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On April 20th, 2018, the European Commission has published Regulation 2018605 amending Annex II to Regulation (EC) No. 11072009 on the Official Journal of the European Union.

This Regulation sets out scientific criteria for the determination of endocrine disrupting properties. It aims to provide greater clarity on endocrine disruptors and ensure safety of both human and animal health.

By October 20th, 2018, all on-going and future evaluations of active substances used in plant protection products will be considered to have endocrine disrupting properties in humans if it meets three criteria:

  • It shows an adverse effect in an intact organism or its progeny (this might, for instance, include issues such as low birth weight in babies).
  • It alters the function(s) of the endocrine system.
  • The adverse effect is a consequence of the endocrine mode of action (i.e., the effect is due to the substance altering the functions of the endocrine system and is not caused by some other factor).

Substances can be exempted if evidence shows that their adverse effects are not relevant to humans. Substances can be considered to have an adverse effect on non-target organisms if:

  • They show an adverse effect on non-target organisms (such as changes in morphology, physiology, growth, development, reproduction or lifespan).
  • They have an endocrine mode of action (i.e., they alter the functions of the endocrine system).
  • The adverse effect is a consequence of the endocrine mode of action, as above.

The document should become available by June 2018.

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