VALBIOTIS SA: Monacolins from Red Yeast Rice: On May 13, EU Member States voted in favor of the draft regulation aimed at banning monacolins from red yeast rice

DJ VALBIOTIS SA: Monacolins from Red Yeast Rice: On May 13, EU Member States voted in favor of the draft regulation aimed at banning monacolins from red yeast rice

VALBIOTIS SA 
VALBIOTIS SA: Monacolins from Red Yeast Rice: On May 13, EU Member States voted in favor of the draft regulation aimed 
at banning monacolins from red yeast rice 
27-May-2026 / 17:40 CET/CEST 
Dissemination of a French Regulatory News, transmitted by EQS Group. 
The issuer is solely responsible for the content of this announcement. 
 
=---------------------------------------------------------------------------------------------------------------------- 

Monacolins from Red Yeast Rice: On May 13, EU Member States voted in favor of the draft regulation aimed at banning 
monacolins from red yeast rice 

   -- On May 13, EU Member States voted in favor of the draft regulation aimed at banning monacolins derived 
  from red yeast rice. 
   -- Projected timeline: The regulations could be published in October 2026, with implementation within the 20 
  days following, and a one-year phase-out period for products placed on the market prior to the measure's 
  implementation (October 2027). 
   -- Strategic impact for Valbiotis: This regulatory change reinforces the validity of Valbiotis' scientific 
  approach to cardiometabolic prevention and provides a new commercial growth driver for its product portfolio, 
  particularly ValbiotisPRO Cholesterol. 
  
 
La Rochelle, May 27, 2026 (5:40 pm CEST) - Valbiotis (FR0013254851 - ALVAL, PEA / PME eligible), a French laboratory 
specializing in cardiometabolic health, draws attention to the vote by European Union Member States of the draft 
regulation providing for a ban on monacolins from red yeast rice in dietary supplements. This change in European 
regulations was initiated following scientific assessments conducted by the European Food Safety Authority (EFSA) and 
reinforces the relevance of the scientific approach developed by Valbiotis in the prevention of cardiometabolic 
imbalances, notably through ValbiotisPRO Cholesterol, a solution formulated without red yeast rice or monacolins. 
 
A major regulatory milestone at the European level 
 
Monacolins from red yeast rice have been under review by European regulatory authorities for several years following 
concerns over their safety. 
 
In a scientific opinion published in 2018, the EFSA concluded that serious adverse effects could occur even at low 
intake levels. Based on these findings, the European Commission adopted restrictive measures in 2022 concerning the use 
of monacolins within the European Union. 
 
Industry players were subsequently granted a period of time during which they could submit additional data regarding 
the safety of these substances. After reevaluating the available evidence, the European authorities continued the 
regulatory discussions surrounding these ingredients. 
 
On May 13, Member States meeting within the SCoPAFF* voted in favor of the draft regulation presented by the European 
Commission regarding a ban on monacolins from red yeast rice. 
 
The text must now continue through the institutional process, which includes: 
 
   -- A three-month review period by the European Parliament and Council. 
   -- Approval by the European Commission and publication in the Official Journal of the European Union. 
 
The regulation will then enter into force 20 days after publication, with a transitional period for the clearance of 
existing stocks placed on the market prior to the entry into force of the new provisions scheduled to last until 
October 2027. 
 
A regulatory change aligned with Valbiotis' approach 
 
This change in regulations underscores the relevance of Valbiotis' scientific approach to preventing cardiometabolic 
disorders. 
 
Through its ValbiotisPRO range, Valbiotis develops innovative, expert nutritional solutions based on ingredients 
selected for their efficacy and safety profiles, in response to the expectations of healthcare professionals and 
consumers. In this context, ValbiotisPRO Cholesterol, a solution designed to help maintain normal cholesterol levels, 
was developed without monacolin K or red yeast rice. The product is based on the proprietary, 100% natural-origin, 
active ingredient Lipidrive, which was the result of more than 10 years of research and development and incorporated 
into a clinically tested formula. 
 
Studies conducted by Valbiotis have demonstrated efficacy on LDL cholesterol in as little as 6 weeks**, providing an 
innovative response to the challenges related to the prevention of cardiometabolic disorders. 
 
