On the 13th of December 2016 the Official Journal of the European Union published Regulation (EU) 2016/2235 adding Entry 66 of Annex XVII to the REACH Regulation as bisphenol A (BPA). It stipulates that thermal paper shall not be placed on the market unless the BPA concentration in it is less than 0.02% by weight after the 2nd of January 2020.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Main Amendments

Substance nameScope and Conditions of Restriction
Bisphenol-A (BPA)   CAS No 80-05-7 EC No 201-245-8 Shall not be placed on the market in thermal paper in concentration equal to or greater than 0.02% by weight [entry into force after 2 January 2020]

Some Other Requirements of BPA

RegulationControl ListRequirements
REACH regulation   (EC) No 1907/2006 SVHC candidate list assessment   (Has not yet been formally adopted) Provide substance information if BPA is present in articles above 0.1 wt%; notify ECHA if BPA is present in articles in quantities totaling over one tonne per producer or exporter per year, and BPA is present in those articles above 0.1 wt%.
CA 65the list of chemicals known to the state to cause cancerFrom 1 October 2016,the MADL (The maximum allowable dose levels)of BPA exposure is 3μg/d in solid materials.
(EU)No.321/2011/BPA in polycarbonate (PC) infant bottles for children under the age 1 is Prohibited.

Risk Analysis

BPA in plastic baby bottles and other plastic products may affect the development of an infant’s growth, damage the child’s brain and other organs. It is mainly used for producing polycarbonate, epoxy resin, polysulfone resin, polyphenylene ether resin, and other polymer materials. It can be used in the production of plasticizers, flame retardants, antioxidants, pesticides, paint and other fine chemical products.