Text · Amendment list
Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)
Full title
Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)
Document CJ53-AM-790938 · COM(2025)1022 – 2025/0406(COD)
- Kind
- Amendment list CJ53-AM-790938
- Date
- 13 July 2026
- Committee
- Committee on Public Health Committee on Industry, Research and Energy
- Dossier
- 2025-0406
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- Official page PDF Word
- Reference
- COM(2025)1022 – 2025/0406(COD)
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| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Foresight Panel shall provide regulatory, scientific and technical expertise on emerging science and technology in the field of health underpinning the development of health biotechnology products to the Commission, the Agency and to relevant Union-level advisory bodies and competent authorities and other entities in the Member States in the area of health. The Foresight Panel shall operate in accordance with the Commission’s framework for expert groups. | 2. The Foresight Panel shall provide regulatory, scientific and technical expertise on emerging science and technology in the field of health underpinning the development of health biotechnology products including foresight on barriers to market entry, availability, affordability and market uptake to the Commission, the Agency and to relevant Union-level advisory bodies and competent authorities and other entities in the Member States in the area of health. The Foresight Panel shall operate in accordance with the Commission’s framework for expert groups, and in synergy with other relevant expert groups established under Union law. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Foresight Panel shall provide regulatory, scientific and technical expertise on emerging science and technology in the field of health underpinning the development of health biotechnology products to the Commission, the Agency and to relevant Union-level advisory bodies and competent authorities and other entities in the Member States in the area of health. The Foresight Panel shall operate in accordance with the Commission’s framework for expert groups. | 2. The Foresight Panel shall provide regulatory, scientific and technical expertise on emerging science and technology in the field of health underpinning the development of health biotechnology products to the Commission, the Agency and to relevant Union-level advisory bodies and competent authorities and other entities in the Member States in the area of health. The Foresight Panel shall operate in accordance with the Commission’s framework for expert groups. Its role shall be advisory and shall not create an additional authorisation, assessment or reporting layer for developers, competent authorities or Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) conduct horizon scanning by analysing, identifying and discussing emerging science and technology with the potential to drive the development of health biotechnology products, including upon request from the Commission, the Agency, Union-level advisory bodies or competent authorities in the Member States in the area of health, and develop and publish related considerations in the form of discussion papers | (a) conduct horizon scanning by analysing, identifying and discussing emerging science and technology with the potential to drive the development of health biotechnology products, including, where relevant, in areas characterised by a major public health and socioeconomic burden and persistent innovation gaps, such as mental health, upon request from the Commission, the Agency, Union-level advisory bodies or competent authorities in the Member States in the area of health, and develop and publish related considerations in the form of discussion papers |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) conduct horizon scanning by analysing, identifying and discussing emerging science and technology with the potential to drive the development of health biotechnology products, including upon request from the Commission, the Agency, Union-level advisory bodies or competent authorities in the Member States in the area of health, and develop and publish related considerations in the form of discussion papers | (a) conduct horizon scanning by analysing, identifying and discussing emerging science and technology with the potential to drive the development of health biotechnology products whilst also assessing their potential impact on European competitiveness, production capacity and the resilience of healthcare systems, including upon request from the Commission, the Agency, Union-level advisory bodies or competent authorities in the Member States in the area of health, and develop and publish related considerations in the form of discussion papers |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) conduct horizon scanning by analysing, identifying and discussing emerging science and technology with the potential to drive the development of health biotechnology products, including upon request from the Commission, the Agency, Union-level advisory bodies or competent authorities in the Member States in the area of health, and develop and publish related considerations in the form of discussion papers | (a) conduct horizon scanning by analysing, identifying and discussing emerging science and technology, in particular regarding NAMs, with the potential to drive the development of health biotechnology products, including upon request from the Commission, the Agency, Union-level advisory bodies or competent authorities in the Member States in the area of health, and develop and publish related considerations in the form of discussion papers |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) engage with the Agency and relevant Union-level advisory bodies and competent authorities and other entities in the Member States in the area of health, to facilitate cross-framework dialogue and consistency; | (b) engage with the Agency and relevant Union-level advisory bodies whose recommendations might affect or have an impact on the pharmaceutical industry and competent authorities and other entities in the Member States in the area of health, to facilitate cross-framework dialogue and consistency; |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) accommodate exchanges among the authorities responsible for the setting up and the operation of regulatory sandboxes in accordance with article 39(5). | deleted |
| Text proposed by the Commission | Amendment |
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| (d) accommodate exchanges among the authorities responsible for the setting up and the operation of regulatory sandboxes in accordance with article 39(5). | (d) engage with national competent authorities in the areas of health technology assessment and pricing and reimbursement, as well as public healthcare payers, in order to improve the identification of unmet medical and societal needs, facilitate the early assessment of access, affordability and market uptake considerations. |
| Text proposed by the Commission | Amendment |
|---|---|
| (da) Facilitate the setting up and the operation of the regulatory sandboxes. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. identify key emerging challenges that could affect the availability, development and deployment of health biotechnology in the Union, making non-binding recommendations to the Commission |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. For the purpose of performing the tasks referred to in paragraph 2, point (a), of this Article, the Foresight Panel may engage in preliminary discussions with the Agency or relevant Union level advisory bodies in the area of health, networks and informal task forces, national competent authorities, developers, and other relevant actors and shall implement a collaborative approach with a view to ensuring an effective uptake of its discussion papers. | 4. For the purpose of performing the tasks referred to in paragraph 2, point (a), of this Article, the Foresight Panel shall engage in preliminary discussions with the Agency or relevant Union level advisory bodies in the area of health, networks and informal task forces, national competent authorities, developers, and other relevant actors and shall implement a collaborative approach with a view to ensuring an effective uptake of its discussion papers. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. For the purpose of performing the tasks referred to in paragraph 2, point (a), of this Article, the Foresight Panel may engage in preliminary discussions with the Agency or relevant Union level advisory bodies in the area of health, networks and informal task forces, national competent authorities, developers, and other relevant actors and shall implement a collaborative approach with a view to ensuring an effective uptake of its discussion papers. | 4. For the purpose of performing the tasks referred to in paragraph 2, point (a), of this Article, the Foresight Panel shall engage in preliminary discussions with the Agency or relevant Union level advisory bodies in the area of health, networks and informal task forces, national competent authorities, developers, and other relevant actors and shall implement a collaborative approach with a view to ensuring an effective uptake of its discussion papers. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The Foresight Panel shall consist of scientific and regulatory experts from the SoHO Coordination Board (‘the SCB’), the Medical Devices Coordination Group (‘the MDCG’), the Coordination group on Health Technology Assessment (‘the HTACG’), the Agency and the competent authorities of the Member States, appointed by the Commission in view of their regulatory, scientific or technical expertise in the relevant identified fields and frameworks. The panel may invite external experts selected to assist with specific tasks when such relevant external expertise is needed. | 5. The Foresight Panel shall consist of scientific and regulatory experts from the SoHO Coordination Board (‘the SCB’), the Medical Devices Coordination Group (‘the MDCG’), the Coordination group on Health Technology Assessment (‘the HTACG’), the Agency and the competent authorities of the Member States, appointed by the Commission in view of their regulatory, scientific or technical expertise in the relevant identified fields and frameworks. |
| The Foresight Panel shall further include, as members in their own right: | |
| (a) at least one person with relevant lived experience of a chronic or long-term condition for which biotechnology-derived medicinal products represent a primary or essential treatment; and | |
| (b) at least one representative of an organisation representing patients living with such conditions, operating at Union level. | |
| The persons referred to in points (a) and (b) shall be appointed by the Commission for a renewable term of three years following an open call for expressions of interest, on the basis of transparent and objective criteria including independence and demonstrated capacity to contribute the perspective of the constituency concerned. They shall participate fully in the deliberations and outputs of the Foresight Panel. | |
| Conflict-of-interest requirements applicable to the persons referred to in points (a) and (b) shall be applied proportionately, having regard to the specific subject matter under deliberation, and shall not exclude persons on grounds, such as personal experience of a condition, membership of a patient organisation or routine receipt of disease-related educational support, that are unrelated to the matter at hand. | |
| For the purposes of Article 38(2), points (a), (b) and (e), the support, remuneration and reimbursement provided by the Commission to the experts composing the Foresight Panel shall extend, on equivalent terms, to the persons referred to in points (a) and (b) of the second subparagraph of this paragraph. The Commission shall in addition ensure that those persons have access to the documentation, training and administrative support necessary to participate effectively. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The Foresight Panel shall consist of scientific and regulatory experts from the SoHO Coordination Board (‘the SCB’), the Medical Devices Coordination Group (‘the MDCG’), the Coordination group on Health Technology Assessment (‘the HTACG’), the Agency and the competent authorities of the Member States, appointed by the Commission in view of their regulatory, scientific or technical expertise in the relevant identified fields and frameworks. The panel may invite external experts selected to assist with specific tasks when such relevant external expertise is needed. | 5. The Foresight Panel shall consist of scientific and regulatory experts from the SoHO Coordination Board (‘the SCB’), the Medical Devices Coordination Group (‘the MDCG’), the Coordination group on Health Technology Assessment (‘the HTACG’), the Agency and the competent authorities of the Member States, appointed by the Commission in view of their regulatory, scientific or technical expertise in the relevant identified fields and frameworks. The panel may invite external experts selected to assist with specific tasks when such relevant external expertise is needed. In order to help the Foresight Panel with its function on Horizon Scanning, the panel will invite industry representatives. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The Foresight Panel shall consist of scientific and regulatory experts from the SoHO Coordination Board (‘the SCB’), the Medical Devices Coordination Group (‘the MDCG’), the Coordination group on Health Technology Assessment (‘the HTACG’), the Agency and the competent authorities of the Member States, appointed by the Commission in view of their regulatory, scientific or technical expertise in the relevant identified fields and frameworks. The panel may invite external experts selected to assist with specific tasks when such relevant external expertise is needed. | 5. The Foresight Panel shall consist of scientific and regulatory experts from the SoHO Coordination Board (‘the SCB’), the Medical Devices Coordination Group (‘the MDCG’), the Coordination group on Health Technology Assessment (‘the HTACG’), the National Competent Authorities for Pricing and Reimbursement and Public Healthcare Payers (NCAPR), the Agency and the competent authorities of the Member States, appointed by the Commission in view of their regulatory, scientific or technical expertise in the relevant identified fields and frameworks. The panel may invite external experts selected to assist with specific tasks when such relevant external expertise is needed. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The Foresight Panel shall consist of scientific and regulatory experts from the SoHO Coordination Board (‘the SCB’), the Medical Devices Coordination Group (‘the MDCG’), the Coordination group on Health Technology Assessment (‘the HTACG’), the Agency and the competent authorities of the Member States, appointed by the Commission in view of their regulatory, scientific or technical expertise in the relevant identified fields and frameworks. The panel may invite external experts selected to assist with specific tasks when such relevant external expertise is needed. | 5. The Foresight Panel shall consist of scientific and regulatory experts from the SoHO Coordination Board (‘the SCB’), the Medical Devices Coordination Group (‘the MDCG’), the Coordination group on Health Technology Assessment (‘the HTACG’), the Policy Board of European excellence reference networks dedicated to therapeutic areas, the Agency and the competent authorities of the Member States, appointed by the Commission in view of their regulatory, scientific or technical expertise in the relevant identified fields and frameworks. The panel may invite external experts selected to assist with specific tasks when such relevant external expertise is needed. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The Foresight Panel shall consist of scientific and regulatory experts from the SoHO Coordination Board (‘the SCB’), the Medical Devices Coordination Group (‘the MDCG’), the Coordination group on Health Technology Assessment (‘the HTACG’), the Agency and the competent authorities of the Member States, appointed by the Commission in view of their regulatory, scientific or technical expertise in the relevant identified fields and frameworks. The panel may invite external experts selected to assist with specific tasks when such relevant external expertise is needed. | 5. The Foresight Panel shall consist of scientific and regulatory experts from the SoHO Coordination Board (‘the SCB’), the Medical Devices Coordination Group (‘the MDCG’), the Coordination group on Health Technology Assessment (‘the HTACG’), the Agency and the competent authorities of the Member States, appointed by the Commission in view of their regulatory, scientific or technical expertise in the relevant identified fields and frameworks, including radiation protections. The panel may invite external experts selected to assist with specific tasks when such relevant external expertise is needed. |
Nuclear medicine and radiopharmaceuticals represent a rapidly expanding segment of health biotechnology, with diagnostic and therapeutic applications — including targeted radionuclide therapy — increasingly relevant to the Biotech Act's scope. The Foresight Panel is tasked with anticipating emerging scientific and regulatory challenges across the biotechnology landscape; however, in its current composition, it lacks explicit reference to radiation protection expertise, creating a gap that risks overlooking the specific safety and regulatory requirements applicable to radiopharmaceutical development and use.
| Text proposed by the Commission | Amendment |
|---|---|
| 5a. For the purpose of identifying priority biomanufacturing technologies and biopharmaceutical platform technologies, in respect of which developers established in the Union have the potential to compete with other regions, address areas of high unmet medical need in the EU and to result in development and manufacturing taking place in the Union, the Commission shall, building on the work of the European Medicines Agency (EMA) Foresight Panel and on its own knowledge, as well as knowledge derived from scientific advice and protocol assistance provided to developers by the Agency, establish and publish a list of 'Strategic Biotechnologies of Common European Interest'. | |
| The Commission shall keep the list updated on a continuous basis, taking into account scientific progress and horizon-scanning on unmet medical needs on the basis of advice from the Agency. |
This list is instrumental to the amendments proposed in Article 27, which provide strategic direction to the application of the SPC.
