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. 

Reference:https://echa.europa.eu