The European commission has recently updated the EU Registration, Evaluation and Authorisation of Chemicals (REACH) annexes to clarify the information that businesses need to submit for their REACH registrations.
REACH registration includes information on the intrinsic properties of a substance and requires registrants to evaluate if their substance has any adverse effects on human health or the environment. This is carried out through the submission of testing or acceptable scientifically justified alternatives such as adaptations or read across.
The European Chemicals Agency (ECHA) regularly reviews the standard information requirements to ensure that the required information for substances is appropriate and reflects new methodologies, so that the substance evaluation process is transparent and reliable. The most recent ECHA review has resulted in the following key changes:
- Requirements and specific rules for adaptation of toxicity, mutagenicity, reproductive toxicity, aquatic toxicity, and degradation and bioaccumulation studies.
- Obligation for Only Representatives to provide details of the non-EU manufacturer they represent.
- Substance identity information including clarification of analytical data requirements, composition information, impurities, and nanoforms in accordance with Annex VII-X, as well as new requirements for reporting compositions and identification for substances with unknown or variable composition, complex reaction products or of biological materials (UVCBs).
These changes will take effect from October 2022. ECHA is currently updating guidance documents and expect to provide more advice later in 2022.
It is important for registrants to review their dossiers and ensure that they are compliant with these new requirements. As part of REACH evaluation, ECHA conducts checks not only on the registered substance itself, to assess if control measures are robust enough to manage properties of concern, but also conduct checks on the dossier to ensure that the required information is included.
In 2021, ECHA carried out 300 full compliance checks, which resulted in 280 draft decisions i.e. 93% of REACH dossiers were identified as requiring more data, specifically to clarify long-term effects on human health or the environment1. Therefore, NCEC strongly suggests that all organisations ensure that their dossiers are reviewed to maintain compliance with the information requirements and include scientifically robust justifications where any adaptations are used.
This extends to checking if new evidence relating to the substance(s) or new guidance recommended by ECHA has been published since the dossier was submitted. If you need any support with dossier updates, please contact us at [email protected].
How NCEC can help
NCEC’s regulatory team has extensive experience with REACH registrations and the standard and non-standard approaches to assess physicochemical, toxicological and environmental fate endpoints. We can review your dossier to fill data gaps, strengthen justifications for adaptations and help to establish if all appropriate information has been gathered to reduce the likelihood of ECHA requesting further information. We can also conduct read-across, quantitative structure-activity relationship (QSARs) and weight-of-evidence approaches to minimise costs and testing.
For more information on how we can help you to stay compliant and minimise the risks of increased costs and business disruption through our EU and UK REACH services, please visit our REACH webpage, email us at n[email protected] or fill in the contact us form.
1https://echa.europa.eu/-/how-to-make-your-registration-fulfil-reach-information-requirements