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WTO notification · SPS

European UnionProposed measure, may since have been adopted

Rice – European Union

Official title

Draft Commission Regulation amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice (Text with EEA relevance)

The European Union notified this proposed SPS measure to the WTO on 4 March 2026. The comment period closed on 3 May 2026.

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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.

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At a glance

Products

Food products

Notifying member
European Union
Status
Proposed measure, may since have been adoptedNotified as a draft on 4 March 2026. Check WTO ePing or the European Union for its current status.
Objectives
  • Food safety
Area
SPS: Food safety, animal and plant healthSanitary and phytosanitary measures
Notification type
Regular notification
Document symbol
G/SPS/N/EU/923
Keywords
Food safety, Human health

Key dates

Distributed by the WTO
Comment deadline
Closed on 3 May 2026
Proposed adoption
Q3 2026
Proposed entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Foodstuffs containing monacolins from red yeast rice, which

How to comment

The comment period closed on 3 May 2026. You can still raise concerns about the measure with your country's WTO SPS enquiry point, quoting the document symbol G/SPS/N/EU/923; it can take them up with the European Union.

Find your country's enquiry point on WTO ePing (opens in a new tab)

What the notification says

This draft Commission Regulation aims to prohibit the use of monacolins from red yeast rice in food based on the scientific opinion of EFSA and following a period of Union scrutiny during which food business operators, or any other interested parties, may submit scientific data to demonstrate the safety of plant preparations in question. On 25 June 2018, EFSA adopted a scientific opinion on the safety of monacolins in red yeast rice. In that opinion, it considered that the available information on the adverse effects reported in humans was judged to be sufficient to conclude that monacolins from red yeast rice were of significant safety concern at intake levels as low as 3 mg/day. EFSA was unable to provide advice on a daily intake of monacolins from red yeast rice that does not give rise to concerns for human health. Considering the significant harmful effect on health associated with the use of monacolins at levels as low as 3 mg/day and that no safe daily intake level could be set, the use of the substance in food was restricted and at the same time placed under Union scrutiny by means of Regulation (EU) 2022/860 of 1 June 2022 for a period of four years from the entry into application of that Regulation. On 29 January 2025, EFSA adopted a 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. In its opinion, EFSA concluded that the data submitted by…

Sources

Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.

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