Monacolins from red yeast rice in food supplements
The 3 mg limit of Regulation 2022/860 and the draft Part A ban in Annex III — what applies now and how the transition period runs

A food supplement containing monacolins from red yeast rice can currently be sold lawfully only if a single portion for daily consumption provides less than 3 mg of monacolins and the label states the monacolin content per portion, the maximum number of portions per day and the four warnings set out in Part B of Annex III to Regulation (EC) No 1925/2006. This position is transitional. On 13 May 2026 the PAFF Standing Committee gave a favourable opinion on a draft regulation that moves monacolins to Part A, the list of prohibited substances. On 8 October 2026 the European Parliament rejected an objection to that draft. Once the new regulation enters into force (on the 20th day after publication), products placed on the market before that date may remain on the market for a further 12 months. There has been no permitted cholesterol claim for monacolin K since 19 August 2024 (Regulation (EU) 2024/2041).

1. The legal position in October 2026: Part B and Part C at the same time

Commission Regulation (EU) 2022/860 entered into force on 22 June 2022. It listed “monacolins from red yeast rice” in two parts of Annex III to Regulation 1925/2006 at once. The Part B entry (“Restricted substances”) sets the conditions of use. The Part C entry (“Substances under Community scrutiny”) opened a four-year period in which operators could submit safety data to EFSA (Art. 8(4)). Both entries apply until the new regulation enters into force. So do the Part B requirements, even after the four years under Art. 8(5) have passed.

The Part B entry consists of one condition of use and four sets of labelling requirements:

The Part B requirements add to the obligations in Art. 6(3) of Directive 2002/46/EC: the recommended daily portion, a warning not to exceed it, and a statement that supplements are not a substitute for a varied diet. They do not replace them. The act provides no tolerance for the “less than 3 mg” condition. The safer reading is therefore that every portion must meet it throughout the shelf life. The specification should account for variability of monacolin content in the raw material and for measurement uncertainty, not only for the batch average.

2. Where 3 mg comes from: monacolin K is lovastatin

The recitals of Regulation 2022/860 summarise the opinion of the EFSA ANS Panel adopted on 25 June 2018 (EFSA Journal 2018;16(8):5368). EFSA found that monacolin K in lactone form is identical to lovastatin, the active substance of medicinal products used for hypercholesterolaemia. Intake from supplements can lead to exposure within the range of therapeutic doses of lovastatin, and the adverse-effect profile of red yeast rice resembles that of lovastatin. In the case reports, adverse effects most often concerned the musculoskeletal system (including rhabdomyolysis), the liver, the nervous system, the gastrointestinal tract and the skin (recital 9).

On that basis EFSA considered monacolins to be of significant safety concern at 10 mg per day. It also noted individual severe reactions, including some requiring hospitalisation, at intakes as low as 3 mg per day taken for between 2 weeks and 1 year. EFSA was unable to identify a daily intake that does not give rise to concern (recitals 9–10). Among the uncertainties it listed the variable composition of preparations, multi-ingredient products and the lack of data for vulnerable groups. It also pointed to interactions with foods and medicines that inhibit CYP3A4, the enzyme that metabolises monacolins.

The Commission therefore did not set a safety threshold, because EFSA had not identified one. The 3 mg boundary corresponds to the lowest intake at which severe cases were described. That is why a daily portion of 3 mg or more was prohibited (recital 14). The Part C listing followed from the persisting scientific uncertainty (Art. 8(2)(b), recital 18).

3. The cholesterol claim has been deleted (Regulation 2024/2041)

Until August 2024, Regulation (EU) No 432/2012 contained a claim that monacolin K from red yeast rice contributes to the maintenance of normal blood cholesterol levels. Its condition was a daily intake of 10 mg of monacolin K (EFSA Journal 2011;9(7):2304). After 2022 the claim had lost practical relevance, because the 10 mg condition was incompatible with the limit of less than 3 mg. Commission Regulation (EU) 2024/2041 of 29 July 2024 deleted the entry “Monascus purpureus (red yeast rice)” from the list “in view of legal certainty” (recital 15). It entered into force on 19 August 2024 without a transition period.

