report parliamentary committee draft, 13 July 2026
On the proposal for a Directive of the European Parliament and of the Council amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs
Document CJ64-PR-789094 · (COM(2025)1031 – C10-0358/2025 – 2025/0405(COD))
Committee on the Environment, Climate and Food Safety Committee on Public Health · Rapporteur: Marta Temido, Adam Jarubas
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Text 2 paragraphs
| Symbols for procedures |
| * Consultation procedure *** Consent procedure ***I Ordinary legislative procedure (first reading) ***II Ordinary legislative procedure (second reading) ***III Ordinary legislative procedure (third reading) (The type of procedure depends on the legal basis proposed by the draft act.) |
| Amendments to a draft act |
| Amendments by Parliament set out in two columns Deletions are indicated in bold italics in the left-hand column. Replacements are indicated in bold italics in both columns. New text is indicated in bold italics in the right-hand column. The first and second lines of the header of each amendment identify the relevant part of the draft act under consideration. If an amendment pertains to an existing act that the draft act is seeking to amend, the amendment heading includes a third line identifying the existing act and a fourth line identifying the provision in that act that Parliament wishes to amend. Amendments by Parliament in the form of a consolidated text New text is highlighted in bold italics. Deletions are indicated using either the ▌symbol or strikeout. Replacements are indicated by highlighting the new text in bold italics and by deleting or striking out the text that has been replaced. By way of exception, purely technical changes made by the drafting departments in preparing the final text are not highlighted. |
Draft european parliament legislative resolution 426 paragraphs
on the proposal for a Directive of the European Parliament and of the Council amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs
(COM(2025)1031 – C10-0358/2025 – 2025/0405(COD))
(Ordinary legislative procedure: first reading)
The European Parliament,
–having regard to the Commission proposal to Parliament and the Council (COM(2025)1031),
–having regard to Article 294(2) and Articles 168(4) and 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C10-0358/2025),
–having regard to Article 294(3) of the Treaty on the Functioning of the European Union,
–having regard to the opinion of the European Economic and Social Committee of [...]1,
–having regard to the opinion of the Committee of the Regions of [...]2,
–having regard to Rule 60 of its Rules of Procedure,
–having regard to the joint deliberations of the Committee on the Environment, Climate and Food Safety and the Committee on Public Health under Rule 59 of the Rules of Procedure,
–having regard to the report of the Committee on the Environment, Climate and Food Safety and the Committee on Public Health (A10-0000/2026),
1.Adopts its position at first reading hereinafter set out;
2.Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;
3.Instructs its President to forward its position to the Council, the Commission and the national parliaments.
Amendment 1
Proposal for a directive
Recital -1 (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-1) According to Article 168(1), first subparagraph, of the Treaty on the Functioning of the European Union (TFEU) and Article 35 of the Charter of Fundamental Rights of the European Union (the ‘Charter’), a high level of human health protection is to be ensured in the definition and implementation of all Union policies and activities. The field of organ transplantation is experiencing continuous innovation aiming to maintain and improve the functional status of organs. Organ processing operations are essential operations for this and not yet regulated by Directive 2010/53/EU. |
Or. en
Amendment 2
Proposal for a directive
Recital 1
| Text proposed by the Commission | Amendment |
|---|---|
| (1) Regulation (EU) …/… [European Biotech Act] establishes a framework to strengthen the competitiveness of the health biotechnology sector in the Union, from research and development to the timely placing on the Union market and production of biotechnology innovations and products, while safeguarding high standards of protection of human health, patient safety and animal health, the environment, ethics, quality of products, food and feed safety and biosecurity. For the purposes of that Regulation, health biotechnology means the application of biotechnology for the promotion, protection, or restoration of human health and biotechnological applications relevant to animal health, plant health, veterinary public health, and food safety, insofar as these areas contribute directly or indirectly to the protection of human health and align with the Union’s public-health objectives, as set out under Article 168 of the Treaty on the Functioning of the European Union. | (1) Regulation (EU) …/… [European Biotech Act] establishes a framework to strengthen the competitiveness of the health biotechnology sector in the Union, from research and development to the timely placing on the Union market and production of biotechnology and medical innovations and products, while safeguarding high standards of protection of human health, patient safety and animal health, the environment, ethics, quality of products, food and feed safety and biosecurity. For the purposes of that Regulation, health biotechnology means the application of biotechnology for the promotion, protection, or restoration of human health and biotechnological applications relevant to animal health, plant health, veterinary public health, and food safety, insofar as these areas contribute directly or indirectly to the protection of human health and align with the Union’s public-health objectives, as set out under Article 168 of the Treaty on the Functioning of the European Union. |
Or. en
Amendment 3
Proposal for a directive
Recital 2
| Text proposed by the Commission | Amendment |
|---|---|
| (2) Given that the objectives of Directive 2001/18/EC of the European Parliament and of the Council3 and Directive 2010/53/EU of the European Parliament and of the Council4 are closely linked to those of Regulation (EU) …/… [European Biotech Act], and considering that, since the adoption of those Directives, significant progress in biotechnology has taken place, it is appropriate to adapt them in order to align with new technological realities and with the objectives and provisions laid down in Regulation (EU) …/… [European Biotech Act]. Those adaptations are intended to improve consistency, legal clarity and the smooth functioning of the Union legislative framework for biotechnology, and eventually to ensure the availability of safe and high-quality therapies and other products for Union citizens. | (2) Given that the objectives of Directive 2001/18/EC of the European Parliament and of the Council and Directive 2010/53/EU of the European Parliament and of the Council are closely linked to those of Regulation (EU) …/… [European Biotech Act], and considering that, since the adoption of those Directives, significant progress in biotechnology, including health applications, have taken place, it is appropriate to adapt them in order to align with new medical and technological realities and with the objectives and provisions laid down in Regulation (EU) …/… [European Biotech Act]. Those adaptations are intended to improve consistency, legal clarity and the smooth functioning of the Union legislative framework for public health and biotechnology, and eventually to ensure and improve the availability of safe, affordable and high-quality therapies and other products. |
| 3 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms, and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1, ELI: http://data.europa.eu/eli/dir/2001/18/oj ) | |
| 4 Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010, p. 14, ELI: http://data.europa.eu/eli/dir/2010/53/oj)). |
Or. en
Amendment 4
Proposal for a directive
