President. – The next item is the short presentation of the report by Dimitris Tsiodras, on behalf of the Committee on the Environment, Climate and Food Safety, on the proposal for a Directive of the European Ϸվ and of the Council amending Directive 2011/65/EU of the European Ϸվ and of the Council as regards the re-attribution of scientific and technical tasks to the European Chemicals Agency ( - C9-0448/2023 - ) (A10-0019/2025)
Dimitris Tsiodras, rapporteur. – Madam President, dear colleagues, dear Commissioner, the 'one substance, one assessment' approach, comprising three legislative reports, is not just a technical reform; it is a fundamental shift in how we assess chemical safety.
This approach ensures faster and more effective protection for our citizens and the environment, while supporting industry innovation and competitiveness. It constitutes a significant step towards a stronger, more transparent and more efficient chemicals policy in the EU.
These three pieces of legislation will ensure that the relevant regulatory actions will be faster, simpler and more transparent. They will increase the predictability to stakeholders while safeguarding the protection of intellectual property rights. At the same time, they will ensure that citizens and the environment are better protected from hazardous chemicals.
We have worked hard to strike the right balance, simplifying procedures, reducing administrative burdens and streamlining assessments while maintaining scientific rigour. This common data platform will serve as a one-stop shop for chemical data from various sources, enhancing transparency and accessibility as well as reducing duplication.We have ensured that the platform streamlines independent scientific work and academic research while centralising hazard information.
Additionally, we promote the reuse of existing data to reduce costs, minimise administrative burdens and limit reliance on animal testing. At the same time, we must guarantee the protection of intellectual property rights and commercially sensitive data. Aiming for maximum transparency, we must also adhere to the principle of 'as open as possible, as closed as necessary', ensuring that companies can continue investing in research and innovation without the risk of unfair competition.The regulatory framework must not impose unnecessary burden on businesses, particularly SMEs, nor expose proprietary data in ways that could undermine European industry.
Let me be clear, the common data platform is a major step forward in assessing chemical safety and reinforcing consumer protection. It will centralise scientific information, benefiting both public health and industry.
We also support the harmonisation of chemical assessments across different agencies. This package strengthens cooperation, increases efficiency, enhances predictability and eliminates costly duplications, benefiting both EU citizens and businesses.
Of course, challenges remain. And that is why we continue to refine the text in the context of the very collaboration with the political groups, the European Commission and the Council.
Dear colleagues, by adopting these measures, we will strengthen protection for citizens and the environment while maintaining Europe's leadership in innovation and sustainability. I am confident that, with our collective commitment, we can achieve this ambitious, necessary goal. I strongly urge you to vote in favour of this report so that we can deliver a stronger, smarter and more sustainable EU chemicals policy.
Catch-the-eye procedure
Christophe Clergeau (S&D). – Madame la Présidente, Madame la Commissaire, je crois qu'avec ce rapport –et je remercie M.Tsiodras pour le très bon travail qui a été fait collectivement– nous avons fait deux pas importants: l'un qui nous permettra de disposer d'une base de données complète pour procéder à l'évaluation des risques chimiques, et l'autre vers une ouverture de cette base de données à des données provenant non seulement des industriels, mais aussi des autorités nationales, du monde de la recherche et de la société civile. Ce sera très important tant pour l'évaluation des risques que pour la protection de la santé.
Mais ce ne sont que deux premiers pas. Il nous reste beaucoup d'autres choses à faire. Une des priorités absolues, Madame la Commissaire, doit être de renforcer les moyens de l'Agence européenne des produits chimiques, non seulement au moyen de financements privés, mais aussi avec le budget propre de la Commission européenne, de sorte que l'Agence puisse faire son travail dans les meilleures conditions.
D'autres étapes seront nécessaires à ce que nous puissions disposer de données encore plus complètes et à ce que nous puissions enfin croiser les données sur les produits chimiques et celles sur la santé humaine. Ainsi pourrons-nous comprendre l'explosion des maladies chroniques que nous observons actuellement et mieux protéger la santé des Européens.
