New obligations for registrants – improving registration dossiers

Even if you have successfully registered your substances up to and including 2018, REACH is not over … after the registration is before the update!

The first dossiers were submitted already in 2009 and many have since been discontinued. Since then, there have been a number of new IUCLID versions, new test regulations, revised and new guidelines, and changes in exposure calculations. Due to this development, registration dossiers submitted by the 2010 and 2013 deadlines may be considered incomplete if assessed by ECHA today or in the future.

On 14 June 2018, Cefic and ECHA signed a Joint Declaration (REACH Action Plan on Reviewing / Improving Registration Dossiers), in which they agreed to work together, inter alia, to promote a gradual and planned review / improvement of REACH registration dossiers.

Companies are expected to develop an implementation plan by the end of 2019 and launch activities to review / improve dossiers.

The obligation to regularly update the registration dossier has existed from the very beginning and is described in Article 22 of the Reach Regulation. However, these obligations have now been further substantiated by an implementing regulation. Also new is the obligation to establish monitoring and tracking systems that ensure the fulfillment of the obligations of Article 22 REACH!

  • The main purpose of the implementing regulation is to clarify deadlines.
  • The indefinite term “without delay” has now been substantiated for each individual duty.
  • In a nutshell, there are three timelines for the updates: Immediately, 1, 6 or 12 months

The complete overview can be found here.

  • Clear (and quite demandingly short) deadlines
  • Obligation to monitor and follow up (documentation!) the implementation
  • Duties not only apply to lead registrants but also to members of a joint submission

Important points from our experience:

  • Short deadlines are demanding if the IUCLID dataset is not up to date with the latest version
  • Especially for substance data sets that are still in IUCLID5, the TCC shows up with failures that require a review of study summaries before re-uploading the dossier.
  • Depending on status, quality and/or completeness of existing exposure scenarios as well as depending on the tool version(s) used, an update and revision of the Exposure- and Risk Assessment may become very time-consuming.
  • It takes some experience to quickly detect and fix these failures
  • Additional manual completeness checks (new since 2016) by ECHA often indicate that the updated dossier is incomplete
    • Since these manual checks are not displayed in the TCC, it takes a lot of experience to avoid these errors
    • Among other things, the following aspects will be examined: substance identity, waiving reasons, justification for test proposals on vertebrates, opt-out justifications
  • ATTENTION: if ECHA rejects the dossier update after an increase in tonnage, there is only one occasion for rectification
    • If ECHA subsequently refuses the update, the registrant may not import or produce the higher tonnage

Our services:

  • Execution of request for Art. 12 (2) -Inquiry- upon reaching the next tonnage band
  • Establishment of monitoring and tracking systems, which ensure the fulfillment of the obligations under Article 22 REACH.
  • Checking your substance datasets or dossiers for revision requirements
    • You will then receive an analysis sheet with individual recommendations for the improvement of your dossier
  • Revision of substance datasets (transfer to the latest IUCLID version) with subsequent error correction and quality improvement
  • Revision of robust study summaries, waiving arguments, QSAR justifications / documentation, justifications for read-across
  • Implementation and documentation of regular searches (literature + reviews of authorities ect.)
  • Revision and Update of Exposure- and Risk Assessment in line with current requirements and with latest versions of all applicable tools.