Changes from report parliamentary committee draft to plenary report

Change 50

RemovedStrengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.

AddedArticle 44 – paragraph 1 j (new): 1j. The task force shall meet at least six times a year, with at least one annual physical meeting of a more strategic nature. Ad hoc meetings may be organised, as needed.

RemovedArticle 44 – paragraph 1 i (new): 1i. The task force shall liaise with on-going inter-agency groups and activities and may establish dedicated working groups to support the activities of the task force.

AddedArticle 44 – paragraph 1 k (new): 1k. By 31 December each year, members of the task force shall draw up and endorse an annual framework for action describing a plan for the joint One Health and exposome work of the agencies referred to in paragraph 1b. / The framework for action shall include objectives to be pursued by the task force, concrete actions and outcomes to achieve them, and an approximate timeline for the implementation of such actions, and shall be built around the following objectives with regards to One Health and exposome: / (a) facilitate strategic coordination in its implementation; / (b) promote research coordination; / (c) enhance capacity building; / (d) strengthen communication and stakeholders' engagement; / (e) support the development of joint partnerships.

RemovedStrengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.

AddedArticle 44 – paragraph 1 l (new): 1l. The framework for action referred to in paragraph 1l shall be consistent with the respective mandates of each agency and shall not hinder their statutory activities.

RemovedArticle 44 – paragraph 1 j (new): 1j. The task force shall not act as a decision-making body. The task force may propose recommendations for action to the senior management of the agencies. Representatives of each agency in the task force shall have an advisory role to the Executive Directors and senior management of its own agency and shall engage with the Commission and other stakeholders for input and advice, as appropriate.

RemovedStrengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.

RemovedArticle 44 – paragraph 1 k (new): 1k. The task force shall meet at least six times a year, with at least one annual physical meeting of a more strategic nature. Ad hoc meetings may be organised, as needed.

RemovedStrengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.

RemovedArticle 44 – paragraph 1 l (new): 1l. By the end of each year, members of the task force shall draw up and endorse an annual framework for action describing a plan for the joint One Health and exposome work of the agencies referred to in paragraph 1b. / The framework for action shall include objectives to be pursued by the task force, concrete actions and outcomes to achieve them, and an approximate timeline for the implementation of such actions, and shall be built around the following objectives: / (a) facilitate strategic coordination in the implementation of the One Health and exposome approach; / (b) promote research coordination and One Health and exposome-driven agenda setting; / (c) enhance capacity building on One Health and exposome; / (d) strengthen One Health and exposome communication and stakeholders' engagement; / (e) support the development of partnerships through joint One Health and exposome activities.

RemovedStrengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.

RemovedArticle 44 – paragraph 1 m (new): 1m. The framework for action referred to in paragraph 1l shall be consistent with the respective mandates of each agency and shall not hinder their statutory activities.

RemovedStrengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.

Article 45 – paragraph 2: 2. Where the Agency identifies a potential source of divergence as referred to in paragraph 1, it shall contact the other body concerned in order to ensure that all relevant scientific or technical information is shared and in order to identify the potentially contentious scientific or technical issues.

Change 51

RemovedAlignment with 'One Substance One Assessment'

Article 45 – paragraph 3: 3. The Agency and the other body concerned shall cooperate to resolve the divergence, taking into consideration the objective of a high level of protection of health and the environment. If the Agency and the other body concerned are not able to resolve the divergence, they shall draw up a joint report. The report shall clearly outline the contentious scientific issues, identify the relevant uncertainties in the data and give the underlying reasons for the divergence of opinions, including reasons related to methodological differences. The report shall be made publicly available. Where the other body concerned is a Union agency or a scientific committee, the Agency shall also present the joint report to the Commission.

Change 52

RemovedThe agreement between co-legislators on the "Proposal on the reattribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals" amended the General Food Law with this wording, the ECHA Basic Regulation should therefore be aligned with the provisions on resolving divergent opinions between agencies.

AddedArticle 46: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

Change 53

ChangedArticle 48 – paragraph 1 – point 3: (3) in Article 77, paragraph 1, and paragraph 3, pointpoints (b), and (c), are deleted;

Change 54

RemovedArticle 77(3)(b) of REACH provides the possibility for RAC at the Executive Director's request, to provide 'technical and scientific support for steps to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries'. This mandate should not be limited to matters regulated under REACH but should be available for all tasks performed by ECHA, regardless of the legislation from which they are emanating. Therefore, this possibility is now included in Article 13 of this proposal to make it a horizontal provision.

RemovedArticle 48 – paragraph 1 – point 6: deleted

Article 54 – title: Evaluation and review

Change 55

ChangedArticle 54 – paragraph 2: 2. The evaluation shall address the possible need to modify the mandate of the Agency, and the financial implications of any such modification. The evaluation shall also assess the functioning of the Committees and whether it would be warrantedappropriate to align or adapt the rules forArticles membership14 and functioning15 of thethis Committees.Regulation.

Change 56

RemovedSCCS has been incorporated into ECHA but the proposal keeps its particular rules and structure intact. BPC members are not independent from their government, whereas members of RAC and SEAC are. While there is no express reasons to change this approach in this draft report, experience might show in the future that rules should be aligned or adapted for the Committees.

AddedArticle 54 – paragraph 3: 3. The Commission shall report to the European Parliament, to the Council, and to the Management Board on the findings of the evaluation. An action plan and a timetable shall be included, if appropriate. The Commission shall, where appropriate, submit a legislative proposal to the European Parliament and to the Council. The findings of the evaluation shall be made public by the Commission.

RemovedArticle 54 – paragraph 3: 3. The Commission shall report to the European Parliament, to the Council, and to the Management Board on the findings of the evaluation. An action plan and a timetable shall be included, if appropriate, and the Commission may propose a legislative proposal, where appropriate. The findings of the evaluation shall be made public by the Commission.