Three consequences follow:

• No entry for monacolins. The list in Regulation 432/2012 no longer contains a claim for red yeast rice or monacolin K. Any statement about cholesterol, the heart or circulation attributed to these ingredients is therefore prohibited by Art. 10(1) of Regulation (EC) No 1924/2006. Recital 15 of Regulation 2024/2041 states expressly that the claim “should no longer be used on foods”.
• A positive EFSA opinion is not an authorisation. Commission Regulation (EU) 2024/2063 of 30 July 2024 refused to authorise an Article 13(5) claim for monacolin K in the SYLVAN BIO preparation. On 24 January 2013 EFSA had confirmed a cause-and-effect relationship, but at 10 mg per day. Taking into account Art. 17 of Regulation 1924/2006 and the limit in Regulation 2022/860, the Commission concluded that the claim could not be authorised (recitals 6–22). Likewise, no EFSA opinion on a multi-ingredient product (e.g. EFSA Journal 2013;11(7):3327) replaces an entry in the list.
• Claims for other ingredients do not transfer to monacolins. A permitted claim for another ingredient (for example a plant substance or a vitamin) may be used only if its conditions are met and only for that ingredient. Art. 10(3) requires a substantive link between a general reference and the claim that accompanies it (see C-524/18 Schwabe).

4. The scrutiny period and the EFSA opinion of 29 January 2025

Art. 8(4) allows anyone to submit to EFSA a file demonstrating the safety of a Part C substance. According to the draft of the new regulation (recital 2), four interested parties submitted files within the period under Art. 5(2) of Implementing Regulation No 307/2012. The files covered analytical data on the composition of supplements, intake of monacolins from other dietary sources, in vitro bioaccessibility and cytotoxicity data compared with statins, nutrivigilance and post-marketing data, case reports and clinical studies. No comments were received in EFSA’s public consultation (recital 3).

The EFSA NDA Panel adopted its opinion on 29 January 2025 (EFSA Journal 2025;23:e9276). It found that the data submitted do not allow the safety of monacolins in supplements to be established at intakes below 3 mg per day. Nor do they allow a daily intake to be identified that raises no safety concern for the general population or vulnerable subgroups. Based on new nutrivigilance data, the Panel reiterated the 2018 assessment that intakes as low as 3 mg per day could lead to severe adverse effects on the musculoskeletal system, including rhabdomyolysis, and on the liver.

This opinion determines the choice under Art. 8(5). After the scrutiny period the Commission has three options: generally allow the substance, list it in Part B, or list it in Part A, “taking into account the opinion of the Authority” on the files submitted. Since safety was not demonstrated at any intake level, the Commission chose Part A (recital 5 of the draft).

5. The draft ban: content and procedural stage

The draft (SANTE/1575/2025, notified to the WTO as G/SPS/N/EU/923) is short:

• Art. 1: inserts “monacolins from red yeast rice” in Part A of Annex III, after the entry for Ephedra herb. It deletes the entries in Parts B and C at the same time.
• Art. 2: foodstuffs containing monacolins that were lawfully placed on the market before the regulation enters into force may remain on the market until 12 months after that date.
• Art. 3: entry into force on the 20th day after publication in the Official Journal.

The procedural steps that can be confirmed in the source documents are as follows. On 13 May 2026 the PAFF Standing Committee (Section General Food Law) delivered a favourable opinion. During the discussion two Member States wanted to replace the 12-month transition with a rule allowing sale until stocks are exhausted. One Member State pointed to ongoing industry studies, and another favoured allowing monacolins under conditions. The Commission replied that EFSA’s conclusions had been known since 29 January 2025, so any further delay would not be justified. The act is subject to the regulatory procedure with scrutiny. The draft was transmitted to Parliament on 9 July 2026 (D113902/02). On 8 October 2026 the European Parliament rejected motion for a resolution B10-0466/2026, which raised an objection (procedure 2026/2821(RPS)). As of 22 October 2026 the regulation had not been published in the Official Journal. The next step is adoption by the Commission and publication.

