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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.

REACH

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.

Registration

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.

Evaluation

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.

Authorisation

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, i.e. 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 could 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 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.

Bisphenol A (BPA) has been included in the REACH Candidate List of Substances of Very High Concern (SVHC) for Authorisation, based on three parameters:

  • 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).

On Sept 5, 2018, the European Chemicals Agency ECHA published its draft proposal to include 18 new substances in the REACH Authorisation List. Bisphenol A (BPA) is included in the draft proposal. This draft proposal is now subject to public consultation, ending December 5. About three months later the ECHA Member State Committee is expected to issue its opinion on the draft proposal.  After submission of the ECHA proposal to the Commission further steps between the European Commission and the Member States Committee need to follow until a final decision would be taken, which substances to be included in the Authorisation list. This will be earliest in 2020.

The vast majority of BPA-uses would not be affected by a potential entry of BPA into the Authorisation list under REACH. BPA is predominantly used as an intermediate to manufacture polymeric materials, mainly polycarbonates and epoxy resins. Such intermediate uses are exempt from Authorisation requirements under REACH. A potential entry of BPA into the Authorisation list would therefore only apply to about 1% of the uses of BPA (non-intermediate uses, such as use as an additive), while its intermediate applications, the vast majority of its uses, would be unaffected. Subjecting BPA to Authorisation obligations under REACH would therefore have limited impact.

Restriction

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.

CLP

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 since 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. 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.