In a statement issued late Friday, the European Federation of Associations of Health Product Manufacturers (EHPM), the European Responsible Nutrition Alliance (ERNA) and the European Botanical Forum (EBF), called on the European Commission to reassess the article 13.1 claims process and sit down with it to address its “deep concerns”.
These concerns revolve around EFSA’s “gold standard” scientific approach to health claim dossier assessment, an approach industry views as being inappropriate and exclusionary for more than 4000 health claims it has to assess.
The call for dialogue comes on the eve of EFSA’s stakeholders’ meeting in Brussels today, where 120 industry members are set to receive guidance from EFSA and EC representatives about the health claims process.
But that meeting’s agenda tackles article 13.5 claims (based on emerging and proprietary science) and article 14 claims (children’s health and development and disease reduction) and it is unlikely industry will get the article 13.1 dialogue it seeks.
“[We] regret that the EFSA technical meeting with stakeholders of June 15 is not scheduled to address article 13.1 claims issues,” the three trade groups said in Friday’s statement.
We need to talk
That being the case, EHPM, ERNA and EBF said it was nonsensical for health claims assessment to proceed in such a state of non-clarity, especially in regard to the generic-style health claims that make up article 13.1.
These include claims linking vitamin, mineral and herbal extract consumption with health maintenance and are therefore, industry argues, more difficult to substantiate using the “gold standard” approach which favours pharma-style intervention trials.
Industry argues it has not been made explicit in the 2006 nutrition and health claims regulation, nor its subsequent interpretation, how much weight is being given to the totality of evidence apparent in dossiers, including observational and historical use data.
“We fear that the current process will lead to dismissal of a majority of the article 13 entries, not because of insufficient substantiation but because of a lack of clarity on an important number of issues that should first be addressed,” said ERNA chairman, Gert Krabichler.
“Therefore we believe that the EC should take the time to carefully clarify all issues in a formal dialogue with stakeholders.”
We (really) need to talk
EHPM chairman, Peter van Doorn, said the regulation jeopardised consumer choice, with many claims approved for decades in various member states likely to be binned.
“We have entered a crucial phase now with the publication of the first EFSA opinions on these claims expected by the end of July, and we are extremely concerned that the process followed is not working,” he said.
The fact half of the 4000 claims have been returned to the EC by EFSA for clarification, indicated how flawed the process had become.
EBF chairman, Manfred Ruthsatz, added: “We believe that a constructive dialogue among all parties involved before the first opinions are published is the only way forward to avoid further confusion.”
The three associations represent more than 2500 mostly small-to-medium food supplements manufacturers in Europe.
To listen to a podcast from the EFSA meeting in Brussels today, click here.