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Proposed changes to REACH to ensure all registration dossiers are kept up-to-date!

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Proposed changes to REACH to ensure all registration dossiers are kept up-to-date!

A draft Commission Implementing Regulation (Ares (2019)7784994 - 18/12/2019) has been published to amend the REACH regulation by including fixed time periods for updating dossiers. This will give the enforcement authorities the ability to take action where registrants appear to unduly delay the updating of their dossiers.

To facilitate compliance with, and enforcement of, Article 22(1) of REACH, specific deadlines for each update obligation will be set. The proposed deadlines specified by the Implementing Regulation will be as short as possible, taking into account what is reasonably expected to be attainable by registrants.

The specific deadlines will be maximum time limits and exceeding the deadline imposed would automatically lead to the conclusion that an undue delay had occurred in updating the registration.

The following are examples of some of the proposed time limits from the Implementing Regulation:

Examples of where the maximum time limit of 3 months would apply:

  • Updating the dossier with a change of registrant’s status or in their identity.

  • Updates to dossiers once new data/information becomes available, e.g. from the date of the final report for a new study.

  • The date where manufacture or import ceased or from the date manufacture or import is re-started.

  • From the date a registrant receives details of a new use or use advised against.

Examples of where the maximum time limit of 6 months would apply:

  • Updating the dossier with a change in substance composition.

  • When the registrant becomes aware or may reasonably be expected to have become aware of new knowledge of the risks to human health and/or the environment.

  • In the case of a change that is due to an adaptation in the classification of a substance as a result of a new evaluation in accordance with Article 15 of CLP/GHS.

Changes in the classification and labelling of the registered substance

In the case of a change that is due to the addition, modification or deletion of a harmonised classification in Annex VI to CLP/GHS, it is proposed that the registration shall be updated and submitted to the Agency no later than the date which that change is to apply.

This would require the registrant to monitor the ATPs to CLP/GHS, publication of CLH dossier decisions on the ECHA website, CoRAP reports, etc., so they can update their dossiers by the required date.

Updates or amendments of the Chemical Safety Report (CSR)

The registration shall be updated and submitted to the Agency no later than 12 months from the date when the need to update or amend the CSR or the guidance on safe use referred to in Section 5 of Annex VI of that Regulation was identified.

What is next?

The draft Implementing Regulation has been published for public consultation and the deadline for submitting comments was the 15th January 2020. If the draft Implementing Regulation comes into force in its current form it will be important to ensure your registrations are kept up to date. It will be important to take note of the different time limits for dossier updates, monitor ATPs for CLP/GHS so you are aware of the implementation dates and regularly check the ECHA website for updates on CoRAP and CLH dossiers etc. More information can be found here

If you require further information, please contact;

peter.godfrey@cea-res.co.uk or sarah.henly@cea-res.co.uk

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