Valbiotis' scientific approach is built on an unprecedented clinical research program in the dietary supplements sector 
, comprising 13 proprietary, randomized, multicenter, international clinical studies, several of which were 
double-blind, placebo-controlled trials, involving a total of over 1,500 participants. 
 
The results of this research have been presented at scientific conferences recognized by leading international learned 
societies, demonstrating the scientific rigor of the solutions developed by Valbiotis (15 publications in peer-reviewed 
international journals and 64 conference presentations since 2021). 
 
Valbiotis thus continues to pursue its mission to provide scientifically validated, innovative nutritional solutions 
tailored to public health challenges linked to cardiometabolic disorders. 
 
This change in regulations, which is expected to support the renewal of offerings in the cardiometabolic prevention 
segment, provides the Company with greater visibility for ValbiotisPRO Cholesterol, a scientifically validated 
alternative formulated without monacolin K, as well as for its broader product portfolio. It further strengthens 
Valbiotis' positioning with its partners and prescribers, healthcare professionals and pharmacy groups, as well as 
across its sales channels, both in pharmacies and online. With this new catalyst for commercial growth, Valbiotis is 
poised to support a continued ramp-up of its revenues. 

* Standing Committee on Plants, Animals, Food, and Feed 
 
** Double-blind, placebo-controlled clinical trial involving 340 participants starting 6 weeks after taking Lipidrive 

About Valbiotis 
 
Valbiotis is a French laboratory specializing in the creation and distribution of dietary supplements scientifically 
tested to maintain health at every stage of life. Through an innovative approach combining scientific excellence, plant 
expertise and a wealth of natural ingredients, Valbiotis offers a new generation of dietary supplements to support 
cardiometabolic balance and well-being, and address everyday health issues such as sleep, fatigue, mood management, 
immunity and vitality. Created at the beginning of 2014 in La Rochelle, France, Valbiotis has forged numerous 
partnerships with leading academic centers. 
 
Valbiotis is a member of the "BPI Excellence" network and has been recognized as an "Innovative Company" by the BPI 
label.  Valbiotis has received major financial support from the European Union for its research programs via the 
European Regional Development Fund (ERDF). Valbiotis is a PEA-SME eligible company. 
 
For more information on Valbiotis, please visit: www.valbiotis.com 

Contacts 
 
Corporate Communication / Valbiotis 
 
Caroline Lamberti 
 
+ 33 6 77 82 56 88 
 
[e-mail] 

Financial communication / Seitosei.Actifin  
 
Marianne Py 
 
[phone] 
 
[e-mail] 

Press Relations / LJ Com by JIN 
 
Valentine Martin 
 
[phone] 
[e-mail] 

Name: Valbiotis 
ISIN Code: FR0013254851 
 
Ticker Symbol: ALVAL 
 
EnterNext© PEA-PME 150 
 
This press release contains forward-looking statements about Valbiotis' objectives. Valbiotis considers that these 
projections are based on rational hypotheses and the information available to Valbiotis at the present time. However, 
they are in no way guarantees of future performance and may be called into question by changes in economic conditions, 
financial markets and by a number of risks and uncertainties, available on the Company's website (www.valbiotis.com). 
 
This press release and the information it contains do not constitute an offer to sell or subscribe, or a solicitation 
to purchase or subscribe to Valbiotis' shares or financial securities in any country. 
 
=---------------------------------------------------------------------------------------------------------------------- 
Regulatory filing PDF file 
File: CP Valbiotis Levure de riz rouge OK_EN 
=---------------------------------------------------- 
Language:    English 
Company:     VALBIOTIS SA 
         12F, Rue Paul Vatine 
         17180 Périgny 
         France 
Phone:      [phone] 
E-mail:     [e-mail] 
Internet:    www.valbiotis.com 
ISIN:      FR0013254851 
Euronext Ticker: ALVAL 
AMF Category:  Inside information / Other releases 
EQS News ID:   2334440 
  
End of Announcement EQS News Service 
=------------------------------------------------------------------------------------ 

2334440 27-May-2026 CET/CEST

Image link: https://eqs-cockpit.com/cgi-bin/fncls2.ssx?fn=show_t_gif&application_id=2334440&application_name=news&site_id=dow_jones%7e%7e%7ebed8b539-0373-42bd-8d0e-f3efeec9bbed

(END) Dow Jones Newswires

May 27, 2026 11:40 ET (15:40 GMT)