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Finally, EU sets out scientific criteria for endocrine disruptors

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Finally, EU sets out scientific criteria for endocrine disruptors

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(BRUSSELS) - The European Commission published Wednesday the scientific criteria needed to identify and reduce exposure to hormone-disrupting chemicals, seen by the WHO as a global threat to public health.

Endocrine disruptors are chemicals that, at certain doses, can interfere with the endocrine (or hormone) system in mammals. These disruptions can cause cancerous tumors, birth defects, and other developmental disorders. Any system in the body controlled by hormones can be derailed by hormone disruptors.

Endocrine disrupting chemicals (EDCs) have been identified in thousands of products such as disinfectants, pesticides and toiletries.

The European Parliament has repeatedly condemned the Commission for failing to publish the criteria - due by end 2013 -  while the European Court of Justice ruled in December 2015, that the EU executive had breached EU law by failing to publish them.

The delay has been put down to lobbying from the chemical industry, as well as objections from the United States negotiating team in the TTIP trade talks. Sweden threatened to sue the Commission in 2014.

The UNEP/WHO report called endocrine disruptors a "global threat", referring inter alia to the upward trends in many endocrine-related disorders in humans and wildlife populations. There is evidence of adverse reproductive outcomes (infertility, cancers, malformations) from exposure to the substances, which could also affect thyroid function, brain function, obesity, metabolism, insulin and glucose homeostasis, it says.

The Commission package includes:

  • A Communication providing an overview of the scientific and regulatory context;
  • an Impact Assessment Report which presents the state of science regarding different criteria to identify endocrine disruptors, and provides information on possible consequences;
  • and two draft legal acts – one under the Biocidal Products legislation, the other under the Plant Protection Products legislation – which set the criteria to identify endocrine disruptors.

Health and Food Safety Commissioner Vytenis Andriukaitis said "The scientific criteria that the Commission is presenting today guarantee that the high level of protection of human health and of the environment set in our legislation on plant protection and biocidal products is maintained. The plant protection products and biocides' legislation are among the strictest in the world because of their prior approval system, their extensive data requirements, and their hazard approach for decision making. The Commission reinforces today its commitment to protect health of people in European Union."

The scientific criteria endorsed by the Commission today are based on the World Health Organisation's (WHO) definition of an endocrine disruptor, for which there is a wide consensus.

 The WHO defines a substance as an endocrine disruptor if:

- it has an adverse effect on human health;

- it has an endocrine mode of action;

- and if there is a causal link between the adverse effect and the mode of action.

 The criteria endorsed today also specify how the identification of an endocrine disruptor should be carried out:

- by making use of all relevant scientific evidence;

- using a weight of an evidence-based approach;

- and applying a robust systematic review.

The Commission Communication accompanying the two acts provides an overview of the scientific and regulatory context around endocrine disruptors. It sets out a number of actions where the Commission says it will increase its efforts to minimise exposure to endocrine disruptors, in the short-term (research and international cooperation), mid-term (test methods) and long-term (regulatory).

The Commission is also asking the European Food Safety Authority and the European Chemicals Agency to begin looking at whether approved individual substances that show indications of being endocrine disruptors can be identified as endocrine disruptors according to the criteria in the draft texts.

The two draft legal acts containing the criteria still need to be formally adopted by the Commission, with votes from the EU Member States, and discussion in a group of experts.

The Commission is also proposing to adjust the ground for possible derogations under the plant protection products legislation in order to take into account the latest scientific knowledge.

Further information

Frequently Asked Questions: Endocrine disruptors


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