The EU regulation on Plant Protection Products (PPP), Regulation (EC) No. 1107/2009, has been amended to include the recently established scientific criteria for the determination of endocrine-disrupting properties.
Although the existing legislation protects consumers from endocrine disruptors, no formal criteria have been established to identify these substances. Last year, EU Member States voted to adopt the scientific criteria proposed by the European Commission under the PPP legislation and the Biocidal Products Regulation (BPR).
For biocides, the criteria were published in the Official Journal of the EU in November 2017 and will apply from 7 June 2018. Now an amendment of Regulation 1107/2009 has been published, and the criteria will apply to PPPs from 20 October 2018. From those dates, substances that demonstrate endocrine-disrupting properties that may cause adverse effects in humans or non-target organisms will not be approved.
For both PPPs and biocides, the same definition is used:
A substance shall be considered as having endocrine-disrupting properties that may cause adverse effect in 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, 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;
- it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system;
- the adverse effect is a consequence of the endocrine mode of action.
A similar definition is used for substances that may cause adverse effects on non-target organisms. The criteria also state that all available relevant scientific data must be taken into account, based on a weight of evidence approach.
If you have any questions about endocrine disruptors or any other aspects of plant protection or biocide regulations, please email the Kerona Scientific team at email@example.com or contact us on +353 1 849 5284.