Call for Information

The European Chemicals Agency (ECHA) is inviting third parties to submit scientifically valid information and studies related to specific substances and hazard endpoints. This initiative aims to enhance the understanding of chemical safety and regulatory compliance.

Accessing Dossier Details

Interested parties can find more information by visiting the "View dossier" links in the ECHA CHEM Database. These links provide access to detailed dossiers that include proposed testing methods, such as modified test methods for repeated dose toxicity studies. Note that if a dossier has not been disseminated or if the substance identity is confidential, these links may not be available.

Understanding Tonnage Bands

The Total Tonnage Band published does not necessarily reflect the actual registered tonnage bands or the associated information requirement obligations. This figure is based on non-confidential quantities of a substance manufactured or imported by all registrants, excluding any quantities used directly as intermediates in other chemical productions.

Specific Testing Proposals

Registrants may propose testing under Annex IX and X of the REACH Regulation even if the registration tonnage band is lower than required. Such proposals are often triggered by concerns identified in previous studies or assessments in the chemical safety report. Each relevant endpoint will indicate if the testing proposal is based on concerns highlighted by the registrant.

Focus on Reproductive Toxicity

For testing proposals related to extended one-generation reproductive toxicity studies (EOGRTS), third parties are especially encouraged to submit valid information and studies concerning reproductive toxicity, immunotoxicity, neurotoxicity, and endocrine disruption.

Read-Across Approach

The registrant may also propose a read-across/category approach for some testing proposals, following the adaptation guidelines in Annex XI.1.5 of the REACH Regulation. Relevant testing proposals will indicate if testing is suggested for a different substance than the registered one, along with the proposed test substance name and, when available, the EC or CAS number.

Please view the details of the substance here: https://apaengineering.com/wp-content/uploads/2024/10/testing-proposals_label-current.csv