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

Directive 2001/18/EC

Article 24d – paragraph 2

Or. en

Amendment 242

Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24d – paragraph 2 a (new)

Or. en

Justification

The amendment narrows the derogation to what the evidence supports: a derogation from performance requirements, not from identifiability. It also requires that the development of analytical methods is pursued after initial authorisation.

Amendment 243

Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24d – paragraph 2 a (new)

Or. en

Amendment 244

Friedrich Pürner

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 1 – paragraph 1 – point 3

Or. de

Amendment 245

Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e

Or. en

Amendment 246

Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 e

Or. fr

Amendment 247

Aurelijus Veryga

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – title

Or. en

Amendment 248

Jessica Polfjärd

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 – title

Or. en

Amendment 249

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – title

Or. en

Justification

The term “low-risk” GMMs is misguiding and unscientific, as it is based on the assumption that with a narrow list of criteria one could evaluate the risk of a certain GMM, assign a status of “low-risk” and only afterwards perform a somewhat simplified risk assessment. However, considering the major scientific knowledge gaps and lack of experience with environmental release of GMMs, their biological diversity and specific characteristics, it is not credible to judge on a potential risk or “low risk” of a certain GMM prior to a profound case-specific ERA.

Amendment 250

Jessica Polfjärd

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1

Or. en

Amendment 251

Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 e – Paragraph 1

Or. fr

Amendment 252

Aurelijus Veryga

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1

Or. en

Amendment 253

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1

Or. en

Amendment 254

Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point a

Or. en

Justification

The term “taxonomically and molecularly well characterised” is not clearly defined and should therefore be specified in the Directive itself, including a requirement for a complete genome sequence. A genome assembly is a representation of the organism’s genome sequence. Complete genome assemblies of both the GMM and its parental organism provide a comprehensive basis for establishing the taxonomic identity and molecular characteristics of the GMM. Comparison of the two genomes enables the genetic modifications introduced into the GMM to be identified and characterised, while also confirming its relationship to the parental organism. This supports a robust and unambiguous assessment of the GMM's identity and genetic composition.

Amendment 255

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point a

Or. en

Justification

Phenotypic characteristics must be well characterised to assess potential risks, including reproduction and dispersal. “Molecularly well characterised” should be clearly defined to avoid partial descriptions. Complete genome assemblies of the GMM and its parental organism provide a robust basis to identify and characterise genetic modifications, confirm their relationship, and ensure an unambiguous assessment of the GMM’s identity and genetic composition.

Amendment 256

Christophe Clergeau

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point a

Or. en

Justification

Particularly in the case of taxonomically very diverse groups, it is not possible to draw conclusions about the entire taxonomic unit on the basis of a single member. Taxonomic classification reflects evolutionary origin and genetic relations and not necessarily phenotypic characteristics such as environmental behaviour, which are essential to draw conclusions on potential risks. Therefore, the characterisation of a GMM should be performed on lowest reasonable taxonomic level and include phenotypic aspects as laid down to in Annex III A

Amendment 257

Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point b

Or. en

Justification

It should be clarified for each QPS-listed taxonomic unit whether its underlying assessment addressed environmental release, as QPS status does not in itself establish the environmental safety of the organism or the GMM. QPS status can be subject to qualification such as ”for production purposes only“, which means that data are lacking on the direct exposure of humans and animals to viable cells.

Amendment 258

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point b

Or. en

Justification

A microorganism may have QPS status because its unmodified form has a long history of safe use, but the genetic modification may introduce entirely new characteristics that QPS was never intended to evaluate. QPS was not designed as a GMO assessment tool. It was developed by EFSA as a streamlined safety assessment system for biological agents, primarily microorganisms intentionally added to the food or feed chain.

A GMM still requires a separate assessment of the genetic modification and any resulting risks.

Amendment 259

Christophe Clergeau

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point b

Or. en

Justification

It should be made explicit that a QPS status can only be assigned to the non-modified parental organism of a GMM, as the QPS assessment was established for non-modified microorganisms and EFSA states that GMM must be additionally assessed according to this directive. Additionally, the QPS status should not assigned to lowest reasonable level and not be transferable among diverse taxonomic units. Taxonomic classification reflects evolutionary origin and genetic relations and not necessarily phenotypic characteristics such as environmental behaviour essential to draw conclusions on potential risks.

Amendment 260

Gerben-Jan Gerbrandy, Stine Bosse, Jeannette Baljeu, Billy Kelleher

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point b

Or. en

Justification

Of the 123 species and families (for viruses) on the current QPS list, 37 carry the qualification "for production purposes only," which implies the absence of viable cells of the production organism in the final product. For these microorganisms data are lacking on the direct exposure of humans and animals to viable cells (EFSA BIOHAZ Panel, 2026).The Commission’s proposal does not distinguish between taxonomic units with or without this qualification. However, since the proposal concerns the environmental release of GMMs, taxonomic units carrying this qualification should not be eligible for classification in the proposed low-risk category.

Amendment 261

Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 e – paragraph 1 – point b

Or. fr

Amendment 262

Jessica Polfjärd

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 – paragraph 1 – point b

Or. en

Justification

Since the current application of QPS is currently limited in scope, it is important to provide an alternative route for expedited procedure for GMMs while EFSA adapts QPS to cover a broader category of microorganisms.

Amendment 263

Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c

Or. en

Justification

Article 24e(1)(c) is unclear because “gene of concern” is not defined in the legislation and the criterion focuses on genes, although relevant genetic modifications may not involve adding a gene. It is preferable to define sequences of concern and to ensure that such sequences do not confer any problematic traits that require specific attention.

Amendment 264

Christophe Clergeau

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c

Or. en

Amendment 265

Victor Negrescu

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c

Or. en

Justification

The amendment aligns the operative provisions with recital 12 and ensures that GMMs carrying virulence factors or toxin-producing genes cannot benefit from the low-risk procedure. It strengthens protection against antimicrobial resistance and other public-health risks without creating additional burdens for genuinely low-risk innovation.

