On 5 September 2018, the European Chemicals Agency ECHA published its draft proposal to include 18 new substances in the REACH Authorisation List1. Bisphenol A (BPA) is included in the draft proposal.
This paper explains the status of the process and gives the industry position on any potential impact of an inclusion of BPA into the Authorisation list (Annex XIV) on polycarbonate and epoxy resin.
BPA in the Authorisation process
Inclusion in the Candidate List
Bisphenol A (BPA) is included in the REACH Candidate List of Substances of Very High Concern (SVHC) for Authorisation, based on three parameters: classification as toxic for reproduction category 1B, alleged endocrine disrupting (ED) properties for human health, as well as alleged endocrine disrupting (ED) properties for the environment.
9th recommendation for the Authorisation list
ECHA proposes to the Commission substances from the Candidate List of SVHC´s for Authorisation for inclusion in the Authorisation list, based on a series of pre-defined prioritization criteria. The most recent ECHA draft recommendation proposal includes BPA. The proposal was subject to three months of public consultation. The 90-day public consultation2 on the ECHA proposal to recommend inclusion of BPA into the Authorisation list ended December 5.
105 days after closure of public consultation the ECHA Member State Committee will issue its opinion, likely close to the end of first quarter of 2019. Subsequently, ECHA will submit the final recommendation for prioritisation to the Commission in the second quarter of 2019.
In parallel to the ECHA public consultation, the European Commission called for information on the possible socio-economic consequences of including BPA and 17 other substances in the Authorisation List. The information received will be passed on directly to the Commission. Further steps between the Commission and the Member States Committee will follow until a final
decision about which substances to be included in the Authorisation list would be taken. Inclusion of BPA in the Authorisation list (REACH Annex XIV) could occur at the earliest during 2020.
The vast majority of BPA uses included in the joint registration dossier would not be affected by a potential inclusion of BPA into the Authorisation list under REACH
BPA is predominantly used as an intermediate to manufacture polymeric materials, mainly polycarbonates and epoxy resins. Intermediates are exempt from Authorisation requirements under REACH. A potential inclusion of BPA in the Authorisation list would therefore only apply to approx. 1% of the overall uses of BPA, i.e. its non-intermediate uses, such as the use as additive or in specific formulations.
Assessment of consequences of potential Authorisation of BPA
The identification as SVHC, the proposed prioritisation for Authorisation, and certainly a potential later Authorisation under REACH may have the effect of a “blacklisting” of the substance. Authorisation is often misinterpreted as “Danger”, “Must be avoided”, “Can no longer be used” or “Is banned or will be banned.”. However, the facts are different:
- The identification as SVHC and inclusion in the Candidate List does not mean that the use of BPA presents a risk. SVHC identification is a hazard-based approach. That means it is based on the intrinsic properties of a substance, without considering actual use, real-life exposure and risk.
- The inclusion of a substance in the SVHC Candidate List, followed by prioritisation
recommendation, and eventual Authorisation under REACH, does not automatically lead to a ban of the uses of the substance. In the case of BPA, the vast majority of its current uses are intermediate uses, which would be exempted from Authorisation obligations.
- BPA-based polymers can continue to be used in food contact applications for consumers. The SVHC-identification and inclusion in the Candidate List, as well as the proposed prioritisation for Authorisation, and even an eventual later inclusion in the Authorisation list would not impact compliance of BPA-based food contact materials with the respective legislation: BPA-based polymers are strictly regulated under the food contact legislation (EC No 1935/2004, No 10/2011 and EU Regulation 2018/213).
For further information please contact:
Jasmin Bird, PC/BPA-Group PlasticsEurope
firstname.lastname@example.org , www.bisphenol-a-europe.org