By Paul Davies and Michael Green
On 16 June 2017, the Member State Committee (MSC) of the ECHA unanimously agreed to identify BPA as a substance of very high concern (SVHC) under the REACH regime. BPA is common in a variety of household products, typically used in the manufacture of plastics and resins found in insulation, reusable containers and bottles, kettles, and DVDs. This identification follows the 2011 EU ban on BPA as an ingredient in babies’ bottles.
At the end of 2015, the European Commission (EC) proposed a roadmap — Proposal for a new measure on bisphenol A (BPA) in food contact materials — to harmonise BPA classification. Further, the British Plastics Federation (BPF) contributed to the Joint Value Chain Input to DG Health & Food Safety in support of option 3 of the roadmap, which proposed a decrease in the migration limit from 0.6mg/kg to 0.05mg/kg. This new Specific Migration Limit (SML) came into force in March 2016, and is applicable to plastics, coatings, and varnishes for metals and other food contact sources of BPA. In addition, in October 2016, the European Food Standards Agency (EFSA) published a review of two 2014 studies, concluding that “New data confirm EFSA’s previous conclusion that BPA might affect the immune system in animals but the evidence is too limited to draw any conclusions for human health.” As a result, EFSA stands by its original position of January 2015 that there is “no consumer health risk from BPA exposure at current exposure levels.” Some argue that, as BPA is one of the most researched chemicals in the industry, and as there are safety measures such as the new SML in place, both the public and the environment are adequately protected. The risk of BPA has also been extensively assessed within the areas of consumer, worker, and environmental safety to ensure that there is no health risk at current exposure levels.
France had initially proposed the re-categorisation of BPA due to the chemical’s well-known endocrine disrupting properties. The MSC were in unanimous agreement on this given the concern that BPA’s serious effects on human health are equivalent to carcinogenic, mutagenic, and toxic to reproduction (CMRs category 1A or 1B) substances. SVHCs will gradually be included in Annex XIV to the REACH Regulation. Once included in this Annex, these substances cannot be placed on the EU market or used in the EU after a set date, unless the EU grants a company prior authorisation.
This has various implications for the plastics industry in relation to BPA-related manufacture of goods. The lack of effective alternatives is a potential area of concern. There is also some confusion about whether the uses of BPA fall under the REACH restrictions. For example, BPA is predominantly used as an intermediate in the production of epoxy resins, and as a monomer in the production of polycarbonates in the plastics industry. However, as intermediates and monomers are not subject to authorisation under REACH legislation, the proposal to list BPA as an SVHC raises questions as to its application as a monomer and/or intermediate and which legislation would apply.
Despite the SVHC identification, it is possible that companies producing and/or using BPA could decide to challenge the ECHA’s decision before the EU courts. Industry stakeholders should stay tuned.
This post was prepared with the assitance of Ei Nge Htut in the London office of Latham & Watkins.
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