After a delay of more than two years, the EU Commission published criteria in mid-June that help unambiguously identify endocrine disruptors – substances that harm the hormonal system in humans. The criteria should help authorities decide whether or not an active ingredient is permissible according to the Biocides and Plant Protection Products Regulation.
The EU Commission accepted and used the definition of the World Health Organization (WHO). According to the WHO, endocrine disruptors are external substances or mixtures that change the functions of the hormonal system and thereby produce harmful effects in an intact organism, in offspring, or in (partial) populations.
The authorities also argue that only substances that have been proven to harm human health should be classified as endocrine disruptors. Only a few substances have met this requirement so far. The harmful effects of other substances have so far been proven only in animal experiments. The crux of the problem is that the required studies on human subjects last many years.
In a joint letter, the environmental ministers of France, Sweden, and Denmark criticized this limited definition. In their eyes, it damages the precautionary principle and inadequately protects the environment and human beings. They also complain that the criteria provide an unsatisfactory foundation for legal realization of Regulation (EG) No. 1107/2009 on the placement of plant protection products on the market and the Biocide Regulation (EG) No. 528/2012. Many German politicians (site available in German only) regard the criteria as unsatisfactory and fear that the criteria will apply not only to the biocide and pesticide regulations, but also to other legal areas, such as children’s toys and cosmetics.
Representatives of the chemicals industry are not enthusiastic about the suggestion of the EU Commission. The European Chemical Industry Council (CEFIC) complained that the criteria do not consider the dosage of a substance, making it impossible to make any kind of statement about when the concentration of dosage of a substance becomes harmful. Use of the criteria also makes it impossible to distinguish between hormonally active substances that can be used safely and those that produce harmful effects even in small quantities or doses.
See our blog entry, EU Publishes Road Map on Endocrine Disruptors, to learn which substances are considered endocrine disruptors.
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