Recital 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) As information about organs reveals information about the health status of the donor, and thus qualifies as ‘data concerning health’ under Article 4(15) General data protection Regulation (EU)2016/679, it is necessary to ensure robust data protection safeguards. Information about organs may also constitute genetic data under Article 4(13) GDPR, notably if it contains an analysis of the deoxyribonucleic acid (DNA) of the donor or otherwise provides information about the inherited or acquired genetic characteristics of a natural person which give unique information about their physiology or health. Both data concerning health and genetic data are considered special categories of data under Article 9(1) GDPR and thus subject to heightened protection. |
Or. en
Justification
Based on European Data Protection Supervisor's opinion point 14
Amendment 5
Proposal for a directive
Recital 2 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (2b) As organ processing requires the processing of personal data, including health data, it should be designed by respecting the principles of data protection; that would imply that processing of personal data should be limited to achieving the objectives and the fulfilment of obligations of this Directive. |
Or. en
Amendment 6
Proposal for a directive
Recital 2 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (2c) Article 17 of Directive 2010/53/EU guarantees that the fundamental right to protection of personal data is fully and effectively applied in all organ transplantation activities including organ processing, in conformity with Union provisions on the protection of personal data such as Regulation (EU)2016/679. |
Or. en
Amendment 7
Proposal for a directive
Recital 4
| Text proposed by the Commission | Amendment |
|---|---|
| (4) Following a Commission mandate, on 19 June 2024, the European Food Safety Authority (‘the Authority’) adopted an opinion on the application of new developments in biotechnology to micro-organisms5 . It concluded that possible hazards relate to the changes introduced, regardless of the method used, and that the risk assessment should be based on the characteristics of the product containing or consisting of micro-organisms. It also concluded that for certain GMMs, fewer requirements for risk assessment would be needed compared to those applicable to GMOs in general. Finally, the Authority considered that, for certain GMMs, the need for post-market environmental monitoring (PMEM) may be waived based on the environmental risk assessment. | (4) Following a Commission mandate, on 19 June 2024, the European Food Safety Authority (‘the Authority’) adopted an opinion on the application of new developments in biotechnology to micro-organisms5 . It concluded that possible hazards relate to the changes introduced, regardless of the method used, and that the risk assessment should be based on the characteristics of the product containing or consisting of micro-organisms. It concluded that possible hazards relate to the changes introduced, regardless of the method used, and that the risk assessment should be based on the characteristics of the product containing or consisting of micro-organisms. It also concluded that in the case of certain low-risk profile GMMs, fewer requirements for risk assessment may be appropriate compared to those applicable to GMOs in general, on the basis of the lower risk profile. Finally, the Authority considered that, for certain GMMs, the need for post-market environmental monitoring (PMEM) may be waived based on the environmental risk assessment. |
| 5 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins, E., Bresson, J.-L., Dewhurst, I. C., Epstein, M. M., Firbank, L. G., Guerche, P., Hejatko, J., Moreno, F. J., Naegeli, H., Nogué, F., Rostoks, N., Sánchez Serrano, J. J., Savoini, G., Veromann, E., Veronesi, F., Cocconcelli, P. S., Glandorf, D., Herman, L., Dalmay, T. (2024). New developments in biotechnology applied to microorganisms. EFSA Journal, 22(7), e8895; point 4: https://doi.org/10.2903/j.efsa.192024.8895 | 5 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins, E., Bresson, J.-L., Dewhurst, I. C., Epstein, M. M., Firbank, L. G., Guerche, P., Hejatko, J., Moreno, F. J., Naegeli, H., Nogué, F., Rostoks, N., Sánchez Serrano, J. J., Savoini, G., Veromann, E., Veronesi, F., Cocconcelli, P. S., Glandorf, D., Herman, L., Dalmay, T. (2024). New developments in biotechnology applied to microorganisms. EFSA Journal, 22(7), e8895; point 4: https://doi.org/10.2903/j.efsa.192024.8895 |
Or. en
Amendment 8
Proposal for a directive
Recital 5
| Text proposed by the Commission | Amendment |
|---|---|
| (5) Considering that Directive 2001/18/EC was primarily designed to regulate genetically modified plants obtained by certain established genomic techniques, in particular techniques that introduce into an organism genetic material from non-crossable species (transgenesis) and taking into account the Authority’s conclusions on GMMs, as well as the biological properties, capabilities and potential applications of GMMs, which differ significantly from those of plants, Directive 2001/18/EC should be adapted to the specificities of GMMs to enable innovative products to reach the market before they become obsolete and without disproportionate authorisation costs, while maintaining a high level of safety. | (5) Considering that Directive 2001/18/EC was primarily designed to regulate genetically modified plants obtained by certain established genomic techniques, in particular techniques that introduce into an organism genetic material from non-crossable species (transgenesis) and taking into account the Authority’s conclusions on GMMs, as well as the biological properties, capabilities and potential applications of GMMs, which differ significantly from those of plants, Directive 2001/18/EC should be adapted to the specificities of GMMs to enable innovative products to reach the market before they become obsolete and without disproportionate authorisation costs, while maintaining a high level of safety for the environment, human and animal health. |
Or. en
Amendment 9
Proposal for a directive
Recital 8
| Text proposed by the Commission | Amendment |
|---|---|
| (8) To reflect the specific properties of GMMs, the information requirements as set down in Annex III to Directive 2001/18/EC to be used in the risk assessment should be adapted based on the available information and evidence in relation to GMMs, while respecting the principles for the environmental risk assessment of GMOs laid down in Annex II to that Directive. In order to carry out those adaptations, the power to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending the information requirements laid down in Annex III to the Directive. | (8) To reflect the specific properties of GMMs, the information requirements as set down in Annex III to Directive 2001/18/EC to be used in the environmental risk assessment (ERA) should be adapted based on the available information and evidence in relation to GMMs, while respecting the precautionary principle and the principles for the environmental risk assessment of GMOs laid down in Annex II to that Directive. In order to carry out those adaptations, the power to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending the information requirements laid down in Annex III to the Directive. |
Or. en
Amendment 10
Proposal for a directive
Recital 9
| Text proposed by the Commission | Amendment |
|---|---|
