EC, EFSA to Examine Endocrine Disruptors

The European Commission (EC) Directorate General for Health and Food Safety will hold a one-day conference in Brussels on June 1, 2015, to determine the criteria to identify endocrine disruptors. In relation, the European Food Safety Authority (EFSA), which is involved in initiatives to develop scientific knowledge in the field of endocrine active substances and related issues, announced it will participate. The chair of EFSA’s Scientific Committee, Anthony Hardy, will attend the conference to provide insight.

According to EFSA, endocrine active substances or “endocrine disruptors” are chemicals that interact or interfere with normal hormonal activity. In the EFSA’s March 2013 scientific opinion, the scientific committee endorsed the World Health Organization’s view of what defines an endocrine disruptor: a material for which there is reasonable evidence of it causing an adverse effect as a result of its interaction or interference with the endocrine system.

Endocrine disruptors are an issue for the personal care industry. According to a 2012 article published by Gordon in Cosmetics & Toiletries, several chemicals used in personal care could act as potential endocrine disruptors. One group is sunscreens, as their use has increased during the past decades due to growing concern over photodamaged skin. Several in vitro, internationally validated bioassays evaluating the active components of sunscreens, i.e., UV filters such as 3-(4-methylbenzylidene) camphor (4-MBC), octyl methoxycinnimate and benzophenone-3, have shown them to be estrogenic.

Indirectly, during the EFSA’s discussions for its 2013 opinion on endocrine disruptors, experts concluded that guidance was necessary on approaches to assess endocrine disruptor risk. In particular, understanding biological relevance was deemed necessary to create a common understanding of how expert judgments would make determinations of risk.

For example:

• Is an adverse effect observed in the organism (e.g., a test animal) a reaction or just an adaptive response?

• And can the test results be extrapolated to humans or another specific population?

Already in June 2012, the EFSA held a scientific colloquium to bring together scientists to discuss the low dose hypothesis, i.e., effects occurring with test substances use at levels below those typically used in toxicology studies. In June 2013, the group commissioned a critical review of all available data and studies on non-monotonic dose-responses of substances for human risk assessment in the area of food safety. This project, awarded to the French and Austrian food safety authorities (ANSES and AGES), together with Sweden’s Karolinska Institute, is ongoing and due to conclude by the end of 2015.

Hypotheses about low dose effects and irregular/non-linear, i.e., or non-monotonic, dose-response relationships of chemicals challenge key concepts in toxicology and risk assessment. Although not addressed in EFSA’s 2013 opinion, EFSA recognized these issues warranted more in-depth attention.

In his article, Gordon also noted, although more clinical studies are required to determine the effects of endocrine disruptors via topical application, “endocrine disruptors have raised alarm for being linked to a wide variety of detrimental effects on human and wildlife populations, e.g., cancers, precocious puberty and obesity. Thus, there is a need to test personal care products and supplements for (endocrine disruptors).”

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