EFSA Issues Health Claims Assistance

The European Food Safety Authority (EFSA; Parma, Italy) has published a Q&A in advance of its stakeholders meeting in Brussels on June 15 to help industry better understand its nutrition and health claims process.

Plausibility between dietary effect and development of disease; the importance of human data; careful wording of claims; the inclusion of the full totality of evidence in regard to a proposed claim were all highlighted by the risk assessor in the seven-page document.

EFSA stated the importance of accurately demonstrating nutritional and physiological effects with “appropriate outcome measures of that claimed effect."

“The claimed effect needs to be specific enough to be testable and measurable by generally accepted methods,” EFSA said. “For example, ‘gut health’ is too general but ‘transit time’ is specific.”

“In the preparation of an application, a rationale/evidence should be provided that the claimed effect is beneficial in the context of the specific claim as described in the application.”

Risk factors in relation to the development of disease were singled out with EFSA emphasising that reduced risk factors for particular diseases must be “biologically plausible”.

The risk factor must also be an independent predictor of disease risk, something that can be established via intervention and/or observational studies.

“For some risk factors, there is strong evidence that they meet both criteria,” EFSA said. “For example, elevated serum LDL cholesterol is a risk factor for coronary heart disease (CHD) for which there is strong evidence for the biological basis through which it can contribute to the development of atherosclerosis (one pathway to CHD).”

EFSA’s document reemphasised the importance of targeted studies carried out on the food/constituent in question; the importance of human data; conditions of use; relevant study groups; usable animal models.

“In addition, it is important that the human studies provided represent all available evidence pertinent to the claim, including evidence that supports the relationship as well as equivocal evidence and evidence of no effect or opposing effects.”

EFSA said it would propose wording on occasion so that claims matched the available science, but noted it was up to the European Commission to take into account how such wordings may be interpreted by consumers.

It said wording must reflect the scientific evidence, complies with criteria established in the regulation and conditions of use are appropriate.

The meeting in Brussels next month has been double over-subscribed as industry seeks answers from EFSA before January, 2010, when the process is due for completion.