Reassess Scientific Criteria Before Rejecting Article 13.1 Claims Say Trade Associations

13 Mar 2012

In joint comments submitted at the end of January on the final three batch opinions from the European Food safety Authority (EFSA) and the risk management decisions taken on the basis of those opinions, the EHPM, EBF and ERNA said that a distinction between maintenance and improvement in the scientific assessment procedure is essential to avoid unnecessary rejections of health claims.

Mar 13 2012 --- The scientific methodology for the assessment of article 13.1 health claims in the European Union (EU) should be changed for the sake of innovation three European trade associations have said.

The groups said that the way in which the assessments are currently done makes it “almost impossible to succeed” with a maintenance claim if there is no data supporting an improvement, despite the Terms Of Reference (TOR) on the article 13.1 list recognising that there are health effects that refer to both the maintenance of a function and to an improvement of a function.

They argued that a clear distinction would enable claims of different strengths to coexist on the EU market and have urged the European Commission against establishing a Union Register of rejected claims until the issues of scientific criteria for evaluating these claims has been addressed.

ERNA Chair Catherine Mignot said: “We appreciate the difficult process the Article 13 list process has gone through because of the lack of clarity and guidance on many aspects. We have also welcomed and supported the many efforts the European Commission has undertaken to try to solve issues that have arisen during the implementation. We nevertheless believe that a number of claims for which evidence is available are now close to rejection because of the approach taken. The current assessment procedure is seriously detrimental to the capacity of companies to innovate and compete on a global market as the methodology is not appropriate for nutritional research.”

EHPM Chairman Peter van Doorn echoed her comments, adding: “Except for essential nutrients – vitamins and minerals – whose role in the body is well established, general information on the role of a substance in the body has not been accepted as pertinent by EFSA. Instead, proof of improvements of physiological functions upon supplementation in a healthy population is needed. This discrepancy is not justifiable.”

“We have indicated repeatedly that we do not believe the approach adopted by EFSA for the assessment of article 13 claims is in line with the proportionality foreseen by the Nutrition and Health Claims Regulation (NHCR) as laid down in Recital 26,” he continued. “Given the way in which claims have been assessed, the reasons invoked for their non-authorisation and a complaint that is currently under consideration by the European Ombudsman, we believe it is not justified nor defendable that rejected claims are included in the Union Register just like that. They should be put on hold until this issue is clarified and resolved.”

EBF Chairman Michel Donat added: “The transient removal of botanicals from the process because of the inconsistency in assessing product claims between medicinal and food law shows the European Commission is really looking for solutions. Our numerous contacts with the European Commission showed it is not a trivial issue to solve, however it is absolutely necessary to consider a different approach, including appropriate assessment methodologies suited to plant-based food products in order to secure consumer protection and to maintain a wide choice of compliant products, produced in Europe, on the market. Thus, the Nutrition and Health Claims Regulation will achieve its main objectives.”

The groups ask that claims that have received a negative or insufficient opinion after assessment of the evidence should remain on hold until these issues are appropriately addressed.

In addition, they propose that claims judged by EFSA to be general and non-specific should not be considered for rejection as they are explicitly allowed in the Nutrition and Health Claims Regulation (justification / wording used).