6. The transition period: what “placed on the market before entry into force” means

Art. 2 of the draft contains no definition of its own. Art. 3(8) of Regulation (EC) No 178/2002 therefore applies: placing on the market means the holding of food for the purpose of sale, including offering for sale or any other form of transfer, and the sale, distribution and other forms of transfer themselves. Four practical conclusions follow:

• Individual units are assessed, not the recipe. The transition covers packs that were already held for sale before the date of entry into force. A batch produced after that date does not benefit, even if the recipe and the GIS notification number are unchanged.
• The deadline is fixed. After 12 months the product must leave the market, regardless of its best-before date. At the PAFF meeting the Commission rejected the proposal of sale until stocks are exhausted.
• Lawfulness at the time of placing on the market. Only a product that complies with Part B benefits from the transition: less than 3 mg per portion, a complete label and no cholesterol claims. A product that already breaches Part B today gains no protection.
• A GIS notification legalises nothing. The notification of first placing of a supplement on the Polish market (Art. 29 of the Act on Food and Nutrition Safety) is a separate obligation and not an authorisation. It does not protect a product that conflicts with Annex III. See the GIS notification procedure.

Online sales and cross-border distribution follow the same rules. The regulation applies directly throughout the EU, so the Member State of destination cannot extend the transition.

7. The Article 8 dispute in the aloe cases and what it means for monacolins

A Part A ban has no quantitative threshold. A similar ban for hydroxyanthracene derivatives (HADs) and preparations from aloe leaves was introduced by Regulation (EU) 2021/468, which was challenged. On 13 November 2024 the General Court, in four judgments (T-189/21, T-271/21, T-274/21, T-302/21), annulled parts of that act. It held that a ban “irrespective of the amount” infringes Art. 8(2)(a)(i) read with Art. 8(1), because the Commission had not established the amounts ingested under a balanced and varied diet (T-302/21, paras 86–90).

The Commission appealed (C-38/25 P, C-48/25 P, C-54/25 P, C-55/25 P). In her Opinion of 10 September 2026 Advocate General Ćapeta proposed setting the judgments aside and referring the cases back. In her view, Art. 8(1) describes a risk-identification step that precedes the decision. At the risk-management step under Art. 8(2), the choice between Parts A, B and C depends on the scientifically established likelihood of harmful effects (paras 65–70). Under the second paragraph of Art. 60 of the Statute of the Court of Justice, a General Court decision declaring a regulation void takes effect only once an appeal has been dismissed. As of the publication of this article the Court had not delivered judgment.

Two conclusions follow for monacolins. First, the monacolin case differs from the aloe case. The Commission relies on Art. 8(5) after a completed scrutiny period, and EFSA identified severe adverse effects at a specific intake (3 mg per day). Second, the Court’s judgment in the HAD cases will settle how Art. 8(1) and (2) are to be read. That will affect the assessment of any Part A ban, including a possible action against the monacolin regulation. An action before the General Court does not by itself suspend the application of the regulation (Art. 278 TFEU).

8. Monacolin-free red yeast rice, citrinin and novel-food status

• What is banned. The Part A entry concerns monacolins from red yeast rice, not the words “red yeast rice”. The entry sets no threshold, so a raw material with detectable monacolins falls within the ban. A “monacolin-free” preparation needs a documented analytical method and a specification with a limit of quantification. The status of such a preparation is not settled, however (see section 9).
• Citrinin. Independently of monacolins, a maximum level of 100 µg/kg citrinin applies to food supplements based on rice fermented with Monascus purpureus (Reg. (EU) 2023/915, Annex I, point 1.7.1). See also metal limits for supplements under Reg. 2023/915.
• Novel food and colour. According to recital 6 of Regulation 2022/860, food supplements with red yeast rice preparations were consumed to a significant degree before 15 May 1997 and are therefore not subject to Regulation (EU) 2015/2283. Use in other food categories requires a novel-food authorisation. Red yeast rice is also not an authorised food colour.