Complex: ATMPs; mRNA; Liposomal preparations; Nanoparticulate preparations; Parenteral modified release preparations; Metered-dose preparations for inhalation and inhalation powders; Multilayer tablets
Novel or Innovative: Continuous manufacturing; Decentralized manufacturing; Additive manufacturing; Use of process models in the control strategy; Manufacture of personalised medicines; Other advanced manufacturing approaches
| Text proposed by the Commission | Amendment |
|---|---|
| 5a. The Foresight Panel shall further include, as members in their own right: | |
| (a) at least one person with relevant lived experience of a chronic or long-term condition for which biotechnology-derived medicinal products represent a primary or essential treatment; | |
| (b) at least one representative of an organisation representing patients living with such conditions, operating at Union level |
The early identification of patient-relevant priorities, of acceptability considerations, of access implications, and of methodological gaps cannot be effectively performed without the participation of those who will be the eventual users of the technologies under foresight. Two categories are added because they perform distinct and non-substitutable functions, on the same logic that justifies their inclusion in the ethics-committee assessment under Amendment 9. A person with relevant lived experience contributes the perspective of someone managing the condition daily: an assessment of acceptable burden, real-world adherence, and what the term "benefit" means as experienced by the patient. A representative of a patient organisation contributes the perspective of the broader patient constituency: the population-level priorities, concerns and acceptability considerations derived
| Text proposed by the Commission | Amendment |
|---|---|
| 5a. The Foresight panel shall regularly consult with relevant stakeholders, including patient and consumer organisations, healthcare professional organisations, public healthcare payers and industry representatives. |
Vytenis Povilas Andriukaitis, Nikos Papandreou, Marta Temido, Romana Jerković, Dario Nardella, Victor Negrescu
| Text proposed by the Commission | Amendment |
|---|---|
| 6a. For the purpose of identifying future technologies, platforms and targets in the form of biotechnology medicinal products or platform technologies (ref GPL Directive Article 4, 30a) where European developers have a potential to compete with other regions and result in development and manufacturing in Europe the Agency shall, based on the work of the Foresight Panel and its own knowledge from scientific advice and protocol assistance to developers, issue a list of Technology of Common European Interest. The Agency shall keep the list updated continuously taking into account scientific progress. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6a. No later than three years after the entry into force of this Act, the Commission shall carry out and publish an evaluation on the performance of the Panel. That evaluation shall assess its effectiveness in strengthening the preparedness of the Union HTA and Regulatory network to support the uptake of innovation, as well facilitating and accelerating its placing onto the Union market. Feedback from relevant stakeholders, including patient organisations, clinicians and innovators shall be taken into account. |
The Foresight Panel should not create additional regulatory complexity. Clear indications are needed on how the Panel will interact with national and Union regulators, HTA bodies and existing sandboxes to avoid overlap and ensure a coherent and innovation-friendly framework. Ensuring that there is an evaluation on whether the panel has achieved its objectives, and how it should move forward in line with its mandate, should promote regulatory streamlining.
| Text proposed by the Commission | Amendment |
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| 2a. A regulatory sandbox may include adaptive biological products and platform-based biotechnology products, including bacteriophage products and therapies, where their development requires progressive optimisation of product composition, manufacturing parameters, or clinical deployment models under predefined quality, safety, comparability, traceability and monitoring conditions. |
Vytenis Povilas Andriukaitis, Marta Temido, Romana Jerković, Dario Nardella, Victor Negrescu, Tiemo Wölken, Nicolás González Casares
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. A regulatory sandbox may include adaptive biological products and platform-based biotechnology products, including bacteriophage products and therapies, where their development requires progressive optimisation of product composition, manufacturing parameters, or clinical deployment models under predefined quality, safety, comparability, traceability and monitoring conditions. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. A regulatory sandbox may include adaptive biological products and platform-based biotechnology products, where their development requires progressive optimisation of product composition, manufacturing parameters, or clinical deployment models under predefined quality, safety, comparability, traceability and monitoring conditions. |
| Text proposed by the Commission | Amendment |
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| 3. The authorities responsible, pursuant to the applicable legislative act, for setting up a regulatory sandbox referred to in paragraphs 1 and 2 of this Article, shall ensure that due consideration is given to the regulatory challenges posed by combination products, and to consultations with the relevant authorities with expertise regarding the associated parts of such products. | 3. The authorities responsible, pursuant to the applicable legislative act, for setting up a regulatory sandbox referred to in paragraphs 1 and 2 of this Article, shall ensure that due consideration is given to the regulatory challenges posed by combination products, including, where relevant, products or interventions whose development involves the interaction of pharmacological and non-pharmacological elements, conditions of administration, structured therapeutic support, patient monitoring or long-term follow-up, and to consultations with the relevant authorities with expertise regarding the associated parts of such products. |
| Text proposed by the Commission | Amendment |
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| 5a. Bacteriophage products and therapies, including adaptive or platform-based bacteriophage technologies, shall have access to regulatory sandboxes in accordance with this Article, where their development raises regulatory questions relating to product composition, susceptibility-guided selection, manufacturing parameters, AI-supported matching systems, adaptive clinical deployment models or comparability following modification. |
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| Upon a substantiated request from developers, the Commission may set up a regulatory sandbox that provides a controlled regulatory environment for the testing and development of a health biotechnology product, that: | Upon a substantiated request from developers, the Commission may set up a regulatory sandbox that provides a controlled regulatory environment for the testing and development of a health biotechnology product, with a view to reducing regulatory uncertainty, fostering responsible innovation and accelerating the identification of an appropriate authorisation pathway that: |
| Text proposed by the Commission | Amendment |
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| Upon a substantiated request from developers, the Commission may set up a regulatory sandbox that provides a controlled regulatory environment for the testing and development of a health biotechnology product, that: | Upon a substantiated request from developers, which may be submitted at any stage of product development and in relation to any relevant type of regulatory sandbox, the Commission may set up a regulatory sandbox that provides a controlled regulatory environment for the testing and development of a health biotechnology product, that: |
| Text proposed by the Commission | Amendment |
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| Upon a substantiated request from developers, the Commission may set up a regulatory sandbox that provides a controlled regulatory environment for the testing and development of a health biotechnology product, that: | Upon a substantiated request from developers, the Commission may set up a regulatory sandbox that provides a controlled regulatory environment for the testing and development of a health biotechnology product, including synthetic cells, that: |
A regulatory sandbox lets a genuinely new product be tested even when it does not yet fit any existing rules. That is the situation for an early-stage synthetic cell and naming them explicitly ensures they can use the sandbox.
| Text proposed by the Commission | Amendment |
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| (ba) where an existing Union regulatory framework applies but does not provide sufficient clarity for the research, development, testing or modification of adaptive or platform-based products. |
| Text proposed by the Commission | Amendment |
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| (ba) where an existing Union regulatory framework applies but does not provide sufficient clarity for the development, testing or modification of adaptive or platform-based products. |
| Text proposed by the Commission | Amendment |
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| (ba) where an existing Union regulatory framework applies but does not provide sufficient clarity for the development, testing or modification of adaptive or platform-based products. |
| Text proposed by the Commission | Amendment |
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| A regulatory sandbox shall not be set up for health biotechnology products which are likely to fall under the scope of the Union legislation in the area of health referred to in Article 39, paragraphs (1) and (2). | A regulatory sandbox shall not be set up for health biotechnology products which are likely to fall under the scope of the Union legislation in the area of health referred to in Article 39, paragraphs (1) and (2), unless the developer demonstrates that the applicable sandbox framework is not suitable to address the specific regulatory uncertainty or innovation challenge concerned. |
| Text proposed by the Commission | Amendment |
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| A regulatory sandbox shall not be set up for health biotechnology products which are likely to fall under the scope of the Union legislation in the area of health referred to in Article 39, paragraphs (1) and (2). | A regulatory sandbox shall not be set up for health biotechnology products which are likely to fall under the scope of the Union legislation in the area of health referred to in Article 39, paragraphs (1) and (2). Products falling within the scope of Regulation (EU) 2015/2283 shall not be eligible for regulatory sandboxes under this Regulation. |
| Text proposed by the Commission | Amendment |
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| Products falling or potentially falling within the scope of Regulation (EU) 2015/2283 shall not be eligible for regulatory sandboxes under this Regulation. |
Food products, in particular novel foods within the meaning of Regulation (EU) 2015/2283, are subject to a dedicated and harmonised regulatory framework ensuring a high level of consumer protection. This Regulation should not create alternative pathways for their development, assessment or placing on the market.
| Text proposed by the Commission | Amendment |
|---|---|
| Products falling or potentially falling within the scope of Regulation EU 2015/2283 shall not be eligible for regulatory sandboxes under this Regulation. |
| Text proposed by the Commission | Amendment |
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| The sandbox shall be set up in accordance with this Article. | The sandbox shall be set up in accordance with this Article. |
| No regulatory sandbox shall be established under this Article for products, services or technologies involving human reproductive cloning, heritable human genome modification, germline intervention, commercial or industrial creation or use of human embryos, eugenic selection, or any intervention designed to introduce heritable genetic changes in human beings. | |
| Regulatory sandboxes may, where appropriate, support the clarification of regulatory pathways, evidence requirements, delivery conditions, monitoring, follow-up and risk-mitigation measures for health biotechnology products or interventions whose development raises regulatory uncertainty due to adaptive product composition, pathogen-susceptibility guided selection, structured therapeutic support, specific conditions of administration, patient-reported or functional outcomes, real-world evidence or the interaction of pharmacological and non-pharmacological elements. Such sandboxes shall not reduce standards of patient safety, informed consent, ethical review, data protection, medical supervision, traceability, quality control or scientific validity. |
| Text proposed by the Commission | Amendment |
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| The sandbox shall be set up in accordance with this Article. | The sandbox shall be set up in accordance with this Article. |
| Where the regulatory sandbox involves the use of artificial intelligence systems or models, to avoid duplication, it shall be coordinated with, and without prejudice to, regulatory sandboxes established under Regulation (EU) 2024/1689, to ensure coherence across frameworks. |
| Text proposed by the Commission | Amendment |
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| 1a. For the purposes of paragraph 1, a health biotechnology product may in particular be considered eligible for a regulatory sandbox where it is intended to address mental health conditions and its development is hindered by significant regulatory uncertainty linked to the interaction of pharmacological and non-pharmacological elements, the conditions of administration, the need for structured therapeutic support, the relevance of patient-reported and functional outcomes, or the challenge of identifying an appropriate pathway for the generation and assessment of evidence. |
| Text proposed by the Commission | Amendment |
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| 1a. A regulatory sandbox under this Article may, where the conditions of this Article are met, address innovations involving novel biotechnology products whose development or use is characterised by decentralised or point-of-care production processes, or by short product half-lives, including on-site radiopharmaceutical production and point-of-care advanced therapy manufacturing, without lowering applicable standards of safety, quality, efficacy, ethics, radiation protection, environmental protection, biosecurity or regulatory oversight. |
This provision would help ensure that the sandbox mechanism can support regulatory learning in areas where conventional centralised production and distribution models are not always technically appropriate.
