Placing on the market of genetically modified micro-organisms and the processing of organs
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With the European Parliament, which is preparing its first-reading position.
Last active 16 Jun 2026
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What this bill does
In plain terms: what it changes and who it affects.
This bill updates EU rules for genetically modified micro-organisms and processed transplant organs to support innovation while maintaining health and safety oversight.
Who it affects
It affects biotechnology businesses developing genetically modified micro-organisms and patients needing organ transplants. It also affects transplant centres using technologies to preserve or improve organs before transplantation.
Core of the proposal
- Creates specific EU rules for placing genetically modified micro-organisms on the market as or in products.
- Allows unlimited-duration consents for genetically modified micro-organisms, subject to safeguards if new risks emerge.
- Introduces low-risk genetically modified micro-organisms with adapted risk assessment, faster procedures and possible no monitoring plan.
- Requires prior authority authorisation before transplant centres apply processed organs to recipients.
Key provisions
- Takes effect
- The Directive enters into force on the twentieth day following publication in the Official Journal of the European Union.
- Transitional law
- Member States must transpose the Directive within 24 months from its entry into force.
Articles changed · 15 across 2 laws
- Directive 2001/18/EC (32001L0018)
- art. 2: adds definitions for micro-organism, GMM and Qualified Presumption of Safety
- art. Part C: inserts Title I heading for general provisions applicable to GMOs as or in products
- art. 24a: inserts specific rules on subject matter and status of GMMs
- art. 24b: inserts power to adapt information requirements for GMM notifications
- art. 24c: inserts unlimited validity rule for GMM consents
- art. 24d: inserts adapted rules for GMM detection methods
- art. 24e: inserts low-risk GMM criteria and delegated powers
- art. 24f: inserts monitoring and reporting rules for low-risk GMMs
- art. 24g: inserts implementing act powers for detection modalities and low-risk supporting information
- art. 29a: replaces Article 29a on exercise of delegation
- Directive 2010/53/EU (32010L0053)
- art. 2(1): replaces scope provision to include processing of organs
- art. 3(q): replaces definition of transplantation
- art. 3(ka): inserts definition of processing
- art. 6a: inserts organ processing authorisation and oversight regime
- art. Annex Part B: adds Processing entry to complementary organ and donor characterisation data
Latest update
05 Jun 2026The most recent development in this bill's progress.
1st reading – European Parliament → 1st reading – European Parliament
1st reading – European Parliament → 1st reading – European Parliament
Documents
1 recentSourcesOEILEUR-LexEU Law Tracker