Safe Use & Stewardship
Hazard and classification of Antimony substances
Some (industrial and other) Antimony substances have been investigated in animal tests over the last decades, with varying degrees of reliability. The most relevant and reliable investigations have been assessed by i2a in preparation of the EU-REACH Dossiers and their subsequent updates. This has resulted in the calculation of hazard levels that are communicated in the extended Safety Data Sheets (eSDS) and compared with exposure levels in order to determine possible risks and applicable risk management measures. The applicable classifications are also communicated in the eSDS.
Several industrial Antimony substances have not (yet) been investigated, and rather than performing systematic (vertebrate) animal tests on all these, a grouping and read-across, and weight of evidence approach has been applied for each (sub-)chronic endpoint (namely: lung toxicity/carcinogenicity and systemic toxicity). Scientific opinions have been prepared for each endpoint, which includes an assessment of the available evidence, a provisional grouping and read-across hypothesis, and an indication of further research opportunities.
Because new animal evidence and evolving requirements become available to justify grouping and read-across, i2a continues to elaborate the read-across and weight of evidence approach through a specifically tailored and designed hazard research program.
Producers and users of Antimony substances are invited to join i2a and/or co-sponsor the scientific investments described above
Exposure to Antimony substances
It is no secret that workers can be exposed to dust and particles which, once present in deep lung tissue, may trigger a number of inflammatory responses. Antimony dust is no exception, and for this reason, workplace exposure limits are established in various jurisdictions. These limits are calculated on the basis of the doses at which adverse effects were observed in animal tests, typically conducted under relatively worst-case conditions.
Assessing the risk related to the production or use of Antimony requires comparing the hazard levels with exposure levels. Every new animal study will trigger a review of the hazard levels, and potentially result in stricter exposure levels being recommended. Documenting the actual exposure situation is key to preventing theoretical conclusions around the risk and safe levels applicable to Antimony.
i2a coordinates a workplace exposure monitoring program to determine for producers and users of Antimony substances, the portion of inhalable versus respirable Antimony that can be present in the workplaces. This campaign concerns the implementation of guidelines aimed at minimizing exposure to Antimony dust in the workplace, and a general recommendation to use less or non-dust creating forms of Antimony substances. This is especially applicable in workplaces with limited ventilation and respiratory protective equipment in place.
All producers and users of Antimony substances are strongly recommended to participate in the workplace exposure monitoring campaign that started in 2019.
Although Antimony is either present in very small (trace) concentrations in consumer products and/or not migrating out of such products in any concerning concentrations, exposure to consumers is also included in the assessments performed by i2a. These are performed as standalone projects with specific downstream users of Antimony, which use Antimony in materials which may end up in consumer products. Downstream user associations and i2a co-sponsor these projects which are then used as evidence to demonstrate the safety of Antimony for the general population too.
Safe use along the value chain & Product Stewardship
Producers and users of Antimony substances are typically very satisfied with the cost-efficient function of Antimony. Beyond the compliance with existing legislative requirements, they are aware of the demonstrated hazards intrinsic to any chemical such as Antimony and implement the risk management measures communicated in the safety data sheets provided by all responsible suppliers, to ensure safe production and use of the substances.
The mission of i2a is to lead product stewardship along the Antimony value chain, by generating and sharing information concerning the environmental and health safety, and societal benefits, of Antimony and Antimony compounds. The REACH Registration Dossiers constitute the reference database for each Antimony substance in the EU and in many other regulatory programs and various jurisdictions worldwide. The Antimony substances Dossiers hosted by i2a are, as foreseen in Article 22 of the REACH Regulation, subject to regular updates, to ensure that these reference sources always reflect the latest available evidence and the applicable classification and risk assessment conclusions.
Responsible producers and users of Antimony substances, and in particular i2a Members, who are the first to know when new evidence and recommendations become available, are true ambassadors of the ‘Antimony Product Stewardship’ initiative lead by i2a. This initiative comprises technical and communication plans, among others, and invites all stakeholders to achieve harmonized risk management and the continued safe use of Antimony and Antimony compounds.
Product Stewardship is a management strategy that involves whomever designs, produces, sells, or uses a product and takes responsibility for minimizing the product’s health or environmental impact throughout all stages of the products’ life cycle, including end of life management. A product stewardship strategy means that everyone within the value chain have their specific roles:
As a responsible producer, your role is to:
- Source materials from legitimate and compliant sources, duly aware of the health and environmental obligations which promote the safe use of Antimony substances
- Comply with industrial, workplace, product and waste/environmental policies and legislations, taking due account of i2a’s reference database for Antimony substances
- Protect workers against inhalation of respirable forms of Antimony substances, by implementing where applicable, i2a’s recommendations and guidelines
- Produce high quality/purity Antimony substances and apply the GHS and transport classification, labeling and packaging recommended by i2a
- Supply dust-free forms of Antimony substances to minimize the risk of inhalation exposure
- Supply safe use information to the value chain
- Respond to i2a’s calls for information to address EHS regulatory developments relevant to Antimony substances
As a responsible trader, your role is to:
- Source materials from legitimate and compliant producers, duly aware of the health and environmental obligations which promote the safe use of Antimony substances
- Comply with product and trade policies and legislations, taking due account of i2a’s reference database for Antimony substances
- Favor the supply of high quality/purity Antimony substances and communicate the GHS and transport classification, labeling and packaging recommended by i2a
- Favor the supply of dust-free forms of Antimony substances to minimize the risk of inhalation exposure
- Cascade safe use information from producers throughthe value chain
- Respond to i2a’s calls for information to address EHS regulatory developments relevant to Antimony substances
As a responsible user, your role is to:
- Source materials from legitimate and compliant sources, duly aware of the health and environmental obligations which promote the safe use of Antimony substances
- Comply with industrial, workplace, product and waste/environmental policies and legislations, taking due account of i2a’s reference database for Antimony substances
- Protect workers against inhalation of respirable forms of Antimony substances, by implementing where applicable, i2a’s recommendations and guidelines
- Prefer high quality/purity Antimony substances and apply the GHS and transport classification, labeling and packaging recommended by i2a
- Prefer dust-free forms of Antimony substances to minimize the risk of inhalation exposure
- Implement safe use information received from the supplier
- Respond to i2a’s calls for information to address EHS regulatory developments relevant to Antimony substances
Workers in protective equipment loading antimony trioxide for a customer. © Campine