The new guidance focuses only on those aspects of appetite ratings, weight management, and blood glucose concentrations that EFSA’s health claims panel has deemed to have, “beneficial physiological effects”.
“The structure of the guidance document released for public consultation has changed considerably after taking into consideration the comments received,” EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) said of the guidance that relates to general function (article 13), proprietary and emerging science (13.5) and disease risk factor reduction and chidren’s claims (14).
“…the revised guidance document has been structured as a guidance to applicants on the beneficial physiological effects identified by the NDA Panel in this field on the basis of the experience gained so far, including the mechanisms which have been proposed by which food/constituent(s) could achieve the claimed effects.”
Others to comment included Cargill, Unilever, TNO, and the European trade groups EHPM and ERNA.
Case by case
A common theme among the comments was the need for more specific biomarkers and guidance in trial design factors such as the use of disease-state populations, but the NDA reiterated its now well-known ‘case by case’ position.
“Given that health claims are often technically complex and unique, outcome measures for claimed effects may need to be considered in the context of a specific application, and cannot be all cover in a guidance document,” it said.
“The guidance may be updated in the future in the light of additional experience gained with the evaluation of health claims.”
For diseased versus healthy populations, the Panel suggested research on obese, elderly and pre-diabetic populations could be submitted, but obese subject extrapolation to healthy subjects could be compromised if weight loss medications were involved.
“A reduction in body weight and/or a reduction in total body fat may not generally be beneficial physiological effects for the normal-weight population, but would be beneficial for adults with an excess body weight/excess body fat,” it said.
Other points addressed in the guidance included:
- Sustainability of effect. The Panel clarified that it is not interested in, ”the persistence of the effect after discontinuation of the food/constituent…To address this aspect, measurements of the outcome variable at different time points during the intervention are generally required.”
- Reduced energy. These are not all deemed as nutrition claims but, “characterisation of foods as meeting the requirements for these nutrition claims (e.g. reduced, low or no energy content) may be insufficient for the scientific substantiation of health claims on the reduction of body fat/body weight.”
- Assessing body composition changes. “Imaging techniques (e.g. DEXA, MRI and CT) are generally appropriate to assess changes in body fat and lean body mass in human intervention studies.”
- Appetite ratings. “The beneficial physiological effect of changing appetite ratings (e.g. hunger, fullness, satiety, and desire to eat) depends on the context of the claim…The scientific evidence for an effect on appetite ratings can be obtained from human intervention studies showing an increase in satiety/a reduced sense of hunger or appetite (behavioural assessment) using methods with appropriate validity and precision (e.g. validated visual analogue scales).”
- Body fat/body weight. “Evidence for a sustained effect with continuous consumption of the food/constituent over, for example, about 12 weeks, should also be provided.”
- Weight maintenance after weight loss. “Evidence for a sustained effect with continuous consumption of the food/constituent over, for example, about six months, should be provided.”
- Reduction of abdominal fat. Imaging techniques and, “surrogate measures of abdominal fat (e.g. waist circumference)” can be used.
- Increase/maintenance of lean body mass. "A sustained increase in lean body mass may be a beneficial physiological effect for physically active subjects, including trained individuals.”
- Post-prandial blood glucose responses are admissible with, “human intervention studies showing a decrease in blood glucose concentrations at different time points after consumption of the test food during an appropriate period of time (i.e. at least two hours) while insulin concentrations at different time points are not increased in comparison to the reference food.”
- Maintenance of normal blood glucose concentrations. “As suggested in the comments provided, maintenance of normal blood glucose concentrations is considered a beneficial physiological effect for the general population.”
The guidance can be found here.