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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)

From: Options for an environmental risk assessment of intentional and unintentional chemical mixtures under REACH: the status and ways forward

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)
  1. aECHA dissemination Website (07/2020)