Product Restrictions

In practice, antimony is typically present at low concentrations and, where used, is subject to regulatory limits designed to ensure a high level of consumer protection.

Antimony may also be present at trace levels as a result of recycling processes. Existing regulatory requirements and material management practices help ensure that such presence remains consistent with applicable safety standards while supporting circular economy objectives.

Consumer exposure

Plastic Food Contact Materials

The use of Diantimony Trioxide as a catalyst in PET production was deemed safe by EFSA, with a migration limit of 0.04 mg/kg food (as Sb), corresponding to 10% of the Tolerated Daily Intake. This limit is reflected in legislation such as EU Regulation 10/2011 on plastic food contact materials. 

Drinking Water

Antimony is regulated under the EU Drinking Water Directive (Directive (EU) 2020/2184), which establishes a parametric value of 10 µg/L for water intended for human consumption. This value contributes to the protection of public health and is supported by extensive international health assessments, including the World Health Organization (WHO) drinking water guideline programme. Antimony-containing materials intended for contact with drinking water are also subject to specific regulatory assessment requirements designed to ensure that migration remains within acceptable limits.

Children’s Products

Antimony may be used as a flame-retardant synergist or in technical pigments. These uses are regulated to prevent excessive exposure to children.

In the US, several state-level lists impose reporting and administrative obligations for antimony in children’s products. i2a notes that available exposure data do not indicate health risk from the levels of antimony currently encountered in children’s products.

In the EU, Directive 2009/48/EC on toy safety sets the following migration limits for antimony:

45 mg/kg in dry, brittle, powder-like or pliable materials

11.3 mg/kg in liquid or sticky materials

560 mg/kg in scraped-off materials

Specific Regulatory Frameworks

California Proposition 65

Diantimony Trioxide is listed as causing cancer under California Proposition 65, based on the IARC classification. Businesses must therefore provide warnings where exposures exceed applicable thresholds.

Companies may alternatively:

demonstrate exposures below the No Significant Risk Level (NSRL);

obtain a Safe Use Determination (SUD) from OEHHA; or

provide appropriate warnings.

RoHS

No antimony substance is currently listed in Annex II of the Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS). 

Diantimony Trioxide has been evaluated under the RoHS review process because of its use as a flame-retardant synergist. Available assessments have considered factors including quantities used, concentrations in polymer matrices, release behaviour, substitution potential and waste-management impacts. 

The most recent EU RoHS assessment (December 2019) did not recommend restriction of Diantimony Trioxide, while noting that the substance may be revisited should new information become available.