Directorates and units
Directorate B – Prioritisation and Integration
The Chemistry Unit manages the assessment of substance identification information and advises on chemistry for all the Agency's work processes under the REACH, CLP, PIC, POP and Biocides regulations.
- Manages the processes under REACH of:
- Chemical identifier adaptation
- Manages substance identification and advises on chemistry in support of all other ECHA processes under the three regulations:
- REACH: dossier evaluation (testing proposal and compliance check), substance evaluation, SVHC identification, restriction and applications of authorisation (on request)
- CLP: proposals for harmonised classification and labelling, alternative names requests
- PIC, POP assessment of chemical identity
- Biocides: technical equivalence (Tier I) and chemical similarity check
- Contributes to establishing groups of substances for ECHAs regulatory processes
- Interprets and advises the scope of the REACH Regulation (identification of complex substances, substance sameness, polymers, intermediates, nanomaterials, etc.)
- Contributes to activities related to substance identification through ECHA internal task forces, the European Commission and OECD working groups e.g. nanomaterials and identification of UVCBs
- Maintains a structural database to support substance identification and grouping of substances
- Specifies business processes and workflow systems dealing with processes under the responsibility of the unit, within IT systems such as REACH-IT, DEP, Dynamic Case and Odyssey
- Prepares or contributes to communications to stakeholders regarding substance identification (e.g. helpdesk, guidance, stakeholders day, warning letters to registrants following evaluation decision or screening)
The Computational Assessment Unit develops methods and tools for data collection, data mining, data delivery, chemical grouping and priority setting. The Unit provides expert advice and support for their use within and outside the Agency. In addition, alternative hazard assessment approaches are being developed, using New Approach Methods (NAM) strategies, as well as other alternative methods (e.g. QSAR).
- Ensures the product management of IUCLID, including IUCLID cloud service: Further specifies and promotes IUCLID for industry and authority use worldwide for reporting, processing, as well as exchanging chemicals related data. Participates in and/or chairs the OECD working groups related to IUCLID and its data format (OECD Harmonised Templates)
- Develops and applies computational methods mainly focusing on grouping, prioritisation and selection of dossiers and substances for further regulatory actions under REACH, CLP and BPR
- Develops and applies methods to report REACH, CLP, BPR and PIC data (such as Registration statistics) including support to policy decisions. This includes ensuring the product management of ECHA databases and integration platforms used for this purpose
- Promotes and applies predictive techniques and tools and use of alternative methods, including integrated testing strategies, focusing on aspects related to QSAR, read-across and categories. Co-manages the OECD QSAR Toolbox development with OECD. Is responsible for the Article 117.3 report on the use of alternative approaches under REACH.
- Develops Alternative approaches for Risk Assessment, using New Approach Methodologies, through international collaboration.
- Communicates and participates in international activities for the above.
The Prioritisation Unit co-ordinates the identification and prioritisation of (groups of) substances requiring further regulatory actions at the EU level and supports the identification of the appropriate regulatory measures. It manages the prioritisation and listing of substances on the Community Rolling Action Plan (CoRAP) and on the Authorisation List.
- Co-ordinate the identification and prioritisation of groups of substances for concerted regulatory action;
- Support the management of groups of substances and the identification of the required regulatory actions (further data generation, further regulatory risk management), including collaboration with MSCAs;
- Contribute to the collaboration with industry on specific groups of substances;
- Co-ordinate the work related to the identification of the most appropriate regulatory management options (RMOAs) at the EU level;
- Co-ordinate the collaboration with MSCAs on the integrated regulatory strategy implementation (e.g. managing the RiME platform);
- Communicate on the progress made in implementing the integrated regulatory strategy and in taking regulatory actions
- Contribute to converging the REACH and CLP implementation with other EU legislation
- Establish the Community Rolling Action Plan (CoRAP) for substance evaluation and updates this plan on a yearly basis
- Prepare recommendations for inclusion of substances in Annex XIV (Authorisation List)
The Exposure and Supply Chain Unit focuses on improving the relevance and communication of information on use and exposure of chemicals under ECHA’s Integrated Regulatory Strategy. The work also covers the use of exposure-modelling tools by industry and the authorities. We are also responsible for ECHA tools and methods developed in support of the Chemical Safety Assessment (via the Chesar tool) and supply chain communication for substances, mixtures, articles and waste. Our work is carried out in regular consultation and cooperation with ECHA’s stakeholders.
- Develop use/exposure based selection criteria for ECHA’s work on prioritising groups of substances for information generation and Regulatory Risk Management
- Provide expert support to ECHA’s REACH and CLP processes in relation to use and exposure related requests
- Maintenance and further development of Chesar and support to the development of exposure modelling tools
- Development of improved methods for supply chain communication on risk management for substances and mixtures
- Maintenance of ECHA’s tasks related to Substances in Articles – in particular the notification system
- Implementation of ECHA’s responsibilities under the Waste Framework Directive.