EFSA issues health claims help
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.
Demonstrating the effect
EFSA stated the importance of accurately demonstrating nutritional and physiological effects with “appropriate outcome measures of that claimed effect”.
Claims must be sufficiently defined and strictly related to the evidence presented.
“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 (unclear what measure can be used) but ‘transit time’ is specific (measurable by generally accepted methods).”
“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.”
Disease reduction risk factors
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).”
Dental plaque was highlighted as a less strong association.
“…while there is evidence that there is an independent association between dental plaque and the incidence of dental caries, it is not generally established that lowering plaque level can lower risk for development of the disease. Nevertheless, if there is evidence that lowering plaque by a specific dietary intervention is accompanied by reduced incidence of dental caries then such a reduction in dental plaque might be considered beneficial in the context of a reduction of disease risk claim for dental caries for that specific dietary intervention.”
Study relevance
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.
“As human data are central for the substantiation of a claim, particular attention should be given to ensuring that the human studies presented are pertinent to the claim,” EFSA said.
“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 and/or opposing effects.”
EFSA added: “While studies in animals or in vitro may provide supportive evidence, human data are central for the substantiation of the claim.”
Wording
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.
The European Responsible Nutrition Alliance (ERNA) will attend the meeting and its secretary general, Patrick Coppens, said he looked forward to an "open and frank discussion".
But he said he was disppointed by the lack of depth in the Q&A and said it contained few surprises or new insights from guidance that had previously been issued under the EU 2006 nutrition and health claims regulation.
The Q&A can be found here.
