On 7 December 2023, the Commission tabled three legislative proposals (the “Proposal(s)”) to implement the “One-substance-one-assessment” (“OSOA”) announced in the European Green Deal and the Chemicals Strategy for Sustainability (“CSS”).
At present, different harmonised agencies may carry out the safety assessments of the same chemicals under different pieces of harmonized legislation, at different times and often using different data. This, according to the Commission, creates inefficiencies and may result in inconsistent and less predictable regulatory outcomes.
The Proposals seek to address this problem and claims to allow a more consolidated assessment of the safety of chemicals, resulting in better scientific basis for regulatory decision-making.The Proposals are complex and will have an overarching impact on the generation and handling of scientific data in the EU. They will affect data generated under over 40 pieces of harmonised EU legislation on the manufacturing and importation of chemicals, but also covering their environmental impact and workers safety as well as their placing on the market in different regulated products, such as biocides, pesticides, medicinal products, food and feed.
As a general trend, the Proposals seek to shift the focus towards the hazard assessment of chemicals under the overarching expertise of the European Chemicals Agency (“ECHA”). While the specialization of the different affected EU agencies seems to be respected, and no scientific work is taken away from them, the fact that ECHA will assume tasks that have been carried out so far by the Commission, supported by ad hoc committees or external consultants, could turn to be problematic.
It will be essential indeed that this re-attribution of competences is accompanied with the necessary accountability, confidentiality, transparency and resources, objectives which ECHA has not always been able to meet so far. In particular, the Commission is yet to publish a proposal for a basic regulation of ECHA tackling the reorganization of ECHA and the takeover of the new or expanded competences attributed to it by the present package. This will be a fundamental piece that could hopefully ensure the proper functioning of the new system that the EU is seeking to implement.
More generally, it remains to be seen how much the proposed package will allow meeting this objective and to what extent it will not generate all sorts of other issues, and possibly derail some of the regulated process organised by the underlying EU regulations that will be affected.
We have identified some potential issues in our initial analysis of the Proposals as outlined below. Companies will need to be extremely vigilant to safeguard their legal rights as the Proposals are going through the decision making process and eventually are implemented.
In particular, the proposal to require companies and laboratories to notify ECHA of any studies being conducted for regulatory purposes will need to be fully assessed to ensure it does not lead to unintended detrimental effects on the fundamental rights of companies and laboratories to carry out their business.
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