/>iREACH 2018 is the big news for Europe. The Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) law, which took affect a decade ago on June 1, 2007 (Regulation (EC) No. 1907/2006 of 18 December 2006), is poised in 2018 to enter its final phase-in registration deadline on May 31, 2018, and much work will be underway in the new year in preparation for the deadline. Entities that pre-registered substances that they manufacture or import from outside the EU above one tonne but not more than 100 tonnes per year and have not already registered them must do so by the May 2018 deadline. Late pre-registration may be an option until May 31, 2017. REACH will also be reviewed by the European Commission (EC) in 2017, but signficant change is not expected.
Endocrine Disruptors
The coming year will see ongoing activity focused on how endocrine disruptors are to be identified, a point of some contention among scientists, regulators, and other stakeholders. Endocrine disruptors already factor into the EC's long-range plans and are reflected in existing legislation. The backdrop is the EC’s 1999 Strategy on Endocrine Disruptors, with its overall aim of minimizing exposures to these substances. Protective measures (including bans) already are available and deployed through the authorization process for chemical substances in REACH and also when endocrine disruptors are incorporated into plant protection products, biocides, or cosmetics. To date, however, despite the tools in place to regulate them, formal criteria for identifying substances with endocrine disrupting properties have proven complex and challenging to articulate and have not been specified in the EU or by any other country.
On June 15, 2016 -- already well past a 2013 EU legal deadline for action -- the EC issued two draft acts establishing scientific criteria for identifying endocrine disruptors in the context of the existing Plant Protection Products Regulation (2009) and Biocidal Products Regulation (2012), respectively. The long draft development pathway involved consultation with EU regulators, in-house and independent scientific groups, authorities in other jurisdictions, and stakeholders. Steps toward adoption will go forward under prescribed procedures, including involvement in each case by the European Parliament and the Council. For purposes of the Plant Protection Regulation, Member States will vote on the draft legal text; for the Biocidal Products Regulation, a group of experts from Members States will discuss the draft before the Commission adopts it.
The draft measures build on the World Health Organization’s (WHO) definition of an endocrine disruptor, which is generally embraced by the European scientific community, as “an exogenous substance or mixture that alters the function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub) populations.” According to the Communication issued by the EC in June 2016, together with the drafts, the proposed identifying criteria embody what the EC terms a “novelty” in the definition, “the introduction of a second element.” While the toxicity of a chemical substance typically is defined in terms of an “endpoint” -- the presence or absence of an adverse effect -- the WHO definition adds a “mode of action” element, which accounts for the way in which the chemical substance has an impact. The identification criteria in the June 2016 drafts are meant to capture this endocrine mode of action as a second factor for consideration, separate from adverse effect. Indeed, for purposes of the identification criteria, EC proposes to define an endocrine mode of action as “the inherent ability of a substance to interact or interfere with one or more components of an endocrine system,” without necessarily leading to an adverse effect and without necessarily posing an (eco) toxicological hazard in itself. The potentially challenging interplay between the WHO definition, which looks at-risk, and the EC’s hazard-centric, precautionary approach to chemical regulation is a source of considerable criticism.
The EC highlighted a number of additional issues in connection with the proposed identification criteria. These include the following: how “adverse effect” is to be defined, especially in terms of assessing potential adversity at a molecular or cellular level; the concept of “biological plausibility,” i.e., reasonable, rather than conclusive, evidence to determine causality between mode of action and adverse effect; why the EC believes that establishing categories of endocrine disruptors is not useful; why the “threshold” concept is neither necessary nor appropriate when defining the identification criteria for an endocrine disruptor; and why “potency” is unnecessary for identifying an endocrine disruptor and becomes relevant only after a substance has been identified as such.
The existence of EU legislation already in place means that the 2016 draft identification criteria are not an initial step in a regulatory process still to unfold. Under both pieces of existing legislation, active substances that are endocrine disruptors are not to be approved for use, except in the event of negligible exposure from a plant protection product or negligible risk from a biocidal product. Many substances deemed to be endocrine disruptors already have been prohibited in the EU. For products now in use, each approval is in effect for only a limited time period, and renewals involve a reassessment of the product. The renewal process will be one visible place where the rubber will meet the road where the new criteria are concerned.
The EC envisions that the new identification criteria will enhance product assessments, including those for renewed approvals, and anticipates that where possible they will be applied immediately. In addition, the EC has asked the European Food Safety Authority and the European Chemicals Agency to begin revisiting individual approved substances where there are indications that those substances could be endocrine disruptors under the new identification criteria. Once the criteria take effect, the regulatory agencies then would be prepared to apply the criteria and take appropriate action more quickly. Given, as noted above, that the Plant Protection Products Regulation and the Biocidal Products Regulation each contain limited derogation provisions, the EC anticipates also that evolving scientific and technical knowledge may enable the grounds for derogation to be updated accordingly. Specifically, the EC has concluded that the basis for possible derogations for plant protection products should be updated to align with the “negligible risk” test for biocidal products. According to the EC, in the context of a hazard-based ban of endocrine disruptors, a revised test for possible derogation of plant protection products could be consistent with overall health and environmental objectives that guide decision-makers’ actions.
While the identification criteria will apply as a matter of legal obligation only under the plant protection products and biocidal products regulations, the EC expects that the criteria will become a resource for EU bodies that administer other regulatory measures for which endocrine disruptors are a matter of concern. Thus, the criteria may have an eventual impact on the regulation of chemical substances under REACH, as well as on assessing the safety of cosmetic ingredients under the Cosmetics Directive and on the implementation of water quality criteria. Also, the regulatory impacts could extend beyond the EU. Substances deemed to be potential endocrine disruptor candidates are found among the “high priority” substances flagged for EPA to evaluate under a timetable under new TSCA. As such, what is determined to be an endocrine disruptor in the EU could well effect the regulatory treatment of the substance involved in the United States. Separately, as a business matter, products currently permissible for export from other jurisdictions into the EU could lose their welcome if they were determined to contain endocrine disruptors during a future review under the proposed identification criteria if the latter remain in their current form, and a derogation for the use at issue has not been made.
A group of scientists has raised the concern that the identification criteria will allow some endocrine disruptors to elude identification due to uncertainty or inconsistency of application. Shortly after the draft criteria were announced, an international group of fifteen scientists shared their views in a letter to the EU’s Health and Food Safety Directorate, characterizing the criteria as presenting a "confused set of processes for identifying, evaluating and integrating scientific evidence.” Also, according to these scientists, 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 conducted inconsistently and/or will under-classify candidate substances as endocrine disruptors. Other criticisms have surfaced as well, and despite the EU’s assertion that development of the criteria were based on consultations with a range of experts and stakeholders, their adoption and legal effect, assuming it proceeds as proposed, will neither silence the critics nor simplify the identification of endocrine disruptors going forward.
