Endocrine Disrupters and Plant Protection Products
On April 20th, 2018, the European Commission published Regulation 2018/605 amending Annex II to Regulation (EC) No. 1107/2009 on the Official Journal of the European Union. This Regulation sets out scientific criteria for the determination of endocrine disrupting properties. It aims to provide greater clarity on endocrine disruptors and ensure safety of both human and animal health.
From October 20th, 2018, all on-going and future evaluations of active substances used in plant protection products will be considered to have endocrine disrupting properties in humans if it meets the following three criteria:
- It shows an adverse effect in an intact organism or its progeny (for example; low birth weight in babies).
- It alters the function(s) of the endocrine system.
- The adverse effect is a consequence of the endocrine mode of action (i.e., the effect is due to the substance altering the functions of the endocrine system and is not caused by some other factor).
Substances can be considered exempt if evidence shows that their adverse effects are not relevant to humans.
Substances can be considered to have an adverse effect on non-target organisms if:
- They show an adverse effect on non-target organisms (such as changes in morphology, physiology, growth, development, reproduction or lifespan).
- They have an endocrine mode of action (i.e., they alter the functions of the endocrine system).
- The adverse effect is a consequence of the endocrine mode of action, as above.
Therefore, active substances that are endocrine disrupters will not be approved under this regulation unless there is negligible exposure to human and non-target species. In addition to this, endocrine disrupting substances approved because of negligible exposure will become candidates for substitution, with less hazardous substances, during the authorisation stage at Member State level.
The burden of proof is placed on the notifier.
Enviresearch has considerable expertise in the area of endocrine disruption and have supported numerous governmental programmes contributing to advancing science in this field. Our services include the Weight of Evidence evaluation in accordance with the EFSA guidance on endocrine disrupters and based on a framework consisting of the following evaluation steps:
- Systematic review - identification of all relevant studies including external data (epidemiological, scientific journals etc).
- Study reliability - assessment of the quality and reliability of studies.
- Study relevance – review of the appropriateness of the data for the intended purpose of the assessment (e.g. evaluation of endpoints relevance to the determination of mechanism and adverse effect).
- Balance of the weight of evidence – determination of the consistency of the available evidence and the biological plausibility of a link between adverse effects and an endocrine mode of action.
- Conclusion on whether available data result in the determination of a substance as an endocrine disrupter, identification of data gaps and strategy for further steps.
- Recommendations for further testing as necessary.
Explore our other realted articles: Endocrine Disrupters and Biocides, Weight Evidence Reviews for Endocrine Disrupting Properties.
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC:https://eur-lex.europa.eu/eli/reg/2009/1107/ojRegulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32018R0605