There are many important Regulatory Watch updates on the roll out of the EU Chemicals Strategy for Sustainability related to persistent and mobile substances this month!
EU Court upheld ECHA’s decision to identify Melamine as SVHC
Following ECHA’s decision on 16 December 2022 identifying melamine as substances of very high concern (SVHC), several melamine producers from several countries (Germany, Austria, Belgium, Switzerland and the United States) had brought an action before the General Court of the European Union seeking the annulment of that decision. In two judgments published on 9 July 2025 (Case T‑163/23 and Case T‑167/23; see also General Court press release), the General Court rejected the arguments presented by the applicants and dismissed the action. In particular, the Court rejected the applicants’ argument that the mobility of melamine could not be regarded as an intrinsic property capable of having serious effects on human health or the environment which give rise to an equivalent level of concern, in the meaning of Article 57(f) of the REACH Regulation.
Commission’s Chemicals Industry Action Plan announced EU-wide PFAS monitoring framework
On 8 July 2025, the Commission published the Communication ‘A European Chemicals Industry Action Plan’, which contained a section on PFAS. Regarding the PFAS restriction, the Commission committed to issue proposal as soon as possible after receiving ECHA’s opinion. In the action plan, the Commission also announced ‘targeted investment and research into safe and sustainable alternatives’ and increased remediation efforts. On remediation, the Commission reiterated the announcement from the Water Resilience Strategy to ‘set up a public-private initiative to achieve a technological breakthrough in feasible and affordable methods for the detection and remediation of PFAS’. Finally, the plan indicated that ‘an EU-wide PFAS monitoring framework will be developed, to centralise information, identify pollution hotspots, highlight successful remediation practices, and collect data from relevant legislation’.
Denmark removed authorisations for 23 plant protection products containing active substances degrading into TFA
The Danish Environmental Protection Agency has decided in July 2025 to withdraw the approval of 23 plant protection products containing six active substances (fluazinam, fluopyram, diflufenican, mefentrifluconazole, tau-fluvalinate, and flonicamid) on the grounds that these six active substances degrade into TFA and leachate TFA to groundwater. Depending on the product, the ban for sale enters into force on 30 August 2025 and 31 December 2025 and the ban for use enters into force respectively on 31 December 2025 and 30 September 2026. The EPA is expected to issue a decision on ten other products containing those six active substances in August-September 2025.
Italy adopted mandatory drinking water parameters for the Sum of 4 PFAS and TFA
Italy adopted in June 2025 a legislative decree amending its transposition of the Drinking Water Directive. The decree removed the parameter ‘Total PFAS’ from the law to maintain only the parameter ‘Sum of PFAS’ from the Directive. In its previous law, Italy had extended the sum parameter to 24 PFAS; the new decree extended it to cover 30 PFAS (Sum of 20+ GenX, ADONA, 6:2 FTSA, C6O4 and six carboxylated chloro-perfluoropolyethers used in the production of fluoropolymers ADV-N2, ADV-N3, ADV-N4, ADV-N5, ADV-M3, ADV-M4). The new decree also introduced two new binding drinking water parameters, one for the Sum of 4 PFAS (PFOA, PFNA, PFHxS, PFOS) of 20ng/L and one for TFA of 10 μg/L. Italy is the second Member States to adopt a drinking water parameter for TFA, after Denmark (9 μg/L).
Commission published proposals for ECHA’s founding Regulation and chemicals omnibus regulation
On 8 July 2025, the Commission published a proposal for a Regulation on the governance of the European Chemicals Agency (currently part of the REACH Regulation). The proposal notably strengthens the capacity of RAC and SEAC (making the nomination of experts by Member States mandatory). On the same day, the Commission released the proposal for a Regulation on the ‘simplification of certain requirements and procedures for chemical products’ (chemicals omnibus regulation). The proposal reviews and/or postpones the implementation of some of the labelling rules adopted last year in the CLP revision (e.g. mandatory font sizes), removes requirements for extended REACH Registration of fertilizers, and simplifies the derogation process for using CMRs in cosmetics.
Upcoming consultation deadlines:
- Deadline to provide feedback to the call for evidence and contribute to the public consultation on the evaluation of the Fertilising Products Regulation: 19 September 2025.
- Deadline to respond to the public consultation launched by EFSA’s Pesticide Peer Review Unit on the Draft statement on consumer health-based guidance values on trifluoroacetic acid (TFA): 22 September 2025. The consultation follows the request from the European Commission to EFSA to issue an EFSA statement and review the recommended toxicological reference values, i.e. acceptable daily intake (ADI) and acute reference dose (ARfD), for TFA.
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/