On December 7, 2023, the European Commission (EC) adopted three legislative proposals in pursuit of ‘one substance, one assessment’ in the EU. The largest of the three proposals concerns the creation of a common Europe-wide chemicals data platform to collect, align, and standardize chemicals information gathered by EU agencies and Member States for over 70 regulations (FPF reported). “This includes data on hazards, physico-chemical properties, presence in the environment, emissions, uses, environmental sustainability of chemical substances and on ongoing regulatory processes.”
In addition to the collection and sharing of chemicals information, the proposal aims to
- Enable agencies to commission testing and monitoring of substances;
- Keep records of studies commissioned or carried out by businesses in a chemicals regulatory context;
- Set up an early warning system for emerging chemical risks; and to
- Establish a monitoring and outlook framework for chemicals
The EC held multiple meetings with stakeholders when developing the proposal (FPF reported). Feedback from the various stakeholder groups was, unsurprisingly, conflicted when it came to data transparency. Currently, different EU regulations have different levels of data transparency or public access. A harmonized system would standardize transparency, but what that would look like was contentious among stakeholders.
Civil society organizations “suggested limiting confidentiality claims to a minimum and applying fees to prevent default claims.” Meanwhile, industry representatives “…highlighted the danger of disclosing proprietary and confidential business information that could undermine competitiveness and innovation. They suggested limiting transparency to chemicals already on the market and ensuring fair sharing of costs involved in generating test data.”
There was relatively common ground concerning industry studies. A civil society organization highlighted that the system “must enable independent scientists to scrutinize industry studies,” and industry representatives “welcomed the dissemination of assessment reports” but with the caveat about confidential information.
The two other proposals adopted by EC are meant to restructure the European Chemicals Agency’s and other agencies’ scientific and technical tasks, as well as improve interagency cooperation.
After a proposal is adopted by EC, as these were, it is forwarded to the Council of the European Union and the European Parliament to begin the legislative negotiation process. When (or if) both the Council and the Parliament agree on the text, it is formally adopted as EU law and Member States are required to implement it as national law.
References
European Commission (December 7, 2023). “Commission proposes ‘one substance, one assessment’ chemicals assessment reform for faster, simplified and transparent processes.”
DG Environment (December 7, 2023). “Proposal for a Regulation establishing a common data platform on chemicals.” European Commission
Read more
Luke Buxton (December 12, 2023). “European Commission proposes common chemicals data platform.” Enhesa
Luke Buxton (December 20, 2023). “Common EU chemicals data platform must avoid duplication – Cefic.” Enhesa
