Being at the center of many considerations (public health, economy, …), endocrine disruptors’ adventure and their evaluation is just beginning. Staphyt Regulatory can help you in managing the regulatory challenges related to your substances and products.
Endocrine disruptors are substances (natural or synthetic) that can interact with the endocrine system of a living being at doses and periods of exposure inducing adverse effects to health.
Until recently, no consensus has established a definition of endocrine disruptors at a European level. Several problems were involved, especially the model on which toxicology is based – sola dosis facit venenum (the dose makes the poison); being jostled by these molecules insofar as the absence of effect at high doses does not certify not to observe any effect at lower doses.
On 04 July 2017, the European Commission finally proposed a definition and identification criteria for plant protection products and biocidal products via two separate adoption procedures.
However, the definition of the endocrine disruptor still does not make the consensus in Europe. Indeed, the proposal of the European Commission on plant protection products was rejected on October 4th after a stormy passage in front of the European Parliament.
On the other hand, that concerning biocidal products was adopted on November 4th by the Commission according to a delegated regulation (non-legislative act) and published in the Official Journal. Without objections from Parliament or the Council, its regulation will be applicable in June 2018.
Following this adoption, Member State representatives voted December 12th/13th 2017 in favor of a new draft Regulation for setting criteria for the identification of endocrine disruptors used in plant protection products. This draft Regulation will now be submitted to the scrutiny of the Council and the European Parliament, which will have three months to examine it before final adoption by the Commission.
To date, pending the application of these regulations, the criteria of phytosanitary and biocide regulations continue to apply:
“Category 2 carcinogens and Category 2 reproductive toxins are considered to have endocrine disrupting properties.”
“Substances classified as Category 2 reproductive toxicants or which meet the criteria for classification as such, and which have endocrine toxicological effects may be considered to have endocrine disrupting properties.”
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