9. What the rules do not settle

• The date of publication in the Official Journal, and therefore the dates of entry into force and of the end of the transition, is not yet known. All deadlines run from publication.
• The Part A ban gives no limit of quantification or test method. It is unclear from what level authorities will treat the presence of monacolins as “use” of the substance.
• The status of a red yeast rice preparation stripped of monacolins has not been settled. A change of process may raise a novel-food question (Art. 3(2)(a)(vii) of Reg. 2015/2283). Recital 6 of Regulation 2022/860 concerns traditional preparations.
• The Court of Justice has not yet ruled in the HAD cases. The Advocate General’s Opinion does not bind the Court.
• The act does not specify how national authorities should check products during the transition or which documents prove placing on the market before the date of entry into force.

10. Checklist: a red yeast rice supplement until the end of the transition

1. Dose: confirm by analysis of every batch that the daily portion contains less than 3 mg of total monacolins throughout the shelf life, taking measurement uncertainty into account.
2. Recommended intake: check that the maximum number of portions per day does not add up to 3 mg or more. Such a direction would contradict the Part B warning.
3. Label: include the monacolin content per portion, the maximum number of portions, the 3 mg warning and the four warnings in the wording of Regulation 2022/860, in the language of the country of sale.
4. Claims: remove from the label, product page and advertising all references to cholesterol, the heart and circulation attributed to red yeast rice. The claim in Reg. 432/2012 has not applied since 19.08.2024.
5. Stocks: plan production so that no new batches are made after the date of entry into force, and document the date each batch was placed on the market (dispatch records, invoices, stock records).
6. Final deadline: set the withdrawal date at 12 months after entry into force, regardless of the best-before date, including for distributors and online platforms.
7. Reformulation: assess any replacement ingredient separately (novel-food status, Annex III, claims). A “monacolin-free” red yeast rice preparation needs a specification, an analytical method and a status analysis.
8. Contaminants: keep citrinin control (100 µg/kg, Reg. 2023/915) in the raw-material specification until sales end.

Frequently asked questions

Are food supplements with monacolins from red yeast rice already banned in the EU?

Not yet. Until the new regulation enters into force, Part B of Annex III to Regulation 1925/2006 applies: less than 3 mg of monacolins per daily portion and mandatory warnings. The draft moving monacolins to Part A received a favourable PAFF opinion on 13.05.2026, and on 8.10.2026 the European Parliament rejected an objection. As of 22.10.2026 the regulation had not been published.

How long after the ban enters into force can products with monacolins be sold?

Under the draft, products lawfully placed on the market before the regulation enters into force may remain on the market for 12 months from that date. The Commission rejected a proposal to allow sale until stocks are exhausted. Batches produced after the date of entry into force do not benefit from the transition.

Can the claim that monacolin K contributes to normal blood cholesterol levels still be used?

No. Regulation (EU) 2024/2041 deleted that claim from Regulation 432/2012 with effect from 19.08.2024. Its condition was 10 mg of monacolin K per day, which in any case conflicted with the limit of less than 3 mg in Regulation 2022/860. Regulation (EU) 2024/2063 also refused authorisation of a similar claim for the SYLVAN BIO preparation.

Why did EFSA not identify a safe dose of monacolins?

Monacolin K in lactone form is identical to lovastatin. EFSA described severe adverse effects, including rhabdomyolysis and liver damage, at intakes as low as 3 mg per day. In 2025 it found that the data submitted during the scrutiny period did not demonstrate safety below 3 mg or allow a safe intake to be set.

Do the General Court’s aloe judgments undermine the monacolin ban?

Not directly. The judgments of 13.11.2024 concerned Regulation 2021/468 and are under appeal by the Commission. On 10.09.2026 the Advocate General proposed setting them aside. The monacolin case rests on Art. 8(5) and on the intake at which EFSA described severe cases. The Court’s judgment will nonetheless shape the interpretation of Art. 8.

