Scientific Opinion on the substantiation of health claims related to foods with reduced amounts of saturated fatty acids (SFAs) and maintenance of normal blood LDL-cholesterol concentrations (ID 620, 671, 4332) 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 foods with reduced amounts of saturated fatty acids and maintenance of normal blood LDL-cholesterol concentrations. 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 constituents that are the subject of the health claim are “saturated fats/saturated fatty acids (decrease)” and “decrease of saturated fatty acids”. This opinion applies to mixtures of saturated fatty acids as present in foods. The Panel considers that saturated fatty acids (SFAs) are sufficiently characterised. The claimed effects are “blood cholesterol and artery/heart health”, and “cardio-vascular system”. The target population is assumed to be the general population. In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effects refer to the maintenance of normal blood LDL-cholesterol concentrations. The Panel considers that maintenance of normal blood LDL-cholesterol concentrations is a beneficial physiological effect. The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that there is good consensus that a mixture of SFAs increases blood total and LDL-cholesterol concentrations relative to carbohydrates, which are considered neutral regarding their effects on LDL-cholesterol concentrations. The effect shows a linear dose-response relationship with blood LDL-cholesterol concentrations, indicating that the effect is proportional to the amounts of SFAs consumed. It is also well established that consumption of a mixture of SFAs results in increased blood HDL-cholesterol concentrations compared with consumption of mixtures of cis-MUFAs or cis-PUFAs, and that, in comparison with other fatty acids except trans fatty acids, SFAs increase the total-to-HDL cholesterol ratio. The Panel concludes that a cause and effect relationship has been established between the consumption of mixtures of dietary SFAs and an increase in blood cholesterol concentrations, and that consumption of foods with reduced amounts of SFAs may help to maintain normal blood LDL-cholesterol concentrations. The Panel considers that in order to bear the claim, foods should contain reduced amounts of saturated fatty acids as per Annex of Regulation (EC) No 1924/2006 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.