Amendment 266

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c

Or. en

Justification

Reference made to “genes not naturally present in the parental organism" fails to reflect today’s reality of microbial genetic engineering. GMMs are often created without adding any genes at all – using deletions and rearrangements of existing sequences instead of insertions. It is the genetic modification that needs to be considered, and whether it may give rise to harm.

Amendment 267

Gerben-Jan Gerbrandy, Stine Bosse, Jeannette Baljeu, Billy Kelleher

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c

Or. en

Justification

A large number of GMMs are created without adding any genes at all – using deletions and rearrangements of existing sequences. What is important in the end is the trait or characteristic of the GMM.

Amendment 268

Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c a (new)

Or. en

Justification

Article 24e(1) should include a criterion on the genomic location of the modification, as its location can significantly affect the risk of genetic transfer.

Amendment 269

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c a (new)

Or. en

Amendment 270

Christophe Clergeau

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c a (new)

Or. en

Amendment 271

Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c b (new)

Or. en

Justification

Article 24e(1) should also consider the intended use and level of environmental exposure, as the same GMM can pose very different risks depending on whether it is used in contained industrial processes or deliberately released into the environment.

Amendment 272

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c b (new)

Or. en

Amendment 273

Christophe Clergeau

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c b (new)

Or. en

Amendment 274

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c c (new)

Or. en

Amendment 275

Christophe Clergeau

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c c (new)

Or. en

Amendment 276

Christophe Clergeau

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c d (new)

Or. en

Amendment 277

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c d (new)

Or. en

Amendment 278

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c e (new)

Or. en

Amendment 279

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c f (new)

Or. en

Amendment 280

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1 – point c g (new)

Or. en

Amendment 281

Christine Anderson, Marc Jongen, Anja Arndt, Volker Schnurrbusch

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 1a (new)

Or. en

Justification

The amendment does not exclude genetically modified viruses from the low-risk category as a matter of principle. It ensures, however, that they cannot enter that category automatically on the basis of a QPS status assigned at family level and that their specific biological characteristics are assessed individually.

Amendment 282

Christophe Clergeau

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 2 – subparagraph 1

Or. en

Amendment 283

Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 2 – subparagraph 1

Or. en

Amendment 284

Jessica Polfjärd

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 2 – subparagraph 1

Or. en

Amendment 285

Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 e – paragraph 2 – first subparagraph

Or. fr

Amendment 286

Aurelijus Veryga

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 2 – subparagraph 1

Or. en

Amendment 287

Christophe Clergeau

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 2 – subparagraph 2

Or. en

Amendment 288

Victor Negrescu

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 2 – subparagraph 2

Or. en

Justification

Streamlined procedures can support innovation only if applicants and national authorities have the capacity to use them effectively. Targeted European guidance and technical assistance would support SMEs and research organisations, reduce geographical innovation gaps and ensure the safe development of biotechnology across all Member States.

Amendment 289

Jessica Polfjärd

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 2 – subparagraph 2

Or. en

Amendment 290

Aurelijus Veryga

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 2 – subparagraph 2

Or. en

Amendment 291

Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 e – paragraph 2 – second subparagraph

Or. fr

Amendment 292

Aurelijus Veryga

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 3 – point a

Or. en

Amendment 293

Jessica Polfjärd

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 3 – point a

Or. en

Amendment 294

Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 e – paragraph 3 – point a

Or. fr

Amendment 295

Christophe Clergeau

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 3 – point a

Or. en

Amendment 296

Christophe Clergeau

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 3 – point b

Or. en

Justification

It must be ensured that any adjustments to the list of criteria for “low-risk GMMs” do not compromise the high level of protection, especially for the environment.

Amendment 297

Jessica Polfjärd

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 3 – point b

Or. en

Amendment 298

Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 e – paragraph 3 – point b

Or. fr

Amendment 299

Aurelijus Veryga

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 3 – point b

Or. en

Amendment 300

Jessica Polfjärd

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 3 – point b a (new)

Or. en

Amendment 301

Christophe Clergeau

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 3 – point c

Or. en

Amendment 302

Aurelijus Veryga

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 3 – point c

Or. en

Amendment 303

Jessica Polfjärd

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 3 – point c

Or. en

Amendment 304

Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 e – paragraph 3 – point c

Or. fr

Amendment 305

Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 3 – point d

Or. en

Justification

Article 24e (3) gives the Commission broad delegated powers to define both which GMMs qualify as low-risk and how much assessment is required, without setting clear minimum safeguards in the Directive.

Amendment 306

Gerben-Jan Gerbrandy, Stine Bosse, Jeannette Baljeu, Billy Kelleher

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 3 – point d

Or. en

Amendment 307

Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 e – paragraph 3 – point d

Or. fr

Amendment 308

Jessica Polfjärd

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24e – paragraph 3 – point d

Or. en

Amendment 309

Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24f

Or. en

Amendment 310

Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24f

Or. en

Justification

Article 24f permits a notifier to propose that no post-market environmental monitoring plan be submitted, and permits theconsent to state that monitoring is not required. The amendment deletes the respective article, which is being replaced by a more comprehensive article 24 (f).

Amendment 311

Jessica Polfjärd

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24f – title

Or. en

Amendment 312

Christophe Clergeau

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24f – title

Or. en

Amendment 313

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24f – title

Or. en

Justification

Adequate monitoring provisions should be implemented for all GMMs not only for “low-risk GMMs” respectively the GMMs in the expedited procedure.

