Directorates and units

Directorate D - Risk Management

Unit D1 - Biocidal Active Substances

Role

The Biocides Active Substances Unit is responsible for ECHA's activities related to the evaluation of active substances, and coordinates the scientific assessments to be performed by the Agency itself under the Biocidal Products Regulation (BPR) for technical equivalence. Furthermore, in close cooperation with the Biocidal Products Unit, the Unit ensures that the Agency's Biocidal Products Committee (BPC) and its working groups operate in an independent, efficient, transparent, and consistent manner and can deliver high-quality scientific opinions or agreements.

Tasks

  • Provides the administrative support to the activities of the BPC Working Groups and the Biocidal Products Committee
  • Provides administrative support for Active substance approval
  • Provides scientific support to Active Substance approval, Union authorisation, Technical equivalence, Access to Active Substance (Article 95), Classification of changes, Article 75(1)(g) and Article 38 BPC opinions
  • Coordinates the processing of applications for technical equivalence
  • Provides scientific support to the working groups for APCP, ENV and AHEE
  • Communicates and provides advice and support (Helpdesk L2) on biocides processes
  • Provides advice and training, as relevant, to Member State Competent Authorities
  • Prepares and updates guidance documents and other relevant documentation Provides product management for R4BP 3, EUSES and supervises R4BP 3 data adaptations
  • Coordinates the support activities by the Biocidal Products Unit and the Biocidal Active Substances Unit (L2 helpdesk coordination, guidance, communication and dissemination)
Unit D2 - Biocidal Products

Role

The Biocidal Products Unit is responsible for ECHA's activities related to the evaluation of Union authorisations and other related processes, and coordinates the scientific assessments to be performed by the Agency itself under the Biocidal Products Regulation (BPR) for applications for active substance supplier and classification of changes. Furthermore, the Unit provides technical and scientific support the Agency's Biocidal Products Committee (BPC) and its working groups in close cooperation with the Biocidal Active Substances Unit and operates the secretariat for the Coordination Group.

Tasks

  • Coordinates the processes for Active Substance approval and Biocidal Products Authorisation
  • Provides administrative support for Union Authorisation
  • Processes Same Biocidal Products applications, applications for administrative changes and Union authorisation pre-submissions),
  • Coordinates the processing of applications for Union authorisation (including minor and major change and renewal), Article 95 inclusion classification of changes
  • Provides scientific support to Active Substance approval, Union authorisation, Technical equivalence, Access to Active Substance (Article 95), Classification of changes, Article 75(1)(g) and Article 38 BPC opinions
  • Provides scientific support to the working groups for EFF, HH, HeadHoc, ArtFood, micro-organisms
  • Communicates and provides advice and support (Helpdesk L2) on biocides processes
  • Provides advice and training, as relevant, to Member State Competent Authorities
  • Prepares and updates guidance documents and other relevant documentation Maintains and updates the Article 95 list
  • Provides the Secretariat to the Coordination Group
  • Coordinates Quality Assurance and the planning and reporting (including budget and fee income) by the Biocidal Products Unit and the Biocidal Active Substances Unit.
Unit D3 - Risk Management I

Role

Unit has the expertise on risk assessment and risk management of hazardous chemicals and collaborates closely in the areas of Classification, Socio-economic Analysis, Substitution and Applications for authorisation. It is responsible for the preparation of restriction proposals and managing the restriction process under REACH. It provides scientific, technical and administrative support to the Committee for Risk Assessment (RAC) on restriction, applications for authorisation. It also provides administrative support to RAC on classification and labelling proposals.

Tasks

  • Manages the technical and scientific aspects of Annex XV restriction dossiers during the development of the opinions in the Committees
  • Prepares Annex XV restriction dossiers on request by the Commission
  • Prepares and updates formats for Annex XV restriction reports and main documents relating to opinion forming
  • Provides advice and training, as relevant, to Member State Competent Authorities when preparing Annex XV restriction proposals
  • Communicates on restriction procedures
  • Prepares and updates guidance documents and other relevant documentation related to the restriction process
  • Carries out studies and updates reference values for health impacts relating to chemicals
  • Improves ECHA's capability and provides methodological advice to Member States and stakeholders about compliance and other costs to manage risks of substances
  • Provides scientific, technical and administrative support to the Committee for Risk Assessment (RAC) and its Chair
  • Supports RAC members, in particular rapporteurs, and external experts in relation to their tasks
  • Manages the contracts with the rapporteurs and/or experts providing a service for RAC
  • Informs stakeholders and the public about the work and outputs of RAC
  • Establishes and maintains appropriate procedures and working relations with other relevant Community committees and scientific advisory bodies, in order to ensure consistency between the opinions of RAC and of other relevant Committees, including those run by other EU bodies
Unit D4 - Risk Management II

Role

Unit has the expertise on socio-economic assessment of hazardous chemicals and collaborates closely with the Unit for Risk Management and Restrictions. It is responsible for managing the application for authorisation process under REACH and provides advice on socio-economic issues. It provides scientific, technical and administrative support to the Committee for Socio-economic Analysis (SEAC) on restriction proposals as well as applications for authorisation.

Tasks

  • Manages technical and scientific aspects of the applications for authorisation during the development of the opinions in the SEAC
  • Prepares and updates formats to prepare and submit applications for authorisation, and main documents relating to opinion forming
  • Provides practical advice (e.g. through seminars) to potential applicants for authorisation
  • Ensures efficient and appropriate stakeholder consultation for the authorisation application and restrictions procedures
  • Communicates on authorisation application procedures
  • Prepares and updates guidance documents and other relevant documentation related to the authorisation application processes, including the guidance on socio-economic analysis on risk management
  • Manages the Network of REACH SEA and Analysis of Alternatives Platform (NeRSAP) where industry and Member State authorities exchange their experiences in using socio-economic methodologies
  • Collaborates through the OECD on the comparison of Risk Management experiences, including socio-economic analysis
  • Provides scientific, technical and administrative support to the SEAC and its Chair
  • Supports SEAC members, in particular rapporteurs, and external experts in relation to their tasks
  • Manages the contracts with the rapporteurs and/or experts providing a service for SEAC
  • Informs stakeholders and the public about the work and outputs of SEAC
  • Establishes and maintains appropriate procedures and working relations with other relevant Community committees and scientific advisory bodies, in order to ensure consistency between the opinions of SEAC and of other relevant Committees, including those run by other EU bodies
  • Updates and implements ECHA’s substitution strategy through collaborative networking with Member States and stakeholders as well as the Commission, including research, technology support and innovation funding

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