| (9) Considering that the product cycles of GMMs are very short and new generation GMMs are developed in short timeframes, with new products building on the experience gained with previous ones, including as regards the risk assessment, the limitation of the period of validity of the consent laid down in Directive 2001/18/EC implies a burden for operators and national competent authorities while bringing limited value to the safety of such products given the short life-time of those products. Directive 2001/18/EC already lays down measures to ensure that any new relevant information is provided by the notifier, as well as safeguard measures in case new risks are identified. Therefore, Directive 2001/18/EC should provide that consents granted for the placing on the market of GMMs should be valid for an unlimited period of time. Any measures necessary to protect human health and the environment should continue to be adopted anytime where such consents granted do no longer meet the safety conditions set out in that Directive, taking into account new information that has become available as well as scientific and technical progress. | (9) The product cycles of GMMs are very short and new generation GMMs are developed in short timeframes, with new products building on the experience gained with previous ones, including as regards the risk assessment. Directive 2001/18/EC already lays down measures to ensure that any new relevant information is provided by the notifier, as well as safeguard measures in case new risks are identified. Therefore, Directive 2001/18/EC should provide that consents granted for the placing on the market of low-risk profile GMMs, following the first initial 10-year period, should be valid for an unlimited period of time. Any measures necessary to protect human health, animal health and the environment should continue to be adopted anytime where such consents granted do no longer meet the safety conditions set out in that Directive, taking into account new information that has become available as well as scientific and technical progress. |
Or. en
Amendment 11
Proposal for a directive
Recital 10
| Text proposed by the Commission | Amendment |
|---|---|
| (10) On 2 October 2025, the European Network of GMO Laboratories (ENGL) Working Group on New Mutagenesis Techniques published a report on the analytical possibilities and challenges related to the detection of micro-organisms modified using new genomic techniques, concluding that analytical testing is not feasible for certain GMMs obtained through those techniques, especially in the context of routine laboratory control8 . Therefore, in cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier, the modalities to comply with analytical method performance requirements should be adapted by means of implementing acts. | (10) On 2 October 2025, the European Network of GMO Laboratories (ENGL) Working Group on New Mutagenesis Techniques published a report on the analytical possibilities and challenges related to the detection of micro-organisms modified using new genomic techniques, concluding that analytical testing is not feasible for certain GMMs obtained through those techniques, especially in the context of routine laboratory control8 . Therefore, in cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier, the modalities to comply with analytical method performance requirements should be adapted by means of implementing acts. Provision should also be made for the EURL, assisted by the ENGL, to adopt guidance for applicants and competent authorities on minimum performance requirements for analytical methods. |
| 8 Sowa, S., Broothaerts, W., Burns, M., De Loose, M., Debode, F. et al., Detection of microorganisms, obtained by new genomic techniques, in food and feed products, Publications Office of the European Union, Luxembourg, 2025, https://data.europa.eu/doi/10.2760/1846532, JRC143597. | 8 Sowa, S., Broothaerts, W., Burns, M., De Loose, M., Debode, F. et al., Detection of microorganisms, obtained by new genomic techniques, in food and feed products, Publications Office of the European Union, Luxembourg, 2025, https://data.europa.eu/doi/10.2760/1846532, JRC143597. |
Or. en
Amendment 12
Proposal for a directive
Recital 11
| Text proposed by the Commission | Amendment |
|---|---|
| (11) Furthermore, for certain GMMs, the Authority concluded that fewer data requirements for risk assessment would be needed9 and provided some criteria to identify those GMMs10 . Thus, Directive 2001/18/EC should establish specific requirements for GMMs with an inherently low risk profile to ensure that the risk assessment and procedures are proportionate to the risks the GMMs raise. Such adaptation should lead to a reduction of time to market for low-risk GMMs, enabling innovation without lowering the safety standards. | (11) Furthermore, for certain low-risk profile GMMs, the Authority concluded that fewer data requirements for risk assessment would be needed9 and provided some criteria to identify those low-risk profile GMMs10. Thus, Directive 2001/18/EC should establish specific requirements for GMMs with an inherently low risk profile to ensure that the risk assessment and procedures are proportionate to the risks the GMMs raise. Such adaptation should lead to a reduction of time to market for low-risk profile GMMs, enabling innovation without lowering the safety standards for human health, animal health and the environment. |
| 9 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins, E., Bresson, J.-L., Dewhurst, I. C., Epstein, M. M., Firbank, L. G., Guerche, P., Hejatko, J., Moreno, F. J., Naegeli, H., Nogué, F., Rostoks, N., Sánchez Serrano, J. J., Savoini, G., Veromann, E., Veronesi, F., Cocconcelli, P. S., Glandorf, D., Herman, L., Dalmay, T. (2024). New developments in biotechnology applied to microorganisms. EFSA Journal, 22(7), e8895; point 3.3.2.9.: https://doi.org/10.2903/j.efsa.2024.8895 | 9 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins, E., Bresson, J.-L., Dewhurst, I. C., Epstein, M. M., Firbank, L. G., Guerche, P., Hejatko, J., Moreno, F. J., Naegeli, H., Nogué, F., Rostoks, N., Sánchez Serrano, J. J., Savoini, G., Veromann, E., Veronesi, F., Cocconcelli, P. S., Glandorf, D., Herman, L., Dalmay, T. (2024). New developments in biotechnology applied to microorganisms. EFSA Journal, 22(7), e8895; point 3.3.2.9.: https://doi.org/10.2903/j.efsa.2024.8895 |
| 10 EFSA Scientific Committee, Bennekou, S. H., Allende, A., Bearth, A., Casacuberta, J., Castle, L., Coja, T., Crépet, A., Halldorsson, T. I., Hoogenboom, R., Jokelainen, P., Knutsen, H. K., Lambré, C., Nielsen, S. S., Turck, D., Civera, A. V., Villa, R. E., Zorn, H., Gómez, M. A., … Glandorf, B. (2025). Guidance on the characterisation of microorganisms in support of the risk assessment of products used in the food chain. EFSA Journal, 23(11), e9705. https://doi.org/10.2903/j.efsa.2025.9705 | 10 EFSA Scientific Committee, Bennekou, S. H., Allende, A., Bearth, A., Casacuberta, J., Castle, L., Coja, T., Crépet, A., Halldorsson, T. I., Hoogenboom, R., Jokelainen, P., Knutsen, H. K., Lambré, C., Nielsen, S. S., Turck, D., Civera, A. V., Villa, R. E., Zorn, H., Gómez, M. A., … Glandorf, B. (2025). Guidance on the characterisation of microorganisms in support of the risk assessment of products used in the food chain. EFSA Journal, 23(11), e9705. https://doi.org/10.2903/j.efsa.2025.9705 |
Or. en
Amendment 13
Proposal for a directive
Recital 12
| Text proposed by the Commission | Amendment |
|---|---|
| (12) Specifically, it is necessary to lay down the criteria defining low-risk GMMs on the basis of general safety standards as expressed in the Authority’s concept of Qualified Presumption of Safety (hereinafter referred to as “QPS”)11 and an absence of genes of concern not naturally present in the parental organism as described in the glossary of the Authority’s guidance on the characterisation of micro-organisms12 , including acquired antimicrobial resistance genes, virulence factors and genes known to contribute to the production of toxins or harmful metabolites. | (12) Specifically, it is necessary to lay down criteria for identifying potentially low-risk profile GMMs on the basis of general safety standards, including the Authority’s concept of Qualified Presumption of Safety (QPS) 11 , an absence of genes of concern not naturally present in the parental organism, or introduced by or resulting as described in the glossary of the Authority’s guidance on the characterisation of micro-organisms 12 , an absence of acquired antimicrobial resistance genes, virulence factors and genes known to contribute to the production of toxins or harmful metabolites, furthermore ensuring that such criteria do not replace a case-by-case assessment at strain level. Such GMMs should also be taxonomically and molecularly well characterised, considering their taxonomic identity, genome sequence and basic biological properties. The attribution of QPS status should constitute a preliminary scientific indication of reduced risk and should not create an automatic presumption of market safety or exempt operators from demonstrating the absence of unacceptable risks to human health, animal health, workers, antimicrobial effectiveness, or the environment. Particular attention should be paid to antimicrobial resistance determinants, horizontal gene transfer, persistence in the environment, toxigenicity, immunogenicity, and unintended effects resulting from genetic modification. |
