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The European Commission has revised certain information requirements for registering chemicals under REACH. This has been done to help clarify the information companies are required to submit in their registrations as well as make ECHA’s evaluation practices more transparent.

These changes will officially take effect in October 2022 so companies not only need to get familiar with the updated annexes but should also prepare to review their registration dossiers. 

According to ECHA’s website, the most significant changes include: 

1. Requirements and specific rules for adaptation of:

• in vitro and in vivo mutagenicity studies 

• reproductive toxicity studies

• aquatic toxicity studies

• toxicity studies on terrestrial and sediment organisms

• degradation and bioaccumulation studies

2. The obligation for Only Representatives (OR) to provide details on the non-EU manufacturer they represent

3. Substance identification information including:

• the obligation to describe the compositions, nanoform or collection of similar nanoforms related to information submitted to fulfil information requirements under Annex VII-X of EU REACH

• new reporting requirements for crystal structures and compositions for substances with unknown or variable compositions, complex reaction products and biological materials (UVCBs)

• clarified requirements for reporting the identification and quantification of  constituents, impurities, and additives

OR obligation to declare their non-EU manufacturers

Only Representatives must identify the non-EU manufacturers they represent and provide their contact information in REACH-IT by 14 October 2022. The information that must be provided includes the:

• Name

• Address, telephone number and email address

• Contact person

• Location of any production or formulation sites

• Company website

• National company identification numbers

All ORs must ensure that there are separate accounts for each non-EU manufacturer. Similarly, ORs that also identify as manufacturers/importers under REACH will need to create separate accounts for the two roles - as an Only Representative and as a manufacturer/importer. 

IUCLID

These changes to the EU REACH annexes will also impact IUCLID. The current IUCLID 6 format already allows data to be reported as required by the revised REACH annexes. The next major IUCLID release - in April 2023, will make some adjustments, including changes to its Validation assistant. At the same time, ECHA’s completeness check will be aligned with the revised information requirements.

How can Yordas help

Yordas Group is a qualified regulatory partner with knowledge of different markets and their registration and notification processes. Contact our team today so we can help you better understand the role of an OR and to stay up-to-date with regulatory changes and new obligations. You can also sign-up for our Upcoming Changes to REACH Information Requirements webinar to learn how to keep up with these changes to EU REACH requirements.