amendment list, 10 September 2026
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-792138 · (COM(2025)1031 – 2025/0405(COD))
Committee on the Environment, Climate and Food Safety Committee on Public Health
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Text 1,264 paragraphs
Amendment 63
Emma Fourreau, Per Clausen, Anja Hazekamp, Catarina Martins, Valentina Palmisano, Günther Sidl
Proposal for a directive
–
| Proposal for rejection | |
| The European Parliament rejects the Commission proposal. |
Or. en
Justification
Microorganisms are essential to life on Earth and the functioning of the biosphere. Genetic engineering of microorganisms poses risks across all domains of life, including humans. GMMs rapidly multiply, recombine and exchange genes with other microorganisms. The damage this could cause to agricultural systems, wild ecosystems and human health will be uncontrollable, as it will be impossible to remove these GMMs from the environment after release. These risks need to be properly assessed and monitored. This deregulation proposal of GMM is irresponsible, and should be rejected.
Amendment 64
Friedrich Pürner
Draft legislative resolution
Paragraph 1
Read the rest (1,252 paragraphs)
| Draft legislative resolution | Amendment |
| 1. Adopts its position at first reading hereinafter set out; | 1. Rejects the Commission proposal; |
Or. de
Justification
The proposal on organ transplantation pertains to an area for which the Member States retain primary responsibility. In view of the considerable differences between the national ethical, legal and health policy frameworks, measures at EU level offer no discernible added value. In accordance with Article 5 TEU, the proposal should therefore be rejected for incompatibility with the subsidiarity principle.
Amendment 65
Friedrich Pürner
Draft legislative resolution
Paragraph 2
| Draft legislative resolution | Amendment |
| 2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal; | 2. Calls on the Commission to withdraw its proposal; |
Or. de
Justification
The proposal as regards the placing on the market of genetically modified micro-organisms (GMMs) is in breach of the precautionary principle, as serious scientific misgivings persist. The effects of interactions between GMMs and the microbiomes of soil, plants, animals and people can emerge indirectly, cumulatively or with a lag, and their release cannot be reversed. The safe use of GMMs therefore cannot be guaranteed.
Amendment 66
Martin Häusling
Proposal for a directive
Title 1
| Text proposed by the Commission | Amendment |
|---|---|
| Proposal for a | Proposal for a |
| DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL | 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 | amending Directives 2001/18/EC as regards the placing on the market of genetically modified micro-organisms |
Or. en
Justification
Two separate legislative instruments are the better choice: one covering genetically modified micro-organisms (GMMs), the other one covering the processing of organs.
Amendment 67
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Citation 1
| Text proposed by the Commission | Amendment |
|---|---|
| Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4) thereof, | Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114, Article 168(4) and Article 191 thereof, |
Or. en
Amendment 68
Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Citation 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| Having regard to the Charter of Fundamental Rights of the European Union, in particular Article 3(2)(c), |
Or. en
Amendment 69
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Citation 1 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| Having regard to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, |
Or. en
Amendment 70
Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
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 sustainability, safety and competitiveness of the health biotechnology sector in the Union, from research and development to the placing on the Union market and production of biotechnology innovations and products, while setting and 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 71
Christine Anderson, Marc Jongen, Anja Arndt, Volker Schnurrbusch
Proposal for a directive
Recital 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (1a) Given that the organ transplantation system is based on trust between donors and recipients, any amendments to these directives should ensure that after the processing of organs they do not become commercial commodities, subject to ownership, market acquisition or trading. |
Or. en
Amendment 72
Christine Anderson, Marc Jongen, Anja Arndt, Volker Schnurrbusch
Proposal for a directive
Recital 1 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (1b) Given the increasing evidence of organ trafficking, including the harvesting of 'organs to order' from prisoners, competent authorities must increase their monitoring of accurate information regarding the source of organs being processed prior to transplantation. |
Or. en
Amendment 73
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
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 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. However, given the highly divergent content of those two Directives, it is appropriate to present two separate legal proposals to adapt them. |
| 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) | 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). | 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 74
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Recital 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) Respect of the precautionary principle, enshrined in Article 191(2) TFEU is of paramount importance. It requires that where scientific uncertainty exists regarding potential risks to health or the environment, preventive measures should be taken even if some cause and effect relationships are not fully established scientifically. This principle empowers Union institutions and Member States to act proactively to avoid or minimise threats to health and the environment, even in the absence of conclusive scientific evidence. |
Or. en
Amendment 75
Martin Häusling
Proposal for a directive
Recital 3
| Text proposed by the Commission | Amendment |
|---|---|
| (3) Genetically modified micro-organisms (GMMs), such as bacteria, algae, fungi and viruses, as or in products for uses other than food and feed are subject to the requirements of Directive 2001/18/EC. Since the adoption of that Directive, significant progress in biotechnology has taken place, and GMMs can now be used for example as or in fertilisers, biocontrol, bioremediation, wastewater treatment, biomining and bioleaching, offering benefits in the wider agri-food, industrial and environmental sectors. | (3) Genetically modified micro-organisms (GMMs), such as bacteria, algae, fungi and viruses, as or in products for uses other than food and feed are subject to the requirements of Directive 2001/18/EC. Since the adoption of that Directive, significant progress in biotechnology has taken place, and GMMs can now be used for example as or in fertilisers, biocontrol, bioremediation, wastewater treatment, biomining and bioleaching, offering benefits in the wider agri-food, industrial and environmental sectors. However, the Union has no practical experience with GMMs authorisation under Part C of the Directive, and validated methodologies for environmental risk assessment and post-market monitoring have not yet been established. Therefore, the Union should support independent research into the environmental applications of GMMs, whereby researchers have access to all relevant materials, as foreseen in Recital (21) of the Directive. |
Or. en
Justification
While GMMs have been used in contained systems for some time, there is less practical experience with their release into the environment. There are also large knowledge gaps in microbial ecology (e.g. microbial biodiversity, microbiome interactions) which necessitate independent research. This research is also needed to inform the development of methodologies and protocols for the environmental risk assessment and post-market monitoring of GMMs required under the Directive.
Amendment 76
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Recital 3
| Text proposed by the Commission | Amendment |
|---|---|
| (3) Genetically modified micro-organisms (GMMs), such as bacteria, algae, fungi and viruses, as or in products for uses other than food and feed are subject to the requirements of Directive 2001/18/EC. Since the adoption of that Directive, significant progress in biotechnology has taken place, and GMMs can now be used for example as or in fertilisers, biocontrol, bioremediation, wastewater treatment, biomining and bioleaching, offering benefits in the wider agri-food, industrial and environmental sectors. | (3) Genetically modified micro-organisms (GMMs), such as bacteria, algae, fungi and viruses, as or in products for uses other than food and feed are subject to the requirements of Directive 2001/18/EC. Since the adoption of that Directive, significant progress in biotechnology has taken place, and some GMMs could be used for example as or in fertilisers, biocontrol, bioremediation, wastewater treatment, biomining and bioleaching, offering potential benefits in the wider agri-food, industrial and environmental sectors. At the same time, GMMs can have significant risks to health and the environment, and should therefore always undergo rigorous risk assessment, proper authorisation and continuous monitoring. |
Or. en
Amendment 77
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
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. | deleted |
| 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 78
Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl
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 also concluded that, on a case-by-case basis, for specific micro-organisms developed using new genomic techniques fewer requirements for risk assessment may be needed compared to those applicable to GMOs in general. Finally, the Authority considered that, for certain GMMs, the need for general surveillance as part of post-market environmental monitoring (PMEM) may be waived in future guidance based on the environmental risk assessment. The Authority also concluded that the existing guidance for the environmental risk assessment of micro-organisms and for post-market environmental monitoring is inadequate and recommended that it be revised and updated. |
| 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
Justification
The text of the Commission overstates and broadens the Authority's conclusions. The changes made mirror better the Authority's conclusions on guidance and brings back the necessary key conditions.
Amendment 79
Gerben-Jan Gerbrandy, Stine Bosse, Jeannette Baljeu, Billy Kelleher
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 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, on a case-by-case basis, the need for post-market environmental monitoring (PMEM) general surveillance may be waived based on the environmental risk assessment. The Authority also found that the current guidance available for PMEM is not sufficient. It recommended a future update to include descriptions of fit-for-purpose approaches to monitor for potential adverse effects resulting from the deliberate environmental release. |
| 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
Justification
This amendment seeks to addresses a critical gap in guidelines post-market environmental monitoring (PMEM) identified by the European Food Safety Authority (EFSA). According to the EFSA opinion, current monitoring framework guidelines lack clear, practical protocols for tracking long-term adverse effects after a deliberate release into the environment. Specifying that the future update needs to reflect this ensures that monitoring mandates remain proportionate, scientifically sound, and adaptable to real-world risk profiles.
Amendment 80
Christophe Clergeau
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 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. In its opinion, the Authority also identified larger knowledge gaps such as, in regard to the gut microbiome, environmental risk assessment and recommended to expand monitoring. |
| 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 81
Marie-Luce Brasier-Clain, Mathilde Androuët
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 also concluded that for certain GMMs, fewer requirements for risk assessment would be needed compared to those applicable to GMOs in general. |
| 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. (‘New developments in biotechnology applied to microorganisms’, EFSA Journal, 22(7), e8895, 2024, 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. (‘New developments in biotechnology applied to microorganisms’, EFSA Journal, 22(7), e8895, 2024, point 4, https://doi.org/10.2903/j.efsa.192024.8895). |
Or. fr
Amendment 82
Martin Häusling
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. However, the characteristics of the specific genetic modification and its potential effects on the biological properties, ecological interactions, persistence, dissemination and evolution of the microorganism should be assessed on a case-by-case basis. Any adaptation of risk assessment requirements should not reduce the level of protection of human health, animal health and the environment. |
| 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 83
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
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. | deleted |
Or. en
Amendment 84
Martin Häusling
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 address the specificities of GMMs while maintaining the precautionary principle and ensuring that Union GMMs authorisation is based on a case-by-case assessment of the characteristics and risks associated with the GMMs concerned. Innovation in biotechnology should not come at the expense of biosafety. Robust risk assessment, monitoring and traceability requirements are needed to ensure a high level of protection of human and animal health and the environment. |
Or. en
Justification
Microorganisms play a key role in fundamental ecological processes (e.g. food webs, cycling of matter/biogeochemical cycles). Additionally, they can be genetically highly volatile due to high reproduction rates, fast evolution and horizontal gene transfer (HGT) and cannot be retrieved after environmental releases. Thus, it is essential to uphold a high level of protection and the precautionary principle when GMMs are deliberately released into the environment, as negative effects could directly or indirectly affect human health, ecosystem services and overall biodiversity.
Amendment 85
Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl
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 already disposes in Annex III A and in Section D.1 of Annex II for information requirements and areas of risk applicable to genetically modified organisms other than higher plants but that those requirements have not been elaborated in guidance to the same extent as the corresponding requirements for genetically modified higher plants 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. Such adaptation should be based on the risk areas and information requirements already set out in Annexes II and III and should be supported by the guidance needed to ensure their consistent application to micro-organisms. |
Or. en
Justification
The Commission proposal is based on the incorrect premise that Directive 2001/18/EC was primarily designed for genetically modified plants, whereas the Directive already contains specific provisions for micro-organisms, meaning that adaptation should build on the existing risk areas and information requirements rather than replace them.
Amendment 86
Aurelijus Veryga
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) Directive 2001/18/EC was designed primarily taking into account genetically modified plants obtained by certain established genomic techniques, in particular techniques that introduce into an organism genetic material from non-crossable species (transgenesis). In view of this 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. This is intended 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 human health. |
Or. en
Amendment 87
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Recital 6
| Text proposed by the Commission | Amendment |
|---|---|
| (6) For that reason, Directive 2001/18/EC should be amended to introduce specific provisions applicable to the placing on the market of GMMs with the aim of creating a tailored, more efficient and streamlined legislative framework, while maintaining a high level of safety for human health and the environment. Considering that possible hazards relate to the changes introduced into the genome of a micro-organism regardless of the method used, and that micro-organisms are often modified through a combination of different techniques, including both established and new genomic techniques6 , those provisions should cover GMMs in general without focus on specific techniques. | deleted |
| 6 Parisi, C., Rodríguez-Cerezo, E., Current and future market applications of new genomic techniques, EUR 30589 EN, Publications Office of the European Union, Luxembourg, 2021, ISBN 978-92-76-30206-3, doi:10.2760/02472, JRC123830. |
Or. en
Amendment 88
Martin Häusling
Proposal for a directive
Recital 6
| Text proposed by the Commission | Amendment |
|---|---|
| (6) For that reason, Directive 2001/18/EC should be amended to introduce specific provisions applicable to the placing on the market of GMMs with the aim of creating a tailored, more efficient and streamlined legislative framework, while maintaining a high level of safety for human health and the environment. Considering that possible hazards relate to the changes introduced into the genome of a micro-organism regardless of the method used, and that micro-organisms are often modified through a combination of different techniques, including both established and new genomic techniques6 , those provisions should cover GMMs in general without focus on specific techniques. | (6) For that reason, Directive 2001/18/EC should be amended to introduce specific provisions applicable to the placing on the market of GMMs with the aim of creating a science-based framework that takes account of the specific characteristics of GMMs while ensuring robust environmental risk assessment, traceability and monitoring while maintaining a high level of safety for human and animal health and the environment. Considering that possible hazards relate to the changes introduced into the genome of a micro-organism regardless of the method used, and that micro-organisms are often modified through a combination of different techniques, including both established and new genomic techniques6 , those provisions should cover GMMs in general without focus on specific techniques. Given that GMMs may replicate, persist, disseminate and interact with naturally occurring microbial communities, regulatory adaptations should not result in reduced capacity to assess, monitor or manage potential risks. |
| 6 Parisi, C., Rodríguez-Cerezo, E., Current and future market applications of new genomic techniques, EUR 30589 EN, Publications Office of the European Union, Luxembourg, 2021, ISBN 978-92-76-30206-3, doi:10.2760/02472, JRC123830. | 6 Parisi, C., Rodríguez-Cerezo, E., Current and future market applications of new genomic techniques, EUR 30589 EN, Publications Office of the European Union, Luxembourg, 2021, ISBN 978-92-76-30206-3, doi:10.2760/02472, JRC123830. |
Or. en
Justification
Microorganisms play a key role in fundamental ecological processes (e.g. food webs, cycling of matter/biogeochemical cycles). Additionally, they can be genetically highly volatile due to high reproduction rates, fast evolution and horizontal gene transfer and cannot be retrieved after environmental releases.
