Natural Products Industry Welcomes New EU Guidance on Health Claim Applications

BRUSSELS, Belgium—European Federation of Associations of Health Product Manufacturers (EHPM) welcomed the European Food Safety Authority’s (EFSA) publication of “pre-submission guidance” on applications for the authorization of certain health claims. The document covers applications for disease risk reduction and children’s health and development claims (article 14), as well as health claims based on newly developed scientific evidence or proprietary data (article 18) of the Nutrition and Health Claims Regulation. It includes a number of key points: separate applications are necessary for every health claim; the summary of the dossier should not contain confidential information, as it will be published on EFSA’s Web site (www.efsa.europa.eu); and an English summary of the application is required.

Concerns that the translation costs of the summary to English would add to the financial burden of small and medium-sized enterprises (SMEs) have been addressed, as the guidance states that in the absence of an English dossier summary, EFSA will initiate the translation and request the applicant to validate it before the start of the scientific evaluation procedure.

“We are happy to see that SME specificities have been taken into account, as required by article 15.5 of the Regulation, by EFSA’s proposal to take charge of the translation of the summary,” said Lorène Courrège, director of regulatory affairs for EHPM (www.ehpm.org). “This could otherwise amount to a high cost for an SME applicant not familiar with the English language. We will remain vigilant that this indeed remains part of the guidelines for applicants.”

EFSA’s Scientific Panel on Dietetic products, Nutrition and Allergies is currently developing further guidance to assist all companies in preparing and presenting their applications under Articles 14 and 18 of the Nutrition and Health Claims Regulation. The document is expected by summer this year, and EFSA has strongly advised companies to wait for its release before submitting their applications.