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BPA and DOTE Among Substances Proposed for Authorization under REACH

September 25, 2018

The European Chemicals Agency (ECHA) has proposed to add 4,4'-isopropylidenediphenol (bisphenol A, BPA) and 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) along with 16 other substances to the REACH Authorization List (Annex XIV of the REACH Regulation). BPA and DOTE are currently authorized for use as a monomer and an additive, respectively, in the manufacture of plastic food-contact materials and articles in the European Union (subject to certain restrictions).

ECHA has requested comments on its proposal to add the 18 substances to the REACH Authorization List. The comments are due by December 5, 2018:

  • BPA (CASRN 80-05-7)  (link to public consultation), and
  • DOTE (CASRN 15571-58-1) (link to public consultation).

It is worth noting that food-contact substances included in Annex XIV of REACH due only to human health hazards are exempted from the REACH authorization requirement for this use, as the EU food-contact legislation specifically addresses health risks. DOTE is proposed for inclusion in the REACH Authorization List on the basis of its classification as toxic for reproduction. Therefore, given that the proposed Annex XIV listing is based on a human health hazard, this listing would not directly impact on the use of DOTE in the manufacture of food-contact materials.  That said, the potential inclusion of DOTE in the REACH Authorization List may cause the European Commission/Member States to look more closely at the use of DOTE in food-contact materials.

The proposed basis for the listing of BPA in Annex XIV of REACH includes endocrine disrupting properties with effects on the environment in addition to human health, as well as reprotoxicity.  Therefore, BPA does not automatically benefit from the general exemption applicable to food-contact materials given that it is also proposed to be included in Annex XIV of REACH due to environmental hazards.  Consequently, interested parties would need to submit a request to ECHA as part of this consultation to exempt BPA from authorization under Art. 58(2) of the REACH Regulation for its use in food-contact materials, in order for BPA to (potentially) benefit from an exemption for this particular use.  To support an exemption request it must be demonstrated, among other things, that existing food-contact or other EU legislation properly controls the risk of the use of BPA to the environment given its endocrine disrupting effects.