Thus, it is essential to uphold a high level of protection and the precautionary principle, when GMMs are deliberately released into the environment, as negative effects could directly or indirectly affect human health, ecosystem services and overall biodiversity.
Amendment 89
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Recital 6 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (6a) All known life is homochiral. DNA and RNA are made from “righthanded” nucleotides, and proteins are made from “left-handed” amino acids. Some researchers have begun work toward creating lifeforms composed entirely of mirror-image biological molecules. Such mirror organisms would constitute a radical departure from known life, and their creation could pose severe unprecedented and irreversible harm. Scientific analysis1a suggests that mirror bacteria would likely evade many immune mechanisms mediated by chiral molecules, potentially causing lethal infection in humans, animals and plants. They are likely to evade predation from natural-chirality phage and many other predators, facilitating spread in the environment. It cannot be ruled out hat mirror bacterium acts as an invasive species across many ecosystems, causing pervasive lethal infections in a substantial fraction of plant and animal species, including humans. Even a mirror bacterium with a narrower host range and the ability to invade only a limited set of ecosystems could still cause unprecedented and irreversible harm. Considering these risks, research into mirror-image biological molecules should not be conducted, and mirror organisms should not be placed on the market or released in the environment. | |
| 1a Katarzyna P. Adamala et al. Confronting risks of mirror life. Science 386, 1351 (2024) DOI: 10.1126/science.ads9158 |
Or. en
Amendment 90
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Recital 6 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (6b) Gene drive is a disruptive biotechnology developed over the past decade with potential applications in public health, agriculture, and conservation biology. This technology relies on an autonomous selfish genetic element able to spread in natural populations through the release of gene drive individuals, with the aim of altering, replacing or eliminating target populations and possibly entire species. Once released into the wild, a gene drive organism actively propagates in free-living populations and can rapidly spread over large distances. The unmanageable diversity of the natural habitats and ecosystems affected will make it particularly difficult to predict and control possible risks. Considering these risks, research into gene drives should not be conducted, and gene drive organisms should not be placed on the market or released into the environment. |
Or. en
Amendment 91
Christophe Clergeau
Proposal for a directive
Recital 7
| Text proposed by the Commission | Amendment |
|---|---|
| (7) For the purpose of Directive 2001/18/EC, the definitions of ‘micro-organism’ and ‘GMM’ should be based on those of Directive 2009/41/EC of the European Parliament and of the Council7 with the exclusion of animal and plant cells in culture. In order to ensure that the overall applicable framework on GMOs remains consistent, animal and plant cells should be subject to the same rules, regardless of whether they are in culture, not in culture or embedded in the complete organisms. The specific provisions should therefore cover only micro-organisms in the biological sense, including the taxonomic groups Archaea and Bacteria, the unicellular species and life stages of Protozoa, Chromista and Fungi, as well as filamentous fungi and viruses, while excluding animal and plant cells in culture. | (7) For the purpose of Directive 2001/18/EC, the definitions of ‘micro-organism’ and ‘GMM’ should be based on those of Directive 2009/41/EC of the European Parliament and of the Council7 with the exclusion of animal and plant cells in culture. In order to ensure that the overall applicable framework on GMOs remains consistent, animal and plant cells should be subject to the same rules, regardless of whether they are in culture, not in culture or embedded in the complete organisms. The specific provisions should therefore cover only micro-organisms in the biological sense, including the taxonomic groups Archaea and Bacteria, the unicellular species and life stages of Protozoa, Chromista and Fungi, as well as filamentous and fungi, while excluding animal, viruses and viroids, and plant cells in culture. |
| 7 Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms, OJ L 125, 21.5.2009, p. 75, ELI: http://data.europa.eu/eli/dir/2009/41/oj ). | 7 Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms, OJ L 125, 21.5.2009, p. 75, ELI: http://data.europa.eu/eli/dir/2009/41/oj ). |
Or. en
Justification
Viruses should not be considered asmicroorganisms in a biological sense (they do not possess essential biologicalfeatures of organisms in a strict sense, because they cannot replicate withoutthe infected cells) and should be excluded from the scope of this text. They also have the ability to spread,mutate and evolve at a high rate. Furthermore, there is a high diversitywithin the virus families that encompass hundreds of species, including avariety of high pathogens.
Amendment 92
Martin Häusling
Proposal for a directive
Recital 7
| Text proposed by the Commission | Amendment |
|---|---|
| (7) For the purpose of Directive 2001/18/EC, the definitions of ‘micro-organism’ and ‘GMM’ should be based on those of Directive 2009/41/EC of the European Parliament and of the Council7 with the exclusion of animal and plant cells in culture. In order to ensure that the overall applicable framework on GMOs remains consistent, animal and plant cells should be subject to the same rules, regardless of whether they are in culture, not in culture or embedded in the complete organisms. The specific provisions should therefore cover only micro-organisms in the biological sense, including the taxonomic groups Archaea and Bacteria, the unicellular species and life stages of Protozoa, Chromista and Fungi, as well as filamentous fungi and viruses, while excluding animal and plant cells in culture. | (7) For the purpose of Directive 2001/18/EC, the definitions of ‘micro-organism’ and ‘GMM’ should be based on those of Directive 2009/41/EC of the European Parliament and of the Council7 with the exclusion of animal and plant cells in culture. In order to ensure that the overall applicable framework on GMOs remains consistent, animal and plant cells should be subject to the same rules, regardless of whether they are in culture, not in culture or embedded in the complete organisms. The specific provisions should therefore cover only micro-organisms in the biological sense, including the taxonomic groups Archaea and Bacteria, the unicellular species of Protozoa, Chromista and Fungi as well as filamentous and fungi while excluding animal and plant cells in culture as well as viruses and viroids. |
| 7 Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms, OJ L 125, 21.5.2009, p. 75, ELI: http://data.europa.eu/eli/dir/2009/41/oj ). | 7 Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms, OJ L 125, 21.5.2009, p. 75, ELI: http://data.europa.eu/eli/dir/2009/41/oj ). |
Or. en
Justification
An organism should not be regulated solely on the basis of one life stage where its life cycle includes both unicellular and multicellular stages. For example, some fungi form unicellular spores that develop into multicellular mycelia and fruiting bodies. Viruses are fundamentally different from cellular microorganisms: they are acellular and depend on host cells for replication. These biological differences are highly relevant for environmental risk assessment.
Amendment 93
Christophe Clergeau
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. | deleted |
Or. en
Justification
The criteria of Annex II and Annex III of the Directive 2001/18/EC are essential for GMO risk assessment and should only be changed by full legislative processes that require consent from Parliament and Council.
Amendment 94
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
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) The information requirements as set down in Annex III to Directive 2001/18/EC to be used in the risk assessment should respect the principles for the environmental risk assessment of GMOs laid down in Annex II to that Directive. |
Or. en
Amendment 95
Martin Häusling
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 risk assessment may be technically adapted, provided that such adaptations do not reduce the information necessary to carry out a comprehensive environmental risk assessment and while respecting the precautionary principle in accordance with article 191 of the Treaty of the Functioning of the European Union 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, however, the essential information requirements necessary to determine the safety of GMMs for all aeras of protection should remain established in this Directive. |
Or. en
Justification
“Safety” of GMM is to be considered regarding human and animal health and particularly the environment.
Amendment 96
Christophe Clergeau
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. | deleted |
Or. en
Justification
The assumption that granting consent for release for an unlimited period of time still ensures adequate protection of human health, animal health, and the environment is not credible and should be rejected; especially for GMMs, for which there are large gaps in knowledge and experience resulting in high uncertainties when assessing their potential environmental risk. Thus, in line with precautionary principle, it must be guaranteed that at least via renewal of authorisations, a regular source of information and re-evaluation of environmental risk assessment is maintained for GMMs. To be functional this should be implemented in combination with obligatory monitoring requirements
Amendment 97
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
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. | deleted |
Or. en
Amendment 98
Aurelijus Veryga
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) 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 may create an administrative burden for operators and national competent authorities. 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. At the same time, it is important to ensure that the competent authorities are able to maintain effective oversight of such products, in particular in cases where low-risk GMMs are not subject to post-market environmental monitoring requirements or where certain GMMs may not be readily detectable by laboratory methods. Any measures necessary to protect human health and the environment should continue to be adopted anytime where such consents granted do not 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. In this context, the appropriateness of an unlimited period of validity should be carefully assessed, including whether a defined validity period or an appropriate review mechanism may be necessary to ensure continued compliance with the safety requirements laid down in Directive 2001/18/EC. |
Or. en
Amendment 99
Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl
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) 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 periodic renewal of consens is the principal occasion on which an authorisation is re-examined in the light of evidence generated after it was granted. 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. Considering further that micro-organisms placed on the market as or in products replicate independently of the operator and cannot be recovered from the environment and that the Union has limited experience of the placing on the market of GMMs, Directive 2001/18/EC should provide that consents granted for the placing on the market of GMMs should be valid for a period of five years, renewable in accordance with Article 17. 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. |
Or. en
Justification
The Commission proposal removes the periodic renewal of consent entirely. The periodic renewal is the most important opportunity under this Directive to re-examine the authorization against evidence that did not exist when it was granted. The proposed text aims to binging back the periodic renewal and proposes that the placing on market of GMM shall be valid for a maximum period of five years.
Amendment 100
Christine Anderson, Marc Jongen, Anja Arndt, Volker Schnurrbusch
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) Considering that the product cycles of GMMs may be short and new generations of GMMs may be developed within short timeframes, the renewal procedure should avoid requiring the unnecessary repetition of assessments where the characteristics of the GMM, its risk profile and the conditions of its use have not materially changed. However, the commercial lifetime of a product should be distinguished from the possible biological persistence of a GMM, its descendants or transferred genetic material in the environment. Consents should therefore remain limited in time and be subject to periodic renewal, taking account of new scientific and technical knowledge, monitoring and incident data, changes in the scale or conditions of use and any evidence concerning persistence, dissemination or genetic transfer. |
Or. en
Justification
A short commercial product cycle does not mean that the possible environmental effects of a living and replicating organism are equally short. Periodic renewal provides a defined point at which new evidence and experience can be assessed. Unnecessary administrative burdens can be avoided where no material change in the risk profile has occurred, without granting consent for an unlimited period.
Amendment 101
Gerben-Jan Gerbrandy, Stine Bosse, Jeannette Baljeu, Billy Kelleher
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) GMMs are developed in short timeframes, with new products building on the experience gained with previous ones. Therefore, the consent should, upon its first renewal, be valid for an unlimited period, unless decided otherwise at the time of that renewal on the basis of the environmental risk assessment and the available information on the product concerned. 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. 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 102
Martin Häusling
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) Considering that GMMs are living organisms capable of replication, persistence, dissemination and interaction with other organisms and microbial communities, the validity of consents for placing on the market must remain limited in time to five years to ensure periodic reassessment in light of new scientific knowledge, technological developments and experience gained from monitoring. Periodic renewal procedures are essential to ensure continued compliance with the requirements of this Directive and the precautionary principle. 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. |
Or. en
Amendment 103
Marie-Luce Brasier-Clain, Mathilde Androuët
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) 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 a renewable period of 10 years. 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. |
Or. fr
Amendment 104
Aurelijus Veryga
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 noting that analytical testing may not be feasible for certain GMMs obtained through those techniques, especially in the context of routine laboratory control. In such cases, it should be considered how effective control of such products could be ensured in the production chain and on the market where no reliable detection method exists, and whether competent authorities would be able to exercise appropriate oversight of such GMMs. Therefore, in cases where it is not feasible to provide an analytical method that identifies and quantifies the GMM as or in products concerned, if duly justified by the notifier, the arrangements for complying with analytical method performance requirements should be adapted by means of implementing acts. |
| 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 105
Martin Häusling
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 . However, the availability of scientifically validated analytical methods enabling the detection, identification and quantification of GMMs should be considered an essential prerequisite for effective monitoring, traceability and enforcement. Therefore, where such methods are not available, the placing on the market of a GMM should not be authorised, in accordance with the precautionary principle. This requirement should incentivise developers to invest in appropriate detection and monitoring technologies alongside the development of GMMs. |
| 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 106
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
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) Detection and analytical methods are essential to monitor GMMs, which is especially needed when contamination or risks appear after their release into the environment. Therefore, it is appropriate that during the notification process, methods for detection, identifying and quantifying GMMs should be provided for each GMM placed on the market. This aims also to protect the organic sector, in which GMMs are prohibited. |
| 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 107
Elena Nevado del Campo, Dolors Montserrat
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, for the time being, 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 taking into account the risk assessment previously carried out. |
| 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 108
Gerben-Jan Gerbrandy, Stine Bosse, Jeannette Baljeu, Billy Kelleher
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 methods developed for certain GMMs obtained through those techniques may fail to meet the current minimum performance requirements for analytical methods of GMO testing.8 Therefore, in cases where it is not feasible to meet these requirements, if duly justified by the notifier, the modalities to comply with analytical method performance requirements should be adapted by means of implementing acts. |
| 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
Justification
A more specific reflection of the ENGL report.
