With the purpose to facilitate the “One substance, one assessment" process, the European Commission plans to review and improve the current way of how chemicals’ required data are gathered and disseminated under different EU laws. This proposal is expected to impact multiple regulations due in the first half of 2023.
This legislative proposal adheres to the Chemical Strategy for Sustainability (CSS), where this action aims at committing the Commission to enhance the information flow of chemical data among EU and national authorities. The current information barriers to data exchange such as intellectual property rights, data exclusivity rules, and regulatory data protection, etc., would be the focus, according to the Commission. Also at the same time, it is one of the main concerns from the industry on how to properly deal with intellectual property and the ‘free-rider’.
Disadvantaged examples of information reuse can be seen from, for instance, ECHA has no legality to reuse copyrighted data on biocidal product authorization for a REACH application authorization, nor to send it to the European Food Safety Authority (EFSA) for approving a pesticide active substance – the data generated is practically far from reusable under different regulatory processes and assessments.
This upcoming proposal regarding data usage will address topics that include the following:
- Introduction of a data generation mechanism that could help the authorities fill information gaps – it is similar to the verification tool under the EU Transparency Regulation in some way, allowing the commissioning of additional studies in exceptional circumstances and no new data requirements is said to be introduced.
- Requirements on business operators and laboratories to notify EFSA if they are commissioned to undertake a study – this helps the authorities keep track of new coming data, which shall be stored in an EFSA database.
- Development of a common data platform.
- EU repository of health-based limit values – this promotes their reuse and harmonization among risk assessors and managers; and
- Tools to improve the uptake of academic data – this could include guidance for minimum quality of studies that will help researchers in designing and reporting them, and a search guide to help regulators and industry find and retrieve relevant academic data.
The proposal is most likely to be formed as an “omnibus regulation” to amend provisions on data flow, dissemination and reuse in individual pieces of chemicals and product legislation. The EU executive will soon launch a call for evidence for the legislative proposal.
As aforementioned, IP concerns remain one big issue for this system-level amendment as it is one of the goals for the EU Commission to open the IP access. Pertinent problems such as data ownership and Intellectual Property (IP) rights are questioned by the industry representatives during the information session. The proposal is directed to where the industry could still be able to claim confidentiality of Confidential Business Information (CBI). As for the data ownership, the tricky part lies in determining the carrier of the cost of data used for multiple assessments yet managing the risks of free-riding to protect property.
To boost the access and reuse procedures of information sharing, the CSS prompts the Commission to establish a common data platform for chemicals. Such platform forms part of the horizontal data proposal, giving the authorities easy access to all legally accessible information, some of which will be made public. The information presented on the platform shows:
- intrinsic properties
- presence in articles and use
- data on emissions
- data on exposure
- hazard and risk assessments, and
- limit values.
The detailed implementation plan is currently being drafted by ECHA along with other agencies and the Commission, ideally going live in 2025. A technical blueprint, operational steps, and the estimation of the resources needed for building and maintenance of the tool, are expected to be included in the implementation guidelines.