No evidence of harmful effects of isoflavones in food supplements for post-menopausal women according to EFSA - How does this affect restrictions on isoflavones at national level? / by Lara Skoblikov

In a recent publication, EFSA delivered a scientific opinion on the possible association between the intake of isoflavones at a daily dose in the range of 35–150 mg/day from food supplements and harmful effects on breast, uterus and thyroid in peri- and post-menopausal women. EFSA concluded that the evidence reviewed does not suggest there are harmful effects on the three target organs.

However, EFSA found that there is no data to assess the safety of these substances for women during the transition period to menopause and for women with a history or family history of breast cancer, women on medication for thyroid diseases or other chronic conditions. The Panel decided further that it was not possible to directly extrapolate observations from the target organ to the others.

Isoflavones are naturally occurring substances which are found, among other sources, in soy, alfalfa, red clover and kudzu root. Maximum levels for the use of isoflavones in food supplements are currently in force in Belgium (40 mg/day, as glycosides of the main component), France (1 mg/kg bw/day, as aglycone) and Italy (80 mg/day total isoflavones). In France, the following warning should in addition be included in the label: “not suitable for women who have a personal or family history of breast cancer”.

These restrictions constitute obstacles to trade. Member States can maintain them only as long as they can justify they are necessary in view of the protection of public health, based on the latest available scientific evidence.

Now, do the conclusions from EFSA affect the abovementioned restrictions? This remains to be seen.

First of all, EFSA’s assessments are generally regarded as very reliable, but are not capable of automatically overruling existing national legislation. Only the Member States themselves can amend or repeal legislation and only the Court of Justice of the EU and national courts can declare it unlawful. In practice, Member States have shown reluctance to revise their rules or administrative practice on the basis of a risk assessment by EFSA.

Secondly, EFSA’s conclusions apply to peri- and post-menopausal women and consider only three organs. This means that if Member States can demonstrate with scientific evidence that a risk to health exists with regard to target groups/aspects falling outside of the scope of EFSA’s assessment, they would be able to keep their national restrictions.

Note however that while Member States may, under the precautionary principle, take protective measures without having to wait for the reality and the seriousness of those risks to be fully demonstrated, purely hypothetical risks that have not been scientifically confirmed, cannot be accepted. Furthermore, the measures should be the least restrictive to achieve the objective pursued. In this sense, labelling the Court of Justice of the EU has accepted labelling requirements as a ‘least restrictive’ measure.

Nevertheless, even the French labelling warning constitutes a barrier to trade and requires a showing of necessity as well as of proportionality. France needs to demonstrate and actual (potential) risk which is not hypothetical and the warning should not go further than strictly necessary for the protection of health. In this light, it could be wondered whether it would be strictly necessary to require the warning irrespective of the amount of isoflavones in a product. Currently, the warning is mandatory for all food supplements containing even the smallest amount of soy.