The Committee for Socio-economic Analysis (SEAC) opinions are based on Bisphenol A (4,4'-isopropylidenediphenol, BPA) in thermal paper and pentadecafluorooctanoic acid (PFOA), its salts and PFOA-related substances.
SEAC prepares opinions of the European Chemicals Agency (ECHA) related to the socio-economic impact of legislative actions on chemicals in the REACH process. Final decisions are taken by the European Commission.
Both consultations are open until 16 November.
PFOA restriction proposal
For PFOA, the restriction proposal is based on concerns caused by the PBT properties of PFOA. It is also highlighted that PFOA is ubiquitous in the environment and in humans, and it has the potential for environmental long-range transport.
Uses of PFOA and PFOA-related substances are reported to be wide-dispersive. Consumer articles and mixtures are placed on the market in all EU Member States.
SEAC considered there is no other foreseeable option than a restriction under REACH to bring significant emission reductions in an acceptable time horizon.
Several manufacturers, under the US EPA Stewardship Program, have voluntarily phased out PFOA.
BPA in thermal paper
A restriction on BPA reads: “Shall not be placed on the market in thermal paper in concentration equal to or greater than 0.02% by weight, after [entry into force + 36 months].”
The dossier reveals the low concentration limit in the proposed restriction is equivalent to a total ban. It is expected BPA will be fully phased out, removing all human exposure from thermal paper.
However, the least expensive alternative is BPS, which is suspected to have many of the same adverse health effects as BPA. A restriction on BPA in thermal paper may only ensure there is a reduction in risk if alternatives other than BPS are chosen by industry as a replacement.
France considered the expected price increase for thermal paper, when switching from BPA to other dye developers. The alternatives included in the analysis are: BPS, D8, and Pergafast 201.
The medium scenario substitution costs are estimated to be in the range €1m to €22m per year. Excluding BPS the range is €19m to €22m per year.
Compliance control costs in the range €150k–€250k per year are expected.
A RAC opinion concluded the risks from BPA in thermal paper to human health are adequately controlled for consumers across the EU so SEAC concluded that action in this regard was not justified on an EU wide basis.
The Committee for Risk Assessment (RAC) prepares the opinions of ECHA related to risks of substances to human health and the environment in REACH and CLP processes.
However, RAC concluded that risks from BPA in thermal paper to human health are not adequately controlled for workers across the EU, and measures to minimise exposure should be implemented.
Based on this, SEAC concluded action to address risks is justified on an EU wide basis.
2012 BPA law
Last month, the ban in France was lifted concerning the manufacture and export of BPA-based food contact materials out of the country but remained in place for items made inside France.
Jasmin Bird, communications manager for the Polycarbonate/BPA-Group of PlasticsEurope, said the French law ignores existing EU food contact regulation and is in direct contradiction to the EFSA opinion.
“The law provides no additional safety benefit for consumers, but creates a severe obstacle to the free movement of goods in the European Union and severely damages the impacted industries in Europe and beyond. Based on scientific and legal facts there is no justification for the French law.
An EFSA opinion in January put the safe level of BPA from 50 micrograms per kilogram of body weight per day (μg/kg of bw/day) to 4 μg/kg of bw/day.
Highest estimates for dietary exposure and for exposure from various sources are three to five times lower than the new TDI.
“From an EU law point of view, the European Commission could start an infringement procedure against the French Government at any time even though the main part of the law has been declared compatible with the French Constitution, because the law infringes valid EU law.”
Bird said evidence-based and thorough risk assessment is, and must remain, the sound and reliable basis for ensuring consumer protection in Europe.
“Starting to give way to disproportionate regulatory responses – like the French ban - to a presumed consumer risk which has been clearly refuted by EFSA as well as by other notable regulatory authorities, would severely weaken the reliability of the European food safety system, which is one of the strictest in the world.
“An increasingly fragmented European market with different national restrictions does not benefit consumer health. Based on scientific facts there is no justification for the French law, and it should therefore be removed in its entirety.”
Belgium is working on a dossier on Bisphenol S and Sweden is preparing dossiers on Bisphenol F/AF.
In CoRap, Germany leads the process of BPA substance evaluation within REACH. This has an official timeline at end of this year for final provision of updated documents by industry, followed by evaluation of the authorities.