| Text proposed by the Commission | Amendment |
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| 2. Such regulatory sandbox shall set out a time limited framework to allow for the generation of evidence and data, in a real-world environment and under supervision of one or more competent authorities. | 2. Such regulatory sandbox shall set out a time limited framework to allow, in a real-world environment and under supervision of one or more competent authorities, for the generation of evidence and data necessary to clarify the appropriate regulatory pathway, evidence requirements, delivery conditions, post-treatment follow-up, and risk-mitigation measures for the health biotechnology product concerned, including, where relevant, products intended to address mental health conditions and products whose development involves structured therapeutic support or the interaction of pharmacological and non-pharmacological elements. |
| Text proposed by the Commission | Amendment |
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| 2a. Participation in a regulatory sandbox shall not constitute, and shall not be presented as constituting, authorisation to place a product on the market. It shall not prejudice the full application of Union and national requirements on ethics, informed consent, patient safety, environmental protection, data protection, liability and judicial remedies. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Developers wishing to participate in a regulatory sandbox referred to in paragraph 1 shall submit a substantiated application to the Commission. That application shall include the following: | 3. Developers wishing to participate in a regulatory sandbox referred to in paragraph 1 may submit an application at any stage of product development. Developers shall submit a substantiated application to the Commission. That application shall include the following: |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Developers wishing to participate in a regulatory sandbox referred to in paragraph 1 shall submit a substantiated application to the Commission. That application shall include the following: | 3. Developers wishing to participate in a regulatory sandbox referred to in paragraph 1 may submit an application at any stage of product development and shall submit a substantiated application to the Commission. That application shall include the following: |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Developers wishing to participate in a regulatory sandbox referred to in paragraph 1 shall submit a substantiated application to the Commission. That application shall include the following: | 3. Developers requesting to participate in a regulatory sandbox referred to in paragraph 1 shall submit a substantiated application to the Commission. That application shall include the following: |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Developers wishing to participate in a regulatory sandbox referred to in paragraph 1 shall submit a substantiated application to the Commission. That application shall include the following: | 3. Developers requesting to participate in a regulatory sandbox referred to in paragraph 1 shall submit a substantiated application to the Commission. That application shall include the following: |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the identification of existing regulatory challenges; | (b) the identification of existing regulatory challenges, including, where relevant, challenges relating to the interaction of pharmacological and non-pharmacological elements, the conditions of administration, therapeutic support, patient monitoring, long-term follow-up, and the adequacy of conventional evidence-generation pathways for mental health innovations; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) the assessment of potential benefits and potential risks of the health biotechnology product to be tested or developed. | (c) the assessment of potential benefits and potential risks of the health biotechnology product to be tested or developed, including the measures envisaged for the continuous monitoring of risks throughout the trial period. |
| Text proposed by the Commission | Amendment |
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| 3a. The establishment of a regulatory sandbox shall require the explicit agreement of the Member State or Member States on whose territory the activities are to take place. Member States may refuse participation in a sandbox on grounds of medical ethics, public health, data protection, environmental protection, reproductive ethics or protection of human dignity. |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) set out the objectives, the specific innovations to be tested in the regulatory sandbox, the relevant activities to be carried out within the regulatory sandbox, the geographical and temporal scope of those activities, as well as the relevant conditions and requirements thereof; | (a) set out the objectives, the specific innovations to be tested in the regulatory sandbox, the relevant activities to be carried out within the regulatory sandbox, the geographical and temporal scope of those activities, the evidence-generation approach, including where relevant real-world evidence and patient-relevant outcomes, as well as the relevant conditions and requirements thereof |
| Text proposed by the Commission | Amendment |
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| (da) include, where relevant, appropriate safeguards to identify, assess and address potential risks to fundamental rights arising from the testing and development activities carried out within the regulatory sandbox, such as safeguards to ensure free and informed consent and to prevent eugenic practices, in accordance with the Charter of Fundamental Rights of the European Union. |
| Text proposed by the Commission | Amendment |
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| 6. When assessing the applications received in accordance with paragraph 3 of this Article and when developing and implementing the sandbox plan, the Commission may consult the Agency, the SCB, the MDCG, or the Foresight Panel, as appropriate. | 6. When assessing the applications received in accordance with paragraph 3 of this Article and when developing and implementing the sandbox plan, the Commission shall consult the Foresight Panel and may consult the Agency, the SCB, or the MDCG, as appropriate. The Foresight Panel should support the coordination and oversight across regulatory sandboxes established under this Article - by identifying cross-cutting regulatory challenges and informing subsequent JCAs – to increase the speed at which breakthrough technologies reach patients. Any consulted entities shall provide its views within 30 days of receiving the consultation request from the Commission. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. When assessing the applications received in accordance with paragraph 3 of this Article and when developing and implementing the sandbox plan, the Commission may consult the Agency, the SCB, the MDCG, or the Foresight Panel, as appropriate. | 6. When assessing the applications received in accordance with paragraph 3 of this Article and when developing and implementing the sandbox plan, the Commission may consult the Agency, the SCB, the MDCG, or the Foresight Panel, as appropriate. Where the application concerns a novel therapy for a rare disease, rare cancer or other complex condition, in particular an advanced therapy medicinal product, the Commission may also consult the relevant European Reference Networks on clinical relevance, feasibility and patient-centred design. |
| Text proposed by the Commission | Amendment |
|---|---|
| 9. When concluding the regulatory sandbox, the Commission shall, at the request of a developer and after having consulted the bodies referred to in paragraph [6] of this Article, deliver a recommendation on an existing appropriate regulatory procedural pathway for authorising the placing on the market and post-marketing surveillance and vigilance of the products concerned. | 9. When concluding the regulatory sandbox, the Commission shall, at the request of a developer and after having consulted the bodies referred to in paragraph [6] of this Article, deliver a recommendation on an existing appropriate regulatory procedural pathway for authorising the placing on the market and post-marketing surveillance and vigilance of the products concerned, as well as, where relevant, guidance on the evidence requirements and procedural pathway for a subsequent joint clinical assessment pursuant to Regulation (EU) 2021/2282. |
| Text proposed by the Commission | Amendment |
|---|---|
| 9. When concluding the regulatory sandbox, the Commission shall, at the request of a developer and after having consulted the bodies referred to in paragraph [6] of this Article, deliver a recommendation on an existing appropriate regulatory procedural pathway for authorising the placing on the market and post-marketing surveillance and vigilance of the products concerned. | 9. When concluding the regulatory sandbox, the Commission shall, at the request of a developer and after having consulted the bodies referred to in paragraph [6] of this Article, deliver a recommendation on an existing appropriate regulatory procedural pathway for authorising the placing on the market and post-marketing surveillance and vigilance of the products concerned as well as, where relevant, guidance on the evidence requirements and procedural pathway for a subsequent joint clinical assessment pursuant to Regulation (EU) 2021/2282. |
| Text proposed by the Commission | Amendment |
|---|---|
| 11. The Commission, after consulting competent authorities of the Member States, and after seeking the opinion of the bodies consulted in accordance with paragraph [6] of this Article, may publish a report on the lessons learned from the regulatory sandbox and, where appropriate, conclusions regarding possible measures at Union level for the regulation of the health biotechnology product or similar innovation categories concerned by the regulatory sandbox. | 11. The Commission, after consulting competent authorities of the Member States, and after seeking the opinion of the bodies consulted in accordance with paragraph [6] of this Article, including the Foresight Panel, shall publish a report on the lessons learned from the regulatory sandbox and, where appropriate, conclusions regarding possible measures at Union level for the regulation of the health biotechnology product or similar innovation categories concerned by the regulatory sandbox. The Foresight Panel shall contribute to the identification of cross-cutting lessons and recommendations relevant to other regulatory sandboxes and future Union regulatory frameworks. By [five years after the date of application of this Regulation], and every five years thereafter, the Commission shall submit a report to the European Parliament and to the Council on the implementation of regulatory sandboxes under this Article. That report shall include information on sandbox applications received, sandboxes established, product categories covered, development stages supported, average assessment timelines, outcomes achieved, regulatory challenges identified, recommendations issued, follow-up actions taken, and any conclusions relevant to future Union regulatory frameworks. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 40a | |
| Ethical exclusions | |
| 1. No project involving human reproductive cloning, heritable human genome modification, germline intervention, commercial or industrial creation or use of human embryos, eugenic selection, or any intervention designed to introduce heritable genetic changes in human beings shall benefit from accelerated procedures, regulatory sandboxes or Union financial support under this Regulation. | |
| 2. This Article shall not prevent Member States from maintaining or introducing stricter ethical safeguards in accordance with national law. | |
| 3. Nothing in this Regulation shall affect Member States’ competence to regulate or prohibit activities concerning reproductive medicine, embryo research, germline interventions, genetic testing and the use of human biological material. |
| Text proposed by the Commission | Amendment |
|---|---|
| VIIa CHAPTER VIIa Biotechnology Innovation for Conditions Affecting Very Small Patient Populations and Characterised by a High Unmet Medical Need | |
| Article 1 Qualification of Conditions Affecting Very Small Patient Populations and Characterised by a High Unmet Medical Need 1. For the purposes of this Chapter, a condition may qualify as a condition affecting a very small patient population and characterised by a high unmet medical need where it: (a) affects a very small patient population within the Union, substantially lower than that addressed under the Union framework for orphan medicinal products; (b) is associated with a scientifically substantiated molecular or genetic mechanism that enables the identification of a defined patient subgroup; (c) lacks satisfactory methods of diagnosis, prevention or treatment authorised in the Union or represents a condition for which the medicinal product is expected to provide a meaningful therapeutic advantage; and (d) is such that the generation of comprehensive clinical evidence through conventional study designs is not reasonably feasible. 2. A condition shall not be considered to meet the criteria set out in this Article where it results from the unjustified subdivision of a broader condition, unless such subdivision is supported by a distinct and causally relevant molecular or genetic mechanism, applying mutatis mutandis the criteria developed by the Committee for Orphan Medicinal Products for the assessment of medically plausible subsets of a condition under Article 3(1) and (2) of Regulation (EC) No 141/2000. Article 2 Principles for Proportionate and Risk-Based Regulatory Assessment 1. The regulatory assessment of medicinal products referred to in Article 1, as carried out by the European Medicines Agency, shall take into account the need for proportionate and risk-based approaches, having regard to: (a) the characteristics of the condition, including its rarity and underlying biological or genetic basis; (b) the nature of the medicinal product, including where it is based on a technological or platform-based approach enabling the reuse of data or knowledge across products; (c) the feasibility of generating comprehensive clinical data using conventional methodologies. 2. In applying paragraph 1, the Agency may, where appropriate and duly justified, on the basis of scientific justification and in accordance with relevant guidelines: (a) consider evidence derived from a scientifically plausible and sufficiently substantiated mechanism of action supported by relevant non-clinical data; (b) take into account alternative approaches to evidence generation, including data from small patient populations, single-arm studies, natural history data, or real-world sources; (c) consider the use of prior knowledge and data generated from related products or technological platforms, where scientific justification is provided. 3. The application of such approaches shall be conditional upon appropriate safeguards, including a risk-based lifecycle evidence generation plan comprising post-authorisation obligations, pharmacovigilance, and, where relevant, long-term follow-up. Article 3 Guidance on Platform-Based Development and Manufacturing 1. The European Medicines Agency shall, following consultation with relevant stakeholders, including competent authorities and, where appropriate, patient representatives, develop and maintain guidelines addressing the application of regulatory requirements to medicinal products referred to in this Chapter. 2. Those guidelines shall, in particular, address: (a) the use of platform-based approaches and the conditions under which data generated for one medicinal product may be leveraged for another, including principles for scientific justification and comparability; (b) the avoidance of unnecessary duplication of non-clinical and other studies, including toxicological studies, where justified by prior knowledge; (c) the application of risk-based and adaptive approaches to quality and manufacturing requirements, including Good Manufacturing Practice, taking into account small-scale, decentralised, or platform-based production; (d) appropriate safeguards to ensure product quality, safety, traceability, and, where relevant, continuity of supply. 3. The guidelines referred to in paragraph 1 shall be regularly updated to reflect scientific and technological progress. Article 4 Regulatory Support for Conditions Affecting Very Small Patient Populations and Characterised by a High Unmet Medical Need 1. Developers of medicinal products addressing conditions referred to in Article 1 shall be entitled, upon request, to access a structured scientific support procedure provided by the European Medicines Agency. 2. The procedure referred to in paragraph 1 shall include: (a) early and iterative scientific advice covering quality, non-clinical and clinical development; (b) coordinated scientific consultation, including, where appropriate, with health technology assessment bodies, conducted in a proportionate and adapted manner, having regard to the specific evidence context of such conditions and therapies, including the early consideration of relevant outcome measures and evidence requirements, with a view to facilitating alignment with those applicable at the regulatory stage, within existing Union frameworks; (c) timely and prioritised support adapted to the specific challenges associated with very small patient populations and highly specialised or personalised therapies. 3. The Agency shall ensure that such support is proportionate, timely, and facilitates efficient development pathways for the medicinal products concerned. |
See relevant recitals starting from Recital 178a. The UK and UK medicines regulators have recently taken similar steps to create a clear regulatory path to market for such therapies. The EU should do so as well using the Biotech Act as a vehicle.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. To enable access to the support measures laid down in Section 2 of Chapter II, the Commission shall recognise projects located in the Union as high-impact health biotechnology strategic projects contributing to the EU Biothreat Radar for the detection, characterisation, identification, analysis and assessment of biological threats, including novel, unknown and engineered pathogens to ensure pathogen-agnostic cross-border surveillance and early threat detection, as well as the generation and sharing of data required for this, only where they comply with the conditions laid down in Article 4[(1)] and make a substantial contribution to at least one of the following: | 1. To enable access to the support measures laid down in Section 2 of Chapter II, the Commission shall recognise projects located in the Union as high-impact health biotechnology strategic projects where appropriate in collaboration with the European Health Emergency Preparedness and Response Authority (HERA) and the European Centre for Disease Prevention and Control (ECDC), each acting within their respective competences, contributing to the EU Biothreat Radar for the detection, characterisation, identification, analysis and assessment of biological threats, including novel, unknown and engineered pathogens to ensure pathogen-agnostic cross-border surveillance and early threat detection, as well as the generation and sharing of data required for this, only where they comply with the conditions laid down in Article 4[(1)] and make a substantial contribution to at least one of the following: |
The wording of Article 41.1 is modified to highlight the specific roles of HERA and ECDC in the EU Biothreat radar and the detection and assessment of biological threats.
| Text proposed by the Commission | Amendment |
|---|---|
| (e) ensuring that sequencing data generated through early detection activities is shared in a timely manner through the European Nucleotide Archive (ENA)70 , to enable access and use by actors across the Union for the development, validation and deployment of advanced pathogen detection and characterisation methods, by engaging in partnerships among industry, academia, public authorities and defence actors to ensure data sharing and integration of warning systems. | (e) ensuring that sequencing data generated through early detection activities is shared in a timely manner through the European Nucleotide Archive (ENA)70 , and other relevant platforms, to enable access and use by actors across the Union for the development, validation and deployment of advanced pathogen detection and characterisation methods, by engaging in partnerships among industry, academia, public authorities and defence actors to ensure data sharing and integration of warning systems, while ensuring that the sharing of benefits derived from the access to these data is compliant with relevant legislation, enabling equitable global access to medical countermeasures. |
| 70 ENA, https://www.ebi.ac.uk/ena. | 70 ENA, https://www.ebi.ac.uk/ena. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. The Commission shall develop and publish an EU Biodefence Strategy, in consultation with Member States, within six months after entry into force of this Regulation. |
Developing a Biodefence Strategy is without prejudice to EU Stockpiling Strategy and the EU Medical Countermeasures Strategy adopted in 2025. Biodedefence and pandemic preparedness form complementary pillars of national resilience, combining public health readiness with security-driven preparedness. The strongest resilience strategy combines both. It ensures that the same platforms, surveillance, diagnostics, vaccine manufacturing, medical countermeasures, and emergency response, can be scaled for routine public health emergencies while also providing the specialised capabilities needed to address intentional biological attacks.
