12 February 2009 - The fact that Member States’ did not reach an agreement last week on EFSA’s unfavourable opinion on article 14 glucosamine claims illustrates that there is still no consensus on all the details of underlying criteria for studies performed to achieve the EU’s approval of claims, EAS has said.
Deliberations in the Standing Committee, on the Food Chain and Animal Health Section on General Law on Tuesday, 26 January, saw no agreement on the issue of the validity of article 14 claims (disease risk reduction) relating to glucosamine and reduced cartilage degeneration.
The lack of consensus came despite the European Food Safety Authority’s (EFSA’s) opinion that it could not draw any scientific conclusions from the submitted clinical studies, which were conducted on “diseased people”. EFSA has said it could not establish that such studies were representative of the target healthy population. A similar conclusion has been drawn by EFSA on a recent Article 13 claim for glucosamine.
The EFSA NDA (Dietetic products, nutrition and allergies) panel that deals with this issue concluded at the end of last year that patients are not the target group for health claims. However, EFSA pointed out that studies in patients may be used to substantiate claims for the general population and this should be decided upon a case-by-case basis.
For example, the NDA expressed that studies including a target group for gastrointestinal discomfort in IBS patients would be acceptable, while joint function in osteoarthritis patients (basis of glucosamine claims) would not be accepted.
"We understand that EFSA needs to ensure that the target group of the claim needs to match the target group on which the studies are performed, or that the studies allow extrapolation to this target group" said EAS Regulatory Affairs Manager Stefanie Geiser. "However, it is currently not clear where the line is drawn. It is difficult for companies to understand which type of health condition will be accepted under the claims Regulation and which will not. In addition it is difficult to understand why and on which basis certain studies performed on patients and relating to certain health conditions should be excluded, taking into account that disease risk reduction claims are included in the scope of the EU claims Regulation. We therefore very much welcome that the Commission, Member States and EFSA are now discussing the criteria for acceptance of such studies in more detail."
The European Commission has now asked the Member States, on basis of the glucosamine case, for their views on EFSA 's opinion regarding these claims, to be discussed in the next Standing Committee on 26 April 2010.
EAS provides strategic consulting advice on European, Asian and international regulation on food and nutritional products. It provides companies with regulatory and strategic advice for the marketing and approval of their products in Europe and Asia. EAS also advises governments, trade associations and companies on the impact of European, Asian and global policy.
EAS has offices in Brussels, Italy and Singapore. EAS Italy is a branch of EAS Europe located in northern Italy to follow EFSA developments in Parma closely.