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Latest Updates of Endocrine Disruptors Regulations and Lists in EU

Little Pro on 2016-03-09 Views:  Update:2018-10-17

WHO defines an endocrine disrupting chemical (EDC) as an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations.The EU has introduced many regulations aimed at phasing out endocrine disruptors in water, industrial chemicals, plant protection products and biocides. In this article, we will try to give you an overview of those regulations.

REACH and Endocrine Disruptors

Under REACH regulation, endocrine disrupting chemicals are considered of similar regulatory concern as substances of very high concern. Some ED chemicals have already been added to SVHC candidate list.

Plant Protection Products Regulation and ED

Under the Plant Protection Products Regulation and the Biocidal Products Regulation, substances considered to have “endocrine disrupting properties” will not be authorized or even be banned.

On 20 Apr 2018, the EU has published COMMISSION REGULATION (EU) 2018/605  amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. The ED criteria will apply from 10 November 2018 to all new and ongoing applications for plant protection products.

An active substance, safener or synergist shall be considered as having endocrine disrupting properties that may cause adverse effect to humans if it is a substance that meets all of the following criteria, unless there is evidence demonstrating that the adverse effects identified are not relevant to humans:

  • it shows an adverse effect in an intact organism or its progeny, and
  • it alters the function(s) of the endocrine system, and
  • the adverse effect is a consequence of the endocrine mode of action

An active substance, safener or synergist shall be considered as having endocrine disrupting properties on non-target organisms if it is a substance that meets all of the following criteria, unless there is evidence demonstrating that the adverse effects identified are not relevant at the (sub)population level for non-target organisms:

  • it shows an adverse effect in non-target organisms, which is a change in the morphology, physiology, growth, development, reproduction or life span of an organism, system or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences; and
  • it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system, and
  • the adverse effect is a consequence of the endocrine mode of action.

Biocides and Endocrine Disruptors

Biocidal substances considered to have “endocrine disrupting properties” will not be authorized. The ED criteria for biocidal products are published by Commission Delegated Regulation (EU) 2017/2100 and entered into force on 7 December 2017. The criteria are the same as the criteria for plant protection products.

"Suspected" Endocrine Disruptors List in EU

It shall be noted that chemical substances are included in this screening exercise above does not mean that the substances should be considered as "endocrine disruptors" or "suspected endocrine disruptors". 

References

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 Tags: Topics - EUEndocrine Disruptors

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