Health claim: A fixed carbohydrate : protein ratio ≤ 1.8

Health claim: A fixed carbohydrate : protein ratio ≤ 1.8

Following an application from Marks and Spencer PLC, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to a fixed carbohydrate : protein ratio ≤ 1.8 on an energy basis consumed in the context of an energy-restricted diet and reduction of body weight.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The application included a request for the protection of proprietary data.

The general approach of the NDA Panel for the evaluation of health claim applications is outlined in the EFSA general guidance for stakeholders on health claim applications and the guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations.

In the application, the food proposed by the applicant as the subject of the health claim is ‘a high-protein moderate-carbohydrate (HPMC) “macronutrient recipe” (used in a range of pre-prepared meals), which is a mixture of food ingredients/whole foods chosen to provide a macronutrient composition with a ratio of carbohydrate : protein (CHO:P) equal to or less than 1.8:1’.

Upon a request from the European Food Safety Authority (EFSA), the applicant acknowledged that the food/constituent that is the subject of the health claim is a CHO:P ratio < 1.8 on an energy basis in the context of an energy-restricted diet, which could be achieved by the combination of a wide range of foods belonging to several food categories in variable amounts. Foods or meals with a CHO:P ratio ≤ 1.8 on an energy basis, when consumed in the context of an energy-restricted diet, are proposed to bear the claim.

The Panel considers that the food/constituent that is the subject of the health claim, a fixed CHO:P ratio ≤ 1.8 on an energy basis to be consumed in the context of an energy-restricted diet, is sufficiently characterised.

The claimed effect proposed by the applicant is ‘reduction in total body weight in overweight adults, under energy restricted conditions’. The target population proposed by the applicant is ‘adults between the ages of 18 and 70 with excess body weight (BMI > 25 kg/m2)’. The Panel considers that reduction of body weight in the context of an energy restricted diet is a beneficial physiological effect.

The applicant provided a total of 16 human intervention studies for the scientific substantiation of the claim. The Panel considers that no conclusions can be drawn from two unpublished studies investigating the effect of a range of ready-to-eat meals with a CHO:P ratio ≤ 1.8 on an energy basis consumed in the context of an energy-restricted diet on body weight for the scientific substantiation of the claim.

The remaining 14 human intervention studies investigated the effect of diets targeting a CHO:P ratio ≤ 1.8 on an energy basis as compared to diets targeting a CHO:P ratio ≥ 3.0 on an energy basis on overweight and obese adults (BMI > 25 kg/m2) in the context of energy restriction.

The Panel notes that four out of seven studies lasting < 12 weeks reported an effect of a CHO:P ratio ≤ 1.8 on an energy basis consumed in the context of energy restriction on body weight in overweight/obese subjects, whereas no significant effect was observed in six out of the seven studies lasting 12 weeks or more. The Panel considers that these studies do not provide evidence for a sustained effect of the food/constituent on body weight.

In the absence of evidence for a sustained effect of a CHO:P ratio ≤ 1.8 on an energy basis consumed in the context of energy restriction on body weight, the studies provided by the applicant on the proposed mechanisms by which the food/constituent could exert the claimed effect were not considered by the Panel for the scientific substantiation of the claim.

On the basis of data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of a fixed CHO:P ratio ≤ 1.8 on an energy basis consumed in the context of an energy-restricted diet and reduction of body weight.

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Ria Van Hoef