Amendment 109
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Recital 10 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (10a) Environmental monitoring is an important biosafety requirement for GMMs deliberately released into the environment, as it serves to verify the assumptions made in the environmental risk assessment and to identify adverse effects that were not anticipated. Such monitoring should, in particular, assess whether the GMMs persists beyond the expected period, disperses materially beyond the site of application, transfers the genetic modification or measurably alters resident microbial communities. However, no standardised methodologies specific to GMMs currently exist. The EFSA GMO Panel has considered existing guidance insufficient for the post-market environmental monitoring of GMMs and recommended updated, fit-for-purpose approaches to monitor potential adverse effects arising from their deliberate environmental release. |
Or. en
Amendment 110
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
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. | deleted |
| 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 |
Or. en
Amendment 111
Martin Häusling
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 GMMs, the Authority concluded that fewer data requirements for risk assessment may be needed, on a case-by-case basis, and suggested possible criteria to identify those GMMs. Thus, Directive 2001/18/EC should establish an expedited procedure for certain GMMs (hereafter ‘GMMs eligible for an expedited procedure’) where, on a case-by-case basis, the available information demonstrates that the specific GMMs and its intended use can be adequately assessed with fewer data requirements while maintaining a high level of protection of human health, animal health and the environment. Eligibility for the expedited procedure should not be based solely on the characteristics of the parental microorganism or the absence of genetic modifications of concern, but should also take into account the effects of the genetic modification on the characteristics, behaviour and ecological interactions of the GMM and its modified genetic material. Such adaptation may lead to a reduction of time to market for GMMs eligible for an expedited procedure, but should under no circumstances lower the Union's safety standards. |
| 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 |
Or. en
Justification
EFSA did not provide any conclusive criteria for GMMs that may be considered of low risk. On the contrary, the Authority recommended updated guidance materials on the risk assessment of GMMs, not only GMMs derived from new genomic techniques. Any reduction of information requirements should take into account this updated guidance, whilst also covering GMMs used outside the food chain.
Amendment 112
Marie-Luce Brasier-Clain, Mathilde Androuët
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 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 GMMs eligible for a fast-track procedure, enabling innovation without lowering the safety standards. |
| 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. (‘New developments in biotechnology applied to microorganisms’, EFSA Journal, 22(7), e8895, 2024, 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. (‘New developments in biotechnology applied to microorganisms’, EFSA Journal, 22(7), e8895, 2024, 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. (‘Guidance on the characterisation of microorganisms in support of the risk assessment of products used in the food chain’, EFSA Journal, 23(11), e9705, 2025, 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. (‘Guidance on the characterisation of microorganisms in support of the risk assessment of products used in the food chain’, EFSA Journal, 23(11), e9705, 2025, https://doi.org/10.2903/j.efsa.2025.9705). |
Or. fr
Amendment 113
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
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. | deleted |
| 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. |
Or. en
Amendment 114
Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl
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 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. QPS status constitutes a preliminary indication which permits certain generic questions not to be reexamined. It does not constitute a presumption of environmental safety, does not replace the case-by-case environmental risk assessment of the notified strain in its intended conditions of use, and does not extend to aspects of environmental risk that the QPS assessment of the taxonomic unit concerned has not itself addressed. Furthermore, genetic modifications may alter the characteristics of a microorganism relevant to its environmental behaviour without introducing any gene that is not naturally present in the parental organism, in particular through deletion, rearrangement, alteration of gene copy number or modification of regulatory sequences. The criteria should accordingly address the genetic modification and its consequences for the characteristics of the resulting microorganism, and not only the presence or absence of particular genes. |
| 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
Justification
The QPS approach was developed to facilitate the safety assessment of micro-organisms used in the food and feed chain, is attributed to taxonomic units rather than to individual strains, and is periodically revised. The QPS assessment should not replace the environmental risk assessment of specific aspects of GMMs.
Amendment 115
Christophe Clergeau
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 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. The QPS concept has to be adapted to environmental risk assessment as established under Directive 2001/18. Data gaps, concerning environmental risks such as toxigenicity, pathogenicity, infectivity, history of use, persistence, invasiveness and selective advantage, horizontal gene transfer, effects on non-target organisms, including humans or animals and the effects on geochemical processes of the parental organisms have to be closed, before the list may be applied. |
| 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
Justification
To achieve an equal level of safety to current GMO legislation, the data of the parental organisms have to be completed in a way that, for the purpose of environmental risk assessment, comparisons can be made with the GMM. Huge data gaps are accepted under current QPS practice. For example, the European Commission approved non-GMM bacterial strains QST 7131, AH22 and RTI3013 (for use in pesticide sprays) and IT-45.4 for use in soil. The Regulation has to make sure that these data gaps are not perpetuated in case of GMMs.
Amendment 116
Martin Häusling
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 may be possible to lay down criteria defining GMMs eligible for expedited procedure on the basis of their taxonomic, phenotypic and molecular characteristics, and an absence of genetic modifications of concern, including but not limited to, modifications that give rise to antimicrobial resistance and the production of toxins or harmful metabolites. Additional criteria are needed to ensure that reduced scrutiny under the expedited procedure does not overlook potential harm, thereby undermining the protection objectives of the Directive. |
| 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. |
Or. en
Amendment 117
Marie-Luce Brasier-Clain, Mathilde Androuët
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 the criteria defining GMMs eligible for a fast-track procedure on the basis of general safety standards 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-organisms, including acquired antimicrobial resistance genes, virulence factors and genes known to contribute to the production of toxins or harmful metabolites. |
| 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. (‘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. (‘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. fr
Amendment 118
Jessica Polfjärd
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 the criteria defining GMMs eligible for an expedited procedure 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. |
| 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 119
Christophe Clergeau
Proposal for a directive
Recital 12 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12a) In general, microorganisms that play a role in the microbiomes of humans, animals or plants as well as microorganisms that provide useful ecosystem services, should be handled with high a level of precaution. Therefore, the provisions of the expedited procedure should not apply to this group. Genetic changes introduced by advanced applications such as new genomic techniques or synthetic biology can alter the characteristics of microorganisms beyond what is achieved by previous methods. It is known that limited but highly specific deletions or inserts obtained from advanced applications can impact the characteristics of the organisms in a complex fashion, introducing a high degree of uncertainties regarding potential risks. Unintended effects may also concern interactions of the microbes with microbiomes that are essential for human, animal and plant health in way that is difficult to predict and identify. Therefore, microorganisms that can persist and / or spread in soil or water, that have a high potential for horizontal gene transfer (HGT) or do play a significant in the microbiomes of soils, plants, animals and humans should be excluded from the concept of 'low risks', as well as viruses and viroids. |
Or. en
Justification
As for example Clauer et al (2025) show,new genomic techniques, also in convergence with artificial intelligence, allow for complex changes of microorganisms and microbial communities. It is likely that these applications may increase in near future. Some of these applications result in effects that are new to nature, while others use the endogenous potentials of microbes. This was confirmed by EFSA in 2020 who stated that“even with the complete genetic information of a synthetic micro-organism, it is beyond the capacity of any existent bioinformatic analysis to fully predict the capability of a synthetic organism to survive, colonise and interact with other organisms under natural conditions, given the uncountable diversity of potential micro-habitats and their temporal variability.” Consequently, the environmental risk assessment of GMMs that are part of the microbiomes and may occur across the borders of the life domains and exchange genetic material across border of species is extremely challenging. Lowering the standards would impair the ability to keep track of or control them.
Amendment 120
Aurelijus Veryga
Proposal for a directive
Recital 12 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12a) Specifically, it is necessary to lay down the criteria defining GMMs eligible for an expedited procedure. Such GMMs should be taxonomically and molecularly well characterized, considering their taxonomic identity, genome sequence and basic biological properties, should respect general safety standards as expressed in the Authority’s concept of Qualified Presumption of Safety (hereinafter referred to as “QPS”) and should not entail genes of concern introduced by or resulting from the genetic modification. |
Or. en
Amendment 121
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Recital 12 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12a) Considering that the Qualified Presumption of Safety (QPS) assessment focuses on the safety of microorganisms used in the food and feed chain, and applies at the level of species and family (for viruses), QPS status should not dispense with a full environmental risk assessment or with the need to consider the characteristics of the parental or recipient organisms, in addition to the genetic modifications introduced, accordance with Annex II of the Directive. |
Or. en
Amendment 122
Jessica Polfjärd
Proposal for a directive
Recital 12 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12a) Since the Authority's current application of the QPS concept is limited in scope, it is necessary to provide an alternative route to eligibility for an expedited procedure. This alternative route should maintain the same level of safety as the QPS status, while providing for streamlined regulatory processes and enabling access to innovative technologies. |
Or. en
Amendment 123
Aurelijus Veryga
Proposal for a directive
Recital 12 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12b) The QPS approach has been implemented by the Authority since 2007 with the aim of facilitating the safety assessment of applications for market authorisation through a simplified evaluation of microbial strains belonging to certain taxonomic units. It entails a pre-assessment of a micro-organism’s taxonomic identity, the related body of knowledge and potential safety concerns for human health, animal health and the environment. The QPS assessment is conducted separately and independently of the risk assessment of individual applications for market authorisation. It is intended to support, not replace, the overall case-by-case environmental risk assessment required under this Directive and carried out in accordance with the precautionary principle. In this regard, the QPS approach facilitates a harmonised and generic assessment of certain aspects of the safety of micro-organisms within the Union. Furthermore, the list of QPS-recommended micro-organisms is updated periodically, including through the assessment of the suitability of new taxonomic units. |
Or. en
Amendment 124
Jessica Polfjärd
Proposal for a directive
Recital 12 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12b) It is important that the criteria for eligibility for an expedited procedure take into account evolving scientific evidence and accumulated knowledge and safety experience. In order to ensure that the criteria remain fit for purpose, and for the purposes of the implementation of Directive 2001/18/EC, the criteria should be proactively reviewed and kept up to date. |
Or. en
Amendment 125
Aurelijus Veryga
Proposal for a directive
Recital 12 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12c) The QPS approach should be used to streamline the environmental risk assessment of certain GMMs belonging to a taxonomic unit for which specific safety concerns have already been excluded, on the basis of scientific knowledge and history of use, as part of the QPS assessment. Such safety concerns should not require reassessment, and the relevant safety data should not need to be resubmitted by notifiers, unless new scientific evidence indicates otherwise. Any aspects not covered by the QPS assessment, in particular potential risks associated with the genetic modification or the specific intended use of the GMM, should continue to be assessed as part of the GMM-specific environmental risk assessment. The QPS assessment should therefore support, but not replace, the case-by-case environmental risk assessment, which remains the responsibility of the competent authorities of the Member States. |
Or. en
Amendment 126
Aurelijus Veryga
Proposal for a directive
Recital 12 d (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (12d) Genes of concern should be understood broadly as any genes whose presence or expression in a GMM may cause harm to human health, animal health or the environment. In the glossary accompanying its guidance on the characterisation of micro-organisms¹¹, the Authority currently defines genes of concern as genes known to contribute to the production of toxins, harmful metabolites or therapeutic antimicrobials, acquired genes conferring resistance to therapeutic antimicrobials and, in the case of active agents, genes encoding virulence factors. Genes resulting from de novo design or other advanced applications of synthetic biology that confer functions not known to occur in nature should also be considered genes of concern. |
Or. en
Amendment 127
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
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. | deleted |
Or. en
Amendment 128
Aurelijus Veryga
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 eligible for an expedited procedure should be established in Directive 2001/18/EC, the rapid evolution of scientific and technical knowledge in this area should also be taken into account. The power to adopt acts in accordance with Article 290 TFEU should therefore be delegated to the Commission to supplement that Directive by further specifying those criteria, in particular the criterion relating to genes of concern, taking into account the Authority’s guidance. The Commission should also be empowered to add further cumulative criteria only insofar as justified by available scientific evidence, technological progress and experience gained from the release of comparable micro-organisms. Furthermore, the Commission should be empowered to amend Directive 2001/18/EC by adapting the data requirements for the environmental risk assessment of GMMs eligible for an expedited procedure, insofar as justified by their characteristics, including by specifying which data are not required as a result of compliance with the eligibility criteria. The Commission should also be empowered to adapt the authorisation procedure to provide for the demonstration of eligibility, streamline certain procedural elements and shorten the applicable timelines in line with the adapted risk assessment requirements. While the basic criteria to be fulfilled for a GMM to be eligible for an expedited procedure should be established in Directive 2001/18/EC, the rapid evolution of scientific and technical knowledge in this area should also be taken into account. The power to adopt acts in accordance with Article 290 TFEU should therefore be delegated to the Commission to supplement that Directive by further specifying those criteria, in particular the criterion relating to genes of concern, taking into account the Authority’s guidance. The Commission should also be empowered to add further cumulative criteria only insofar as justified by available scientific evidence, technological progress and experience gained from the release of comparable micro-organisms. Furthermore, the Commission should be empowered to amend Directive 2001/18/EC by adapting the data requirements for the environmental risk assessment of GMMs eligible for an expedited procedure, insofar as justified by their characteristics, including by specifying which data are not required as a result of compliance with the eligibility criteria. The Commission should also be empowered to adapt the authorisation procedure to provide for the demonstration of eligibility, streamline certain procedural elements and shorten the applicable timelines in line with the adapted risk assessment requirements. |
Or. en
Amendment 129
Martin Häusling
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 certain technical elements relating to the assessment of GMMs may need to be adapted in light of scientific and technical progress, the criteria determining whether a GMM qualifies as a GMM for expedited procedure directly affects the level of protection of human and animal health and the environment and should therefore be established by the co-legislators. The Commission should only be empowered, in accordance with Article 290 of the Treaty on the Functioning of the European Union, to update technical aspects of the implementation of those criteria. Any adaptation of risk assessment requirements or procedures for low-risk GMMs should remain subject to scientific assessment of the Authority and Member States to ensure the principle that regulatory simplification cannot result in reduced safety standards, reduced monitoring capacity or weakened application of the precautionary principle. |
Or. en
Amendment 130
Victor Negrescu
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 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. The benefits of these simplified procedures should be accessible to researchers, SMEs and innovators in all Member States and regions, including those with more limited scientific and regulatory capacity, thereby helping to reduce territorial disparities in biotechnology innovation. |
Or. en
Amendment 131
Gerben-Jan Gerbrandy, Stine Bosse, Jeannette Baljeu, Billy Kelleher
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 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 and scientifically justified. 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 when justified by available evidence of advances in scientific knowledge and technological progress and experience gained from the release of comparable micro-organisms, 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. |
Or. en
Amendment 132
Marie-Luce Brasier-Clain, Mathilde Androuët
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 lower risk GMM should be established in Directive 2001/18/EC, the Commission, under the strict supervision of the Member States, 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 to streamline certain procedural elements and expedite the timelines to reflect the adapted risk assessment requirements. |
Or. fr
Amendment 133
Jessica Polfjärd
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 eligible for an expedited procedure 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 eligibility for an expedited procedure, to streamline certain procedural elements and to expedite the timelines to reflect the adapted risk assessment requirements. |
Or. en
Amendment 134
Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl
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. | deleted |
| 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
Justification
Recital 14 should be deleted because it uses EFSA’s conditional recommendation to justify a broad exemption from post-market monitoring. EFSA’s recommendation applies only to certain GMMs, is based on an environmental risk assessment, and refers to future updated guidance, given current guidance is insufficient.