As there is no experience with GMM authorisations under part C of the Directive monitoring is important in order to identify possible long-term, cumulative or unforeseen environmental effects at an early stage and to confirm or adjust risk assessment. Especially considering the specific properties of GMMs as the fast reproduction rate and genetic instability as well as the non-retrievability of GMMs

Amendment 314

Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 f – title

Or. fr

Amendment 315

Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 f – paragraph 1

Or. fr

Amendment 316

Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24f – paragraph 1

Or. en

Amendment 317

Gerben-Jan Gerbrandy, Stine Bosse, Jeannette Baljeu, Billy Kelleher

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24f – paragraph 1

Or. en

Justification

Before the need of a monitoring plan can be waived, the proper guidance on such a monitoring plan should first be in place, which the EFSA stated was currently not sufficient.

Amendment 318

Christophe Clergeau

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24f – paragraph 1

Or. en

Justification

It is key to obtain environmental data via post-market monitoring to inform during the renewal of consent whether the criteria for a “low-risk” status are still met and therefore whether the previously assigned “low-risk” status can be either confirmed or should be withdrawn.

Amendment 319

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24f – paragraph 1

Or. en

Justification

The evaluation of the intended trait is an important information for ERA, as different environmental conditions could alter the behaviour of the GMM and hence change the basis for formulating risk hypotheses. It is also important not only to evaluate the conclusion of the ERA, but also the assumptions on which the conclusion are based, since these assumptions involve most likely a high degree of uncertainty. For example the assumption of low environmental persistence of a GMM should be evaluated during the monitoring.

Amendment 320

Christine Anderson, Marc Jongen, Anja Arndt, Volker Schnurrbusch

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24f – paragraph 1 a (new)

Or. en

Justification

Even where a genetically modified virus is found to have a low-risk profile following an individual assessment, its specific capacity for genetic change, transmission or interaction with host organisms justifies proportionate post-market monitoring. The requirement does not prescribe identical monitoring for all viruses but allows its scope and intensity to reflect the individual risk profile.

Amendment 321

Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24f – paragraph 2

Or. en

Amendment 322

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24f – paragraph 2

Or. en

Justification

The status of low-risk GMM should be evaluated under various field conditions, as microorganisms do react on environmental conditions and can adapt fast, thereby evolving unforeseen characteristics that could change the low-risk GMM status. Therefore, the stability of the GMM (including the stability of the genetic modification and the stability of the predicted environmental behavior) and the persistence in the environment shall be observed at least for 10 years and the results should be considered for reevaluation of the GMM.

Amendment 323

Gerben-Jan Gerbrandy, Stine Bosse, Jeannette Baljeu, Billy Kelleher

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24f – paragraph 2

Or. en

Justification

Introduces a flexible, risk-based approach to post-market environmental monitoring (PMEM).

Amendment 324

Christophe Clergeau

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24f – paragraph 2

Or. en

Justification

Possibility to waive post market environmental monitoring should only be possible upon first renewal of consent, and only if results from monitoring show that the assumptions of the environmental risk assessment and newly available information suggest that the criteria for a “low-risk” status are still met.

Amendment 325

Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 f – paragraph 2

Or. fr

Amendment 326

Christophe Clergeau

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24f – paragraph 2 a (new)

Or. en

Justification

Monitoring of GMOs has so far been implemented for GM crops. However, due to the biological characteristics of microorganisms, which differ substantially from those of plants, existing monitoring approaches for GM crops are inadequate for the monitoring of GMMs. Therefore, to enable the adequate monitoring of GMMs, monitoring concepts must be developed and harmonized regulatory guidances implemented that take into account not only different groups of organisms but also various receiving environments.

Amendment 327

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24f – paragraph 2 a (new)

Or. en

Amendment 328

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 f – paragraph 2 b (new)

Or. en

Amendment 329

Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 f a (new)

Or. en

Justification

Article 24f should be replaced by a monitoring requirement applying to all GMMs, as the current provision can waive post-market monitoring for low-risk GMMs while providing no GMM-specific monitoring requirements for other GMMs.

Amendment 330

Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 f a (new)

Or. en

Amendment 331

Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24g

Or. en

Amendment 332

Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 g – paragraph 1 – point a

Or. fr

Amendment 333

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24g – paragraph 1 – point a

Or. en

Justification

Essential safety criteria - e.g. genetic stability, absence of pathogeniciy/toxicity and a well-characterised risk profile need to be fixed in the basic act and not to be determined by the European Commission via implementing acts.

Amendment 334

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24g – paragraph 1 – point b

Or. en

Amendment 335

Jessica Polfjärd

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24g – paragraph 1 – point b

Or. en

Amendment 336

Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 g – paragraph 1 – point b

Or. fr

Amendment 337

Gerben-Jan Gerbrandy, Stine Bosse, Jeannette Baljeu, Billy Kelleher

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 g a (new)

Or. en

Amendment 338

Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 g a (new)

Or. en

Justification

The proposal should include Union guidance on the environmental risk assessment and post-market monitoring of GMMs, as current guidance is insufficient and does not adequately cover their specific risks and exposure routes.

Amendment 339

Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 g a (new)

Or. en

Amendment 340

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 g a (new)

Or. en

Justification

For three identifiable classes of GMM, science — including EFSA on gene drives — concludes that no ERA methodology can reliably bound the extent, duration or reversibility of effects after release. Where ERA cannot reliably determine environmental impacts, market authorisation is inappropriate. Under Article 191(2) TFEU, the precautionary response should be exclusion from the market, not a risk assessment beyond what current science can support.

Amendment 341

Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 g b (new)

Or. en

Justification

The proposal introduces reduced scrutiny for certain GMMs but lacks a corresponding category for GMMs whose spread or environmental impact cannot be reliably contained or assessed. This concerns in particular three types of GMMs that have been proposed: gene drives, self-spreading viruses and mirror organisms

Amendment 342

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 g b (new)

Or. en

Justification

Article 31(3) of Directive 2001/18/EC requires Member States to establish registers recording the location of GMOs. This information is equally relevant for GMMs. Although the provision applies in principle to all GMOs, the reference to GMOs “grown under Part C” could be interpreted as plant-specific. Specific provisions on GMM registers should therefore be included in the new GMM articles.