Such a Biodefence Strategy should have two windows: 1) procurement and stockpiling against prioritised known and lethal pathogens; 2) maintaining ever-warm manufacturing capacities of vaccines and other medical countermeasures, including dual use.
| Text proposed by the Commission | Amendment |
|---|---|
| (d) robust pathogen-agnostic pharmaceutical and non-pharmaceutical defences against biological threats; | (d) Research, including translational research, using NAMs where applicable, and development to produce and validate robust pathogen-agnostic pharmaceutical and non-pharmaceutical defences against biological threats; |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) robust pathogen-agnostic pharmaceutical and non-pharmaceutical defences against biological threats; | (d) robust pathogen-agnostic pharmaceutical and non-pharmaceutical defences against biological threats, including for the prevention of disease particularly through vaccine development, manufacturing and deployment; |
In the context of biodefence, it is essential to explicitly include disease prevention, particularly vaccination. Vaccines offer a unique capability to protect a large population rapidly against serious diseases. This swift and broad protection is vital for maintaining the sustainability of healthcare systems and the economy, especially during times of existing strain or in response to a biothreat. Prioritising prevention ensures robust readiness and resilience against future health security challenges.
| Text proposed by the Commission | Amendment |
|---|---|
| (d) robust pathogen-agnostic pharmaceutical and non-pharmaceutical defences against biological threats; | (d) robust pathogen-agnostic pharmaceutical and non-pharmaceutical defences against biological threats, including for prevention of disease particularly through vaccine development, manufacturing, and deployment; |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) robust pathogen-agnostic pharmaceutical and non-pharmaceutical defences against biological threats; | (d) robust pathogen-agnostic pharmaceutical and non-pharmaceutical defences against biological threats including diagnostic, therapeutic, logistical and population-protection capabilities; |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) robust pathogen-agnostic pharmaceutical and non-pharmaceutical defences against biological threats; | (d) robust pharmaceutical and non-pharmaceutical defences against biological threats including for prevention of disease particularly through vaccine development, manufacturing, and deployment; |
| Text proposed by the Commission | Amendment |
|---|---|
| (e) development, validation and benchmarking of methods for the detection and attribution of genetic engineering, including the creation of open genetic engineering detection tools; | (e) development, validation and benchmarking of methods for the detection and attribution of genetic engineering, including the creation of open, interoperable, and, where appropriate, open-source genetic engineering detection tools; |
| Text proposed by the Commission | Amendment |
|---|---|
| (f) civilian and defence research, testing or demonstration infrastructures for biotechnology activities relevant to defence, security and resilience, provided that governance ensures clear separation of mandates and access regimes, with appropriate confidentiality and security safeguards, in line with relevant requirements arising from the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (‘BTWC’), Union and national law. | (f) civilian and defence research, testing or demonstration infrastructures for biotechnology activities relevant to defence, security and resilience, provided that governance ensures clear separation of mandates and access regimes, with appropriate confidentiality and security safeguards, in line with relevant requirements arising from the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (‘BTWC’), Union and national law, while ensuring that civilian applications remain primary and that defence-related uses are strictly limited to protective and defensive purposes. |
| Text proposed by the Commission | Amendment |
|---|---|
| (f) civilian and defence research, testing or demonstration infrastructures for biotechnology activities relevant to defence, security and resilience, provided that governance ensures clear separation of mandates and access regimes, with appropriate confidentiality and security safeguards, in line with relevant requirements arising from the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (‘BTWC’), Union and national law. | (f) civilian and defence research, including translational research, testing, using NAMs where applicable, or demonstration infrastructures for biotechnology activities relevant to defence, health security, security and resilience, provided that governance ensures clear separation of mandates and access regimes, with appropriate confidentiality and security safeguards, in line with relevant requirements arising from the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (‘BTWC’), Union and national law. |
| Text proposed by the Commission | Amendment |
|---|---|
| (f) civilian and defence research, testing or demonstration infrastructures for biotechnology activities relevant to defence, security and resilience, provided that governance ensures clear separation of mandates and access regimes, with appropriate confidentiality and security safeguards, in line with relevant requirements arising from the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (‘BTWC’), Union and national law. | (f) civilian and defence research, including translational research testing using NAMs where applicable, or demonstration infrastructures for biotechnology activities relevant to defence, security and resilience, provided that governance ensures clear separation of mandates and access regimes, with appropriate confidentiality and security safeguards, in line with relevant requirements arising from the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (‘BTWC’), Union and national law. |
| Text proposed by the Commission | Amendment |
|---|---|
| (f) civilian and defence research, testing or demonstration infrastructures for biotechnology activities relevant to defence, security and resilience, provided that governance ensures clear separation of mandates and access regimes, with appropriate confidentiality and security safeguards, in line with relevant requirements arising from the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (‘BTWC’), Union and national law. | (f) civilian research, testing or demonstration infrastructures for biotechnology activities relevant to defence, security and resilience, provided that governance ensures clear separation of mandates and access regimes, with appropriate confidentiality and security safeguards, in line with relevant requirements arising from the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (‘BTWC’), Union and national law. |
| Text proposed by the Commission | Amendment |
|---|---|
| (fa) EU manufacturing capacity for vaccines, antimicrobials and related APIs, diagnostics and medical countermeasures, including dual use, contributing to the EU’s global health and antimicrobial resistance objectives, addressing civilian health security and military medical readiness. |
Sovereign EU manufacturing capacity, especially such capacity that is not reliant on the import of key APIs, is of foundational importance for EU biodefence.
| Text proposed by the Commission | Amendment |
|---|---|
| (fb) the surveillance of biothreat pathogens and the discovery, development, scale-up and manufacturing of medical countermeasures against biological threats, including vaccines, antibiotics, antivirals, antifungals and antiparasitic medicinal products, through resilient end-to-end manufacturing capabilities within the Union, ensuring that priority antimicrobials and other medical countermeasures of strategic importance to the Union’s preparedness can continue to be discovered, developed and produced within the Union throughout the full value chain. |
Effective biodefence requires the integration of three capabilities: pathogen surveillance, in order to detect emerging and engineered threats; the discovery and development of medical countermeasures, including antimicrobials across all four therapeutic classes; and the manufacturing capacity to produce those countermeasures at scale within the Union. Strengthening end-to-end manufacturing capabilities for priority antimicrobials and other medical countermeasures enhances the Union’s preparedness, resilience and security of supply in response to biological threats, in line with the Preparedness Union Strategy and complementary to the Critical Medicines Act. The integrated formulation ensures that biodefence projects under this Article cover the full value chain rather than isolated stages
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. Projects shall assess, prevent, and mitigate any significant adverse environmental impacts throughout the entire lifecycle of biotechnology activities, including effects on biodiversity and ecosystems. Where significant risks are identified, appropriate mitigation measures shall be required. Projects shall comply with applicable Union environmental law and contribute to the Union’s environmental and sustainability objectives. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1b. Support measures provided under this Regulation for high-impact health biotechnology strategic projects for biodefence capability shall be financed exclusively from Union or national appropriations dedicated to security or defence. Such support shall not reduce or reallocate funding available for public health research, patient-centred innovation, or activities addressing unmet medical needs. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Commission is empowered to adopt delegated acts in accordance with Article 64 (2) to amend Annex I by adding, removing or modifying categories of biotechnology products of concern, setting or adjusting thresholds or exclusions, and specifying technical parameters, in order to reflect developments in scientific evidence, biosecurity and biosafety risks or patterns of misuse, also considering the latest developments under relevant international fora and instruments. | 2. The Commission is empowered to adopt delegated acts in accordance with Article 64 (2) to amend Annex I by adding, removing or modifying categories of biotechnology products of concern, setting or adjusting thresholds or exclusions, and specifying technical parameters, in order to reflect developments in scientific evidence, biosecurity and biosafety risks or patterns of misuse, also considering the latest developments under relevant international fora and instruments. The Commission shall ensure that any amendments to Annex I adopted pursuant to this paragraph are limited to technical updates necessary to reflect scientific and technological developments. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. For the purposes of verification of legitimate need, an economic operator may presume that the armed forces, law enforcement authorities, civil protection authorities, public health authorities or other competent public authorities of a Member State, have a legitimate need in accordance with national law, where the order is made through an official procurement channel or by a duly authorised representative. That presumption shall not affect obligations relating to sequence screening, transaction recording and retention, or the refusal and reporting of suspicious transactions. It shall not apply where the economic operator has reasonable grounds to suspect unauthorised acquisition, diversion, or misuse |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 43a | |
| Prohibited biotechnology applications | |
| 1. Biotechnology products, technologies or processes shall not be developed, placed on the market, made available, supplied, transferred or used where they are specifically designed or intended to enable: (a) the selection of persons based on their genetic characteristics; (b) the modification of human genetic characteristics other than for therapeutic purposes, or any biotechnology application intended to achieve the enhancement of human capacities, characteristics or abilities; (c) interventions intended to modify the human germline or introduce heritable genetic modifications. | |
| 2. The prohibition laid down in paragraph 1 shall apply irrespective of any alleged legitimate need or intended use and shall be without prejudice to stricter provisions laid down under Union or national law. |
| Text proposed by the Commission | Amendment |
|---|---|
| For the purposes of conducting the verification referred to in paragraph 1, the economic operator shall request the following information from the prospective customer prior to facilitating the exchange: | For the purposes of conducting the verification of legitimate need as referred to in paragraph 1, the economic operator shall request the following information from the prospective customer prior to facilitating the exchange: |
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) delivery address of the requested product; |
| Text proposed by the Commission | Amendment |
|---|---|
| The first subparagraph, with the exception of transaction recording, shall not apply where the economic operator has conducted an equivalent verification for the same customer within the preceding five years and the new transaction does not significantly deviate in nature or scale from previous transactions. | The requirement to obtain and review the information in this paragraph may be waived where the economic operator has conducted an equivalent verification of legitimate need for the same customer and product within the preceding twelve months, provided that: |
| (i) the economic operator verifies that the identity of the customer remains valid; and | |
| (ii) the new transaction does not materially deviate in nature, scale, or risk profile from previous transactions. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. Operators handling biotechnology products of concern shall establish appropriate internal compliance and reporting mechanisms. Member States shall ensure that effective, proportionate and dissuasive penalties apply to infringements of this Section, including the deliberate misuse of biotechnology products of concern, in accordance with national law. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Economic operators shall keep and retain records of the transactions referred to in this Article for three years and shall make them available without undue delay to the competent authorities upon request. | 6. Economic operators shall keep and retain records of the transactions referred to in this Article for ten years and shall make them available without undue delay to the competent authorities upon request. |
| Text proposed by the Commission | Amendment |
|---|---|
| Benchtop nucleic acid synthesis devices made available in the Union shall contain a mechanism to screen for sequences of concern as defined in Annex I, provided that databases of sequences of concern are not stored on the equipment itself, in an unencrypted manner or a manner that could allow users to extract the database. | Benchtop nucleic acid synthesis devices made available in the Union shall contain a mechanism to screen for sequences of concern as defined in Annex I, prior to synthesis. That mechanism shall be capable of receiving updates necessary to reflect changes to sequences of concern and relevant screening determinations. Databases of sequences of concern shall are not be stored on the equipment itself, in an unencrypted manner or a manner that could allow users to extract the database. The making available of benchtop nucleic acid synthesis devices shall be without prejudice to the verification requirements set out in Article 44. Devices shall enable the retention of audit-relevant synthesis logs for five years, with integrity safeguards designed to prevent undetected alteration, and shall make such logs available to competent authorities upon request. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ga) places multiple orders that, taken separately, are not biotechnology products of concern but that, taken together, would constitute such a product or a sequence of concern as defined in Annex I. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Economic operators and online marketplaces shall have appropriate, reasonable and proportionate procedures in place to detect suspicious transactions, adapted to the specific environment in which biotechnology products of concern are made available. | 2. Economic operators and online marketplaces shall have appropriate, reasonable and proportionate procedures in place to detect suspicious transactions, adapted to the specific environment in which biotechnology products of concern are made available. The Commission shall, by means of guidance adopted pursuant to Article 54, provide typologies of suspicious transaction patterns and sector-specific indicators to assist operators in the proportionate application of this Article, including in low-risk research contexts, and shall update such guidance regularly to reflect emerging patterns of misuse. |
Article 46(2) relies on a non-exhaustive list of red flags, leaving operators with broad discretion and liability risk. Anti-money laundering regimes function effectively because competent authorities provide ongoing typologies. Without equivalent guidance in this instance, operators in low-risk research contexts face uncertainty and unwarranted regulatory risk.
| Text proposed by the Commission | Amendment |
|---|---|
| 4. Economic operators and online marketplaces shall refuse a suspicious transaction. They shall report any suspicious transaction or attempted suspicious transaction within 24 hours of determining that it is suspicious. Reports shall include, where possible, the identity of the prospective customer and the facts that led to the suspicion and shall be addressed to the national contact point of the Member State where the transaction was concluded or attempted. | 4. Economic operators and online marketplaces shall refuse a suspicious transaction. They shall retain the transaction records in accordance with Article 44 and report any suspicious transaction or attempted suspicious transaction within immediatly and no later than 24 hours of determining that it is suspicious to the respective national contact point. Reports shall include, all information received in accordance with Article 44 paragraph 2 and the facts that led to the suspicion and shall be addressed to the national contact point of the Member State where the transaction was concluded or attempted. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. The Commission shall provide a template for reporting of suspicious behaviour for the purposes of reporting pursuant to paragraph 4. The template shall be made available in all official EU laguages. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. Member states shall establish auditing mechanisms, including vulnerability and conformity testing by independent entities, to establish that economic operators are compliant with requirements in Articles 44 and 46. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may support and monitor national competent authorities in the enforcement of this section, by taking actions such as requesting information and records and running training exercises. | The Commission may support and monitor national competent authorities in the enforcement of this section by supporting operational coordination, the exchange of information and the dissemination of best practices among Member States, and by taking actions such as requesting information and records and running training exercises. |
| Text proposed by the Commission | Amendment |
|---|---|
| When suitable clinical trial sites do not exist in the patient’s home country, provisions for safe and coordinated cross-border access should be considered. The Commission should work with Member States and stakeholders, in particular patient organisations, to develop harmonised reccomendations. |
It would welcome clearer recognition within the Act that patient safety must remain at the core of the framework. In this context, shorter timelines must be accompanied by adequate resourcing of both the reporting Member State and ethics committees in order to maintain high-quality evaluations. In addition, it is important to ensure that the regulation also addresses major inequalities related to patients’ rights to post-trial access to treatments, as well as barriers to cross-border clinical trials across the Union.
