On September 27, 2023, ECHA received a mandate from the European Commission, instructing ECHA to prepare an Annex XV report for possible restriction of chromium substances (CrVI). ECHA will submit the restriction proposal by October 4, 2024. This restriction proposal intends to improve the effectiveness and management of chromium (VI) substances in the European Union.
Background:
Chromium trioxide, along with chromium (VI) substances and 10 other substances containing chromium (VI), was added to the Authorisation List in March 2013 and August 2014. These substances can cause cancer, genetic mutation and reproductive toxicity, and some of them are also skin and respiratory sensitisers. Their sunset date was on September 21, 2017 and January 22, 2019, respectively. However, the number of applications for authorisation for the use of certain Cr(VI) substances far exceeded the predictions from the Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC) and the European Commission, which also exerted an adverse influence on the oversight of hazardous chemicals. Therefore, the European Commission believes that the current method of substance authorisation is no longer applicable to control their risk management.
Restriction scope:
The European Commission requires ECHA to prepare a restriction dossier in line with the requirements of Annex XV in view of a possible restriction of at least two Cr(VI) substances: chromium trioxide and chromic acid.
If ECHA identifies a potential risk of regrettable substitution to other chromium (VI) substances during the preparation of the restriction proposal, an extension of the mandate to cover additional chromium (VI) substances is possible. However, consensus shall be reached by the European Commission.
Once the restriction proposal is adopted, substances within scope will be removed from the Authorisation List, which marks the first time that ECHA has taken such an action. It is estimated that the restriction proposal may be adopted in 3 years after ECHA receives the authorisation.
Comments：
Authorization and restriction serves as a safety net within the REACH regulation. Substances on the Authorisation List are granted a specific transitional period before being phased out of the EU market. Generally speaking, a substance is not simultaneously listed on both of these lists. If a substance is restricted, it will not be added to the Authorisation List. It is the first time that chromium trioxide has been restricted after being included in the Authorization List.
Chromium trioxide may not be introduced to the EU market (its sunset date has expired) since the Court of the European Union has annulled the authorisation of substances containing chromium trioxide. This restriction proposal marks that chromium trioxide will be officially phased out in the EU market.
The European Commission also published a Q&A document involving REACH and chromium (VI) substances for companies. This Q&A document also covers main questions concerning the judgment of the European Court of Justice annulling the authorisation of a consortium covering many chromium trioxide downstream users (Chemservice decision).