Amendment 343

Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 g b (new)

Or. en

Amendment 344

Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 g c (new)

Or. en

Justification

The proposal should explicitly address biological containment, including its effectiveness, reliability under environmental conditions and potential loss through mutation or selection.

Amendment 345

Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 g c (new)

Or. en

Amendment 346

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 g c (new)

Or. en

Justification

Article 26b of Directive 2001/18/EC gives EU Member States the possibility to restrict or prohibit the cultivation of GMOs authorised in the EU. Member States should be in the position to restrict or prohibit also the release of EU-authorised GMMs.

Since Article 26b refers to “cultivation” it cannot be assumed to hold also for GMMs. This is why a new article should be inserted in the newly added part on GMMs.

Amendment 347

Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 g d (new)

Or. en

Justification

Directive 2001/18/EC gives EU Member States the possibility to restrict or prohibit the cultivation of GMOs authorised in the EU. Since the respective article refers to “cultivation” it cannot be assumed to hold also for GMMs. This is why a new article should be inserted in the new Title on GMMs.

Amendment 348

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 3

Directive 2001/18/EC

Article 24 g d (new)

Or. en

Justification

Article 26a of Directive 2001/18/EC allows Member States to prevent the unintended presence of GMOs in other products, including organic crops. As unintended GMM presence may similarly affect GMO-free and organic production, Member States should have the same possibility for GMMs, supported by appropriate guidance. Although Article 26a applies in principle to GMMs, its references to cultivation and crops suggest a plant focus. A specific provision for GMMs is therefore needed.

Amendment 349

Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther

Proposal for a directive

Article 1 – paragraph 1 – point 3 a (new)

Directive 2001/18/EC

Article 26a – paragraph 1

Or. en

(32010L0053)

Amendment 350

Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther

Proposal for a directive

Article 1 – paragraph 1 – point 3 b (new)

Directive 2001/18/EC

Article 26 a a (new)

Or. en

Amendment 351

Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther

Proposal for a directive

Article 1 – paragraph 1 – point 3 c (new)

Directive 2001/18/EC

Article 26b – title – paragraph 1

Or. en

(32010L0053)

Amendment 352

Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther

Proposal for a directive

Article 1 – paragraph 1 – point 4

Directive 2001/18/EC

Article 29a

Or. en

Amendment 353

Martin Häusling

Proposal for a directive

Article 1 – paragraph 1 – point 4

Directive 2001/18/EC

Article 29a – paragraph 4

Or. en

Amendment 354

Jessica Polfjärd

Proposal for a directive

Article 1 – paragraph 1 – point 4 a (new)

Directive 2001/18/EC

Annex V a (new)

Or. en

Justification

Adapted from Directive 2009/41/EC Annex II Part B, containing criteria establishing the safety of GMMs for human health and the environment. This would provide an alternative route for eligibility for an expedited procedure for GMMs in cases where EFSA has not yet considered a taxonomic unit for QPS, while maintaining strong safeguards.

Amendment 355

Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther

Proposal for a directive

Article 1 – paragraph 1 – point 4 a (new)

Directive 2001/18/EC

Article 31 – paragraph 3 – point b

Or. en

(32010L0053)

Amendment 356

Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Martin Günther

Proposal for a directive

Article 1 a (new)

Directive 98/44/EC

Articles 4, 8 and 9

Or. en

Justification

The European Parliament has repeatedly voiced its concerns regarding patentability of plants and genetic traits. The patent framework does not provide sufficient clarity and safeguards on the patentability of genetic traits that may also occur naturally or be achieved through conventional breeding. Concerns relate in particular to access to genetic resources, freedom to operate and possible market concentration in the seed sector. This amendment reflects the position of the European Parliament on the issue of patents, adopted in the mandate on the new genomic techniques regulation on 7 February 2024

Amendment 357

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph -1 (new)

Directive 2010/53/EU

Article 6a – paragraph –1 (new)

Or. en

Amendment 358

Aurelijus Veryga

Proposal for a directive

Article 2 – paragraph 1 – point 1

Directive 2010/53/EU

Article 2 – paragraph 1

Or. en

Amendment 359

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 1

Directive 2010/53/EU

Article 2 – paragraph 1

Or. en

Amendment 360

Aurelijus Veryga

Proposal for a directive

Article 2 – paragraph 1 – point 1

Directive 2010/53/EU

Article 2 – paragraph 1

Or. en

Amendment 361

Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Martin Günther

Proposal for a directive

Article 2 – paragraph 1 – point 1

Directive 2010/53/EU

Article 2 – paragraph 1

Or. en

Amendment 362

Nicolás González Casares, Leire Pajín

Proposal for a directive

Article 2 – paragraph 1 – point 1

Directive 2010/53/EU

Article 2 – paragraph 1

Or. en

Justification

Reinforces, at the level of the scope of application and not only of the definitions, the intention that no organ intended for transplantation should fall outside the donation and transplantation system by reason of its processing.

Amendment 363

Aurelijus Veryga

Proposal for a directive

Article 2 – paragraph 1 – point 1

Directive 2010/53/EU

Article 2 – paragraph 1

Or. en

Amendment 364

Nicolás González Casares, Leire Pajín

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point a

Directive 2010/53/EU

Article 3 – point q

Or. en

Justification

An organ donated for transplantation retains that nature regardless of the processing to which it is subjected, preventing interpretations that would allow its reclassification as a medicinal product or as any other marketable good.

Amendment 365

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point a

Directive 2010/53/EU

Article 3 – point q

Or. en

Amendment 366

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point a

Directive 2010/53/EU

Article 3 – point q

Or. en

Justification

This amendment is re-introducing original text of the directive.

