Table 1 Information availability for an environmental assessment (requirements are laid down in Annex VII-IX of REACH and the respective chapters of ECHA GD) and tasks of the different actors in the supply chain (implying numerous subsequent downstream user and end user)
Knowledge | Registrant | Downstream user | Authorities |
|---|---|---|---|
Obligations and tasks | Assessment of hazards/exposures/risks of single substances, supporting (or excluding) certain uses | Adaptation or own derivation of Msafe, safe use conditions for own uses | Specific evaluations and regulatory risk management measures if unacceptable risks or hazards are identified |
Number of substances addresseda | In total: 22.873 1–10 t/a: 3.249 10–100 t/a: 2.923 100–1000 t/a: 2.272  > 1000 t/a: 2.455 (without intermediates) | All substances and indefinite number of formulations | SVHC identified in total: 197 (ED ENV: 12, PBT: 13) Restrictions (Annex XVII): 70 |
Communication and assessment obligations | 1 t/a: Registration dossier and CSA; SDS (including PNEC, Msafe, RMM, OC for intended DU uses), CSR for NM  > 10 t/a: CSR, with ES and eSDS for hazardous chemicals Self-classification of substances and PBT assessment | (e)SDS/mixture SDS (with ES for all substances) Optional DU CSR for substance(s) in a mixture Classification of a mixture | In case of identified concerns: Dossiers for substance evaluation (SEV) and/or proposals for regulatory measures (SVHC-identification, restrictions) CLH proposals for substances |
Information available (details see below) | Study results from own tests or publicly available literature Generic information from DU associations | Receives (e)SDS from REG for substances used | MS CA/ECHA: Registration dossier (IUCLID, CSR). Evaluated on random basis (CCH) or concern (SEV) Additional information on request, during consultations or by Surveillance authorities ((e)SDS from DU, information on sites) |
Effect data (see Annex VII–IX REACH) | Basic requirements depending on tonnage and properties (also non-test information or waiving): 1–10 t/a: Phys.-Chem 10–100 t/a: short-term Algae, Daphnia 100–1000 t/a: long-term fish or daphnia (ITS), short-term soil (invertebrates, plants, MO) if soil exposed  > 1000t/a: long-term soil (invertebrates, plants), sediment, birds Calculation of PNEC for each compartment | (e)SDS: Most sensitive PNEC for classified substances, PBT status | ECx and/or NOEC, PNECs and robust study summaries (RSS) available in technical IUCLID dossier and CSR Results from publicly available scientific studies |
Exposure data | Calculation of PECs and RCRs for each use category and env. compartment Monitoring data usually not considered | Emission values, release factor, PEC and Msafe received via eSDS from REG if indicated Concentrations used, OC and RMM for each use category | Access to PECs, RCRs, yearly processed tonnage, OC, RMM in CSR and IUCLID for identified use categories and compartments. Publicly available literature on monitoring data |
Use of substance | Receives generic sector-specific information on uses, processed tonnages, OC and RMM from DU associations (own surveys, communication) | Information on ingredients (substances or pre-formulations) and own formulation. Information on subsequent uses only on demand | Use categories in CSR from REG No detailed information on specific uses (only via surveys or on request or very generic information in SPIN database) |