The document offers some clarification on matters such as the most appropriate articles (13.1, 13.5 or 14) of the nutrition and health claim regulation for various types of claims, and its communication policies, but there are few insights that will hearten industry’s attempts to win health claims.
“In the end there is nothing ground breaking in terms of what is required to achieve a claim,” said Nigel Baldwin, the senior scientific and regulatory consultant and EU manager at Cantox Health Sciences.
“ I am not sure for example we will see any immediate solutions for probiotics claims once they have sorted out the characterisation issues. So that dialogue will continue.”
The fact EFSA will normally only communicate with applicants under the article 13.5 and article 14 routes was now clear, Baldwin said, meaning those who hoped article 13.4 may offer hope for rejected article 13.1 claims was only going to happen in a “tortuous and slow” way, due to the indirect communications.
EFSA’s document summarises its position on subjects that have featured in previous EFSA health claims guidance such as nutrient characterisation, relevance of studies, claims substantiation and risk factors. It can be found here.
The guidance reiterates EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) position on the extrapolation of studies outside of target groups. Gastrointestinal discomfort is held up as an example where extrapolation is possible among patients with irritable bowel syndrome (IBS).
However, osteoporosis is not deemed fit for extrapolation to the general population in the bone health area.
“It is the responsibility of the applicant to provide the evidence that results from a study group other than the target population can be extrapolated to the target population,” the guidance states.
It adds: “Applications for claims that 422 specify target groups other than the general (healthy) population are the subject of ongoing discussions 423 with the Commission and Member States with regard to their admissibility.”
EFSA highlighted that its communications with applicants were conducted through NDA staff, not the actual Panel members. These consisted of direct and indirect communications before and during evaluation.
EFSA said it published a consolidated list consisting of 4637 article 13.1 claims.