Following an application from Raisio Nutrition Ltd, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Finland, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to 3 g plant stanol esters per day and lowering blood LDL-cholesterol by 12 % and reduced risk of (coronary) heart disease. The applicant has further requested that the minimum duration for the effect be stated to be one to two weeks, and that the claims be authorised for an extended range of foods, including yellow fat spreads, dairy products, cheese, rye bread, oatmeal, fermented soy milk based products (drinkable and spoonable yoghurt-type products), and oat based milk drinks.
The Panel notes that the applicant’s request specifically relates to the amendment of an already authorised claim laid down in Regulation (EC) No 376/2010 so that it would refer to an intake of 3.0 g/d of plant stanol esters added to an extended range of foods which would lead to an LDL-cholesterol lowering effect of 12 % within 1 - 2 weeks. The application included a request for the protection of proprietary data.
The applicant provided an unpublished meta-analysis on 18 randomised, controlled human studies on the LDL-lowering efficacy of plant stanols (as plant stanol ester) at intakes between 2.7 to 3.3 g per day in matrices approved by the European Commission. In this analysis the relative pooled LDL-cholesterol lowering effect was 11.4 % (95% CI, 9.8 - 13.0 %). The Panel notes some limitations of the applicant’s meta-analysis that contribute to uncertainty of the estimate of the LDL-cholesterol lowering effect (e.g. the study quality not being taken into account, and the estimation of the relative net changes of LDL-cholesterol levels and variance parameters which were not reported in most of the original articles).
The applicant claimed that the minimum duration required for efficacy was one to two weeks. In two of three treatment arms, in which the earliest LDL-cholesterol measurement was made after one week of intervention with plant stanol ester enriched foods, the maximum LDL-cholesterol lowering effect was achieved already after one week of intervention; in the third study the maximum effect was achieved after two intervention weeks. In four out of eight treatment arms in which the earliest LDL-cholesterol measurement was made after two weeks of the plant stanol ester intervention the maximum LDL-cholesterol lowering effect was attained after two weeks of intervention, while in the four other treatment arms most of the reduction was already achieved after two weeks. The Panel considers that the minimum duration required to achieve the maximum effect of plant stanols on LDL-cholesterol lowering is two to three weeks.
With regards to the proposed conditions of use, the applicant suggested that the food matrices should not be limited to those specified in Regulation (EC) No 376/2010 (yellow fat spreads, dairy products, mayonnaise and salad dressings) and that the claimed effect can also be achieved with other matrices (rye bread, oatmeal, fermented soy milk based products (drinkable and spoonable yoghurt-type products), and oat based milk drinks). The Panel notes that all of the 18 treatment arms analysed in the meta-analysis used matrices specified in Commission Regulation (EC) No 376/2010 and that no human intervention study has been provided by the applicant to demonstrate that 3 g plant stanols consumed with other food matrices can lower blood LDL-cholesterol by 12 %.
On the basis of the data presented, the Panel concludes that plant stanol esters at a daily intake of 3 g plant stanols (range 2.7 g to 3.3 g) in matrices approved by Regulation (EC) No 376/2010 (yellow fat spreads, dairy products, mayonnaise and salad dressings) lowers LDL-cholesterol by 11.4 % (95% CI: 9.8 – 13.0), that the minimum duration required to achieve the maximum effect of plant stanol esters on LDL-cholesterol lowering is two to three weeks, and that while plant stanol esters added to foods such as margarine-type spreads, mayonnaise, salad dressings, and dairy products such as milk, yoghurts including low-fat yoghurts, and cheese have been shown consistently to lower blood LDL-cholesterol levels, the size of the cholesterol-lowering effect of plant stanols added to other food formats is less well established.
The Panel could have reached these conclusions without considering the unpublished meta-analysis claimed as proprietary by the applicant.