Article

Draft published on the requirement to update the Registration dossier under REACH

Posted on: January 27, 2020

by Dr. Martina Schneider

photo of hands on a laptop keyboard - learn more about REACH

After a REACH registration has been submitted successfully, ECHA is advising registrants to consider their Registration dossier a “living document” and keep the submitted information up to date. Under Article 22 of REACH, companies that have submitted their registration have the requirement to update the dossier “without undue delay” in case an update on certain information is available. However the results of the latest REACH review indicate that companies have not fulfilled their duties in updating the registration dossier in a timely manner.

As a result of the latest review, a new draft regulation has been published by the European Commission to specify fixed deadlines for the updates listed in Article 22. Updates of a more administrative nature are allowed a deadline of no later than 3 months. Six or twelve months are allowed for more complex updates, such as those requiring the generation of data, an evaluation and change to the classification and labeling, and compositional changes which may require new analytical data to be provided. The following deadlines are listed in the draft regulation:

Update Deadline no later than
Changes in a registrant’s status or in his identity 3 months
Changes in the composition of the substance 6 months
Changes in the tonnage band 3 months
New identified uses and uses advised against 3 months
New knowledge of the risks to human health and/or the environment 6 months
Changes in the classification and labelling of the registered substance (based on a new evaluation) 6 months
Changes in the classification and labelling of the registered substance (based on a update Annex VI, CLP) date as of application
Updates or amendments of the chemical safety report 12 months, possibly less if other deadlines apply at the same time
Testing proposals prior to conducting a test listed in Annex IX or Annex X 6 or 12 months
Changes in the access granted to information in the registration 3 months
Updates of joint submissions 3 months

The deadlines listed above are considered as upper limits. Registrant are still required to provide updates as soon as possible but now no later than the relevant specified deadline. For certain updates, the co-registrants updates will depend on the submission of the lead registrant of the joint submission. Therefore for the co-registrant, the deadline will be a month from the date when ECHA confirms that the update to the lead registrant registration is complete. The feedback period for the draft ended on January 15, 2020 and the Commission will now have to adopt the draft regulation.

This Regulation shall enter into force on the sixtieth day following that of its publication in the Official Journal of the European Union.

Recommended actions:

• Review the contents of your current REACH registrations for any updates.
• If applicable, review any new information that has been provided by the SIEF.
• Consider instituting a standard review period for existing registrations which allows for possible updates on a regular bases to avoid any time conflicts.
• To comply with the new deadlines, ensure that procedures and documentation are ready and up to date in preparation to take action in case new information becomes available for your substance.

References:

Commission Implementing Regulation (EU)…/… on the duties placed on registrants to update their registrations under Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH): https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2019-7784994_en

Regulation (EC) No 1907/2006 (REACH): https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX:32006R1907

Keywords:

– REACH
– Registration
– European Union


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