Thomas Pauquai, PhD, the head of health claims and food safety at French-based Nutraveris, said the 143-page guidance was unlikely to shed much light on winning claims for appetite ratings, weight management and blood glucose concentrations under the EU nutrition and health claims regulation (NHCR).
Those 143 pages included consultation period comments from 49 parties including the University of Leeds, GlaxoSmithKline, Unilever, Kraft, Kellog’s, DSM, Tate&Lyle and Danone.
“It appears that the usefulness of this new guidance is low and does not revolutionise the knowledge to perform a high scientific study level on slimming,” Pauquai observed.
“While this kind of document may be useful for novices in this area, it is not sufficient for companies already experienced and performing clinical trials in order to receive a positive opinion from EFSA for their application.”
Pauquai said there were gains in some areas such as measures of body fat like dual energy X-ray absorptiometry, magnetic resonance imaging and computed tomography.
For the maintenance of normal blood glucose concentrations, “glycated haemoglobin” is specified as a valid measure.
“Similarly, as previously in the cardiovascular guidance, the time of 12 weeks has been proposed for studies necessary for the substantiation of these types of claims related to body fat and glucose concentration,” he said.
But, “no real additional data and clarification has been added about appetite ratings.”
It is the third subject-specific guidance issued by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) after previous missives on immunity and gut health and antioxidants and cardiovascular health.
The current guidance focused on several areas including:
- Healthy versus diseased populations. 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.
- 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.