Text · Amendment list
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
Document CJ64-AM-792139 · COM(2025)1031 – 2025/0405(COD)
- Kind
- Amendment list CJ64-AM-792139
- Date
- 10 September 2026
- Committee
- Committee on the Environment, Climate and Food Safety Committee on Public Health
- Dossier
- 2025-0405
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- Formats
- Official page PDF Word
- Reference
- COM(2025)1031 – 2025/0405(COD)
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| Text proposed by the Commission | Amendment |
|---|---|
| 2. The competent authority shall assess whether the information on the analytical method provided by the notifier justifies the application of adapted modalities to comply with detection method requirements in accordance with paragraph 1. | 2. The competent authority shall assess whether the information enabling the detection, identification and quantification of the GMM provided by the notifier is complete and correct. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The competent authority shall assess whether the information on the analytical method provided by the notifier justifies the application of adapted modalities to comply with detection method requirements in accordance with paragraph 1. | 2. The competent authority shall assess whether the information on the analytical method provided by the notifier justifies the application of adapted modalities to comply with analytical method requirements in accordance with paragraph 1. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Where adapted modalities are applied in accordance with paragraph 1, the notifier shall: (a) deposit the complete genome sequence of the GMM and of its parental organism, together with reference material, in a publicly accessible repository designated for that purpose; (b) submit an analytical method fulfilling the applicable minimum performance requirements as soon as such a method becomes technically feasible. The competent authority shall re-examine, on the occasion of each renewal of the consent, whether such a method has become feasible. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. The Commission shall ensure that obstacles to the detection of GMMs are removed, taking into account the findings and recommendations of the European Network of GMO Laboratories (ENGL). |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24e | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24e | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| Low-risk GMMs | GMMs eligible for an accelerated procedure |
| Text proposed by the Commission | Amendment |
|---|---|
| Low-risk GMMs | Expedited procedure |
| Text proposed by the Commission | Amendment |
|---|---|
| Low-risk GMMs | Expedited procedure |
| Text proposed by the Commission | Amendment |
|---|---|
| Low-risk GMMs | Expedited procedure |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| A GMM shall be considered a ‘low-risk GMM’ where it fulfils all of the following criteria: | A GMM shall be eligible for the expedited procedure under this Article where it fulfils all of the following criteria: |
| Text proposed by the Commission | Amendment |
|---|---|
| A GMM shall be considered a ‘low-risk GMM’ where it fulfils all of the following criteria: | A GMM shall be considered a GMM eligible for an accelerated procedure where it fulfils all of the following criteria: |
| Text proposed by the Commission | Amendment |
|---|---|
| A GMM shall be considered a ‘low-risk GMM’ where it fulfils all of the following criteria: | A GMM shall be eligible for the expedited procedure where it fulfils all of the following criteria: |
| Text proposed by the Commission | Amendment |
|---|---|
| A GMM shall be considered a ‘low-risk GMM’ where it fulfils all of the following criteria: | A GMM can be considered for expedited procedure where it fulfils all of the following criteria: |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) it is taxonomically and molecularly well characterised; | (a) it is taxonomically and molecularly well characterised on the basis of a complete genome assembly of the GMM and of its parental organism, in which plasmids and other mobile genetic elements are resolved, and of a comparison establishing the identity, genomic location and copy number of all differences between them; |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (a) it is taxonomically and molecularly well characterised; | (a) it is taxonomically, phenotypically and molecularly well characterised on the basis of a complete genome assembly of the GMM and of its parental organism; |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (a) it is taxonomically and molecularly well characterised; | (a) it is taxonomically and molecularly well characterised and phenotypically well characterised on lowest taxonomic level such as strain-level for bacteria; |
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
| Text proposed by the Commission | Amendment |
|---|---|
| (b) it belongs to a taxonomic unit having the Status of Qualified Presumption of Safety; | (b) it belongs to a taxonomic unit having the Status of Qualified Presumption of Safety provided that the attribution of that status to the taxonomic unit concerned is not subject to a qualification restricting it to use for production purposes or to products not containing viable cells, and that the assessment underlying the attribution of that status has addressed potential effects on the environment for a use comparable to the use notified; |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (b) it belongs to a taxonomic unit having the Status of Qualified Presumption of Safety; | (b) a case-by-case environmental risk assessment demonstrating that the GMM does not pose additional risks to human health, animal health or the environment compared to the non-modified parental organism and that any identified risks remain negligible under the intended conditions of use; |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (b) it belongs to a taxonomic unit having the Status of Qualified Presumption of Safety; | (b) its parental organism belongs to a taxonomic unit having the Status of Qualified Presumption of Safety, while the QPS Status must be assigned to the lowest reasonable taxonomic level such as strain level for bacteria; |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (b) it belongs to a taxonomic unit having the Status of Qualified Presumption of Safety; | (b) it belongs to a taxonomic unit having the Status of Qualified Presumption of Safety, and is not subject to a qualification restricting its QPS status to production purposes |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (b) it belongs to a taxonomic unit having the Status of Qualified Presumption of Safety; | (b) it belongs to a taxonomic unit having the Status of Qualified Presumption of Safety, taking into account the post-release potential environmental risks; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) it belongs to a taxonomic unit having the Status of Qualified Presumption of Safety; | (b) it belongs to a taxonomic unit having the Status of Qualified Presumption of Safety, or it fulfils the criteria set out in Annex V a; |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (c) it does not contain genes of concern which are not naturally present in the parental organism, in particular acquired antimicrobial resistance genes. | (c) the genetic modification does not introduce or result in any sequence of concern, in particular acquired antimicrobial resistance genes, and does not confer on the GMM, relative to its parental organism, any trait that can reasonably be expected to increase its environmental persistence, its capacity to disperse or establish beyond the site of application, or its host range |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (c) it does not contain genes of concern which are not naturally present in the parental organism, in particular acquired antimicrobial resistance genes. | (c) it does not contain genes of concern which are not naturally present in the parental organism, in particular acquired antimicrobial resistance genes, de novo and/or AI-driven designed genes or gene functions, modifications intended for RNA interference and/or genome editing and/or designed for self-spreading properties; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) it does not contain genes of concern which are not naturally present in the parental organism, in particular acquired antimicrobial resistance genes. | (c) it does not contain genes of concern which are not naturally present in the parental organism, in particular acquired antimicrobial resistance genes, virulence factors and genes known to contribute to the production of toxins or harmful metabolites. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (c) it does not contain genes of concern which are not naturally present in the parental organism, in particular acquired antimicrobial resistance genes. | (c) it does not contain any ‘genetic modification of concern’ which are not naturally present in the parental organism |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (c) it does not contain genes of concern which are not naturally present in the parental organism, in particular acquired antimicrobial resistance genes. | (c) the genetic modification does not introduce or result in any genes of concern or traits that give rise to potential harm to the environment, animal or human health; |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) the genetic modification is neither located on, nor flanked by, a mobile or mobilisable genetic element, and the notifier has demonstrated, on the basis of the complete genome assembly referred to in point (a), that no genetic element present in the GMM is capable of mobilising the modification; |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) the notifier demonstrates that the GMM has a negligible likelihood to establish, persist or disseminate in the receiving environment beyond the intended use; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) it does not belong to species that are constituents of the microbiomes of humans, animals, plants or soil; |
| Text proposed by the Commission | Amendment |
|---|---|
| (cb) the type and extent of the environmental exposure resulting from the intended conditions of use have been characterised, and that exposure is limited in extent and duration, in particular in that the GMM is not expected to multiply, persist or disperse beyond the site and the period of application; and (cc) the GMM is not intended to establish, persist or propagate in the receiving environment. Where eligibility rests on the limitation of exposure under point (cb), the written consent shall require monitoring sufficient to verify that the limitation holds. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (cb) the notifier demonstrates that the GMM is unlikely to adversely affect microbial communities, biodiversity, non-target organisms, ecosystem functions or ecosystem services, including soil biodiversity and pollinators; |
| Text proposed by the Commission | Amendment |
|---|---|
| (cb) it is not a virus or viroid; |
| Text proposed by the Commission | Amendment |
|---|---|
| (cc) the notifier demonstrates that validated methods are available for the detection, identification, traceability and monitoring of the GMM and its genetic modifications in the environment; |
| Text proposed by the Commission | Amendment |
|---|---|
| (cc) it does not have known or intended, direct or indirect negative effects on other organisms; |
| Text proposed by the Commission | Amendment |
|---|---|
| (cd) the GMM or its modified genetical material has a negligible likelihood to establish, persist or disseminate in the receiving environment beyond the intended use. |
| Text proposed by the Commission | Amendment |
|---|---|
| (cd) it does not belong to species that are part of the microbiomes of humans, animals or plants; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ce) it is not a virus or viroid; |
| Text proposed by the Commission | Amendment |
|---|---|
| (cf) it does not have known or intended, direct or indirect negative effects on other organisms; |
| Text proposed by the Commission | Amendment |
|---|---|
| (cg) the GMM itself or its modified genetic material has a negligible likelihood to establish, persist or disseminate in the receiving environment beyond the intended use. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. A genetically modified virus shall not be considered a low-risk GMM solely on the basis that the taxonomic family to which it belongs has the Status of Qualified Presumption of Safety. Such a virus may be considered a low-risk GMM only where the notifier has provided the relevant evidence and the competent authority concludes, following a specific case-by-case assessment, that its replication capacity, host range, genetic stability, potential for recombination, persistence, transmission pathways and conditions of use do not give rise to risks requiring the application of the general requirements under Title I. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| The risk assessment of low-risk GMMs and the specific information requirements in notifications concerning their placing on the market shall be adapted to their characteristics. | The risk assessment of low-risk GMMs and the specific information requirements in notifications concerning their placing on the market shall be adapted to their characteristics, while ensuring that the general principles for the environmental risk assessment in Annex II are met as provided for in paragraph 3, point (c). |
| The Commission shall mandate the Authority to close the data requirements in the existing QPS assessment in regard to environmental risk assessment of low-risk GMMs, to bring it in line with data requirements as established under Directive 2001/18/EC. |
| Text proposed by the Commission | Amendment |
|---|---|
| The risk assessment of low-risk GMMs and the specific information requirements in notifications concerning their placing on the market shall be adapted to their characteristics. | The risk assessment of low-risk GMMs and the specific information requirements in notifications concerning their placing on the market shall be adapted to their characteristics, while taking into account the principles for the environmental risk assessment laid down in Annex II and the information requirements referred to in Article 24b paragraph 1a. |
| Text proposed by the Commission | Amendment |
|---|---|
| The risk assessment of low-risk GMMs and the specific information requirements in notifications concerning their placing on the market shall be adapted to their characteristics. | The risk assessment of GMMs eligible for an expedited procedure and the specific information requirements in notifications concerning their placing on the market shall be adapted to their characteristics. |
| Text proposed by the Commission | Amendment |
|---|---|
| The risk assessment of low-risk GMMs and the specific information requirements in notifications concerning their placing on the market shall be adapted to their characteristics. | The risk assessment of GMMs eligible for an accelerated procedure and the specific information requirements in notifications concerning their placing on the market shall be adapted to their characteristics. |
| Text proposed by the Commission | Amendment |
|---|---|
| The risk assessment of low-risk GMMs and the specific information requirements in notifications concerning their placing on the market shall be adapted to their characteristics. | The specific information requirements in notifications concerning the placing on the market of GMMs eligible for an expedited procedure shall be adapted to their characteristics. |
| Text proposed by the Commission | Amendment |
|---|---|
| The procedural requirements laid down in Title I shall be adapted as provided for in paragraph 3, point (d), to provide for the demonstration of low-risk status, to streamline certain procedural elements and to expedite the timelines. Such adaptations shall ensure a high level of protection of human health and the environment as well as the necessary consultations of competent authorities and the public. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| The procedural requirements laid down in Title I shall be adapted as provided for in paragraph 3, point (d), to provide for the demonstration of low-risk status, to streamline certain procedural elements and to expedite the timelines. Such adaptations shall ensure a high level of protection of human health and the environment as well as the necessary consultations of competent authorities and the public. | The procedural requirements laid down in Title I shall be adapted as provided for in paragraph 3, point (d), to provide for the demonstration of low-risk status, to streamline certain procedural elements and to expedite the timelines. Such adaptations shall ensure a high level of protection of human health and the environment as well as the necessary consultations of competent authorities and the public. The Commission shall, in cooperation with the Authority and the competent authorities of the Member States, facilitate access to regulatory guidance and technical assistance for SMEs, research organisations and competent authorities, with particular attention to Member States with limited regulatory and scientific capacity. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| The procedural requirements laid down in Title I shall be adapted as provided for in paragraph 3, point (d), to provide for the demonstration of low-risk status, to streamline certain procedural elements and to expedite the timelines. Such adaptations shall ensure a high level of protection of human health and the environment as well as the necessary consultations of competent authorities and the public. | The procedural requirements laid down in Title I shall be adapted as provided for in paragraph 3, point (d), to provide for the demonstration of the GMM being eligible for an expedited procedure, to streamline certain procedural elements and to expedite the timelines. Such adaptations shall ensure a high level of protection of human health and the environment as well as the necessary consultations of competent authorities and the public. |
