A crucial update for the nutraceutical sector
The food supplements sector is constantly evolving and requires continuous updates from manufacturers, distributors, and healthcare professionals. One of the main sources of regulatory change in Europe is the application of Article 8 of Directive 2002/46/EC, which allows the European Commission to take preventive action on ingredients considered potentially risky, even in the absence of conclusive EFSA evaluations.
Under this provision, a meeting of the Working Group of the European Commission and Member States on food supplements was held on Tuesday, 13 May 2025. Although the official agenda was not initially disclosed, significant unofficial information has emerged about some substances currently under discussion.
In this article, we examine in detail the developments regarding five key ingredients: Alpha Lipoic Acid, Monacolins, Hydroxyanthracene Derivatives, Green Tea Catechins, and Garcinia Cambogia, analyzing the regulatory and commercial implications for the sector.
Article 8 supplements: a preventive tool
Article 8 of Directive 2002/46/EC allows the Commission to take precautionary action on substances used in food supplements that pose potential risks to public health. If there are reasons for concern, the Commission may propose the inclusion of substances in Annex III, divided into three parts:
- Part A – Prohibited substances
- Part B – Substances subject to restrictions
- Part C – Substances under surveillance
This system makes it possible to balance consumer protection with evolving scientific evidence and the positions of Member States.
Alpha Lipoic Acid EU: proposal for Part C
During the meeting on 13 May, the Commission presented its updated position on Alpha Lipoic Acid (ALA), a molecule widely used for its potential antioxidant and neuroprotective effects.
Rather than proposing a ban, the Commission suggested inclusion in Part C of Annex III, requesting that Member States submit any written comments by the end of May.
In practice: ALA would remain on the market, but under enhanced surveillance pending further safety data.
Monacolins banned: restrictive proposals
The case of monacolins from red yeast rice is becoming more severe. Following a negative EFSA opinion, the Commission has proposed their inclusion in Part A of Annex III, thereby banning them at the European level.
This position will significantly impact the market, as monacolins have long been among the most widely used ingredients for supporting lipid metabolism. Member States are also expected to provide feedback on this.
Hydroxyanthracene Derivatives (HADs): decision expected end of 2025
The issue of HADs (anthraquinone compounds found in plants such as senna, rhubarb, and cascara) remains unresolved, as they are under observation for potential genotoxic effects.
The Commission announced that a final decision is expected in November/December 2025, leaving manufacturers in a state of regulatory uncertainty until the end of the year.
Green tea catechins: heading toward market exclusion
The potential impact is also serious for green tea extracts with high catechin content (especially EGCG). In the absence of new safety data, the Commission declared its intention to ban their use in supplements, except for traditional tea and beverage infusions.
This measure would result in their placement in Part A of Annex III, leading to their withdrawal from the European market.
Garcinia Cambogia: France takes a position
At the request of France and following evaluations by ANSES regarding adverse events linked to Garcinia Cambogia, an extraordinary standing committee was held. The Commission confirmed that France may adopt restrictive national measures, pending a decision at the EU level.
This is a concrete example of how Member States can take direct action, invoking the precautionary principle when they perceive an urgent public health risk.
Conclusions: A stricter regulatory future for supplements
The proposals discussed at the 13 May meeting represent a significant shift in the European regulatory approach to food supplements. The emphasis is clearly shifting towards greater caution, with new bans or enhanced monitoring for ingredients that have been widely marketed until now.
Companies in the sector must prepare for reformulations, market withdrawals, or new regulatory strategies to remain compliant and ensure consumer safety.
As manufacturers of food supplements, medical devices, and cosmetics, we provide our in-house regulatory and scientific expertise to help navigate an ever-evolving market. We are the ideal partner for companies seeking to grow while confidently addressing regulatory changes.
