regulation became law in 2007.
“It is an acknowledegement by the EC that there are so many practical complications that they have returned to their initial standpoint. It buys some time for the industry and maybe frees up EFSA to focus on other substances.”
EC statement
In reconsidering its position, the EC acknowledged input from member states and industry stakeholders.
“Without moving away from the principle of the progressive adoption of the list, the Commission is to amend the process in a pragmatic way to address issues highlighted during discussions with the Member States and interested parties,” it said.
Botanicals will be dealt with after June 2011, with the Commission underlining incongruity between the nutrition and health claims regulation’s treatment of botanicals and that of the THMPD, as “a potential problem”.
Regarding batches the EC said: “In the past months, many concerns have been raised by a number of Member States and by stakeholders. These referred to potential distortion on the market between operators whose claims are rejected, and operators using claims for which assessment is still pending.”
It added: “The solution adopted today will increase legal certainty for operators and national enforcement authorities and reduce implementation burden. Furthermore, it will allow the Commission to reflect on a consistent treatment of claims on botanicals (which include, for example, Linum usitatissimum, Aloe barbadensis, Hypericum perforatum, Echinacea pallida).”