| Text proposed by the Commission | Amendment |
|---|---|
| The procedural requirements laid down in Title I shall be adapted as provided for in paragraph 3, point (d), to provide for the demonstration of low-risk status, to streamline certain procedural elements and to expedite the timelines. Such adaptations shall ensure a high level of protection of human health and the environment as well as the necessary consultations of competent authorities and the public. | The procedural requirements laid down in Title I shall be adapted as provided for in paragraph 3, point (d), to provide that the GMM meets the eligibility criteria for expedited procedure, to streamline certain procedural elements and to expedite the timelines. Such adaptations shall ensure a high level of protection of human health and the environment as well as the necessary consultations of competent authorities and the public. |
| Text proposed by the Commission | Amendment |
|---|---|
| The procedural requirements laid down in Title I shall be adapted as provided for in paragraph 3, point (d), to provide for the demonstration of low-risk status, to streamline certain procedural elements and to expedite the timelines. Such adaptations shall ensure a high level of protection of human health and the environment as well as the necessary consultations of competent authorities and the public. | The procedural requirements laid down in Title I shall be adapted as provided for in paragraph 3, point (d), to streamline certain procedural elements and to expedite the timelines. Such adaptations shall ensure a high level of protection of human health and the environment as well as the necessary consultations of competent authorities and the public. |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) supplement this Directive by further specifying the low-risk criteria of GMMs as referred to in paragraph 1, first subparagraph, points (a), (b) and (c); | (a) supplement this Directive by further specifying the eligibility criteria for an expedited procedure as referred to in paragraph 1, first subparagraph, points (a), (b) and (c); |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) supplement this Directive by further specifying the low-risk criteria of GMMs as referred to in paragraph 1, first subparagraph, points (a), (b) and (c); | (a) supplement this Directive by further specifying the eligibility criteria for an expedited procedure as referred to in paragraph 1, first subparagraph, points (a), (b) and (c); |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) supplement this Directive by further specifying the low-risk criteria of GMMs as referred to in paragraph 1, first subparagraph, points (a), (b) and (c); | (a) supplement this Directive by further specifying the criteria referred to in paragraph 1, first subparagraph, points (a), (b) and (c); |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) supplement this Directive by further specifying the low-risk criteria of GMMs as referred to in paragraph 1, first subparagraph, points (a), (b) and (c); | (a) supplement this Directive by further specifying the low-risk criteria of GMMs as referred to in paragraph 1, first subparagraph, points (a) to (cd); |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) supplement this Directive by establishing, where necessary, additional low-risk criteria of GMMs as referred to in paragraph 1; | (b) supplement this Directive by establishing, where necessary, additional low-risk criteria of GMMs as referred to in paragraph 1 ensuring a high level of protection for human health, animal health and the environment; |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (b) supplement this Directive by establishing, where necessary, additional low-risk criteria of GMMs as referred to in paragraph 1; | (b) supplement this Directive by establishing, where necessary, additional eligibility criteria for an expedited procedure as referred to in paragraph 1; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) supplement this Directive by establishing, where necessary, additional low-risk criteria of GMMs as referred to in paragraph 1; | (b) supplement this Directive by establishing, where necessary, additional criteria for GMMs eligible for an accelerated procedure as referred to in paragraph 1; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) supplement this Directive by establishing, where necessary, additional low-risk criteria of GMMs as referred to in paragraph 1; | (b) supplement this Directive by establishing, where necessary, additional eligibility criteria for an expedited procedure referred to in paragraph 1; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) amend this Directive by adapting or further specifying the criteria set out in Annex V a in line with scientific and technical advice; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) amend this Directive by providing for specific information requirements in Annex III in notifications concerning the placing on the market of low-risk GMMs; | (c) amend this Directive by providing for specific information requirements in Annex III in notifications concerning the placing on the market of low-risk GMMs, while ensuring that the general principles for the environmental risk assessment defined in Annex II can be met; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) amend this Directive by providing for specific information requirements in Annex III in notifications concerning the placing on the market of low-risk GMMs; | (c) amend this Directive by providing for specific information requirements in Annex III for GMMs eligible for an expedited procedure to the extent justified by the characteristics of these GMMs; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) amend this Directive by providing for specific information requirements in Annex III in notifications concerning the placing on the market of low-risk GMMs; | (c) amend this Directive by providing for specific information requirements in Annex III in notifications concerning the placing on the market of GMMs eligible for an expedited procedure; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) amend this Directive by providing for specific information requirements in Annex III in notifications concerning the placing on the market of low-risk GMMs; | (c) amend this Directive by providing for specific information requirements in Annex III in notifications concerning the placing on the market of GMMs eligible for an accelerated procedure; |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) amend this Directive by setting out procedural requirements for the risk assessment of low-risk GMMs adapted to their characteristics. | (d) amend this Directive by setting out procedural requirements for the risk assessment of low-risk GMMs adapted to their characteristics. |
| Delegated acts adopted under points (a) to (d) shall not extend the scope of the GMMs qualifying as low-risk GMMs, and shall be without prejudice to the principles for the environmental risk assessment laid down in Annex II. When adopting a delegated act under point (b), the Commission shall publish a report justifying the additional criteria, including an up-to-date review of the scientific literature concerning the safety of GMMs, their environmental risk assessment and their characterisation. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (d) amend this Directive by setting out procedural requirements for the risk assessment of low-risk GMMs adapted to their characteristics. | (d) amend this Directive by setting out procedural requirements for the risk assessment of low-risk GMMs adapted to their characteristics, to the extent justified by the characteristics of these GMMs and without prejudice to the principles for the environmental risk assessment laid down in Annex II. Such procedural requirements shall be science-based, ensure a high level of protection of human health, animal health and the environment as well as the necessary consultations of competent authorities and the public. |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) amend this Directive by setting out procedural requirements for the risk assessment of low-risk GMMs adapted to their characteristics. | (d) amend this Directive by setting out procedural requirements for the risk assessment of GMMs eligible for an accelerated procedure adapted to their characteristics and to available scientific data. |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) amend this Directive by setting out procedural requirements for the risk assessment of low-risk GMMs adapted to their characteristics. | (d) amend this Directive by setting out procedural requirements for the risk assessment of GMMs eligible for an expedited procedure adapted to their characteristics. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24f | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24f | deleted |
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).
| Text proposed by the Commission | Amendment |
|---|---|
| Monitoring and reporting of low-risk GMMs | Monitoring and reporting of GMMs eligible for an expedited procedure |
| Text proposed by the Commission | Amendment |
|---|---|
| Monitoring and reporting of low-risk GMMs | Monitoring and reporting of GMMs |
| Text proposed by the Commission | Amendment |
|---|---|
| Monitoring and reporting of low-risk GMMs | Monitoring and reporting of GMMs |
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
| Text proposed by the Commission | Amendment |
|---|---|
| Monitoring and reporting of low-risk GMMs | Monitoring and reporting |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. If, on the basis of the results of any release notified in accordance with Article 6, of the findings of the environmental risk assessment carried out in accordance with Article 13(2), point (b), of the characteristics of the GMM, of the characteristics and scale of its expected use, and of the characteristics of the receiving environment, the notifier considers that a monitoring plan referred to in Article 13(2), point (e), is not needed, the notifier may propose not to submit a monitoring plan. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. If, on the basis of the results of any release notified in accordance with Article 6, of the findings of the environmental risk assessment carried out in accordance with Article 13(2), point (b), of the characteristics of the GMM, of the characteristics and scale of its expected use, and of the characteristics of the receiving environment, the notifier considers that a monitoring plan referred to in Article 13(2), point (e), is not needed, the notifier may propose not to submit a monitoring plan. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. If, on the basis of the results of any release notified in accordance with Article 6, of the findings of the environmental risk assessment carried out in accordance with Article 13(2), point (b), of the characteristics of the GMM, of the characteristics and scale of its expected use, and of the characteristics of the receiving environment, the notifier considers that a monitoring plan referred to in Article 13(2), point (e), is not needed, the notifier may propose not to submit a monitoring plan. | 1. By [12] months after the date of entry into force of this Directive], the Authority, with the assistance of national competent authorities, shall develop detailed guidance to enable notifiers to prepare scientifically robust monitoring plans in accordance with Article 13(2), point (e). |
| If, on the basis of the results of any release notified in accordance with Article 6, of the findings of the environmental risk assessment carried out in accordance with Article 13(2), point (b), of the characteristics of the GMM, of the characteristics and scale of its expected use, and of the characteristics of the receiving environment, the notifier considers that a monitoring plan referred to in Article 13(2), point (e), is not needed, the notifier may propose not to submit a monitoring plan. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. If, on the basis of the results of any release notified in accordance with Article 6, of the findings of the environmental risk assessment carried out in accordance with Article 13(2), point (b), of the characteristics of the GMM, of the characteristics and scale of its expected use, and of the characteristics of the receiving environment, the notifier considers that a monitoring plan referred to in Article 13(2), point (e), is not needed, the notifier may propose not to submit a monitoring plan. | 1. The assessment report required for a renewal of consent, as referred to in Article 17 paragraph 3 point (a), shall additionally indicate whether the GMM shall still be considered a “low-risk GMM” as referred to in Article 24e paragraph 1. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. If, on the basis of the results of any release notified in accordance with Article 6, of the findings of the environmental risk assessment carried out in accordance with Article 13(2), point (b), of the characteristics of the GMM, of the characteristics and scale of its expected use, and of the characteristics of the receiving environment, the notifier considers that a monitoring plan referred to in Article 13(2), point (e), is not needed, the notifier may propose not to submit a monitoring plan. | 1. On the basis of the results of any release notified in accordance with Article 6, of the findings of the environmental risk assessment carried out in accordance with Article 13(2), point (b), of the characteristics of the GMM, of the characteristics and scale of its expected use, and the expected exposure of the receiving environment, the notifier shall submit a monitoring plan which aims to evaluate the intended trait and the specific GMM for persistence, dissemination and interaction with other organisms in the receiving environment. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. Paragraph 1 shall not apply to a GMM consisting of or containing a genetically modified virus. The notification for such a GMM shall include a post-market environmental monitoring plan proportionate to its replication capacity, host range, genetic stability, potential for recombination, persistence, transmission pathways, scale and conditions of use and the characteristics of the receiving environment. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The written consent referred to in Article 19 shall either specify the monitoring requirements, as provided in Article 19(3), point (f), or state that monitoring is not required. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The written consent referred to in Article 19 shall either specify the monitoring requirements, as provided in Article 19(3), point (f), or state that monitoring is not required. | 2. Monitoring of GMMs in all cases shall be obligatory at least during the first five years of authorisation in order to confirm the assumptions of the environmental risk assessment, taking into account the ability of microorganisms to evolve quickly and to adapt to various environmental conditions. The authorisation holder is responsible for carrying this out and submitting the evidence to the European Commission and EFSA respectively. The Post-Market Environmental Monitoring (PMEM) for GMMs for expedited procedure shall provide information about the stability of the intended genetic modification and stability of the predicted environmental behavior, including confirmation of negligible environmental persistence beyond the intended use. |
| The results of the PMEM shall be used for re-evaluation of the GMMs for expedited procedure during renewal of consent to support the following conclusions: | |
| (a) If the results of PMEM identified unforeseen environmental behaviour of GMMs for expedited procedure such as persistence in the receiving environment beyond the intended use, the status of GMMs for expedited procedure shall be reevaluated, taking into account this unexpected environmental behaviour of the GMM, and PMEM must be continued after renewal of consent; | |
