On July 8, the European Commission has informed the registrants to provide more information’s on the substances to be reviewed under the REACH registration/ REACH annex. Hence, the substance owner or companies (scope under the REACH ) needs to comply with this new law, will possibly apply from 8 January 2022. 

These additional requirements will bring a more transparent and predictable evaluation of substance information while registering under the REACH. Also, ECHA would have clarified the new information’s needs to be submitted by the companies as below:

New Additional Information Required

  • ● Need substance information’s against the new required properties such as surface tension/ water solubility of metals/ less soluble metal compounds.
  • ● Testing reports, output practiced from in vitro testing for eye irritation & in vivo testing for skin or eye irritation.
  • ● Need to perform dose toxicity studies again and again within the adaptions time frame for 28-day and 90-day. Also, should match with definite rules to adapt under reproductive toxicity studies.

Basic Needs for Adaption

  • ● Using the available data with the highest level of evidence.
  • ● substance-tailored exposure-driven testing and Substance grouping based on UVCBs.
  • ● low octanol-water partition coefficient effects in the environment – studies
  • ● For dissociation constant and viscosity, new definite rules are to have complied.
  • ● Best practices should carry out both in human health as well as in the environment with the highest dose levels.

To understand more about the upcoming rules/requirements, ECHA will update the guidance materials and provide more clarification to support registrants as much as possible. 


If this regulation is applicable to you and you are interested in knowing more about this topic and available solutions, then schedule a free consult with our experts.