Glossary

Monacolins

Compounds formed when rice is fermented with yeasts (mainly Monascus purpureus). The most important, monacolin K, is identical to lovastatin in its lactone form.

Annex III, Part A / B / C

Prohibited substances / substances allowed only under specified conditions / substances under Union scrutiny because of scientific uncertainty (Art. 8(2) of Reg. 1925/2006).

Scrutiny period

Up to four years from listing in Part C. During this time safety data can be submitted to EFSA, after which the decision under Art. 8(5) is taken.

Regulatory procedure with scrutiny

A procedure in which the European Parliament and the Council may object for three months to a draft Commission act after the opinion of the Member States’ committee.

Citrinin

A mycotoxin produced by Monascus fungi. Its maximum level in red yeast rice supplements is set by Reg. 2023/915.

Conclusion

In the EU, monacolins from red yeast rice have gone from a permitted cholesterol claim at 10 mg per day to a ban that now awaits only adoption and publication. Today a limit of less than 3 mg per daily portion and a full set of warnings apply, and there have been no claims since August 2024. Once the Part A regulation enters into force, there will be two cut-off dates: the day of entry into force, after which no new batches may be placed on the market, and the day 12 months later, after which the product must leave the market. The Article 8 dispute in the aloe cases does not suspend this timetable. Manufacturers should plan withdrawal and reformulation now, and neither a GIS number nor a best-before date extends the selling period. More on the Article 8 mechanism: fortified food and “other substances” and the comparable entry for EGCG from green tea (Reg. 2022/2340).

Primary sources

1. Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods: Art. 8(1)–(5), Annex III.
2. Commission Regulation (EU) 2022/860 of 1.6.2022 as regards monacolins from red yeast rice, OJ L 151, 2.6.2022, p. 37: recitals 6–18, Art. 1.
3. Commission Regulation (EU) 2024/2041 of 29.7.2024 amending Reg. (EU) No 432/2012 as regards the health claim on monacolin K from red yeast rice (OJ L, 30.7.2024) and Commission Regulation (EU) 2024/2063 of 30.7.2024 refusing to authorise a claim for monacolin K in SYLVAN BIO.
4. EFSA ANS Panel, Scientific opinion on the safety of monacolins in red yeast rice, EFSA Journal 2018;16(8):5368.
5. EFSA NDA Panel, Scientific opinion on additional scientific data related to the safety of monacolins from red yeast rice submitted pursuant to Article 8(4) of Regulation (EC) No 1925/2006, EFSA Journal 2025;23:e9276.
6. EFSA NDA Panel, EFSA Journal 2011;9(7):2304 (monacolin K and LDL-cholesterol concentrations) and EFSA Journal 2013;11(7):3327 (multi-ingredient product, Art. 14).
7. European Commission, draft Commission Regulation amending Annex III to Reg. 1925/2006 as regards monacolins from red yeast rice (SANTE/1575/2025; WTO G/SPS/N/EU/923).
8. European Commission, Summary report, Standing Committee on Plants, Animals, Food and Feed, Section General Food Law, 13 May 2026, item B.01.
9. European Parliament, Legislative Observatory, procedure 2026/2821(RPS): D113902/02 (9.7.2026), B10-0466/2026, decision of 8.10.2026.
10. General Court, judgment of 13.11.2024, T-302/21 Aboca and Others v Commission, ECLI:EU:T:2024:808, paras 86–91.
11. Court of Justice, Opinion of Advocate General Ćapeta of 10.9.2026 in Cases C-38/25 P, C-48/25 P, C-54/25 P and C-55/25 P, points 61–85.
12. Commission Regulation (EU) 2023/915 on maximum levels for certain contaminants in food: Annex I, point 1.7.1 (citrinin).
13. Regulation (EC) No 178/2002: Art. 3(8) (placing on the market); Implementing Regulation (EU) No 307/2012: Art. 5.