27 Jan 2017
EU Upping Efforts to Restrict Use of Bisphenol A Under REACH
Hong Traders will be aware of the growing wave of opposition to the presence of Bisphenol A (BPA) in consumer products in the EU. The ubiquitous substance has already been singled out for restrictions on its use in food contract materials (FCMs), toys and baby bottles, due to its dangerous endocrine disrupting properties. Now two more developments, just recently announced, suggest that the EU’s determination to challenge the use of this high profile substance shows no signs of dissipating.
One of those developments relates to the Commission’s decision to restrict the concentration of BPA in thermal paper while the other relates to the European Chemical Agency (ECHA)’s announcement that BPA has been added to REACH’s candidate list of Substances of Very High Concern (SVHCs). The latter development, in particular, paves the way for a wider EU crackdown on the substance’s use in other products.
As for the first development, on 13 December 2016, the Commission published Regulation 2016/2235 restricting the maximum concentration of BPA in thermal paper to no more than 200 mg/kg. Thermal paper is a special type of paper with a chemical coating (often including BPA) that changes colour when exposed to heat, thus allowing printed characters to appear. It is used most commonly in devices such as cash registers, adding machines and credit card terminals.
The new Regulation is based on a proposal submitted by France outlining that under the current regime, workers, consumers and their unborn children are at risk of harmful exposure to BPA through the handling of receipts made of thermal paper.
Upon examination of the proposal, ECHA’s Committee for Risk Assessment (RAC) had found that health risks were adequately controlled for consumers but not for workers, particularly cashiers. It concluded that the proposed restriction was the most appropriate means to offer adequate protection.
Following this, ECHA’s Committee for Socio-Economic Analysis (SEAC) issued an opinion stating that the proposed restriction was unlikely to be proportionate from the perspective of a costs-benefits analysis, but raised possible favourable considerations. Especially, the fact that any affected sectors could offset their increased costs by redistributing them among their customers by means of a nominal increase in the price of goods. Like the RAC, it issued a positive decision in favour of pushing through the proposal.
Based on those opinions, the Commission concluded that the current risk to the health of workers handling thermal paper was unacceptable. The Commission therefore agreed to adopt the measure, proposed by France, as it would address the identified risks without imposing a significant burden on industry, the supply chain, or consumers.
The new law amends Annex XVII of REACH by introducing an entirely new entry 66 in that Annex. Hong Kong traders will be familiar with REACH; the regulation concerning the registration, evaluation, authorisation and restriction of chemicals in the EU.
The measure will become effective on 2 January 2020. After this date, thermal paper in a concentration equal to or greater than 0.02% by weight cannot be placed on the EU market.
The Commission has also added that it intends to monitor the use of bisphenol S (BPS) in thermal paper. It notes that BPS is a common substitute for BPA which, although not evaluated, may have a similar toxicological profile due to their structural similarities. To avoid circumvention of the measure relating to BPA, the Commission states that authorities will take regulatory actions to also restrict BPS under REACH, should this prove necessary.
The second recent development refers to ECHA’s announcement that it has added BPA to the REACH candidate list, after its Member State Committee unanimously agreed that it should be designated as an SVHC. BPA was formally placed on the candidate list on 12 January 2017. This means a proposal to restrict the substance to authorised uses looks set to follow.
Specifically, it may be proposed to add BPA to the list of substances subject to authorisation, set out in Annex XIV of REACH. If added, this would mean its use will have to be phased out for all purposes except those for which a time-limited authorisation for continued use has been granted. When such an authorisation runs out, another authorisation may be applied for via a costly process.
As regards the expected timeline for the adoption of such a proposal, it should be noted that some lower profile substances have remained on the candidate list for over eight years, and are still without proposed measures. Nevertheless, BPA’s characteristics as a widely used, high volume substance suggest proposals will be made much sooner.
Industry reaction to the decision has not been as gloomy as one might expect. This is because BPA producers consider that the substance’s main use is as an intermediate – specifically, in the manufacture of polycarbonate and epoxy resins – and as a consequence, is exempt from the authorisation process under REACH.
However, French authorities disagree, maintaining that its use in the manufacture of goods made of polycarbonate and its use in the blending of polycarbonate both qualify for the REACH authorisation process. According to them, its use as a laboratory reagent and antioxidant for processing PVC and its uses in professional repackaging and formulation would also be subject to REACH authorisation.