December was major month of activity as the EU goes forward in implementing its Chemicals Strategy for Sustainability in relation to persistent and mobile substances!
Commission publishes the legislative proposal for establishing a common data platform on chemicals
The Commission adopted on 7 December the ‘One substance, one assessment’ legislative Package. The Package includes three legislative proposals deriving from the ‘one substance, one assessment’ initiative, announced in the Chemicals Strategy for Sustainability, aiming to increase the efficiency and coherence of safety assessment of chemicals across legislation. The Package contains a proposal for a Regulation establishing a common data platform on chemicals and a proposal for a Regulation and Directive amending several existing legal acts with the aim of streamlining risk assessment tasks and improving cooperation across EU agencies.
The common data platform will bring all information and data on chemicals from EU agencies and authorities in the same platform. It will include information on physico- chemical properties, hazard properties, use, exposure, risk, occurrence, emissions and manufacturing process of the chemicals, environmental sustainability related information, including climate change related information, on those chemicals, and applicable legal obligations and regulatory process-related information on chemicals. The platform will be composed of seven building blocks, some of which already exist and will be integrated into the platform: 1) the Information Platform for Chemical Monitoring (‘IPCHEM’); 2) a repository of reference values adopted under EU legislation; 3) a database of study notifications, 4) information on regulatory processes, 5) information on obligations under Union chemicals legislation; 6) a repository of standard formats and controlled vocabularies, 7) a database on environmental sustainability-related data. The common data platform will be created and operated by ECHA, within three years from the entry into force of the Regulation, and will be publicly available.
The Regulation also creates a framework for monitoring chemical risks, measure the effectiveness of chemicals legislation and measure the transition towards the production of safe and sustainable chemicals. This framework includes a set of indicators, to be included in an indicator dashboard on the common platform, an EU early warning system to track emerging chemicals risks, and an observatory for specific chemicals requiring additional scrutiny.
Council and Parliament reach provisional deals on the CLP Regulation, the Industrial Emissions Directive (IED) and the Ecodesign Regulation
In December, the Council and the European Parliament reached provisional agreements on three main Green Deal legislative procedures: The revision of the Industrial Emission Directive and the Regulation on the Emissions Portal, the proposed Regulation establishing a framework for setting ecodesign requirements for sustainable products and the revision of the Regulation for the classification, labelling and packaging of chemicals (CLP). Texts of the provisional agreements have not yet been made public – they will be published when the trialogues are finalised. Details to follow in the next regulatory watch.
Pesticide reduction targets rejected in European Parliament
The European Parliament rejected the Sustainable Use of Pesticides Regulation in a plenary vote on 20 November 2023. The text, amended by the ENVI Committee, contained binding targets to reduce by 2030 the use and risk of chemical plant protection products by at least 50% and the use of more hazardous products by 65%, compared to the 2013-2017 average. Following the rejection of the text, a majority of MEPs also voted against a referral back to the ENVI Committee for further deliberations, leading to the closure of the first reading for this file. The ball is now in the Council’s Court – if the Council reaches a compromise, it will be sent to the Parliament for a second reading.
The text is on the agenda of the Agrifish Council on 10-11 December to present the presidency’s progress report on the proposal. The current compromise still contains the 50% PPP reduction target by 2030 (with 2015-2017 period as a baseline) but leaves each Member States free to decide on its own quantitative objectives, targets, measures and timetables to contribute to the overall EU target. According to the progress report, there is however no clear consensus yet and more time will be needed before the Council general approach can be adopted. In its programme, the Belgian presidency (starting on 1 January 2024) indicated that they will continue the ongoing discussions on the revision of the Sustainable Use of Pesticide Directive.
EU Court of Justice rejects final appeal from Chemours to overturn listing of GenX on Candidate List
Chemours’ legal challenge following the inclusion of GenX in the Candidate List of substances of very high concern (SVHCs) for authorisation in 2019 had been dismissed by the CJEU in 2022. On 9 November 2023, the Court dismissed the company’s final appeal against the ruling, concluding that the grounds of appeal were inadmissible or unfounded.
Final exemption for PFOS under the POPs Regulation to be removed
Perfluorooctane sulfonic acid and its derivatives (PFOS) is listed in Annex I to the POPs regulation, prohibiting or severely restricting the production, placing on the market and use of Persistent Organic Pollutants. The PFOS entry currently includes Unintentional Trace Contaminant (UTC) limits in substances, mixtures and articles and a specific exemption for the use as mist suppressant for non-decorative hard-chromium plating. The draft Regulation revising the PFOS entry in the POPs Regulation, open for consultation until 1 January 2024, reduces the UTC limits and brings them in line with those for PFOA and removes the exemption.