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. Economic operators that have failed to comply with the obligations set out in this Section shall also be excluded from any public funding mechanisms and from the facilitations provided under this Regulation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Advisory Group shall provide independent scientific advice to the Commission on biosecurity risks arising from the rapid development of biotechnology, including from AI models as described in Regulation (EU) 2024/1689 in biological applications (‘AI models in biological applications’). It shall be selected and operate in accordance with the Commission’s framework for expert groups73 . | 2. The Advisory Group shall provide independent scientific advice to the Commission on biosecurity risks arising from the rapid development of biotechnology, including from AI models as described in Regulation (EU) 2024/1689 in biological applications (‘AI models in biological applications’) and research that advances toward the creation of mirror life as well as synthetic biology, gene-editing technologies, nucleic acid synthesis, biological materials and other emerging biotechnological or technological approaches with potential for misuse. . It shall be selected and operate in accordance with the Commission’s framework for expert groups73 . |
| 73 Commission Decision establishing horizontal rules on the creation and operation of Commission expertgroups, C(2016)3301. | 73 Commission Decision establishing horizontal rules on the creation and operation of Commission expertgroups, C(2016)3301. |
Vytenis Povilas Andriukaitis, Marta Temido, Romana Jerković, Dario Nardella, Victor Negrescu, Tiemo Wölken, Nicolás González Casares
| Text proposed by the Commission | Amendment |
|---|---|
| (b) monitoring the capabilities and risk profile of AI models in biological applications throughout their life cycle; | (b) monitoring the capabilities and risk profile of AI models in biological applications throughout their life cycle as well as the ethical use of AI in the biotechnology sector; |
| Text proposed by the Commission | Amendment |
|---|---|
| (da) monitoring the consistency of projects recognised under Articles 41 and 42, and of the data- and benefit-sharing arrangements established under this Regulation, with the Union’s and Member States’ commitments to equitable global preparedness and response to health emergencies under relevant international instruments. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. Where the Advisory Group has reasonable grounds to suspect that an AI model in a biological application not covered by Regulation (EU) 2024/1689, poses biological systemic risk, it shall issue a qualified alert to the Commission and to the Member States. A qualified alert may be issued following a decision of the Advisory Group or at the initiative of at least 50% of its members. The alert shall be concise and duly reasoned and shall indicate at least the point of contact of the developer of the model concerned and the factual basis for the alert. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The Commission shall monitor biological systemic risk from AI models in biological applications and propose mitigating actions, based on advice provided by the Advisory Group and in line with the Union harmonisation legislation on AI, including boosting biodefence capabilities or regulation, including on assessment and mitigation of systemic risk from those AI models, as appropriate. | 1. The Commission shall monitor biological systemic risk from AI models in biological applications, such as, and including, research that advances toward the creation of mirror-life or stemming from AI models and propose mitigating actions, based on advice provided by the Advisory Group and in line, inter alia, with the Union harmonisation legislation on AI, including boosting biodefence capabilities or regulation, including on assessment and mitigation of systemic risk from those AI models, as appropriate. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission, based on advice by the Advisory Group on Biosecurity, and where appropriate, in cooperation with the Steering Group, may issue and regularly update guidance, to assist actors in the supply chain and the competent authorities. The guidance may provide: | The Commission, based on advice by the Advisory Group on Biosecurity, and in cooperation with the Steering Group, shall, where appropriate, issue and regularly update guidance, to assist actors in the supply chain and the competent authorities. The guidance shall provide: |
| Text proposed by the Commission | Amendment |
|---|---|
| IX AMENDMENTS TO REGULATIONS (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 | IX AMENDMENTS TO REGULATIONS (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 and Directive 2013/59 EURATOM |
Therapeutic radiopharmaceuticals (tRPs) are an emerging class of medicinal products with great potential for patients, challenged by an unclear EU legislative framework that spans across medicinal products and radiation protection requirements.
As tRPs are medicinal products, it is important that the EU legislative framework clearly states they are regulated as medicinal products, appropriately considering the requirements for radiation protection. This would reflect the pharmacological and pharmacokinetic properties of (systemic) administered tRPs which allow for population-based dosing with the same considerations as for non-radioactive drugs. This also allows the development of a clear framework, unlocking the potential of this treatment class for the benefit of patients.
Euratom Directive Art 56 should therefore be amended via the Biotech Act to ensure the EU legislative framework is clear and future proof, allowing the full potential of both academic research and medicinal product evidence generation to be applied to tRP.
| Text proposed by the Commission | Amendment |
|---|---|
| (1) in Article 3, the following points 19, 20 and 21 are added: | deleted |
| ‘19. ‘regulatory sandbox’ means a controlled environment where participants can test innovative products or substances and related processes as well as data and other regulatory requirements at a pre-market stage under a set of defined rules and monitoring and for a limited period of time; | |
| 20. ‘regulatory sandbox plan’ means a plan setting out the scope, the requirements and the conditions governing the operation of a specific regulatory sandbox; | |
| 21. ‘participants’ means any natural or legal person participating in a regulatory sandbox to whom specific tasks are assigned in the regulatory sandbox plan, such as business operators, Union and national agencies, final consumers, academia and research institutions.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| 19. ‘regulatory sandbox’ means a controlled environment where participants can test innovative products or substances and related processes as well as data and other regulatory requirements at a pre-market stage under a set of defined rules and monitoring and for a limited period of time; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 19. ‘regulatory sandbox’ means a controlled environment where participants can test innovative products or substances and related processes as well as data and other regulatory requirements at a pre-market stage under a set of defined rules and monitoring and for a limited period of time; | 19. ‘regulatory sandbox’ means a controlled environment where participants can test innovative products or substances and related processes or adapted regulatory solutions as well as data and other regulatory requirements at a pre-market stage under a set of defined rules and monitoring, and for a limited period of time and under regulatory supervision; |
| Text proposed by the Commission | Amendment |
|---|---|
| 20. ‘regulatory sandbox plan’ means a plan setting out the scope, the requirements and the conditions governing the operation of a specific regulatory sandbox; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 20. ‘regulatory sandbox plan’ means a plan setting out the scope, the requirements and the conditions governing the operation of a specific regulatory sandbox; | 20. ‘regulatory sandbox plan’ means a plan setting out the justification for the necessity to establish a regulatory sandbox, the scope, the requirements and the conditions governing the operation of a specific regulatory sandbox; |
| Text proposed by the Commission | Amendment |
|---|---|
| 21. ‘participants’ means any natural or legal person participating in a regulatory sandbox to whom specific tasks are assigned in the regulatory sandbox plan, such as business operators, Union and national agencies, final consumers, academia and research institutions.; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) in Article 22(5), a new point (ca) is added: | |
| (ca) advice or exploratory dialogue on the regulatory applicability of alternative approaches to animal testing, in line with the recommendations from the Commission's Roadmap towards phasing out animal testing for chemical safety assessments. |
| Text proposed by the Commission | Amendment |
|---|---|
| (2b) In Article 23, the following point is added, after point f: | |
| (fa) to undertake action to promote the the development and uptake of human-centered NAMs, as well as to cooperate with relevant bodies; |
| Text proposed by the Commission | Amendment |
|---|---|
| (aa) in paragraph 4, the following point is added: | |
| (ka) the panel on New Approach Methodologies |
| Text proposed by the Commission | Amendment |
|---|---|
| (h) the role of the Authority when chairing the Scientific Committee and the Scientific Panels. | (h) the role of the Authority when chairing the Scientific Committee and the Scientific Panels, as well as the measures and safeguards therein to ensure independence and prevent conflicts of interest. |
| Text proposed by the Commission | Amendment |
|---|---|
| (h) the role of the Authority when chairing the Scientific Committee and the Scientific Panels. | (h) the role of the Authority when chairing the Scientific Committee and the Scientific Panels as well as the measures and safeguards therein to ensure independence and prevent conflicts of interest. |
| Text proposed by the Commission | Amendment |
|---|---|
| (h) the role of the Authority when chairing the Scientific Committee and the Scientific Panels. | (h) the role of the Authority when chairing the Scientific Committee and the Scientific Panels as well as the measures and safeguards therein to ensure independence and prevent conflicts of interest |
| Text proposed by the Commission | Amendment |
|---|---|
| (4) in Article 32a, paragraph 1 is replaced by the following: | deleted |
| ‘1. Where Union law contains provisions for the Authority to provide a scientific output, including a scientific opinion, the Authority shall, at the request of a potential applicant or notifier, provide advice on the content of the application or notification, prior to its submission, including the rules applicable to and the required content thereof as well as on the design of the studies and testing strategies to support such an application or notification. Such advice provided by the Authority shall be without prejudice and non-committal as to any subsequent assessment of applications or notifications by the Scientific Panels.’ |
It is imperative for the independence of EFSA, and for the credibility of its assessments and opinions, that the current provision to prevent conflicts of interests is maintained. This amendment aims to maintain the current text in force: "The staff of the Authority providing the advice shall not be involved in any preparatory scientific or technical work that is directly or indirectly relevant to the application or notification that is the subject of the advice"
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Where Union law contains provisions for the Authority to provide a scientific output, including a scientific opinion, the Authority shall, at the request of a potential applicant or notifier, provide advice on the content of the application or notification, prior to its submission, including the rules applicable to and the required content thereof as well as on the design of the studies and testing strategies to support such an application or notification. Such advice provided by the Authority shall be without prejudice and non-committal as to any subsequent assessment of applications or notifications by the Scientific Panels. | 1. Where Union law contains provisions for the Authority to provide a scientific output, including a scientific opinion, the Authority shall, at the request of a potential applicant or notifier, provide advice on the content of the application or notification, prior to its submission, including the rules applicable to and the required content thereof as well as on the design of the studies and testing strategies to support such an application or notification. Such advice provided by the Authority shall be without prejudice and non-committal as to any subsequent assessment of applications or notifications by the Scientific Panels. |
| The Authority shall put in place appropriate organisational arrangements to ensure that the provision of pre-submission advice is functionally separated from the subsequent scientific assessment of the corresponding application or notification, thereby preserving the independence and impartiality of the scientific evaluation.Where pre-submission advice has been provided, the application or notification shall describe how that advice has been taken into account in the preparation of the dossier and, where relevant, explain any significant departures from it. The Scientific Opinion referred to in Article 29 of Regulation (EC) No 178/2002 shall make reference to the provision of pre-submission advice. | |
| The Authority shall publish general guidance on its website regarding the rules applicable to, and the content required for, applications and notifications, including, where appropriate, general guidance on the design of required studies. The Authority shall ensure that such guidance is kept up to date. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Where Union law contains provisions for the Authority to provide a scientific output, including a scientific opinion, the Authority shall, at the request of a potential applicant or notifier, provide advice on the content of the application or notification, prior to its submission, including the rules applicable to and the required content thereof as well as on the design of the studies and testing strategies to support such an application or notification. Such advice provided by the Authority shall be without prejudice and non-committal as to any subsequent assessment of applications or notifications by the Scientific Panels. | 1. Where Union law contains provisions for the Authority to provide a scientific output, including a scientific opinion, the Authority shall, at the request of a potential applicant or notifier, provide advice on the content of the application or notification, prior to its submission, including the rules applicable to and the required content thereof as well as on the design of the studies and testing strategies to support such an application or notification. Such advice provided by the Authority shall be without prejudice and non-committal as to any subsequent assessment of applications or notifications by the Scientific Panels. |
| The Authority shall publish and regularly update,general guidance on its website regarding the rules applicable to, and the content required for, applications and notifications, including, where appropriate, general guidance on the design of required studies. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Where Union law contains provisions for the Authority to provide a scientific output, including a scientific opinion, the Authority shall, at the request of a potential applicant or notifier, provide advice on the content of the application or notification, prior to its submission, including the rules applicable to and the required content thereof as well as on the design of the studies and testing strategies to support such an application or notification. Such advice provided by the Authority shall be without prejudice and non-committal as to any subsequent assessment of applications or notifications by the Scientific Panels. | 1. Where Union law contains provisions for the Authority to provide a scientific output, including a scientific opinion, the Authority shall, at the request of a potential applicant or notifier, provide advice on the content of the application or notification, prior to its submission, including the rules applicable to and the required content thereof as well as on the design of the studies and testing strategies to support such an application or notification. including in the form of one-on-one meetings with the applicant or notifier. Such advice provided by the Authority shall be without prejudice and non-committal as to any subsequent assessment of applications or notifications by the Scientific Panels. |
To be most effective, the pre-submission advice should take the form of one-on-one meetings. This allows for more timely and targeted advice, and is particularly important given that applications often contain sensitive information, so applicants may feel more comfortable discussing their dossier one-to-one.
