Directorates and units

Directorate C - Hazard Assessment

Unit C1 - Hazard I

Role

The Hazard I Unit manages all Agency tasks resulting from the CLP Regulation and in particular supports the opinion-making process for proposals for harmonising the classification and labelling of hazardous substances.

In addition, the Unit works with two of the Agency's technical and scientific Committees, the Committee on Risk assessment (RAC) and the Member State Committee (MSC). The Unit works with the RAC Chairman and RAC secretariat in the development of the CLH opinions. The Unit coordinates the scientific, technical and administrative support to the MSC. Furthermore, the Unit supports the MSC Chairman and together they ensure that MSC can operate in an independent, efficient, transparent, and consistent manner and can deliver high-quality scientific opinions or decisions and agreements, the latter two based on proposals by ECHA or Member State Competent Authorities.

Tasks

Classification and labelling team:

  • Coordinates classification activities in ECHA
  • Provides advice to MSCAs regarding the preparation of CLH dossiers
  • Manages technical and scientific aspects of CLH dossiers submitted by MSCAs and industry during the development of the opinions in the Committees
  • Manages requests for alternative names
  • Maintains the C&L Inventory
  • Provides input to the further development of the Globally Harmonized System of Classification and Labelling of Chemicals
  • Contributes to awareness raising activities on the duties of manufacturers and importers related to C&L.

The MSC Secretariat:

  • Provides the Secretariat for the Member State Committee – MSC, and plans, prepares, organises and follows up their workSupports the Chairman in planning MSCs case-load, case-analysis, and preparations for written procedures, Webexes and meetings.
  • Supports Committee members, including rapporteurs, and external experts in relation to their Committee tasks
  • Provides membership management including support to appointment and renewal of members
  • Maintains the Manual of Decisions
  • Informs stakeholders and the public about the work and outputs of the MSC
  • Establishes and maintains appropriate procedures and working relations with other relevant ECHA committees, as well as Community committees and scientific advisory bodies, among others to ensure consistency between the opinions of MSC and of other relevant Committees and in procedures, including those run by other EU bodies
Unit C2 - Hazard II

Role

The Hazard II Unit manages the dossier evaluation processes, namely compliance check of the registration dossiers and examination of testing proposals; examines information obtained under dossier evaluation; provides coordination on IT developments in support of Evaluation processes, as well as expert support on scientific issues, including test methods to other units and processes.

Tasks

  • Supports the assessment of groups of substances and the identification of the required regulatory actions (further data generation, further regulatory risk management), including collaboration with MSCAs
  • Ensure optimal coordination of processes to generate new information, i.e. dossier evaluation and substance evaluation, and identify hazard
  • Conduct dossier evaluations, including compliance check of dossiers and examination of testing proposals
  • Examine the information obtained under dossier evaluation and notify the Commission and Member State Competent Authorities of the conclusions made
  • Supports the MSCAs during the decision-making process under dossier evaluation
  • Support the MSC in discussion and adoption of dossier evaluation decisions
  • Coordinate ECHA's positions on animal welfare, animal testing, and on (alternative) testing methods
  • Provide scientific advice at international level (e.g. OECD) in the area of testing methods
  • Provides coordination on IT developments in support of Evaluation processes
  • Provide the annual report on evaluation activities according to REACH Article 54,
  • Coordinate ECHA's positions on animal welfare, animal testing, and on (alternative) testing methods and coordinate answers on questions touching such subjects
  • Provide hazard expertise when required in any activity undertaken by the Agency, including e.g. occupational exposure limits, ad hoc and new tasks
Unit C3 - Hazard III

Role

The Hazard III Unit manages the evaluation processes, including the compliance check of the registration dossiers, the examination of testing proposals and the coordination of substance evaluations undertaken by Member State Competent Authorities. It also manages the listing of substances on the Candidate List and the Authorisation List. It coordinates the expert groups (PBT and endocrine disruptor) that support evaluation and hazard identification. It coordinates the decision making and agreement seeking process for substance evaluation and SVHC identification, respectively, and manages the interface with the Member State Competent Authorities.

Tasks

  • Supports the assessment of groups of substances and the identification of the required regulatory actions (further data generation, further regulatory risk management), including collaboration with MSCAs;
  • Ensure optimal coordination of processes to generate new information, i.e. dossier evaluation and substance evaluation, and identify hazard
  • Conduct dossier evaluations, including compliance check of dossiers and examination of testing proposals
  • Coordinate the substance evaluation undertaken by the Member States
  • Under substance evaluation, provide Member States with scientific, technical and legal support to ensure a harmonised approach to requests further information
  • Coordinate ECHA's positions on animal welfare, animal testing, and on (alternative) testing methods
  • Provide scientific advice at international level in the area of testing methods
  • Prepares SVHC dossiers on request by the Commission, supports MSCAs preparing SVHC dossiers and manages the technical and scientific aspects related to the Candidate List.
  • Manages the work of expert groups (e.g. PBT / ED) on hazard assessment
  • Provide the annual report on evaluation activities according to REACH Article 54
  • Provide hazard expertise when required in any activity undertaken by the Agency, including e.g. support to POP regulation, nanomaterials, occupational exposure limits, ad hoc and new tasks
Unit C4 - Hazard IV

Role

The Hazard IV Unit manages the dossier evaluation processes, namely compliance check of the registration dossiers and examination of testing proposals; coordinates the decision-making process of dossier evaluation, manages the interface with the Member State Competent Authorities; provides expert support on scientific issues, including read-across to other units and processes as well as scientific support to MSC.

Tasks

  • Supports the assessment of groups of substances and the identification of the required regulatory actions (further data generation, further regulatory risk management), including collaboration with MSCAs;
  • Ensure optimal coordination of processes to generate new information, i.e. dossier evaluation and substance evaluation, and identify hazard
  • Conduct dossier evaluations, including compliance check of dossiers and examination of testing proposals
  • Supports the MSCAs during the decision-making process under dossier evaluation
  • Support the MSC in discussion and adoption of dossier evaluation decisions
  • Coordinate ECHA's positions on animal welfare, animal testing, and on (alternative) testing methods
  • Provide scientific advice at international level in the area of testing methods
  • Manages the work of expert group on nanomaterials
  • Provide expert scientific support in any activity undertaken by the Agency, including e.g. support to POP regulation, nanomaterials, occupational exposure limits, ad hoc and new tasks
  • Provides support and capacity building on read-across and grouping
  • Provide scientific support to European Commission for Evaluation decisions adopted through the REACH Committee

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