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WTO notification · TBT

European UnionProposed measure, may since have been adopted

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT

Official title

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs

The European Union notified this proposed TBT measure to the WTO on 17 February 2026. The comment period closed on 18 April 2026.

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

Published here:

At a glance

Products

11- Health care technology

Notifying member
European Union
Status
Proposed measure, may since have been adoptedNotified as a draft on 17 February 2026. Check WTO ePing or the European Union for its current status.
Objectives
  • Protection of human health or safety
  • Quality requirements
  • Harmonization
  • Reducing trade barriers and facilitating trade
  • Cost saving and productivity enhancement
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/EU/1190

Key dates

Distributed by the WTO
Comment deadline
Closed on 18 April 2026
Proposed adoption
To be determined
Proposed entry into force
The Directive shall enter into force on the twentieth day following that of its publication in

How to comment

The comment period closed on 18 April 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/EU/1190; 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 proposal accompanies the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938, which establishes a legislative framework to strengthen the competitiveness of the health biotechnology sector. For the new framework to operate effectively within the existing acquis, targeted updates are required in two pieces of sectoral legislation. Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms The proposal amends Directive 2010/53/EU (organ processing) to expressly include processing alongside donation, testing, characterisation, procurement, transport and transplantation, and to clarify that where organs are used for research purposes, the Directive applies only where they are intended for transplantation into the human body. A new Article 6a is introduced to require transplantation centres to obtain prior authorisation from the competent authority before applying a processed organ to a recipient, oblige transplantation centres to perform a benefit–risk assessment of the processing

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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