Provisional agreement on the common data platform includes databases on substances in articles and alternatives to substances of concern
The Council and the European Parliament reached a provisional agreement on the One Substance One Assessment package on 12 June 2025. The Package contains a Regulation establishing a common data platform on chemicals and a Regulation and Directive amending several existing legal acts with the aim of streamlining risk assessment tasks and improving cooperation across EU agencies. The ENVI Committee of the European Parliament voted in favour of the agreements on 3 July; they still need to be formally adopted in the Parliament’s plenary and by the Council.
As set out in the Commission proposal, the common data platform will include the Information Platform for Chemical Monitoring (‘IPCHEM’), a repository of reference values adopted under EU legislation, a database of study notifications, information on regulatory processes, information on obligations under Union chemicals legislation; a repository of standard formats and controlled vocabularies, a database on environmental sustainability-related data. In addition to these data services, the agreement on the common data platform maintained the proposal from the Parliament to include in the platform a database of information on substances in articles and a database of information on alternatives to substances of concern.
The Regulation tasks the EEA and ECHA with the creation of a framework of indicators to monitor chemical pollution throughout a chemical’s lifecycle (emissions, occurrence and fate) and the drivers and impacts of exposure to chemicals. Indicators should also measure the effectiveness of chemicals legislation and the transition towards the production of safe and sustainable chemicals. The framework will include, to the extent possible, ‘an aggregated territory-based risk indicator’ to monitor time and spatial trends in exposure of populations to chemicals and associated health risks. The framework of indicators will be accessible in the form of an indicator dashboard made available through the common data platform. The Regulation also tasks ECHA and EFSA, in cooperation with the EEA, to commission an EU-wide human biomonitoring study covering all Member States 4 years after entry into force of the Regulation. No regular EU-wide biomonitoring study (as was proposed by the Parliament) is however required in the final agreement.
The Regulation tasks the EEA to establish an early warning system for emerging chemical risks, within one year of the entry into force of the Regulation, aggregating signals from various sources (including data from EU agencies and national early warning systems). While the final agreement maintained the possibility for ECHA to commission scientific studies to investigate further emerging chemical risks identified through the early warning system, other amendments from the Parliament related to follow-up actions from authorities were not included in the final agreement.
Amendments from the Council limiting the scope of data on medicinal products to be included in the platform were maintained in the final agreement. The Commission will carry out an assessment to analyse whether other chemicals data related to medicinal products should be included in the platform in the future. Legacy data from the European Medical Agency (data submitted before the entry into force of the regulation) will be gradually integrated into the platform, starting six years after the regulation enters into force.
The common data platform will be created and operated by ECHA, within three years from the entry into force of the Regulation (likely end of 2028), with the exception of the database on environmental sustainability related data, to be established six years after the date of entry into force of the Regulation.
Provisional agreement on Toys regulation bans the intentional use of PFAS in toys
On 10 April, the Council and the European Parliament reached a provisional agreement on the Toy Safety Regulation, which was made public on 11 June. The agreement maintained the proposal from the European Parliament to prohibit the intentional use of PFAS (defined according to the OECD definition) in toys, components of toys or micro-structurally distinct parts of toys. The prohibition does not apply to batteries in toys and toy components necessary for electronic or electric functions of the toy if the substance is full inaccessible. As initially proposed by the Commission, generic prohibitions based on CLP classification, which already existed for CMRs in the previous Toys Directive, are extended to endocrine disruptors for human health category 1 or 2; substances toxic to a specific target organ category 1 (single or repeated exposure), respiratory sensitisers category 1, to which were added in the final text skin sensitisers 1A. Proposals from the Parliament to add to this list endocrine disruptors for the environment, PMT/vPvM and PBT/vPvB were not maintained in the final agreement. Exemptions to generic prohibitions and to the PFAS prohibition may be granted by the Commission following safety and alternative assessments by ECHA. The Regulation will apply 54 months after the entry into force of the Regulation (Q1 2030 if the Regulation enters into force Q4 2025).
ECHA identifies regulatory actions for several groups of PMT / vPvM substances
ECHA published two assessments of regulatory needs identifying potential PMT / vPvM substances. The assessment of regulatory needs for azohydroxynaphthoic acid pigments identifies potential PMT/vPvM hazard for all 22 substances from the group and the assessment of regulatory needs for alkoxy (phenyl and chlorinated alkyl) and chlorinated chloro alkyl silanes identifies potential PMT / vPvM hazard for 13 substances (out of 23 in the group). In both cases, the assessment proposes CLH as first step to clarify the PMT/vPvM hazard.
European Parliament Research Service points to delays in implementation of the Chemicals Strategy for Sustainability
The European Parliament Research Service (EPRS) published a ‘Targeted scrutiny of the EU chemicals strategy for sustainability’, in which they assess the achievements of the strategy adopted in 2020. The briefing concludes that, if significant progress has been made in the implementation of the 85 actions contained in the strategy, several key actions, such as the revision of REACH, have not yet been implemented. The EPRS also concludes that efforts to manage risks from hazardous substances, and in particular chemical mixtures and persistent substances such as PFAS, are ‘undermined by regulatory delays and fragmented implementation’.
Upcoming consultation deadlines:
- Deadline to provide feedback on the draft Commission implementing regulation establishing the list of safeners and synergists to be included in the work programme for the gradual review of safeners and synergists that exist on the market: 8 July 2025.
- 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.
- Deadline to respond to the public consultation on EFSA’s Assessment Report on the active substance bromuconazole: 16 August 2025.
- Deadline to respond to the public consultation on the CLH dossier of bromuconazole: 18 August 2025.
- 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.
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/