Beatrice Timgren (ECR). – Fru talman! EU:s dataplattform för kemikalier skulle kunna vara en plattform som hade givit transparens, bättre tillgänglighet för data och mindre dubbelarbete. Men som förslaget ser ut nu – det som har arbetats fram tillsammans med PPE, vänstern och de gröna – ser faktiskt ut att bli en byråkratisk mardröm, där företag ska tvingas att rapportera varje beställd studie, även om den kommer att lämnas in senare.
Det här är en massa onödig rapportering utan någon säkerhetsnytta. De som kommer att drabbas är framför allt små företag, innovationer som kommer att bromsas in och arbetstillfällen som kommer att hotas.
EU pratar ofta om att vi måste minska regelbördan, men här gör man precis tvärtom. EU måste sluta tro att mer byråkrati och mer regelbörda ökar välståndet.
Det är faktiskt våra företag och våra arbetare som ökar vårt välstånd.
Sebastian Tynkkynen (ECR). – MadamPresident, I stand here as a voice for citizens like those in Finland, who value their country's independence.
These proposals – centralising chemical data collection, reassigning tasks to the EU level, and thus empowering the European Chemicals Agency over local actors – strip away control from Member States.
Member States, with their unique industries and features, deserve to make their own decisions – not to follow a one-size-fits-all EU uniform that fits no one properly.
We have seen enough to say that EU centralisation often ignores local needs, adds bureaucracy and takes power away from where it should be: close to the people.
I urge you to protect national sovereignty and reject those measures that undermine Member States' rights to govern themselves.
(End of catch-the-eye procedure)
Jessika Roswall, Member of the Commission. – Madam President, honourable Members, thank you for inviting me to give this short presentation on the one substance, one assessment package. And while we have, Madam President, three presentations on the agenda this evening, I will cover all my main points in this initial statement.
This is clearly a package that contributes to our simplification agenda. The three legislative proposals on the package consolidate scientific and technical work on chemicals in the EU agencies. They also improve cooperation and ensure that agencies can use all data available to them in the safety assessment of chemicals. This package is part of the one Substance, one assessment. It will improve the efficiency and the coherence of safety assessments of chemicals in the benefit of all. Our objective is to simplify procedures and ensure predictability for authorities and stakeholders. Most importantly, we want to protect citizens and the environment from hazardous chemicals.
I welcome Ϸվ's strong interest in this legislative package, and thank you, honourable Member Tsiodras, for the important work and constructive discussions on this report. Many of the proposed amendments bring clarification, which we welcome. We are also happy to see that you addressed the comments made by the European Data Protection Supervisor to better safeguard the protection of personal data. At the same time, we believe there are some points that require further discussion.
On the regulation establishing a common data platform on chemicals, your amendments propose a substantial broadening of the scope. You also suggest implementing the system within eight years, compared to the ten years initially proposed by the Commission. While we appreciate the ambition and acknowledge the importance of the proposed amendments, we would like to highlight that an expansion of the scope would have notable implications on the capacity and resources of the European Chemicals Agency. At the same time, they have a lot of tasks already. That was also a question from Mr Clergeau, regarding the capacities of the ECHACommittee, and that will be addressed in a special proposal for the basic regulation, which is under preparation as we speak.
Concerning the directive amendment, the Restricting of Hazardous Substances in Electrical and Electronic Equipment Directive, we take note of your proposal to adopt a delegate act on exemptions within six months of receiving the European Chemical Agency's opinion. In the light of the number of exemptions typically typically processed and procedural requirements for adopting delegated acts, we note that six month deadline will be difficult to accommodate in practice, so we should avoid putting such short deadlines.
The proposal to review the list of restricted substances at least every 36 months would also be difficult to align with in current practice, as each review currently requires close to that timeline to complete.
Dear President, honourable Members, the Commission stands ready to support co-legislators to reach an agreement on this package. The changes proposed by the Council are largely in line with the Ϸվ's amendments. I'm therefore hopeful that a political agreement can be reached within a swift manner.
I would like to renew my commitment as to act as an honest broker and help to reach the necessary compromises.
President. – Thank you. The debate is closed. The vote will be held tomorrow.