| (b) if the results of PMEM confirmed all assumptions of the environmental risk assessment, the notifier may propose not to continue monitoring activities during renewal of consent. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The written consent referred to in Article 19 shall either specify the monitoring requirements, as provided in Article 19(3), point (f), or state that monitoring is not required. | 2. The competent authority shall assess the proposal referred to in paragraph 1 and decide whether monitoring requirements may be waived. Where the monitoring plan is required, the written consent referred to in Article 19 shall specify the monitoring requirements, as provided in Article 19(3), point (f). |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The written consent referred to in Article 19 shall either specify the monitoring requirements, as provided in Article 19(3), point (f), or state that monitoring is not required. | 2. The written consent referred to in Article 19 shall either specify the monitoring requirements, as provided in Article 19(3), point (f), or state, in case the GMM was approved to be considered a “low-risk GMM” according to paragraph 1, that further monitoring is not required. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The written consent referred to in Article 19 shall either specify the monitoring requirements, as provided in Article 19(3), point (f), or state that monitoring is not required. | 2. The written consent referred to in Article 19 shall either specify the monitoring requirements, as provided in Article 19(3), point (f), or propose a reduction in monitoring in accordance with the most recent safety rules. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. The Authority shall publish detailed technical and scientific guidance to assist notifiers in the preparation and implementation of post market environmental monitoring plans differentiating various groups of microorganisms and receiving environments. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. The written consent referred to in Article 19 shall specify the monitoring requirements, as provided in Article 19(3), point (f), and shall specify appropriate case-specific monitoring and, where relevant, general surveillance measures. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2b. The Authority shall develop guidance documents for Post-Market Environmental Monitoring (PMEM) and environmental risk assessment (ERA) differentiating various groups of microorganisms and receiving environments. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24fa | |
| Monitoring of GMMs | |
| 1. The monitoring plan referred to in Article 13(2), point (e), shall for every GMM address: (a) the survival and persistence of the GMM in the receiving environments it may reach; (b) its dispersal beyond the site of application; (c) the persistence of the genetic modification and indicators of its transfer to other micro-organisms; (d) surveillance of antimicrobial resistance; (e) effects on the composition and functioning of resident microbial communities and on non-target organisms; (f) unexpected adverse effects on human health, animal health or the environment. | |
| 2. Paragraph 1 is without prejudice to the distinction drawn in Annex VII between case-specific monitoring and general surveillance, and the monitoring plan shall provide for both. | |
| 3. The extent and duration of the monitoring required shall be proportionate to the type and extent of the exposure characterised under Article 24e(1), point (e). | |
| 4. The competent authority shall determine the monitoring requirements in the written consent in accordance with Article 19(3), point (f). A consent shall not state that monitoring is not required. | |
| 5. Monitoring results shall be reported in accordance with Article 20. The competent authority shall make publicly available those results that do not constitute confidential information within the meaning of Article 25, together with the methods used to obtain them. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24fa | |
| Monitoring and reporting GMMs | |
| In addition to the monitoring plan referred to in Article 13(2), point (e), Article 20 and the relevant parts of Annex III and ANNEX VII, the monitoring plan of GMMs will also cover the persistence, spread and effects of the GMM itself, and the transfer of its genetic material to other micro-organisms or species, including through horizontal gene transfer. | |
| After completion of a release, and thereafter, at any intervals of two years, the notifier shall send to the competent authority the result of the release in respect of any risk to health or the environment. | |
| The Authority, in consultation with the national competent authorities, shall develop detailed guidance to enable notifiers to prepare scientifically robust monitoring plans in accordance with Article 13(2), point (e), and Annex VII. In view of the diversity of the microorganisms covered by Article 2(9), the guidance shall establish biologically and ecologically relevant categories of microorganisms, taking into account their distinct biological characteristics, environmental behaviour and potential exposure pathways, in order to ensure that monitoring requirements are appropriately adapted to the characteristics of the microorganisms concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24g | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) adapted modalities to comply with analytical method requirements referred to in Article 24d(1); | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) adapted modalities to comply with analytical method requirements referred to in Article 24d(1); | (a) adapted modalities to comply with analytical method requirements referred to in Article 24d(1), while ensuring the availability of reliable methods for the detection, identification, traceability and monitoring of GMMs;; |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the supporting information to be submitted in the notification referred to in Article 13(2) to demonstrate fulfilment of the criteria referred to in Article 24e(1) for being considered a low-risk GMM. | (b) the supporting information to be submitted in the notification referred to in Article 13(2) to demonstrate fulfilment of the criteria referred to in Article 24e(1) for being considered a low-risk GMM, without altering, supplementing or adding to those criteria. |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the supporting information to be submitted in the notification referred to in Article 13(2) to demonstrate fulfilment of the criteria referred to in Article 24e(1) for being considered a low-risk GMM. | (b) the supporting information to be submitted in the notification referred to in Article 13(2) to demonstrate fulfilment of the criteria referred to in Article 24e(1) for being eligible for an expedited procedure. |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the supporting information to be submitted in the notification referred to in Article 13(2) to demonstrate fulfilment of the criteria referred to in Article 24e(1) for being considered a low-risk GMM. | (b) the supporting information to be submitted in the notification referred to in Article 13(2) to demonstrate fulfilment of the criteria referred to in Article 24e(1) for being considered a GMM eligible for an accelerated procedure. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24ga | |
| Guidance and research | |
| 1. Provision shall be made for the Authority to adopt guidance to assist notifiers in the preparation and the presentation of the notification for the placing on the market of GMMs, including as regards the monitoring plan for environmental effects. This guidance should be regularly updated.2. The Commission shall establish and fund a dedicated research programme to support the development, validation and further improvement of methods and approaches for the environmental risk assessment of GMMs. The Commission shall ensure that the results of this research programme are made publicly available and are taken into account in the guidance updates and requirements for the environmental risk assessment. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24ga | |
| Guidance | |
| 1. The Authority shall publish detailed guidance to assist notifiers in the preparation and the presentation of the notification for the placing on the market of GMMs in accordance with this Title. | |
| 2. The European Union Reference Laboratories, assisted by the European Network of GMO Laboratories, shall publish detailed guidance to assist the notifier in the application of Article 24d. | |
| 3. By [24 months after the date of entry into force of this Directive], the Authority shall publish guidance on the environmental risk assessment and the post-market environmental monitoring of GMMs, in cooperation with the European Environment Agency and after consultation of experts in microbial ecology and environmental science. That guidance shall cover all GMMs falling within this Title and all their intended uses, and shall not be limited to microorganisms used in the food chain. It shall address at least: survival and persistence in the receiving environment; dispersal beyond the site of application; transfer of the genetic modification to other micro-organisms and its dependence on genetic context; effects on the composition and functioning of resident microbial communities and on non-target organisms; genetic stability and reversion; and the cumulative effects of repeated or combined application. In view of the diversity of the micro-organisms covered by Article 2, point (9), the guidance shall establish biologically and ecologically relevant categories of micro-organisms, so that assessment and monitoring requirements can be adapted to the characteristics of the micro-organisms concerned. | |
| 4. Article 24e shall apply from the date of publication of the guidance referred to in paragraph 3. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24ga | |
| High risk GMOs, including GMMs | |
| 1. Member States shall not give consent to mirror-image biological molecules or gene drive organisms for deliberate release into the environment under part B or for placing on the market under part C. | |
| 2. Researchers and operators shall refrain from research towards creating mirror-image biological molecules and gene drive organisms. | |
| 3. The Commission and the Member States shall endeavour to ensure that the Union’s bans on mirror-image biological molecules or gene drive organisms will be included in the Cartagena Protocol on Biosafety in a timely manner. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24ga | |
| GMMs excluded from placing on the market | |
| 1. Notwithstanding any other provision of this Directive, including Article 24e, no consent shall be granted for the placing on the market of a GMM as or in a product under Part C where the GMM falls within one or more of the following categories: | |
| (a) mirror organisms: the GMM's genome, proteome, or both, are constituted, in whole or in substantial part, of nucleic acids, amino acids, or other essential biomolecules of a chirality not naturally occurring in terrestrial life, such that its interactions with, and potential impacts on, human health, animal health or the environment cannot be reliably assessed; | |
| (b) self-sustaining gene drive organisms: the GMM contains a genetic element engineered to bias its own inheritance above Mendelian frequencies with the design objective, or reasonably foreseeable effect, of propagating through a wild or feral population beyond the treated site, and which is not designed with molecular or genetic mechanisms sufficient to limit the number of generations, geographic extent, or duration over which such propagation can occur; | |
| (c) self-spreading viral constructs: the GMM is, or contains, a virus or viral vector that is replication-competent in a wild-type or non-laboratory host and is designed, or reasonably expected, to self-propagate or transmit — whether by horizontal transmission between hosts, vertical transmission across generations, or both — to organisms or populations beyond the individual organism directly treated. | |
| 2. The Commission is empowered to adopt delegated acts in accordance with Article 29a to add categories of GMMs presenting comparable or greater risks to paragraph 1 in light of scientific and technical progress, the opinions of the Authority, and relevant international instruments, provided that such delegated acts shall not remove, narrow or otherwise weaken the categories listed in paragraph 1 or lower the level of protection of human health and the environment established by this Article.3. Where, in the course of the procedure under Article 13, the competent authority or the Authority identifies that a GMM falls within paragraph 1, the notification shall be rejected and the GMM shall not be eligible for the low-risk status under Article 24e. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24gb | |
| GMMs excluded from placing on the market | |
| 1. Notwithstanding any other provision of this Title, no consent shall be granted for the placing on the market of a GMM as or in a product where the GMM falls within one or more of the following categories: | |
| (a) self-sustaining gene drive organism: the GMM contains a genetic element engineered to bias its own inheritance above the frequencies expected under Mendelian inheritance, with the objective or the reasonably foreseeable effect of propagating through a wild or feral population beyond the organisms to which it is applied, and is not designed with mechanisms sufficient to limit the number of generations, the geographical extent or the duration over which such propagation can occur; | |
| (b) self-spreading viral constructs: the GMM is, or contains, a virus or viral vector that is replication-competent in a host outside laboratory conditions and is designed, or reasonably expected, to transmit to organisms beyond those to which it is directly applied; | |
| (c) mirror organisms: the genome or the proteome of the GMM is constituted, in whole or in substantial part, of nucleic acids, amino acids or other essential biomolecules of a chirality not occurring in terrestrial life. | |
| 2. Where, in the course of the procedure under Article 13, the competent authority or the Authority establishes that a GMM falls within paragraph 1, the notification shall be rejected, and Article 24e shall not apply. | |
| 3. The Commission is empowered to adopt delegated acts in accordance with Article 29a to amend paragraph 1 in the light of scientific and technical progress, the opinions of the Authority and relevant international instruments, provided that such amendments do not lower the level of protection of human health, animal health and the environment established by this Article. |
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
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24gb | |
| Information on sites of release | |
| Member States shall establish registers for recording the exact sites where GMMs authorised under Part C are released into the environment. These locations shall: | |
| — be notified to the competent authorities, and | |
| — be made known to the public in the manner in accordance with national provisions. | |
| For GMMs targeted at human or at animals not confined to specific facilities, this shall include their points of distribution, intended areas of use, or release sites. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24gb | |
| Impact assessment | |
| The Commission shall publish a full and independent impact assessment on GMMs. That impact assessment shall examine the effects and impacts of GMM and their release into the environment on health, the environment, the agricultural system, including the organic and other GMO-free sectors, and economic and social and ethical consequences. The assessment shall examine, in particular, effects on microbiomes, non-food applications, detection and control capacities, coexistence with organic and GMO-free supply chains, and the costs liable to be borne by the various stakeholders. It shall be subject to public consultation. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24gc | |
| Dispersal and biological containment | |
| 1. Where the notifier relies on biological containment measures, including auxotrophy, dependence on substances not present in the receiving environment, or engineered lethality, to limit the survival, replication or dispersal of the GMM, the notification shall include: (a) a quantification of the frequency at which the containment measure fails, and the conditions under which it was determined; (b) an assessment of the stability of the containment measure over the number of generations expected in the intended use, taking into account mutation and the acquisition of genetic material from other micro-organisms; and (c) a monitoring plan capable of verifying that the containment measure performs as assessed under the conditions of use. | |
| 2. Biological containment measures shall not by themselves constitute grounds for dispensing with the monitoring plan referred to in Article 13(2), point (e). |
The proposal should explicitly address biological containment, including its effectiveness, reliability under environmental conditions and potential loss through mutation or selection.
