EUROPEAN LEGISLATION ON BPA
The European Union has one of the most comprehensive regulatory frameworks on chemicals in the world. The manufacture and use of chemical substances – including Bisphenol A (BPA) – must comply with a comprehensive legislative framework.
This section highlights some of the main features of current regulations on BPA in Europe.
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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. BPA was one of the first 36 substances to undergo the substance evaluation process. The substance evaluation, led by the German risk assessment authorities was concluded in December 2017. 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 on BPA was 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.
In October 2020, the German authorities communicated their intention to restrict the use of BPA due to alleged risks to the environment; the process is ongoing.
Under REACH „substances of very high concern“ (SVHC) may become subject to “Authorisation” in order to ensure that the risks from these substances are properly controlled. SVHC identification is a hazard-based approach: It is based solely on the intrinsic properties of the substance, without considering its actual use, real-life exposure and respective potential risk. It is the formal first step which can ultimately lead to Authorisation requirements under REACH.
Substances may be identified as an SVHC based on hazard properties, e.g. substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in accordance with the CLP Regulation (EC) No 1272/2008. As a first step, substances of very high concern are added to the "Candidate List for eventual inclusion in the Authorisation List". Following further assessment, ECHA may decide to prioritise substances from the Candidate List to propose their inclusion into the Authorisation List.
Bisphenol A (BPA) was 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 list of substances to be included in the Authorisation list based on the 9th prioritisation list from ECHA.
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 may damage fertility (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 April 2019, the German authorities submitted the proposal to classify BPA as hazardous to the aquatic environment, both acute and chronic category 1. The proposal was assessed by ECHA’s Risk Assessment Committee which adopted its opinion in October 2020. If no objections are raised in the following procedures, the Commission is expected to include BPA into Part 3 of Annex VI to the CLP Regulation. Implementation into national legislation then follows.