Amendment 135
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
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. | deleted |
| 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 136
Aurelijus Veryga
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 Authority, and in order not to impose a disproportionate administrative burden, GMMs eligible for an expedited procedure should not be subject to the obligation to establish a post-market environmental monitoring plan where they do not give rise to concerns warranting such monitoring, including potential indirect, delayed or unforeseen effects on human health, animal health or the environment. The competent authority should therefore be able, where duly justified, not to require post-market environmental monitoring, taking into account the results of any previous releases, the findings of the environmental risk assessment, the characteristics of the GMM, the characteristics and scale of its intended use, and the characteristics of the receiving 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 |
Or. en
Amendment 137
Martin Häusling
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, post-market environmental monitoring requirements should be proportionate to the characteristics and risks of the specific GMMs, but should not be waived completely as monitoring is necessary to detect indirect, delayed, cumulative or unforeseen effects on human health or 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
Justification
Since we have no experience with GMM authorisations under Part C of the Directive, we need monitoring in each case to develop knowledge and methods, and to review the risk assessment.
Amendment 138
Christophe Clergeau
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) Due to the biological characteristics of microorganisms, including their dispersal dynamics, rapid evolutionary adaptability and potential for horizontal gene transfer, improved monitoring concepts must be developed and implemented that take into account not only different groups of organisms but also various receiving environments. |
| 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
Justification
Due to lack of experience with releases of GMMs and in the light of the ongoing technological developments, post-market environmental monitoring cannot be dispensed. It also has to be considered that, due to the potential of several market authorisations within short periods of time, there is a need to monitor possible interactions between different GMMs. Environmental monitoring 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.This allows to obtain important environmental data via during the first period of authorisation, which has to be be taken into account in the re-evaluation of the specific GMM during renewal of consent. If the results of environmental monitoring confirm the assumptions of the environmental risk assessment and newly available information suggest that the criteria for authorisation are still met, the requirements for monitoring can be adjusted. Already under current legislation,it is possible to adopt the measures for monitoring, for example after renewal to the data that were provided before.
Amendment 139
Marie-Luce Brasier-Clain, Mathilde Androuët
Proposal for a directive
Recital 14
| Text proposed by the Commission | Amendment |
|---|---|
| (14) In line with the recommendations of the Authority, 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, GMMs eligible for a fast-track procedure 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. (‘New developments in biotechnology applied to microorganisms’, EFSA Journal, 22(7), e8895, 2024, 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. (‘New developments in biotechnology applied to microorganisms’, EFSA Journal, 22(7), e8895, 2024, point 3.3.2.9, https://doi.org/10.2903/j.efsa.2024.8895). |
Or. fr
Amendment 140
Gerben-Jan Gerbrandy, Stine Bosse, Jeannette Baljeu, Billy Kelleher
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, the notifier may be waived the obligation to establish a post-market environmental monitoring plan for low-risk GMMs 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 141
Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Recital 14 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (14a) The Parliament has called for the Union and its Member States not to grant patents on biological material and to safeguard the freedom to operate and the breeders’ exemption for varieties. It should be ensured that breeders have full access to the genetic material of NGT plants, which by definition are not transgenic plants. Access to genetic materials can best be secured when the right of patent holders is exhausted in the hand of the breeder (breeder’s exemption). As current provisions in patent law do not provide for a full breeder’s exemption, it should be ensured that patents should not restrict the use of NGT plants by breeders and farmers. Hence, NGT plants should not be subject to patent legislation, but should for the protection of intellectual property solely be subject to the Community Plant Variety Rights (CPVR) system, as laid down in Council Regulation (EC) No 2100/94, which allows the use of the breeder’s exemption. NGT plants, their derived seeds, their plant material, associated genetic material such as genes and gene sequences, and plant traits should therefore be excluded from patentability. The exclusion from patentability should be applied in a consistent manner across legislation. Furthermore, in order to avoid patents being granted or patent applications being submitted between the date of the entry into force of this Regulation and the application of its provisions, it should be ensured that plant material is excluded from patentability from the day of entry into force of this Regulation. For patents already granted or pending patent applications covering plant material, the effects of patents should be further limited. In addition, the Commission should assess and address, in the forthcoming study, how the broader problem of patents being granted, directly or indirectly, on plant material despite previous efforts to close loopholes, should be further addressed. The assessment should address in particular the role and impact of patents on breeders' and farmers' access to plant reproductive material, seed diversity and affordable prices, as well as on innovation and in particular on opportunities for SMEs. The report of the Commission should be accompanied by the appropriate legislative proposals in order to ensure further necessary adjustments are made to the intellectual property rights framework. |
Or. en
Justification
The European Parliament has repeatedly voiced its concerns regarding patentability of plants and genetic traits. The patent framework does not provide sufficient clarity and safeguards on the patentability of genetic traits that may also occur naturally or be achieved through conventional breeding. Concerns relate in particular to access to genetic resources, freedom to operate and possible market concentration in the seed sector.
Amendment 142
Christine Anderson, Marc Jongen, Anja Arndt, Volker Schnurrbusch
Proposal for a directive
Recital 14 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (14a) Genetically modified viruses require particular consideration due to their specific biological characteristics, including their dependence on host organisms, potential capacity for replication and transmission, genetic variability and potential for recombination or changes in host range. Moreover, the Status of Qualified Presumption of Safety may be granted at the level of a taxonomic family in the case of viruses, whereas for several other groups of micro-organisms it is generally granted at species level. A genetically modified virus should therefore not qualify automatically as a low-risk GMM solely by virtue of the status assigned to its taxonomic family. Its low-risk status should require a specific case-by-case assessment. In view of the remaining uncertainties and the possible difficulty of reversing dissemination, a post-market environmental monitoring plan should be required for genetically modified viruses. |
Or. en
Justification
The QPS status may apply to viruses at family level. This level of taxonomic generalisation, combined with the particular characteristics of viruses, does not provide a sufficient basis for automatic access to the low-risk procedure or for an exemption from post-market monitoring.
Amendment 143
Aurelijus Veryga
Proposal for a directive
Recital 14 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (14a) Vascularised composite allografts, such as hands or faces, are differentiated parts of the human body composed of different tissues, including skin, muscles, bones, tendons, nerves and blood vessels, and require the surgical connection of blood vessels and, where appropriate, nerves for transplantation. Once transplanted, they maintain their structure, vascularisation and capacity to develop physiological functions with a significant level of autonomy. They are also subject to time constraints comparable to those applicable to organs, owing to their vulnerability to ischaemia, limited preservation options and the need for immunosuppressive therapy. Vascularised composite allografts should therefore be considered organs for the purposes of this Directive. |
Or. en
Amendment 144
Martin Häusling
Proposal for a directive
Recital 14 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (14a) Certain GMMs possess characteristics such that an environmental risk assessment is inherently unable to establish the containment, reversibility or predictability of their effects following release into the environment. This applies, inter alia, to mirror organisms, to self-sustaining gene drives and to self-spreading viral constructs. Where scientific evidence is inconclusive but the consequences of release are potentially severe or irreversible, the precautionary principle set out in Article 191(2) of the Treaty on the Functioning of the European Union requires that no consent for the placing on the market of such GMM be granted. |
Or. en
Amendment 145
Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl
Proposal for a directive
Recital 14 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (14a) Certain GMMs may pose environmental risks that cannot be fully assessed before they are placed on the market. This is particularly the case for micro-organisms designed to spread beyond the place where they are applied or made from biological molecules that do not naturally occur in terrestrial life. Where the extent and reversibility of their release cannot be established, placing them on the market should not be authorised, in line with the precautionary principle under Article 191(2) TFEU, until sufficient scientific evidence is available to demonstrate that the release can be contained and reversed. |
Or. en
Justification
The proposal introduces reduced scrutiny for certain GMMs without providing safeguards for GMMs with potentially uncontrolled or irreversible spread, whose environmental risks cannot be reliably assessed or contained.
Amendment 146
Gerben-Jan Gerbrandy, Stine Bosse, Jeannette Baljeu, Billy Kelleher
Proposal for a directive
Recital 14 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (14a) Following the EFSA opinion, the Authoirty should adopt and update 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. To inform this guidance, the Commission should 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. |
Or. en
Justification
EFSA concluded that the guidance should be improved. Moreover, as there is limited research available for this field, suggestion to establish a dedicated research programme to further inform decisions, requirements and guidance.