| 11 https://doi.org/10.5281/zenodo.1146566 | 11 https://doi.org/10.5281/zenodo.1146566 |
| 12 EFSA Scientific Committee, Bennekou, S. H., Allende, A., Bearth, A., Casacuberta, J., Castle, L., Coja, T., Crépet, A., Halldorsson, T. I., Hoogenboom, R., Jokelainen, P., Knutsen, H. K., Lambré, C., Nielsen, S. S., Turck, D., Civera, A. V., Villa, R. E., Zorn, H., Gómez, M. A., … Glandorf, B. (2025). Guidance on the characterisation of microorganisms in support of the risk assessment of products used in the food chain. EFSA Journal, 23(11), e9705; page 22: https://doi.org/10.2903/j.efsa.2025.9705. | 12 EFSA Scientific Committee, Bennekou, S. H., Allende, A., Bearth, A., Casacuberta, J., Castle, L., Coja, T., Crépet, A., Halldorsson, T. I., Hoogenboom, R., Jokelainen, P., Knutsen, H. K., Lambré, C., Nielsen, S. S., Turck, D., Civera, A. V., Villa, R. E., Zorn, H., Gómez, M. A., … Glandorf, B. (2025). Guidance on the characterisation of microorganisms in support of the risk assessment of products used in the food chain. EFSA Journal, 23(11), e9705; page 22: https://doi.org/10.2903/j.efsa.2025.9705. |
Or. en
Amendment 14
Proposal for a directive
Recital 13
| Text proposed by the Commission | Amendment |
|---|---|
| (13) While the basic criteria to be fulfilled for a GMM to be considered a low-risk GMM should be established in Directive 2001/18/EC, the Commission should be empowered, in accordance with Article 290 of the Treaty on the Functioning of the European Union, to supplement Directive 2001/18/EC by further specifying these criteria and adding further criteria if necessary. Moreover, the Commission should be empowered, in accordance with Article 290 of the Treaty on the Functioning of the European Union, to amend Directive 2001/18/EC by adapting the risk assessment requirements and the authorisation procedure to provide for the demonstration of low-risk status, to streamline certain procedural elements and to expedite the timelines to reflect the adapted risk assessment requirements. | (13) While the basic criteria to be fulfilled for a GMM to be considered a low-risk profile GMM should be established in Directive 2001/18/EC, the Commission should be empowered, in accordance with Article 290 of the Treaty on the Functioning of the European Union, to supplement Directive 2001/18/EC by further specifying these criteria and adding further criteria if necessary. Moreover, the Commission should be empowered, in accordance with Article 290 of the Treaty on the Functioning of the European Union, to amend Directive 2001/18/EC by adapting the risk assessment requirements and the authorisation procedure to provide for the demonstration of low-risk profile status where scientifically justified, to streamline certain procedural elements and to expedite the timelines to reflect the adapted risk assessment requirements. |
Or. en
Amendment 15
Proposal for a directive
Recital 14
| Text proposed by the Commission | Amendment |
|---|---|
| (14) In line with the recommendations of the Authority13 , and in order to not impose disproportionate administrative burden, low-risk GMMs should not be subject to the obligation to establish a post-market environmental monitoring plan if the GMM does not give rise to concerns that warrant monitoring, such as indirect, delayed or unanticipated effects on human health or on the environment. | (14) In line with the recommendations of the Authority13 , and in order to not impose disproportionate administrative burden, low-risk profile GMMs should not be subject to the obligation to establish a post-market environmental monitoring plan if the GMM does not give rise to concerns that warrant monitoring, such as indirect, delayed or unanticipated effects on human health or on the environment. |
| 13 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins, E., Bresson, J.-L., Dewhurst, I. C., Epstein, M. M., Firbank, L. G., Guerche, P., Hejatko, J., Moreno, F. J., Naegeli, H., Nogué, F., Rostoks, N., Sánchez Serrano, J. J., Savoini, G., Veromann, E., Veronesi, F., Cocconcelli, P. S., Glandorf, D., Herman, L., Dalmay, T. (2024). New developments in biotechnology applied to microorganisms. EFSA Journal, 22(7), e8895; point 3.3.2.9.: https://doi.org/10.2903/j.efsa.2024.8895 | 13 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins, E., Bresson, J.-L., Dewhurst, I. C., Epstein, M. M., Firbank, L. G., Guerche, P., Hejatko, J., Moreno, F. J., Naegeli, H., Nogué, F., Rostoks, N., Sánchez Serrano, J. J., Savoini, G., Veromann, E., Veronesi, F., Cocconcelli, P. S., Glandorf, D., Herman, L., Dalmay, T. (2024). New developments in biotechnology applied to microorganisms. EFSA Journal, 22(7), e8895; point 3.3.2.9.: https://doi.org/10.2903/j.efsa.2024.8895 |
Or. en
Amendment 16
Proposal for a directive
Recital 15 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (15a) Organ processing bears the potential to increase availability of organs and therefore improve patients access to transplantations, which may save lives or improve quality of life through improved preservation of organs, longer time frame for transplantation, wider number of organs suitable for transplantation as well as by improving organ quality which lowers the risk of rejection, complications or future organ failure. The Union legislative framework on organ transplantation should address procedures and oversight for organ processing to support safe and ethical application of organ processing through improved legal certainty, predictability and transparency. |
Or. en
Amendment 17
Proposal for a directive
Recital 15 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (15b) The protective provisions of Directive 2010/53/EC will continue to apply in full to organ processing which should help to ensure citizens' trust in both organ transplantation and the new technique of organ processing. An organ that undergoes processing, including through the use of medicinal products, medical devices or SoHO preparations, should be subject to the rules on quality and safety for organs set out in this Directive and to the applicable national and EU law concerning organ procurement, allocation and transplantation. |
Or. en
Amendment 18
Proposal for a directive
Recital 16
| Text proposed by the Commission | Amendment |
|---|---|
| (16) The uptake of those preservation and processing technologies not only allows for more efficient organisational set-up, but also for improving human organs during the extended ex-vivo time window, increasing treatment options for patients on waiting lists. Such activities need to be subject to oversight by the competent authorities in order to ensure their quality, optimise the effectiveness of transplants and protect recipients’ health. | (16) The uptake of those preservation and processing technologies not only allows for more efficient organisational set-up, but also for improving human organs during the extended ex-vivo time window, increasing and improving treatment options for patients. Such activities need to be subject to oversight by the competent authorities in order to ensure their quality, optimise the effectiveness of transplants and protect recipients’ health without affecting the transplantation centres with administrative burdens or risking delays due to additional administrative obligations. |
Or. en
Amendment 19
Proposal for a directive
Recital 17 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (17a) In cases where the authorisation of organ processing involves the transfer of data on organs to third countries, the provisions in Chapter V of Regulation 2016/679 apply. |
Or. en
Justification
This amendment is based on input by the EDPS opinion point 18.
