European Water Resilience Strategy contains limited actions on water pollution
The European Commission published the European Water Resilience Strategy on 4 June 2025. The Strategy sets an overall water efficiency goal of ‘enhancing water efficiency by at least 10% by 2030’ by reducing demand, over-abstraction and improving efficiency across sectors. The Strategy however leaves the development of a methodology to set water efficiency targets to future work with Member States and stakeholders and the establishment of common targets to the review of the strategy in 2027.
Regarding water pollution, the Strategy recognises that ‘Water quality and quantity are two sides of the same coin’ and that Europe ‘must continue working on preventing pollution at source’. It also states that ‘urgent action is needed to tackle pollutants which pose a risk to our vital sources of drinking water’ including highly persistent pollutants such as PFAS and claims that ‘the EU must take decisive efforts to clean up sites already strongly polluted by these, and other, ubiquitous, persistent, bio-accumulative and toxic substances’. In terms of planned actions, the main initiatives listed in the Strategy concern increasing efforts to better implement EU water legislation in the Member States and funding for remediation. The Commission announces the establishment of a ‘public-private initiative to achieve a technological breakthrough in feasible and affordable methods for the detection and remediation of PFAS and other persistent chemicals’, with the caution that the right financial partners must be found first to launch the initiative. Regarding funding, the Strategy also announces further cooperation between the Commission and the European Investment Bank to deploy water investments.
The Strategy also makes references to the extended producer responsibility system under the Urban Wastewater Treatment Directive, against which legal actions have been taken by the cosmetic and pharmaceutical industries and announces that ‘the Commission will conduct an updated study of costs and its potential impacts on concerned sectors’.
Soil Monitoring Directive establishes requirements to monitor PFAS, pesticides and their metabolites and a common approach to the identification and management of contaminated sites
On 10 April, the Council and the Parliament reached a provisional agreement on the Soil Monitoring Directive, which has now been made public. The provisional agreement is currently undergoing formal approval by both institutions. The ENVI Committee of the European Parliament has voted in favour of the text on 4 June. The Council should hold a formal vote on the text after the summer.
The Directive establishes the first EU-wide framework requiring Member States to monitor and assess soil health using common descriptors. To gather data on soil contamination, Member States are required to establish a list of soil contaminants including pesticides, their metabolites and PFAS. The Commission is also mandated to adopt, within 18 months of the Directive’s entry into force, an indicative list of high-risk contaminants, including PFAS and pesticides, for which further data is needed. Member States will monitor the selected PFAS (PFAS-21, PFAS-43, or their own selection in their national list) and selected pesticides and metabolites, although, to limit the monitoring costs, Member States are allowed to perform measurements only on a limited number of sampling points.
Regarding contaminated sites, the final agreement remains relatively close to the original Commission proposal, although with longer deadlines provided to Member States. Member States must identify all potentially contaminated sites within 10 years of the Directive’s entry into force (instead of 7 years in the Commission’s proposal). As proposed by the Council during negotiations, only sites existing at or before that date are included. Potentially contaminated sites then undergo soil investigations to confirm contamination, and if contamination is confirmed, site-specific risk assessments to evaluate risks to health and the environment. As in the original Commission proposal, Member State define individually what constitutes an unacceptable risk for human health and the environment. Member States are required to take appropriate risk reduction measures ‘without undue delay’ (no other timeline is provided in the Directive). Member States must also set up a public register of contaminated and potentially contaminated sites within four years of the Directive’s entry into force.
Council mandate on the pharmaceutical package maintains main provisions on environmental risk assessments of medicinal products
The Council adopted its mandate for negotiations with the European Parliament on the pharmaceutical legislative package, consisting of a Directive and a Regulation, on 4 June 2025. The Council maintained the main provisions from the Commission proposal on environmental risk assessments of medicinal products, including the proposal that the ERA must indicate whether the pharmaceutical product contains PBT, vPvB, PMT, vPvM, or endocrine disruptor. The Council also retained that the incompleteness of the ERA or deficiencies in addressing environmental risks is a ground for refusing the marketing authorisation of a medicinal product. However, the Council added a caveat that such deficiencies would not justify a refusal of the market authorisation if ‘these deficiencies are justified by the applicant and either post-authorisation environmental risk assessment studies can be requested, or the identified risks can be mitigated with appropriate risk mitigation measures’. Finally, the Council also maintained the provision subjecting to medical prescription medicinal products containing active substances that are PBT, vPvB, PMT or vPvM (where medical prescription is required as an environmental risk minimisation measure and unless other circumstances of use justify otherwise).
The Parliament had adopted its resolution on the package in April 2024, in which MEPs had also kept without significant changes provisions from the Commission’s proposal on environmental risk assessment of medicinal products and medical prescription for products containing PBT, vPvB, PMT or vPvM active substances. There should therefore be a broad consensus on these provisions during upcoming interinstitutional negotiations.
ECHA launches consultation on classification of TFA and sodium trifluoroacetate as PMT and vPvM
ECHA has published the two CLH dossiers prepared by the German authorities to revise the harmonised classification of trifluoroacetic acid (TFA) and adopt a new harmonised classification for sodium trifluoroacetate and other inorganic salts of trifluoroacetic acid. New proposed hazards include PMT, vPvM and Reprotoxic 1B. The public consultations on the two dossiers are open until 27 July 2025.
German authorities also submitted to ECHA a CLH dossier to revise the harmonised classification of benzotriazole; sodium 1H-benzotriazolide; potassium 1H-benzotriazolide; and other inorganic salts. New proposed hazards include PMT, vPvM, endocrine disruptor for environment 1, carcinogen 1 and reprotoxic 2. ECHA is running the accordance check on the dossier.
Third workshop on the Roadmap to phase out animal testing on 16-17 June will be livestreamed
The Commission and ECHA jointly organise a third workshop to discuss elements of the roadmap to phase out animal testing for chemical safety assessments on 16-17 June. The workshop will be livestreamed from ECHA’s website and ECHA’s youtube channel (registration in Helsinki is closed). The purpose of the workshop is to present proposed recommendations of the roadmap for stakeholder consultation.
Upcoming consultation deadlines:
- Deadline to contribute to the public consultations on the classification of trifluoroacetic acid and sodium trifluoroacetate and other inorganic salts of trifluoroacetic acid: 25 July 2025.
- Deadline to respond to the public consultation on the evaluation of the Cosmetic Products Regulation: 28 July 2025.
More information of upcoming actions related to persistent and mobile substances
For more information of regulations under the regulatory watch, as well as a Gantt Chart of the roll out, continuously updated spreadsheet and more information, please visit https://zeropm.eu/regulatory-watch/