Amendment 147
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Recital 14 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (14b) Genetic information contained in humans and all other living organisms is a public good and should not be patented. |
Or. en
Amendment 148
Ignazio Roberto Marino
Proposal for a directive
Recital 15
| Text proposed by the Commission | Amendment |
|---|---|
| (15) Processing, including preservation, of human organs is increasingly frequent and allows the ex-vivo time window between procurement from the donor and transplantation into the recipient to be extended. | (15) Processing, including preservation, assessment, repair and other techniques aimed at maintaining or improving the viability of donated human organs while preserving their status as donated human organs, is increasingly frequent and allows the ex-vivo time window between procurement from the donor and transplantation into the recipient to be extended. |
Or. en
Amendment 149
Aurelijus Veryga
Proposal for a directive
Recital 15
| Text proposed by the Commission | Amendment |
|---|---|
| (15) Processing, including preservation, of human organs is increasingly frequent and allows the ex-vivo time window between procurement from the donor and transplantation into the recipient to be extended. | (15) Processing, including preservation, of human organs outside the body is increasingly frequent and allows the time window between procurement from the donor and transplantation into the recipient to be extended. |
Or. en
Amendment 150
Ondřej Knotek, Jana Nagyová, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
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 support safe and ethical application of biological characteristics or suitability for transplantation of organ processing through improved legal certainty, predictability and transparency. |
Or. en
Amendment 151
Christine Anderson, Marc Jongen, Anja Arndt, Volker Schnurrbusch
Proposal for a directive
Recital 15 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (15a) Where organ donation follows euthanasia, particular safeguards should apply to ensure that the decision concerning euthanasia is taken entirely independently of any consideration of organ donation or transplantation. Vulnerable persons must be protected from any direct or indirect pressure or conflict of interest, and consent to organ donation must be free, informed and clearly documented. Member States should remain free to apply stricter ethical requirements, including restrictions on the transplantation of organs procured following euthanasia. |
Or. en
Amendment 152
Ignazio Roberto Marino
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 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. Where processing involves novel techniques or substantial modification of organs, appropriate ethical oversight should also be ensured. The development and use of such technologies should contribute to improved outcomes for all patients and should not lead to inequalities in access to transplantation based on economic or other non-medical factors, while respecting the principles of voluntary and unpaid donation and the non-commercialisation of the human body and its parts. |
Or. en
Amendment 153
Victor Negrescu
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 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. Such oversight should also promote transparency by ensuring that healthcare professionals and patients have access to clear and relevant information on the intended use, benefits, risks and, where available, clinical outcomes of organ processing techniques authorised in accordance with the applicable Union framework and applied to organs intended for transplantation. |
Or. en
Amendment 154
Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
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, including through the application of medicinal products, medical devices or substances of human origin (SoHO). These developments can improve the quality and functionality or modify the properties of organs available for transplantation, contributing to expand treatment options for patients on waiting lists or to enhance post-transplant outcomes. 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. |
Or. en
Amendment 155
Elena Nevado del Campo, Dolors Montserrat
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) Organ processing technologies not only allow for more efficient organisational set-up, but also for the improvement or modification of human organs during the extended ex-vivo time window, including through the application of medicinal products, medical devices or substances of human origin (SoHO). These developments can improve the quality and functionality or modify the properties of organs available for transplantation, contributing to expand treatment options for patients on waiting lists and improving post transplant outcomes. 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. |
Or. en
Amendment 156
Aurelijus Veryga
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 processing methods not only allows for more efficient organisational set-up, but also for improving the functional status of human organs during the extended time window outside the body, 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. |
Or. en
Amendment 157
Romana Jerković, Vytenis Povilas Andriukaitis
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) Organ processing technologies not only allow 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. |
Or. en
Amendment 158
Margarita de la Pisa Carrión
Proposal for a directive
Recital 16 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (16a) The processing, procurement and transplantation of organs should at all times respect the human dignity, right to life and integrity of the donor person. In particular, actions aimed at preserving, improving or facilitating the procurement or subsequent use of an organ should not aim to cause or accelerate the death of the donor or prioritise the viability of the organ over the protection of the donor’s life and health. In the case of donation after death, the procurement and processing of organs may only be carried out after the death has been duly certified in accordance with the applicable legislation and with the guarantees of independence provided for in the Additional Protocol to the Convention on Human Rights and Biomedicine on the Transplantation of Organs and Tissues of Human Origin. |
Or. es
Amendment 159
Ondřej Knotek, Jana Nagyová, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
Proposal for a directive
Recital 16 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (16a) The increasing use of innovative and proprietary technologies in organ processing should not undermine the fundamental principles governing organ donation and transplantation. A distinction should therefore be maintained between the donated organ and the medicinal products, medical devices, technologies and services used for its processing. The use of proprietary products or technologies to process an organ should not, in itself, result in the donated organ becoming a commercial good or affect the voluntary and unpaid character of its donation or the non-profit nature of its procurement. This should be without prejudice to legitimate intellectual property rights and to the remuneration of products, technologies and services used for organ processing. |
Or. en
Amendment 160
Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Recital 16 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (16a) Article 3(2)(c) of the Charter of Fundamental Rights of the European Union provides that, in the fields of medicine and biology, the human body and its parts shall not, as such, give rise to financial gain. This principle is intended to safeguard human dignity by preventing the commercialisation of the human body and its parts. Accordingly, human organs should not be regarded as commercial commodities, irrespective of the processing or modifications to which they are subjected or of the therapeutic, preventive or other purposes for which they may subsequently be used. Therefore, organs intended for transplantation should remain within the scope of this Directive irrespective of any processing applied to them. |
Or. en
Amendment 161
Romana Jerković, Vytenis Povilas Andriukaitis
Proposal for a directive
Recital 16 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (16a) Article 3(2)(c) of the Charter of Fundamental Rights of the European Union provides that, in the fields of medicine and biology, the human body and its parts shall not, as such, give rise to financial gain. This principle is intended to safeguard human dignity by preventing the commercialisation of the human body and its parts. Accordingly, human organs should not be regarded as commercial commodities, irrespective of the processing or modifications to which they are subjected or of the therapeutic, preventive or other purposes for which they may subsequently be used. |
Or. en
Amendment 162
Christine Anderson, Marc Jongen, Anja Arndt, Volker Schnurrbusch
Proposal for a directive
Recital 16 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (16a) Transplantation services must follow the dead donor rule, whereby they cannot kill for the purpose of organ recovery for transplantation. |
Or. en
Amendment 163
Ondřej Knotek, Jana Nagyová, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
Proposal for a directive
Recital 16 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (16b) Where the processing involves a medicinal product or a technology falling within the competence of another authority under Union law, the competent authority shall, where necessary, cooperate with and seek the scientific and technical expertise of that authority on matters falling within its competence. Relevant assessments already carried out under applicable Union legislation shall be taken into account in order to avoid unnecessary duplication of assessments and requirements. The scientific and technical assessment referred to in this paragraph shall be without prejudice to the responsibility of the competent authority under this Directive for the authorisation of the processing of the organ. |
Or. en
Justification
Novel organ-processing techniques, in particular genetic, biological or immunological modifications performed ex vivo, may present additional risks that require strengthened assessment of the quality, safety, functionality and effectiveness of the processed organ. Such assessment should be proportionate to the level of risk and, where appropriate, draw on the scientific and technical expertise available to authorities responsible for medicinal products or other technologies used in the processing.Assessment and authorisation should, however, be clearly distinguished. The application of assessment standards inspired by pharmaceutical legislation, or the involvement of medicines authorities in the scientific and technical evaluation of a processing technique, should not in itself determine the regulatory status of the processed organ or transfer responsibility for its authorisation from the competent transplantation authority.The amendment therefore provides for cooperation between the relevant authorities while maintaining a clear allocation of responsibilities. The competent transplantation authority remains responsible for authorising the processing of the organ under this Directive, while specialised authorities may contribute to the assessment of matters falling within their respective fields of expertise.Where relevant assessments have already been performed under other applicable Union legislation, they should be taken into account in order to avoid duplication, unnecessary administrative burdens and delays. This approach combines rigorous, risk-proportionate evaluation of innovative organ-processing techniques with legal certainty and preserves the integration of processed organs within existing donation and transplantation systems.
Amendment 164
Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Recital 16 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (16b) Organ processing should be understood as any operation involving the manipulation of organs outside the body, including, but not limited to, preservation, the application of medicinal products, medical devices or SoHO preparations, and surgery, performed to maintain, improve or modify the functioning or properties of an organ prior to transplantation, with the exception of the preparatory handling of the organ before or during the surgical transplantation intervention. |
Or. en
Amendment 165
Elena Nevado del Campo, Dolors Montserrat
Proposal for a directive
Recital 17
| Text proposed by the Commission | Amendment |
|---|---|
| (17) To ensure a consistent and comprehensive legislative framework by providing clarity for all actors involved, Directive 2010/53/EU should cover processing of organs, beyond preservation of such organs. In order to ensure coherence and efficient coordination among authorities operating under different Union legislative frameworks in the health area, provisions should be laid down to clarify which of the technologies used fall under Union legislative frameworks other than Directive 2010/53/EU, in particular the frameworks established in Directive 2001/83/EC of the European Parliament and of the Council14 , Regulation (EC) No 726/2004 of the European Parliament and of the Council15 , Regulation (EU) 2017/745 of the European Parliament and of the Council16 and Regulation (EU) 2024/1938 of the European Parliament and of the Council17 . Such provisions should aim to at ensuring coherence and efficient coordination among authorities operating under those frameworks. Directive 2010/53/EU should therefore be amended accordingly. | (17) To ensure a consistent and comprehensive legislative framework by providing clarity for all actors involved, Directive 2010/53/EU should cover processing of organs, beyond preservation of such organs. In order to ensure coherence and efficient coordination among authorities operating under different Union legislative frameworks in the health area, provisions should be laid down to clarify the interaction between this Directive and the Union legislation governing medicinal products, medical devices and substances of human origin (SoHO), in particular Directive 2001/83/EC of the European Parliament and of the Council14 , Regulation (EC) No 726/2004 of the European Parliament and of the Council15 , Regulation (EU) 2017/745 of the European Parliament and of the Council16 and Regulation (EU) 2024/1938 of the European Parliament and of the Council17 . Specific attention should be paid to medicinal products developed solely for use in organ processing and whose effects are mediated through the processed organ. In such circumstances, their use as part of the organ-processing procedure should be authorised, in accordance with this Directive, by the competent authority responsible for organ processing, instead of requiring a marketing authorisation under Directive 2001/83/EC or Regulation (EC) No 726/2004. This approach should not affect the application of the relevant requirements of Union pharmaceutical legislation, including those concerning manufacturing authorisations, good manufacturing practice, quality, safety and regulatory supervision. This approach would preserve the distinction between the non-commercial status of human organs and the legitimate remuneration of transplantation-related services, including justified costs and investment in research and innovation, while remaining consistent with the ethical principles governing organ donation and transplantation in the Union. It would also support regulatory coherence, transparency and equitable access to transplantation therapies. Directive 2010/53/EU should therefore be amended accordingly. |
| 14 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, p. 67, ELI: http://data.europa.eu/eli/dir/2001/83/oj). | 14 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, p. 67, ELI: http://data.europa.eu/eli/dir/2001/83/oj). |
| 15 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/726/oj). | 15 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/726/oj). |
| 16 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj). | 16 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj). |
| 17 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (OJ L, 2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj). | 17 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (OJ L, 2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj). |
Or. en
Amendment 166
Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Recital 17
| Text proposed by the Commission | Amendment |
|---|---|
