New recommendations from ECHA to improve REACH registration dossiers

New recommendations from ECHA to improve REACH registration dossiers
15 March 2023

Keeping your registration dossiers up to date is a legal obligation under REACH. The European Chemicals Agency (ECHA) run compliance checks on dossiers to ensure that they are compliant and to promote the safe use of chemicals.
In 2022, ECHA conducted 330 compliance checks covering 295 substances as part of the REACH Evaluation Joint Action Plan. These checks resulted in 249 substances coming under scrutiny and organisations were asked to provide more data on the long-term effects on human health or the environment from their products. Of these, 40% were notified to Member States for enforcement as they had failed to comply with REACH requirements.

To help organisations comply with REACH requirements ECHA have updated their recommendations, which include new recommendations to limit animal testing and provide specific guidance on use of read-across. They also provide advice on the requirements for mutagenicity information and chronic aquatic toxicity studies for poorly soluble substances. 

In our recent webinar on REACH dossier quality our experts discuss data submissions for sections 5 to 7 in IUCLID, which cover environmental fate, ecotoxicology and toxicology data. With experience in assessing complex and difficult-to-test chemicals, our Environmental Chemistry and Toxicology team provide our customers with technical expertise and guidance on the testing and assessment of substances with challenging properties, such as low water solubility, volatile substances with multi-constituents and UVCBs, substances of unknown or variable composition, complex reaction products, and biological materials. 

From 2009 until the end of 2022, ECHA ran compliance checks on more than 15% of registered substances and 20% of all submitted dossiers, including 27% of high-tonnage substances registered in quantities of 100 tonnes or more per year. Remember, if ECHA finds a compliance failure, it could lead to problems with the REACH registration and subsequent market access.

How can NCEC help?

As part of NCEC’s REACH dossier service, and to reduce the likelihood of ECHA requesting further information, our experts will review your dossiers to identify data gaps, provide advice on how to address those gaps, strengthen justifications for adaptations and establish if all appropriate information has been gathered. We have extensive experience with standard and non-standard approaches to assessing physicochemical, ecotoxicological and environmental fate endpoints.

If you have any questions regarding ECHA’s updated recommendations on dossier compliance, or require support with updating your REACH dossiers to maintain market access, please contact us through the form on the right hand side or email us at [email protected]