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On 9 October 2020 the European Commission adopted legislation that supplements the REACH Regulation (1907/2006/EC) by formally establishing deadlines for registrants to meet their REACH Article 22 duties to update existing registration dossiers.
Verisk 3E Review
Under Article 22(1) of REACH, registrants - regardless whether individual registrants, the lead registrant, or other members of a joint submission - are required to update their registrations without undue delay with relevant new information and submit them to the European Chemicals Agency (ECHA).
Published on 12 October 2020 in the EU Official Journal, Articles 1 to 13 of Regulation (EU) 2020/1435 set down explicit conditions and establish concrete deadlines for registrants to submit dossier updates to ECHA in accordance with points a through i of Article 22(1).
The conditions triggering an update to registrations, along with the time given to submit the update to ECHA, include:
- Changes in registrant’s status or in identity (Article 1) - 3 months
- Changes in composition of substance (Article 2) - 3 months
- Changes in tonnage band (Article 3) - 3 months
- New identified uses and new uses advised against (Article 4) - 3 months
- New knowledge of the risks to human health and/or the environment (Article 5) - 6 months
- Changes in the classification and labeling of the registered substance (Article 6) - 6 months or, in cases due to new harmonized classifications (i.e., per Table 3 of Annex VI to CLP), as of the date such new classification applies
- Updates or amendments of the chemical safety report (Article 7) -12 months
- Testing proposals prior to conducting a test listed in Annex IX or Annex X (Article 8) - for individual substances, 6 months and for a testing strategy addressing a group of substances, 12 months
- Changes in access granted to information in the registration (Article 9) - 3 months
Verisk 3E Analysis
With the introduction of Regulation (EU) 2020/1435, the EU has established explicit requirements to improve compliance with the general obligation placed on registrants to update their existing registrations pursuant to Article 22(1) of REACH.
Recital 3 of the new legislation states in part that, “Compliance with that obligation is important to ensure that registration dossiers reflect the current situation at all times, so that [ECHA] and member states can evaluate dossiers and substances in an efficient manner and advice on safe use is based on up-to-date and reliable data.”
Regulation (EU) 2020/1435 enters into force on 11 December 2020.