International Bromine Council (BSEF) response to ECHA (RAC) CLH opinion on ammonium bromide (NH4Br)
2nd November 2020
The Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) recently adopted a proposed harmonized classification of NH4Br. To date the substance has no existing entry in Annex VI to the CLP Regulation.
Ammonium bromide is a relatively small volume chemical. A few thousand tonnes are estimated to be used in the EU each year. Ammonium bromide is used in a few well-defined industrial applications with well controlled exposures; it is not used by consumers. Its main application (> 90%) is as a precursor to the in situ biocidal active substance Bromide Activated Chloramine (BAC), which is extremely effective in controlling biofilm growth in industrial water applications especially with respect to paper production. Given this use, there is no exposure of ammonium bromide to the general public and environment.
RAC agreed to the CLH proposal by Sweden to classify ammonium bromide as a substance that causes serious eye irritation (Eye Irrit. 2; H319), may damage fertility and the unborn child (Repr. 1B; H360FD), may cause harm to breast-fed children (Lact.; H362) and may cause drowsiness or dizziness (STOT SE 3; H336). RAC also concluded that classification as STOT RE 1, H372 with the nervous system as the target organ after repeated exposure was warranted. RAC did not agree with the proposal by Sweden to state the thyroid as a target organ after repeated exposure.
BSEF queries the decision by RAC to support a reprotoxic 1b classification of the substance, as reflected in extensive comments submitted during the consultation period. In particular, new data from detailed studies that were carefully designed to characterize the relationship between systemic and reproductive toxicity and exposure to bromide clearly indicate that studies in rats have limited relevance for humans.
For such situations, in accordance with the CLP guidance, we are convinced that a category 2 would be more appropriate.
Bromides such as ammonium bromide are ubiquitous in the natural environment and in humans and are known to form an important part of a normal healthy diet and lifestyle. The World Health Organisation (WHO) has assessed dietary exposure to bromides. It determined a safe level of exposure for bromides and concluded bromide is not a toxicological concern in nutrition in humans.
BSEF – the International Bromine Council, is the global representative body for bromine producers and producers of bromine technologies. Originally founded in 1997, BSEF works to foster knowledge on the societal benefits of bromine and its applications. The members of BSEF are Albemarle Corporation, ICL Industrial Products, Lanxess and Tosoh. Further information:
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