Amendment 20
Proposal for a directive
Recital 18
| Text proposed by the Commission | Amendment |
|---|---|
| (18) To ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. Those powers should cover, in particular, the adapted modalities to comply with analytical method requirements and the supporting information to be submitted to demonstrate the fulfilment of the criteria for being considered a low-risk GMM concerning Directive 2001/18/EC, as well as the establishment of detailed rules for the authorisation of organ processing, concerning Directive 2010/53/EU. Those implementing acts should be adopted in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council18 . | (18) To ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. Those powers should cover, in particular, the adapted modalities to comply with analytical method requirements and the supporting information to be submitted to demonstrate the fulfilment of the criteria for being considered a low-risk GMM concerning Directive 2001/18/EC, as well as the establishment of detailed rules for the authorisation of organ processing, concerning Directive 2010/53/EU. Those implementing acts should be adopted in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council18 . Where such implementing acts provide for the processing of personal data, the EDPS should be consulted pursuant to Article 42(1) EUDPR. |
| 18 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13, ELI: http://data.europa.eu/eli/reg/2011/182/oj). | 18 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13, ELI: http://data.europa.eu/eli/reg/2011/182/oj). |
Or. en
Justification
This amendments builds on the EDPS opinion point 18
Amendment 21
Proposal for a directive
Recital 18
| Text proposed by the Commission | Amendment |
|---|---|
| (18) To ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. Those powers should cover, in particular, the adapted modalities to comply with analytical method requirements and the supporting information to be submitted to demonstrate the fulfilment of the criteria for being considered a low-risk GMM concerning Directive 2001/18/EC, as well as the establishment of detailed rules for the authorisation of organ processing, concerning Directive 2010/53/EU. Those implementing acts should be adopted in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council18 . | (18) To ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. Those powers should cover, in particular, the adapted modalities to comply with analytical method requirements and the supporting information to be submitted to demonstrate the fulfilment of the criteria for being considered a low-risk profile GMM concerning Directive 2001/18/EC and related to the post-market monitoring plan, as well as the establishment of detailed rules for the authorisation of organ processing, concerning Directive 2010/53/EU. Those implementing acts should be adopted in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council 18 . |
| 18 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13, ELI: http://data.europa.eu/eli/reg/2011/182/oj). | 18 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13, ELI: http://data.europa.eu/eli/reg/2011/182/oj). |
Or. en
Amendment 22
Proposal for a directive
Recital 19 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (19a) The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 1a and delivered an opinion on 27 May 2026, | |
| 1a Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39, ELI: http://data.europa.eu/eli/reg/2018/1725/oj). |
Or. en
Amendment 23
Proposal for a directive
Article 1 – paragraph 1 – point 1
Directive 2001/18/EC
Article 2 – point 11
| Text proposed by the Commission | Amendment |
|---|---|
| (11) ‘Status of Qualified Presumption of Safety’ means the safety status assigned by the Authority to selected groups of micro-organisms on the basis of an assessment showing no safety concerns;’ | (11) ‘Status of Qualified Presumption of Safety’ means the safety status assigned by the Authority to selected groups of micro-organisms on a case-by-case assessment of the taxonomic identity of the microorganism, the related body of knowledge and potential safety concerns. |
Or. en
Amendment 24
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24a – paragraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Articles 24e and 24f shall apply only to the placing on the market of GMMs with a low-risk profile as or in products. | deleted |
Or. en
Amendment 25
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24b – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission is empowered to adopt delegated acts in accordance with Article 29a to amend Annex III in order to provide for specific information requirements in notifications concerning the placing on the market of GMMs, so as to adapt them to scientific and technical progress. | The Commission is empowered to adopt delegated acts in accordance with Article 29a to amend Annex III in order to provide for specific information requirements in notifications concerning the placing on the market of GMMs, where justified by scientific evidence related to the safety and risk characteristics of the GMMs. |
Or. en
Amendment 26
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24c – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| Without prejudice to Article 20(2) and (3) and Article 23, the consent granted under Part C shall be valid for an unlimited period of time and Article 17 shall not apply. | Consent for the placing on the market of GMMs shall, upon the first renewal in accordance with Article 17, be valid for an unlimited period, unless the decision referred to in the first section of Articles 17(6) and 17(8), or Article 18(2), provides that the renewal is for a limited period, on justified grounds based on the findings of the environmental risk assessment carried out pursuant to this Directive and on experience with the use, including the results of monitoring, if so specified in the consent. |
Or. en
Amendment 27
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24d – Title
| Text proposed by the Commission | Amendment |
|---|---|
| Detection methods | Analytical methods |
Or. en
Amendment 28
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24d – paragraph 2
| 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 detection method requirements in accordance with paragraph 1. |
| The competent authority shall determine that the EURL, assisted by the ENGL, must adopt guidance for applicants and competent authorities on minimum performance requirements for identification and quantification methods. |
Or. en
Amendment 29
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24e – Title
| Text proposed by the Commission | Amendment |
|---|---|
| Low-risk GMMs | Low-risk profile GMMs |
Or. en
Amendment 30
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24e – paragraph 1
| 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 ‘low-risk profile GMM’ where it fulfils all of the following criteria: |
Or. en
Amendment 31
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24e – paragraph 2
| 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 profile 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. |
Or. en
Amendment 32
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24e – paragraph 3 – point a