| (17) To ensure a consistent and comprehensive legislative framework by providing clarity for all actors involved, Directive 2010/53/EU should cover processing of organs, beyond preservation of such organs. In order to ensure coherence and efficient coordination among authorities operating under different Union legislative frameworks in the health area, provisions should be laid down to clarify which of the technologies used fall under Union legislative frameworks other than Directive 2010/53/EU, in particular the frameworks established in Directive 2001/83/EC of the European Parliament and of the Council14 , Regulation (EC) No 726/2004 of the European Parliament and of the Council15 , Regulation (EU) 2017/745 of the European Parliament and of the Council16 and Regulation (EU) 2024/1938 of the European Parliament and of the Council17 . Such provisions should aim to at ensuring coherence and efficient coordination among authorities operating under those frameworks. Directive 2010/53/EU should therefore be amended accordingly. | (17) In order to ensure legal clarity and coherence across Union legislation, it is necessary to establish that organ processing falls within the scope of Directive 2010/53/EU and to clarify its interaction with Union legislation governing medicinal products, medical devices and SoHO, in particular Directive 2001/83/EC of the European Parliament and of the Council14, Regulation (EC) No 726/2004 of the European Parliament and of the Council15, Regulation (EU) 2017/745 of the European Parliament and of the Council16 and Regulation (EU) 2024/1938 of the European Parliament and of the Council17. Special consideration should be given to medicinal products used exclusively within organ processing. Where such medicinal products are intended solely for use during organ processing and their effects are exerted through the processed organ, it is therefore appropriate that their use be authorised by the competent authority responsible for organ processing in accordance with this Directive, rather than being subject to a marketing authorisation under Directive 2001/83/EC or Regulation (EC) No 726/2004. This should be without prejudice to the applicable requirements of Union pharmaceutical legislation relating to manufacturing authorisations, good manufacturing practice, quality, safety and regulatory oversight. Such an approach would ensure that the use of medicinal products exclusively within organ processing is considered a specialised technical service performed prior to the transplantation of the organ. It would thereby preserve the distinction between prohibited financial gain derived from the human body and remuneration for legitimate transplantation-related services, including the recovery of justified costs and appropriate investment in research, development and innovation. In doing so, it would ensure consistency with the ethical principles governing organ donation and transplantation within the Union, while promoting regulatory coherence, transparency, sustainable innovation and equitable access to transplantation therapies. |
| 14 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, p. 67, ELI: http://data.europa.eu/eli/dir/2001/83/oj). | 14 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, p. 67, ELI: http://data.europa.eu/eli/dir/2001/83/oj). |
| 15 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/726/oj). | 15 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/726/oj). |
| 16 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj). | 16 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj). |
| 17 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (OJ L, 2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj). | 17 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (OJ L, 2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj). |
Or. en
Amendment 167
Ignazio Roberto Marino
Proposal for a directive
Recital 17
| Text proposed by the Commission | Amendment |
|---|---|
| (17) To ensure a consistent and comprehensive legislative framework by providing clarity for all actors involved, Directive 2010/53/EU should cover processing of organs, beyond preservation of such organs. In order to ensure coherence and efficient coordination among authorities operating under different Union legislative frameworks in the health area, provisions should be laid down to clarify which of the technologies used fall under Union legislative frameworks other than Directive 2010/53/EU, in particular the frameworks established in Directive 2001/83/EC of the European Parliament and of the Council14 , Regulation (EC) No 726/2004 of the European Parliament and of the Council15 , Regulation (EU) 2017/745 of the European Parliament and of the Council16 and Regulation (EU) 2024/1938 of the European Parliament and of the Council17 . Such provisions should aim to at ensuring coherence and efficient coordination among authorities operating under those frameworks. Directive 2010/53/EU should therefore be amended accordingly. | (17) To ensure a consistent and comprehensive legislative framework by providing clarity for all actors involved, Directive 2010/53/EU should cover processing of organs, beyond preservation of such organs. Processing should remain limited to interventions performed on donated human organs after procurement and before or during chirugical transplantation for the purposes of preservation, assessment, repair or restoration of viability and should not alter the legal status of the organ as a donated human organ. In order to ensure coherence and efficient coordination among authorities operating under different Union legislative frameworks in the health area, provisions should be laid down to clarify which of the technologies used fall under Union legislative frameworks other than Directive 2010/53/EU, in particular the frameworks established in Directive 2001/83/EC of the European Parliament and of the Council14 , Regulation (EC) No 726/2004 of the European Parliament and of the Council15 , Regulation (EU) 2017/745 of the European Parliament and of the Council16 and Regulation (EU) 2024/1938 of the European Parliament and of the Council17 . Where medicinal products are intended solely for use during organ processing and their effects are exerted through the processed organ, it is therefore appropriate that their use be authorised by the competent authority responsible for organ processing in accordance with this Directive, rather than being subject to a marketing authorisation under Directive 2001/83/EC or Regulation (EC) No 726/2004. This should be without prejudice to the applicable requirements of Union pharmaceutical legislation relating to manufacturing authorisations, good manufacturing practice, quality, safety and regulatory oversight. Such provisions should aim to at ensuring coherence and efficient coordination among authorities operating under those frameworks. Directive 2010/53/EU should therefore be amended accordingly. |
| 14 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, p. 67, ELI: http://data.europa.eu/eli/dir/2001/83/oj). | 14 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, p. 67, ELI: http://data.europa.eu/eli/dir/2001/83/oj). |
| 15 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/726/oj). | 15 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/726/oj). |
| 16 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj). | 16 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj). |
| 17 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (OJ L, 2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj). | 17 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (OJ L, 2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj). |
Or. en
Amendment 168
Ondřej Knotek, Jana Nagyová, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
Proposal for a directive
Recital 17
| Text proposed by the Commission | Amendment |
|---|---|
| (17) To ensure a consistent and comprehensive legislative framework by providing clarity for all actors involved, Directive 2010/53/EU should cover processing of organs, beyond preservation of such organs. In order to ensure coherence and efficient coordination among authorities operating under different Union legislative frameworks in the health area, provisions should be laid down to clarify which of the technologies used fall under Union legislative frameworks other than Directive 2010/53/EU, in particular the frameworks established in Directive 2001/83/EC of the European Parliament and of the Council14 , Regulation (EC) No 726/2004 of the European Parliament and of the Council15 , Regulation (EU) 2017/745 of the European Parliament and of the Council16 and Regulation (EU) 2024/1938 of the European Parliament and of the Council17 . Such provisions should aim to at ensuring coherence and efficient coordination among authorities operating under those frameworks. Directive 2010/53/EU should therefore be amended accordingly. | (17) To ensure a consistent and comprehensive legislative framework by providing clarity for all actors involved, Directive 2010/53/EU should cover processing of organs, beyond preservation of such organs. In order to ensure coherence and efficient coordination among authorities operating under different Union legislative frameworks in the health area, provisions should be laid down to clarify which of the technologies used fall under Union legislative frameworks other than Directive 2010/53/EU, in particular the frameworks established in Directive 2001/83/EC of the European Parliament and of the Council14 , Regulation (EC) No 726/2004 of the European Parliament and of the Council15 , Regulation (EU) 2017/745 of the European Parliament and of the Council16 and Regulation (EU) 2024/1938 of the European Parliament and of the Council17 . The application of such Union legislation to a medicinal product or technology used for organ processing should not, in itself, exclude the application of Directive 2010/53/EU to the organ or alter its status for the purposes of that Directive. Where specialised scientific or technical expertise is required for the assessment of an organ-processing procedure, the competent authorities under Directive 2010/53/EU should cooperate, where necessary, with the competent authorities under the relevant Union legislative framework, within their respective competences. Relevant assessments already carried out under those frameworks should be taken into account in order to avoid unnecessary duplication of assessments and requirements and administrative burden. Such cooperation should be without prejudice to the responsibility of the competent authority under Directive 2010/53/EU for the authorisation of organ processing under that Directive. Directive 2010/53/EU should therefore be amended accordingly. |
| 14 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, p. 67, ELI: http://data.europa.eu/eli/dir/2001/83/oj). | 14 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, p. 67, ELI: http://data.europa.eu/eli/dir/2001/83/oj). |
| 15 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/726/oj). | 15 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/726/oj). |
| 16 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj). | 16 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj). |
| 17 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (OJ L, 2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj). | 17 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (OJ L, 2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj). |
Or. en
Justification
Novel organ-processing techniques may fall under several Union regulatory frameworks. Clear coordination is needed to avoid regulatory gaps, duplication and unnecessary burdens. Relevant scientific assessments should be shared between competent authorities, while the application of other Union rules should not remove the organ from Directive 2010/53/EU or affect the transplant authority’s responsibility for authorization.
Amendment 169
Victor Negrescu
Proposal for a directive
Recital 17
| Text proposed by the Commission | Amendment |
|---|---|
| (17) To ensure a consistent and comprehensive legislative framework by providing clarity for all actors involved, Directive 2010/53/EU should cover processing of organs, beyond preservation of such organs. In order to ensure coherence and efficient coordination among authorities operating under different Union legislative frameworks in the health area, provisions should be laid down to clarify which of the technologies used fall under Union legislative frameworks other than Directive 2010/53/EU, in particular the frameworks established in Directive 2001/83/EC of the European Parliament and of the Council14 , Regulation (EC) No 726/2004 of the European Parliament and of the Council15 , Regulation (EU) 2017/745 of the European Parliament and of the Council16 and Regulation (EU) 2024/1938 of the European Parliament and of the Council17 . Such provisions should aim to at ensuring coherence and efficient coordination among authorities operating under those frameworks. Directive 2010/53/EU should therefore be amended accordingly. | (17) To ensure a consistent and comprehensive legislative framework by providing clarity for all actors involved, Directive 2010/53/EU should cover processing of organs, beyond preservation of such organs. In order to ensure coherence and efficient coordination among authorities operating under different Union legislative frameworks in the health area, provisions should be laid down to clarify which of the technologies used fall under Union legislative frameworks other than Directive 2010/53/EU, in particular the frameworks established in Directive 2001/83/EC of the European Parliament and of the Council14 , Regulation (EC) No 726/2004 of the European Parliament and of the Council15 , Regulation (EU) 2017/745 of the European Parliament and of the Council16 and Regulation (EU) 2024/1938 of the European Parliament and of the Council17 . Such provisions should aim to at ensuring coherence and efficient coordination among authorities operating under those frameworks. Enhanced cooperation between competent authorities should also support the safe cross-border exchange for transplantation of legally donated human organs that have undergone authorised processing and improve access to transplantation for patients, especially where the necessary processing technology is not available in the Member State where they are treated. Directive 2010/53/EU should therefore be amended accordingly. |
| 14 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, p. 67, ELI: http://data.europa.eu/eli/dir/2001/83/oj). | 14 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, p. 67, ELI: http://data.europa.eu/eli/dir/2001/83/oj). |
| 15 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/726/oj). | 15 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/726/oj). |
| 16 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj). | 16 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj). |
| 17 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (OJ L, 2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj). | 17 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (OJ L, 2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj). |
Or. en
Amendment 170
Aurelijus Veryga
Proposal for a directive
Recital 17 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (17a) With a view to ensuring streamlined procedures and avoiding duplication, the requirements laid down in this Directive concerning benefit-risk assessments, clinical-outcome monitoring plans and the authorisation of new organ-processing methods should not apply where such methods are used within a clinical trial, clinical investigation, performance study or SoHO clinical study authorised under the applicable Union health legislation for the same clinical indication and scope of use. Those requirements should likewise not apply where the organ-processing method involves the use of a medicinal product, medical device or SoHO preparation in accordance with the terms of the applicable marketing authorisation, conformity assessment or SoHO preparation authorisation. The competent authorities responsible for implementing Directive 2010/53/EU and the relevant national rules governing organ procurement, allocation and transplantation should be informed before such clinical studies are authorised, so as to ensure compliance with those provisions. |
Or. en
Amendment 171
Nicolás González Casares, Leire Pajín
Proposal for a directive
Recital 17 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (17a) The principle that the human body and its parts shall not, as such, give rise to financial gain constitutes a cornerstone of European bioethics law. That principle is enshrined in Article 3(2)(c) of the Charter of Fundamental Rights of the European Union, as well as in Article 21 of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Oviedo Convention) and in Article 21 of its Additional Protocol concerning Transplantation of Organs and Tissues of Human Origin. No human organ intended for transplantation should be made subject, directly or indirectly, to a legal regime oriented towards its commercial exploitation, regardless of the technological process to which it has been subjected. |
Or. en
Justification
Establishes the legal and ethical basis for the amendments that follow, preventing the revision of the Directive from opening an indirect pathway towards the commercialisation of the human body.
Amendment 172
Aurelijus Veryga
Proposal for a directive
Recital 17 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (17b) To ensure a consistent and comprehensive legislative framework and provide legal clarity for all actors involved, Directive 2010/53/EU should cover the processing of organs outside the human body, for both allogeneic and autologous use, beyond their preservation. Such processing should be intended to maintain or improve the functioning of the organ or to modify its properties without altering its original functions. Modifications may include, for example, the genetic modification of an organ to improve immunocompatibility or the administration of medicinal products to prevent disease transmission from the donor to the recipient. Member States should establish requirements for the authorisation by the competent authorities of new organ-processing methods. Authorisation should be required where the benefit-risk assessment identifies a high risk to the quality of the organ or to the safety or effectiveness of the transplantation or autologous use. Clinical-outcome monitoring plans should also be required where the available scientific evidence and clinical data are insufficient to permit a comprehensive assessment. |
Or. en
Amendment 173
Nicolás González Casares, Leire Pajín
Proposal for a directive
Recital 17 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (17b) The principles governing organ donation and transplantation in the Union — voluntary and unpaid donation, the allocation of organs according to transparent and equitable clinical and social criteria, and the absence of any profit motive — are shared by the World Health Organization, the Council of Europe and the European Union. Those principles underpin the public trust on which altruistic donation is based, and on which thousands of transplants depend each year in the Union. |
Or. en
Justification
Reflects the common principles of the WHO, the Council of Europe and the European Union identified in recent scientific literature (Cuende, Izeta and Domínguez-Gil, 2026) as the foundation for any amendment of the Directive.
