PLASTICS AND HEALTH
EU Commission finally presents proposals for regulating endocrine disruptors / Trade associations critical / Forward strategy based on WHO criteria
More than two years behind schedule, the European Commission (EC) on 15 June presented its proposals for regulating suspected endocrine disruptors such as phthalates used in plasticisers or bisphenol A, the chemical used to produce polycarbonate and epoxy resin-based can liners. While the Commission said it would be the first-ever to take action in this field, some industry stakeholders wondered aloud why it took so long to develop a strategy based simply on criteria long established by the World Health Organization (WHO).
Criticism focused in major part on the Commission’s statement that it would base its approach on scientific data defined by WHO. This classifies a substance as an endocrine disruptor if it has an adverse effect on human health, an endocrine mode of action or if there is a causal link between the adverse effect and the mode of action. While the EC said it uses “a weight of an evidence-based approach and applying a robust systematic review,” chemical and plastics industry stakeholders expressed scepticism that this approach would work.
In a joint statement, the European Chemical Industry Council (Cefic; www.cefic.org), the European plastics producers association PlasticsEurope (Brussels / Belgium; www.plasticseurope.org) and the European Crop Protection Association said that while acknowledging the WHO’s definition, they were “disappointed that we still do not have a set of scientific criteria that are suitable for the purposes of regulatory decision making.” Trade groups and environmentalists alike were unhappy about the lack of a consensus as to whether a hazard-based or a risk-based approach to regulation should be taken.
“The decision as to whether a substance is in need of regulation should take into account the severity of harmful effects, the reversibility of a negative effect and the informative value of scientific data,” said the German chemical industry association Verband der Chemischen Industrie (www.vci.de). PlasticsEurope was especially concerned about the lack of commonly accepted working criteria, which its executive director, Karl-H. Foerster, said “would allow differentiation between a substance of regulatory concern and a substance of no or low concern.” In part, disagreements about this differentiation have held up regulation of products such as BPA or the herbicide ingredient glyphosate.
The Commission’s position is that endocrine disruptors must first be defined before the regulatory process can begin. As a first step, it said it would ask the European Food Safety Authority (EFSA; www.efsa.europa.eu) and the European Chemicals Agency (ECHA; http://echa.europa.eu), the body that administrates REACH, to study whether individual substances already approved in the EU can be identified as endocrine disruptors. This, it said, would help to ensure that the two agencies are “ready to apply the criteria” as soon as the rules enter into force. Along with defining criteria, the EC said it would step up efforts to minimise exposure to endocrine disruptors, in the short term through research and international cooperation, in the mid-term through developing test methods, and in the long term through regulation.
Legislation regulating endocrine disruptors was originally scheduled to be presented by the Commission in December 2013. Several EU member states have already clashed with Brussels over its perceived foot dragging, with mixed results. In 2014. Denmark had to back away from plans to single-handedly ban certain phthalates – see Plasteurope.com of 17.07.2014. However, a year later, Sweden won a lawsuit as the EU’s second highest court, the General Court in Luxembourg, ruled the Commission had breached EU law by not making provisions to identify such chemicals in everyday products, despite having a “clear, precise and unconditional obligation” to do so by December 2013 – see Plasteurope.com of 22.12.2015. Most recently, France hit a stone wall in its attempt to place its proposition for reclassifying BPA on the agenda of the Commission’s regulatory committee meeting – see Plasteurope.com of 06.06.2016. In early June, the European Parliament adopted a resolution demanding immediate action on endocrine disruptors.
Criticism focused in major part on the Commission’s statement that it would base its approach on scientific data defined by WHO. This classifies a substance as an endocrine disruptor if it has an adverse effect on human health, an endocrine mode of action or if there is a causal link between the adverse effect and the mode of action. While the EC said it uses “a weight of an evidence-based approach and applying a robust systematic review,” chemical and plastics industry stakeholders expressed scepticism that this approach would work.
In a joint statement, the European Chemical Industry Council (Cefic; www.cefic.org), the European plastics producers association PlasticsEurope (Brussels / Belgium; www.plasticseurope.org) and the European Crop Protection Association said that while acknowledging the WHO’s definition, they were “disappointed that we still do not have a set of scientific criteria that are suitable for the purposes of regulatory decision making.” Trade groups and environmentalists alike were unhappy about the lack of a consensus as to whether a hazard-based or a risk-based approach to regulation should be taken.
“The decision as to whether a substance is in need of regulation should take into account the severity of harmful effects, the reversibility of a negative effect and the informative value of scientific data,” said the German chemical industry association Verband der Chemischen Industrie (www.vci.de). PlasticsEurope was especially concerned about the lack of commonly accepted working criteria, which its executive director, Karl-H. Foerster, said “would allow differentiation between a substance of regulatory concern and a substance of no or low concern.” In part, disagreements about this differentiation have held up regulation of products such as BPA or the herbicide ingredient glyphosate.
The Commission’s position is that endocrine disruptors must first be defined before the regulatory process can begin. As a first step, it said it would ask the European Food Safety Authority (EFSA; www.efsa.europa.eu) and the European Chemicals Agency (ECHA; http://echa.europa.eu), the body that administrates REACH, to study whether individual substances already approved in the EU can be identified as endocrine disruptors. This, it said, would help to ensure that the two agencies are “ready to apply the criteria” as soon as the rules enter into force. Along with defining criteria, the EC said it would step up efforts to minimise exposure to endocrine disruptors, in the short term through research and international cooperation, in the mid-term through developing test methods, and in the long term through regulation.
Legislation regulating endocrine disruptors was originally scheduled to be presented by the Commission in December 2013. Several EU member states have already clashed with Brussels over its perceived foot dragging, with mixed results. In 2014. Denmark had to back away from plans to single-handedly ban certain phthalates – see Plasteurope.com of 17.07.2014. However, a year later, Sweden won a lawsuit as the EU’s second highest court, the General Court in Luxembourg, ruled the Commission had breached EU law by not making provisions to identify such chemicals in everyday products, despite having a “clear, precise and unconditional obligation” to do so by December 2013 – see Plasteurope.com of 22.12.2015. Most recently, France hit a stone wall in its attempt to place its proposition for reclassifying BPA on the agenda of the Commission’s regulatory committee meeting – see Plasteurope.com of 06.06.2016. In early June, the European Parliament adopted a resolution demanding immediate action on endocrine disruptors.
20.06.2016 Plasteurope.com [234332-0]
Published on 20.06.2016