Trade associations have renewed calls for regulators to reassess the way claims are handled under article 13.1 of the health claims regulation after a long-awaited meeting in Brussels failed to provide answers.
The meeting, held on June 15, was designed to provide more clarity for applicants about how to compile dossiers under articles 13.5 and 14 of the regulation. However, trade associations were also hoping to urge the European Food Safety Authority (EFSA) to shelve plans to publish its first batch of 1,024 article 13.1 health claims this summer until the assessment process is re-evaluated.
Lorene Courrege, director of regulatory affairs at the European Health Products Manufacturers association, said: "We regret that the meeting did not address article 13.1 claims, but we hope that EFSA and the EC now acknowledge there is an urgent need for dialogue with stakeholders before the first article 13.1 claims evaluations are published."
European Responsible Nutrition Alliance secretary general Patrick Coppens said: "We welcome EFSA's proposals to provide more guidance for applicants on articles 14 and 13.5. But we didn't get any answers on 13.1 claims."
EFSA was also not prepared to change its emphasis on clinical studies as the gold standard of scientific evidence for assessing claims, despite the fact that many experts believed more weight should be given to observational, historical and other data, he said. "There is no credible way the article 13.1 assessment process can proceed before the issues are discussed fully with stakeholders."
l See Healthy Flak, p50