| 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 for consideration of low-risk profile GMMs as referred to in paragraph 1, first subparagraph, points (a), (b) and (c); |
Or. en
Amendment 33
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24e – paragraph 3 – point b
| 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 and cumulative criteria for consideration of low-risk profile GMMs as referred to in paragraph 1; |
Or. en
Amendment 34
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24e – paragraph 3 – point c
| 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 profile GMMs and the necessary consultations of competent authorities and the public; |
Or. en
Amendment 35
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24e – paragraph 3 – point d
| 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. | deleted |
Or. en
Amendment 36
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24e – paragraph 3 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. When adopting delegated acts as provided in point (b) of paragraph 3, the Commission shall publish a report to justify the additional eligibility criteria for low-risk profile GMMs, including scientific literature review concerning the safety of GMMs, their environmental risk assessment and characterisation. These delegated acts shall not extend the scope of low-risk profile GMMs. |
Or. en
Amendment 37
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24f – Title
| Text proposed by the Commission | Amendment |
|---|---|
| Monitoring and reporting of low-risk GMMs | Monitoring and reporting of low-risk profile GMMs |
Or. en
Amendment 38
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24f – paragraph 1
| 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 monitoring plan for of low-risk profile GMMs shall include, where relevant: |
| (a) antimicrobial resistance surveillance; | |
| (b) environmental persistence; | |
| (c) horizontal gene transfer indicators; | |
| (d) unexpected adverse health or ecological effects. | |
| 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. |
Or. en
Amendment 39
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24f – paragraph 2
| 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 assess the proposal referred to in paragraph 1 and decide on whether a monitoring plan is required. 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). |
Or. en
Amendment 40
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24g – paragraph 1 – point b
| 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 profile GMM. |
Or. en
Amendment 41
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24g – paragraph 1 – point b a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) the information to be included in Article 13(2) where there is a proposal for non submission of a monitoring plan, pursuant to Article 24f(1). |
Or. en
Amendment 42
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24g – paragraph 1 – point b b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (bb) the information referred to in Article 24f (2) concerning the post-market environmental monitoring plan. |
Or. en
Amendment 43
Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2001/18/EC
Article 29a – paragraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The power to adopt delegated acts referred to in Article 16(2), Article 21(2) and (3), Article 24b, Article 24e(3), Article 26(2) and Article 27 shall be conferred on the Commission for a period of five years from [the date of entry into force of this Directive]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. | deleted |
Or. en
Amendment 44
Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2001/18/EC
Article 29a– paragraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The delegations of power referred to in Article 16(2), Article 21(2) and (3), Article 24b, Article 24e(3), Article 26(2) and Article 27 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. | deleted |
Or. en
Amendment 45
Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2001/18/EC
Article 31a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (4a) In PART D, after Article 31, the following Article 31a is inserted: | |
| ‘ Article 31a | |
| Reporting and evaluation | |
| 1. By [five years after the date of application of this Directive], and every five years thereafter, the Commission shall submit to the European Parliament and to the Council a report on the implementation and functioning of Title II concerning GMMs. | |
| 2. The report shall, in particular, assess: | |
| a) the effectiveness, proportionality and efficiency of the authorisation procedures for GMMs, including low-risk profile GMMs; | |
| b) the environmental impact of the measures of Title II; | |
| c) the impact of this Title on market access for biotechnology products in the Union; | |
| 3. Where appropriate, the report shall be accompanied by a legislative proposal. | |
| ' |
Or. en
Amendment 46
Proposal for a directive
Article 2 – paragraph 1 – point 2 – point b
2010/53/EU
Article 3 – point ka
| 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) "organ processing” means the handling of an organ, including in particular, preservation, application of chemotherapy and surgery, with a view to maintaining or improving its functional status prior to transplantation, and excluding: |
Or. en
Amendment 47
Proposal for a directive
Article 2 – paragraph 1 – point 2 – point b
Directive 2010/53/EC
Article 3 – point ka – point –i (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (-i) the preparatory handling of the organ during the surgical transplantation intervention; |
Or. en
Amendment 48
Proposal for a directive
Article 2 – paragraph 1 – point 2 – point b
Directive 2010/53/EU
Article 3 – point ka (new)
| 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. | (ii) the use of a medicinal product as defined in Article 1 of Directive 2001/83/EC2a, included any substance with a pharmacological, immunological or metabolic action that aims to treat or prevent a disease in the patient to whom the organ will be transplanted’ |
| 2a Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use OJ L 311, 28.11.2001, pp. 67–128, ELI: http://data.europa.eu/eli/dir/2001/83/oj). |
Or. en
Amendment 49
Proposal for a directive
Article 2 – paragraph 1 – point 2 – point b a (new)
Directive 2010/53/EU
Article 3 – point ba (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) ‘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. |
Or. en
Justification
Defining the clinical outcome monitoring plan will help to clarify the use of data that is generated in its context. The definition is closely aligned with what Member States would like to see.
Amendment 50
Proposal for a directive
Article 2 – paragraph 1 – point 2 – point b b (new)
Directive 2010/53/EU
Article 3 – point b b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (bb) 'clinical outcome data' means any data processed for the purpose of the clinical outcome monitoring plan or resulting from the clinical outcome monitoring plan. |
Or. en
Justification
The European Data Protection Supervisor in its opinion point 17 suggested to define the term. Any personal data processed that is part of the clinical outcome data is protected by the general data protection safety provision of Article 16 of the base act.
