Inside U.S. Trade - 07/25/2014
EU Lays Out 'Endocrine Disruptor' Criteria Options, Setting Stage For Fight
Posted: July 24, 2014
After months of delay, the European Commission late last month revealed the options it is weighing for how to define a class of substances known as "endocrine disruptors" that affect human hormones, initiating another round in a fight over an issue that U.S. pesticides and chemicals makers warn has major ramifications for transatlantic trade.
Depending on how EU regulators craft the definition, the term "endocrine disruptor" could sweep in dozens of products and subject them to marketing bans or other restrictions under European laws.
CropLife America, which represents pesticides makers, has warned that a broad definition could cause massive trade disruptions for major U.S. exports of agricultural goods because it would capture the insecticidal products with which crops like tree nuts, fruits, soybeans and peanuts are treated (Inside U.S. Trade, Nov. 15, 2013).
The commission is also considering proposing amendments to EU legislation known as the Plant Protection Products Regulation (PPPR) that would alter the consequences of a pesticide product being classified as an endocrine disruptor, although any such changes are unlikely in the near term (see related story).
The EU revealed the criteria options it is weighing in a June 17 "roadmap" on how it could move forward in regulating endocrine disruptors. The roadmap offers a preview of a questionnaire the commission is expected to issue in September seeking public comment on the best approach.
Under the PPPR and a separate law known as the Biocidal Products Regulation, which governs products like herbicides and fungicides also used on crops, the European Commission was supposed to issue criteria for what constitutes an "endocrine disruptor" by the end of 2013.
But after facing a huge industry outcry, the commission decided to hold off and initiate a public consultation period, in addition to conducting its own assessment of the impact of each possible option.
Since the PPPR's entry into force, the European Commission has relied upon "interim criteria" that identify substances as endocrine disruptors if they have a negative impact on reproductive capabilities. Scientific experts on both sides of the debate say that this approach is blunt and inaccurate because it focuses on adverse symptoms that may or may not be mediated through the endocrine system, and ignores the possibility that they are caused by other maladies.
The new roadmap lays out four options for how to define criteria going forward: leaving in place the current interim criteria; adopting a definition established by the World Health Organization's International Program on Chemical Safety (IPCS); using an expanded adaptation of the WHO/IPCS definition; or conversely tweaking the WHO/IPCS definition in such a way that would further narrow the scope of affected products.
Generally speaking, the WHO/IPCS definition would only categorize a substance as an "endocrine disruptor" if there is concrete evidence that it produces an endocrine-mediated adverse effect. Non-governmental groups critical of the pesticides industry argue that this approach is not sufficiently precautionary, especially given continuing disagreement within the scientific community about how endocrine disruptors affect humans.
Angeliki Lysimachou, an expert on endocrine disruptors for Pesticide Action Network (PAN) Europe, said in an interview with Inside U.S. Trade that she would prefer the expanded WHO/IPCS definition foreseen in the roadmap, which would create additional "categories" of endocrine disruptors.
Under this approach, substances with proven adverse effects along with "suspected" endocrine disruptors and "endocrine active" substances would all be captured, imposing restrictions on a broader range of products. The roadmap document, however, indicates that the commission foresees implementing differing degrees of restrictive measures depending on which category a substance falls into.
How the criteria are set will have broader ramifications beyond the pesticides industry. Other pieces of EU legislation governing biocides, cosmetics and industrial chemicals, for example, also place restrictions on substances identified as endocrine disruptors. The PPPR and the Biocidal Product Regulation uniquely required the commission to set criteria for what constitutes an endocrine disruptor, but the commission has said it will apply any criteria horizontally across all different pieces of relevant legislation.
This has especially alarmed the cosmetics industry because of a ban on animal testing it has faced since 2013 under the EU Cosmetics Regulation. Instead, cosmetics firms have to rely on "in vitro" tests -- essentially done on a collection of cells in a petri dish -- to test for potentially harmful effects.
But according to industry experts, determining whether something is an endocrine disruptor requires an analysis of how a substance interacts with a complete endocrine system and therefore cannot be assessed through in vitro testing.
The industry fears a definition that captures substances that do not have demonstrated adverse effects could potentially rope in a range of ingredients currently in use based on existing data, but without any way to prove that they do not have adverse effects. This would stigmatize those products and chill innovation of new ingredient, they argue.
In a February 2014 public submission to the European Commission on the issue, the industry group Cosmetics Europe called for the commission to adopt the WHO/IPCS definition and not broaden it to include other sub-categories. The commission roadmap also warns that because of the ban animal testing for cosmetics ingredients, an expanded WHO/IPCS definition could mean substances would be permanently listed as "endocrine active."
The Cosmetics Regulation, however, does not spell out specific restrictions related to endocrine disurptors, as the PPPR does. Instead, it states that when "[EU] or internationally agreed criteria for identifying substances with endocrine-disrupting properties are available, or at the latest on 11 January 2015, the Commission shall review this Regulation with regard to substances with endocrine-disrupting properties."
Inside U.S. Trade - 07/25/2014, Vol. 32, No. 30