Disodium tetraborate update
Following discussions at OIC 2016, disodium tetraborate (CAS 1303-96-4 EINECS 215-540-4) was removed from the PLONOR list in October 2016 because of concerns raised by some Contracting Parties relating to its reprotoxicity. The registration requirements under the HMCS mean that HOCNF submissions must now be supported by test data for this substance. In view of the short notice of this change, Cefas are willing to issue short-term templates, valid until May 2017, to allow time for any necessary testing to be carried out. As an alternative to testing, suppliers are reminded that if good quality literature data are available, these can be used for registration purposes. As always, suppliers should retain copies of the relevant literature and/or reports so that they can be provided to Cefas if requested.
Please note also that the latest issue of the Pre-Screening Scheme came into effect on January 1st 2017. From this point, disodium tetraborate also carries a substitution warning related to the reprotoxicity, since the substance is listed on the Candidate List of Substances of Very High Concern for Authorisation established pursuant to REACH. Templates will be issued in January reflecting this status and, where appropriate, the shortened period of validity. Chemical permit applications for disodium tetraborate, or products containing the chemical, that are submitted after January 1st 2017 will also need to include a chemical justification. However, we would expect risk-based justifications to highlight the high background levels of borates in sea water, which can be expected to mitigate the overall risk.
It should be noted that the existing PLONOR list entries for Sodium borate and Boric acid, sodium salt are not affected by these changes.