19 March 2007- EFSA’s "pre-submission guidance" issued last week on applications for the authorisation of certain health claims has been welcomed by trade association EHPM.
The document, which is available on EFSA’s website, covers applications for disease risk reduction and children health and development claims (article 14), and 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, notably that separate applications are necessary for every health claim; that the summary of the dossier should not contain confidential information as it will be published on EFSA’s website, and that 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 SME’s have been set aside, 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, EHPM Director of Regulatory Affairs. “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 (NDA Panel) are 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.
The European Food Safety Authority’s (EFSA) pre-submission guidance for applicants can be seen at
European Federation of Associations of Health Product Manufacturers (EHPM) represents more than 2000 specialist health product manufacturers in Europe. For more information contact Lorène Courrège, Director of Regulatory Affairs, EHPM, email [email protected], tel + 32 2 209 11 45, or visit www.ehpm.org