Scientific Opinion on the substantiation of health claims related to meal replacements for weight control (as defined in Directive 96/8/EC on energy restricted diets for weight loss) and reduction in body weight (ID 1417), and maintenance of body weight after weight loss (ID 1418) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This Opinion addresses the scientific substantiation of health claims in relation to meal replacements for weight control (as defined in Directive 96/8/EC on energy restricted diets for weight loss) and reduction in body weight, and maintenance of body weight after weight loss. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food that is the subject of the health claims is "meal replacement for weight control", which is defined in Directive 96/8/EC on foods intended for use in energy-restricted diets for weight reduction. The Panel considers that "meal replacement for weight control" is sufficiently characterised in relation to the claimed effects. Reduction in body weight The claimed effect is "safe, effective & healthy weight loss; greater weight loss than with conventional calorie counting". The target population is assumed to be overweight subjects in the general population who wish to reduce their body weight. The Panel considers that reduction in body weight is a beneficial physiological effect. In weighing the evidence, the Panel took into account that in the first meta-analysis provided, weight loss achieved with meal replacement products was significantly greater (almost double) than with conventional energy restricted diets prescribed with the same calorie content, and that in another meta-analysis provided, both weight loss strategies were equally effective, although the intensity of the intervention was three times higher for the conventional energy restricted diets than for meal replacements. The Panel also took into account that all the meal replacement studies included in the meta-analyses used commercial products for the replacement of meals that usually contain up to 250 kcal/serving and generally comply with the characterisation described in this opinion, except for a lower protein content expressed on energy basis (generally 18-25 % energy as protein), and that biologically plausible mechanisms have been proposed by which meal replacements could exert the claimed effect, mostly in relation to their controlled energy content and relatively high protein, low fat content. On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of meal replacements in substitution of regular meals in the context of energy restricted diets and reduction in body weight. In order to bear the claims, a food should contain a maximum of 250 kcal/serving and comply with specifications laid down in Directive 96/8/EC in relation to food products under Article 1 (2b) of that Directive. In order to achieve the claimed effect, two meals should be substituted with meal replacements daily. The target population is overweight subjects in the general population who wish to reduce their body weight. Maintenance of body weight after weight loss The claimed effect is "maintenance of weight loss". The target population is assumed to be overweight subjects in the general population who wish to maintain their body weight after significant weight loss. The Panel considers that maintenance of body weight after weight loss is a beneficial physiological effect. In weighing the evidence, the Panel took into account that most of the studies presented report significantly better weight maintenance after weight loss when meal replacements are used in the maintenance phase, that all the meal replacement studies presented used commercial products for the replacement of meals that usually contain up to 250 kcal/serving and generally comply with the characterisation described in this opinion, except for a lower protein content expressed on energy basis (generally 18-25 % energy as protein), and that biologically plausible mechanisms have been proposed by which meal replacements could exert the claimed effect, mostly in relation to their controlled energy content and relatively high protein, low fat content. On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of meal replacements in substitution of regular meals and the maintenance of body weight after weight loss. In order to bear the claims, a food should contain a maximum of 250 kcal/serving and comply with specifications laid down in Directive 96/8/EC in relation to food products under Article 1 (2b) of that Directive. In order to achieve the claimed effect, one or two meals should be substituted with meal replacements daily. The target population is overweight subjects in the general population who wish to maintain their body weight after significant weight loss.