Endocrine disrupters are chemicals which under certain conditions can impact on the hormonal system of humans and animals. In recent years the scientific community and authorities worldwide have been discussing this topic and how to regulate these chemicals and significant progress has been achieved, both in the EU and international organizations.
Endocrine disrupting properties require specific evaluation under European legislation, including the regulation for Plant Protection Products (EC) No 1107/2009, the Biocidal Products Regulation (EU) No 528/2012, and REACH (EC) No 1907/2006.
The new hazard-based EU criteria for identifying endocrine disrupters, legally defined in in Commission Delegated Regulation (EU) No 2017/2100 and Commission Regulation No 2018/605 for biocidal products and plant protection products respectively, have now entered into force and will apply to all, also to already on-going renewal/approval processes. Therefore, the marketing and use of chemicals can only be supported providing they do not have endocrine disrupting properties which may cause adverse effects in humans or non-target wildlife species.
The REACH regulation indicates that substances with endocrine disrupting properties will require further investigation before they can be authorised for use; continued use of these substances will be subject to restrictions.
In June 2018, the guidance on the identification of endocrine disrupters was published by EFSA and ECHA with support from Joint Research Centre. Following the acceptance of the criteria, companies who have previously submitted active substances dossier for plant protection products and biocides will be asked by the authorities to update them by including the assessment of endocrine disrupting properties in accordance with the new guidance. For the majority of dossiers submitted prior to the publication of the guidance and ED criteria, the endocrine activity will most likely be considered insufficiently investigated and additional studies may be required.
Enviresearch has considerable expertise in the area of endocrine disruption and our scientists have supported several governmental programmes contributing to advancing science in this field. We are able to help you interpret the guidance and provide insights on how to prepare the assessment of endocrine disputing potential of your active substance as required by the authorities.
Our services include:
- Weight of evidence reviews of endocrine disrupting properties for agrochemicals and biocides, using the step-wise approach suggested in the guidance to evaluate endocrine disputing potential of your compounds.
- Data search (as per the strategy of Appendix F of the ECHA/EFSA guidance).
- Gathering of available studies (DAR/RAR/CAR, other relevant studies).
- Data/study relevance and reliability evaluation.
- Assessment of the preliminary evidence of ED properties.
- EATS mediated adversity evaluation by setting specific scenarios.
- MoA (Mechanism of Action) analysis.
- Data Gap identification.
- Development of testing strategies.
- Placement and study monitoring.
- Dossier preparation including reporting of available information on excel file (as per ECHA/EFSA guidance Appendix E).