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24gc | |
| QPS status and environmental risk assessment | |
| 1. The attribution of Qualified Presumption of Safety (QPS) status to a microorganism shall not exempt the notifier from carrying out the environmental risk assessment required under this Directive, covering all areas set out in Annex II, Section D.1, nor shall it limit the scope of that assessment. | |
| 2. Where a GMM is derived from a microorganism belonging to a taxonomic unit having QPS status, the environmental risk assessment shall, in accordance with Annex II, take into account the relevant characteristics of the recipient or parental organism, as well as the characteristics of the genetic modification and of the resulting GMM. | |
| 3. QPS status shall not be considered to constitute sufficient evidence of the environmental safety of the recipient or parental organism, or of the resulting GMM, and shall not replace or dispense with the assessment of: | |
| (a) potential adverse effects associated with the recipient or parental organism in the relevant receiving environment; and | |
| (b) any new or increased risks arising from the genetic modification or from interactions between the genetic modification, the GMM, the recipient or parental organism and the receiving environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24gc | |
| National measures | |
| 1. During the authorisation procedure for a GMM under Part C, a Member State may demand that the geographical scope of the notification be adjusted so that all or part of its territory is excluded from the placing on the market of that genetically modified microorganism. The Member State shall communicate that demand to the Commission within the period laid down in Article 14(2) or, as applicable, following receipt of the opinion of the European Food Safety Authority. | |
| 2. Where the notifier has not adjusted or confirmed the geographical scope of the notification following a demand pursuant to paragraph 1, a Member State may adopt measures restricting or prohibiting the placing on the market of the GMM, or of a group of GMMs defined by their characteristics or intended use, in all or part of its territory once that microorganism has been authorised in accordance with Part C of this Directive. | |
| 3. The measures referred to in paragraph 2 shall: (a) be in conformity with Union law; (b) be reasoned, proportionate and non-discriminatory; and (c) be based on compelling grounds, such as those relating to: (i) environmental policy objectives; (ii) protection of specific ecosystems or habitats; (iii) land or water use; (iv) socioeconomic impacts; (v) public policy; (vi) prevention of the unintended presence or dissemination of genetically modified microorganisms or genetic material in other organisms or environments; or (vii) other legitimate objectives related to the particular environmental or geographical characteristics of the Member State, region or area concerned. | |
| 4. The grounds referred to in paragraph 3 may be invoked individually or in combination, with the exception of public policy, which shall not be used as the sole ground. | |
| 5. The measures adopted pursuant to this Article shall not conflict with the environmental risk assessment carried out pursuant to this Directive. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24gd | |
| National measures | |
| 1. During the authorisation procedure for a genetically modified microorganism under Part C, a Member State may demand that the geographical scope of the notification be adjusted so that all or part of its territory is excluded from the placing on the market of that genetically modified microorganism. The Member State shall communicate that demand to the Commission within the period laid down in Article 14(2) or, as applicable, following receipt of the opinion of the European Food Safety Authority. | |
| 2. Where the notifier has not adjusted or confirmed the geographical scope of the notification following a demand pursuant to paragraph 1, a Member State may adopt measures restricting or prohibiting the placing on the market of the genetically modified microorganism, or of a group of genetically modified microorganisms defined by their characteristics or intended use, in all or part of its territory once that microorganism has been authorised in accordance with Part C of this Directive. | |
| 3. The measures referred to in paragraph 2 shall: (a) be in conformity with Union law; (b) be reasoned, proportionate and non-discriminatory; and (c) be based on compelling grounds, such as those relating to: (i) environmental policy objectives; (ii) protection of specific ecosystems or habitats; (iii) land or water use; (iv) socioeconomic impacts; (v) public policy; (vi) prevention of the unintended presence or dissemination of genetically modified microorganisms or genetic material in other organisms or environments; or (vii) other legitimate objectives related to the particular environmental or geographical characteristics of the Member State, region or area concerned. | |
| 4. The grounds referred to in paragraph 3 may be invoked individually or in combination, with the exception of public policy, which shall not be used as the sole ground. | |
| 5. The measures adopted pursuant to this Article shall not conflict with the environmental risk assessment carried out pursuant to this Directive. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24gd | |
| Measures to avoid unintended presence | |
| Member States may take appropriate measures to avoid the unintended presence of GMMs in certain geographic areas, public spaces or products. These measures may be aimed at the protection of organic production or biodiversity, or the prevention of cross-border contamination from neighbouring Member States in which the release of those GMMs has been prohibited. Measures to avoid the unintended presence of GMMs should be developed in cooperation with all relevant stakeholders and in a transparent manner. |
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.
| Present text | Amendment |
|---|---|
| (3a) In article 26a, the first paragraph is amended as follows: | |
| 1. Member States may take appropriate measures to avoid the unintended presence of GMOs in other products. | "'1. Member States shall take appropriate measures to avoid the unintended presence of GMOs in other products.'" |
| Text proposed by the Commission | Amendment |
|---|---|
| (3b) After Article 26a, a new Article 26aa is inserted: | |
| Article 26aa | |
| Measures to avoid, mitigate and compensate the unintended presence of GMMs | |
| 1. Member States shall take appropriate measures to avoid the unintended presence of GMMs in other products, certain geographic areas, public spaces or products or property. | |
| 2. These measures shall include minimum separation distances, buffer zones and mandatory containment and monitoring protocols designed to protect organic and GMO-free farms, operators and supply chains from contamination with GMMs, and measures to prevent cross-border contamination to neighbouring Member States in which the release of those GMMs has been prohibited. | |
| 3. Member States shall establish a clear and legally binding mechanism to ensure liability for damage, including financial damage, resulting from the use or release of GMMs. These shall include that the consent holder shall be liable for the costs of prevention, monitoring, control, containment, withdrawal and remediation resulting from the release of the GMM. The mechanisms shall provide an effective compensation mechanism for organic and GMO-free producers in cases of proven contamination, including loss of organic certification, downgrading, batch withdrawals, analyses and any necessary cleaning or reorganisation measures, loss of market access and associated economic damage. | |
| 4. These measures shall be developed in cooperation with all relevant stakeholders and in a transparent manner. | |
| 5. The European Commission shall, without delay, publish recommendations for the practical implementation of such measures. | |
| 6. The Commission shall gather and coordinate information based on studies at Community and national level, observe the developments regarding coexistence and the occurrence of unintended presence of GMMs in the Member States and, on the basis of the information and observations, develop guidelines to avoid the unintended presence of GMMs. |
| Present text | Amendment |
|---|---|
| (3 c) In Article 26b, the heading and first paragraph are amended as follows: | |
| Cultivation | "'Cultivation and release |
| 1. During the authorisation procedure of a given GMO or during the renewal of consent/authorisation, a Member State may demand that the geographical scope of the written consent or authorisation be adjusted to the effect that all or part of the territory of that Member State is to be excluded from cultivation. That demand shall be communicated to the Commission at the latest 45 days from the date of circulation of the assessment report under Article 14(2) of this Directive, or from receiving the opinion of the European Food Safety Authority under Article 6(6) and Article 18(6) of Regulation (EC) No 1829/2003. The Commission shall present the demand of the Member State to the notifier/applicant and to the other Member States without delay. The Commission shall make the demand publicly available by electronic means. | 1. During the authorisation procedure of a given GMO, including GMMs, or during the renewal of consent/authorisation, a Member State may demand that the geographical scope of the written consent or authorisation be adjusted to the effect that all or part of the territory of that Member State is to be excluded from cultivation or release. That demand shall be communicated to the Commission at the latest 45 days from the date of circulation of the assessment report under Article 14(2) of this Directive, or from receiving the opinion of the European Food Safety Authority under Article 6(6) and Article 18(6) of Regulation (EC) No 1829/2003. The Commission shall present the demand of the Member State to the notifier/applicant and to the other Member States without delay. The Commission shall make the demand publicly available by electronic means.'" |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 29a | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making**. | 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State, the European Food Safety Authority and stakeholders through a public consultation in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making**. |
| Text proposed by the Commission | Amendment |
|---|---|
| (4a) after Annex V, the following new Annex Va is inserted: | |
| ANNEX Va | |
| CRITERIA FOR THE ELIGIBILITY FOR AN EXPEDITED PROCEDURE FOR GENETICALLY MODIFIED MICRO-ORGANISMS | |
| 1. Introduction | |
| The alternative criteria for eligibility for an expedited procedure for GMMs in cases where the taxonomic unit does not have the Status of Qualified Presumption of Safety according to Article 24e(1)(b) are set out below. | |
| 2. General criteria | |
| 2.1. Strain verification/authentication | |
| Identity of the strain must be precisely established. Modification must be known and verified. | |
| 2.2. Documented and established evidence of safety | |
| Documented evidence of the safety of the organism must be provided. | |
| 2.3. Genetic stability | |
| Where any instability could adversely affect safety, evidence of stability is required. | |
| 3. Specific criteria | |
| 3.1. Non-pathogenic | |
| The GMM should not be capable of causing disease or harm to a healthy human, plant or animal. Since pathogenicity includes both toxigenicity and allergenicity, the GMM should therefore be: | |
| 3.1.1. Non-toxigenic | |
| The GMM should not produce increased toxigenicity as a result of the genetic modification nor be noted for its toxigenic properties. | |
| 3.1.2. Non-allergenic | |
| The GMM should not produce increased allergenicity as a result of the genetic modification nor be a noted allergen, having, for example, allergenicity comparable in particular with that of the micro-organisms identified in Directive 2000/54/EC. | |
| 3.2. No harmful adventitious agents | |
| The GMM should not harbour known harmful adventitious agents such as other micro-organisms, active or latent, existing alongside or inside the GMM, that could cause harm to human health and the environment. | |
| 3.3. Transfer of genetic material | |
| The modified genetic material must not give rise to harm if transferred; nor should it be self-transmissible or transferable at a frequency greater than other genes of the recipient or parental microorganism. | |
| 3.4. Safety for the environment | |
| The GMM must not produce adverse effects on the environment, immediate or delayed, as a result of its deliberate release. |
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.
