Overview
The Board of Appeal (BoA) of the European Chemicals Agency ruled that ECHA is required to consider tonnage downgrades (reducing the standard information requirements), even if these occur after the receipt of a draft decision.[1] Whilst ECHA previously had, at its own discretion, adopted the date of the draft decision as the administrative cut-off point where after updates to the registration dossier were no longer considered the BoA did not accept such “systematic and absolute refusal to take into account any tonnage downgrade” after the draft decision.[3] Instead, the BoA found that downgrades constitute “substantial new information” which the Agency has to take into account[4] and is subject to an individual assessment.[5] The BoA expressly limits its ruling to cases that do not constitute an abuse of process. It elaborated that a downgrade can amount to an abuse of process if it is not based on “objective industrial or commercial considerations”.[6] According to the BoA, one of the factors that may constitute such objective consideration is “the correlation between the tonnage downgrade and the annual production volumes of the substance at issue in the period preceding that tonnage downgrade.”[7]
This approach has since been confirmed in two more recent decisions by the BoA, in one of which the applicants had expressly relied on the findings in the above-described decisions.[8] Our understanding is that standard communications and guidance of ECHA has not yet been updated, but is expected shortly. In the meantime, companies are faced with:
- a final decision, which did not consider tonnage downgrades, may appeal this decision, aiming to obtain a rectification within 30 days.[9]
- a draft compliance check (or by analogy draft testing proposal decision) may assess whether they can respond to a draft decision with a tonnage downgrade. This would include an assessment and documentation that the downgrade is based on objective industrial or commercial considerations.
Please feel free to reach out to us in case of any questions on the above or the impact of those decisions on your REACH registrations.
[1] Decision of the Board of Appeal in Joined Cases A-006-2020 and A-007-2020 dated 9 November 2021.
[2] See press release ECHA/NR/19/42 ECHA does not consider dossier updates during evaluation decision making: “(…) Furthermore, ECHA does not take new information on tonnage, uses and exposure into account after it has sent the draft decision to registrants for comments. Registrants cannot retrospectively downgrade their tonnage band or remove certain uses from their registration to remove requests for information from ECHA’s decisions. This is because the registration dossier has to comply with the REACH information requirements for the registered tonnage band and uses at the time the dossier evaluation was opened. (…)”
[3] Decision of the Board of Appeal in Joined Cases A-006-2020 and A-007-2020, paragraph 71.
[4] Decision of the Board of Appeal in Joined Cases A-006-2020 and A-007-2020, paragraphs 49-66.
[5] Ibid., paragraphs 67-71.
[6] Ibid., paragraph 72.
[7] Ibid., paragraph 73.
[8] See Decision of the Chairman of the Board of Appeal in case A-015-2021 of 19 January 2022 and appeal announcement in that case and also see Decision of the Chairman of the Board of Appeal in case A-010-2021 of 1 March 2022 and appeal announcement in that case
[9] Articles 92(2) and 83(2)(m) of the REACH Regulation.
