Industry has criticised the findings for flying in the face of scientific consensus, while it remains unclear how the opinion will be viewed and utilised by French and other regulators.
The ANSES opinion agreed with the European Food Safety Authority (EFSA) that, “consumption of foods fortified with phytosterols/stanols at levels of 1.5-2.4 g/day lead to an average reduction in plasma concentrations of LDL-C of about 10%.”
But it said:
- this was not the case in a “considerable” 30% of people.
- increases in phytosterol-stanol plasma concentrations had unquantified cardiovascular consequences and needed further study.
- that it was not established that cholesterol reduction was a disease risk reduction factor in heart disease.
- that the products were available to children despite warnings they should not consume them.
- that plant sterol-stanol food consumption should be accompanied by an increase in consumption of fruits and vegetables, “to compensate for the resulting reduction in levels of plasma carotenoids.”
“…as regards public health, the available data do not make it possible to consider foods fortified with phytosterols/stanols as a suitable way of preventing cardiovascular disease,” the report concluded.
Individuals should only be prescribed sterol-stanol foods after a, “risk/benefit assessment on a case-by-case basis by a health professional.”
Unilever, owner of plant sterol-based brand ‘pro.activ’ that includes margarine and yoghurt drinks, said the findings run counter to, “the current scientific consensus and all regulatory approvals already obtained…”.
Aside from EU approvals, “Numerous authorities outside Europe have also independently confirmed the safety and efficacy of sterols,” Unilever added, noting the most recent in March this year in Canada.
Unilever, along with Raisio (Benecol) and Danone (DanActiv), were among the first winners under the nutrition and health claims regulation (NHCR) back in 2008.
Earlier this year the European Atherosclerosis Society (EAS) found 2 g of plant sterols or plant stanols per day in functional foods can help manage cholesterol for those with moderate heart disease risk and who are taking statin drugs.
ANSES (l’Agence Nationale de Sécurité Sanitaire de l’Alimentation) was requested to investigate stanols and sterols by the French consumer watchdog, UFC-Que Choisir.
It said results of such studies, "are provided to the relevant French Ministries so that they may implement appropriate management measures."
EFSA’s findings on plant sterols and stanols can be found here.