Bisphenol A (BPA), identified by the ECHA as a Substance of Very High Concern
On June 16 2017, the ECHA Member State Committee (MSC) unanimously agreed to identify 4,4′-isopropylidenediphenol (bisphenol A, BPA) (EC 201-245-8, CAS 80-05-7) as a Substance of Very High Concern (SVHC) under REACH due to alleged endocrine disrupting (ED) properties which cause probable serious effects to human health which give rise to an equivalent level of concern to carcinogenic, mutagenic, toxic to reproduction (CMRs category 1A or 1B) substances. This was a proposal from France (https://echa.europa.eu/es/-/msc-unanimously-agrees-that-bisphenol-a-is-an-endocrine-disruptor).
Since January 2017, Bisphenol A (BPA) has already been included in the REACH Candidate List of Substances of Very High Concern for Authorisation based on its classification as reproductive 1B substance. But according to this new agreement the entry of the candidate list for bisphenol A has also been updated to include endocrine-disrupting properties. In practical terms, it makes no difference whether a substance is listed once or several times, the obligations related to a listing on the Candidate List are the same.
SVHC identification does not determine whether the use of a substance is dangerous, is a hazard-based approach meaning that it is based solely on the intrinsic properties of a substance, without considering its actual use, real-life exposure and respective potential risk. The inclusion of BPA in the Candidate List as such therefore does not mean it´s uses are unsafe. The identification as SVHCs is the formal first step which could ultimately lead to Authorisation requirements under REACH.
BPA can be used in food contact applications for consumers. Generally, food contact materials (FCMs) are regulated by the Framework Regulation for all food contact materials (EC No 1935/2004) and the use of BPA as monomer for plastic is explicitly permitted by the Regulation (EU No 10/2011). In order to assess the safety of substances used to manufacture food contact materials, the European Food Safety Authority (EFSA) carries out safety evaluations and risk assessments. In its most recent comprehensive scientific opinion on the safety of BPA (published January 2015), the authority concludes that BPA poses no health risk to consumers of any age group (including unborn children, infants and adolescents) at current exposure levels. Exposure from the diet or from a combination of sources (diet, dust, cosmetics and thermal paper) is considerably under the safe level (the “tolerable daily intake” or TDI) (https://www.efsa.europa.eu/en/press/news/150121). Until now, the Candidate List inclusion does not impact compliance of BPA-based food contact materials with the respective legislation.