How is Echa conducting a 'combined' substance evaluation of antimony?
Q&A with Caroline Braibant, Secretary-General, International Antimony Association
Last year, Chemical Watch held its first conference on REACH substance evaluation. Ahead of the event, we spoke to Caroline Braibant, one of the expert panellists and speakers at the conference. Caroline is secretary general of the International Antimony Association (i2a). Antimony is currently undergoing a “combined evaluation”. We asked her to explain its implications.
Q) Would you explain ‘Echa’s combined evaluation’?
The REACH evaluation of antimony substances is one of the first (metal) cases where: i) both dossier evaluation/compliance check and substance evaluation are taking place in parallel, and ii) the evaluation is performed on a group of substances.
The International Antimony Association welcomes this approach because it can trigger various synergies and bring a number of improvements in terms of efficiency to the evaluation process. Indeed, as the endpoints under evaluation by Echa and the German REACH competent authority (Baua) are very much interrelated, and may be relevant for a set of chemically similar antimony substances, it is worth addressing these in a combined manner.
For this combined approach to yield a set of achievable decisions, it should however consider the following aspects:
• the truly scientific questions around antimony”s effects and read-across (beyond the mere REACH Annex information requirements and standard OECD test guidelines not designed to resolve these);
• the varying use profile of the antimony substances in scope (with different exposure scenarios and actual likelihood of risk); and,
• the specific set-up/nature, geographical spread, and financial capacity of the antimony industry. Antimony is a minor metal supplied in lower volumes than most of the well-studied base metals, for instance.
Q) The evaluation of antimony was scheduled for 2018. How is it proceeding?
According to the community rolling action plan (Corap), the start of the substance evaluation was set for April 2018. From that moment in time, authorities had a year to issue their draft decision. This was sent to all registrants on 18 April of this year. The evaluation took place as per the planned schedule and faced no delay at all.
Actually, thanks to a voluntary participation in 2016-2017 between i2a and the Baua using Echa’s collaborative approach towards the evaluation of groups of substances (Colla’), the ‘content discussion’ of the evaluation actually started earlier, and enabled a very efficient and timely start of the formal process, as per the formal Corap schedule.
As regards the compliance checking, no formal timing is established for this in the REACH text, but we expected it to take place (maybe one year?) before the start of the substance evaluation. We had understood that Echa’s most recent practice was to resolve ‘completeness’ and ‘compliance’ aspects before member state competent authorities would address the risk assessment and classification aspects, based on a ‘complete’ and ‘compliant’ dataset.
One of the antimony substances was subject to a targeted compliance check in 2016. After addressing the decision from that, we thought that it was the one that we had been expecting to take place prior to the substance evaluation. Actually, it was a targeted one, focusing only on reproductive toxicity evidence.
The ‘real’ substance evaluation-related compliance check took place in parallel to the evaluation, and so we were slightly surprised when we received draft decisions for this on 18 April as well.
Q) At what stage – and by which party – was the idea of grouping for the purposes of evaluation suggested?
Three antimony substances had already been listed on Corap by decision of Echa and the member state competent authorities: antimony metal, trioxide and trisulfide (all are trivalent antimony substances).
Antimony trioxide was listed because new evidence became available that would require it to be scrutinised. It is our understanding that antimony metal and trisulfide were listed because they were also registered in relatively high tonnage bands, and because they share a number of similarities with antimony trioxide.
In 2016, Echa set-up its dedicated pilot project – Colla – aimed at improving the efficiency of the evaluation process, and called for volunteers. i2a regarded this project as an opportunity to: i) ‘prepare’ for the evaluation of the three Corap-listed antimony substances, ii) replicate the learning lessons in the dossiers of its other seven REACH registered antimony substances, and iii) share views to ensure that the grouping of metals is made on the basis of relevant criteria.
The Baua also volunteered for the project and as a result, an open and constructive dialogue was established between all parties, before the start of the formal substance evaluation process. At the end of the Colla, the authorities decided to add two more antimony substances to the Corap: antimony trichloride and tris(ethylene glycolate) to cover all REACH registered trivalent antimony substances in one evaluation.
Because of the way in which the Corap is set up, the five antimony substances are listed individually and not as a group, but in practice the five substances are looked at together by the Baua.
Q) What – in broad terms – does the supply chain for antimony and antimony containing substances look like? Are there many/few small/large companies with operations that are integrated/not integrated in relation to derivatives?
Antimony is produced from two main sources – mine production outside the EEA (80% of the substance is sourced from China) and through the recycling of lead-acid batteries and other chemical compounds. In 2018, global mine production accounted for 120 kilotons (kt), recycling from lead-acid batteries for 57kt and 5-10kt from other chemical compounds.
The three main applications for antimony are:
• flame retardants (48%) in plastics, textiles and rubber;
• lead-acid batteries (33%); and
• as a catalyst for polyester and PET (7%).
In total, around 100 legal entities have registered one or more of the ten REACH-registered antimony substances, in the following tonnage bands (June 2019):
• 1-10: 25
• 10-100: 26
• 100-1000: 36
• 1000-1999: 13
The antimony value chain is not more or less complex than that of other metals.
In terms of the work that will be triggered by the evaluation, it is expected that the cost already shared by each registrant for the data generated over the period of 2008-2017, whether via letter of access purchase or i2a membership, will be repeated over the estimated 2018-2025 evaluation period. This may put some registrants (who include producers, traders/distributors and users) and the SMEs who depend on them in a very difficult situation and could lead to supply disruptions. SMEs constitute more than 90% of the value chain in the EU.
Q) How might grouping in this instance avoid regrettable substitution with reference to specific applications of antimony?
Most antimony substances are typically not competing for uses as they each have the relevant physical form and chemical formulation that is the most compatible with each specific use. Should any of the CLP classifications of antimony substances change however, it is possible that some users may opt for another antimony substance, due to their known versatility, technical and cost-performance.
With the research programme deployed by i2a and the (combined) evaluation process, we anticipate that no regrettable substitution will take place. It is important to note that while the evaluation process covers the five trivalent antimony substances in scope of i2a’s work, our research covers also the additional five pentavalent antimony substances. By doing this, we anticipate a further formal evaluation of these pentavalent antimony substances (that may or may not be necessary in the end), and further avoid possible regrettable substitution decisions taken for or towards these substances.
In short, the antimony industry is not waiting for the formal evaluation process to address the knowledge gaps. It is working to deliver complete and robust hazard, exposure and risk profiles for each one of the ten REACH registered antimony substances. With such a profile, downstream users of the substances will have all the necessary evidence they need to make an informed selection of their preferred flame-retardant synergist, catalyst, or alloying compound.
The views expressed in this interview are those of the interviewee and are not necessarily shared by Chemical Watch.
