23 Dec 2016
European Commission’s Definition of Endocrine Disruptors Still Controversial Despite Revisions, Meeting Persistent Opposition from Member States
Hong Kong traders may be interested to know that the European Commission has recently made revisions to its proposed EU regulatory definition of endocrine disrupting chemicals (EDCs) in an attempt to address Member States’ concerns that the proposals will weaken protection for human and animal health, as well as the environment. Discussions with Member States and experts are ongoing and the criteria are expected to enter into force in 2017.
Endocrine disrupting substances are chemicals that, according to experts, can be found in food and daily-use consumer products. These include several exported to and sold in the EU by Hong Kong manufacturers, such as 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, including hormonal cancers, fertility problems and autism.
A report published by Public Health France on 7 December 2016 revealed traces of at least one endocrine disruptor in almost all of the 4,000 pregnant women who took part in the survey. Bisphenol A was discovered in over 70% of the women surveyed and more than 99.6% of the urine samples analysed also had traces of phthalates. According to the report, the main source of exposure was through food consumption, as well as indoor and outdoor air. The results were at lower levels than previous studies, partly due to the introduction of regulatory measures.
Hong Kong sellers of a variety of consumer goods may recall that on 15 June 2016, the European Commission presented its long-awaited package relating to criteria for the identification of EDCs in plant protection products (also known as pesticides) and biocides. The Commission proposed to change the definition of EDCs so that only substances proven to have adverse effects on human health could be classified as endocrine disruptors. However, the proposal to change the wording from “may cause” adverse effects to humans to “known to cause” adverse effects was strongly criticised by some Member States for lowering the standard of protection. This criticism prompted the Commission to revert to the phrase “may cause adverse effects” and to drop the alternative proposed phrasing.
On 18 November 2016, a standing committee meeting with experts and Member States took place in Brussels with the aim of discussing the revised version of the draft criteria. According to the Commission, the revised criteria clarify the scope of the World Health Organisation (WHO) definition of EDCs, the burden of proof, and the kind of scientific evidence that can be used to identify endocrine disruptors. After the meeting, only one Member State indicated that it would support the Commission’s proposed text, while four Member States were against the draft act, and two Member States indicated that they would abstain if they were required to vote. A staggering 17 Member States had not yet adopted a final position on the draft changes, and four Member States were absent.
The results of the meeting are consistent with campaigners’ predictions that the Commission’s latest revisions would likely not be enough to persuade Member States to accept the Commission’s proposals. Before the Commission’s change in approach, it was reported that Member States, including France, Italy, Spain and Germany, indicated that they would block the proposals. The main reason for this was that the Commission’s proposed wording would set an excessively high level of proof to classify a substance as an EDC.
Member States expressed concern over the proposed wording representing a shift away from the precautionary approach, traditionally favoured by the EU, and pointed out it was inconsistent with the WHO’s definition of an EDC. In particular, the change in the wording of the terms “negligible exposure” to “negligible risk”, which shifted EDC testing from a “hazard”-based to a “risk”-based assessment approach has been a cause for concern, especially for Germany. In documents outlining its position, Germany called on the Commission to elaborate on why the change in phrasing was necessary.
Campaigners at Pesticide Action Network Europe (PAN) stated that the Commission’s most recent revision to its proposals will “make life easier” for Member States because it maintains the status quo that the burden of proving that the chemical is not an EDC falls on the applicant. Therefore, according to PAN, Member States will not have the “impossible” challenge of proving a substance is a known EDC.
In addition, many Member States have continued to challenge whether the Commission is acting beyond the scope of its given mandate under the Plant Protection Products Regulation by changing the criteria. Such concerns prompted the EU’s Commissioner for Health and Food Safety, Vytenis Andriukaitis, to publically rebut accusations that the Commission was exceeding its powers by introducing the suggested amendments to the Regulation which should in theory only be agreed upon by the EU legislature. He relied on the fact that the Regulation contained a provision which foresaw the possibility of introducing amendments “in light of scientific progress”.
A fourth meeting with experts and Member States is scheduled for the second half of December 2016 to discuss the revised version of the texts, in which the Commission has addressed the latest comments received from Member States regarding the burden of proof and the scope of the criteria.
Once the criteria for the identification of EDCs have entered into force, harmonised guidance will be necessary to ensure that they can be applied consistently and in a timely manner by applicants and authorities in the EU. EFSA and ECHA, supported by the Commission’s Joint Research Centre, declared that they will produce an outline of the guidance. A draft document is expected to be prepared during the first half of 2017 and made available for public consultation. The finalised guidance is anticipated for next year.