Statement on REACH Authorization Status for Borates
This statement concerns the following U.S. Borax products:
Background
U.S. Borax, through the European Borates Association (EBA), has been leading the effort to actively engage with the European Chemicals Agency (ECHA) over the years to advocate for borates’ exclusion from Authorisation based on sound consideration of science and due process. We continue to advocate that REACH Authorisation is not an appropriate control measure for borates.
SVHC listing
Boric acid, disodium tetraborate and diboron trioxide were included in the REACH Candidate List of Substances of Very High Concern (SVHC) in 2011. Disodium octaborate was included in the same list in 2018. Inclusion on the Candidate List does not automatically trigger inclusion on the Authorization list (Annex XIV), nor any market restrictions. It does trigger certain communication requirements and these are explained on ECHA’s website.
Prioritization
On 1 September 2014, ECHA launched a public consultation to seek feedback on which substances it should prioritize and put on the “6th list” for Authorization. Four borate substances were initially proposed, including boric acid, disodium tetraborate and diboron oxide (but not disodium octaborate). A vast number of comments were submitted by industry, which has helped regulators to understand the situation for borates is not straight forward.
After the public consultation and a long review process, ECHA published its decision on the 6th list on 1 July 2015. Boric acid, disodium tetraborate and diboron trioxide were finally included in this list. Inclusion in ECHA’s proposed list has not led to any market restrictions at this time.
A coalition comprised of EBA member companies and various associations representing downstream users of borates based in the EU have continued to advocate against Authorization.
Arguments developed by and for the Coalition have been prepared. Requiring Authorisation for borates does not represent regulatory effectiveness and is not proportional. Borates are relatively benign substances which have been used safely for generations. The actual health risk is small based on human exposure data from the United States, Turkey and China. Further, exposure is already controlled adequately through existing legislation and industry practices and subjecting borates to authorisation will not lead to additional protection for workers and consumers. The European Commission itself has recently recognised the socioeconomic importance of borates by including them as a Critical Raw Material for the EU. In summary, it is our view that there are many other substances that are eligible for authorisation that should be prioritised ahead of borates.
2016 update
A draft amendment of the REACH Annex XIV was issued by the European Commission on October 2016. In this revision, borates were explicitly excluded from the proposal of the Commission to add substances to the Authorization list.
Resources
May 2020