Amendment 174
Nicolás González Casares, Leire Pajín
Proposal for a directive
Recital 17 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (17c) The coexistence of two pathways of access to organs — one based on altruistic donation and subject to the established allocation criteria, and another resulting from the incorporation into the organ of commercialised products or technologies — would compromise the equity of the system and could undermine public trust in donation, with the consequent risk of a reduction in donation rates to the detriment of patients on waiting lists. This Directive should prevent such coexistence, ensuring that organs subjected to technological processes remain fully within the single donation and allocation system. |
Or. en
Amendment 175
Aurelijus Veryga
Proposal for a directive
Recital 17 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (17c) With regard to the provisions on organ processing laid down in this Directive, it is important to recall that Article 3 of the Charter of Fundamental Rights of the European Union prohibits making the human body and its parts as such a source of financial gain. |
Or. en
Amendment 176
Aurelijus Veryga
Proposal for a directive
Recital 17 d (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (17d) To ensure a high level of human health protection in organ donation, transplantation and autologous use, personal data, including data concerning health and genetic data, collected for donation, allocation, organ processing, transplantation and follow-up should, where necessary and proportionate, be permitted to be further processed for reasons of public interest in the area of public health. Such processing may include cross-border data sharing within the Union to ensure patient safety and high standards of quality and safety of healthcare and to support the analysis of transplantation and autologous-use outcomes across larger patient cohorts. Such processing should be carried out in accordance with Regulation (EU) 2016/679 and be subject to appropriate and specific safeguards for the rights and freedoms of data subjects. |
Or. en
Amendment 177
Nicolás González Casares, Leire Pajín
Proposal for a directive
Recital 17 d (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (17d) Scientific and technological advances applied to organs intended for transplantation — including ex vivo or ex situ perfusion, gene therapy, and cellular or organoid-based reconstruction, remodelling or repair techniques — should not result in such organs being excluded from the scope of Directive 2010/53/EU or made subject to the regulatory frameworks laid down for medicinal products or other marketable goods. The donation and transplantation framework should instead be adapted to safely accommodate such advances, while preserving at all times the non-commercial nature of the organ. |
Or. en
Justification
It warns of the risk that the definition of 'processing' proposed by the Commission would exclude from the scope of the Directive manipulations carried out by means of medicinal products
Amendment 178
Nicolás González Casares, Leire Pajín
Proposal for a directive
Recital 17 e (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (17e) The Union already has a proportionate, well-tested risk-assessment methodology developed for substances of human origin under Regulation (EU) 2024/1938 — the European Good Tissue and Cells Practices, second edition (EuroGTP II) methodology. That methodology, adapted to the specific characteristics of organs, should serve as a reference for classifying the risk of processes applied to organs, determining the scope of clinical evidence required, and calibrating follow-up obligations, thereby avoiding the automatic transposition to organs of requirements designed for the pharmaceutical framework. |
Or. en
Amendment 179
Nicolás González Casares, Leire Pajín
Proposal for a directive
Recital 17 f (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (17f) Innovation in organ processing requires the involvement of companies developing the relevant technologies. Such involvement should be structured through the provision of technical services subject to public oversight, so that companies may own the technology used, but never the processed organ, which remains under the social ownership and allocation regime proper to the donation and transplantation system. |
Or. en
Amendment 180
Nicolás González Casares, Leire Pajín
Proposal for a directive
Recital 17 g (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (17g) The regime established in this Directive for the processing of organs constitutes a permanent legal framework of direct application by the Member States. It is therefore for the Member States to designate, and to provide with sufficient means, the competent authorities for organs referred to in Article 17, ensuring their effective and stable cooperation with the national competent authorities for medicinal products. |
Or. en
Amendment 181
Anja Hazekamp, Emma Fourreau, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
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 and the coordination and exchange of information between competent authorities responsible for organ processing and those responsible for medicinal products, medical devices and SoHO. Those implementing acts should be adopted in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council18 . |
| 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 182
Aurelijus Veryga
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 arrangements for complying with analytical method performance requirements and the supporting information to be submitted to demonstrate the fulfilment of the criteria for being considered a GMM eligible for an expedited procedure 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 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 183
Marie-Luce Brasier-Clain, Mathilde Androuët
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 GMM eligible for a fast-track procedure 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 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. fr
Amendment 184
Jessica Polfjärd
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 eligible for an expedited procedure 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 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 185
Ignazio Roberto Marino
Proposal for a directive
Recital 19 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (19a) Patients who are highly sensitised, including those presenting a very high panel-reactive antibody (PRA) level, face significantly reduced prospects of receiving a compatible kidney through conventional national allocation systems, since the probability of identifying a compatible donor decreases sharply as the degree of sensitisation increases. Enlarging the pool of donor-recipient pairs available for matching beyond national borders substantially increases the likelihood of identifying an immunologically compatible living-donor kidney for such patients. Member States should therefore cooperate to establish a Union-wide paired kidney exchange mechanism, supported where appropriate by validated organ perfusion and preservation technologies enabling longer-distance transport without compromising organ viability. Such cooperation should be conducted in full compliance with Union rules on the protection of personal data and with the quality and safety requirements laid down in this Directive, and should aim to minimise the time during which highly sensitised patients remain without access to a compatible organ and to prevent, to the extent medically and technically possible, their exclusion from transplantation solely on account of immunological incompatibility. The Commission should also assess the feasibility of extending paired kidney exchange programmes to third countries applying standards equivalent to those of the Union. |
Or. en
Amendment 186
Romana Jerković, Vytenis Povilas Andriukaitis
Proposal for a directive
Recital 19 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (19a) Organ processing technique should be authorised on the basis of the available scientific evidence and clinical data, taking into account the processing steps applied to the organ, the organ concerned, the intended clinical indication, the expected benefits for the recipient, the risks associated with the processing and any remaining scientific uncertainty. |
Or. en
Amendment 187
Romana Jerković, Vytenis Povilas Andriukaitis
Proposal for a directive
Recital 19 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (19b) Where the processing of an organ entails the use of a medicinal product, medical device or SoHO preparation, compliance of that medicinal product, medical device or SoHO preparation with the applicable Union legislation should not in itself be considered sufficient to establish the safety of the processing of the organ. The benefit-risk assessment should also take into account the interaction between the processing applied to the organ and the medicinal product, medical device or SoHO preparation concerned. |
Or. en
Amendment 188
Romana Jerković, Vytenis Povilas Andriukaitis
Proposal for a directive
Recital 19 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (19c) Where the processing of an organ raises questions concerning the application of the Union legislation on medicinal products, medical devices or SoHO preparations, the competent authorities under the respective Union legislative frameworks should cooperate within their respective competences with a view to ensuring a consistent application of those frameworks and avoiding gaps in regulatory oversight. |
Or. en
Amendment 189
Romana Jerković, Vytenis Povilas Andriukaitis
Proposal for a directive
Recital 19 d (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (19d) Serious adverse events and reactions and other serious safety concerns associated with organ processing identified in one Member State may be relevant to processed organs applied in other Member States. Such information should therefore be rapidly exchanged between competent authorities through an EU Alert Mechanism for Organ Processing. |
Or. en
Amendment 190
Romana Jerković, Vytenis Povilas Andriukaitis
Proposal for a directive
Recital 19 e (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (19e) Member States and the Commission should, within their respective competences, monitor the impact of the cost and availability of technologies used for organ processing, including the impact of intellectual property rights, on access to transplantation. |
Or. en
Amendment 191
Romana Jerković, Vytenis Povilas Andriukaitis
Proposal for a directive
Recital 19 f (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (19f) The use of technologies developed or supplied by economic operators for organ processing should be without prejudice to the principles governing organ donation laid down in this Directive. Economic interests relating to such technologies should not influence organ allocation or recipient selection. |
Or. en
Amendment 192
Romana Jerković, Vytenis Povilas Andriukaitis
Proposal for a directive
Recital 19 g (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (19g) Where a processed organ is to be applied to a recipient, the recipient should receive appropriate and comprehensible information concerning the processing applied and, where relevant, any additional risks or scientific uncertainty associated with that processing, in accordance with applicable national rules on consent. |
Or. en
Amendment 193
Martin Häusling
Proposal for a directive
Article 1 – paragraph 1 – point 1 – introductory part
| Text proposed by the Commission | Amendment |
|---|---|
| (1) in Article 2, the following points (9), (10) and (11) are added: | (1) in Article 2, the following points (9), (10), (11) and (11a) are added: |
Or. en
Amendment 194
Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl
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 taxonomic units of micro-organisms on the basis of a preassessment of their taxonomic identity, the related body of knowledge and potential safety concerns, conducted separately from and without prejudice to the risk assessment of any individual notification;’ |
Or. en
Justification
Article 24e(1)(b) incorrectly uses QPS status as a basis for reduced environmental data requirements, although QPS was not designed as an environmental safety criterion.
Amendment 195
Martin Häusling
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 microorganisms used in the food chain, which may be subject to qualifications and does not, by itself, establish the environmental safety of GMMs released into the environment. |
Or. en
Justification
QPS status applies to microorganisms used in food and feed production. It is attributed based on a review of the scientific literature and involves four pillars:
⦁ the taxonomic unit (TU) for which QPS is sought (‘taxonomic identification’);
⦁ whether sufficient relevant information is available about the proposed TU to conclude on human/animal exposure via food/feed (‘body of knowledge’)
⦁ whether the TU proposed contains known ‘safety concerns’ and,
⦁ the intended end use (‘intended use’).
Standard qualifications include "for production purposes only," which implies the absence of viable cells 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).
Amendment 196
Aurelijus Veryga
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 as a result of a case-by-case pre-assessment of their taxonomic identity, the related body of knowledge and potential safety concerns; |
Or. en
Amendment 197
Jessica Polfjärd
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 the basis of an assessment, covering their taxonomic identity and the related body of knowledge, showing no safety concerns;’ |
Or. en
Amendment 198
Marie-Luce Brasier-Clain, Mathilde Androuët
Proposal for a directive
Article – 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 provisional and indicative safety status assigned by the Authority to selected groups of micro-organisms on the basis of an assessment showing no safety concerns;’ |
Or. fr
Amendment 199
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
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 subject to qualifications assigned by the Authority to selected groups of micro-organisms on the basis of an assessment showing no safety concerns;’ |
Or. en
Amendment 200
Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl
Proposal for a directive
Article 1 – paragraph 1 – point 1
Directive 2001/18/EC
Article 2 – point 11 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (11a) 'sequence of concern' means any nucleic acid sequence, whether or not coding for a protein, that can cause harm to human health, animal health or the environment when present in a GMM, including sequences contributing to the production of toxins, harmful metabolites or therapeutic antimicrobials, acquired sequences conferring resistance to therapeutic antimicrobials, virulence determinants, sequences resulting from de novo design or other advanced applications of synthetic biology that provide functions that are new to nature, and regulatory sequences that alter the expression of any of the foregoing; |
Or. en
Justification
The amendment defines sequence of concern, complementing amendment to Article 24e(1) point (c).
Amendment 201
Martin Häusling
Proposal for a directive
Article 1 – paragraph 1 – point 1
Directive 2001/18/EC
Article 2 – point 11 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (11a) ‘Genetic modification of concern’ means a genetic modification that may give rise to traits that could adversely affect human or animal health or the environment. This includes, but is not limited to, genetic modifications that contribute to the production of toxins or other harmful metabolites, antimicrobial substances of therapeutic relevance, or virulence factors, as well as genetic modifications that confer resistance to therapeutically relevant antimicrobials or introduce traits that are entirely new to nature. |
Or. en
Amendment 202
Jessica Polfjärd
Proposal for a directive
Article 1 – paragraph 1 – point 1 a (new)
Directive 2001/18/EC
Article 3 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (1a) in Article 3, the following paragraph (2a) is added: | |
| ‘2a. This Directive shall not apply to organisms obtained through the techniques listed in Annex II, Part A in Directive 2009/41/EC of the European Parliament and of the Council1a. | |
| 1a Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (OJ L 125, 21.5.2009, p. 75, ELI: http://data.europa.eu/eli/dir/2009/41/oj)’; |
Or. en
Justification
This amendments aims to ensure legal coherence between this directive and Directive 2009/41/EC. Directive 2009/41/EC contains more updated and appropriate regulation of certain GMM-technologies, so it is important to ensure that identical techniques are not treated differently in different parts of the acquis.
Amendment 203
Aurelijus Veryga
Proposal for a directive
Article 1 – paragraph 1 – point 1 a (new)
Directive 2001/18/EC
Article 3 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (1a) in Article 3, the following paragraph (2a) is added: | |
| ‘2a. This Directive shall not apply to micro-organisms obtained through the techniques of genetic modification listed in Annex II, Part A in Directive 2009/41.’; |
Or. en
Justification
This amendment ensures legal coherence between Directive 2001/18/EC on the deliberate release of GMOs and Directive 2009/41/EC on their contained use. The respective scope and exemptions of the texts are not fully aligned. As a result, certain micro organisms obtained through genetic modification techniques that are explicitly excluded from the scope of Directive 2009/41/EC when used under contained conditions may nevertheless fall within the scope of Directive 2001/18/EC when their use changes context, even though the underlying process and risk profile remain identical. The proposed amendment to Article 3 of Directive 2001/18/EC addresses this inconsistency by introducing a targeted exemption for the same categories of micro organisms already excluded under the contained use regime.
In the context of a process-based GMO framework, this amendment ensures that organisms obtained through identical genetic modification techniques are treated consistently across the EU acquis.
Amendment 204
Martin Häusling
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
Justification
To prevent use of QPS for low-risk status
Amendment 205
Aurelijus Veryga
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 206
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 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 207
Marie-Luce Brasier-Clain, Mathilde Androuët
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24 a – 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. | 2. Articles 24e and 24f shall apply only to the placing on the market of GMMs with a low-risk profile and eligible for a fast-track procedure as or in products. |
Or. fr
Amendment 208
Jessica Polfjärd
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. | 2. Articles 24e and 24f shall apply only to the placing on the market of GMMs eligible for an expedited procedure as or in products. |
Or. en
Amendment 209
Christophe Clergeau
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24b
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24b | deleted |
Or. en
Amendment 210
Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl
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 information requirements for notifications shall be adapted to the characteristics of GMMs. To this end 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 to the extent justified by the characteristics of the GMMs and without prejudice to the principles for the environmental risk assessment laid down in Annex II. When preparing delegated acts under this paragraph the Commission shall base itself on scientific evidence related to the safety and risk assessment of GMMs including relevant scientific opinions from the Authority. |
| The information requirements shall in all cases enable the environmental risk assessment referred to in Article 13(2), point (b), to address the areas of risk set out in Section D.1 of Annex II, and shall retain the elements of Annex III A concerning: the survival and persistence of the GMM in the receiving environments it may reach, its dispersal beyond the site of application, the potential for transfer of the genetic modification to other micro-organisms, taking into account the genomic location of the modification and the presence of mobile or mobilisable genetic elements capable of mobilising it, the genetic stability of the modification and the potential for reversion, the effects of the GMM on the composition and functioning of resident microbial communities and on nontarget organisms, and the cumulative effects of repeated application of the GMM and of its application together with, or in sequence with, other authorised GMMs in the same receiving environment. The intended frequency and duration of application are already required by point III.A.2 of Annex III A, and the conditions of use by Article 13(2), point (c), those requirements shall be applied to GMMs accordingly. The notification shall in addition state any co-applied GMMs known to the notifier, the environmental risk assessment being otherwise conducted for each notification separately. |
Or. en
Justification
The proposed amendment to define more clearly the powers given to the Commission to change the information requirements in Annex III, which provide the basis for the environmental risk assessment.
