ZeroPM Regulatory Watch Update July 2024

Council negotiating mandate introduces a groundwater quality standard for the Sum of four PFAS but pushes legal deadlines for compliance to 2039

The Council adopted its negotiating mandate on the revisions of the Water Framework Directive, Groundwater Directive and Environmental Quality Standards Directive on 19 June.

Environmental quality standards for surface waters: The Council maintained the Commission’s proposal on setting environmental quality standards for the sum of 24 PFAS in surface water, and deleted the EQS for total active substances in pesticides, their relevant metabolites, degradation and reaction products. The Council also delayed the legal deadline for compliance with revised EQS to 2033 and with newly introduced substances (including PFAS, diclofenac or ibuprofen) to December 2039.

Ground water pollutants: As groundwater is the main source for drinking water in many Member States, the Council aligned the groundwater quality standard for the Sum of PFAS with the Drinking Water Directive, which set a parametric value for the Sum of 20 PFAS – the original proposal from the Commission had set a groundwater quality standard for the Sum of 24 PFAS. The Council negotiating mandate however recognised that the Drinking Water Directive parameter for the Sum of PFAS is not in line with the latest scientific developments should be revised according to recent knowledge, including on new parameters such as TFA. In addition, the negotiating mandate introduced a groundwater quality standard for the sum of the four most problematic PFAS (PFOA, PFOS, PFNA, PFHxS), set at 0,0044 μg/l. The Council delayed the legal deadline for compliance with new groundwater quality standards, including for PFAS, to December 2039.

The Council simplified the groundwater quality standard for non-relevant metabolites of pesticides and added an obligation for the Commission to establish a list of known pesticides, indicating if they are relevant or not, and to update it at least every six years. This list should support Member States in selecting the active substances to monitor. Regarding pharmaceuticals, the Council maintained the listing of individual pharmaceutical products, but deleted the groundwater quality standard for the total of pharmaceutical active substances.

Watch lists for surface and groundwater pollutants: The Council maintained the maximum number of substances that can be included in both watch lists (5 for groundwater, 10 for surface water), when the Parliament, in its negotiating position, had removed those caps. The Council also requested the Commission to consider the creation of a joint monitoring facility for samples submitted by the Member States, for the analysis of the substances on the surface and groundwater watch lists and for the substances listed for which quality standards have been defined in the Groundwater Directive and the EQS Directive. A joint monitoring facility is also supported by the European Parliament.

Review of surface and groundwater quality standards: Like the European Parliament, the Council removed the possibility for the Commission to amend the list of priority substances and surface and groundwater quality standards through delegated acts. The review of these lists every six years may lead to a revision through legislative procedure.

Council mandate on soil monitoring provides more flexibility to Member States in soil health monitoring and identification of contaminated sites

The Council adopted its general approach on the Soil Monitoring Directive on 17 June. The Commission proposal set out an obligation for Member States to set up a monitoring framework for soil health based on soil descriptors and criteria for healthy soil defined at EU or Member State level. The Council introduced an approach to monitoring and assessing soil health consisting of non-binding sustainable target values defined at EU level and operational trigger values, set at member states level. According to the Council, the non-binding sustainable target values ‘reflect the long-term aspirational objective of the Directive’ and describe’ the ideal situation where the capacity of soils to provide ecosystem services will not decrease and no significant harm will occur to human health or the environment’. On the contrary, Member States must set operational trigger values for each soil descriptor listed in Annex to the Directive and take appropriate measures to restore soil health according to these values. The monitoring framework proposed by the Council provides more flexibility to Member States – compared to the Commission proposal – as all operational criteria for assessing soil health will be defined at national level.

Earlier this year, in April, the European Parliament proposed an assessment of soil health based on a five-level classification for the ecological status of soils (high, good, moderate, degraded and critically degraded) and a fully revamped monitoring framework, including, regarding soil contamination, the monitoring of POPs, PFAS, biocide residues and plant protection products. Positions from legislators are quite far apart before interinstitutional negotiations, which should happen in Q4 2024.

Like the European Parliament, the Council proposed the establishment of a watch list of soil contaminants having a high potential to affect soil health, human health or the environment. This list should be established by the Commission within 18 months of the entry into force of the Directive and should be updated regularly (no specific timeframe proposed). Regarding contaminated sites, the Council called for a ’risk-based and stepwise approach’ to the identification, investigation and risk assessment of potentially contaminated sites and postpones the deadline for their identification to 10 years after the entry into force of the Directive (instead of 7 years in the Commission proposal).

Germany proposes harmonised classification as PMT and vPvM for TFA

Germany has submitted two dossiers for revising the harmonised classification of trifluoroacetic acid (TFA) and adopt a new harmonised classification for sodium trifluoroacetate and other inorganic salts of trifluoroacetic acid in June 2024. New proposed hazards include PMT, vPvM and Reprotoxic 1B. ECHA is currently running the accordance check on both dossiers. If the accordance check is successful, ECHA will launch the public consultation.

Update of restriction roadmap plans restriction of 1,4 dioxane in surfactants in 2025

The Rolling List of (groups of) substances for restriction, updating Annex I to the Restriction Roadmap, was updated on 1 July 2024. The list includes the restriction of the manufacture, placing on the market and use of 1,4-dioxane in surfactants, for which the Annex XV restriction report is planned to be submitted in October 2025.

Hungarian presidency program prioritises soil monitoring, water and OSOA files

Hungary took the rotating presidency of the Council on 1 July. In the presidency programme, the Member State commits to ‘make significant progress on legislative proposals on microbeads, soil monitoring, priority substances in surface and groundwater, as well as the One Substance One Assessment (OSOA) package’.

Upcoming consultation deadlines:

  • Deadline to provide feedback on the ‘safe and sustainable by design’ framework: 30 August 2024.

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/