i2a coordinates the REACH registration of ten antimony substances under Regulation (EC) No 1907/2006 (REACH).
The registration dossiers contain information on:
- Substance identity
- physico-chemical properties
- hazard assessment
- classification and labelling
- uses and exposure scenarios
- Risk management measures.
Where scientifically justified, read-across and weight-of-evidence approaches are applied in accordance with REACH requirements to maximise the use of existing information and minimise unnecessary animal testing. Registration dossiers are maintained and updated as new scientific information, regulatory guidance or legal requirements emerge.
Regulatory scrutiny and follow up-
EU REACH Substance Evaluation
Background
Several antimony substances, including antimony metal, antimony trioxide, antimony trisulfide, antimony trichloride and antimony tris(ethylene glycolate), have been subject to Substance Evaluation under the REACH Community Rolling Action Plan (CoRAP).
Germany acts as the evaluating Member State on behalf of the European Chemicals Agency (ECHA).
Evaluation Focus
The evaluation was initiated primarily to assess new toxicological information, including the 2017 US NTP inhalation studies on antimony trioxide, together with additional concerns related to human health endpoints such as carcinogenicity, mutagenicity, reproductive toxicity and specific target organ toxicity.
Progress
- 2018: Evaluation initiated and dossier updates submitted
- 2019: Draft evaluation decisions issued and comments received from registrants
- 2020: Final evaluation decisions adopted, including appeals on selected decisions
- 2020–present: Information gathering and interim dossiers updates submitted when data became available. Assessment of newly generated information and dossier improvement plan including the revision of the category approach is still ongoing.
Potential Regulatory Follow up
As with any REACH Substance Evaluation, the outcome may inform further regulatory consideration under relevant EU legislation. Potential follow-up actions could include:
- review of existing classification and labelling requirements
- proposals for harmonised classification and labelling
- occupational health measures
- product-specific regulatory measures where appropriate.
Any such action would require a separate regulatory process, including scientific assessment, stakeholder consultation and regulatory decision-making.
i2a Position and Interim Risk Management
REACH Evaluation enables a stepwise, evidence-based approach to chemicals regulation. Pending final outcomes, the existing precautionary principle supported by i2a remains valid:
where dust generation and inhalation are effectively controlled, no increased risk to workers or users is expected.
This precaution should be applied consistently across the antimony value chain.
Stakeholder Involvement
Successful evaluation requires active participation from the entire value chain, including:
- contribution to data requests and exposure monitoring;
- participation in i2a technical meetings and events;
- membership in i2a and relevant downstream user associations.