Amendment 211
Martin Häusling
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 solely to update the technical specifications and scientific references contained in Annex III in notifications concerning the placing on the market of GMMs, so as to adapt them to scientific and technical progress. Those delegated acts shall neither reduce the minimum information necessary for the environmental risk assessment nor alter the level of protection of human health, animal health and the environment established by this Directive. |
Or. en
Justification
Given the Commission's demonstrated tendency to push authorisations through even without institutional consensus, e.g. in regards to Regulation (EC) 1829/2003, we should not additionally weaken oversight by delegating essential protection-level decisions.
Amendment 212
Aurelijus Veryga
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, so as to adapt them to scientific and technical progress. When preparing delegated acts under this paragraph, the Commission shall base itself on scientific evidence related to the safety and risk assessment of GMMs, including relevant scientific opinions from the Authority. |
Or. en
Amendment 213
Marie-Luce Brasier-Clain, Mathilde Androuët
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24 b – 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, so as to base decisions on the available scientific evidence. |
Or. fr
Amendment 214
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 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 supplement 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. |
Or. en
Amendment 215
Friedrich Pürner
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24c
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24c | deleted |
Or. de
Amendment 216
Christophe Clergeau
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24c
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24c | deleted |
Or. en
Amendment 217
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24c
| Text proposed by the Commission | Amendment |
|---|---|
| Article 24c | deleted |
Or. en
Amendment 218
Christine Anderson, Marc Jongen, Anja Arndt, Volker Schnurrbusch
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24c – title
| Text proposed by the Commission | Amendment |
|---|---|
| Validity of the consent | Validity and renewal of the consent |
Or. en
Amendment 219
Christine Anderson, Marc Jongen, Anja Arndt, Volker Schnurrbusch
Proposal for a directive
Article 1 – paragraph 1 – point 3
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. | 1. Without prejudice to Article 20(2) and (3) and Article 23, the period of validity of a consent granted under Part C shall be determined on a case-by-case basis, taking account of the risk profile of the GMM, the conditions and scale of its intended use, its potential persistence and dissemination and the characteristics of the receiving environment. That period shall not exceed ten years. |
| 2. Article 17 shall apply to the renewal of the consent. | |
| 3. When assessing an application for renewal, the competent authority shall take account, in particular, of: (a) new scientific and technical knowledge; (b) the results of post-market environmental monitoring and any information on incidents or unexpected effects; (c) any change in the characteristics of the GMM or in the scale, conditions or geographical extent of its use; (d) any evidence concerning its persistence or dissemination in the environment, changes in its host range or the transfer of genetic material; and (e) any change in the characteristics of the receiving environment that may be relevant to the risk assessment. | |
| 4. Where the competent authority concludes that the elements referred to in paragraph 3 do not indicate a material change in the risk profile of the GMM, the consent may be renewed without requiring the repetition of assessments or the resubmission of information that remains scientifically valid. |
Or. en
Justification
The Commission proposes unlimited consents principally on the basis of the short commercial lifetime of GMM products. Commercial obsolescence is, however, distinct from biological persistence. A risk-based period of validity, subject to a maximum of ten years and a proportionate renewal procedure, preserves regulatory learning while avoiding the unnecessary duplication of valid assessments.
Amendment 220
Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl
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. | Without prejudice to Article 20(2) and (3) and Article 23, the consent granted under Part C for the placing on the market of a GMM shall be valid for a maximum period of five years from the date on which the consent is issued. Article 17 shall apply to the renewal of the consent. The renewal shall be for a maximum period of five years and the assessment report referred to in Article 17 (4) shall take into account the results of the monitoring carried out pursuant to Article 13 (2), point (e). |
Or. en
Justification
The Commission proposal removes the periodic renewal of consent entirely. The periodic renewal is the most important opportunity under this Directive to re-examine the authorization against evidence that did not exist when it was granted. The proposed text aims to binging back the periodic renewal and proposes that the placing on market of GMM shall be valid for a maximum period of five years.
Amendment 221
Gerben-Jan Gerbrandy, Stine Bosse, Jeannette Baljeu, Billy Kelleher
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. | The consent granted under Part C should, upon its first renewal, be valid for an unlimited period of time, unless the decision referred to in Article 17(6) or (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 results of the monitoring. |
Or. en
Amendment 222
Aurelijus Veryga
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. | 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 unless the decision referred to in Article 17(6) or (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. |
Or. en
Amendment 223
Martin Häusling
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. | Without prejudice to Article 20(2) and (3) and Article 23, the consent granted under Part C shall be valid for a period not exceeding five years and shall be subject to renewal in accordance with Article 17. |
Or. en
Justification
As a general principle, authorisations for the release of GMMs should not be granted indefinitely. Rather, there are sound reasons for limiting authorisations to a shorter period, for example a maximum of five years, and for making them strictly conditional on monitoring requirements, given the particular characteristics of microorganisms and the lack of experience with GMM releases.
Amendment 224
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 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. | Without prejudice to Article 20(2) and (3) and Article 23, the consent granted under Part C shall be valid for a maximum period of five years starting from the date on which the consent is issued. |
Or. en
Amendment 225
Marie-Luce Brasier-Clain, Mathilde Androuët
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24 c
| 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. | Without prejudice to Article 20(2) and (3) and Article 23, the consent granted under Part C shall be valid for a renewable period of 10 years. |
Or. fr
Amendment 226
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24d – title
| Text proposed by the Commission | Amendment |
|---|---|
| Detection methods | deleted |
Or. en
Amendment 227
Martin Häusling
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 for detection, identification and quantification |
Or. en
Justification
As Article 24d deals with more than only detection methods, this should also be reflected in its title.
Amendment 228
Gerben-Jan Gerbrandy, Stine Bosse, Jeannette Baljeu, Billy Kelleher
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 229
Aurelijus Veryga
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 230
Marie-Luce Brasier-Clain, Mathilde Androuët
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24 d – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. In cases where it is not feasible to provide a method for detection, identification and quantification of the transformation event as detailed in point 7 of Section A of Annex IV, to which Article 13(2), point (a), refers, and where this is duly justified by the notifier, the modalities to comply with analytical method performance requirements shall be adapted as specified in the implementing act adopted in accordance with Article 24g(1), point (a). | deleted |
Or. fr
Amendment 231
Emma Fourreau, Anja Hazekamp, Per Clausen, Catarina Martins, Valentina Palmisano, Martin Günther
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24d – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. In cases where it is not feasible to provide a method for detection, identification and quantification of the transformation event as detailed in point 7 of Section A of Annex IV, to which Article 13(2), point (a), refers, and where this is duly justified by the notifier, the modalities to comply with analytical method performance requirements shall be adapted as specified in the implementing act adopted in accordance with Article 24g(1), point (a). | 1. The notifier shall provide a validated method enabling the detection, identification and quantification of the GMM, together with the reference materials necessary for its implementation. |
Or. en
Amendment 232
Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24d – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. In cases where it is not feasible to provide a method for detection, identification and quantification of the transformation event as detailed in point 7 of Section A of Annex IV, to which Article 13(2), point (a), refers, and where this is duly justified by the notifier, the modalities to comply with analytical method performance requirements shall be adapted as specified in the implementing act adopted in accordance with Article 24g(1), point (a). | 1. In cases where it is not feasible to provide a method for detection, identification and quantification of the transformation event as detailed in point 7 of Section A of Annex IV, to which Article 13(2), point (a), refers, which fulfils all applicable minimum performance requirements and where this is duly justified by the notifier, the modalities to comply with analytical method performance requirements shall be adapted as specified in the implementing act adopted in accordance with Article 24g(1), point (a). The adaption of those modalities shall not dispense with the requirement to provide a method capable of establishing the presence of the GMM. |
Or. en
Justification
Article 24d could weaken post-market monitoring and enforcement by allowing analytical requirements to be adapted without distinguishing between methods needed to detect, identify and verify GM micro-organisms. Detection and identification of a given GMM is a prerequisite for environmental monitoring.
Amendment 233
Aurelijus Veryga
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24d – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. In cases where it is not feasible to provide a method for detection, identification and quantification of the transformation event as detailed in point 7 of Section A of Annex IV, to which Article 13(2), point (a), refers, and where this is duly justified by the notifier, the modalities to comply with analytical method performance requirements shall be adapted as specified in the implementing act adopted in accordance with Article 24g(1), point (a). | 1. In cases where it is not feasible to provide an analytical method for identification and quantification of the GMM concerned, the arrangements for complying with analytical method performance requirements shall be adapted as set out in the implementing act adopted in accordance with Article 24g(1), point (a). |
Or. en
Amendment 234
Martin Häusling
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24d – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. In cases where it is not feasible to provide a method for detection, identification and quantification of the transformation event as detailed in point 7 of Section A of Annex IV, to which Article 13(2), point (a), refers, and where this is duly justified by the notifier, the modalities to comply with analytical method performance requirements shall be adapted as specified in the implementing act adopted in accordance with Article 24g(1), point (a). | 1. The placing on the market of a GMM shall not be authorised where scientifically validated methods enabling its detection, identification and quantification are not available to ensure effective monitoring, traceability and enforcement throughout its intended use and following its release into the environment. |
Or. en
Justification
With modern techniques (PCR, DNA sequencing etc.) it is/should always be possible for developers to detect the intended genetic modifications. Therefore, they should also be required to disclose this information. Furthermore, it is illogical to assume that developers would be unable to detect an event they created themselves. How else would they be able to work with it?
Detection is a prerequisite for PMEM, which is required for each GMM release. Also the safeguard clause and other post-authorisation provisions rely on it.
Amendment 235
Christophe Clergeau
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24d – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. In cases where it is not feasible to provide a method for detection, identification and quantification of the transformation event as detailed in point 7 of Section A of Annex IV, to which Article 13(2), point (a), refers, and where this is duly justified by the notifier, the modalities to comply with analytical method performance requirements shall be adapted as specified in the implementing act adopted in accordance with Article 24g(1), point (a). | 1. The notifier shall provide analytical methods for detection, identification and quantification of the GMM concerned. Where the notifier duly justifies that it is not feasible to provide an analytical method for identification and quantification of the GMM concerned, the arrangements for complying with analytical method performance requirements shall be adapted as set out in the implementing act adopted in accordance with Article 24g(1), point (a). |
Or. en
Justification
With modern techniques (PCR, DNA sequencing etc.) it is always possible for developers to detect the intended genetic modifications. Therefore, they should also be required to disclose this information. Otherwise,it has to be assumed that developers would be unable to detect an event they created themselves.
Amendment 236
Gerben-Jan Gerbrandy, Stine Bosse, Jeannette Baljeu, Billy Kelleher
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. |
| Where adapted modalities are applied in accordance with paragraph 1, the notifier shall 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, upon the renewal of the consent, whether such a method has become feasible. |
Or. en
Justification
If an analytical method becomes technically feasible, a notifier should apply this. The renewal of consent is a suitable point in time to re-examine this.
Amendment 237
Martin Häusling
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 analytical methods provided by the notifier enable the detection, identification and quantification of the GMM to a degree sufficient to ensure effective monitoring, traceability and enforcement. |
| The European Commission shall ensure that the obstacles to the detection of GMMs are removed, taking into consideration the findings and recommendations of the European Network of GMO Laboratories (ENGL), and by launching research and development programmes to overcome those obstacles |
Or. en
Justification
To prevent the notifier from invoking current obstacles to the detection of certain GMMs as a pretext for relaxing detection obligations that remain essential should hazards subsequently arise, given that such obstacles can be overcome through research and development programmes.
Amendment 238
Maria Noichl, Christophe Clergeau, Delara Burkhardt, Günther Sidl
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24d – paragraph 2
| 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. |
| Where appropriate, the competent authority may request expert assistance from the European Union Reference Laboratory or from the relevant national reference laboratories for the purposes of that assessment. |
Or. en
Amendment 239
Marie-Luce Brasier-Clain, Mathilde Androuët
Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2001/18/EC
Article 24 d – 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, in case of difficulty in providing a method for the detection, identification and quantification of the transformation event as referred to in point 7 of Section A of Annex IV, to which point (a) of Article 13(2) refers, the information on the analytical method provided by the notifier justifies the application of adapted modalities. |
Or. fr