Amendment 51
Proposal for a directive
Article 2 – paragraph 1 – point 2 a (new)
Directive 2010/53/EU
Article 4 – 2a – (new)
| Present text | Amendment |
|---|---|
| (2a) Article 4 is amended as follows | |
| 1. Member States shall ensure that a framework for quality and safety 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. | "1. 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 to transplantation or disposal, in compliance with the rules laid down in this Directive." |
Or. en
(https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02010L0053-20100806&qid=1779799612116)
Amendment 52
Proposal for a directive
Article 2 – paragraph 1 – point 2 b (new)
Directive 2010/53/EU
Article 4 – 2.d
| Present text | Amendment |
|---|---|
| (2b) Article 4.2 is amended as follows | |
| (d) the procurement, preservation, packaging and labelling of organs in accordance with Articles 5, 6 and 8; | "2 (d) the procurement, processing, preservation, packaging and labelling of organs in accordance with Articles 5, 6, 6a and 8;" |
Or. en
(https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02010L0053-20100806&qid=1779799612116)
Amendment 53
Proposal for a directive
Article 2 – paragraph 1 – point 2 c (new)
Directive 2010/53/EU
Article 4 –paragraph 3
| Present text | Amendment |
|---|---|
| (2c) Article 4 is amended as follows | |
| 3. In addition, the framework for quality and safety shall ensure that the healthcare personnel involved at all stages of the chain from donation to transplantation or disposal are suitably qualified or trained and competent, and shall develop specific training programmes for such personnel. | "3. In addition, the framework for quality and safety shall ensure that the healthcare personnel involved at all stages of the chain from donation to processing to transplantation or disposal are suitably qualified or trained and competent, and shall develop specific training programmes for such personnel." |
Or. en
(https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02010L0053-20100806&qid=1779799612116)
Amendment 54
Proposal for a directive
Article 2 – paragraph 1 – point 3
Directive 2010/53/EU
Article 6a – paragraph –1 (new)
| Text proposed by the Commission | Amendment |
|---|---|
| -1. An organ that undergoes processing, including through the use of medicinal products, medical devices or SoHO preparations, is subject to the rules on quality and safety for organs set out in this Directive and to the applicable national and EU law concerning organ procurement, allocation and transplantation. |
Or. en
Justification
Taking into account that the area in question is at the interface or overlapping regulations, it is necessary to secure against legal loopholes, contradictions or possible emerging unregulated areas, in order to emphasize the validity of existing EU and national regulations
Amendment 55
Proposal for a directive
Article 2 – paragraph 1 – point 3
Directive 2010/54/EU
Article 6a – paragraph 3a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. Where transplantation centres justify of an urgent medical case and where the benefit-risk assessment, conducted with sufficient scientific evidence and clinical data, did not identify any significant risk, the competent authority shall process the application in accordance with a simplified and accelerated procedure. |
Or. en
Justification
The Rapporteurs want to ensure that in urgent medical cases the administrative procedures will not slow down the authorisation and therefore suggest that administrations must have a simplified accelerated procedure.
Amendment 56
Proposal for a directive
Article 2 – paragraph 1 – point 3
Directive 2010/53/EU
Article 6a – paragraph 4
| 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, the competent authority shall verify that the medicinal product has been authorised or otherwise allowed for use 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**. |
Or. en
Amendment 57
Proposal for a directive
Article 2 – paragraph 1 – point 3
Directive 2010/53/EU
Article 6a – paragraph 6
| 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 or otherwise allowed for use by a notified body in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council***. |
Or. en
Amendment 58
Proposal for a directive
Article 2 – paragraph 1 – point 3
Directive 2010/53/EU
Article 6a – paragraph 7
| 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 that the SoHO preparation has been authorised or otherwise allowed for use by the competent authority in accordance with Regulation (EU) 2024/1938 of the European Parliament and of the Council****. |
Or. en
Amendment 59
Proposal for a directive
Article 2 – paragraph 1 – point 3
Directive 2010/53/EU
Article 6a – paragraph 8
| 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, the competent authorities referred to in this Directive and the competent authorities referred to in Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EU) 2017/745 and Regulation (EU) 2024/1938 shall cooperate in order to exchange clinical outcome data within the remits of those Union legislative frameworks including the clinical outcome monitoring plan referred to in 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. |
Or. en
Amendment 60
Proposal for a directive
Article 2 – paragraph 1 – point 3 a (new)
Directive 2010/53/EU
Article 16 – introductory part
| Present text | Amendment |
|---|---|
| (3a) Article 16 is amended as follows: | |
| 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, organ processing and transplantation activities, in conformity with Union provisions on the protection of personal data, such as Regulation (EU) 2016/679, and in particular Article 9(3), 29, 32, and 36(4) thereof. Pursuant to Regulation (EU)2016/679, Member States shall take all necessary measures to ensure that:" |
Or. en
(https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02010L0053-20100806&qid=1779799612116)
Amendment 61
Proposal for a directive
Article 2 – paragraph 1 – point 3 b (new)
Directive 2010/53/EU
Article 16– point a
| Present text | Amendment |
|---|---|
| (3b) Article 16(a) is amended as follows | |
| (a) the data processed are kept confidential and secure in accordance with Articles 16 and 17 of Directive 95/46/EC. Any unauthorised accessing of data or systems that makes identification of donor or recipients possible shall be penalised in accordance with Article 23 of this Directive; | "(a) the data processed including the clinical outcome data containing personal data are kept confidential and secure in accordance with Articles 29 and 32 of Regulation (EU)2016/679. Any unauthorised accessing of data or systems that makes identification of donor or recipients possible shall be penalised in accordance with Article 23 of this Directive;" |
Or. en
(https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02010L0053-20100806&qid=1779799612116)
Justification
The revision introduces a new type of data collected, “clinical outcome data” which would benefit from being mentioned in the protective provision
Amendment 62
Proposal for a directive
Article 2 – paragraph 1 – point 4
Directive 2010/53/EU
Article 22 (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (3a) the following article is inserted: Article 22 (new) By … [5 years from the date of application of this Directive], the Commission shall present a report to the European Parliament and the Council on the application of Article 2 of this Directive concerning the processing of organs, including an assessment of the fulfilment of its objectives. |
Or. en
Explanatory statement 19 paragraphs
The rapporteurs for the Committee on Public Health (SANT) and the Committee on the Environment, Climate and Food Safety (ENVI) present amendments to the Commission proposal within their respective competences. While both sets of amendments relate to the Commission proposal, they address different legislative acts and pursue objectives falling within the remit of each committee. The separate explanatory statements below set out the rationale for the amendments proposed by each rapporteur.
Explanatory Statement (SANT)
The rapporteur for the Committee on Public Health (SANT) welcomes the proposal to amend Directive 2010/53/EU on standards of quality and safety of human organs intended for transplantation. Scientific and technological developments in organ processing create new opportunities to improve organ preservation, increase the availability of organs for transplantation and enhance transplantation outcomes. At the same time, these developments require a regulatory framework that ensures legal certainty, maintains high standards of quality and safety, and upholds the ethical principles underpinning the Union system of organ donation and transplantation.
