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.
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, and updated 2008. The BPA 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 is one of the first 36 substances to undergo the substance evaluation process.
In that context, in November 2013, ECHA requested further data on BPA in the area of skin contact and environmental exposure. The BPA REACH Consortium accepted the request and provided the additional input within the timeline by end of 2015. The substance re-evaluation under REACH is currently in the final phase; it is led by the German risk assessment authorities. The draft evaluation report is expected to become available in 2016.
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. In summer 2016 France submitted an Annex XV dossier, requesting to identify BPA as an SVHC based on the reprotox 1B classification. By February 2017, it announced a second dossier based on alleged endocrine active properties. The reprotox 1B classification of BPA entered into force in August 2016, it will apply from March 2018. It makes BPA eligible to be added to the Candidate list. Identification as an SVHC could be the entry point into a potential authorisation under REACH at a later stage.
However, BPA is mainly used as an intermediate to manufacture polymeric materials. Such intermediate uses are exempt from REACH authorisation. No direct impact of a potential authorisation would therefore be expected for polymeric uses of BPA such as in polycarbonate.
In the area of food contact applications, the use of BPA is in compliance with the Framework Regulation for all food contact materials (EC No 1935/2004) and permitted by the Regulation on plastics used as food contact materials (EU No 10/2011). Therefore, neither an identification of BPA as SVHC nor an eventual authorisation under REACH would affect its approved use as monomer in plastics for food contact applications such as polycarbonate.
In March 2015, the members of the REACH BPA Consortium, which represents leading producers and importers of BPA, decided to no longer cover the use of BPA in thermal paper in the joint dossier as the Consortium members do not dispose of the necessary information covering the entire life cycle of these uses.
During 2014 and 2015, based on a respective restriction proposal from France, ECHA´s Risk Assessment Committee (RAC) evaluated the use of BPA in thermal paper. In its June 2015 opinion the Committee stated unequivocally: "Significantly, RAC did not identify a risk for consumers", thus being consistent with the EFSA opinion on BPA (January 2015) confirming the safety of these applications for consumers. At the same time, RAC proposed that the use of BPA in thermal paper for cashiers handling point of sale tickets and cash slips should be restricted.
In December 2015, ECHA´s Socio Economic Assessment Committee (SEAC) concluded that the socio-economic benefits of restricting bisphenol A (BPA) in thermal paper are unlikely to be higher than the socio-economic costs of the proposed restriction, however also noted that there could be other considerations in favour of the restriction that should be taken into account.
In April 2016, the European Commission concluded, that the restriction proposed by France is an appropriate Union wide measure to address the identified risks to the health of workers who handle point of sale receipts made of thermal paper containing BPA. Thus the EU COM proposed to add the following entry in Annex XVII to Regulation (EC) No 1907/2006: “Shall not be placed on the market in thermal paper in a concentration equal to or greater than 0,02 % by weight …”
The measure was adopted in the REACH Committee on 6 July, and forwarded on 15.7. to the European Parliament and Council for the three month scrutiny period. If not opposed, it will be adopted by the Commission and then be published in the Official Journal of the EU. The Regulation will then enter into force 20 days after the publication in the OJ. The restriction will apply 36 months after the Regulation comes into force.
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.
In March 2014, the Risk Assessment Committee supported a dossier filed by France proposing to re-classify BPA as reprotoxic 1B i.e. ‘presumed human reproductive toxicant’, under the EU Regulation on the classification, labelling and packaging of substances and mixtures EC No 1272/2008 (CLP). In February 2016, the REACH Committee supported the adoption of the proposal from the European Commission to re-classify BPA, following the respective 2014 RAC opinion. As a consequence, BPA will be re-classified as reprotoxic 1B, i.e. ‘presumed human reproductive toxicant’, under the EU Regulation on the classification, labelling and packaging of substances and mixtures EC No 1272/2008 (CLP). BPA was previously classified as reprotoxic 2, ‘suspected human reproductive toxicant’, under the CLP.
The new classification was published in the Official Journal of the EU on July 20, 2016. It will enter into force 20 days after publication of the 9th ATP, and applies from March 1st 2018, leaving a transition phase of 19 months.
The reclassification of BPA will not have any impact on consumer products made from BPA-based materials, i.e. polycarbonate and epoxy resins. BPA can continue to be used in food contact applications for consumers. The use of BPA in food contact materials is in compliance with the Framework Regulation for all food contact materials (EC No 1935/2004) and permitted by the Regulation on plastics used as food contact materials (EU No 10/2011). The reprotox 1B classification of BPA – when it is enforced – will not affect compliance of BPA based food contact materials with the respective legislation.
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