| Present text | Amendment |
|---|---|
| (4a) In Article 31, paragraph 3, point b is amended as follows: | |
| (b) Member States shall also establish registers for recording the location of GMOs grown under part C, inter alia so that the possible effects of such GMOs on the environment may be monitored in accordance with the provisions of Articles 19(3)(f) and 20(1). Without prejudice to such provisions in Articles 19 and 20, the said locations shall: | "(b) Member States shall also establish registers for recording the location of GMOs grown and GMMs released under part C, inter alia so that the possible effects of such GMOs on the environment may be monitored in accordance with the provisions of Articles 19(3)(f) and 20(1). Without prejudice to such provisions in Articles 19 and 20, the said locations shall: |
| — be notified to the competent authorities, and | — be notified to the competent authorities, and |
| — be made known to the public in the manner deemed appropriate by the competent authorities and in accordance with national provisions. | — be made known to the public in the manner deemed appropriate by the competent authorities and in accordance with national provisions." |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 1a | |
| Amendments to Directive 98/44/EC | |
| 1. Article 4 of Directive 98/44/EC on the legal protection of biotechnological inventions is amended as follows: (a) In paragraph 1, the following points are added: | |
| ‘(ba) NGT plants, plant material, parts thereof, genetic information and process features they contain, as defined in Regulation (EU) .../... [O.J. please insert the number of this Regulation]; (bb) plants, plant material, parts thereof, genetic information and process features they contain that can be yielded by techniques excluded from the scope of Directive 2001/18/EC as listed in Annex I B to that directive.’ | |
| (b) the following paragraph 3 a is added: ‘3a. Paragraphs 2 and 3 shall be without prejudice to the exclusions from patentability covered in paragraph 1.’ | |
| 2. In Article 8, the following paragraph is added: | |
| ‘2a. By way of derogation from paragraphs 1 and 2, the protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention shall not extend to biological material possessing the same characteristics that is obtained independently of the patented biological material and from essentially biological processes, or to biological material obtained from such material through propagation or multiplication.’ | |
| 3. In Article 9, the following paragraphs are added: | |
| 1a. By way of derogation from paragraph 1, a plant product containing or consisting of genetic information obtained by a patentable technical process shall not be patentable if it is not distinguishable from plant products containing or consisting of the same genetic information obtained by an essentially biological process. | |
| 1b. By way of derogation from paragraph 1, the protection conferred by a patent on a product containing or consisting of genetic information shall not extend to plant material in which the product is incorporated and in which the genetic information is contained and performs its function but which is not distinguishable from plant material obtained or which can be obtained by an essentially biological process. | |
| 1c. The protection conferred by a patent on a technical process that enables the production of a product containing or consisting of genetic information shall not extend to plant material in which the product is incorporated and in which the genetic information is contained and performs its function but which is not distinguishable from plant material obtained or which can be obtained by an essentially biological process.’ |
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
| Text proposed by the Commission | Amendment |
|---|---|
| (1) Processing of a donated human organ, including through the use of medicinal products, medical devices or SoHO preparations, shall not alter its legal status as a donated human organ. Such organ shall remain subject to the rules on quality and safety for organs set out in this Directive and to applicable Union and national law concerning organ procurement, allocation and transplantation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. This Directive applies to the donation, testing, characterisation, procurement, processing, transport and transplantation of organs intended for transplantation. | 1. This Directive applies to the donation, testing, characterisation, procurement, processing, transport and transplantation of organs intended for transplantation, as well as to the processing of organs intended for autologous use. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. This Directive applies to the donation, testing, characterisation, procurement, processing, transport and transplantation of organs intended for transplantation. | 1. This Directive applies to the donation, testing, characterisation, procurement, processing, preservation, transport and transplantation of organs intended for transplantation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. Where an organ is processed outside the human body using a substance with a pharmacological, immunological or metabolic action within the meaning of Article 1, point 2(b), of Directive 2001/83/EC, with the aim of treating or preventing a disease in the patient into whom the organ is to be transplanted or to whom it is to be reapplied for autologous use, this Directive shall apply to the organ-processing method. The substance and its use shall be governed by Directive 2001/83/EC, Regulation (EC) No 1394/2007, Regulation (EC) No 726/2004 and Regulation (EU) No 536/2014, as applicable. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. An organ that undergoes processing, including through the use of medicinal products, medical devices or SoHO preparations, remains an organ subject to the rules on quality and safety for organs set out in this Directive and to the applicable national provisions regarding organ procurement, allocation and transplantation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. This Directive applies to human organs intended for transplantation regardless of whether they have been subjected to a processing operation within the meaning of Article 3, and regardless of the technology used in that process, provided that the organ retains its physiological function as such after the process. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 1b. Where an organ is processed using a substance of human origin preparation (‘SoHO preparation’) within the meaning of Regulation (EU) 2024/1938, with the aim of treating or preventing a disease in the patient into whom the organ is to be transplanted or to whom it is to be reapplied for autologous use, this Directive shall apply to the organ-processing method. The SoHO preparation and its use shall be governed by Regulation (EU) 2024/1938. |
| Text proposed by the Commission | Amendment |
|---|---|
| (q) “transplantation” means a process intended to restore certain functions of the human body by transferring an organ to a recipient; | (q) “transplantation” means a process intended to restore certain functions of the human body by transferring an organ to a recipient; it being understood that an organ shall in no case lose its status, nor be excluded from the scope of this Directive, by reason of the type of manipulation or processing to which it has been subjected, nor of the purpose pursued or the outcome obtained through that processing, provided that the organ continues, after the process, to perform the physiological function proper to an organ. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (q) “transplantation” means a process intended to restore certain functions of the human body by transferring an organ to a recipient; | (q) “transplantation” means a process intended to restore certain functions of the human body by transferring an organ from a donor to a recipient; |
| Text proposed by the Commission | Amendment |
|---|---|
| (q) “transplantation” means a process intended to restore certain functions of the human body by transferring an organ to a recipient; | (q) “transplantation” means a process intended to restore certain functions of the human body by transferring an organ from a donor to a recipient; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ka) “processing” means any operation involving the handling of organs, including but not limited to preservation, application of chemotherapy and surgery, performed to maintain or improve the functional status of an organ prior to transplantation, with the exception of the preparatory handling of the organ during the surgical transplantation intervention, and excluding the following: | (ka) processing' means any operation involving the handling of an organ, including but not limited to preservation, the application of substances with a pharmacological, immunological, genetic or metabolic action, and surgery, performed to maintain or improve organ function prior to transplantation or the survival of the graft. The following are excluded from this definition: |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (ka) “processing” means any operation involving the handling of organs, including but not limited to preservation, application of chemotherapy and surgery, performed to maintain or improve the functional status of an organ prior to transplantation, with the exception of the preparatory handling of the organ during the surgical transplantation intervention, and excluding the following: | (ka) ‘processing’ means any operation involving the handling of organs outside the body, including but not limited to preservation, application of medicinal products, medical devices or SoHO preparations and surgery, performed with the aim to maintain or improve the functioning of an organ or modify its properties, such as immunocompatibility prior to transplantation, or autologous use, with the exception of the preparatory handling of the organ within the surgical field during the transplantation intervention or during autologous use; |
Ondřej Knotek, Jana Nagyová, Laurent Castillo, Aleksandar Nikolic, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
| Text proposed by the Commission | Amendment |
|---|---|
| (ka) “processing” means any operation involving the handling of organs, including but not limited to preservation, application of chemotherapy and surgery, performed to maintain or improve the functional status of an organ prior to transplantation, with the exception of the preparatory handling of the organ during the surgical transplantation intervention, and excluding the following: | (ka) “processing” means any operation involving the handling of organs, including but not limited to preservation, application of chemotherapy and surgery, performed to maintain or improve the functional status, biological characteristics or suitability for transplantation of an organ prior to transplantation, with the exception of the preparatory handling of the organ during the surgical transplantation intervention, and excluding the following: |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (ka) “processing” means any operation involving the handling of organs, including but not limited to preservation, application of chemotherapy and surgery, performed to maintain or improve the functional status of an organ prior to transplantation, with the exception of the preparatory handling of the organ during the surgical transplantation intervention, and excluding the following: | (ka) “processing” means any operation involving the manipulation of organs outside the body, including but not limited to preservation, application of medicinal products, medical devices or SoHO preparations and surgery, performed to maintain or improve the functional status of an organ prior to transplantation, with the exception of the preparatory handling of the organ before or during the surgical transplantation intervention. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ka) “processing” means any operation involving the handling of organs, including but not limited to preservation, application of chemotherapy and surgery, performed to maintain or improve the functional status of an organ prior to transplantation, with the exception of the preparatory handling of the organ during the surgical transplantation intervention, and excluding the following: | (ka) “processing” means any operation involving the handling of organs, including but not limited to preservation, application of medicinal products, medical devices or SoHO preparations and surgery, performed to maintain, improve or modify the functioning or the properties of an organ prior to transplantation, with the exception of the preparatory handling of the organ before or during the surgical transplantation intervention. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ka) “processing” means any operation involving the handling of organs, including but not limited to preservation, application of chemotherapy and surgery, performed to maintain or improve the functional status of an organ prior to transplantation, with the exception of the preparatory handling of the organ during the surgical transplantation intervention, and excluding the following: | (ka) “processing” means any operation involving the handling of organs outside of human body, including but not limited to preservation, application of chemotherapy and surgery, performed to maintain or improve the functional status of an organ prior to transplantation, with the exception of the preparatory handling of the organ during the surgical transplantation intervention, and excluding the following: |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (ka) “processing” means any operation involving the handling of organs, including but not limited to preservation, application of chemotherapy and surgery, performed to maintain or improve the functional status of an organ prior to transplantation, with the exception of the preparatory handling of the organ during the surgical transplantation intervention, and excluding the following: | (ka) "processing” means any operation performed on a donated human organ after procurement and before or during surgical transplantation, including preservation, assessment, repair or other innovative techniques aimed at maintaining or improving the viability of the organ for transplantation, while preserving its status as a donated human organ. Processing shall exclude: |
| Text proposed by the Commission | Amendment |
|---|---|
| (-i) the preparatory handling of the organ during the surgical transplantation intervention; |
| Text proposed by the Commission | Amendment |
|---|---|
| (i) the repurposing of organs into tissues or cells; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (i) the repurposing of organs into tissues or cells; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (i) the repurposing of organs into tissues or cells; | (i) the repurposing of organs into tissues or cells, in which case the resulting product shall be subject, as appropriate, to Regulation (EU) 2024/1938 or to Regulation (EC) No 1394/2007 and Directive 2001/83/EC; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ia) the use of a medicinal product not specifically developed for the processing of the organ and whose therapeutic indication is autonomous and independent of that processing, such as antibiotics, chemotherapeutic agents, anticoagulants or other medicinal products with an intrinsic therapeutic purpose unrelated to the organ. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ia) routine preparatory handling of the organ during the surgical transplantation intervention that does not constitute a separate processing activity affecting the quality, safety or functional status of the organ. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ii) the use of a substance with a pharmacological, immunological or metabolic action with the aim to treat or prevent a disease in the patient to whom the organ will be transplanted, where such use does not constitute processing of the organ. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (ii) the use of a substance with a pharmacological, immunological or metabolic action with the aim to treat or prevent a disease in the patient to whom the organ will be transplanted, where such use does not constitute processing of the organ. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) 'clinical outcome monitoring plan’ means a structured programme aimed at generating evidence on the effects of an organ processing method on the quality and viability of the organ and on the safety, clinical benefit and effectiveness of transplantation, as demonstrated by recipient outcomes, while monitoring potential implications for equitable access to transplantation. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) “clinical-outcome monitoring plan“ means a plan for the systematic collection and assessment of clinical outcome data following the application of a processed organ to a recipient, for the purpose of assessing the quality and safety of the processed organ and reassessing the benefit-risk assessment referred to in Article 6a(2); |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) ‘composite vascular allograft’ means a differentiated part of the human body, formed by multiple types of tissue, that requires for transplantation from a donor to a recipient, the surgical connection of blood vessels and, where appropriate, nerves; |
| Text proposed by the Commission | Amendment |
|---|---|
| (bb) “clinical outcome data“ means data concerning the clinical outcomes following the application of a processed organ to a recipient, including, where relevant, organ function, graft survival, recipient survival and serious adverse events and reactions; |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (bb) 'high-risk organ processing method’ means an organ processing method associated with an increased likelihood of graft failure or a serious adverse health outcome for the recipient; |
| Text proposed by the Commission | Amendment |
|---|---|
| (bc) 'clinical-outcome monitoring plan’ means a programme aiming to gather evidence on the effects of an organ processing method on the quality of the organ and on the safety and effectiveness of the organ transplantation or autologous use, as demonstrated by recipient outcomes; |
| Text proposed by the Commission | Amendment |
|---|---|
| (bd) ‘significant change’ means any modification to an organ processing method that is reasonably expected to affect clinical outcomes, organ viability, or properties like immunological compatibility; |
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) in Article 4, paragraph 1 is replaced by the following: ‘1. Member States shall ensure that a framework for quality and safety, including procedures to verify and document compliance with the requirements governing organ donation, procurement, consent and traceability, is established to cover all stages of the chain from donation to transplantation or disposal, in compliance with the rules laid down in this Directive.’ |
Ondřej Knotek, Jana Nagyová, Laurent Castillo, Aleksandar Nikolic, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) Member States shall ensure that a framework for quality and safety is established to cover all stages of the chain from donation through organ processing or disposal, including autologous use, to transplantation or disposal, in compliance with the rules laid down in this Directive. |
| Text proposed by the Commission | Amendment |
|---|---|
| Organ processing | Donated human organ processing |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Transplantation centres shall not apply a processed organ to a recipient without prior authorisation by the competent authority, other than in the context of an approved clinical-outcome monitoring plan referred to in paragraph 3 of this Article, as part of an organ processing authorisation. | 1. Transplantation centres shall not apply a processed organ to a recipient without prior authorisation by the competent authority for organs referred to in Article 17, other than in the context of an approved clinical-outcome monitoring plan referred to in paragraph 3 of this Article, as part of an organ processing authorisation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The cross-border transport of a processed organ shall not be delayed or prohibited, provided that the processing activity complies with an authorisation or an approved clinical-outcome monitoring plan issued by the competent authority of the Member State of procurement. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The organ processing authorisation shall be granted to a transplantation centre and shall specify the processing technique authorised, the type or types of organs concerned and the intended clinical indication or indications. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The processing of donated human organs shall respect the principles of voluntary and unpaid donation, ensure patient safety, and contribute to equitable access to transplantation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1b. An organ processing authorisation granted to a transplantation centre shall not constitute an authorisation for another transplantation centre to carry out the same processing. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 1c. Where an application for an organ processing authorisation concerns processing already authorised for a transplantation centre in another Member State, the competent authority shall take into account the available scientific evidence, benefit-risk assessment and relevant clinical outcome data relating to that processing. Where the scientific evidence and clinical data available remain insufficient, or where the benefit-risk assessment identifies a significant risk, the transplantation centre shall submit a proposal for a clinical-outcome monitoring plan in accordance with paragraph 3. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 1d. Where the processing of an organ entails the use of a medicinal product, medical device or SoHO preparation, the benefit-risk assessment shall take into account any risks arising from the interaction between the processing applied to the organ and the medicinal product, medical device or SoHO preparation concerned. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 1e. The competent authority may request the transplantation centre to provide additional scientific evidence or clinical data where necessary for the assessment referred to in paragraph 2. |
This amendment allows allows the competent authority to request additional evidence or data where the information submitted by the transplantation centre is insufficient.
