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EFSA’s live culture: Help agency revise its gut and immune health claim guidance

By Shane Starling+


"The NDA Panel notes that new health relationships and outcome measures have been considered in the context of specific applications related to gut and immune function since April 2011.”

The European Food Safety Authority (EFSA) is calling for input from all stakeholders as it goes about revising its controversial gut and immune health claim guidance that dates back to 2011.

In calling for input until September 10, the Parma-based agency focuses on areas including:

  • Suitability of the study population
  • Evaluation of claims related to essential nutrients compared to non-essential nutrients
  • Considerations on the validity of tools used to measure outcomes (e.g. questionnaire)
  • Appropriate reporting of human studies
  • Handling of data which are claimed as confidential

“The outcome of the public consultation together with new scientific evidence available to the NDA Panel (Dietetic products, Nutrition and Allergies) and the experience gained with the evaluation of health claims will serve as a basis for revising the guidance on the scientific requirements for health claims related to gut and immune function,” EFSA said.

In justifying the need for a revised guidance EFSA said there had been a, “considerable number of requests for clarification” and that fresh guidance would, “benefit both industry (by providing clearer requirements) and evaluators of health claims (through receiving better applications).”

It added: To date, over 570 scientific opinions related to health claims have been published. The NDA Panel notes that new health relationships and outcome measures have been considered in the context of specific applications related to gut and immune function since April 2011.”

“The NDA Panel also emphasises the importance of engaging in consultation with experts from academia and with stakeholders in the process of updating existing guidance documents and/or developing new guidance documents.”

While not exclusively about these ingredients, under the current guidance, no prebiotic or probiotic has won a health claim while 100s of submissions have been rejected.

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