Amendment 367

Nicolás González Casares, Leire Pajín

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b

Directive 2010/53/EU — definition of 'processing'

Article 3 – point ka

Or. en

Justification

The third exclusion in the Commission's proposal reproduces, almost verbatim, the definition of a medicinal product under Directive 2001/83/EC, meaning that any manipulation of an organ by means of a medicinal product — including genetic modification through a viral vector, such as the one recently classified as a gene therapy medicinal product by the EMA's Committee for Advanced Therapies — would fall outside the scope of the Directive. The amendment retains the exclusion only for medicinal products with an autonomous therapeutic purpose unrelated to the processing of the organ itself, thereby preserving the scope of the Directive for any manipulation whose object is the organ itself.

Amendment 368

Aurelijus Veryga

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b

Directive 2010/53/EU

Article 3 point ka

Or. en

Amendment 369

Ondřej Knotek, Jana Nagyová, Laurent Castillo, Aleksandar Nikolic, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b

Directive 2010/53/EU

Article 3 – point ka

Or. en

Justification

The proposed definition of the Commission limits processing to operations performed to maintain or improve the “functional status” of an organ. This may create uncertainty as regards novel ex vivo interventions which alter biological, genetic or immunological characteristics of an organ without necessarily producing an immediate or directly measurable improvement in its functional status.In particular, emerging technologies may modify an organ prior to transplantation in order to improve its suitability for transplantation, reduce the risk of rejection or otherwise improve transplant outcomes. Such interventions should not fall outside the organ-processing framework merely because their principal effect cannot be characterised as maintaining or improving the organ’s functional status.Extending the definition to the “biological characteristics or suitability for transplantation” of the organ provides greater legal certainty and ensures that the regulatory framework remains technologically neutral and capable of accommodating developments in organ processing, while maintaining the quality, safety and oversight requirements of Directive 2010/53/EU.

Amendment 370

Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Martin Günther

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b

Directive 2010/53/EU

Article 3 – point ka

Or. en

Amendment 371

Elena Nevado del Campo, Dolors Montserrat

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b

Directive 2010/53/EC

Article 3 – point ka

Or. en

Amendment 372

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b

Directive 2010/53/EU

Article 3 – point ka

Or. en

Justification

This AM introduces a safeguard in defining the processing, clarifying that processing techniques of organs are operations undertaken while the organ is outside of the human body.

Amendment 373

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b

Directive 2010/53/EU

Article 3 – point ka

Or. en

Amendment 374

Nicolás González Casares

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b

Directive 2010/53/EU

Article 3 – point ka – point -i (new)

Or. en

Amendment 375

Elena Nevado del Campo, Dolors Montserrat

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b

Directive 2010/53/EC

Article 3 – point ka – point i

Or. en

Amendment 376

Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Martin Günther

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b

Directive 2010/53/EU

Article 3 – point ka – point i

Or. en

Amendment 377

Nicolás González Casares

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b

Directive 2010/53 /EU

Article 3 – point ka – point i

Or. en

Amendment 378

Nicolás González Casares

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b

Directive 2010/53 /EU

Article 3 – point ka – point i a (new)

Or. en

Amendment 379

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b

Directive 2010/53/EU

Article 3 – point ka – point i a (new)

Or. en

Amendment 380

Elena Nevado del Campo, Dolors Montserrat

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b

Directive 2010/53/EC

Article 3 – point ka – point ii

Or. en

Amendment 381

Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Martin Günther

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b

Directive 2010/53/EU

Article 3 – point ka – point ii

Or. en

Amendment 382

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b a (new)

Directive 2010/53/EU

Article 3 b a (new)

Or. en

Amendment 383

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b a (new)

Directive 2010/53/EU

Article 3 b a (new)

Or. en

Justification

This amendment introduces a definition of a clinical-outcome monitoring plan to ensure the systematic collection and assessment of clinical outcome data following the application of a processed organ.

Amendment 384

Aurelijus Veryga

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b a (new)

Directive 2010/53/EU

Article 3 b a (new)

Or. en

Amendment 385

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b b (new)

Directive 2010/53/EU

Article 3 b b (new)

Or. en

Justification

This amendment introduces a definition of clinical outcome data to clarify the information to be collected following the application of a processed organ to a recipient.

Amendment 386

Aurelijus Veryga

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b b (new)

Directive 2010/53/EU

Article 3 b b (new)

Or. en

Amendment 387

Aurelijus Veryga

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b c (new)

Directive 2010/53/EU

Article 3 b c (new)

Or. en

Amendment 388

Aurelijus Veryga

Proposal for a directive

Article 2 – paragraph 1 – point 2 – point b d (new)

Directive 2010/53/EU

Article 3 b d (new)

Or. en

Amendment 389

Christine Anderson, Marc Jongen, Anja Arndt, Volker Schnurrbusch

Proposal for a directive

Article 2 – paragraph 1 – point 2 a (new)

Directive 2010/53/EU

Article 4 – paragraph 1

Or. en

Amendment 390

Ondřej Knotek, Jana Nagyová, Laurent Castillo, Aleksandar Nikolic, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain

Proposal for a directive

Article 2 – paragraph 1 – point 2 a (new)

Directive 2010/53/EU

Article 4 – paragraph 2 a (new)

Or. en

Amendment 391

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a

Or. en

Amendment 392

Nicolás González Casares

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 1

Or. en

Amendment 393

Stine Bosse, Billy Kelleher

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 1 a (new)

Or. en

Justification

Ensures the free movement of authorized organs across EU borders, which prevents bureaucratic delays or duplicate approvals when an organ is urgently needed for transplantation.

Amendment 394

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 1 a (new)

Or. en

Justification

This amendment clarifies the scope of an organ processing authorisation by identifying the transplantation centre to which it is granted, the processing technique authorised, the organ or organs concerned and the intended clinical indication or indications.

Amendment 395

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph – 1 a (new)

Or. en

Amendment 396

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 1 b (new)

Or. en

Justification

This amendment clarifies that an organ processing authorisation is specific to the transplantation centre to which it is granted. Another transplantation centre wishing to carry out the same processing must obtain its own authorisation from the competent authority.

