EU evaluation of Antimony substances


Several Antimony substances (including Antimony metal, Antimony trioxide and Antimony trisulphide) have been included in the EU’s “Community Rolling Action Plan” (CoRAP) for Evaluation under REACH (1907/2006/EC), the EU‘s framework legislation on chemicals. Evaluation is the process whereby selected substances are subject to additional regulatory scrutiny by ECHA or one of the Member States. The main reason for the Evaluation of Antimony trivalent substances is the assessment of new toxicological evidence regarding their potential carcinogenicity. 
Germany is the EU Member State responsible for the EU Evaluation of antimony substances, starting in 2018. Exchanges between the German Institute for Occupational Safety and Health (BAuA), the European Chemicals Agency (ECHA) and the International Antimony Association (i2a) were initiated in 2017, as part of a voluntary collaborative project (COLLA) whose objective was to assess how substances could be evaluated in groups. 
An additional development is the US NTP (National Toxicology Program) Report on Carcinogens, which concluded that Antimony Trioxide is “reasonably expected to be a human carcinogen”. i2a were involved in the NTP discussions and will be monitoring the regulatory progress on this issue over the coming years. Further scientific details and a position statement are available on the i2a website.   

Upcoming steps

i2a is in the process of updating the relevant joint REACH dossiers so that they reflect the most recent toxicological evidence and exposure information.  During 2018 and 2019, a number of exchanges are expected to take place between i2a and BAuA as part of the Substance Evaluation.  BAuA are expected to request additional dossier adjustments to make the information as complete, and up to date as possible.  
Upon finalization of the Substance Evaluation, BAuA will issue a draft decision that needs to be approved by the ECHA Member State Committee (MSC). It is expected that a final decision will be available in early 2020.  This final decision could include a request for additional toxicological or exposure information, and/or recommendation for follow-up regulatory action, such as a EU harmonized classification, or EU restrictions.

How can the value chain contribute to the Evaluation?

The existing precautionary measure advocated by i2a and its Members remains valid: as long as the generation and inhalation of dust is avoided, there is no increased risk for workers or users of Antimony and its compounds.  This should be implemented throughout the value chain.

i2a will be coordinating the generation and collection of information necessary to BAuA’s and ECHA’s decision-making.  Information requests will be made to i2a Members and members of the relevant downstream user associations, who use Antimony substances.  Some of the information requests will be subject to strict deadlines and/or require the engagement and commitment of various representatives of the Antimony value chain.  

In order to participate in a successful Substance Evaluation, you can:
Participate in the events organized by i2a (e.g. technical workshops, annual Antimony Days, etc.); and
Become a Member of i2a, as Full or Associate Member; and/or
Become a Member of the relevant Antimony Downstream user association(s); and
Contribute to the information requests by the given deadlines.

Download ECHA’s guide on how to act in Substance Evaluation

Do not hesitate to contact i2a for more information at: info@antimony.com

International Antimony Association VZW
Avenue de Broqueville 12
BE-1150 Brussels
T : +32 2 762 30 93
F : +32 2 762 82 29
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