Regulatory Developments

Scientists Issue Letter Criticizing EDC Criteria And Other Recent BPR Developments

July 28, 2016 PRINT

Scientists Issue Letter Criticizing EDC Criteria: On July 6, 2016, a group of 15 European and U.S. researchers wrote to the European Union's (EU) Health and Food Safety Directorate, criticizing recent proposals for the identification of endocrine disrupting chemicals (EDC) under the Plant Protection Products (PPP) Regulation and the Biocidal Products Regulation (BPR).

The scientists addressed two major concerns relating to the proposed criteria:

  • The criteria place an "under-defined, potentially unprecedentedly high, burden of proof" on identifying problem compounds as having endocrine-disrupting properties, with the result that the identification process will be either conducted inconsistently, or only a very small proportion of EDCs may be classified as such; and
     
  • The criteria present a "confused set of processes for identifying, evaluating and integrating scientific evidence," and these processes unnecessarily privilege certain types of data, and cannot be operationalized adequately for regulatory identification of EDCs.

The researchers' suggestions to "resolve the issues" include: (1) a clear, unambiguous definition of "known to cause adverse effects relevant for human health"; (2) allowance for regulatory identification of a chemical substance as an EDC in the absence of "sufficient" evidence of harm from epidemiological studies; (3) the introduction of a hierarchy of categories for EDCs; (4) the articulation of a systematic and coherent process for integrating evidence across the three components of the World Health Organization’s (WHO) definition of EDC; and (5) ensuring all evidence is assessed on merit without privileging certain study types.

 

ClientEarth Suggests EC's EDC Plan Is Illegal: In its July 28, 2016, press release entitled "Commission endocrine disruptor plan is illegal," ClientEarth stated "[the EC's] call for reaction to its [EDC] plan [closed on July 28, 2016] ... In saying that only EDCs known to harm people should be outlawed, the [EC] is ignoring [BPR and the PPP Regulation]. These two laws require that chemicals presumed to cause harm are outlawed."

ClientEarth Lawyer Vito Buonsante stated "[the EC's] plan makes people the lab rats in a hugely dangerous experience. EDCs cause cancer, development problems and infertility. Under the [EC's] proposal, the only way to outlaw them would be to wait for human health to suffer." ClientEarth suggests that the EC wants to change the way risks are managed, and that such a major change in law should be negotiated between the EP and the Council of the EU. Furthermore, ClientEarth stated that if the EC "forces through its proposals," the European Court of Justice can reject them on the grounds that the EC has overstepped its powers.

In the legal opinion on behalf of ClientEarth, the authors state "[g]iven the BPR and the [PPP Regulation] are 'underpinned by the precautionary principle,' the scientific criteria, too, need to reflect the precautionary principle ... Based on [the] findings the conclusion can be drawn that the [EC] is not legally entitled to use its powers mandated by the BPR and the [PPP Regulation] to implement the [EDC] criteria as defined by the draft proposals."

More information is available in ClientEarth's analysis summary, "How will the EU identify EDCs and ban or approve their use? -- The Commission cannot change the scope and basis of the mechanism through the back door."

 

EC Issues Scientific Criteria For Identifying EDCs: The EC has issued much anticipated scientific criteria for the identification of EDCs. In its June 15, 2016, press release, "Commission presents scientific criteria to identify endocrine disruptors in the pesticides and biocides areas," the EC states "[t]he scientific criteria endorsed by the [EC] today are based on the [WHO] definition of [EDC], for which there is a wide consensus ... The WHO defines an [EDC] as 'an exogenous 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 EC has a legal obligation to specify criteria for the identification of substances with endocrine-disrupting properties under BPR and the Plant Protection Products (PPP) Regulation. The obligations arise in Article 5(3) BPR, Article 78(1)(a) of the PPP Regulation, and 3.6.5 of Annex II to the PPP Regulation. In the Judgment in Case T-521/14, Sweden v Commission, the General Court of the EU concluded that the EC, "by failing to adopt delegated acts to specify scientific criteria for the determination of endocrine-disrupting properties, has failed to [fulfill] its obligations under the first subparagraph of Article 5(3) of [BPR]."

The EC's "Communication from the Commission to the [European Parliament (EP)] and the Council on Endocrine Disruptors and the Draft Commission Acts Setting Out Scientific Criteria for their Determination in the Context of EU Legislation on [PPPs] and Biocidal Products" provides a background on the EDC definition debate and discusses management of EDCs under BPR, the PPP Regulation, and the REACH Regulation. The EC's Communication was accompanied by an Impact Assessment and draft measures setting out scientific criteria for the determination of endocrine-disrupting properties in biocides and PPPs.

