By June 2, 2021 No Comments

ECHA updating guidance concerning REACH information requirements for nanoforms

The European Chemicals Agency (ECHA) is in the process of updating its guidance on the information requirements and chemical safety assessment (IR&CSA) for nanoforms under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.

ECHA has developed three appendices concerning information requirements to provide advice to registrants for use when preparing REACH registration dossiers that cover nanoforms. The draft update states that the advice provided focuses on specific recommendations for testing materials that are nanoforms of substances.

Annex VI defines the terms “nanoform” and “set of similar nanoforms” and establishes the requirements for characterization of the identified nanoforms/sets of similar nanoforms of the substance. According to the draft update, part of the advice provided is not strictly nanoform specific and may also be applicable to other particulate forms of substances (e.g., relevance of dissolution rate).

Chemicals data need updating in post-Brexit registration transfer

Companies must review chemical registrations that have been transferred from Great Britain in the wake of Brexit, the European Chemicals Agency (ECHA) announced.

Safety information for more than 8,000 chemicals that have been transferred to the EU, eurozone or Northern Ireland under the EU’s Reach regulatory system may need to be reviewed and updated following the transfer.

Administrative information on the company’s role in the supply chain may also need to be revised by the new registrant.

If changes are required, registrants have up to three months to update administrative information, or up to six, nine or twelve months for more complex updates, according to the European Commission’s Implementing Regulation on dossier updates.

Updates are necessary for products registered under Reach and previously notified substances (NONS) under the Dangerous Substances Directive.

All information in a registration dossier is checked for completeness – whether newly submitted or included in a previous registration – as the ECHA has been checking the completeness of chemical safety reports since March 2021.

As the transfer of all registrations has now been completed, 2,964 UK-registrations were not transferred. They are therefore legally void and now indicated as ‘revoked’ in ECHA’s database and on ECHA’s website.

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