WG FS Proposal: Restriction or Ban on 13 Substances

The Heads of European Food Safety Agencies (HoA) have recently released a significant report from their working group on food supplements (WG FS). The report proposes restrictions or bans on 13 substances commonly used in dietary supplements. This initiative aims to enhance consumer protection and ensure a harmonized regulatory approach across the European Union (EU).

The WG FS reviewed a total of 117 substances, evaluating their potential health risks when consumed in supplement form. Based on this review, 13 substances have been identified for prioritization due to their potential health risks. For these 13 substances CAFAB (Competent Authority Food Assessment Body) WG on Novel Food has already been contacted and the status as ‘not novel’ or ‘not NFS’ has been confirmed.

An overview of the 13 substances

• Coumarin in plant preparations
• Curcumin in Curcuma spp.-preparations
• Hypericum perforatum
• Melaleuca spp.-essential oils
• Melatonin
• Piperine
• p-Synephrine in Citrus spp.-preparations
• Tryptophan
• Actaea racemose
• Lepidium meyenii
• Ocimum tenuiflorum
• Tribulus terrestris
• Withania somnifera

Not Novel: Substances classified as ‘not novel’ have a significant history of consumption in the EU prior to May 15, 1997, meaning they do not require a pre-market authorization under the Novel Food Regulation (EU) 2015/2283.

Not NFS (Not for Supplement Use): Substances considered ‘not NFS’ are those for which sufficient scientific evidence suggests they should not be used in supplements due to potential health risks.

Future Plans: Decision by the European Commission in Consultation with EFSA

The next steps involve the European Commission (EU COM) deciding on these recommendations in consultation with the European Food Safety Authority (EFSA). The substances deemed to pose a potential health risk will be subject to the ‘Article 8 procedure’ under Regulation (EC) No 1925/2006. This procedure allows for the inclusion of these substances in Annex III of the regulation, which lists substances that are either prohibited, restricted, or under scrutiny within the EU.

Current Situation in Japan

Japan is also witnessing a significant overhaul of its functional food labeling system, driven in part by incidents like the red yeast rice (Monascus) case.

This incident involved concerns over the safety of Monascus purpureus, a common ingredient in red yeast rice products known for its cholesterol-lowering effects. It has been reported that the cause might be the production of compounds such as “puverulic acid” (source 1, source 2 (Japanese).

The main change to Japan’s functional food labeling system is the inclusion of Good Manufacturing Practice (GMP) requirements.

Conclusion

As the European Commission and EFSA move forward with these recommendations, it is crucial for stakeholders to stay informed and prepared for potential regulatory changes. Similarly, Japan’s revisions in response to the red yeast rice incident underscore the global shift towards stricter regulation of functional foods and supplements. Both regions’ efforts demonstrate a commitment to protecting consumers while maintaining the integrity of the food supplement industry.

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