Member State Committee unanimously agrees that Bisphenol A is an endocrine disruptor
ECHA/PR/17/12 – The Member State Committee (MSC) supported the French proposal to additionally identify Bisphenol A as a substance of very high concern because of its endocrine disrupting properties which cause probable serious effects to human health. The committee also agreed to identify the substance PFHxS as an SVHC.
Helsinki, 16 June 2017 – The Member State Committee (MSC) unanimously agreed on the identification as substances of very high concern (SVHCs) of:
- 4,4′-isopropylidenediphenol (bisphenol A, BPA) (EC 201-245-8, CAS 80-05-7), proposed by France, due to its endocrine disrupting properties for human health;
- Perfluorohexane-1-sulphonic acid and its salts (PFHxS), proposed by Sweden, due to their very persistent and very bioaccumulative (vPvB) properties.
Bisphenol A is already listed in the Candidate List due to its toxic for reproduction properties. At the MSC meeting earlier this week, MSC unanimously agreed on its additional identification as an SVHC because of its endocrine disrupting 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.
ECHA will include PFHxS in the Candidate List and will update the current entry for BPA accordingly by the end of June 2017. Companies may have legal obligations with respect to these substances upon publication of the updated Candidate List.
Bisphenol A is recognised by ECHA for its endocrine-disrupting properties, based on a proposal by France
In February 2017, ANSES submitted a proposal to the European Chemicals Agency (ECHA) to classify bisphenol A (BPA) as a substance of very high concern (SVHC) within the framework of the European REACh regulation, based on its “endocrine-disrupting” properties which cause probable serious effects to human health. This proposal has just been adopted by ECHA’s Member State Committee. The decision means that industry players must notify ECHA of the presence of bisphenol A in all imported or manufactured items and must also inform buyers when items contain the substance. The inclusion of BPA on ECHA’s list of substances of very high concern also means that it may be submitted to authorisation as a substance, with its uses subject to the granting of a temporary, renewable authorisation.
Bisphenol A is a synthetic chemical which has been used for over 50 years, mainly in the plastics industry. ANSES has identified close to sixty business sectors that are potential users of the substance in France. Studies by ANSES on the uses and health effects of bisphenol A, conducted as part of the National Endocrine Disruptor Strategy, led the Agency to recommend, as of September 2011, a reduction in population exposure to the substance through its substitution in food contact materials in particular. Therefore since 1 January 2015 bisphenol A has been banned in food containers in France, and has led to a significant reduction in exposure levels.
Furthermore, in 2012, in the framework of implementation of the European regulation on the labelling of chemical substances (CLP regulation), ANSES submitted a proposal to ECHA for amending the classification of bisphenol A in order to include it in category 1B – substances toxic to reproduction (fertility). This proposal was adopted by the European Commission in July 2016.
Following this, a measure restricting BPA use in certain widely available items such as receipts made of thermal paper, was also adopted by the European Commission in December 2016, based on a dossier filed by ANSES with ECHA as part of the REACh regulation.
Identification of bisphenol A as a substance of very high concern
The REACh regulation specifies that substances that may have serious and often irreversible effects on human health and the environment can be identified as substances of very high concern (SVHC). In February 2017, ANSES submitted a proposal to ECHA for identifying BPA as an SVHC based on its “endocrine disrupting” properties which cause probable serious effects to human health.
This proposal has just been adopted by the Member State Committee of ECHA. As a direct result of BPA’s identification as an SVHC, industry players will now have to notify ECHA of the presence of bisphenol A in all imported or manufactured items and must also inform buyers, upon request, when items contain the substance.
BPA’s inclusion on the list of substances of very high concern means that its uses may be limited and subject to the granting of a temporary, renewable authorisation.