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. To preserve the integrity of the work and activities of the Authority, as a general rule, the staff of the Authority providing the advice shall not be involved in any preparatory scientific or technical work that is directly or indirectly relevant to the application or notification that is the subject of the advice. In situations where specific expertise is required and can be provided only by the same staff, which would normally disqualify or limit their involvement, it may still be possible to allow these individuals to provide observations before a scientific assessment is finalised, while excluding them from direct involvement in discussions or decision-making. |
Katri Kulmuni, Stine Bosse, Morten Løkkegaard, Billy Kelleher, Bart Groothuis, Sigrid Friis, Sophie Wilmès
| Text proposed by the Commission | Amendment |
|---|---|
| (4a) The Union may establish regulatory dialogue platforms to support the efficient and consistent authorisation of food and feed products subject to a scientific assessment by the Authority. Such platforms may: (a) facilitate structured pre-submission dialogue between potential applicants or notifiers and competent authorities on applicable data requirements, study design and dossier preparation; (b) develop common frameworks, dossier templates and guidance on best practice, including in cooperation with other Member States and, where appropriate, with the Authority; (c) organise joint training for applicants, regulatory consultants and national assessors to improve mutual understanding of scientific expectations and procedural requirements. The Commission shall be notified and make such reports publicly available and shall facilitate the sharing of findings across Member States. A platform established pursuant to this paragraph shall not grant authorisations, approvals, waivers or rights of market placement, shall not constitute a stage of the authorisation procedure under Union food law, and participation therein shall not confer preferential treatment in any authorisation procedure nor affect the rights and obligations of applicants or notifiers under Union food law, including as regards confidentiality and the notification of studies pursuant to Article 32b. |
This new paragraph gives Member States an enabling framework to establish regulatory dialogue platforms covering all food and feed products requiring EFSA authorisation, including novel foods.
| Text proposed by the Commission | Amendment |
|---|---|
| (5) Article 32b is amended as follows: | deleted |
| (a) in paragraph 4, the third subparagraph is replaced by the following: | |
| ‘The assessment of the validity or the admissibility of such re-submitted application or notification shall commence three months after the date of re-submission of the application and provided that a notification of the studies pursuant to the second subparagraph has taken place.’ | |
| ‘The assessment of the validity or admissibility of such re-submitted application or notification shall commence three months after the date of re-submission of the application and provided that all studies that had previously been notified in accordance with paragraph 2 or 3 are included in the resubmitted application or notification.;’ | |
| ‘6. Where the Authority detects, during its risk assessment, that studies notified in accordance with paragraph 2 or 3 are not included in the corresponding application or notification in full, and in the absence of a valid justification of the applicant or notifier to that effect, the applicable time limits within which the Authority is required to deliver its scientific output shall be suspended. That suspension shall end three months after the submission of all data of those studies.’ |
The "transparency-update" of the General Food Law introduced a 'stop the clock' of 6 months for companies who intentionally have failed to pre-notify studies accompanying their applications, of have failed to include pre-notified studies in their application. An intentional failure to pre-notify studies is done with the intention to hide crucial information related to the safety of products and substances for human, animal and environmental health. Serious offences should be penalised as such. This amendment aims to maintain the current 6 months 'stop the clock' as penalty
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Where the Authority detects, during its risk assessment, that studies notified in accordance with paragraph 2 or 3 are not included in the corresponding application or notification in full, and in the absence of a valid justification of the applicant or notifier to that effect, the applicable time limits within which the Authority is required to deliver its scientific output shall be suspended. That suspension shall end three months after the submission of all data of those studies. | 6. Where the Authority detects, during its risk assessment, that studies notified in accordance with paragraph 2 or 3 are not included in the corresponding application or notification in full, and in the absence of a valid justification of the applicant or notifier to that effect, the applicable time limits within which the Authority is required to deliver its scientific output shall be suspended. That suspension shall end three months after the submission of all data of those studies. Risk analysis shall, where relevant, take into account the One Health approach, including risks and evidence relating to human health, animal health and welfare, plant health, food and feed safety and the environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6a. The procedural simplifications introduced by this Regulation shall not modify, reduce or affect the requirements applicable to novel foods under Regulation (EU) 2015/2283. |
Food products, in particular novel foods within the meaning of Regulation (EU) 2015/2283, are subject to a dedicated and harmonised regulatory framework ensuring a high level of consumer protection. This Regulation should not create alternative pathways for their development, assessment or placing on the market.
| Text proposed by the Commission | Amendment |
|---|---|
| 6a. The procedural simplifications introduced by this Regulation shall not modify, reduce or affect the requirements applicable to novel foods under Regulation (EU) 2015/2283. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) the following paragraph is added: | |
| 6a. The procedural simplifications introduced by this Regulation shall not modify, reduce or affect the requirements applicable to novel foods under Regulation EU 2015/2283. |
| Text proposed by the Commission | Amendment |
|---|---|
| (6) in Article 32c, paragraph 1 is deleted. | deleted |
The consultation of stakeholders and the public on the intended studies for renewal, including on the proposed design of studies by EFSA is a crucial mechanisms to ensure that all relevant studies are performed, and to avoid unnecessary animal testing. This amendment aims to maintain that essential mechanism.
| Text proposed by the Commission | Amendment |
|---|---|
| [...] | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| [...] | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 49aa | |
| Recommendation for the establishment of regulatory sandboxes at Union level | |
| 1. The Authority may, on its own initiative or upon request by the Commission or one or more Member States, issue a scientific recommendation to the Commission for the establishment of a regulatory sandbox encompassing: | |
| (a) all stages of the production, processing and distribution of food, and also of the feed produced for, or fed to food-producing animals; | |
| (b) food contact materials, with the exception of plastic recycled materials; | |
| (c) products, other than food and feed, containing or consisting of genetically modified organisms as defined in Article 2, point (2), of Directive 2001/18/EC. | |
| 2. The making available of products within a regulatory sandbox shall not be regarded as placing on the market. Where appropriate, the Commission and or the Authority shall recommend measures in order to mitigate any possible distortion of market conditions as a result of establishing a regulatory sandbox. Where the Commission deems it appropriate to establish a regulatory sandbox, it shall communicate to the Member States a draft regulatory sandbox plan, which shall contain the following elements: | |
| (a) the objectives of the regulatory sandbox; | |
| (b) a description of the specific areas that the regulatory sandbox will cover, including the products or substances, processes, technologies and practices; | |
| (c) a clearly defined geographical scope; | |
| (d) a clearly defined and limited temporal scope; | |
| (e) the regulatory or scientific justifications rationale for setting up the regulatory sandbox including its expected contribution to evidence generation, scientific understanding, regulatory learning and innovation; | |
| (f) an identification of the relevant provisions of Union law that apply for the purposes of the regulatory sandbox and those that do not apply or are adapted; | |
| (g) the procedure for the application and selection for participants, including clearly defined eligibility criteria, the modalities governing the provision of the explicit and prior consent from participating final consumers as well as the modalities by which the participants may end their participation; | |
| (h) the involvement of the Authority, other Union agencies and national agencies, where relevant, provided that they have expressed interest to join the regulatory sandbox; | |
| (i) the activities allowed to be carried out and the conditions, requirements and safeguards that apply; | |
| (j) an assessment that identifies how potential risks to public health, animal health or welfare, plant health or the environment are eliminated or mitigated; | |
| (k) details on how activities will be monitored, including responsibilities of the competent authorities entrusted with the supervision of the implementation of the sandbox plan. | |
| 3. On the basis of the recommendation of the Authority, the Commission may, by means of implementing acts, establish a regulatory sandbox at Union level or authorise the coordinated establishment of a multinational regulatory sandbox by participating Member States. Prior to adopting an implementing act pursuant to this paragraph, the Commission shall consult the Member States taking into account the recommendation of the Authority and the sandbox plan pursuant to paragraphs 1 and 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 58(2) of this Regulation. | |
| 4. Regulatory sandboxes established pursuant to this Article shall be subject to periodic monitoring and evaluation. The Authority shall submit to the Commission a report on the operation and outcomes of the sandbox, including any implications for food and feed safety, human health, animal health and the environment. | |
| 5. The Commission may adopt implementing acts laying down detailed rules for the operation, supervision, monitoring, suspension and termination of regulatory sandboxes established pursuant to this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 58(2) of this Regulation. |
| Text proposed by the Commission | Amendment |
|---|---|
| Regulatory sandboxes may be established in relation to the following: | 2. Regulatory sandboxes may be established in relation to the following where pathways for controlled testing, notification or authorisation are not available or appropriate:: |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) all stages of the production, processing and distribution of food with the exception of novel foods, and also of the feed produced for, or fed to food-producing animals; | (a) all stages of the production, processing and distribution of food, and also of the feed produced for, or fed to food-producing animals; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) all stages of the production, processing and distribution of food with the exception of novel foods, and also of the feed produced for, or fed to food-producing animals; | (a) all stages of the production, processing and distribution of food including novel foods where appropriate safeguards are ensured, and also of the feed produced for, or fed to food-producing animals; |
Regulatory sandboxes should also be available for novel foods, where appropriate safeguards are ensured. Novel food approval pathways are often lengthy and difficult to adapt to rapidly evolving biotechnology-enabled food innovations, including fermentation-derived products. This would contribute to a more predictable, science-based and innovation-friendly regulatory framework and support the faster market entry of innovative biotechnology solutions.
Katri Kulmuni, Stine Bosse, Morten Løkkegaard, Billy Kelleher, Bart Groothuis, Sigrid Friis, Sophie Wilmès
| Text proposed by the Commission | Amendment |
|---|---|
| (a) all stages of the production, processing and distribution of food with the exception of novel foods, and also of the feed produced for, or fed to food-producing animals; | (a) all stages of the innovation value-chain, including development, testing production, processing and distribution of food and also of the feed produced for, or fed to food-producing animals; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) all stages of the production, processing and distribution of food with the exception of novel foods, and also of the feed produced for, or fed to food-producing animals; | (a) all stages of the production, processing and distribution of food and also of the feed produced for, or fed to food-producing animals; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) all stages of the production, processing and distribution of food with the exception of novel foods, and also of the feed produced for, or fed to food-producing animals; | (a) all stages of the production, processing and distribution of food, and also of the feed produced for, or fed to food-producing animals; |
The Commission’s proposal to exclude novel foods from regulatory sandboxes on the grounds of cultural sensitivity is insufficiently substantiated. The rationale provided is not supported by scientific evidence, nor does take into account the significant social, economic, and innovation-related consequences of such an exclusion for both society and the European food industry. Europe’s novel foods ecosystem is driven primarily by innovators, start-ups, and SMEs. At a time when the EU is seeking to strengthen food security and reduce its dependence on non-EU countries, excluding novel foods from regulatory sandboxes sends a contradictory signal. Diversifying food value chains and increasing their resilience to geopolitical shocks requires regulatory frameworks that enable, rather than constrain, responsible innovation. Concerns regarding novel foods have been raised by a small number of Member States and typically relate to specific product categories rather than the novel foods sector as a whole. Treating novel foods as a homogeneous category and excluding them wholesale from regulatory sandboxes disregards their diversity, which ranges from seeds and fungi to a wide variety of other food sources. Regulatory sandboxes are precisely the tool needed to address uncertainty and public concerns in a transparent and evidence-driven manner. They would allow authorities, innovators, and consumers to generate real-world data on safety, sustainability, and consumer perception while operating under strict regulatory oversight and maintaining the EU’s high food safety standards. Excluding novel foods from this mechanism not only limits evidence generation but also delays consumer awareness and acceptance and informed public debate. In addition, it could jeopardise the EU´s leading position in food research and innovation and biotechnology.
| Text proposed by the Commission | Amendment |
|---|---|
| (a) all stages of the production, processing and distribution of food with the exception of novel foods, and also of the feed produced for, or fed to food-producing animals; | (a) all stages of the production, processing and distribution of food, and also of the feed produced for, or fed to food-producing animals; |
Katri Kulmuni, Stine Bosse, Morten Løkkegaard, Billy Kelleher, Bart Groothuis, Sigrid Friis, Sophie Wilmès
| Text proposed by the Commission | Amendment |
|---|---|
| (aa) products, other than food and feed, that employ innovative biotechnologies, including plants, food ingredients, precision and biomass fermentation, microbial production systems, cell-based techniques, and other innovative manufacturing methods. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) activities that involve the derivation, use or destruction of human embryos or reproductive cloning of human beings shall not be eligible for regulatory sandboxes. |
Safeguards the ethical limits of Directive 98/44/EC by excluding embryo-related activities from sandbox pilots.
