Certain REACH registration information requirements have been amended by the European Commission. Companies should start planning now, as the changes are set to take effect in October 2022. ECHA will publish new guidance later this year.

The REACH annexes have been revised to clarify the information that businesses must include in their registrations and to make ECHA's evaluation methods more transparent and predictable. The changes will take effect from October 14, 2022. Companies should familiarize themselves with the new annexes and prepare to examine their registration dossiers.

The following are the major changes: 

1. Specific guidelines and requirements for adaption of: 

● Mutagenicity studies in vitro and in vivo, indicating when extra investigations are required due to mutagenicity concerns;

● Reproductive toxicity studies, describing the recommended animal species and dosage routes, and elucidating the conditions that necessitate more research owing to concerns;

● Toxicity studies on aquatic, terrestrial, and sediment organisms, stating when long-term studies are required rather than short-term studies, and emphasizing that long-term testing must study both degradation and transformation products; and

● Degradation and bioaccumulation investigations are performed to determine when additional testing is required.

2. Only representatives are required to reveal information about the non-EU manufacturer for whom they work.

3. Information about identifying compounds, including:

● The necessity to specify the compositions, Nano forms, or Nano form groups connected to information submitted to fulfill REACH Annex VII-X information requirements;

● Extra requirements for reporting a crystal structure and compositions for chemicals of unknown or variable composition, complex reaction products, or biological materials (UVCBs); and

● Components, impurities, and additions, as well as analytical data, must be reported consistently.

The changes will have an impact on IUCLID. The current IUCLID 6 format already allows data reporting under the REACH annexes as revised. Changes to the Validation assistance will be included in the next major IUCLID release, scheduled for April 2023.

At the same time, the ECHA's completeness check will be revised to reflect the additional information requirements. 

APA Engineering is offering a system-system software solution, which can be used for all industries to meet their compliance requirements without any barriers. If you are looking out for any services like REACh, RoHS, IMDS, SCIP, Conflict Minerals, Prop65, and other regulations you can write to us at compliance@apaengineering.com

Further Information :

1. Commission Regulation

2. Recommendations to registrants

Reach out to our regulation experts on product regulatory compliances