Member registrants will start receiving dossier evaluation decisions in 2019

ECHA/NR/18/52

As of 2019, ECHA will send its dossier evaluation decisions to all non-compliant registrants of a substance. Other changes will be implemented at the same time, so you need to take a pro-active role to be ready.

Helsinki, 26 September 2018 – As of 1 January 2019, ECHA will start checking the compliance of all relevant dossiers for a given substance and will address its decisions to all registrants with non-compliant dossiers. This is a change from the current practice of addressing mainly the lead registrants. Similarly, the Agency will address its decisions on testing proposals to all those registrants intending to rely on the proposed tests to fulfil their information requirement.

At the same time, the content of ECHA’s decisions will be streamlined to provide more focused justifications for the information requested and clear information to registrants about their legal obligations.

The change aims to support the collaboration and communication between registrants regarding their joint submissions after the substance information exchange forums (SIEFs) ceased to exist as of 1 June 2018. After that date, the registrants of the same substance are nonetheless still bound by the obligation to submit the information on their substance jointly.

In addition, in line with the expectation that registrants are keeping their dossiers up to date, as required by the REACH Regulation, the Agency will no longer consider changes related to the tonnage band, uses or the intermediate status of a registration after a draft decision is notified to the concerned registrants.

How you can prepare as a registrant

Be sure to review and update your registration dossiers before 2019. Pay special attention to the following:

• Changes in production or import volumes (increase or decrease)
• New or obsolete uses
• New or changed measures to ensure the safe use of your substance
• Your transported or on-site isolated intermediate status
• New data on the intrinsic properties of your substance
• Your justification for relying on waivers for the required information, or on adaptations such as category or read-across approaches

This is particularly important for substances registered in the highest tonnage bands, with wide dispersive uses but also if you rely on opt-outs or adaptations for endpoints needed at the highest tonnages. These are ECHA’s criteria for prioritising evaluation activities.

In addition, make sure that your contact details are up to date both in REACH-IT and in your joint submission, so that you can always be reached regarding your registration. As of 1 January 2019, if you and other registrants within the joint submission receive an ECHA decision because of missing information or a testing proposal evaluation, you should coordinate your reply to ECHA, and speak with one voice during the entire process.