Following an application from Lactalis B&C submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to “low fat and low trans spreadable fat rich in unsaturated and omega-3 fatty acids” and reduction of LDL-cholesterol concentrations.
The scope of the application was proposed to fall under a health claim referring to disease risk reduction.
The foods that are the subject of the health claim are “low fat and low trans spreadable fat rich in unsaturated and omega-3 fatty acids (“soft margarine”)” which should replace “fat rich in saturated/trans fatty acids (“hard fat”, butter, stick margarine)” in order to obtain the claimed effect. In the context of the information provided by the applicant, the Panel notes that the food constituents which are responsible for the claimed effect are unsaturated fatty acids (mixtures of cis-MUFA and/or cis-PUFA), which should replace saturated fatty acids (SFAs) and trans fatty acids (TFAs) in the diet in order to obtain the claimed effect. The Panel considers that the food constituents, mixtures of SFAs and TFAs as present in foods or diets, and the food constituents by which SFAs and TFAs should be replaced in foods or diets, i.e. mixtures of cis-MUFAs and/or mixtures of cis-PUFAs, which are the subject of the health claim, are sufficiently characterised.
The claimed effect is “helps to reduce LDL cholesterol. LDL cholesterol is a cardiovascular risk factor”. The target population as proposed by the applicant is moderately hypercholesterolaemic subjects in the general population and people who want to improve their diet. The Panel considers that lowering blood LDL-cholesterol concentrations is a beneficial physiological effect by reducing the risk of coronary heart disease.
A claim on the replacement of mixtures of SFAs with cis-MUFAs and/or cis-PUFAs in foods or diets and maintenance of normal blood LDL-cholesterol concentrations has already been assessed with a favourable outcome.
The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that there is consensus on the role of trans-MUFA in increasing total and blood LDL-cholesterol concentrations compared to cis-MUFA or cis-PUFA. The Panel notes that foods containing TFA typically contain high amounts of SFA, which are likely to have similar effects to TFA on LDL-cholesterol concentrations on a gram-for-gram basis. The Panel also notes that the effects of replacing marginal amounts of TFA in foods high in SFA may be small as compared to the effects of replacing SFA in those foods.
The Panel concludes that a cause and effect relationship has been established between the consumption of mixtures of dietary SFAs and an increase in LDL-cholesterol concentrations, and that replacement of a mixture of SFAs with cis-MUFAs and/or cis-PUFAs in foods or diets on a gram per gram basis reduces LDL cholesterol concentrations.
The Panel considers that the following wording reflects the scientific evidence: “Consumption of saturated fat increases blood cholesterol concentrations; consumption of mono and/or polyunsaturated fat in replacement of saturated fat has been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of (coronary) heart disease”.
The Panel considers that in order to bear the claim, significant amounts of mixed SFAs should be replaced by cis-MUFAs and/or cis-PUFAs in foods or diets on a gram per gram basis as per Annex of Regulation (EC) No 1924/2006 as amended by Regulation (EC) No 116/2010 and in accordance with the Guidance on the implementation of Regulation (EC) No 1924/2006 of the Standing Committee on the Food Chain and Animal Health for comparative nutrition claims made on foods (section 2.2.3). The target population is subjects who want to lower their blood cholesterol.