Assessing hazard and risk

Assessing hazard and risk

An important part of the work with your co-registrants is to compile information on uses, hazards and risks in order to demonstrate safe use of the substance.

You will need to consider the following regulatory, scientific and technical requirements:

  • Gather information on uses and current conditions of use from the supply chain. Contact your industry association for best practice in your sector;
  • Collect hazard data as requested by REACH information requirements triggered by the tonnage and uses of the substance;
  • Assess the coverage and quality of the hazard information about the substance available amongst the co-registrants;
  • Define the strategy to fill in any resulting data gaps (e.g. carrying out new studies, justifying missing information using scientifically solid read across, data waivers, etc.);
  • Agree on the classification and labelling amongst the co-registrants (based on the hazard data);
  • Record all hazard data and classification in the registration dossier; and
  • If manufacturing or importing more than 10 tonnes per year, you need to carry out the chemical safety assessment (CSA) and record it in a chemical safety report (CSR). Additionally, during the discussions the co-registrants decide if the lead registrant will submit the chemical safety report jointly on behalf of the co-registrants or if the individual registrants will submit their own CSR separately .

The minimum data requirements for registration of your substance are specified in Annexes VI - X of REACH. The legal requirements (standard information requirements) are cumulative and depend on the tonnage that you manufacture or import your substance. For each individual substance the precise information requirements will differ, depending on tonnage, use and exposure, and the properties of the substance.

You report this information in your registration dossier, which is to be prepared jointly by all companies registering the same substance. Your registration dossier should be based on reliable test results or on information obtained by alternative means, if this can be scientifically justified.  Some information requirements may be adapted due to the nature of your substance.

Detailed specific guidance on meeting these information requirements is given in the appropriate subchapters of the Guidance on Information Requirements and Chemical Safety Assessment, Chapters R.7.

New studies to fulfil the information requirements defined in Annex IX and X shall not be conducted at the stage of registration. Instead, you will have to develop a testing proposal, include it in your registration dossier and submit to ECHA.

You need three main types of information for the joint part of your registration dossier:

  1. Physical and chemical characteristics of the substance.
  2. Environmental properties of the substance.
  3. Human health properties of the substance.

Check with your co-registrants what information is already available and what information you need to acquire or generate. You need to assess the quality of the hazard information. Despite the joint submission obligation, every registrant is individually responsible for the data they rely on for their registration.

The amount of information required depends on the highest tonnage needed to be covered within the joint submission. Data sharing and joint submission are designed to share the actual costs between all co-registrants who need the data.

Depending on the substance properties and available information, some tests cannot or do not need to be performed. These situations are called “adaptations” (Annex XI to REACH).  

In addition, in your individual part of the dossier, you need to include company-specific information on:

  • Substance identification (constituents, impurities, additives).
  • Use and conditions of use of the substance for the whole lifecycle of the substance (from manufacture to waste).