Scientific Opinion on the substantiation of health claims related to the replacement of mixtures of saturated fatty acids (SFAs) as present in foods or diets with mixtures of monounsaturated fatty acids (MUFAs) and/or mixtures of polyunsaturated fatty acids (PUFAs), and maintenance of normal blood LDL-cholesterol concentrations (ID 621, 1190, 1203, 2906, 2910, 3065) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)

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 related to the replacement of mixtures of saturated fatty acids (SFAs) as present in foods or diets with mixtures of monounsaturated fatty acids (MUFAs) and/or mixtures of polyunsaturated fatty acids (PUFAs) 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 foods/food constituents that are the subject of the health claims are unsaturated fats/fatty acids (poly and/or mono unsaturates), low or reduced saturated fat (hard fat) or replacement of saturated fat with MUFA, PUFA (soft fat) low cholesterol, milk, yoghurt, cheese and butter products based on raw milk with an improved ratio between saturated and unsaturated fatty acids and an increased level of omega 3 fatty acids due to naturally altered feeding of the cows, spreadable fats as defined in Article 115 and Annex XV of Council Regulation (EC) No 1234/2007 and matiere grasse laitiere optimisee (beurre). This opinion applies to the replacement of mixtures of SFAs as present in foods or diets with mixtures of cis-MUFAs (e.g. oleic acid) and/or mixtures of cis-PUFAs (e.g. LA (linoleic acid) and ALA (alpha-linolenic acid)). The Panel considers that the food constituent, SFAs as present in foods or diets, and the food constituents by which SFAs should be replaced in foods, 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 effects are blood cholesterol and artery/heart health, contribution to the maintenance of healthy total and LDL blood cholesterol levels by replacing saturated spreadable fat, lipides sanguins, cholesterol sanguin, maintains healthy LDL cholesterol levels arterial/heart health, and decreased intake of saturated fatty acids and increased intake of unsaturated fatty acids contributes to the maintenance of a healthy heart. The target population is assumed to be the general population. 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 mixtures of cis-MUFAs and/or cis-PUFAs. 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 replacement of a mixture of SFAs with cis-MUFAs and/or cis-PUFAs in foods or diets on a gram-per-gram basis may help maintain normal blood LDL-cholesterol concentrations. 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 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.