Navigating the EU Health Claim Regulation

Abstract

Abstract The Health Claim Regulation (HCR) is the legal framework used by food businesses to highlight the benefits of their food products on labels or in promotional communications in the European Union (EU). The rules aim to ensure consumer protection from misleading health claims and to promote fair competition, the free circulation of foods bearing health claims and innovation. There are different authorisation procedures managed by the European Commission (EC) for distinct types of claims and considerable guidance is available both on the presentation of the dossier and the scientific aspects of substantiation of the health claim. While thousands of health claims have been submitted by applicants, only a small percentage have been authorised and the rate of submission has slowed dramatically from the early years of the HCR’s introduction. Nevertheless, applicants have been successful and health claims have been authorised in each health claim type. More recently, the introduction of the Transparency Regulation has impacted the submission process in significant ways, and it remains to be seen if this change will encourage or deter applicants from submitting. While the HCR has been in place for 16 years, there are still many outstanding items, such as nutrition profiling and “on hold” claims that affect businesses. In addition, authorities often take different views on the flexibility that can be applied to authorised health claim wording. This makes implementation of authorised health claims across the EU often complex for businesses to manage. However, despite these issues, the HCR has made strides to protect consumers from misleading claims and provided a robust framework for the scientific evaluation of health claims which is highly regarded worldwide. Information © The Author 2023