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EUROPEAN LEGISLATION ON CHEMICALS
In the European Union, the manufacture and use of chemical substances – including Bisphenol A (BPA) – must comply with a comprehensive legislative framework.
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 CLP Regulation (EC) No 1272/2008 is the European Regulation on Classification, Labelling and Packaging of chemical substances and mixtures. The CLP ensures that hazards presented by chemical substances and mixtures are clearly communicated to workers and consumers in the EU through classification and labelling.
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.
Under REACH, manufacturers and importers are required to register their substances with the European Chemicals Agency (ECHA).
For a substance manufactured or imported in a quantity ≥1 tonne/year manufacturers must compile a Technical Dossier on the physico-chemical, human health and environmental properties of that substance. For a substance manufactured or imported in a quantity ≥10 tonnes/year, like BPA, a Chemical Safety Assessment must be carried out and documented in a Chemical Safety Report (CSR).
The leading manufacturers and importers of BPA formed the BPA REACH Consortium and developed the registration dossier for BPA, based on the EU BPA Risk Assessment Report 2003, updated 2008. The BPA registration dossier was submitted to ECHA in August 2010.
Under a 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. The objective is to request further information from the registrants of the substance to verify any suspected concern. BPA has been 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.
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.
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 would be 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.
In August 2016, the French authorities submitted a proposal to identify BPA as a substance of very high concern due to its CMR 1B classification. Following ECHA’s Member State Committee agreement in December 2016, as of 12 January 2017 BPA has been included in the Candidate List of substances of very high concern, based on its harmonised classification as reprotox 1B.
In March and September 2017, the French and German authorities respectively submitted proposals to identify BPA as a substance of very high concern due to alleged endocrine disrupting properties for human health and the environment. Following ECHA’s Member State Committee agreements, the entry in the Candidate List has been updated to cover alleged endocrine disrupting properties.
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 for the use of BPA in thermal paper.
The restriction was published in the Official Journal of the EU on 13 December 2016. It entered into force 20 days later, i.e. 2 January 2017. After a 3 year transition phase the restriction will be fully applicable as of 2 January, 2020.
The CLP Regulation (EC) No 1272/2008 is the European Regulation on Classification, Labelling and Packaging of chemical substances and mixtures.
The CLP ensures that hazards presented by chemical substances and mixtures are clearly communicated to workers and consumers in the EU through classification and labelling.
At the initiative of the French authorities, Bisphenol A (BPA) has been reclassified from a category 2 reprotoxic substance to a category 1B reprotoxic substance. This is not the result of new scientific data, but the effect of an adapted interpretation of the classification criteria. The new classification applies from 1 March 2018.
Whilst the CMR 1B classification can trigger certain processes under REACH (as described above), the new classification of BPA – when it is enforced – will not affect compliance of BPA-based food contact materials with the respective legislation.
Criteria to identify endocrine disruptors
Within REACH, substances suspected of having endocrine disrupting properties are not yet assessed based on regulatory criteria. Instead, authorities and experts review available data using a number of reference documents such as the OECD Guidance Document on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption.
In accordance with the Regulations on Biocides and Plant Protection Products, the European Commission had to define criteria for identifying endocrine disruptors. On 4 July 2017, more than a year after the European Commission published the first proposal for criteria to identify endocrine disruptors, Member States’ representatives formed a qualified majority supporting the most recent version of the proposal. The criteria are based on the WHO-criteria, but are modified in certain elements. In the short term, these criteria will only apply to biocides and plant protection products. The Commission has however indicated that they will also be used as basis beyond these regulations and would eventually be applied in other pieces of EU legislation, e.g. REACH.
The European Food Safety Authority (EFSA) and ECHA are developing guidance for the implementation of the criteria.