News on compelling science

A major step forward in the discussion and development of policy to regulate chemicals with endocrine disrupting properties occurred last week when the European Commission released an important report, “State of the Art of the Assessment of Endocrine Disruptors.”

The voluminous report, written by Professor Andreas Kortenkamp and a specially-constituted research team, was contracted by the Directorate-General of Environment in the European Commission, a unit which is responsible for the overarching Strategy document guiding European Union actions on Endocrine Disrupting Chemicals.

The report will inform both the revision of this Strategy, now 12 years old, and the Commission’s deliberations on how to improve existing and develop specific future EU regulatory processes that define, identify and regulate endocrine disrupting chemicals.

In particular, the report will serve to inform the EU’s work over the next two years to develop the criteria that will be used to identify and regulate hormone disruptors under the EU Pesticides and Biocides laws, and to some extent REACH *(the so-called industrial chemicals regulation). Later these criteria will potentially be deployed in other relevant EU laws, such as those on cosmetics, food contact materials, and toys safety.

The report is available as a pdf at State of the Art Assessment of Endocrine Disrupters, Final Report

Endocrine disrupting chemicals have been called hormone highjackers or gender benders among other things, because of their capacity to disrupt the natural hormone signaling functions, some of which are responsible for healthy development of reproductive organs.

Scientific research increasingly confirms their capacity, at very low levels of exposure, to disrupt a number of the body’s systems, leading to neurological, metabolic, immune, reproductive and behavioral difficulties and to diseases such as diabetes, infertility, hormonally-linked cancers (breast, prostate, testicular), learning and developmental disabilities and other chronic health conditions.

Recent scientific literature unveils other worrying characteristics such as transgenerational effects. The chemicals with these hormone disrupting properties can be found in certain plastics, pesticides, flame retardants in electronics and soft furnishings, fragrances and additives in cosmetics and personal care products and many more products in daily use. These chemicals are being constantly detected in humans through human biomonitoring, and in other organisms and both indoor and outdoor environments through environmental monitoring.

Ubiquity is a characteristic of EDCs (e.g. schools, homes, health care facilities, work places, from all manner of products ranging from toys, food, food packaging, clothing, electronics, furniture, automobiles, building materials, to cleaning products) with large implications for public health.

Learning how to ascertain which chemicals substances have endocrine disrupting (ED) properties, and determining which uses should be regulated has been an ongoing concern, in the European Union, as well as in the United States and internationally. In principle, the European Union has already decided in 3 of its regulations that Endocrine Disrupting Chemicals must be strictly controlled or banned, but the development of some of the key details have been postponed or the enactment of specific new regulatory processes has not yet or only just begun.

Content of the Report

The Report covers the following areas: • Definition of EDCs • Frameworks for Regulatory Testing & Screening • Scientific Results of Regulatory Significance (including Weight of Evidence Approaches, Low Dose Effects, Critical Windows of Sensitivity, Mixtures, Chemicals of Concern) • European Regulatory Framework • Proposals by EU Member State Authorities and Stakeholders. • Testing requirements and decision criteria • Research and development needs • Annex 1- Summary of the State of the Science (including Definitions, Overarching Issues, Human Health Endpoints, Wildlife Endpoints) • Annex 2- Summary of Expert Consultations on Approaches to the Regulatory Assessment of EDs (Experts from various European countries, competing economies internationally – USA, Canada, Japan, Intergovernmental Agencies, Industry and Public Interest Associations) • Annex 3- Comparative Analysis of Endpoints and Assays by Human Health and Wildlife Endpoint.

Current testing and screening methods

The Kortenkamp report points out that current testing and screening methods, while useful, are inadequate for capturing the full range of ED effects. Furthermore, testing during critical windows of development is currently not being done with the most sensitive methods now available. Consequently, adequate information about what chemicals can act as EDs and when, is severely limited.

Identifying EDCs

One of the current views circulating in the discussion of how to best identify EDCs is to tackle the most powerful ones, and to exclude from consideration those below a certain level of potency. The Kortenkamp report suggests that proposed potency ‘cut-off’ levels for chemicals with endocrine disrupting properties are arbitrary and scientifically unsound due to the lack of basic scientific information. The implication is that further research may indicate that there may be no safe levels of exposure to ED chemicals. Thus the report conveys that properly identifying EDCs means taking potency only as one amongst other identifying criteria, at most.

Weight of Evidence

The report recommends that a decision tree, based on a weight of evidence approach which considers the severity and irreversibility of effects as well as endocrine disruption modes of action, needs to be developed to screen chemicals for their ED capacity. Such a decision tree should be implemented on a non-sequential, non-rigid basis so that no chemical with ED properties falls through the cracks. Lack of information should not remove a chemical from consideration.

Mixtures

The report recommends as well that evaluation of the effects of chemicals mixtures is critically important, given that we all carry within our bodies reservoirs of chemical mixtures taken in through a variety of exposure pathways encountered every day throughout a lifetime. Professor Kortenkamp has produced another report entirely on this subject for the European Commission.

A Separate Category from other harmful chemicals

A final recommendation is that a separate category for ED chemicals be established in the EU. Such a category would accord EDCs equal importance to the existing categories of regulated chemicals such as PBTs (persistent, bioaccumulative and toxic chemicals) and CMRs (carcinogenic, mutagenic, and reprotoxic chemicals).

Although the Kortenkamp report evaluates and provides reccommendations for European regulations concerning pesticides and biocides and seeks to inform regulatory policies of REACH*, the paper and the discussions it will catalyze will also inform US regulators and Congressional bodies as these struggle to reform current US toxic chemical regulations. For example, the Toxic Substance Control Act, a set of regulations that determines how the United States defines and regulates toxic chemicals was promulgated more than 30 years ago, before scientific research had a solid grasp on the capacity of chemicals to wreak havoc in the human body through their capacity to mimic hormones.

The report and more information about the EU processes can be found on:

• The Health and Environment Alliance (HEAL) website at http://www.env-health.org/spip.php?article1395

• The CHEM Trust website at http://www.chemtrust.or.uk/docs

The following publication “A CHEM Trust and HEAL Briefing: Challenges and solutions in the regulation of chemicals with endocrine disrupting properties” will be available shortly on the HEAL and CHEM Trust websites, in English, Spanish, French and German.

• The European Commission’s Endocrine Disrupters Website at http://ec.europa.eu/environment/endocrine/documents/studies_en.htm (The Kortenkamp report can be found by scrolling to the bottom of the page)

For a list of chemicals with endocrine disrupting properties visit:

• The Endocrine Disruption Exchange at http://www.endocrinedisruption.com/endocrine.TEDXList.overview.php

• The ChemSec SIN List 2.0 (chemicals subject to REACH ) at http://www.chemsec.org/list/sin-list-20

• The European Commission’s website on Combination Effects of Chemicals, featuring Professor Kortenkamp’s contracted study on mixtures toxicity at http://ec.europa.eu/environment/chemicals/effects.htm

*REACH, the relatively new EU law governing the identification and use of industrial and toxic substances. (Registration, Evaluation, Authorization and restriction of CHemical substances). REACH entered into force on 1 June 2007.