The European Commission has updated the information requirements for chemicals registration under the EU REACH, intending to make the European Chemical Agency (ECHA) evaluation practices more transparent. The updates of the EU REACH annexes describe the information requirements for the companies that must be submitted during the chemical’s registration. The law came into effect on July 8, 2021, and will be effective from January 8, 2022.

Some of the significant changes include: 

  • requirements for water solubility and surface tension of metals and sparingly soluble metal compounds
  • adaptations and requirements for 28-day and 90-day repeated dose toxicity studies
  • requirements for in vivo testing for skin or eye irritation and in vitro testing for eye irritation
  • rules for adaptation of reproductive toxicity studies
  • general rules for adaptation based on: 
    • weight of evidence
    • use of existing data
    • substance-tailored exposure-driven testing
    • grouping of substances – particularly unknown/variable composition, biological materials and complex reaction products
  • new rules for adapting for viscosity and dissociation constant
  • new rules for adapting studies based on fate and behaviour in the environment 
  • additional requirements for testing of human health and environment at appropriately high dose levels

By the end of 2021, the ECHA is expected to publish the guidance materials to provide more advice to the registrants. Therefore, manufacturers registering any chemical substances mentioned above must thoroughly understand the additional information requirements and be ready to align with the upcoming changes. Reach out to Freyr - a Regulatory expert to avoid hassles during the registration process.

Stay informed. Stay updated.

 

Related Posts by Category

Global HA Mandates
 
x