You must include a chemical safety report (CSR) in your registration for substances that are manufactured or imported in quantities of more than 10 tonnes per year and are subject to registration under the REACH Regulation (Article 10). You can submit the CSR either separately by yourself or the lead registrant of your joint submission can send it on behalf of all co-registrants.

When you are required to provide a CSR, note:

• It must contain an exposure assessment and risk characterisation if the substance is classified as hazardous or fulfils the criteria for a persistent, bioaccumulative or toxic (PBT) substance, as described in REACH Article 14(4).

• The exposure assessment and risk characterisation must address all the identified hazards of the substance.

• Each use reported in IUCLID Section 3.5 must have a corresponding exposure scenario in the CSR.

• The exposure scenarios must contain contributing scenarios that correspond to the contributing activities reported in IUCLID Section 3.5:
  • Environment: Environmental release category (ERC)
  • Workers: Process category (PROC)
  • Consumers: Article category (AC) and/or product category (PC)

• Each contributing scenario must contain:
  • Conditions of use describing the operational conditions and the risk management measures.
  • Exposure estimates for all relevant routes / compartments.
  • A risk characterisation ratio for all individual routes / compartments.
  • A risk characterisation ratio for combined routes.
  • Environmental Contributing scenarios must also contain local releases for water, air and soil.

• Humans exposed via the environment must be included in the assessment when:
  • The tonnage is above 1 000 tonnes per year; or
  • The tonnage is above 100 tonnes per year and the substance is classified as toxic to specific target organ from repeated exposure (STOT RE) 1, carcinogen, mutagen (any category), or toxic to reproduction (categories 1A or 1B).

• If any of the above elements are missing, a justification must be provided in the CSR.

• If no CSR is provided, a justification must be provided in line with Article 14(2).