European Groups Question Article 13 Model

BRUSSELS, BelgiumA new model to assess article 13 health claims is needed, according to the European Federation of Associations of Health Product Manufacturers (EHPM), which released a proposal defining the differences between types of health claims and offering insights on levels of detail required. The European Commission (EC) and European Food Safety Authority (EFSA) are currently reviewing their process for assessing article 13 claims.

The nutrition and health claims regulation makes it clear that there should be a different type of assessment for claims submitted for inclusion in the article 13.1 list and applications for authorization under article 14, said Peter van Doorn, chairman, EHPM. Both EFSA and the [EC] continue to say there is no distinction possible as to the criteria and level of scientific evidence. Our model shows that the application of the regulations provisions and the terms of reference will automatically result in different assessment criteria for article 13.1 claims than that required for article 14 claims.

The model was developed in conjunction with trade organizations European Responsible Nutrition Alliance (ERNA) and the European Botanical Forum (EBF). It analyzes essential elements of the scientific assessment of article 13 claims, including the characterization of the substance, the extent of cause-effect relationship, and how closely the claim verbiage reflects the totality of the state of scientific evidence.