Plant sterols and stanols are added to foods such as margarine, milk and bread, because of their cholesterol-lowering effect. Most foods with such additives are novel foods which must accordingly be assessed and approved in terms of their potential health risks. Plant sterols are found in low quantities in all fatty plant-based foods such as oils, nuts, seeds and cereals. For humans, they are not essential and are hardly used in the human metabolism. Plant stanols are hydrolysed plant sterols which are not naturally present in plant-based foods. The Federal Institute for Risk Assessment (BfR) below assesses a study from the Netherlands which provides valuable information on the unwanted effects of plant sterols on human retinal microvessels. Retinal vessels analysis is increasingly used for early diagnosis of cardiovascular risks. The findings of the study indicate that intake of plant sterols may entail cardiovascular risks for healthy persons who consume foods containing plant sterols in relatively large quantities and over a long period of time. Due to the amount of data available, the extent of this potential risk cannot currently be quantified. The BfR has already pointed out in earlier opinions that foods to which plant sterols or stanols are added are largely consumed by persons who do not have increased cholesterol levels as well as by children. The European Food Safety Agency currently recommends that daily consumption of plant sterols and stanols be limited to three grams. In view of the results of the Dutch study, the BfR is of the opinion that the use of plant sterols as a food additive should be reassessed at the European level. ; DE; de; efsa-focal-point@bfr.bund.de