EFSA gut/immune health meeting

CIAA calls for drug-like health claim pre-submission advice

By Shane Starling

- Last updated on GMT

Related tags: Efsa, European union

CIAA is calling for greater dialogue with EFSA's health claims panel
CIAA is calling for greater dialogue with EFSA's health claims panel
The CIAA says EFSA’s immunity/gut health workshop has revealed the lack of clarity that remains in the European Union health claims process and called for pre-submission meetings between applicants and EFSA’s health claims panel.

CIAA (Confederation of the food and drink industries of the EU) director general, Mella Frewen, suggested the European Food safety Authority (EFSA) could take a lead from the way claims are dealt with in the drug industry.

“In the absence of more precise guidelines for claims, one significant move towards improving the evaluation procedure could, we believe, be achieved by introducing pre-submission meetings between EFSA and the applicant, as is the case for applications made to the European Medicines Evaluation Agency (EMEA),” ​Frewen said.

“We understand that this is being considered by EFSA but that they do not yet have the means to introduce such a process. The CIAA would support moves to give EFSA the resources needed to achieve this.​"

The CIAA affirmed that it remained a supporter of the nutrition and health claims regulation (NHCR), even if the process was making life difficult for many of its members.

Frewen added: "The CIAA has always supported the nutrition and health claims regulation, but has always expressed the need for greater clarity and for more dialogue between the applicant and the risk assessor. We look forward to continuing to work with EFSA on improving the functioning of the claims approval process.”

Some things EFSA said

In response to some questions on the day, EFSA said:

  • We can not tell you how to measure stool consistency
  • The NDA does not have the resources to engage in pre-assessment of claim submissions to give guidance on matters such as trial design
  • Questionnaires (for instance in regard to IBS) are submissible
  • Reducing diarrhoea is a beneficial physiological effect
  • Effects recorded in non-EU populations are admissible

A webcast of the day can be found here​ .

The panelists were Albert Flynn, Henk van Loveren, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Martinus Løvik, Stephan Strobel, Maria Saarela and Juliane Kleiner.

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