New regulation provides greater clarity on endocrine disruptors

Endocrine disruptors are chemicals that are thought to interfere with the body's endocrine system potentially impacting fertility and immunity

The European Commission has published Regulation 2018/605 outlining its criteria for determining endocrine disruptors.

It will apply from 20 October this year and amends Annex II to Regulation (EC) No 1107/2009.

The regulation could affect cosmetics producers at the raw materials end of the supply chain, with regard to pesticide use, but might also have implications for biocides and preservatives used in cosmetics and health care products.

From 20 October, a substance 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 (ie, 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 excepted 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 (ie, they alter the functions of the endocrine system).
  • The adverse effect is a consequence of the endocrine mode of action, as above.

In this case, substances can be excepted if it can be shown that the adverse effects are not relevant at the population level for non-target organisms.

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