Emerging risks in food supplements: which ingredients could be considered for future Article 8 assessments?

The European Food Supplement Project, created within the framework of tailor-made activities coordinated by EFSA Focal Points, gathers information to facilitate the prioritisation of substances that are likely to be regulated under Article 8 of Regulation (EC) No 1925/2006. 

Recently, the European Food Supplement Project published a report highlighting ingredients and substances that may represent emerging risks when used in food supplements. 

The working group was composed of seven active Member States (France, Belgium, Denmark, Ireland, Italy, Netherlands, Portugal) responsible for data collection and analysis, as well as 16 observers invited to comment on the results. Their objectives were to: 

1. Identify potential emerging risks through nutrivigilance data (Vigilance Work Package);
2. Assess the potential exposure of European consumers to substances of concern naturally occurring in plants, as identified in the EFSA Compendium of Botanicals (Plant Work Package). 

As part of the Vigilance Work Package, the working group considered six ingredients as possible sources of emerging risks : Bifidobacterium, Coleus (Plectranthus barbatus), Guggul (Commiphora mukul), Toothed clubmoss (Huperzia serrata), Black radish (Raphanus sativus L.) and Ginseng (Panax ginseng). 

This conclusion was reached by first identifying 130 case reports with high severity (life-threatening or fatal outcomes) and high causality (likely or very likely) from national vigilance systems. This was followed by a literature review that enabled the working group to rank ingredient-case report pairs and highlight ingredients associated with potential emerging risks, i.e., those possibly involved in nutrivigilance cases but for which the available evidence remains limited (isolated clinical case reports or animal studies). 

As part of the Plant Work Package, the working group showed that furfural, emodin and chrysophanol are substances of concerns present in a high number of food supplements available in the five Member States studied (France, Italy, Ireland, the Netherlands and Portugal). 

These three substances are considered as genotoxic, carcinogenic or reprotoxic according to the EFSA Compendium of Botanical. 

This report represents a first step in the process of identifying substances that could be further discussed for potential assessment under Article 8 of Regulation (EC) No 1925/2006. However, there is still a long way to go before any of these substances enters the Article 8 evaluation process and is included in the annexes of Regulation (EC) No 1925/2006. 

Additional data, including analytical, exposure and safety data, are still required to adequately characterise the risk to consumers. 

Author: Emilie Chauvigné, Regulatory Affairs – Project Expert Nutrition