On 13 November 2024, the Court of Justice of the European Union (CJEU) issued a landmark ruling in case T-274/21, brought by the Syndicat national des compléments alimentaires (SYNADIET). The decision invalidates several key sections of Regulation (EU) 2021/468, which restricted the use of herbal preparations containing compounds such as aloe-emodin, emodin and aloe leaves, as well as certain plants including senna, rhubarb, buckthorn and cascara.
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The regulatory context: Regulation (EU) 2021/468
Regulation (EU) 2021/468, based on Article 8 of Regulation No 1925/2006, established restrictions on plant-derived products containing hydroxyanthracenes (HAD), arguing potential health risks.
However, the CJEU found that the interpretation of this article was inappropriate when applied to herbal “preparations”, a term whose scope is broader than that provided for in the original text.
The Court also noted that no clear toxicity thresholds associated with HAD compounds were identified, which invalidates the scientific basis for the ban and makes it incompatible with the legal principles set out in Article 8 of Regulation No 1925/2006.
Impact on the food supplements industry
This resolution represents a significant step forward for the food supplements sector. From now on, manufacturers can market products containing hydroxyanthracene derivatives, provided they can scientifically justify their safety for human consumption, in compliance with general food safety regulations.
Regulatory implications
The CJEU decision obliges the European Commission and Member States to review and adapt current regulations on the use of plant compounds in food supplements . This underlines the need to establish clear, evidence-based thresholds before implementing restrictions that impact both industry and consumers.
Conclusion
The annulment of Regulation (EU) 2021/468 not only strengthens the European regulatory framework by requiring more precise and transparent criteria, but also provides an opportunity for innovation in the food supplements sector. This ruling highlights the importance of balancing consumer safety with market freedom, supporting operators that meet safety and quality standards in their products.
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