EUROPEAN LEGISLATION ON BPA
In the European Union, the manufacture and use of chemical substances – including Bisphenol A (BPA) – must comply with a comprehensive legislative framework.
The European Union has one of the most comprehensive regulatory frameworks on chemicals in the world. This section highlights some of the main regulations on BPA in Europe. For more information, please refer to our resource hub.
REACH is the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals and constitutes the framework legislation on chemicals in the EU (Regulation (EC) No 1907/2006).
The main aim of REACH is to improve the protection of human health and the environment from risks that may be posed by chemical substances, while enhancing innovation and competitiveness of the EU chemicals industry. This is done by the four processes of REACH, namely the registration, evaluation, authorisation and restriction of chemicals.
All chemical substances on the EU market have to be registered under REACH. To register a substance, manufacturers have to provide a comprehensive dataset containing hazard information and, where relevant, an assessment of the risks that the use of the substance may pose and how these should be controlled.
Bisphenol A was amongst the first substances to be registered under REACH. The first registration dossier was submitted in March 2011 and has been regularly updated since then. The registration dossier of the substance has been jointly prepared by European manufacturers and importers of the substance and can be found here.
Under the so-called Community Rolling Action Plan (CoRAP) established by ECHA, REACH substance dossiers can be evaluated to clarify any grounds for considering whether a substance constitutes a risk to human health or to the environment. Based on the evaluation further information may be requested from the registrants of the substance to verify any suspected concern.
Back in 2012, BPA was included on the first Community Rolling Action Plan for substance evaluation and in 2013 the German Authorities (BfC, BfR and UBA) started the formal assessement of the substance by issuing a Decision including a formal request to BPA registrants for further information requirements. Based on the registration updates provided by the registrants and further information supplied during the follow-up phase, Germany finalised the evaluation in 2016 concluding that follow-up regulatory action at EU level was needed and that BPA had to be identified as a substance of very high concern (SVHC). The evaluation conclusions can be found here.
Under REACH, restrictions are a targeted risk management tool to protect human health and the environment from unacceptable risks posed by chemicals. Restrictions may limit or ban the manufacture, placing on the market or use of a substance.
At the initiative of the French authorities, a targeted restriction has been adopted which restricts the use of BPA in thermal paper. During their assessment, the ECHA Committees did not identify a risk for consumers. It was however concluded that potential risks to the health of workers that are handling the receipts should be addressed by setting a concentration limit of 0.02 % (w/w) for the use of BPA in thermal paper. The restriction is fully applicable since 2 January 2020.
The German authorities have communicated their intention to further restrict the use of BPA due to alleged risks to the environment in October 2020. Germany is proposing to restrict the level of free BPA in articles and mixtures and to limit the releases from articles. Germany has 12 months from the publication of its intention to submit its restriction proposal.
The route to authorisation starts when a Member State or ECHA, at the request of the Commission, proposes a substance to be identified as an SVHC. The aim is to progressively replace such substances by less dangerous substances or technologies where technically and economically feasible alternatives are available.
Annex XIV of REACH lists the substances subject to authorisation obligations. Once included in that annex, a substance cannot be placed on the market for a use or used after a given date (the so-called 'sunset date') unless the companies concerned, who cannot replace that substance, are granted a dedicated authorisation for the specific use(s). The authorisation is time limited and subject to renewal.
The formal first step is SVHC identification, which could ultimately lead to Authorisation requirements under REACH.
The identification as an SVHC is based on hazard properties, without considering its actual use, real-life exposure and respective potential risk. Once identified, SVHCs are added to the "Candidate List for Authorisation".
Following further assessment, ECHA regularly prioritises substances from the Candidate List and proposes their inclusion into the Authorisation List (REACH Annex XIV).
Bisphenol A (BPA) has been identified as SVHC and included in the REACH Candidate List of Substances of Very High Concern (SVHC) for Authorisation, based on three reasons:
- January 2017, based on its classification as toxic for reproduction category 1B (dossier provided by France)
- July 2017, based on alleged endocrine disrupting (ED) properties for human health (dossier provided by France)
- January 2018, based on alleged endocrine disrupting (ED) properties for the environment (dossier provided by Germany).
The European Commission is currently preparing the final list of substances to be included in the Authorisation list. The final transposition of this 9th prioritisation is expected to take place at the earliest by the end of 2021.
As a matter of principle intermediate uses are exempt from Authorisation requirements under REACH. A potential entry of BPA into the Authorisation list would therefore only apply to non-intermediate uses of BPA.
The CLP Regulation (EC) No 1272/2008 is the European Regulation on Classification, Labelling and Packaging of chemical substances and mixtures.
The CLP aims at ensuring that hazards presented by chemical substances and mixtures are clearly communicated to workers and consumers in the EU through classification and labelling.
Bisphenol A is classified in the EU as a substance that causes toxic effects on our ability to reproduce (Repr. 1B); may cause respiratory irritation (STOT SE 3); causes serious eye damage (eye dam. 1); and may cause skin allergies (skin sens. 1).
In addition to the existing classifications, in April 2019, the German authorities have submitted their proposal to classify BPA as hazardous to the aquatic environment, both acute and chronic category 1. The proposal has been assessed by ECHA’s Risk Assessment Committee which adopted its opinion in October 2020. ECHA has sent the RAC opinion along with its annexes to the European Commission for its decision The Commission, assisted by the expert group CARACAL (the Competent Authorities for the REACH and CLP Regulations), will prepare a delegated act for the classification and labelling of BPA, in accordance with the CLP Regulation and with consultation of stakeholders. The adoption of the delegated act will be the notified to the Council and the European Parliament and if o objection is raised the European Commission will be allowed to include the substances in Part 3 of Annex VI to the CLP Regulation. Delegated Acts are published in the Official Journal after the expiry of the objection period.