15 Sept 2016
Negative Reaction to the Commission’s “Endocrine Disruptors” Package
On 3 August 2016, the European Chemical Industry Council (CEFIC) warned that the Commission’s criteria for the identification of endocrine disruptors are insufficient and therefore inadequate to protect the public and environment from their negative effects.
Hong Kong traders may recall that on 15 June 2016, the European Commission presented its long-awaited package relating to criteria for the identification of endocrine disrupting chemicals in plant protection products (also known as pesticides) and biocides.
It may be recalled that around a year earlier, in July 2015, the Commission had published a report of an online public consultation on defining criteria for identifying endocrine disruptors in the context of the implementation of the Plant Protection Products Regulation 1107/2009 and the Biocidal Products Regulation 528/2012.
Then on 16 December 2015, the EU’s General Court ruled in favour of Sweden in the controversial “endocrine disruptors” proceeding. The Court ruled that the European Commission breached EU law by failing to publish a definition for chemicals that have an adverse impact on hormones, namely, “endocrine disruptors”.
Following the demand for legally-binding scientific criteria to determine what an endocrine disruptor is, the Commission finally published its package, comprising an Impact Assessment Report, a Communication and two draft legal acts which set out the criteria.
Endocrine disrupting substances are chemicals that, according to experts, can be found in food and daily-use consumer products, including cosmetics, clothes, sports equipment, carpets and plastics. The chemicals, which are believed to be able to imitate hormones, have been linked to serious adverse health effects, such as hormonal cancers, fertility problems and autism.
Following the publication of the Commission’s package, the public was invited to provide feedback on the two legal draft acts to be adopted as part of the package. One of the two draft legal acts concerns the Biocidal Products legislation, while the other act will be brought under the Plant Protection Products legislation. The feedback mechanism procedure concluded on 28 July 2016. In total, it is reported that the Commission received 126 public responses concerning the draft legal act to be bought under the biocidal products legislation and 260 responses concerning the draft act for plant protection products.
On 5 August 2016, the criteria were further criticised by the environmental NGO ClientEarth, which claimed that the Commission’s rules to identify endocrine disruptors are illegal as they contradict the Plant Protection Products Regulation 1107/2009 and the Biocidal Products Regulation 528/2012. Furthermore, ClientEarth claimed that the proposal, which establishes rules for identifying endocrine disruptors, sets such a high burden of proof that it will leave people and the environment at risk of exposure.
ClientEarth claims that by limiting its definition of endocrine disruptors, the Commission contradicts the Pesticides and Biocides Regulations which state that a substance cannot be approved if it is considered to have endocrine disrupting properties that may cause adverse effects. ClientEarth argues that by contradicting an element of the regulations the Commission has thereby exceeded its power. ClientEarth states that such a change to the law should have been negotiated between the European Parliament and Council, and if forced through by the Commission, can be rejected by the European Court of Justice.
However, the Commission has stated that its scientific criteria are based on the World Health Organization (WHO) definition of an endocrine disruptor. In 2002, the WHO defined an endocrine disruptor as a substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub) populations. The Commission’s criteria specify how the identification of an endocrine disruptor should be carried out and state that, when identifying an endocrine disruptor, all relevant scientific evidence should be used, using an evidence-based approach, and applying a robust systematic review.
The EU’s CEFIC has claimed that the definition should incorporate all elements of hazard characterisation such as potency, severity, lead toxicity and (ir)reversibility. A hazard-based approach is also supported by the European Consumer Organisation (BEUC) particularly as chemicals with endocrine-disrupting properties can be found in everyday products such as children’s toys, cleaning products, food containers and food products.
The Commission has instructed the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) to examine whether approved individual substances that show indications of being endocrine disruptors, can be identified as such in light of the Commission’s new criteria. Their reports are awaited.
Hong Kong traders with interests in products containing endocrine disruptors can access the tabled criteria in the Commission's Communication.