European Parliament backs the ban on PFAS in food contact packaging
The European Parliament adopted its negotiating position on the Packaging and Packaging Waste Regulation on 22 November. The final text includes the ENVI Committee’s proposal to ban the placing on the market of food packaging containing intentionally added PFAS and Bisphenol A, starting 18 months after the entry into force of the Regulation.
Belgian Presidency programme published – upcoming race to close files before the end of April
Belgium, which takes the presidency of the Council on 1 January 2024, presented its programme on 8 December. If the presidency committed to finalise two files from the Fit for 55 package, on other Green Deal files – Urban Waste Water Treatment Directive, the Packaging and Packaging Waste Directive, and the Air Quality Directive – the presidency indicated that it will ‘advance interinstitutional negotiations’, without committing to finalise the negotiations. The presidency also mentioned its intentions to ‘make every effort to advance negotiations’ on the Soil Monitoring Directive and ‘pursue the sound implementation of the Chemicals Strategy for Sustainability, and foster discussions on some of its aspects, such as microplastics and PFAS’. The Work programme does not mention the revision of the water legislation (WFD, Groundwater and EQS Directives). On health, the presidency indicated it will continue the work on the revised pharmaceutical legislation, without promising the adoption of a Council mandate. Belgium holds the last presidency before the European elections in June 2024 and will have around four months before the Parliament’s session ends to close as many files as possible. Presently, 150 legal files are still under negotiations.
Transposition of the Drinking water Directive
- 24 Member States have now transposed the revised Drinking Water Directive (three have not transposed yet (AT, MT, PL) + in BE, transposing acts from the Brussels Capital region are expected early 2024).
- 15 MS have transposed both PFAS parameters in their law (often with the caveat that it will be decided to use either or both parameters after the publication of the technical guidelines by the Commission); 9 have transposed only sum of 20 PFAS.
- None of the Member States have adopted stricter parametric values for Sum of 20 PFAS and Total PFAS.
- Three Member States have extended the parameter Sum of 20 PFAS to additional substances:
- Denmark has adopted a parameter for Sum of 22 PFAS: the 20 PFAS listed in the DWD + 6:2 FTS and PFOSA
- Italy has adopted a parameter for Sum of 24 PFAS: the 20 PFAS listed in the DWD + GenX, ADONA, 6:2 FTS and C6O4
- Sweden has adopted a parameter for Sum of 21 PFAS: the 20 PFAS listed in the DWD + 6:2 FTS
- Three Member States have adopted a binding parametric value for the Sum of 4 PFAS (PFOA, PFNA, PFHxS, PFOS), and two have established guideline / recommended values for the Sum of 4 PFAS.
| Binding parametric values | |
| Denmark | 2 ng/l |
| Germany | 20 ng/l (from 12/01/2028) |
| Sweden | 4 ng/l (from 01/01/2026) |
| Recommended parametric values | |
| Flanders | 4 ng/l (drinking water distributors must strive to meet this target value by March 2028; it is a best-efforts obligation, not an obligation of results) |
| Netherlands | 4.4 ng/l (guideline value from RIVM) |
In the wake of the controversy sparked by drinking water contamination with PFAS in Wallonia and Brussels, authorities from both regions have announced supplementary measures for the monitoring of PFAS in drinking water: in Wallonia (which has transposed the DWD and so far stuck to the EU parametric values), the establishment of alert thresholds of 30ng/l for the Sum of 20 PFAS and 4 ng/l for the Sum of 4 PFAS, which will trigger actions from authorities and communication to residents (but are not limit values); in Brussels (which acts transposing the DWD are expected early 2024), a recommendation not to exceed a threshold of 4ng/l for the Sum of 4 PFAS, quite similar to the target value in Flanders, could be established (although likely not yet in the 2024 transposing acts).
Upcoming consultation deadlines:
- Deadline to provide feedback on the draft Regulation on data requirements and gradual review of safeners and synergists: 20 December 2023
- Deadline to provide feedback on the draft regulation reducing the maximum PFOS concentration allowed as unintentional trace contaminant in substances, mixtures and articles and removing exemptions under the POPs Regulation: 1 January 2024
- Deadline to provide feedback on the draft Regulation establishing a common data platform on chemicals: 5 February 2024
- Deadline to provide feedback on the draft Regulation on the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals: 5 February 2024
- Deadline to provide feedback on the draft Directive on the re-attribution of scientific and technical tasks to the European Chemicals Agency: 5 February 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/