Alpha Lipoic Acid (ALA)
Discussions between the European Commission (EC) and Member States about Alpha Lipoic Acid (ALA) have concluded. EC has confirmed that it has presented a proposal to ban ALA in foods, including Food Supplements.
The industry and various trade associations proposed managing the risk of ALA consumption through labelling requirements, as handled already by some Member States at the national level.
The debate in Europe remains open, and a draft regulatory text will shortly be subject to consultation. If approved, the measure will proceed to a three-month scrutiny period. If no objections are raised, the EC will adopt the measure.
The estimated timeline for adoption is Q4 2025 and no transition period is expected.
The above means that the ALA subject is not 100% resolved yet.
Monacolins from Red Yeast Rice
EFSA, the European Food Safety Authority, has published its Scientific Opinion on additional data related to the safety of monacolins from red yeast rice.
Despite the submission of scientific papers and post-market surveillance data showing an extremely low incidence of potential adverse events – especially given the substantial number of product units available on the market – EFSA:
– reiterated concerns previously raised that an intake of monacolin K from red yeast rice, even at levels as low as 3 mg/day, could lead to severe adverse effects on the musculoskeletal system and the liver.
– concluded that the submitted data does not establish the safety of supplements containing monacolin K from red yeast rice at levels below 3 mg/day
– did not identify any daily intake level that would be considered safe for the general population, including vulnerable subgroups.
Based on this opinion, the European Commission will propose the final regulatory measure within one year. At this point, a total ban on monacolins from red yeast rice at any level in food supplements can not be discarded. Another possible outcome could be the confirmation of the current regulatory approach, which limits daily to less than 3 mg and requires mandatory warnings on the product label.
This change may also affect products that currently carry permitted health claims related to monacolin K for cholesterol reduction.
Ashwagandha
Following a critical advisory that highlights potential health risks associated with ashwagandha, including the possibility of liver damage and its historical use to induce abortions, the authorities in the Netherlands have proposed a ban on ashwagandha.
Industry stakeholders were invited to submit safety data and express concerns before the consultation period period closes on March 24.
Green Tea extracts containing catechins
The European Commission (EC) may propose to ban green tea extracts containing (-) epigallocatechin-3-gallate.
In Regulation (EU) 2022/2340, the EC included these extracts in :
– Part B, outlining restrictions on quantity and labelling requirements
– Part C, putting the extracts under scrutiny, allowing for the collection of data to demonstrate their safety.
No data was submitted during the scrutiny period, which ended on December 21, 2024.
The EC now has two years to decide whether to ban the use of these extracts in food products.
Garcinia cambogia
The French Agency ANSES issued a warning against the consumption of Food Supplements containing Garcinia cambogia.
In a recent scientific opinion, ANSES highlighted the adverse events associated with the consumption of food supplements containing Garcinia cambogia and advised the general population to avoid these supplements due to the potential serious health risks.
The agency also noted regulatory inconsistencies in France. Although classified as a medicinal product with restrictions on its importation and sale since 2012, it remains available in food supplements.
Until further guidance is provided by EFSA, ANSES encourages consumers to be cautious and seek professional medical advice before using such supplements. The agency also called for a harmonised European approach to regulating botanical ingredients and on-hold health claims, which are neither explicitly authorised nor prohibited.
This is a developing narrative. We will keep you briefed as new information becomes available.
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‡Photo by Roman Kraft on Unsplash
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