ECHA has proposed a restriction on all 11 chromium trioxide substances that are currently covered by the REACH authorisation regime, initiating a process towards a comprehensive ban set to come into force in 2028 in the European Economic Area (EEA).
The agency said that the ban, which would replace existing authorisation requirements for Cr(VI) (chromium VI) uses, is justified as the substances are "among the most potent workplace carcinogens, and people living near industrial sites that release the substances into the environment are also at risk of lung and intestinal cancers".
The Annex XV dossier published today will undergo a six-month public consultation starting on 18 June and then be reviewed by ECHA’s scientific committees before being submitted to the European Commission for a final decision.
ECHA said the scope of its restriction proposal includes barium chromate to avoid ‘regrettable substitution’ from Cr(VI) substances. The chemical does not have a harmonised classification, and is not on the candidate list or the authorisation list.
In the agency's proposal, certain industrial use categories have been exempted when they meet defined limits for worker exposure and environmental emissions. These are:
- formulation of mixtures;
- electroplating on plastic substrate;
- electroplating on metal substrate;
- use of primers and other slurries;
- other surface treatment; and
- functional additives/process aids.
The restriction applies to substances currently subject to authorisation. In practice, ECHA said, this means that the manufacture of mixtures containing the Cr(VI) is within the scope of the restriction, but the manufacture of the actual Cr(VI) substances themselves is not. It proposed an 18-month transition period.
Restriction options
The agency presented three restriction options (see box) that would impose different scientific limit values for each use category, but it picked two of the less stringent options as more favourable because the limits would be more cost-effective for companies to implement and easier to comply with.
"With some investment, compliance with the limit values proposed under RO1 and RO2 within the proposed 18-month transition period appears feasible for the majority of companies," it said.
"Compliance with RO3 may be more challenging as a significant proportion of actors may not be able to afford the investments required to comply with the most stringent set of limit values."
The restriction could prevent up to 17 tonnes of Cr(VI) from being released into the environment and avoid up to 195 cancer cases each year, it said. It estimated the total benefits over 20 years at 331 million or 1.07 billion euros, depending on the restriction option chosen. Costs, including investment in risk management measures and safer alternatives, could be 314 million or 3.23 billion euros.
Authorisation to restriction
The Commission took the unprecedented decision in 2023 to move the substances from authorisation to restriction, after a legal defeat when an EU court annulled an upstream authorisation decision. This means that the use can carry on through transitional rights pending a new decision. But it leaves hundreds of downstream companies in chrome-plating and surface treatment industries looking for a potential alternative solution for the future use of the chemical.
Placing the substances on the restriction list would help prevent a flood of individual applications, which are already consuming significant Commission resources under REACH and contributing to lengthy delays.
The saga surrounding Cr(VI) has sparked intense debate over the future of REACH authorisation in general, and the Commission, in its plans in early April to revise the law, said authorisation could be prioritised for high-volume chemicals with fewer users and uses, instead of substances with widespread uses.
ECHA said that since 2015, it has received several hundred applications for authorisation of Cr(VI) uses, far exceeding the numbers expected when the substances were included in the authorisation list.
Even though registered use volumes have dropped significantly since 2010, it added, the substances are widely used with close to 4,000 notified uses across many sectors, including chemicals, automotive, transport and packaging.
‘Safer’ alternatives?
If the Commission adopts the restriction, companies will have to weigh up investment in risk management measures and alternatives to maintain production, or consider ceasing production altogether.
ECHA said that there are currently no "drop-in" substitutes in any of the identified use categories. Although several alternatives have been identified, it added, their performance is lower compared to the Cr(VI) substances, or are not yet technologically mature, and in most cases, they are less hazardous but not benign.
Moreover, the adoption of any of these alternatives requires significant investment and is likely to raise production costs by 10-20%.
It concluded that "with or without regulatory pressure, the widespread adoption of substitutes for the Cr(VI) substances covered by this restriction proposal is unlikely to happen as long as imports of Cr(VI)-treated articles from third countries cannot be prevented".
Restriction options
ECHA presented the three options as a matrix of limit values (LVs) for worker protection and environmental limit values (ELVs) that differ for each use, rather than a set of limit values that apply to all uses consistently.
An EU-wide binding occupational exposure limit (BOEL) of 5 μg Cr(VI)/m3 came into force in January. The BOEL applies the same limit value for all uses.
The three options propose occupational limit values for different uses in the scope of the restriction, so that:
- option one (RO1) has the most lenient limit values (either at the current BOEL or one-step lower);
- RO2 is more stringent (either 1 ug/m3 or 0.5 ug/m3, depending on the use); and
- RO3 has the strictest limit values (either 0.5 ug/m3 or 0.1 ug/m3, depending on the use).
For the general population, and in the absence of a dedicated environmental quality standard for Cr(VI), a restriction can establish harmonised ELVs for releases to air and water that are applicable to all facilities using the Cr(VI) substances in scope.
Each of the ELVs can be combined with the LVs to form a restriction option that combines both worker and general population protection, with the most lenient ELVs combined with the LVs of RO1, the second most lenient ELVs with the LVs of RO2, and the strictest ELVs combined with the LVs of RO3.