Amendment 397

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 1 c (new)

Or. en

Justification

This amendment seeks to avoid unnecessary duplication by allowing competent authorities to take into account scientific evidence and clinical outcome data already available for the same processing in another Member State. However, where the available scientific evidence and clinical data remain insufficient, or where a significant risk is identified, the transplantation centre concerned should remain subject to the clinical-outcome monitoring requirements laid down in paragraph 3.

Amendment 398

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 1 d (new)

Or. en

Justification

This amendment aims to ensure that the benefit-risk assessment considers not only the regulatory status of any medicinal product, medical device or SoHO preparation used in organ processing, but also any risks arising from its interaction with the processing applied to the organ. This is necessary to ensure a comprehensive assessment of the quality and safety of the processed organ.

Amendment 399

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 1 e (new)

Or. en

Justification

This amendment allows allows the competent authority to request additional evidence or data where the information submitted by the transplantation centre is insufficient.

Amendment 400

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 2

Or. en

Amendment 401

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a

Or. en

Justification

This amendment clarifies the elements to be taken into account in the benefit-risk assessment, with a view to ensuring a comprehensive and consistent assessment of the expected benefits and risks of organ processing, including its impact on the quality and safety of the organ.

Amendment 402

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a

Or. en

Amendment 403

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a

Or. en

Justification

This amendment establishes minimum requirements for the content of a clinical-outcome monitoring plan, in order to ensure that relevant clinical outcome data are collected over an appropriate period and reported to the competent authority in a consistent manner.

Amendment 404

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a

Or. en

Justification

This amendment ensures that competent authorities can take appropriate regulatory action where clinical outcome data obtained after authorisation show that the benefit-risk balance is no longer favourable or reveal a serious safety concern.

Amendment 405

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a

Or. en

Justification

This amendment ensures that recipients of processed organs receive appropriate and comprehensible information on the processing applied and on any additional risks or scientific uncertainty relevant to them and, where applicable, on clinical-outcome monitoring and related follow-up.

Amendment 406

Nicolás González Casares

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 4

Or. en

Amendment 407

Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Martin Günther

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 4 a (new)

Or. en

Amendment 408

Elena Nevado del Campo, Dolors Montserrat

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/54/EU

Article 6a – paragraph 4 a (new)

Or. en

Amendment 409

Ondřej Knotek, Jana Nagyová, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 5

Or. en

Justification

Novel organ processing may require expertise from both transplant and medicines authorities. The amendment strengthens their cooperation in line with their respective competences and promotes risk-proportionate assessment, while ensuring that existing assessments are taken into account to avoid duplication and unnecessary administrative burdens.

Amendment 410

Nicolás González Casares

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 5

Or. en

Amendment 411

Stine Bosse, Billy Kelleher

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 5 a (new)

Or. en

Justification

This amendment supplements Article 8 to ensure that intra-state transport and cross-border movements, from procurement to processing and transplantation facilities, do not compromise organ quality.

Amendment 412

Stine Bosse, Billy Kelleher

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 5 b (new)

Or. en

Justification

This amendment delivers clear EU added value by preventing unnecessary double-authorizations and reducing unnecessary bureaucracy when organs cross borders by enabling receiving authorities to verify compliance instantly.

Amendment 413

Nicolás González Casares

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 6

Or. en

Amendment 414

Ondřej Knotek, Jana Nagyová, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 6

Or. en

Amendment 415

Stine Bosse, Billy Kelleher

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 6

Or. en

Justification

Specifies the precise timing (namely ex-ante) for authority verification, eliminating ambiguity and ensuring compliance before organ processing begins.

Amendment 416

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 6 a (new)

Or. en

Amendment 417

Stine Bosse, Billy Kelleher

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 6 a (new)

Or. en

Justification

This amendment fills a gap in the original Article 18 by making sure all organ processing organizations are registered, even if they fall outside the existing procurement and transplantation sites. As organ processing becomes more specialized, new types of laboratories and facilities can be expected to do ex-vivo organ processing work. Keeping a clear record ensures authorities always know who is processing organs and allows entities across the EU to easily verify any authorizations.

Amendment 418

Stine Bosse, Billy Kelleher

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 7

Or. en

Justification

Specifies the precise timing (namely ex-ante) for authority verification, eliminating ambiguity and ensuring compliance before organ processing begins.

Amendment 419

Victor Negrescu

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article: 6a – paragraph 8

Or. en

Justification

Access to transplantation involving processed organs should not depend on a patient's place of residence or financial situation. The amendment promotes timely, equitable and affordable access, particularly for patients in Member States where advanced organ-processing capacities are limited or unavailable.

Amendment 420

Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Martin Günther

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 8

Or. en

Amendment 421

Ondřej Knotek, Jana Nagyová, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 8

Or. en

Justification

Novel organ processing may require expertise from different competent authorities. Cooperation should therefore extend beyond data exchange to relevant scientific and technical assessment, while respecting existing competences. Taking account of assessments already performed will strengthen safety, avoid duplication and reduce unnecessary administrative burdens.

Amendment 422

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 8

Or. en

Amendment 423

Stine Bosse, Billy Kelleher

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 8

Or. en

Justification

An EU-wide approach pools small national data samples into a more powerful Union-wide dataset. Such data collection would ensure the statistical power needed to make scientifically sound statements on the safety and efficacy of innovative organ processing techniques, helping develop better therapies for patients and strengthening the innovativeness of the Union life sciences ecosystem.

Amendment 424

Nicolás González Casares

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 8

Or. en

Amendment 425

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 8 a (new)

Or. en

Justification

This amendment ensures regulatory clarity where organ processing involves medicinal products, medical devices or SoHO preparations and uncertainty arises as to the applicable Union legislative framework. Cooperation between the competent authorities concerned is therefore necessary to ensure the consistent application of the relevant Union legislative frameworks and to avoid gaps in regulatory oversight.

