May 24, 2022
New REACH regulation information requirements
by Tatjana Benko, senior regulatory specialist, UL’s Supply Chain team
Companies need to review their registration dossier and submit additional information in accordance with updated annexes (Annex VI-X) of the REACH regulation. Changes in REACH regulation requirements will apply beginning on Oct. 14, 2022.
What will be new?
1) Requirements to substance identification:
- Compositions, nanoform or set of similar nanoforms related to information provided to meet information requirements under Annex VII-X of REACH
- Reporting a crystal structure and compositions for UVCB substances
- Clarified requirements for reporting constituents, impurities, and additives
- Clarified requirements for analytical information
2) The 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
- Current IUCLID 6 version is already aligned with updated REACH annexes
- New IUCLID release in April 2023 will make the following adjustments:
- Validation assistant changes
- ECHA’s Completeness Check
4) Obligation for Only Representatives (OR)
The Only Representative must declare their non-EU manufacturers they represent and provide their contact information in REACH-IT by October 14, 2022, starting from April 26, 2022.
The non-EU manufacturer can appoint one Only Representative. One REACH-IT account can contain registrations from only one non-EU manufacturer. If you are an OR and you represent several non-EU manufacturers you need to transfer registrations to the correct REACH-IT accounts.
Only Representatives must have separate REACH-IT accounts for each non-EU manufacturer and provide the following non-EU manufacturer contact information:
- Name, address, telephone number and email address
- Contact person
- Location of any production or formulation sites
- Company website
- National company identification numbers
Furthermore, if you are an OR, you have to ensure that your account represents only one non-EU manufacturer, but if you are an OR and a manufacturer/importer under REACH at the same time, you will need separate REACH-IT accounts for the OR and for the manufacturer/importer roles.
The REACH-IT account from which you start transfer is called the ‘initiator account’ and the account that you will transfer to, is called the ‘successor account.’
It is important to note that the fee for transferring registrations in REACH-IT accounts can be waived until October 14, 2022. After this date, the legal entity change fees will not be waived anymore.
ECHA has published very detailed Guidance entitled "Only representatives: How to ensure that your account represents only one non-EU manufacturer" that can help Only Representatives to reorganize REACH-IT accounts. The Guidance document contains step-by step practical instructions for transferring registrations in REACH-IT.
- Keep your registration dossier up to date in accordance with new REACH information requirements
- Reorganize your REACH-IT account until October 14, 2022 if necessary