Note: The EU’s review of endocrine disruptors has begun!

Release Date:

2018-07-09

On June 7, 2018, with the publication of the EU guidance document on the identification of endocrine disruptors—applicable to the registration and evaluation of disinfectants and pesticides in the EU—products currently under application or newly submitted for registration under the EU Biocidal Products Regulation (BPR) are required to submit endocrine disruption assessment data. Effective November 10, 2018, products under application or newly submitted for registration under the EU Plant Protection Products Regulation (PPP) must also provide endocrine disruption assessment data. In addition, already authorized products will gradually…

　On June 7, 2018, with the publication of the EU’s guidance document on the identification of endocrine disruptors (applicable to EU disinfectants and… Pesticide (Registration and evaluation), products that are currently under application or newly submitted under the EU Biocidal Products Regulation (BPR) must submit data on endocrine disruption assessment. As of November 10, 2018, the European Union… Pesticide (PPP) Products that are currently under application or newly submitted must also submit endocrine-disrupting‑related assessment data. In addition, already authorized products will be progressively subject to assessments for endocrine disruptors.
　　What are endocrine disruptors?
　　Endocrine disruptors are exogenous substances or mixtures that can alter the endocrine functions of an organism and exert adverse effects on the organism, its offspring, or the population; potential endocrine disruptors are exogenous substances or mixtures that may interfere with the endocrine system of an organism, its offspring, or the population. This definition of endocrine disruptors was established by the World Health Organization (WHO) and has been widely endorsed by organizations such as the European Food Safety Authority (EFSA). The criteria for identifying endocrine disruptors are as follows:
　　(1) This chemical substance has adverse effects on organisms or their offspring;
　　(2) This chemical substance possesses an endocrine-disrupting mechanism of action;
　　(3) The adverse effects of this chemical substance on organisms or their offspring are attributable to endocrine-disrupting mechanisms.
　　How does the European Union conduct the assessment of endocrine disruptors?
　　Companies first submit data on endocrine‑disrupting properties to the competent authorities. The authorities then evaluate this information and issue an assessment report, which is forwarded to ECHA (the European Chemicals Agency). Subsequently, the BPC (Biocidal Products Committee) reviews the submitted data and the assessment report and, on behalf of ECHA, makes a decision on the approval or renewal of the active substance. Finally, the European Commission adopts the definitive decision on whether the substance possesses endocrine‑disrupting properties. In addition, the EU authorities have established a dedicated expert group on endocrine disruption to provide technical support throughout the evaluation process and to offer expert advice.
　　How can one determine whether a product possesses endocrine-disrupting properties?
　　If a product contains an active substance with endocrine-disrupting properties, that product shall be deemed to possess endocrine-disrupting properties.
　　An assessment of endocrine-disrupting properties shall be conducted for inactive substances; if an inactive ingredient exhibits endocrine-disrupting characteristics, the product shall also be deemed to possess such characteristics.
　　For a product group (BPF, or biocidal product family—a set of biocidal products with similar intended uses, the same active substance specifications, and compositional variations that do not increase risks or reduce efficacy), if an active substance is identified as an endocrine disruptor, all products in the group will be deemed to possess endocrine‑disrupting properties; if a non‑active substance is classified as an endocrine disruptor, any product within the group containing that non‑active ingredient will be subject to usage restrictions.
　　If a product is identified as having endocrine-disrupting properties, its authorization or renewal will be revoked or amended.