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The 2013 Berlaymont Declaration on Endocrine ... - Brunel University

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<str<strong>on</strong>g>The</str<strong>on</strong>g>se proposals focus <strong>on</strong> the use of potency-based cut-off values as the basis for<br />

classifying pesticides as endocrine disrupters. We are c<strong>on</strong>cerned that these values<br />

set the bar too high, with the serious possibility that hardly any substance will be<br />

classified as an endocrine disrupter in the regulatory sense, thus effectively<br />

undermining the intenti<strong>on</strong> of the legislati<strong>on</strong>.<br />

Given the likelihood of mixture effects from exposures to numerous EDCs with<br />

similar effect profiles, even EDCs c<strong>on</strong>sidered to be weakly potent are of c<strong>on</strong>cern<br />

because they may add to the combined effect.<br />

8. We are c<strong>on</strong>cerned that the discussi<strong>on</strong> about so-called low dose effects has paid too little<br />

attenti<strong>on</strong> to the possibility that many endocrine disrupters may act without thresholds<br />

because of pre-existing internal exposures to natural horm<strong>on</strong>es and, in the case of<br />

background exposures, to substances with similar effect profiles.<br />

In such situati<strong>on</strong>s, endocrine disrupters entering a biological system will add to the<br />

internal load, without having to overcome a dose threshold. This is particularly<br />

relevant to estrogenic agents and to chemicals with effects similar to dioxins.<br />

It is plausible that these types of endocrine disrupters will act independent of<br />

thresholds, as would be expected, e.g., for genotoxic carcinogens. This should be<br />

c<strong>on</strong>sidered during the <strong>on</strong>going REACH revisi<strong>on</strong>.<br />

9. In the foreseeable future, endocrine disrupter regulatory activities will have to cope with the<br />

tensi<strong>on</strong> between the plausibility of serious, irreversible damage and the delays in generating<br />

the data that are indispensable for comprehensive risk assessment. This tensi<strong>on</strong> can <strong>on</strong>ly be<br />

resolved by promoting further research into endocrine disrupters. We call <strong>on</strong> the European<br />

Commissi<strong>on</strong> to implement in Horiz<strong>on</strong> 2020 a targeted endocrine disrupter research<br />

programme, with a focus <strong>on</strong>:<br />

Exposure assessments and the identificati<strong>on</strong> of substances with endocrine disrupting<br />

properties: <str<strong>on</strong>g>The</str<strong>on</strong>g>re is a serious mismatch between substances that are wellresearched<br />

and the vast numbers of chemicals in commercial use, for which<br />

endocrine disrupting properties have not been investigated very well, if at all.<br />

Despite years of endocrine disrupter research, the full spectrum of chemicals that<br />

might c<strong>on</strong>tribute to endocrine-related diseases and wildlife effects is unknown. This<br />

deadlock can <strong>on</strong>ly be broken by dedicated research strategies that harness the<br />

recent advances in unbiased chemical analytical technologies.<br />

Assay development: Important aspects of endocrine disrupti<strong>on</strong> cannot be<br />

investigated, because suitable laboratory models and assessment criteria are<br />

missing altogether. This is especially relevant in the areas of horm<strong>on</strong>al<br />

carcinogenesis, female reproductive health, metabolic syndrome, obesity, and<br />

neuro-endocrine effects. Assays and assessment methodologies for many wildlife<br />

phyla and taxa are absent and fundamental research <strong>on</strong> the endocrinology of many<br />

invertebrate taxa is necessary. C<strong>on</strong>certed research and development efforts are<br />

urgently needed to fill these gaps.<br />

Research in support of better human health studies: Due to the lack of relevant<br />

laboratory models for numerous health effects, endocrine disrupter research will<br />

have to depend <strong>on</strong> epidemiological studies in the foreseeable future. But human

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