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) novel antimicrobial drugs and treatments, notably those which circumvent existing antimicrobial resistance pathways and mechanisms. |
| Text proposed by the Commission | Amendment |
|---|---|
| The making available of products within a regulatory sandbox shall not be regarded as placing on the market. | The making available of products within a regulatory sandbox shall not be regarded as placing on the market. Where appropriate, the Commission and or the Authority shall also recommend measures in order to mitigate any possible distortion of market conditions as a result of establishing a regulatory sandbox. |
| Text proposed by the Commission | Amendment |
|---|---|
| The making available of products within a regulatory sandbox shall not be regarded as placing on the market. | The making available of products within a regulatory sandbox shall not be regarded as placing on the market for the purposes of this Regulation, without prejudice to Union sectoral legislation laying down pre-market authorisation or, where applicable, notification requirements. |
| Text proposed by the Commission | Amendment |
|---|---|
| Recommendation for the establishment of regulatory sandboxes at Union level | |
| 1. The Authority may, on its own initiative or upon request by the Commission or one or more Member States, issue a scientific recommendation to the Commission for the establishment of a regulatory sandbox where pathways for controlled testing, notification or authorisation are not available or appropriate: | |
| (a) all stages of the production, processing and distribution of food , and also of the feed produced for, or fed to food-producing animals; | |
| (b) food contact materials, with the exception of plastic recycled materials; | |
| (c) products, other than food and feed, containing or consisting of genetically modified organisms as defined in Article 2, point (2), of Directive 2001/18/EC. The making available of products within a regulatory sandbox shall not be regarded as placing on the market. Where appropriate, the Commission and or the Authority shall also recommend measures in order to mitigate any possible distortion of market conditions as a result of establishing a regulatory sandbox. | |
| 2. Where the Commission deems it appropriate to establish a regulatory sandbox, it shall communicate to the Member States a draft regulatory sandbox plan, which shall contain the following elements: | |
| (a) the objectives of the regulatory sandbox; | |
| (b) a description of the specific areas that the sandbox will cover, including the products or substances, processes, technologies and practices; | |
| (c) a clearly defined geographical scope; | |
| (d) a clearly defined and limited temporal scope; | |
| (e) the regulatory or scientific justifications for setting up the regulatory sandbox including a justification as to why the pathways for controlled testing, notification or authorisation are not available or appropriate; | |
| (f) an identification of the relevant provisions of Union law that apply for the purposes of the regulatory sandbox and those that do not apply or are adapted; | |
| (g) the procedure for the application and selection for participants, including clearly defined eligibility criteria, the modalities governing the provision of the explicit and prior consent from participating final consumers as well as the modalities by which the participants may end their participation; | |
| (h) the involvement of the Authority, other Union agencies and national agencies, where relevant, provided that they have expressed interest to join the regulatory sandbox; | |
| (i) the activities allowed to be carried out and the conditions, requirements and safeguards that apply; | |
| (j) an assessment that identifies how potential risks to public health, animal health or welfare, plant health or the environment are eliminated or mitigated; (k) details on how activities will be monitored, including responsibilities of the competent authorities entrusted with the supervision of the implementation of the sandbox plan | |
| 3. On the basis of the recommendation of the Authority, the Commission may, by means of implementing acts, establish a regulatory sandbox at Union level or authorise the coordinated establishment of a multinational regulatory sandbox by participating Member States. Prior to adopting an implementing act pursuant to paragraph 3, the Commission shall consult the Member States taking into account the recommendation of the Authority and the sandbox plan pursuant to paragraph 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 51. | |
| 4. Regulatory sandboxes established pursuant to this Article shall be subject to periodic monitoring and evaluation. The Authority shall submit to the Commission a report on the operation and outcomes of the sandbox, including any implications for food and feed safety, human health, animal health and the environment. | |
| 5. The Commission shall be empowered to adopt implementing acts laying down detailed rules for the operation, supervision, monitoring, suspension and termination of regulatory sandboxes established pursuant to this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 51. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) supporting the sharing of best practices through cooperation with the relevant authorities; |
| Text proposed by the Commission | Amendment |
|---|---|
| (cb) fostering innovation and competitiveness and facilitating the development of innovative ecosystems; |
| Text proposed by the Commission | Amendment |
|---|---|
| (cc) contributing to evidence generation and evidence-based regulatory learning; |
| Text proposed by the Commission | Amendment |
|---|---|
| (cd) facilitating and accelerating access to the Union market for innovative food and feed products, in particular those innovated or manufactured provided by SMEs, including start-ups and scale-ups. |
These additions correspond to the ones in the EU AI Act (2021). The purpose is to ensure that regulation is future proofed to accommodate technological and scientific progress, creating certainty for investments, or avoid excessive red tape. In this context, regulatory sandboxes can be used to learn about the potential and possible risks that a particular innovation carries and to develop the right regulatory environment to accommodate it. Often, regulatory frameworks are not in compliance with cutting-edge innovations as the rapid advancement of technological development runs way ahead of regulatory adaptations. Thus, regulatory sandboxes can offer the possibility to converge the uncertainties of innovation with the uncertainties of regulation and give the opportunity to maximize the benefits while minimizing the risks. At the same time, they can allow for regulating innovations based on real-world evidence and gain knowledge when drafting new policies for innovation. Decision-makers can observe the dynamics of technological development and identify the most appropriate and effective regulatory interventions to facilitate the development of new solutions, working towards an evidence-based regulatory environment and better regulation. Regulatory sandboxes thereby provide an important tool for regulatory innovation and adaptation to the rapidly evolving scientific and technological advancements, which together will help uphold the EU’s leading position in the food space/market.
| Text proposed by the Commission | Amendment |
|---|---|
| 4. Member States shall monitor and supervise the operation of regulatory sandboxes that they establish and ensure compliance with the regulatory sandbox plan. | 4. Member States shall monitor and supervise the operation of regulatory sandboxes that they establish and ensure compliance with the regulatory sandbox plan. Member States shall also systematically collect, and where relevant transmit to other regulatory bodies, results of regulatory sandboxes for the purpose of improving regulatory frameworks, approval pathways and guidance. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. In duly justified cases, Member States may grant a time-limited national authorisation for a product undergoing testing within a regulatory sandbox, where this is necessary to generate real-world evidence under controlled conditions. Such authorisations shall: | |
| (a) take effect exclusively within the territory of the Member State concerned; | |
| (b) be subject to enhanced monitoring and reporting; | |
| (c) be notified to relevant EU authorities without undue delay; | |
| (d) not preempt or replace an EU-wide authorisation procedure. |
| Text proposed by the Commission | Amendment |
|---|---|
| 10. A Member State may prolong the duration once of a regulatory sandbox for a limited time where this is justified by the need to attain the objective of the specific regulatory sandbox at hand and shall inform the Commission, the Authority and the other Member States thereof. | 10. A Member State may prolong the duration once of a regulatory sandbox once for a limited time where this is duly justified by the need to attain the objective of the specific regulatory sandbox at hand and shall inform the Commission, the Authority and the other Member States thereof. |
| Text proposed by the Commission | Amendment |
|---|---|
| Establishment of regulatory sandboxes | Establishment of regulatory sandboxes by Member States |
| Text proposed by the Commission | Amendment |
|---|---|
| (e) the regulatory or scientific justifications for setting up the regulatory sandbox; | (e) the regulatory or scientific justifications for setting up the regulatory sandbox, including a justification as to why the pathways for controlled testing, notification or authorisation are not available or appropriate; |
| Text proposed by the Commission | Amendment |
|---|---|
| (i) the activities allowed to be carried out and the conditions and requirements that apply; | (i) the activities allowed to be carried out and the conditions, requirements and safeguards that apply; |
| Text proposed by the Commission | Amendment |
|---|---|
| (j) an assessment that identifies how potential risks to public health, animal health or welfare, plant health or the environment are mitigated; | (j) an assessment that identifies how potential risks to public health, animal health or welfare, plant health or the environment are eliminated or mitigated; |
| Text proposed by the Commission | Amendment |
|---|---|
| (k) details on how activities will be monitored, including responsibilities of the competent authorities entrusted with the supervision of the implementation of the sandbox plan. | (k) details on how activities will be monitored, including responsibilities of the competent authorities entrusted with the supervision of the implementation of the sandbox plan, and corresponding reporting and exchange of information to the Commission and the Authority, as appropriate.. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Member States shall engage with relevant stakeholders during the preparation of a draft regulatory sandbox plan to gather diverse perspectives and foster collaboration. | 3. Member States shall engage with relevant stakeholders during the preparation of a draft regulatory sandbox plan to gather diverse perspectives and foster collaboration, including by enabling national authorities to provide structured opportinities to clarify regulatory requirements, documentation needs and possible approval pathways. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Member States shall engage with relevant stakeholders during the preparation of a draft regulatory sandbox plan to gather diverse perspectives and foster collaboration. | 3. Member States shall engage with relevant stakeholders, including civil society representatives, trade unions and non-govermental organisations during the preparation of a draft regulatory sandbox plan to gather diverse perspectives and foster collaboration. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. On the basis of the outcomes and lessons learned from regulatory sandboxes, the Commission shall assess the need for amendments to Union legislation and shall report on the conclusions of that assessment, including any follow-up actions, to the European Parliament and to the Council. |
| Text proposed by the Commission | Amendment |
|---|---|
| Regulation (EC) No 1394/2007 is amended as follows: | The Commission is empowered to adopt delegated acts in accordance with Article 25a to amend this Regulation in order to amend the definitions referred to in paragraph 1, including, but not limited o, what constitutes a tissue engineered product, in light of technical and scientific advancements in the field of advance therapy medical products and taking into account definitions agreed at Union and international level without extending the scope of this definition. The delegated acts shall be adopted after consultations with the European Medicines Agency and the SoHO Coordination Board. |
| Text proposed by the Commission | Amendment |
|---|---|
| [...] | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| Advanced therapy investigational medicinal products containing or consisting of genetically modified organisms presenting no or negligible risks | Advanced therapy investigational medicinal products or vaccines containing or consisting of genetically modified organisms presenting no or negligible risks |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of exemption from Article 5a of Regulation (EU) No 536/2014 [as added by the revised Regulation No (EC) 726/2004], sponsors of clinical trials that concern advanced therapy investigational medicinal products as defined in Article 2(7) of that Regulation, consisting or containing GMOs, are not required to submit an environmental risk assessment, if those products belong to at least one of the following categories: | 1. By way of exemption from Article 5a of Regulation (EU) No 536/2014 [as added by the revised Regulation No (EC) 726/2004], sponsors of clinical trials that concern (i) advanced therapy investigational medicinal products as defined in Article 2(7) of that Regulation or (ii) vaccines as defined in Article 4(1) (28) of [revised Directive 2001/83/EC], consisting or containing GMOs, are not required to submit an environmental risk assessment, if those products belong to at least one of the following categories set out in points (a) to (d) of this paragraph or in a delegated act adopted pursuant to paragraph 2: |
Expanded to include certain viral-derived vaccines with known low or negligible risk to the environment. This was relevant exemption as showing during COVID-19 pandemic for vaccines containing or consisting of GMOs.
Vytenis Povilas Andriukaitis, Marta Temido, Romana Jerković, Dario Nardella, Victor Negrescu, Tiemo Wölken, Nicolás González Casares
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of exemption from Article 5a of Regulation (EU) No 536/2014 [as added by the revised Regulation No (EC) 726/2004], sponsors of clinical trials that concern advanced therapy investigational medicinal products as defined in Article 2(7) of that Regulation, consisting or containing GMOs, are not required to submit an environmental risk assessment, if those products belong to at least one of the following categories: | 1. By way of exemption from Article 5a of Regulation (EU) No 536/2014 [as added by the revised Regulation No (EC) 726/2004], sponsors of clinical trials that concern advanced therapy investigational medicinal products as defined in Article 2(7) of that Regulation, consisting or containing GMOs, are not required to submit an environmental risk assessment, if those products belong to at least one of the following categories and provided that they present no or negligible risk to human health, animal health, ecosystems and the environment : |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of exemption from Article 5a of Regulation (EU) No 536/2014 [as added by the revised Regulation No (EC) 726/2004], sponsors of clinical trials that concern advanced therapy investigational medicinal products as defined in Article 2(7) of that Regulation, consisting or containing GMOs, are not required to submit an environmental risk assessment, if those products belong to at least one of the following categories: | 1. By way of exemption from Article 5a of Regulation (EU) No 536/2014 [as added by the revised Regulation No (EC) 726/2004], sponsors of clinical trials that concern advanced therapy investigational medicinal products as defined in Article 2(7) of that Regulation, consisting or containing GMOs, are not required to submit an environmental risk assessment, if those products belong to at least one of the following categories and provided they present no or negligible risk to human health, animal health, ecosystems and the environment: |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of exemption from Article 5a of Regulation (EU) No 536/2014 [as added by the revised Regulation No (EC) 726/2004], sponsors of clinical trials that concern advanced therapy investigational medicinal products as defined in Article 2(7) of that Regulation, consisting or containing GMOs, are not required to submit an environmental risk assessment, if those products belong to at least one of the following categories: | 1. By way of exemption from Article 5a of Regulation (EU) No 536/2014 [as added by the revised Regulation No (EC) 726/2004], sponsors of clinical trials that concern advanced therapy investigational medicinal products as defined in Article 2(7) of that Regulation, consisting or containing GMOs, shall submit an environmental risk assessment proportionate to the nature, scale and foreseeable environmental exposure of the GMO concerned |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) non-viable or replication deficient viral vector that is used to deliver a genetic sequence of human origin, and the vector does not carry an antimicrobial resistance gene; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) non-viable or replication deficient viral vector that is used to deliver a genetic sequence of human origin, and the vector does not carry an antimicrobial resistance gene; | (a) non-viable or replication deficient viral vector or non-viral delivery system that is used to deliver a genetic sequence of human origin, and the vector or non-viral delivery system does not carry an antimicrobial resistance gene; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) non-viable or replication deficient viral vector that is used to deliver a genetic sequence of human origin, and the vector does not carry an antimicrobial resistance gene; | (a) non-viable or replication deficient viral vector that is used to deliver a genetic sequence, and the vector does not carry an antimicrobial resistance gene; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) genetically modified somatic cells, that cannot secrete or produce infectious agents due to the genetic modification; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) genetically modified bacteria that do not carry an antimicrobial resistance gene; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) genetically modified bacteria that do not carry an antimicrobial resistance gene; | (c) genetically modified bacteria which carry a genetic switch to render them inviable outside of clinical environments and that do not carry an antimicrobial resistance gene; |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) genetic material altered using genome editing techniques (ex vivo or in vivo), provided that it has generally negligible adverse effects on human health and the environment. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) genetic material altered using genome editing techniques (ex vivo or in vivo), provided that it has generally negligible adverse effects on human health and the environment. | (d) genetic material altered using genome editing techniques (ex vivo or in vivo), |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) genetic material altered using genome editing techniques (ex vivo or in vivo), provided that it has generally negligible adverse effects on human health and the environment. | (d) genetic material altered using genome editing techniques (ex vivo or in vivo), provided that it has generally negligible adverse effects on human health and cannot proliferate in the environment; |
| Text proposed by the Commission | Amendment |
|---|---|
| (da) any other category of product specified by the European Commission in accordance with paragraph 1a. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The Commission is empowered to adopt delegated acts in accordance with Article 25a to amend paragraph 1 in order to add further categories of advanced therapy investigational medicinal products consisting of or containing GMOs that present no or negligible risks to human health and the environment, on the basis of scientific advice provided by the Agency. |
The four categories listed in Article 4a address a well-documented bottleneck affecting a broad range of ATMPs, including gene therapy medicinal products and genetically modified cell therapies. The COVID-19 derogation has already shown that risk-proportionate exemptions are workable in practice and helped accelerate clinical trial and marketing authorisations across the Union without adverse safety outcomes. The relevance of the exemption is reinforced by the current pipeline: replication-deficient viral vectors underpin 466 of the 581 ongoing vector-based ATMP clinical trials globally in Q4 2025. As viral vector design, genome editing and synthetic biology continue to evolve, further well-characterised low-risk product types are likely to emerge. Empowering the Commission to add further low-risk or negligible-risk categories through delegated acts, on the basis of scientific advice from the Agency, ensures the list remains evidence-based and future-proof.