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The transplantation centre shall conduct a benefit-risk assessment of the processing of the organ, considering with the intended clinical indication for which the organ processing authorisation is requested. | 2. The transplantation centre shall conduct a benefit-risk assessment of the processing of the organ, , taking into account the intended clinical indication, the available scientific evidence, the expected clinical benefit for recipients, and potential risks to patients. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a The benefit-risk assessment shall take into account the available scientific evidence and clinical data, the organ concerned, the processing applied, the intended clinical indication, the expected benefits for the recipient and the risks associated with the processing, including any impact on the quality and safety of the organ. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. Where organ processing involves novel techniques, substantial modification or significant uncertainty regarding clinical outcomes, the competent authority shall ensure that an appropriate ethical assessment is carried out before granting authorisation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. The clinical-outcome monitoring plan shall specify the clinical outcomes to be monitored, the duration of the monitoring and the arrangements for reporting clinical outcome data to the competent authority. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 3b. Where clinical outcome data indicate that the benefit-risk balance is no longer favourable or identify a serious safety concern, the competent authority shall restrict, suspend or withdraw the organ processing authorisation, as appropriate. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 3c. Where a processed organ is to be transplanted to a recipient, the recipient shall, subject to the urgency of the clinical situation, receive appropriate and comprehensible information on the processing applied and on any additional risks or scientific uncertainty relevant to the recipient and, where the transplantation takes place in the context of an approved clinical-outcome monitoring plan, on the purpose of the monitoring and any follow-up applicable to the recipient, in accordance with national law. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 4. Where the processing of an organ entails the use of a medicinal product, the competent authority shall verify that the medicinal product has been authorised by a competent authority of a Member State or by the European Commission in accordance with Directive 2001/83/EC of the European Parliament and of the Council* or Regulation (EC) No 726/2004 of the European Parliament and of the Council**. | 4. Where the processing of an organ entails the use of a medicinal product specifically developed for the processing of organs within the meaning of Article 6b(1) and (3), the competent authority shall, instead of applying paragraph 5 of this Article, verify that the authorisation of use required under Article 6b(3) has been granted, and shall cooperate with the national competent authority for medicinal products in accordance with Article 6b(5) and Article 17(3) and (4). |
| Where the processing of an organ entails the use of a medicinal product other than one referred to in paragraph 4 of this Article — namely a medicinal product which has not been specifically developed for the processing of organs and which has an autonomous therapeutic indication independent of that processing, within the meaning of Article 6b(4) — the competent authority shall verify that the medicinal product has been authorised by a competent authority of a Member State or by the European Commission in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. By way of derogation from paragraph 4 of this article, where the use of a medicinal product is exclusively within organ processing as defined in point (ka) of Article 3, such use shall be exempt from the requirement for a marketing authorisation under Directive 2001/83/EC or Regulation (EC) No 726/2004 and: | |
| (i) the manufacture of the medicinal product shall comply with the applicable requirements of Union legislation governing medicinal products, including manufacturing authorisations and good manufacturing practice; | |
| (ii) the quality, non-clinical and clinical data supporting such use shall be assessed jointly by the competent authority responsible for medicinal products and the competent authority responsible for organ processing; | |
| (iii) the use of the medicinal product within organ processing shall be authorised by the competent authority responsible for organ processing in accordance with this Directive. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. By way of derogation from paragraph 4, where a medicinal product is intended exclusively for use in organ processing as defined in Article 3, point (ka), such use shall not be subject to the requirement to obtain a marketing authorisation under Directive 2001/83/EC or Regulation (EC) No 726/2004, provided that: | |
| (i) the medicinal product is manufactured in accordance with the applicable requirements of Union pharmaceutical legislation, including those relating to manufacturing authorisations and good manufacturing practice; | |
| (ii) the quality, non-clinical and clinical data supporting such use are jointly assessed by the competent authority responsible for medicinal products and the competent authority responsible for organ processing; | |
| (iii) the use of the medicinal product in organ processing is authorised, in accordance with this Directive, by the competent authority responsible for organ processing. |
Ondřej Knotek, Jana Nagyová, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Competent authorities shall, after consulting the authorities designated under Directive 2001/83/EC, publish guidelines setting out the necessary requirements for the benefit-risk assessment and the management of the organ after the administration of the medicinal product. | 5. Competent authorities shall, after consulting the authorities designated under Directive 2001/83/EC, publish guidelines setting out the necessary requirements for the benefit-risk assessment and the management of the organ after the administration of the medicinal product. Those guidelines shall provide for a risk-proportionate approach, take into account relevant assessments already carried out under applicable Union legislation, and avoid unnecessary duplication of assessments, requirements and administrative burdens. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Competent authorities shall, after consulting the authorities designated under Directive 2001/83/EC, publish guidelines setting out the necessary requirements for the benefit-risk assessment and the management of the organ after the administration of the medicinal product. | 5. Competent authorities shall, after consulting the authorities designated under Directive 2001/83/EC, publish guidelines setting out the necessary requirements for the benefit-risk assessment and the management of the organ after the administration of a medicinal product referred to in paragraph 5 of this Article. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5a. Guidelines referred to in paragraph 5 shall include specific requirements for the labelling of the organ post-processing, requiring at a minimum the contact details, address, and emergency telephone number of the processing entity in such cases where that entity is distinct from the transplantation centre. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 5b. The cross-border transport of organs should also include the clear display of the unique reference identifier of the organ processing authorisation or approved clinical-outcome monitoring plan, as well as any specific preservation or environmental conditions required during transit. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Where the processing of an organ entails the use of a medical device, the competent authority shall verify that the medical device has been certified by a notified body in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council***. | 6. Where the processing of an organ entails the use of a medical device, the competent authority shall verify that the medical device has been certified by a notified body in accordance with Regulation (EU) 2017/745. Medical devices used in the processing of organs are not subject to an authorisation of use under Article 6b and remain governed exclusively by this paragraph. |
Ondřej Knotek, Jana Nagyová, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Where the processing of an organ entails the use of a medical device, the competent authority shall verify that the medical device has been certified by a notified body in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council***. | 6. Where the processing of an organ entails the use of a medical device, the competent authority shall verify that the medical device has been certified by a notified body or otherwise allowed for use in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Where the processing of an organ entails the use of a medical device, the competent authority shall verify that the medical device has been certified by a notified body in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council***. | 6. Where the processing of an organ entails the use of a medical device, the competent authority shall verify ex-ante that the medical device has been certified by a notified body in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council***. |
Specifies the precise timing (namely ex-ante) for authority verification, eliminating ambiguity and ensuring compliance before organ processing begins.
| Text proposed by the Commission | Amendment |
|---|---|
| 6a. Member States shall facilitate, where clinically appropriate, the use of validated portable hypothermic and normothermic machine perfusion technologies for the preservation, viability assessment and long-distance transport of donor organs, in particular where necessary to support the effective implementation of the cross-border priority mechanism referred to in Article 17a and the Union-wide paired kidney exchange mechanism referred to in Article 21a, and to maximise access to suitable organs across the Union, including through cooperation with third countries applying regulatory, ethical, quality and safety standards equivalent to those of the Union. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6a. The competent authorities shall establish and maintain a record of processing organisations, in case such organisations do not fall under the existing categories of procurement organisations or transplantation centres. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 7. Where the processing of an organ entails the use of a SoHO preparation, the competent authority shall verify that the SoHO preparation has been authorised by the competent authority in accordance with Regulation (EU) 2024/1938 of the European Parliament and of the Council****. | 7. Where the processing of an organ entails the use of a SoHO preparation, the competent authority shall verify ex-ante that the SoHO preparation has been authorised by the competent authority in accordance with Regulation (EU) 2024/1938 of the European Parliament and of the Council****. |
Specifies the precise timing (namely ex-ante) for authority verification, eliminating ambiguity and ensuring compliance before organ processing begins.
| Text proposed by the Commission | Amendment |
|---|---|
| 8. Where applicable, competent authorities under this Directive and the competent authorities under Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EU) 2017/745 and Regulation (EU) 2024/1938 shall collaborate in order to exchange clinical outcome data under such Union legislative frameworks including the clinical outcome monitoring plan under this Directive. | 8. Where applicable, competent authorities under this Directive and the competent authorities under Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EU) 2017/745 and Regulation (EU) 2024/1938 shall collaborate in order to exchange clinical outcome data under such Union legislative frameworks including the clinical outcome monitoring plan under this Directive. Such cooperation shall also facilitate the safe cross-border exchange for transplantation of legally donated human organs that have undergone authorised processing and patients' timely, equitable and affordable access to transplantation, in particular where the necessary organ processing is not available in the Member State where the patient is treated. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 8. Where applicable, competent authorities under this Directive and the competent authorities under Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EU) 2017/745 and Regulation (EU) 2024/1938 shall collaborate in order to exchange clinical outcome data under such Union legislative frameworks including the clinical outcome monitoring plan under this Directive. | 8. Where applicable, competent authorities under this Directive and the competent authorities under Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EU) 2017/745 and Regulation (EU) 2024/1938 shall collaborate in order to exchange clinical outcome data under such Union legislative frameworks including the clinical outcome monitoring plan under this Directive. Such clinical outcome data shall be processed in full compliance with Regulation (EU)2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and Regulation (EU) 2025/327 on the European Health Data Space. |
Ondřej Knotek, Jana Nagyová, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
| Text proposed by the Commission | Amendment |
|---|---|
| 8. Where applicable, competent authorities under this Directive and the competent authorities under Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EU) 2017/745 and Regulation (EU) 2024/1938 shall collaborate in order to exchange clinical outcome data under such Union legislative frameworks including the clinical outcome monitoring plan under this Directive. | 8. Where applicable, competent authorities under this Directive and the competent authorities under Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EU) 2017/745 and Regulation (EU) 2024/1938 shall collaborate, within their respective competences, to support the scientific and technical assessment of organ processing and in order to exchange clinical outcome data under such Union legislative frameworks including the clinical outcome monitoring plan under this Directive, taking into account relevant assessments already carried out and avoiding unnecessary duplication. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 8. Where applicable, competent authorities under this Directive and the competent authorities under Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EU) 2017/745 and Regulation (EU) 2024/1938 shall collaborate in order to exchange clinical outcome data under such Union legislative frameworks including the clinical outcome monitoring plan under this Directive. | 8. Where applicable, competent authorities under this Directive and the competent authorities under Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EU) 2017/745 and Regulation (EU) 2024/1938 shall collaborate in order to exchange clinical outcome data under such Union legislative frameworks including the clinical outcome monitoring plan under this Directive. Such clinical outcome data must be processed in full compliance with Regulation (EU)2016/679 General Data Protection Regulation and Regulation (EU) 2025/327 on the European Health Data Space. |
| Text proposed by the Commission | Amendment |
|---|---|
| 8. Where applicable, competent authorities under this Directive and the competent authorities under Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EU) 2017/745 and Regulation (EU) 2024/1938 shall collaborate in order to exchange clinical outcome data under such Union legislative frameworks including the clinical outcome monitoring plan under this Directive. | 8. Where applicable, competent authorities under this Directive and the competent authorities under Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EU) 2017/745 and Regulation (EU) 2024/1938 shall collaborate in order to exchange clinical outcome data, including across Member State borders, under such Union legislative frameworks including the risk-benefit assessments, organ processing authorisations, and the clinical outcome monitoring plans under this Directive. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 8. Where applicable, competent authorities under this Directive and the competent authorities under Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EU) 2017/745 and Regulation (EU) 2024/1938 shall collaborate in order to exchange clinical outcome data under such Union legislative frameworks including the clinical outcome monitoring plan under this Directive. | 8. Where applicable, competent authorities under this Directive and the authorities designated under Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EU) 2017/745 and Regulation (EU) 2024/1938 shall collaborate in order to exchange clinical outcome data under such Union legislative frameworks, including the clinical outcome monitoring plan under this Article and the authorisation of use under Article 6b. |
| Text proposed by the Commission | Amendment |
|---|---|
