Evaluations

EU evaluation of Antimony substances


Background


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.


Overview of timeline of substance evaluation of five Antimony substances



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


EU Shortlisting of Antimony Trioxide under RoHS

Background

Antimony trioxide has been shortlisted by the EU Commission to be assessed for possible addition to Annex II of RoHS.  “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.

The original Directive (also known as RoHS I) restricted the following substances: lead, mercury, cadmium, chromium VI, Polybrominated biphenyls (PBB), and Polybrominated diphenyl ether (PBDE).  

A recast of the directive was adopted in January 2013, leading to “RoHS2”. Article 6 of RoHS2 requires a periodic review of the list of restricted substances, which appear in Annex II to the Directive.  So far, one update of the list of restricted substances has been conducted, and in June 2015 four phthalates (DEHP, BBP, DBP, DIBP) were added to Annex II.

In December 2017, the EU Commission appointed the Oeko Institut for Applied Ecology and Fraunhofer IZM to review and update the existing methodology to identify and assess substances for possible restriction, as well as to perform a detailed assessment of a number of shortlisted substances for possible future restrictions.  Antimony trioxide is on this shortlist of substances to be assessed by the appointed consultants.

Upcoming steps

All relevant information about Pack 15 (RoHS work packaged assigned to Oeko Institut and Fraunhofer) is available on: http://rohs.exemptions.oeko.info/index.php?id=288

The work of Oeko Institut for Applied Ecology and Fraunhofer IZM is expected to be complete by June 2019. It explicitly allows for stakeholder participation. Three interim reports and three stakeholder meetings are foreseen, as described in the following schedule:




For each stakeholder consultation, i2a will produce a draft response to be commented and completed by the relevant value chain representatives.  The final response will cover main general points and trends and will be submitted by i2a.  More specific and in-depth descriptions/demonstrations of the points included in the i2a response will be submitted by the value chain.  A dedicated i2a RoHS Expert Task Force has been pooled together to facilitate  the exchanges between suppliers and users.

i2a’s response to the first consultation was submitted along 13 other submissions.  All of these are in line with i2a’s submission and add granularity to some of i2a’s statements and arguments.  There seems to be a unanimity around the fact that there are no alternatives to the BFR+ATO solution for applications requiring high flame retardancy performance, and that any adaptation to a possible restriction would trigger a decrease in such performance, a decreased investment in circular economy solutions, and a substantial impact on DU industries having to redesign many parts of the equipment, which would take up to 12 years to succeed.  The consultants will produce ‘Initial Dossiers’ on each one of the shortlist substances which will not yet contain any restriction recommendation but serve to collect general comments and further data from stakeholders where gaps may still exist.  The ATO Initial Dossier should be available in autumn 2018.  I2a intends to provide comments on this Dossier and participate in the stakeholder workshop to be organized by the Commission.

The second consultation (aimed to start in June 2018) i2a will participate in aims to collect comments on the proposed methodology to identify substances to be shortlisted.  

After the study is finalised, the EU Commission will consider the study’s outcome and issue its decisions through a Delegated Act, which will have to go through the appropriate legislative procedure, including a 4-week public consultation and a 2-month period for Parliament or Council to raise objections. Therefore, no regulatory decision is likely to emerge from this review before end 2019, at the earliest.


How can the value chain contribute to the Evaluation?

i2a’s view is that ATO’s use in EEE is safe and there is no scientific basis to add it to RoHS’ Annex II (list of restricted substances). i2a plans to fully participate in the review and ensure that the updated methodology is underpinned by science and the resulting assessment of ATO takes full account of the most recent data on the use of ATO in EEE.

i2a will be coordinating the generation and collection of information necessary to the consultants’ assessment and the subsequent EU Commission decision-making.  The following information will be of particular relevance to avoid an over-conservative and precautionary decision:
  • 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.). 
In order to more closely participate in i2a’s work under RoHS, please contribute to the information requests circulated by i2a by the given deadlines.

You may also consider:
  • Joining the i2a RoHS Expert Task Force; and/or
  • Becoming a Member of i2a, as Full or Associate Member; and/or
  • Becoming a Member of the relevant EEE Downstream user association(s).
Do not hesitate to contact i2a for more information at: info@antimony.com. Last update: 18 July 2018
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