On September 27, 2023, ECHA was mandated to prepare an Annex XV report for possible restriction of chromium (VI) substances. ECHA should submit a 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 ten other substances containing chromium (VI), were 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 sensitizers. Their sunset date was September 21, 2017, and January 22, 2019, respectively. However, the number of applications for authorisation for the use of certain chromium (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 Therefore, the European Commission believes that the current method of substance authorisation is no longer applicable to control their risk management.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 chromium (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, a consensus shall be reached by the European Commission.
Once the restriction proposal is adopted, substances within the scope will be removed from the Authorisation List, this is the first time ECHA has taken such action. It is estimated that the restriction proposal may be adopted in three years after ECHA receives the authorisation.
CIRS comments
Authorization and restriction form a safety net for 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 a substance has been restricted after being included in the Authorisation 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. The proposal of the restriction means 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. This Q&A document also covers the 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).
Source from www.cirs-group.com
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