| 8a. Where uncertainty arises as to the Union legislative framework applicable to a medicinal product, medical device or SoHO preparation used in the processing of an organ, the competent authorities concerned shall cooperate, within their respective competences, with a view to ensuring the consistent application of the relevant Union legislative frameworks. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 9a. Where a change to the processing steps applied is immediately 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 transplantation centre may make that change to the extent necessary to address that risk and shall inform the competent authority without undue delay. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 9a. Member States shall ensure that personnel directly involved in organ processing activities are appropriately qualified, trained, and competent to execute the specific processing steps authorised. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 10. Competent authorities may suspend the authorisation where there is reasonable ground to suspect that the performed processing activities are not in compliance with the authorisation. | 10. Competent authorities may suspend the authorisation referred to in paragraph 1, or, where applicable, propose the suspension of the authorisation of use referred to in Article 6b, where there is reasonable ground to suspect that the performed processing activities are not in compliance with the authorisation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 10. Competent authorities may suspend the authorisation where there is reasonable ground to suspect that the performed processing activities are not in compliance with the authorisation. | 10. Competent authorities may restrict the scope of, suspend or withdraw the authorisation where there is reasonable ground to suspect that the performed processing activities are not in compliance with the authorisation. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 10a. A decision to restrict the scope of, suspend or withdraw an organ processing authorisation shall state the reasons on which it is based and shall be communicated without undue delay to the transplantation centre concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| 11. The Commission shall publish a list of operations that have been authorised as organ processing or have received approval for a clinical outcome monitoring plan, including, where relevant, the use of medicinal products, medical devices or SoHO preparations. | 11. The Commission shall establish and maintain a Union register of operations that have been authorised as organ processing or have received approval for a clinical outcome monitoring plan, including, where relevant, the use of medicinal products, medical devices or SoHO preparations. The register shall contain, for each entry, the unique reference identifier of the authorisation or approved plan, the authorising competent authority, the processing entity, the processing protocol and the clinical indication concerned. Competent authorities shall update the register without delay following the granting, modification, suspension or withdrawal of an authorisation. The register shall be accessible to competent authorities, transplantation centres and processing entities in all Member States, and its non-confidential content shall be made publicly available. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 11. The Commission shall publish a list of operations that have been authorised as organ processing or have received approval for a clinical outcome monitoring plan, including, where relevant, the use of medicinal products, medical devices or SoHO preparations. | 11. The Commission shall establish and maintain a publicly accessible Union database of operations authorised as organ processing or approved under a clinical outcome monitoring plan. The database shall include information on the nature and purpose of the processing, the available evidence on safety, quality and clinical outcomes, the use of medicinal products, medical devices or SoHO preparations, and confirmation that the processing does not alter the legal status of the organ as a donated human organ. |
| Text proposed by the Commission | Amendment |
|---|---|
| 11. The Commission shall publish a list of operations that have been authorised as organ processing or have received approval for a clinical outcome monitoring plan, including, where relevant, the use of medicinal products, medical devices or SoHO preparations. | 11. The Commission shall publish a list of operations that have been authorised as organ processing or have received approval for a clinical outcome monitoring plan, including, where relevant, the medicinal products, medical devices or SoHO preparations used, or the authorisations of use granted under Article 6b. |
| Text proposed by the Commission | Amendment |
|---|---|
| 11. The Commission shall publish a list of operations that have been authorised as organ processing or have received approval for a clinical outcome monitoring plan, including, where relevant, the use of medicinal products, medical devices or SoHO preparations. | 11. The Commission shall publish a list of operations that have been authorised as organ processing or have received approval for a clinical outcome monitoring plan including the type or types of organs concerned and, where relevant, the use of medicinal products, medical devices or SoHO preparations. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 11a. Member States shall ensure that competent authorities, transplantation centres and processing entities record organ processing data and associated clinical outcome data in a format that is interoperable across the Union, and that they have reciprocal access to such data recorded in other Member States for the purposes of the risk-benefit assessment referred to in paragraph 2 and the clinical outcome monitoring plans referred to in paragraph 3. | |
| The Commission shall adopt implementing acts, in accordance with the procedure referred to in Article 30(2), laying down a common minimum data set and common technical and semantic specifications for the recording and exchange of that data, building on existing Union standards for the exchange of electronic health data and avoiding duplication of reporting obligations. | |
| Personal data shall be processed in accordance with Article 16 of this Directive and with Regulation (EU) 2016/679. Data made accessible under this paragraph shall be anonymised or, where anonymisation would defeat the purpose pursued, pseudonymised, and access shall be limited to what is necessary and proportionate to that purpose. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 11a. The Commission shall establish an EU Alert Mechanism for Organ Processing for the rapid exchange between competent authorities and the Commission of information on serious adverse events and reactions and other serious safety concerns associated with organ processing that may be relevant to more than one Member State. Where a competent authority identifies such a serious safety concern, it shall notify the Commission and the competent authorities of Member States in which the processing concerned has been authorised, without undue delay. Competent authorities receiving such information shall assess whether action is necessary in relation to organ processing authorisations under their responsibility. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 11a. The Commission shall, in cooperation with Member States, competent authorities and relevant scientific and professional bodies, periodically review authorised organ processing techniques, including available evidence on their safety, quality and clinical outcomes, in order to ensure that the requirements applicable to organ processing remain adapted to scientific and technological developments. |
| Text proposed by the Commission | Amendment |
|---|---|
| 11b. The Commission shall keep the list up to date, including, where relevant, on the basis of information received through the EU Alert Mechanism for Organ Processing referred to in paragraph 11a. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 12. The Commission shall adopt implementing acts laying down detailed rules for the application and authorisation of organ processing in accordance with the procedure referred to in Article 30(2). | 12. The Commission shall adopt implementing acts laying down detailed rules concerning the procedural requirements for applications for organ processing authorisations, clinical-outcome monitoring plans, reporting of clinical outcome data and exchange of information between competent authorities, in accordance with the procedure referred to in Article 30(2). |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 12. The Commission shall adopt implementing acts laying down detailed rules for the application and authorisation of organ processing in accordance with the procedure referred to in Article 30(2). | 12. The Commission shall adopt implementing acts laying down detailed rules for the application and authorisation of organ processing, including, where relevant, procedural rules complementing the authorisation of use referred to in Article 6b, in accordance with the procedure referred to in Article 30(2). |
| Text proposed by the Commission | Amendment |
|---|---|
| 12a. By [three years after the date of application], and every three years thereafter, the Commission shall submit to the European Parliament and the Council a report on the implementation of the provisions of this Directive concerning organ processing. The report shall assess, in particular: | |
| (a) the number and types of organ processing authorisations granted, restricted in scope, suspended or withdrawn; | |
| (b) the quality and safety of processed organs and relevant clinical outcomes; | |
| (c) the impact of organ processing on organ utilisation and transplantation outcomes; | |
| (d) differences between Member States in access to organ processing; | |
| (e) the impact of the cost and availability of technologies used for organ processing on access to transplantation; | |
| (f) the consistency of the assessment and authorisation of organ processing between Member States; and | |
| (g) the functioning of cooperation and exchange of safety information between competent authorities. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| 12a. The Commission and competent authorities shall ensure appropriate involvement of patient organisations and relevant civil society stakeholders in the development of guidance, recommendations and evaluation frameworks concerning novel organ processing techniques. |
| Text proposed by the Commission | Amendment |
|---|---|
| (3a) The following article 6b is inserted: | |
| 'Article 6b | |
| Processing of organs by means of medicinal products or other technologies: authorisation of use | |
| 1. This Article applies to any process applied to a human organ intended for transplantation, whether autologous or allogeneic, by means of which a medicinal product or other technology is used with the aim of maintaining, improving or restoring its function or the survival of the graft, provided that the organ, following that process, continues to perform its physiological function as an organ. | |
| 2. Where the process results in a product that no longer performs the physiological function proper to an organ, that product shall be excluded from the scope of this Article and shall be assessed exclusively under Regulation (EU) 2024/1938 or Regulation (EC) No 1394/2007 and Directive 2001/83/EC, as applicable. | |
| 3. Medicinal products specifically developed for the processing of organs, whose administration is inseparably linked to the organ for which they are intended, shall be manufactured in accordance with medicinal products legislation and shall be subject to the same quality, safety and efficacy requirements, under the supervision of the competent authorities for medicinal products. However, their use in the processing of an organ shall be subject to an authorisation of use for organ processing, granted by the competent authority for organs referred to in Article 17, and not to a marketing authorisation under Directive 2001/83/EC or Regulation (EC) No 726/2004. | |
| 4. Paragraph 3 shall not apply to medicinal products which, although capable of being used in the processing of an organ, have not been specifically developed for that purpose and have an autonomous therapeutic indication independent of the organ, such as antibiotics, chemotherapeutic agents, anticoagulants or other medicinal products with an intrinsic therapeutic purpose unrelated to the processing of the organ. Such medicinal products shall remain subject to the ordinary marketing authorisation regime. | |
| 5. The authorisation of use referred to in paragraph 3 shall be granted by the competent authority for organs, acting in cooperation with the national competent authority for medicinal products. The latter shall assess the aspects relating to the quality, manufacturing and pharmacological safety of the medicinal product in accordance with criteria equivalent to those laid down in pharmaceutical legislation, without this giving rise, in any case, to a marketing authorisation procedure. | |
| 6. The authorisation of use shall be based on a risk classification of the process, adapted, in so far as possible, from the risk-assessment methodology developed for substances of human origin under Regulation (EU) 2024/1938, the EuroGTP II methodology; taking into account the degree of manipulation of the organ, its reversibility, and its potential effect on graft function and recipient safety. The Commission may adopt technical guidelines, following consultation of the Member States, the SoHO Coordination Board, the European Medicines Agency and the European transplant coordination organisations, in order to foster convergence of the criteria applied by the competent authorities of the different Member States. | |
| 7. The authorisation of use shall be of a legal nature distinct from a marketing authorisation for a medicinal product. It authorises the process applied to the organ and does not confer, and shall not be interpreted as conferring, any authorisation in respect of the organ as a product. The grant of the authorisation of use shall not, in any case, alter the legal classification of the organ as such for the purposes of this Directive. | |
| 8. No economic or commercial consideration deriving from the process applied shall attach to the organ, nor shall it influence its allocation. This is without prejudice to the remuneration of legitimate technical processing services, which shall be transparent, traceable and proportionate to the actual costs of the service provided, including those relating to quality, safety, infrastructure and justified investment in innovation, and shall in no case give rise to a commercial profit unrelated to those costs. | |
| 9. The provision of the processing services referred to in paragraph 1 may be externalised or licensed to a third party, following a case-by-case assessment by the competent authority for organs, provided that the conditions laid down in paragraphs 7 and 8 are met. Companies providing such services may own the technology employed, but never the processed organ. | |
| 10. Clinical evaluation of the processes referred to in this Article shall remain within the competence of, or shall be carried out in close coordination with, the competent authorities for organs. Applicants may rely on the clinical trials framework established by Regulation (EU) No 536/2014 for methodological purposes, without prejudice to the outcome-monitoring obligations and the allocation criteria proper to the transplantation system. | |
| 11. Organs subjected to a process authorised under this Article shall remain fully incorporated into the official system of waiting lists and organ allocation, in accordance with the medical and social criteria established by the competent authorities, and no differentiated pathway of access may be established according to the processing applied. | |
| 12. The selection of donors of organs intended to be subjected to a process within the meaning of this Article shall be carried out in accordance with scientific and ethical criteria approved by the competent authorities for organs, the donation process remaining under the responsibility of the donation coordinators or the procurement organisations designated pursuant to this Directive. | |
| 13. Transplantation of organs subjected to a process authorised under this Article may only be carried out in transplant centres specifically authorised for that purpose by the competent authority. | |
| 14. Member States shall require the establishment of long-term follow-up registries for living donors and recipients of organs subjected to a process within the meaning of this Article, and shall strengthen accordingly the biovigilance and traceability mechanisms provided for in Articles 11 and 15. The competent authorities shall have access to the data necessary for such follow-up, in full compliance with Union data protection law, and shall facilitate the international exchange of information for safety and pharmacovigilance purposes. | |
| 15. Member States shall designate the authorities responsible for granting the authorisations of use referred to in this Article and shall communicate that designation to the Commission, which shall make it public and keep it up to date. | |
| 16. On the basis of the information transmitted by the Member States pursuant to paragraph 15 and to Article 22, the Commission shall submit to the European Parliament and to the Council, no later than four years after the transposition deadline of this Directive, a report on the application of this Article, accompanied, where appropriate, by proposals to strengthen its convergence or effectiveness.' |
| Present text | Amendment |
|---|---|
| (3a) In Article 11, paragraph 1 is replaced by the following: | |
| Member States shall ensure that there is a reporting system in place to report, investigate, register and transmit relevant and necessary information concerning serious adverse events that may influence the quality and safety of organs and that may be attributed to the testing, characterisation, procurement, preservation and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities. | "Member States shall ensure that there is a reporting system in place to report, investigate, register and transmit relevant and necessary information concerning serious adverse events that may influence the quality and safety of organs and that may be attributed to the testing, characterisation, procurement, processing and transport of organs, as well as any serious adverse reaction observed during or after transplantation or autologous use which may be connected to those activities." |
| Present text | Amendment |
|---|---|
| (3a) In Article 11, paragraph 1 is replaced by the following: | |
| 1. Member States shall ensure that there is a reporting system in place to report, investigate, register and transmit relevant and necessary information concerning serious adverse events that may influence the quality and safety of organs and that may be attributed to the testing, characterisation, procurement, preservation and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities. | "1. Member States shall ensure that there is a reporting system in place to report, investigate, register and transmit relevant and necessary information concerning serious adverse events that may influence the quality and safety of organs and that may be attributed to the testing, characterisation, procurement, processing, preservation and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities." |
| Present text | Amendment |
|---|---|
| (3a) In Article 11, paragraph 1 is replaced by the following: | |
| Member States shall ensure that a reporting system is in place to report, investigate, register and transmit relevant and necessary information concerning serious adverse events that may influence the quality and safety of organs and that may be attributed to the testing, characterisation, procurement, preservation and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities. | "Member States shall ensure that a reporting system is in place to report, investigate, register and transmit relevant and necessary information concerning serious adverse events that may influence the quality and safety of organs and that may be attributed to the testing, characterisation, procurement, processing, preservation and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities." |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (3b) In Article 11, the following paragraph 5a is added: | |
| '5a. The traceability and serious adverse reaction and event notification systems established under this article and article 10 shall also apply to organs subjected to a process within the meaning of Article 6a, including the specific monitoring of any adverse effect related to the process itself or to the medicinal product or other technology employed.' |
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.
