Combating EDCs in the EU

Society Expands EDC ADVOCACY in the EUROPEAN UNION

As part of its efforts to raise awareness of endocrinedisrupting chemicals (EDCs) and improve understanding of the underlying biology through which these chemicals exert their effects, The Endocrine Society has implemented an advocacy strategy in the European Union (EU). The Society’s messages about how endocrine principles need to inform policy are particularly timely in this arena, as the EU is evaluating a number of laws and regulations related to EDCs with decisions expected throughout the coming months and year. Further, individual EU member countries will implement their own EDC strategies in response to changes to EU laws and regulations. Beginning with previously reported meetings in 2012 and early 2013 (as reported in the June issue of Endocrine News), the Society has devised an advocacy plan that targets both central EU-level decisions and processes in key member countries.

Letter to EU Officials on Endocrine Principles

In June the Society sent an open letter to the European Commission and to 16 key Members of the European Parliament (MEPs) calling attention to endocrine science and its application to EDC regulations. In the letter, the Society urges the Commission to call upon the expertise of endocrinologists during its deliberations and to incorporate endocrine science into the regulatory process.

Last year, the Society outlined key principles of endocrinology that must be incorporated into hazard/ risk assessment protocols and must be considered when devising regulations to minimize exposure to EDCs (Endocrinology 2012 153: 4097-4110; doi: 10.1210/en.2012-1422). Drawing on this Statement of Principles, the letter emphasizes central tenets of endocrinology, including:

• Hormone effects are mediated by receptors • Hormone effects can occur at very low doses • Hormones exert multiple actions in tissue-, cell-, and receptor-specific fashion
• Hormone effects are dependent upon developmental stage
• Effects of aberrant exposure can be irreversible, especially at critical stages of development
• Effects of aberrant exposure can become manifest latently, years after the exposure occurs
• Effects of aberrant exposure can be passed down for generations

The letter further states it cannot be assumed that a safe “threshold” level of exposure to any given EDC can be identified, given the possibility of low-level results and the impossibility of accurately assessing exposure over time.

Meetings with EU Policymakers

Working with Liege, Belgium–based Society expert JeanPierre Bourguignon, MD, PhD, and an international consultant, the Society has conducted meetings with several key officials in the Cabinets of EU Commissioners and in EU Directorates General that hold some level of influence over EDC laws and regulations.

In July, the Society met with a member of Commissioner Janez Potocnik’s Cabinet. Commissioner Potocnik oversees the work of the Directorate General on the Environment (DG ENV); he and his staff have a key role in developing the EU’s new criteria for definition of EDCs. The objective of DG ENV is to protect, preserve, and improve the environment for present and future generations. Meeting participants welcomed Dr. Bourguignon’s expertise and encouraged the Society to remain engaged in the process. DG ENV works closely with other DGs and with chief science advisor Ann Glover to decipher the complex scientific issues involved in regulating EDCs, and the Society was encouraged also to engage with officials from these offices to ensure broad dissemination of the Society’s scientific messages.

A September meeting with staff of DG Health and Consumers (DG SANCO) was an opportunity to have deeper exchanges of views on the latest scientific research on EDCs, their impact on health and approaches of EU regulators. An impending “road map” will clearly delineate the timing and approach proposed for an upcoming impact assessment on criteria for identifying EDCs for their better regulation in the EU. Th e impact assessment, which will likely be performed by consultants under the direction of the European Commission, will inform ongoing policy discussions, specifically in areas of economic impacts associated with regulations. As part of the impact assessment a public consultation will be organized, most likely in early 2014. DG SANCO’s stated goal is “to make Europe a healthier, safer place, where consumers can be confident that their interests are protected.” Several DG SANCO officials who participated in the meeting have a background in science, and they suggested the Society engage in the upcoming public consultation period as a means to ensure a public discourse of critical scientific principles.

Most recently, the Society met with officials in DG Enterprise and Industry (ENTR), which also plays an active role in EU EDC regulations. DG ENTR has the mission to promote a growth-friendly framework for European enterprises. This perspective puts DG ENTR in a position of representing the interests of the chemical industry in discussions about new or revised EDC policies. As the industry stands to suffer some financial burden as a result of stringent chemical regulations, DG ENTR seeks to balance the industry’s interests with the overall political will that is driving the EU toward new and improved laws and regulations for health and environmental protection. DG ENTR was receptive to the Society’s science-based messages and encouraged the Society to become involved with the work of the European Chemical Agency.

Political Pressure Mounts

In October, eight MEPS (seven of whom had received the Society’s June letter) sent a letter to EU Commission president Manuel Barroso questioning the Commission’s decision to perform an impact assessment before defining EDC criteria. In the letter, the MEPs emphasize that the criteria are to be purely science-based and should apply horizontally across all laws and regulations. Conversely, the planned impact assessment is based on only two laws and would introduce a political aspect if the results are used in developing EDC criteria and definition. Th e MEPs, therefore, request clarification from the Commission on its intent in delaying publication of criteria until after the impact assessment is performed.

France Takes a Proactive Approach

While the EU agencies will establish central governing laws, individual member countries will implement and enforce those laws through their own EDC strategy. France has taken a proactive approach to this, having already initiated the process for drafting its national strategy and submitting it to a public consultation period in late summer. Th e Society took its first steps in the French process in September, submitting a letter to the French Ministry of Health and the French Ministry for Sustainable Development outlining the key endocrine principles that must be incorporated into policies governing EDCs.

As the French process continues, and as more EU member countries will have to engage at the EU level, the Society will remain active with the EU and key member countries to influence the debate in Europe, which is likely to set the stage for future work in the U.S. and globally. Efforts continue in capacity building, and it is important for Society members who live and work in the EU to become involved. As constituents of EU policymakers and direct beneficiaries of improved regulations, EU endocrinologists have a critical role to play in informing EU and national officials of the unique and critical endocrine scientific perspective as it relates to EDCs.

To learn more about advocacy in the EU and to become involved, Society members may contact me at ldoan@endocrine.org.

— Loretta L Doan, PhD, Director, Science Policy, The Endocrine News

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