Health claims list could be ‘decimated’
The ‘article 13’ list of applications under the EU health claims legislation will be “decimated” if regulators insist on applying pharmaceutical standards to nutritional research, the European Responsible Nutrition Alliance (ERNA) has predicted.
Commenting on the recently published 4,185-strong list of applications submitted under article 13.1 of the EU health claims Regulation, ERNA said foods were not medicines. It was therefore unrealistic to expect short-term studies feeding foods to healthy volunteers to generate the kind of measurable ‘improvements’ seen in pharmaceutical trials testing powerful drugs on sick people, said secretary general Patrick Coppens.
He said: “Many of the nutrients and substances that we eat have a certain function, and their intake is intended to contribute to the maintenance of that function, not necessarily to a measurable improvement of it. If the European Food Safety Authority (EFSA) does not appreciate this, the list will be decimated.”
But regulators were in a difficult position, said Jeya Henry, professor of human nutrition at Oxford Brookes University. “On the one hand, if you are over-prescriptive on health claims, you risk stifling innovation, and you don’t want to throw the baby out with the bathwater. Look at Chinese herbal medicine; there are some profoundly important insights that have come out of it. But on the other hand, we have to have evidence-based science. The challenge is trying to find a balance.”
However, many article 13 claims would be rejected, “not because they are not true, but because they will not meet criteria that EFSA has defined”, predicted Coppens. “EFSA scientists are looking for proof from intervention trials to show cause-effect relationships with measurable effects. This is and should be possible for submissions under the authorisation procedure [article 13.5 and article 14 claims], but is not necessarily appropriate for many claims submitted in the article 13.1 list.”
Professor Albert Flynn, who chairs the EFSA panel tasked with analysing health claims, said all claims, regardless of which article of the Regulation they fell under, would be scrutinised with the same rigour.
He added: “Scientific evidence is scientific evidence, whether the application route is different or not. Some people thought that the standard of evidence required to support claims in the article 13.1 list (claims backed by generally accepted scientific evidence) was different to article 14 (disease risk reduction claims). That is not the case.”
Article 13.1 claims refer to the role of a nutrient/substance in the growth, development and the functions of the body; psychological and behavioural functions; and weight control claims. A list of approved claims will be published in 2010 and will become available for any company to use, provided they adhere to the conditions of use.
