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European Commission Updates on Approach to REACH Restriction of Chromium VI Substances

REACH
28
August 2024
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450
Dr Steven Brennan
The REACH restriction adoption is expected by end of 2026, about three years after the mandate was issued.
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The European Commission has initiated a process to restrict the use of hazardous Chromium VI (Cr(VI)) substances under the REACH regulation. Chromium VI, known for its carcinogenic properties, has overwhelmed the existing authorisation system, prompting the need for stricter controls. The process, led by the European Chemicals Agency (ECHA), is expected to result in a restriction by the end of 2026. The restriction will cover all Cr(VI) substances listed in Annex XIV of REACH, with ongoing authorisations being reviewed. This initiative is part of a broader effort to enhance public health and environmental protection in the EU.

What is the timeline for implementing the restriction?

The restriction process is expected to take approximately three years, with final adoption anticipated by the end of 2026. The timeline began on 27 September 2023, when the European Commission issued a mandate to the European Chemicals Agency (ECHA) to develop an Annex XV dossier, which is the first step in the restriction process. The initial mandate provided a 12-month period for ECHA to complete the dossier, but this was later extended to 18 months to accommodate the additional work required. After the dossier is completed, it will undergo a conformity check by ECHA’s scientific committees, followed by a 9 to 12-month period for finalising opinions. Once these steps are completed, the Commission will draft the amending regulation, present it to the REACH Committee, and, after obtaining a positive opinion, will forward it to the European Parliament and the Council for a three-month scrutiny period. If approved, the restriction will be officially adopted, marking the end of a thorough multi-year regulatory process.

How will existing authorisations be affected?

Existing authorisations for the use of Chromium VI (Cr(VI)) substances will undergo a comprehensive review as part of the restriction process. This review will assess the appropriateness and effectiveness of current risk management measures, including data on exposure and emissions. The European Chemicals Agency (ECHA) has been tasked with analysing these authorisations to determine whether they effectively control the risks posed by Cr(VI) substances.

As a result of this review, the new restriction may include derogations—specific exemptions—from the general rule, allowing certain uses of Cr(VI) substances to continue under defined conditions. These derogations will likely come with differentiated transitional periods, which means that some industries or applications may be given more time to find and implement safer alternatives, depending on factors like the level of risk involved, the socio-economic impact of the restriction, and the availability of viable substitutes.

However, it’s important to note that these derogations may not align exactly with the conditions or timelines of existing authorisations. In other words, companies holding current authorisations might face new deadlines or additional requirements as the substances transition from being authorised under Annex XIV of REACH to being restricted under Annex XVII. Once the restriction is fully in place and the substances are de-listed from Annex XIV, the previous authorisation framework will no longer apply, and all remaining uses will be governed by the new restriction rules.

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The European Commission has commenced a critical regulatory process to restrict the use of Chromium VI (Cr(VI)) substances under the REACH regulation. This significant move is aimed at strengthening the protection of human health and the environment from the hazardous effects of Cr(VI) compounds.

Key Dates in the Restriction Process

  • 27 September 2023: The European Commission issued a mandate to the European Chemicals Agency (ECHA) to begin the process of developing an Annex XV dossier aimed at restricting Cr(VI) substances under REACH.
  • 29 April 2024: The initial mandate was revised, extending the timeline from 12 to 18 months to accommodate additional work.
  • End of 2026: The anticipated timeline for the adoption of the restriction, approximately three years after the mandate was issued.

Why Restrict Chromium VI Substances?

Chromium VI substances, including chromium trioxide and other related compounds, are known for their carcinogenic properties. Initially listed under REACH in 2013 and 2014, these substances were expected to be phased out by September 2017 and January 2019. However, the number of applications for continued use has greatly exceeded expectations, overwhelming the processing capacity of both ECHA and the European Commission.

Key Risks:

  • Carcinogenicity: Chromium VI substances are highly toxic and pose serious health risks, particularly due to their carcinogenic nature.
  • Environmental Impact: These substances also present significant environmental hazards, leading to contamination and long-term ecological damage.

Scope of the Restriction

The Commission’s restriction will cover all uses of Cr(VI) substances listed in Annex XIV of REACH, with the exception of lead chromates, which are not considered likely substitutes. ECHA has been tasked with developing several restriction options to effectively control the risks posed by these substances while encouraging the substitution with safer alternatives.

Impact on Existing Authorisations

Existing authorisations for the use of Cr(VI) substances will undergo a thorough review. This review will assess the appropriateness and effectiveness of current risk management measures, including exposure and emissions data. The restriction may include derogations with differentiated transitional periods based on risk, socio-economic considerations, and the availability of alternatives.

Procedural Considerations

To implement the restriction, the Commission plans to simultaneously amend Annex XIV (to de-list the substances) and Annex XVII (to introduce the restriction) of REACH. This approach ensures no regulatory gaps occur during the transition.

Ongoing Authorisation Management

Until the restriction is fully in place, the current authorisation framework under REACH will remain operational. ECHA will continue to evaluate applications, and the Commission will proceed with decision-making processes, ensuring that current authorisation measures remain valid until the substances are formally de-listed.

Coordination with Other EU Legislation

This initiative is aligned with other EU regulations, such as the Industrial Emissions Directive (IED) and Occupational Safety and Health (OSH) legislation. Notably, discussions are ongoing about lowering the binding occupational exposure limit for Cr(VI), further enhancing worker protection.

The restriction of Cr(VI) substances under REACH represents a crucial step in safeguarding public health and the environment. With the planned regulations set to be fully adopted by the end of 2026, the European Union continues to demonstrate its commitment to stringent chemical safety standards and the promotion of safer alternatives.

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