The EC's Communication provides that, relying on WHO's definition of EDC, "the draft scientific criteria now being presented aim to introduce in legal form this concept of the 'endocrine mode of action' as one of the elements to consider when determining what is an endocrine disruptor for the two product areas concerned ... More specifically, the criteria set out that an endocrine mode of action is 'the inherent ability of a substance to interact or interfere with one or more components of an endocrine system.'"

Regarding the "adverse effect" element of the criteria for EDCs, the EC states in its Communication that it will rely on the definition provided by the International Program on Chemical Safety. This is a "change in the morphology, physiology, growth, development, reproduction, or, life span of an organism, system, or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress, or an increase in susceptibility to other influences." For causality, the EC favored the adoption of a reasonable evidence or "biological plausibility" approach over one that requires "conclusive evidence."

In the EC's opinion, "establishing different categories of what may be an endocrine disruptor does not help to define what is an endocrine disruptor in the context of biocides and pesticides." For this reason, along with concerns over "certainty for regulators and stakeholders," a category approach has not been proposed by the EC. Although the concept of safe thresholds "is used by regulators worldwide," the EC considered that "answering the question of whether a threshold exists is neither necessary nor appropriate when defining scientific criteria for determining what is an [EDC]."

The EC concluded that considerations of potency were not relevant for the specific purpose of setting scientific criteria for EDCs. In its Communication, the EC states "[p]otency is a question to be asked only once it has been established that a substance is an [EDC] at all." In its press release, the EC states that identification of an EDC should be conducted by making use of all relevant scientific evidence, by using a weight of evidence-based approach, and by applying a robust systematic review. The scientific criteria provided by the EC apply only for biocidal products and PPPs, and do not have a direct legal consequence in other areas of EU law. The EC states "[t]he adoption of criteria to identify [EDCs] will [fulfill] the legal obligations under the [PPP] and biocides legislation. Once adopted, the EU regulatory system will be the first regulatory system worldwide to define scientific criteria for [EDCs] in legislation."

The EC requested the European Food Safety Authority (EFSA) and ECHA to start looking at whether approved individual substances that show indications of being EDCs can be identified as EDCs according to the draft texts presented. The draft legal texts containing the criteria require adoption by the EC under the relevant procedures. For the PPP Regulation, the draft legal text will be voted on by Member States. In the context of the BPR, the draft measure will be discussed in a group of experts of Member States prior to adoption by the EC. Both measures involve the EP and the Council. The EC stated that "to ensure coherence between the two acts, the EC will present both texts simultaneously to the EP and the Council for them to exercise their functions." Important progress is expected on the draft measures in July 2016.

HEAL, the Danish Environment and Food Ministry, the European Chemical Industry Council (Cefic), the European Crop Protection Association (ECPA), and Plastics Europe have issued statements highlighting a number of concerns related to the scientific criteria proposed by the EC. Some of these concerns relate to the lack of consideration given to potency in development of scientific criteria for EDCs; the potential of the proposed criteria to ban "crop protection products with the same endocrine disrupting properties found in everyday products like coffee"; and the burden of proof for EDCs being too high with the consequence that there will be "years of harm to health" before their removal from the European market.

On June 20, 2016, environment ministers from Sweden (Karolina Skog), Denmark (Esben Lunde Larsen), and France (Ségolène Royal) issued a joint letter to Vytenis Andriukaitis, European Commissioner for Health and Food Safety, and EC President Jean-Claude Juncker, stating "[w]hile we welcome the fact that the [EC] refers to WHO definitions of [EDCs] and dispenses with potency among the proposed criteria, this project remains unacceptable."

The letter provides that "two provisions raise deep concerns." The first issue addressed in the letter is that only substances that are known to cause adverse effects relevant for human health or non-target organisms can be identified as EDCs "for the implementation of these regulations." The ministers state that since "the scientific validation process is very long and comes after irreparable damage to human health and the environment has appeared," the precautionary principle should be applied to decide on prohibitions "as soon as environmental impacts are proven or even when endocrine disruption suspicions appear."

The second issue addressed is that from the ministers' standpoint "[t]he draft modification of the regulation on [PPPs] does not fulfill the need to ensure the highest level of human protection." The ministers also highlight and urge consideration of the health costs of EDC use, which are estimated in the letter at € 160 billion within the EU. The ministers invited amendment of the EC's proposal on EDCs to provide greater protection for EU citizens' health, "for now and for future generations."

EDCs were discussed during the Environment Council's June 20, 2016, meeting at France's request. The "Outcome of the Council Meeting - 3476th Council Meeting" states "[s]ome ministers expressed strong concerns about the [EC's] approach, based only on evidence, and asked the [EC] to respect the precautionary principle and address also the suspected [EDCs] for which no evidence is yet available."


 
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