Challenges for the chemical industry after the REACH May deadline

The European Chemicals Agency (ECHA) expected approximately 25 000 unique substance covered by 60 000 registrations to be submitted by the last REACH registration deadline at the end of May this year. However, this estimate was not reached as only half of the expected number of registrations were received by the deadline. This has raised the question of what happened to the substances that were not registered by the deadline and what can be done to mitigate this acute absence of substances on the EU market?
The reason for not REACH registering by the last deadline of 31st of May 2018 can be any number of things, ranging from business decisions to registration non-compliance issues to mere ignorance related to the duty to REACH register substances on the EU market. The overwhelming reason seems to be business decision related, where the cost of compliance is simply too high and thus the substance is withdrawn from the market once it cannot rely on the pre-registration anymore, this being from 1st of June 2018. Whatever the reason, if your substance is not registered, it cannot be place on the EU market at 1 t/a or above.
This acute absence of certain substances in the supply chain has scrambled some organisations to secure their supply of critical substances by e.g. importing these from outside the EU and thus giving them the opportunity to register the substance themselves. This in turn has in some cases been met by difficulties when there simply is no lead registrant for the substance and thus registering would mean taking up the lead registration role and incurring all costs on one self, at least until someone else wants to register the same substance. Furthermore, lead registering substances takes time and thus there is a delay in the go-to-market of new substances. In some unfortunate cases, where the lead registrant did submit the lead registration but did so under a Directors Contact Group procedure (DCG issue 10.3 ) where ECHA allows under certain circumstances for the submission of an incomplete dossier but provides a deadline for submission of the complete information later e.g. spring of 2019, the new registrants wanting to join this registration, not having submitted a registration by the deadline, are unable to joint the registration until the lead registrant has complemented the initial submission by the set deadline by ECHA. This situation currently means that the new registrant cannot register the substance until e.g. the spring of 2019 and thus cannot make business out of it until the lead registrant has complemented their registration and done so successfully. This is a severe hinderance to business on the EU market and surely not the intention of the REACH regulation and new solutions from ECHA may be coming soon to address this issue.

To conclude, the following is a list of some options organisations have for not-REACH-registered substances they are manufacturing or importing at 1 t/a or more:

    • 1. Lower the annual volume to less than 1 tonne per year


    • 2. Cease business activities regarding the substance


    • 3. If the substance is in stock within the EU (at any volumes), it can be used even though the stock is not registered, as it was presumably either manufactured in or imported into the EU/EEA before the last REACH registration deadline under a pre-registration number.


    • 4. Stop manufacture/import of the substance immediately and for substances where a Joint Submission is available, contact the Lead Registrant/Consortium for access to the joint submission. For a substance that does not have a Joint Submission available, you need to become the Lead Registrant. As part of the registration work, submit an inquiry to ECHA with information on the substance identify and await acceptance before going forward with submitting the registration dossier for the substance. It is still allowed to use a pre-registration number instead of the inquiry if one is available for the substance. Only once the registration dossier has been accepted and ECHA has issued a registration number, can the manufacture/import of the substance continue.


    5. In some special cases, a so-called PPORD (product and process orientated research and development) notification may be possible avoiding the acute need to register a substance.

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