After the 2018 REACH registration deadline passed, many expected that REACH activity would reduce significantly. However, although the 2018 registration deadline is now well behind us, there has been no significant reduction in the work required to secure and maintain REACH compliance.
Here, our REACH Team Leader considers some of the challenges which may require your attention over the coming months and years.
1. BREXIT. The UK has now left the European Union. A transitional period – during which the UK will continue to be subject to the EU REACH regulations – is expected to end on 31st December 2020. Thereafter, it is anticipated that a separate UK REACH regime will be implemented. Depending on your supply chains, you may need to take action, in order to retain access to both the UK and EU markets. Our experts have been involved in testing the UK Government’s in-development ‘Comply with UK REACH’ service, and can assist you in developing and implementing your REACH Brexit strategy.
2. Updated requirements for the registration of nanomaterials: On 1st January 2020, additional REACH information requirements for nanoforms of substances were introduced. If your inventory of registered substances includes any nanoforms, then you will need to update relevant registrations accordingly in order to be REACH compliant. Additional information, including on particle size distribution, shape, crystallinity and surface treatment should now be included in updated dossiers. Of the updated dossiers submitted so far, ECHA advises that around half have failed the technical completeness checks.
3. Increasing ECHA Compliance Check Activity: ECHA reports that in 2019, they achieved a 50% increase in the volume of REACH dossier compliance checks. By 2027, ECHA aims to have checked all registration dossiers which were submitted before the 2018 deadline. The current focus is on registrations at >100 tonnes per annum, which ECHA aims to have checked by 2023. Activity to date demonstrates that waivers and read-across arguments are frequently challenged by ECHA, with compliance check decisions often requiring additional testing to be conducted. In parallel, ECHA’s technical completeness checks are being enhanced, applicable to all new registrations and updates of existing registrations. From April 2020, automated checks will cover use information in more detail, whilst manual checks will also consider the Chemical Safety Report. IUCLID will be updated to accommodate these changes.
4. REACH and the Fertilising Products Regulations (EU) 2019/1009: Regulation (EU) 2019/1009 will come into force in July 2022. Substances or mixtures contained within EU fertilising products should already be REACH registered. But to ensure that the “safety of the intended use” can be demonstrated in a manner comparable to that of other regulatory regimes for products intended for use on arable soil or crops, additional information is required for Annex VII (1 – 10 tpa) REACH registrations for most of the Component Material Categories. Specifically, for in scope registrations at 1 – 10 tpa, the annex VIII (10 – 100 tpa) information requirements will be applicable. Relevant registration dossiers should be updated accordingly.
5. Future challenges: Future challenges can be expected to emerge in the following areas:
Polymer registrations: Polymers are currently exempt from registration under REACH, though monomers are not. ECHA proposals for the registration of polymers are anticipated.
Endocrine disruptors: Current information requirements under REACH do not explicitly address endocrine disruptors. Proposals to include ED assessment are anticipated.
Mandatory dossier updates: Currently, REACH requirements on updating dossiers are vague. For example, where new information becomes available, or where a tonnage band is exceeded, registrants should update dossiers “without undue delay”. It is anticipated that this will be clarified via a new implementing regulation, which will specify the time-periods within which dossier updates must be performed. The consultation on the draft commission implementing regulation “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)” closed on 15th January 2020.
Our experts can assist you with all aspects of REACH, including:
– Registration strategy, including in relation to Brexit, and maintaining access to both the EU and UK markets following the end of the transitional ‘Implementation’ period;
– Preparation and submission of lead and non-lead registration dossiers, including study monitoring if required;
– Chemical Safety Reports/exposure assessment;
– Provision of Only Representative services, including in the context of Brexit;
– REACH Compliance Audits, including for manufacturers, importers, and downstream users;
– Classification and labelling;
– SDS and eSDS review and authoring.
Please don’t hesitate to contact us if you would like to discuss any of these matters in more detail. For further information on the services that we offer, you can also visit the REACH section of our website.
REACH Team Leader
+44 (0)7889 047 419