Amendment 426

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 9 a (new)

Or. en

Justification

This amendment aims to ensure that transplantation centres can take immediate action where a change to the processing steps is necessary to address a serious risk to the quality or safety of the organ or to the recipient and prior written agreement cannot be obtained in time. The competent authority must be informed without undue delay, thereby ensuring continued regulatory oversight while allowing proportionate action in urgent situations.

Amendment 427

Stine Bosse, Billy Kelleher

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 9 a (new)

Or. en

Justification

The original directive demands that personnel involved in the chain from donation to transplantation are trained and qualified in Article 12. However, this legislation introduces a new step in that chain dealing with innovative approaches that are potentially not previously taught in medical school, which therefore warrants explicit mention.

Amendment 428

Nicolás González Casares

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 10

Or. en

Amendment 429

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 10

Or. en

Justification

This amendment aims to ensure a proportionate regulatory response and it allows the competent authority, where appropriate, to restrict the scope of the authorisation rather than suspend it in its entirety, while also providing for withdrawal in cases where continued authorisation is no longer justified.

Amendment 430

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 10 a (new)

Or. en

Justification

This amendment serves as a procedural safeguard and improves legal certainty.

Amendment 431

Stine Bosse, Billy Kelleher

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 11

Or. en

Justification

A list published by the Commission cannot be relied on operationally. A living register, updated in real time and carrying the unique reference identifier that is already required for transport, allows any authority or centre in the Union to verify instantly what a processing protocol is and whether it remains valid. This avoids duplicate authorisations, prevents organs being declined for want of information, and turns 27 national practices into one shared source of truth.

Amendment 432

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 11

Or. en

Amendment 433

Nicolás González Casares

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 11

Or. en

Amendment 434

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 11

Or. en

Justification

This amendment ensures that the list published by the Commission reflects the scope of organ processing authorisations by identifying the type or types of organs concerned and the intended clinical indication or indications.

Amendment 435

Stine Bosse, Billy Kelleher

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 11 a (new)

Or. en

Justification

Innovative processing techniques are novel and each Member State alone will see too few cases to judge them. Pooled, interoperable data delivers statistical power that no national dataset can match on its own. A centre in one Member State should be able to learn from a protocol used in another Member State, rather than repeat the learning curve on its own patients. Union-wide interoperability must be built into this legislation from the outset and any data must be shared in accordance with the GDPR.

Amendment 436

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 11 a (new)

Or. en

Justification

This amendment establishes a Union-level alert mechanism to ensure the rapid exchange of information on serious safety concerns associated with organ processing that may affect more than one Member State. It complements the Commission list of authorised organ processing by enabling competent authorities in Member States where the processing concerned has been authorised to assess without undue delay whether action is necessary in relation to authorisations under their responsibility.

Amendment 437

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 11 a (new)

Or. en

Amendment 438

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 11 b (new)

Or. en

Justification

This amendment ensures that the list published by the Commission reflects the current status of organ processing authorisations, including relevant changes identified through the EU Alert Mechanism for Organ Processing.

Amendment 439

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 12

Or. en

Justification

This amendment clarifies the scope of the implementing acts by specifying the procedural matters for which detailed rules may be adopted, while ensuring that the substantive requirements for organ processing authorisation and clinical-outcome monitoring remain laid down in this Directive.

Amendment 440

Nicolás González Casares

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 12

Or. en

Amendment 441

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 12 a (new)

Or. en

Justification

This amendment ensures periodic reporting on the implementation of the provisions concerning organ processing, including their impact on quality and safety, clinical outcomes and access to transplantation. It also enables the assessment of consistency in the application of the authorisation framework across Member States and of cooperation between competent authorities.

Amendment 442

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 3

Directive 2010/53/EU

Article 6a – paragraph 12 a (new)

Or. en

Amendment 443

Nicolás González Casares, Leire Pajín

Proposal for a directive

Article 2 – paragraph 1 – point 3 a (new)

Directive 2010/53/EU

Article 6b (new)

Or. en

Amendment 444

Aurelijus Veryga

Proposal for a directive

Article 2 – paragraph 1 – point 3 a (new)

Directive 2010/53/EU

Article 11 – paragraph 1

Or. en

(32010L0053)

Amendment 445

Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Martin Günther

Proposal for a directive

Article 2 – paragraph 1 – point 3 a (new)

Directive 2010/53/EU

Article 11 – paragraph 1

Or. en

(32010L0053)

Amendment 446

Romana Jerković, Vytenis Povilas Andriukaitis

Proposal for a directive

Article 2 – paragraph 1 – point 3 a (new)

Directive 2010/53/EU

Article 11 – paragraph 1

Or. en

(32010L0053)

Justification

This amendment ensures that serious adverse events attributable to organ processing are covered by the reporting system established under Article 11, in line with the inclusion of organ processing within the scope of this Directive.

Amendment 447

Nicolás González Casares, Leire Pajín

Proposal for a directive

Article 2 – paragraph 1 – point 3 b (new)

Directive 2010/53/EU

Article 11 – paragraph 5 a (new)

Or. en

Justification

Ensures that pharmacovigilance and biovigilance of processed organs do not depend on a parallel system, but are integrated into the mechanisms already existing under the Directive, with their scope reinforced.

Amendment 448

Ondřej Knotek, Jana Nagyová, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain

Proposal for a directive

Article 2 – paragraph 1 – point 3 a (new)

Directive 2010/53/EU

Article 13 – paragraph 4 a (new)

Or. en

Justification

The development of innovative organ-processing techniques increasingly involves medicinal products, medical devices and other proprietary technologies provided by commercial operators. Such involvement is essential for innovation in transplantation but should not affect the fundamental principles governing the donation and procurement of human organs.Article 13 of Directive 2010/53/EU establishes the voluntary and unpaid character of organ donation and requires procurement to be carried out on a non-profit basis. The introduction of “processing” into the regulatory framework should not create uncertainty as to the continued application of those principles where proprietary products or technologies are used to modify an organ prior to transplantation.The amendment therefore clarifies that commercial or proprietary rights relating to the products, technologies or services used for organ processing do not affect the legal and ethical principles applicable to the donation and procurement of the organ itself. This allows technological innovation and legitimate commercial activity relating to processing technologies while safeguarding the altruistic basis of organ donation and public trust in transplantation systems.

