European Commission signals intention to regulate chromium trioxide using restriction instead of authorisation under REACH
The European Commission has asked the European Chemicals Agency (ECHA) to prepare a REACH restriction proposal for chromium trioxide and certain other chromium (VI) substances currently subject to authorisation under REACH. This marks the first time a substance on the REACH authorisation list has been ‘re-directed’ for restriction. The announcement is remarkable for this reason alone, but perhaps more so because chromium trioxide has already been on the authorisation list for over 10 years. It also signals yet another significant change for industry to manage. A call for evidence has been launched by ECHA to support the preparation of a restriction report.
What’s happening and why?
On 11 October 2023, the European Commission requested that ECHA prepare a REACH restriction proposal covering entries 16 and 17 of Annex XIV of REACH (the authorisation list). The move aims to avoid the anticipated fresh slew of authorisation applications for chromium trioxide, which EU regulators lack the capacity to handle.
The upsurge in applications is driven to a large extent by the Commission’s recent legal defeat in April when the European Court of Justice (ECJ) annulled the decision to grant authorisation for 4 of the 5 uses of chromium trioxide which had received a positive decision in the upstream application made by the CTACSub consortium (1) , now led by Chemservice (2). The annulment, which comes into effect from 20 April 2024, left hundreds of downstream users covered by that authorisation in limbo. The next steps by the Commission will be critical and could lead to numerous cases of business interruption or closure.
The Commission must now prepare a new decision on the annulled uses in the original Chemservice application, taking into account the ECJ’s findings. The implications for industry in the face of the ECJ judgement have been the subject of differing legal interpretations, stoking confusion across industry. In any event, there is little confidence the Commission will grant the authorisations a second time and the outcome for other upstream applications for authorisation of chromium trioxide does not appear to be favourable. Downstream users each need to understand how this very complicated situation affects them; it is likely in many cases a new authorisation will be needed.
As a result, EU authorities anticipate hundreds of new downstream user applications in the short term, which ECHA and its committees do not have the resources to process.
In the meantime, Chemservice submitted a review report in February 2023, given that the end of the review period of their original application is approaching. The Commission has agreed to Chemservice’s suggestion that this review report be treated as a new application for authorisation (AfA) under REACH, submitted after the latest application date.
What will the restriction proposal look like?
Little is yet known about the detail of the proposed restriction although a Question & Answer document prepared by the Commission suggests it may include derogations with different transitional periods for different uses, given existing information from authorisation applications on socio-economic impacts and availability of alternatives. The Commission has also asked ECHA to analyse existing authorisation conditions, in particular, the appropriateness and effectiveness of risk management measures.
In terms of its scope, the focus is initially on two entries in the REACH authorisation list – chromium trioxide and acids generated from chromium trioxide and their oligomers – although the Commission notes that other chromium (VI) substances could also be targeted if there was a risk of ‘regrettable substitution’.
A call for evidence was launched on 13 December 2023 and will run until 13 February 2024. Its aim is to gather specific evidence on the costs and effectiveness of risk management measures (RMMs) to limit exposure to, and emissions of, Cr(VI). This is to enable ECHA and its committees to weigh up the various restriction options open to them.
The Commission estimates that it will take at least 3 years for any restriction to come into effect. The removal of the relevant chromium (VI) substances from the authorisation list and the date of application of any restriction is planned to occur simultaneously.
Out of the frying pan, into the fire?
These developments still leave industry in a complex and challenging situation. For instance:
- If the Commission does not retake its decision on the original Chemservice application by the time the ECJ’s annulment takes effect (20 April 2024), the legal position will be as if no decision has yet been taken. Consequently, all current conditions of authorisation and monitoring requirements should also fall, a significant step backwards in regulatory control for a high-hazard substance.
- The Chemservice authorisation is valid only until September 2024; if the authorisation had been extended beyond this date, any downstream users that did not subscribe to the review report would no longer benefit from the authorisation. Revoking the authorisation temporarily favours the wider downstream user set that benefit from the original application. However, if the original authorisation for the annulled uses is refused, as now seems inevitable, then the many hundreds of downstream users covered by the original Chemservice application can no longer continue to lawfully use chromium trioxide unless already a party to the review report or otherwise covered by another authorisation.
- The Commission appears to intend to treat the Chemservice review report submitted in February 2023 as an entirely new application for authorisation – in that case, no transitional measures apply because this new application post-dates the latest application date for chromium trioxide. If the Commission’s decision on the review report takes longer than a decision on the original application, then there will be a period of time where even the downstream users that subscribed to the Chemservice review report will not be covered by any authorisation (or transitional application) and their continued use of chromium trioxide will be unlawful, if only for a period of time. In any case, significant impacts are likely for many businesses who have not made their own arrangements at this point.
- Many downstream users who have not already done so are expected to react by preparing and submitting their own AfA. As any such AfA will be submitted after the latest application date, the transitional rules again would not apply. Considering delays at ECHA and the Commission in terms of processing applications for authorisation, this step does not guarantee continued use of the substance either. Businesses may (understandably) be reluctant to commit to the costs involved in preparing and submitting an AfA given the expectation that chromium trioxide will cease being subject to authorisation in the years ahead, but there is no workaround for businesses that wish to continue to use chromium trioxide in the EU before any change in the law that would bring such a restriction into force and revoke the need for authorisation.
- No mention is made in the Commission’s Q&A document of enforcement, so we can expect various different (and likely inconsistent) enforcement approaches taken across the EU.
- The details of the restriction are not yet known and could still be onerous. The Commission’s current proposals to restrict PFAS show just how bold and extensive they are prepared to be. It will be important for stakeholders to contribute to the consultation process to influence the outcome.
What about decorative chrome plating?
One of the six uses that formed part of the original Chemservice AfA was use in functional chrome plating with decorative character. The Commission is still yet to reach a decision on this use. Until a decision has been taken on that use, downstream users in-scope of that use can continue to use chromium trioxide as this remains covered by the transitional arrangements as long as they subscribe to CTAC’s requirements and comply with the conditions in the application.
TSG Consulting can help
Businesses will be justifiably concerned by these developments and need to understand and act if they, or others in their supply chain, are affected.
Led by Sue Bullock, TSG’s Head of Chemical Compliance, Stewardship and Sustainability, our industry and regulatory experts can support you in understanding what implications these developments might have for your business and supply chain.
- We provide clear and reliable advice about the impact of regulatory developments under REACH and help you determine the right strategy for compliance and business continuity.
- We help you prepare and submit applications for authorisation for optimal outcomes considering risks to workers and the public and broader social and economic benefits of your use.
- We help you assess substitution options considering the risks and implications of reduced performance from potential alternatives.
- We help make your voice heard as public authorities progress proposals to restrict the use of chromium (VI) substances.
- We help businesses develop practical roadmaps for REACH compliance. We work with you to assess potential options and identify the preferred strategy, based on available regulatory, technical and commercial considerations, minimising business risks in the event of authorisation listing.
If you’d like to speak with our team, please get in touch at [email protected].
(1) A decision on a further use (plating with decorative character) is still awaited following a negative opinion by ECHA
(2) Previously Lanxess