BRUSSELLS—The European Ombudsman is investigating a complaint submitted by The European Federation of Associations of Health Product Manufacturers (EHPM) regarding the implementation of article 13 health claims evaluations. The European Ombudsman investigates complaints about maladministration in institutions and bodies of the European Union.
EHPM filed the complaint in September, which said the assessment of article 13.1 claims is not in accordance with the requirements of the EU Nutrition and Health Claims Regulation. The organization argued the European Commission and the European Food Safety Authority (EFSA) ignored the regulation’s requirement for a different type of assessment for article 13.1 claims as compared to article 13.5 and article 14 claims (referring to the reduction of disease risk and children’s development and health).
EHPM said the same type of assessment has been used for both types of claims, which the organization believes compromises the regulation’s intended proportionality and undermines its aims of achieving a high level of consumer protection, increased legal security for food companies, fair competition and the promotion and protection of innovation.
The complaint will now undergo a full investigation by the Ombudsman. On completion, the Ombudsman will give its decisions and recommendations.
“We hope this process will clarify the need for the application of a different type of assessment," said EHPM chairman Peter van Doorn. "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."
van Doorn added this reappraisal is essential to provide scientifically justified information to consumers and maintain the potential for innovation. "If not, the outcome of the process is expected to be seriously detrimental. The Ombudsman has been installed precisely to help find solutions in such cases, and we hope that through this mediation we can reach a compromise agreeable to all parties."