On 8 April the European Food Safety Authority (EFSA) published 263 opinions providing scientific advice on more than 2,150 “general function” health claims. The EFSA has now completed 80% of article 13 general function health claims and expects to complete the evaluation of those prioritised by the Commission by the end of June 2011. However, the high rejection rate remains contentious.

“General function” claims under Article 13.1 of EU Regulation 1924/2006/EC on Nutrition and Health Claims refer to the role of a nutrient or substance in growth, development and body functions; psychological and behavioural functions; slimming and weight control, satiety or reduction of available energy from the diet. These claims do not include those related to child development or health or disease risk reduction (Article 14 claims.)

The Regulation requires the scientific substantiation of claims and pre-market approval of all claims used, through a review by the EFSA.

The latest April batch of opinions approves certain claims including those relating to caffeine and alertness and increased physical endurance and that some sugar replacers may maintain tooth mineralization and can lower the increase in blood glucose levels after eating.

However, about 80% of the opinions were negative including in this latest batch those concerning probiotics and lutein.

The assessment process has been criticised by industry for this high rejection rate.

  • It is argued that Article 13.1 claims are more difficult to substantiate using the ‘gold standard’ pharmaceutical approach because it is not appropriate for food products. Intervention trials are unsuitable and illustrating a cause-effect relationships with measurable effects of a nutrient or other substance in, for example, growth, development and the functions of the body can be extremely difficult. Such nutrients often do not exist in isolation and may contribute to a process rather than be solely responsible for it.
  • Discrepencies between dossiers and the assessment process used due to a lack of guidance means some claims are rejected without an appropriate assessment of the evidence.
  • Finally, industry groups argue the EFSA has adopted an unduly restrictive interpretation of the meaning and aims of the Regulation for general function health claims.

 It remains to be seen whether certain rejected claims may be resubmitted under different criteria and if not how this will impact consumer choice and innovation.