Product Restrictions
A number of product restrictions apply on Antimony, based on its known emetic and gastric irritation properties. However, Antimony is either present in very small (trace) concentrations in consumer products and/or not migrating out of such products in any concerning concentrations. Antimony has however been ‘dragged’ into a number of restrictions due to its practical proximity to historically dangerous flame retardants which have now been banned, or its chemical proximity to ‘heavy’ metals which have now been demonstrated to have much more severe toxicities than Antimony (e.g. certain arsenic compounds).
Antimony can also be present in products as a result of the recycling of plastic waste streams, but specific sorting obligations apply so that the resulting presence will generally be at trace/impurity level, which should not lead to any measurable risk for health (and rather enable an efficient circularity of resources).
California Proposition 65
Diantimony Trioxide is listed as causing cancer (based on the IARC classification) in the California Proposition 65 or Safe Drinking Water and Toxic Enforcement Act of 1986. This listing requires businesses to provide warnings to Californians about significant exposures to Antimony trioxide that are present in and released from products that Californians purchase, in their homes or workplaces.
Companies may either be in the position of determining and demonstrating that the exposure potential is below or at the calculated No Significant Risk Levels (NSRL) for Diantimony Trioxide, obtain a confirmation from the Office of Environmental Health Hazard Assessment (OEHHA) that their use is safe (Safe Use Determination (SUD)), or provide a warning on the possible presence and release of Diantimony Trioxide from the supplied products.
Plastic food contact materials
The use of Diantimony Trioxide as catalyst for the polymerization of PET resin was deemed safe by the European Food Safety Administration (EFSA), with a migration limit established at 0.04 mg/kg of food (as Antimony) (allowing for 10% of the Tolerated Daily Intake (TDI) being allocated to food contact materials. This migration limit will be typically taken up in food contact material legislation, such as the EU Plastic Food Contact Materials Regulation 10/2011.
Children Products
Antimony may be used in a number of articles as a flame-retardant synergist, or as a constituent of a technical pigment. These uses are regulated in a number of ways to protect children from excessive chemical exposures.
A number of US State lists impose limitations on the presence of Antimony in products for children, such as clothing and products that “facilitate sleep” (e.g. Washington State list of high priority chemicals). Such a listing triggers a number of administrative obligations including, the requirement to submit notices regarding the use of Antimony in children’s products, their manufacture or their import/distribution. i2a is of the opinion that the scientific literature does not support listing of Antimony as a CHCC under the statutory criteria for listing, and that there is in particular no evidence of a potential for exposure of children to Antimony that could result in health risks that are the subject of the CHCC regulation.
In the EU, Directive 2009/48 relating to the safety of toys foresees three limits for Antimony in toys:
- 45 mg/lg in dry, brittle, powder-like or pliable toy material
- 3 mg/kg in liquid or sticky toy material
- 560 mg/kg in scraped-off toy material
Electric and electronic equipment (On-going)
“RoHS” stands for the “Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (EEE)”. RoHS-like legislation also exists in various jurisdictions in Latin America, EurAsia and Asia; these typically find inspiration in the EU RoHS Directive. Annex II of RoHS lists the substances which are restricted in EEE. There is no Antimony substance listed in Annex II of RoHS.
The RoHS Directive and Annex II in particular are subject to regular reviews, aiming to prevent negative impacts on the management of waste from EEE. A number of chemicals used in EEE are regularly reviewed for possible restriction/inclusion in Annex II of RoHS.
Diantimony Trioxide has been considered for restriction due to its use as flame-retardant synergist with brominated flame retardants and in soft PVC. i2a’s view is that Diantimony Trioxide’s use in EEE is safe and that it does not meet the criteria to be listed on Annex II of RoHS. The following information is used to articulate this opinion:
- Amounts of ATO used in EEE applications
- EEE polymers/matrices in which ATO is used,
- Amounts in which ATO is used in each polymer and resulting concentration in the polymer,
- Release/migration from the various matrices,
- Exact function and substitutability in each EEE application,
- Waste management issues (exposure of workers, emissions to environment, quality of recyclate, etc.).
The most recent EU assessment of Diantimony Trioxide under RoHS (December 2019) concluded that ATO should NOT be restricted under RoHS, but that it may be reconsidered for restriction in a future review. i2a disagrees with the second part of this conclusion, as the risk of using ATO in EEE has not been demonstrated, and none of the four conditions in Article 6 of RoHS to be restricted are met by ATO. The final consultants’ report is expected to be published in July 2020. More information can be found here.
Many stakeholders are of the opinion that the EU REACH restriction process in place since 2008 may progressively become the most logical evolution step for the EU RoHS restriction process. The RoHS Directive Review due in 2021 should shed light on the effectiveness, efficiency, relevance and consistency of the Directive with other EU and national legislations. i2a’s objective is to ensure the fair and documented assessment of Diantimony Trioxide under RoHS, and promote an increased regulatory effectiveness and efficiency in the EU.
PET bottles.