Second chance saloon may help health claims rejects

If - as expected - a large number of 'article 13.1' health claims are not approved for use in Europe, it is not the end of the regulatory road for firms making these claims, the European Food Safety Authority (EFSA) has revealed.

If an article 13.1 claim is rejected, firms could simply reapply under article 13.5 of the same Regulation, said Dr Hans Verhagen, who sits on the EFSA panel for claims assessment.

Article 13.1 claims are based on generally accepted science about the role of nutrients in the body (eg 'calcium is necessary for the normal structure of bone') and have been collated by the Commission for assessment by EFSA based on lists of references to supporting science. Those that make it on to an approved 'Community list' will become available for any firm to use.

Article 13.5 claims are based on new or emerging science or proprietary evidence and require applicants to submit a full dossier of supporting evidence.

Speaking at a conference run by Leatherhead Food Research, Verhagen said: "If a claim doesn't make it onto the article 13.1 list, you can always come back via the route of article 13.5." He did not make it clear whether this would require applicants to commission new studies to support claims.

But reapplying under 13.5 would at least give firms more control over the process, said Nigel Baldwin at consultant Cantox Health Sciences International. "Given the way article 13.1 claims were collated by the Member States and then filtered by the Commission before they even reached EFSA, no one actually knows exactly what EFSA has been given to assess.

"Do the lists of references EFSA was given accurately reflect the totality of the data? I think many companies are now realising that the only way they can control the process is to submit their own dossier directly, which means going through article 13.5."

l See Healthy Flak, p50