Ondřej Knotek, Jana Nagyová, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
| Text proposed by the Commission | Amendment |
|---|---|
| (3a) The processing of an organ, including through the use of proprietary medicinal products, medical devices or other technologies, shall not affect the voluntary and unpaid character of the donation or the non-profit nature of the procurement of that organ. The use of such products or technologies shall be without prejudice to the principles governing organ donation laid down in this Article.’ |
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.
| Present text | Amendment |
|---|---|
| (3b) In Article 16, paragraph 1 is replaced by the following: | |
| Member States shall ensure that the fundamental right to protection of personal data is fully and effectively protected in all organ donation and transplantation activities, in conformity with Union provisions on the protection of personal data, such as Directive 95/46/EC, and in particular Article 8(3), Articles 16 and 17 and Article 28(2) thereof. Pursuant to Directive 95/46/EC, Member States shall take all necessary measures to ensure that: | "Member States shall ensure that the fundamental right to protection of personal data is fully and effectively protected in all organ donation and transplantation activities as well as in the context of processing of organs, in conformity with Union provisions on the protection of personal data, such as Directive 95/46/EC, and in particular Article 8(3), Articles 16 and 17 and Article 28(2) thereof. Pursuant to Directive 95/46/EC, Member States shall take all necessary measures to ensure that:" |
| Text proposed by the Commission | Amendment |
|---|---|
| (3c) The following Article 16a is inserted: | |
| ‘Article 16a | |
| Use of personal data for reasons of public interest in the area of organ transplantation | |
| Member States shall ensure that the processing of personal data, including data concerning health and genetic data, collected in the context of organ donation and transplantation activities, as well as the processing of organs, may be carried out for purposes beyond those for which the data were initially collected, where necessary: | |
| (i) to ensure patient safety and high standards of quality and safety of human organs and healthcare; or | |
| (ii) for cross-border data sharing within the Union to support the analysis of transplant outcomes across larger patient cohorts.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (3c) In Article 17 the following paragraphs are inserted : | |
| '2a. The competent authorities designated pursuant to this Article shall also be the authorities responsible for granting the authorisations of use referred to in Article 6b, for which purpose they shall establish the necessary channels of cooperation, including the conclusion of formal cooperation arrangements, with the national competent authorities for medicinal products designated pursuant to Directive 2001/83/EC. | |
| 2b. The competent authority for organs shall grant the authorisation of use referred to in Article 6b only after having obtained the prior and favourable opinion of the national competent authority for medicinal products, established by each Member State pursuant to Directive 2001/83/EC, as regards the quality, manufacturing process and pharmacological safety of the medicinal product concerned. Where that authority issues an unfavourable opinion, the competent authority for organs shall refuse to grant the authorisation of use. The opinion referred to in this paragraph shall not, under any circumstances, be treated as, or substitute for, a marketing authorisation procedure under Directive 2001/83/EC.' |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (3a) The following Article 17a is inserted: | |
| ‘Article 17a Cross-border priority in cases of imminent risk of death | |
| 1. Where the competent authority of a Member State has established and notified, in accordance with the applicable procedures, that a patient is at imminent risk of death and requires the urgent transplantation of a life-saving organ, in particular a heart, lung or liver, that patient shall be granted priority for the allocation of a medically suitable organ throughout the Union. | |
| 2. The priority referred to in paragraph 1 shall be recognised and applied by the competent authorities and relevant organ allocation organisations of all Member States, irrespective of the Member State in which the patient is registered or in which the organ becomes available. | |
| 3. The priority referred to in paragraph 1 shall be applied without prejudice to medical suitability, clinical assessment, and the quality and safety requirements laid down in this Directive. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (3d) In Article 18 the following paragraph 2a is inserted : | |
| '2a. Organs subjected to a process within the meaning of Article 6a shall be incorporated into the organ characterisation and allocation system on an equal footing with other organs, and their availability may not be made subject to criteria other than those established generally by the competent authorities on medical and social grounds.' |
| Text proposed by the Commission | Amendment |
|---|---|
| (3b) In Article 20, the following paragraph 3a is added: | |
| ‘3a. The Commission shall, in cooperation with the Member States, assess the feasibility of extending Union-wide paired kidney exchange programmes referred to in Article 21a to third countries applying regulatory, ethical, quality and safety standards equivalent to those of the Union, including the potential for intercontinental paired kidney exchange programmes.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (3c) The following Article 21a is inserted: | |
| ‘Article 21a European paired kidney exchange for highly sensitised patients | |
| 1. Where a patient requiring a kidney transplantation is identified as highly sensitised, including on the basis of a very high panel-reactive antibody (PRA) level, and is consequently unlikely to obtain a compatible kidney through conventional allocation mechanisms, Member States shall ensure that the patient has access, without undue delay, to a Union-wide paired kidney exchange mechanism. | |
| 2. The mechanism referred to in paragraph 1 shall enable the identification and matching of incompatible donor-recipient pairs across the territories of all Member States, with the objective of maximising the availability of immunologically compatible living-donor kidneys for highly sensitised patients. | |
| 3. Member States shall cooperate and take the necessary measures to ensure the timely exchange of the medical, immunological and other relevant information necessary to perform cross-border matching under this Article, in accordance with Union law on the protection of personal data, including the requirements set out in Article 16, and with the applicable requirements concerning the quality and safety of human organs under this Directive.’ |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (3d) In Article 22, the following paragraph 2a is added: | |
| 2a. Member States shall report to the Commission from [date of transposition of this amending Directive] on the operation of the cross-border priority mechanism referred to in Article 17a and the Union-wide paired kidney exchange mechanism referred to in Article 21a, including data on the number of patients benefiting from those mechanisms, waiting times, cross-border transplant outcomes and, where relevant, the number of highly sensitised patients matched. |
| Text proposed by the Commission | Amendment |
|---|---|
| Processing steps applied to the organ with the aim of improving its functional status and with a potential impact on its quality and safety, including in particular, but not limited to, preservation, application of chemotherapy and surgery. | Processing steps applied to the organ with the aim to maintain or improve the functioning of an organ or modify its properties such as immunocompatibility prior to transplantation, or autologous use, and with a potential impact on its quality and safety, including in particular, but not limited to, preservation, application of medicinal products, medical devices or SoHO preparations and surgery.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| Processing steps applied to the organ with the aim of improving its functional status and with a potential impact on its quality and safety, including in particular, but not limited to, preservation, application of chemotherapy and surgery. | Processing steps applied to the organ with the aim of maintaining, improving or modifying the functioning or properties of an organ prior to transplantation and with a potential impact on its quality and safety, including in particular, but not limited to, preservation, application of medicinal products, medical devices or SoHO preparations and surgery. |
| Text proposed by the Commission | Amendment |
|---|---|
| Processing steps applied to the organ with the aim of improving its functional status and with a potential impact on its quality and safety, including in particular, but not limited to, preservation, application of chemotherapy and surgery. | Processing steps applied to the organ with the aim of maintaining, improving or modifying the functioning or properties of an organ prior to transplantation and with a potential impact on its quality and safety, including in particular, but not limited to, preservation, application of medicinal products, medical devices or SoHO preparations and surgery. |
Ondřej Knotek, Jana Nagyová, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
| Text proposed by the Commission | Amendment |
|---|---|
| Processing steps applied to the organ with the aim of improving its functional status and with a potential impact on its quality and safety, including in particular, but not limited to, preservation, application of chemotherapy and surgery. | Processing steps applied to the organ with the aim of maintaining or improving its functional status, biological characteristics or suitability for transplantation and with a potential impact on its quality and safety, including in particular, but not limited to, preservation, application of chemotherapy and surgery. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| Processing steps applied to the organ with the aim of improving its functional status and with a potential impact on its quality and safety, including in particular, but not limited to, preservation, application of chemotherapy and surgery. | Processing steps applied to a donated human organ for the purpose of preservation, assessment or restoration of viability prior to transplantation and having a potential impact on its quality and safety. |
Ondřej Knotek, Jana Nagyová, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
| Text proposed by the Commission | Amendment |
|---|---|
| (4a) Where the processing of an organ involves a medicinal product or technology subject to Union legislation on medicinal products, the application of that legislation shall not, in itself, exclude the application of this Directive to the organ or alter its status for the purposes of this Directive. The competent authorities referred to in this Directive and the competent authorities under Union legislation on medicinal products shall cooperate, within their respective competences, with a view to ensuring legal certainty, avoiding duplication of assessments and requirements, and preventing unnecessary administrative burdens. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (1a) in Article 20(3), the following points (c), (d) and (e) are added: | |
| (c) the lawfulness of obtaining and exporting it; | |
| (d) compliance with the rules applicable to consent and confirmation of death; | |
| (e) the absence of financial gain or comparable benefit from the human organ as such; |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 3a | |
| (3a) In PART D, after Article 31, the following Article 31a is inserted: | |
| ‘Article 31a | |
| Evaluation | |
| 1. No later than five years after the expiry of the transposition period referred to in Article 3(1), the Commission shall carry out an evaluation of the implementation and impact of the amendments introduced by Article 1 of this Directive and shall submit a report to the European Parliament and to the Council. | |
| 2. The evaluation shall assess, in particular: | |
| (a) the number and type of applications submitted and consents granted, including the number of GMMs considered to have a low-risk profile; | |
| (b) the duration and administrative cost of the authorisation and renewal procedures; | |
| (c) the extent to which the Directive has contributed to research commercialisation, investment, company formation, scale-up and production of GMM-based products in the Union; | |
| (d) the number and type of consents granted without a post-market environmental monitoring plan; | |
| (e) the use of adapted modalities pursuant to Article 24d where a method for detection, identification and quantification could not be provided; | |
| (f) monitoring results, reported incidents, unexpected effects and measures adopted pursuant to Articles 20 and 23; | |
| (g) available evidence concerning the persistence and dissemination of authorised GMMs, changes in their host range and the transfer of genetic material; | |
| (h) the effectiveness of detection, identification, traceability and enforcement measures; | |
| (i) the implementation of the specific provisions applicable to genetically modified viruses; and | |
| (j) the use and effects of the delegated and implementing powers introduced by this Directive. | |
| 3. The report shall identify any remaining gaps in evidence and data and shall be accompanied, where appropriate, by a legislative proposal. | |
| 4. Member States and, as regards matters falling within its remit, the Authority shall provide the Commission with relevant information already available to them for the purposes of the evaluation. This paragraph shall not require the collection of additional data solely for the purposes of the evaluation.' |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. | Article 1a, 2, 3, 4 and 5 of this Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 1 of this Directive shall enter into force only after the European Commission has published a full and independent impact assessment covering their health, environmental, agricultural, economic and social consequences. The assessment shall examine, in particular, effects on microbiomes, non-food applications, detection and control capacities, coexistence with organic and GMO-free supply chains, and the costs liable to be borne by the various stakeholders. It shall be subject to public consultation. |
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- Licensed CC BY 4.0.
- Retrieved
- 25 September 2026
Cite as
European Parliament (2026). “AMENDMENTS 240 - 465 - Draft report 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”. Text, 10 September 2026. docId CJ64-AM-792139. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/CJ64-AM-792139 (retrieved 25 September 2026). Data: EP Open Data API: document record, https://data.europarl.europa.eu/api/v2/documents/CJ64-AM-792139 (CC BY 4.0).
BibTeX
@misc{epw-text-cj64-am-792139,
author = {{European Parliament}},
title = {{AMENDMENTS 240 - 465 - Draft report 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}},
year = {2026},
date = {2026-09-10},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/CJ64-AM-792139}},
url = {https://news.eu-parl.st-solutions.dev/texts/CJ64-AM-792139},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. docId CJ64-AM-792139. Data: EP Open Data API: document record (CC BY 4.0)}
}