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The exemption provided for in paragraph 1 of this Article is subject to the sponsor submitting, through the EU Portal and as part of the clinical trial application dossier, a reasoned declaration confirming that the advanced investigational therapy medicinal product concerned falls into one or more of the categories referred to in points (a) to (d) of paragraph 1, of this Article. The Committee for Medicinal Products for Human Use (CHMP) referred to in Article [148] of Regulation […] [revised Regulation No (EC) 726/2004] shall verify this declaration and the reasons provided, and the CHMP may, to this end, access the information on the clinical trial application in the EU portal. The CHMP shall communicate its opinion on the declaration to the sponsor and to the reporting Member State within 21 days after the submission date referred to in Article 5(1) of Regulation (EU) No 536/2014 [as revised by European Biotech Act]. | 2. The exemption provided for in paragraph 1 of this Article is subject to the sponsor submitting, through the EU Portal and as part of the clinical trial application dossier, a reasoned declaration confirming that the advanced investigational therapy medicinal product concerned falls into one or more of the categories referred to in points (a) to (d) of paragraph 1, of this Article. The Committee for Medicinal Products for Human Use (CHMP) referred to in Article [148] of Regulation […] [revised Regulation No (EC) 726/2004] shall verify this declaration and the reasons provided, and the CHMP may, to this end, access the information on the clinical trial application in the EU portal. The CHMP shall take into account any recommendation it has previously provided with respect to the product pursuant to Article 17a. The CHMP shall communicate its opinion on the declaration to the sponsor and to the reporting Member State within 14 days after the submission date referred to in Article 5(1) of Regulation (EU) No 536/2014 [as revised by European Biotech Act]. The Commission shall adopt guidance specifying the content and format of the declaration. |
The list of categories should be capable of adaptation to allow for advances in scientific knowledge. The purpose of the declaration is to confirm and document the fact that the GMO-IMP falls within one of the categories allowing for the exemption provided, and allow the CHMP (and EU MS) to check for regulatory compliance. The timeline for opinion on declaration should be shortened from 21 to 14 days. It is considered that an assessment of compliance with exemption criteria can be undertaken in a significantly shorter period allowed for assessment of a clinical trial application (as little as 47 days under Article 58(10) of the Biotech Act. The EC should publish explanatory (scientific) text that includes what will be (minimally) required for a declaration to be approved without delay. Such a “Good practice document” could also include specific examples of IMPs that do and do not currently fall into the categories (and why they do not).
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The exemption provided for in paragraph 1 of this Article is subject to the sponsor submitting, through the EU Portal and as part of the clinical trial application dossier, a reasoned declaration confirming that the advanced investigational therapy medicinal product concerned falls into one or more of the categories referred to in points (a) to (d) of paragraph 1, of this Article. The Committee for Medicinal Products for Human Use (CHMP) referred to in Article [148] of Regulation […] [revised Regulation No (EC) 726/2004] shall verify this declaration and the reasons provided, and the CHMP may, to this end, access the information on the clinical trial application in the EU portal. The CHMP shall communicate its opinion on the declaration to the sponsor and to the reporting Member State within 21 days after the submission date referred to in Article 5(1) of Regulation (EU) No 536/2014 [as revised by European Biotech Act]. | 2. The exemption provided for in paragraph 1 of this Article is subject to the sponsor submitting, through the EU Portal and as part of the clinical trial application dossier, a reasoned declaration confirming that the advanced investigational therapy medicinal product concerned falls into one or more of the categories referred to in points (a) to (d) of paragraph 1, of this Article. The Committee for Medicinal Products for Human Use (CHMP) referred to in Article [148] of Regulation […] [revised Regulation No (EC) 726/2004] shall verify this declaration and the reasons provided, and the CHMP may, to this end, access the information on the clinical trial application in the EU portal. The CHMP shall communicate its opinion on the declaration to the sponsor and to the reporting Member State within 14 days after the submission date referred to in Article 5(1) of Regulation (EU) No 536/2014 [as revised by European Biotech Act]. The declaration shall be proportionate and limited to the information necessary to demonstrate eligibility for the exemption. |
| The Commission shall define the content and format of the declaration in guidance. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The exemption provided for in paragraph 1 of this Article is subject to the sponsor submitting, through the EU Portal and as part of the clinical trial application dossier, a reasoned declaration confirming that the advanced investigational therapy medicinal product concerned falls into one or more of the categories referred to in points (a) to (d) of paragraph 1, of this Article. The Committee for Medicinal Products for Human Use (CHMP) referred to in Article [148] of Regulation […] [revised Regulation No (EC) 726/2004] shall verify this declaration and the reasons provided, and the CHMP may, to this end, access the information on the clinical trial application in the EU portal. The CHMP shall communicate its opinion on the declaration to the sponsor and to the reporting Member State within 21 days after the submission date referred to in Article 5(1) of Regulation (EU) No 536/2014 [as revised by European Biotech Act]. | 2. The exemption provided for in paragraph 1 of this Article is subject to the sponsor submitting, through the EU Portal and as part of the clinical trial application dossier, a reasoned declaration confirming that the investigational vaccine or the advanced investigational therapy medicinal product concerned falls into one or more of the categories referred to in points (a) to (d) of paragraph 1, of this Article. The Committee for Medicinal Products for Human Use (CHMP) referred to in Article [148] of Regulation […] [revised Regulation No (EC) 726/2004] shall verify this declaration, and the CHMP may, to this end, access the information on the clinical trial application in the EU portal. The CHMP shall communicate its opinion on the declaration to the sponsor and to the reporting Member State within 14 days after the submission date referred to in Article 5(1) of Regulation (EU) No 536/2014 [as revised by European Biotech Act]. The Commission shall adopt guidance specifying the content and format of the declaration. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The exemption provided for in paragraph 1 of this Article is subject to the sponsor submitting, through the EU Portal and as part of the clinical trial application dossier, a reasoned declaration confirming that the advanced investigational therapy medicinal product concerned falls into one or more of the categories referred to in points (a) to (d) of paragraph 1, of this Article. The Committee for Medicinal Products for Human Use (CHMP) referred to in Article [148] of Regulation […] [revised Regulation No (EC) 726/2004] shall verify this declaration and the reasons provided, and the CHMP may, to this end, access the information on the clinical trial application in the EU portal. The CHMP shall communicate its opinion on the declaration to the sponsor and to the reporting Member State within 21 days after the submission date referred to in Article 5(1) of Regulation (EU) No 536/2014 [as revised by European Biotech Act]. | 2. The exemption provided for in paragraph 1 of this Article is subject to the sponsor submitting, through the EU Portal and as part of the clinical trial application dossier, a reasoned justification confirming that the advanced investigational therapy medicinal product concerned falls into one or more of the categories referred to in points (a) to (d) of paragraph 1, of this Article and present no or negligible risk to human health, animal health, ecosystems and the environment.. The Committee for Medicinal Products for Human Use (CHMP) referred to in Article [148] of Regulation […] [revised Regulation No (EC) 726/2004] shall verify this declaration and the reasons provided, and the CHMP may, to this end, access the information on the clinical trial application in the EU portal. The CHMP shall communicate its opinion on the declaration to the sponsor and to the reporting Member State within 21 days after the submission date referred to in Article 5(1) of Regulation (EU) No 536/2014 [as revised by European Biotech Act]. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The exemption provided for in paragraph 1 of this Article is subject to the sponsor submitting, through the EU Portal and as part of the clinical trial application dossier, a reasoned declaration confirming that the advanced investigational therapy medicinal product concerned falls into one or more of the categories referred to in points (a) to (d) of paragraph 1, of this Article. The Committee for Medicinal Products for Human Use (CHMP) referred to in Article [148] of Regulation […] [revised Regulation No (EC) 726/2004] shall verify this declaration and the reasons provided, and the CHMP may, to this end, access the information on the clinical trial application in the EU portal. The CHMP shall communicate its opinion on the declaration to the sponsor and to the reporting Member State within 21 days after the submission date referred to in Article 5(1) of Regulation (EU) No 536/2014 [as revised by European Biotech Act]. | 2. The exemption provided for in paragraph 1 of this Article is subject to the sponsor submitting, through the EU Portal and as part of the clinical trial application dossier, a reasoned declaration confirming that the advanced investigational therapy medicinal product concerned falls into one or more of the categories referred to in points (a) to (d) of paragraph 1, of this Article and present no or negligible risk to human health, animal health, ecosystems and the environment. The Committee for Medicinal Products for Human Use (CHMP) referred to in Article [148] of Regulation […] [revised Regulation No (EC) 726/2004] shall verify this declaration and the reasons provided, and the CHMP may, to this end, access the information on the clinical trial application in the EU portal. The CHMP shall communicate its opinion on the declaration to the sponsor and to the reporting Member State within 21 days after the submission date referred to in Article 5(1) of Regulation (EU) No 536/2014 [as revised by European Biotech Act]. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The reporting Member State, giving due consideration to the opinion of the CHMP, shall assess if the conditions of paragraph 1 of this Article apply or if the sponsor is to be requested to submit an environmental risk assessment pursuant to Article 5a of Regulation (EU) No 536/2014 [as introduced by the revised Regulation No (EC) 726/2004]. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. Where the CHMP concludes that the conditions set out in paragraph 1 are fulfilled, any decision by the reporting Member State to require an environmental risk assessment shall be duly justified on the basis of scientific grounds. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. Where an advanced therapy investigational medicinal product falling within the scope of paragraph 1 is developed using a platform technology for which the conditions set out in that paragraph have already been positively assessed, including where such assessment is documented in a platform technology master file or equivalent documentation, the sponsor may rely on that previous assessment, provided that no material changes are introduced that could affect the environmental risk profile of the product. Any such reliance shall be duly justified in the declaration submitted pursuant to paragraph 2. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The exemptions provided for in this Article shall apply only for the duration of the clinical trial, limited to the activities within the clinical trial.; | 5. The exemptions provided for in this Article shall apply for the duration of the clinical trial, limited to the activities within the clinical trial.; However, where the declaration referred to in paragraph 2 is relevant to more than one clinical trial, it may be cross-referenced in subsequent applications. The declaration shall form part of the investigational medicinal product core dossier and shall be referenced in all related clinical trial applications for which that dossier has been established in accordance with Article 27a. The maintenance and amendment of the declaration shall be carried out in accordance with Articles 27b. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The exemptions provided for in this Article shall apply only for the duration of the clinical trial, limited to the activities within the clinical trial.; | 5. The exemptions provided for in this Article shall apply only for the duration of the clinical trial, limited to the activities within the clinical trial. However, where the declaration referred to in paragraph 2 is relevant to more than one clinical trial, it may be cross-referenced in subsequent applications. The declaration shall form part of the investigational medicinal product core dossier and shall be referenced in all related clinical trial applications for which that dossier has been established in accordance with Article 27a. The maintenance and amendment of the declaration shall be carried out in accordance with Articles 27b. |
The option for a product level assessment rather than trial level assessment is already possible in certain member states such as NL, AT.
| Text proposed by the Commission | Amendment |
|---|---|
| 5a. Article 4b is inserted: | |
| Article 4b | |
| ERN-associated ATMP administration and follow-up sites | |
| For advanced therapy medicinal products intended for rare, ultra-rare or complex diseases, Member States shall ensure that also healthcare providers participating in ERNs may be designated, where they meet applicable quality, safety and traceability requirements, as preferred sites for administration, patient monitoring, safety reporting and long-term follow-up. Also such sites shall can be eligible for multinational clinical trials and post-authorisation evidence generation, including cross- border referral and shared ERN protocols. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5a. To ensure that the exemptions under this Article 4a are adapted to technical progress and relevant new evidence relating to public health and environmental protection, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 to amend the product categories and criteria in paragraph 1. The Commission shall review and, where appropriate, update those categories and criteria at least every five years.’; |
| Text proposed by the Commission | Amendment |
|---|---|
| 5a. The Commission shall be empowered to adopt delegated acts to amend and update the eligibility criteria referred to in paragraph 1, in order to reflect scientific and technological progress, accumulated regulatory experience and emerging advanced therapy medicinal product modalities. |
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- Licensed CC BY 4.0.
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- 25 September 2026
Cite as
European Parliament (2026). “AMENDMENTS 2331 - 2521 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)”. Text, 13 July 2026. docId CJ53-AM-790938. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/CJ53-AM-790938 (retrieved 25 September 2026). Data: EP Open Data API: document record, https://data.europarl.europa.eu/api/v2/documents/CJ53-AM-790938 (CC BY 4.0).
BibTeX
@misc{epw-text-cj53-am-790938,
author = {{European Parliament}},
title = {{AMENDMENTS 2331 - 2521 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)}},
year = {2026},
date = {2026-07-13},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/CJ53-AM-790938}},
url = {https://news.eu-parl.st-solutions.dev/texts/CJ53-AM-790938},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. docId CJ53-AM-790938. Data: EP Open Data API: document record (CC BY 4.0)}
}