The amendments therefore seek to reinforce the public health dimension of the proposal. While the proposal forms part of the broader Biotech Act, the amendments to Directive 2010/53/EU should explicitly reflect Article 168(4) of the Treaty on the Functioning of the European Union, which requires a high level of human health protection in measures setting standards for the quality and safety of organs of human origin, as well as Article 35 of the Charter of Fundamental Rights of the European Union. These references ensure that the Directive remains firmly anchored in its public health objective, while providing a framework within which scientific and technological progress can be safely integrated.
The rapporteur considers it appropriate that the proposal more clearly recognises the potential benefits of innovative organ-processing techniques. Such techniques may contribute to improving organ preservation, increasing the number of organs suitable for transplantation, and enhancing the quality of organs prior to transplantation. In turn, this may help reduce waiting times and improve clinical outcomes for patients. The regulatory framework should therefore be adapted to allow these developments to be implemented in clinical practice while maintaining public confidence in the Union’s transplantation system.
At the same time, greater legal clarity is required regarding the interaction between Directive 2010/53/EU and other relevant Union legislation, including the pharmaceutical framework, the legislation on substances of human origin (SoHO), and, where appropriate, the Medical Devices Regulation. Without clear delineation of applicable rules, legal uncertainty may arise, potentially leading to divergent implementation across Member States or delays in access to innovative techniques. The amendments therefore seek to ensure a coherent regulatory framework that enables organ processing to be carried out safely and efficiently, while maintaining full respect for the prohibition of financial gain and the non-commercialisation of organs intended for transplantation.
The rapporteur considers it necessary that organ processing be expressly included within the scope of Directive 2010/53/EU. This would ensure that such activities are fully subject to the Directive’s quality and safety requirements, including provisions on traceability, vigilance and oversight by competent authorities, thereby ensuring consistent application across the Union.
The protection of personal data is of particular importance in this context. Organ processing and transplantation involve the handling of highly sensitive health and genetic data. The amendments take into account the concerns raised by the European Data Protection Supervisor in Opinion 11/2026 and reinforce alignment with Regulation (EU) 2016/679 (GDPR). These safeguards should apply throughout the organ processing and transplantation pathway. The amendments also clarify provisions relating to clinical outcome monitoring plans and clinical outcome data, ensuring that data collection and processing remain proportionate, necessary and subject to appropriate safeguards.
Finally, the rapporteur supports the introduction of minimum reporting obligations under Article 2 relating to organ processing. Such reporting would enhance transparency, support regulatory oversight and contribute to evidence generation on the safety and effectiveness of innovative techniques.
Overall, the amendments aim to ensure that Directive 2010/53/EU remains fit for purpose in light of scientific and technological developments. They strengthen the Directive’s public health foundation, clarify its interaction with related Union legislation, reinforce data protection safeguards and introduce proportionate reporting requirements, thereby providing a coherent framework that enables innovation while maintaining high standards of quality, safety and ethical protection in organ transplantation across the European Union.
Explanatory Statement (ENVI)
The rapporteur for the Committee on the Environment, Climate and Food Safety (ENVI) welcomes the proposal to adapt Directive 2001/18/EC to the rapid pace of scientific progress in biotechnology regarding genetically modified micro-organisms (GMMs). The rapporteur stresses that any adaptation to new technological realities must firmly uphold the precautionary principle and ensure a high level of protection for human health, animal health, and the environment. The amendments introduce critical safeguards to the regulatory framework proposed for GMMs:
Terminology and risk profiling: the rapporteur replaces the open-ended term “low-risk” with “low-risk profile GMMs” throughout the text. This linguistic precision emphasises that QPS (Qualified Presumption of Safety) status represents a preliminary scientific indication of reduced risk based on a case-by-case assessment of taxonomic identity, rather than an automatic presumption of market safety or an exemption from demonstrating safety.
Strict safety criteria: the amendments clarify that any streamlined procedures for low-risk profile GMMs must consider the environmental risk assessment (ERA) principles in Annex II. Criteria must ensure that such strains are taxonomically and molecularly well-characterised, with a proven absence of genes of concern, acquired antimicrobial resistance genes, virulence factors, or toxins.
Time-limited authorisation and renewals: the rapporteur explicitly rejects the proposal for an open-ended, unlimited initial validity of market consent. The amendments reinstate a mandatory initial 10-year period before any unlimited validity can be granted upon the first renewal. This ensures that any transition to an unlimited period is strictly grounded in actual post-market monitoring data and environmental safety findings.
Analytical methods: reflecting technical realities, the amendments shift from generic “detection methods” to rigorously defined “analytical methods”. To support operators and competent national authorities, the EURL (European Union Reference Laboratory), assisted by the ENGL (European Network of GMO Laboratories), is mandated to adopt clear guidance on minimum performance requirements for identification and quantification methods.
Enhanced post-market monitoring: proposals by a notifier to waive a post-market environmental monitoring plan must be formally assessed and decided upon by competent authorities. Where monitoring is conducted, it must explicitly address indicators such as antimicrobial resistance surveillance, environmental persistence, horizontal gene transfer, and unexpected ecological impacts.
Delegated powers and reporting: the scope of the Commission’s delegated acts to modify criteria cannot be extended arbitrarily. When modifying criteria, the Commission must publish a comprehensive report including a scientific literature review. Furthermore, a new reporting and evaluation clause ensures that five years after application, and every five years thereafter, the Commission must submit a formal implementation report assessing the environmental impact, procedural efficiency, and market access dynamics of the GMM framework.
Through these measures, the rapporteur wants to ensure that the update to Directive 2001/18/EC fosters biotechnology innovation safely and transparently without weakening the Union’s robust biosafety architecture.
Annex: declarations of input 4 paragraphs
Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteurs declare that they included in their report input on matters pertaining to the subject of the file that they received, in the preparation of the draft report, from the following interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register1, or from the following representatives of public authorities of third countries, including their diplomatic missions and embassies:
| 1. Interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register |
| European Data Protection Supervisor (EDPS) |
| Natividad Cuende Melero MD, MPH, PhD - Deputy Director of the Andalusian Transplant Coordination - Servicio Andaluz de Salud - Calle Imagen 12, 1º planta. 41003 Sevilla |
| Testbiotech |
| 2. Representatives of public authorities of third countries, including their diplomatic missions and embassies |
| None. |
The list above is drawn up under the exclusive responsibility of the rapporteurs.
Where natural persons are identified in the list by their name, by their function or by both, the rapporteurs declare that they have submitted to the natural persons concerned the European Parliament’s Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.