Amendment 449

Aurelijus Veryga

Proposal for a directive

Article 2 – paragraph 1 – point 3 b (new)

Directive 2010/53/EU

Article 16

Or. en

(32010L0053)

Amendment 450

Aurelijus Veryga

Proposal for a directive

Article 2 – paragraph 1 – point 3 c (new)

Directive 2010/53/EU

Article 16 a (new)

Or. en

Amendment 451

Nicolás González Casares, Leire Pajín

Proposal for a directive

Article 2 – paragraph 1 – point 3 c (new)

Directive 2010/53/EU

Article 17 – paragraph 2 a (new) – paragraph 2 b (new)

Or. en

Justification

Anchors the new authorisation of use within the institutional structure already existing under the Directive, avoiding the creation of ad hoc bodies and ensuring stable cooperation between the transplant and medicines authorities in each Member State.

Amendment 452

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 3 a (new)

Directive 2010/53/EU

Article 17 a (new)

Or. en

Justification

While welcoming the Commission's proposal to modernise the framework for organ processing and innovative preservation technologies, Parliament should also ensure that these developments translate into better cross-border access to transplantation, particularly for patients facing an imminent risk of death and highly sensitised kidney patients.

Amendment 453

Nicolás González Casares, Leire Pajín

Proposal for a directive

Article 2 – paragraph 1 – point 3 d (new)

Directive 2010/53/EU

Article 18 – paragraph 2 a (new)

Or. en

Amendment 454

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 3 b (new)

Directive 2010/53/EU

Article 20 – paragraph 3 a (new)

Or. en

Amendment 455

Ignazio Roberto Marino

Proposal for a directive

Article 2 – paragraph 1 – point 3 c (new)

Directive 2010/53/EU

Article 21 a (new)

Or. en

Justification

While welcoming the Commission's proposal to modernise the framework for organ processing and innovative preservation technologies, Parliament should also ensure that these developments translate into better cross-border access to transplantation, particularly for patients facing an imminent risk of death and highly sensitised kidney patients.

Amendment 456

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a directive

Article 2 – paragraph 1 – point 3 d (new)

Directive 2010/53/EU

Article 22 – paragraph 2 a (new)

Or. en

Amendment 457

Aurelijus Veryga

Proposal for a directive

Article 2 – paragraph 1 – point 4

Directive 2010/53/EU

Annex – Part B

Or. en

Amendment 458

Elena Nevado del Campo, Dolors Montserrat

Proposal for a directive

Article 2 – paragraph 1 – point 4

Directive 2010/53/EU

Annex – Part B

Or. en

Amendment 459

Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Martin Günther

Proposal for a directive

Article 2 – paragraph 1 – point 4

Directive 2010/53/EU

Annex – Part B

Or. en

Amendment 460

Ondřej Knotek, Jana Nagyová, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain

Proposal for a directive

Article 2 – paragraph 1 – point 4

Directive 2010/53/EU

Annex – Part B

Or. en

Justification

This amendment aligns Part B of the Annex with the amended definition of “processing” in Article 3(ka).Novel ex vivo processing techniques may modify the biological, genetic or immunological characteristics of an organ or improve its suitability for transplantation without necessarily producing an immediate improvement in its functional status. Information concerning such processing may nevertheless be essential for assessing the quality and safety of the organ and for an appropriate evaluation of the donor organ by the transplant team.The information requirements in Part B should therefore cover the same range of processing operations as the definition of “processing” in Article 3(ka), ensuring consistency and avoiding uncertainty as to whether information on novel processing techniques, including ex vivo biological or genetic modification, must accompany the organ.

Amendment 461

Ignazio Roberto Marino

on behalf of the Verts/ALE Group

Proposal for a directive

Article 2 – paragraph 1 – point 4

Directive 2010/53/EU

Annex – Part B

Or. en

Amendment 462

Ondřej Knotek, Jana Nagyová, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain

Proposal for a directive

Article 2 – paragraph 1 – point 4 a (new)

Directive 2010/53/EU

Annex – Part B

Or. en

Justification

Novel organ-processing techniques may involve medicinal products or technologies that are also subject to Union legislation on medicinal products. This may create uncertainty as to the relationship between the respective regulatory frameworks and risk overlapping or duplicative requirements.The amendment clarifies that the application of medicinal-products legislation to a product or technology used in organ processing does not, in itself, remove the organ from the scope of Directive 2010/53/EU. At the same time, it does not extend the scope of either regulatory framework or prejudge the classification of products under Union medicinal-products legislation.Competent transplantation and medicines authorities should cooperate within their respective competences to provide legal certainty, avoid duplication of assessments and requirements and minimise unnecessary administrative burdens, while maintaining the quality and safety safeguards applicable to organs intended for transplantation.

Amendment 463

Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a directive

Article 2 – paragraph 1 a (new)

Directive 2010/53 EU

Article 20

Or. fr

Amendment 464

Christine Anderson, Marc Jongen, Anja Arndt, Volker Schnurrbusch

Proposal for a directive

Article 3 a (new)

Directive 2001/18/EC

Article 31 a (new)

Or. en

Justification

The Directive introduces a new regulatory regime on the basis of limited practical experience and was proposed without an accompanying formal impact assessment. A review after five years of national application is necessary to determine whether the intended gains in competitiveness and regulatory efficiency have materialised and whether the low-risk, monitoring and detection provisions adequately protect human health and the environment.

Amendment 465

Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Martin Günther

Proposal for a directive

Article 4 – paragraph 1

Or. en