EU Ombudsman Opens Investigation of EFSA Article 13 Health Claims Process

December 1, 2011

The complaint says EFSA is using the same type of stringent assessment for both Article 13 and 14 claims, which may have unfairly resulted in the high number of rejected Article 13.1 claims.

Deeming valid a complaint filed against the European Food Safety Authority’s (EFSA; Parma, Italy) Article 13 health-claims evaluations process, the European Ombudsman, which investigates complaints about maladministration in EU institutions, has agreed to further investigate the matter.

The complaint was filed by the European Federation of Associations of Health Product Manufacturers (EHPM) in September. EHPM argues that EFSA’s assessment of Article 13.1 claims has not been in accordance with the requirements of the EU Nutrition and Health Claims Regulations, stating that the European Commission and EFSA have “ignored the regulation’s requirement for a different type of assessment for Article 13.1 claims [general-function health claims] as compared to Article 13.5 and Article 14 claims [claims based on new or proprietary information or referring to disease-risk reduction and children’s development and health].” EHPM says that instead, EFSA is using the same type of stringent assessment for all of these claims, which may have unfairly resulted in the high number of rejected Article 13.1 claims.

EHPM says that the Ombudsman will now open a full investigation of its complaint.

“We have worked with the European Commission to ensure an appropriate interpretation of the regulation, and this has led to a number of welcomed changes in the implementation,” stated EHPM chairman Peter van Doorn, in a press release. “It has not, however, resulted in a fundamental reappraisal of the assessment process that is directly responsible for the rejection of more than 95% of the claims for other substances.”

“We hope the outcome of this investigation will confirm that the Article 13 claims evaluation should include an assessment of the totality of the evidence, the provision of clear indications on the extent or degree to which the food-health relationship is substantiated rather than the current yes/no opinions, and will lead to the use of accepted scientific methodologies for assessing strength, consistency, and plausibility of the evidence,” he continued.