Speciality Chemicals Magazine JUL / AUG 2022 | Page 41

REGULATORY & COMPLIANCE
Adverse
Data from in vitro testing
Adverse effects potentially ED-related

Rationale for ED concerns !

ED among metabolites
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Similarity with known ED !

Rationale for ED concerns

Missing information
Human data
Similarity with known ED
Figure 2 - Rationale for ED concerns under substance the evaluation CoRAP
Missing information
use endpoints that may be considered ED-specific . New approaches are needed to fill the gap between the number of chemicals in use and the number of chemicals assessed to date . Epidemiologic research provides key information towards our understanding of the relationship between environmental exposures like EDCs and human health outcomes , but regulatory toxicologists often overlook it . Ho et al . advocate for an integrative approach of expertise in the fields of epidemiology , exposure science , risk assessment
and toxicology to adequately study the health risks associated with EDCs while tackling their challenges . 6 Overall , there is concern and uneasiness among the chemical industry that the assessment of EDCs may be too precautionary , which would assume a substance to be an EDC until proved otherwise . It is becoming critical to properly identify EDCs to determine their exposure and provide a justification when it is considered appropriate to use such substances . Many EDCs will be affected by new regulatory changes under the EC
Chemicals Strategy for Sustainability , largely due to tighter regulations on endocrine disruptors in the EU . These and other regulatory changes globally mean that the industry is preparing for a big shake-up . Many companies have also been investing in sustainable chemistries for at least the past decade or more , particularly in using natural feedstocks , but also in new biotechnology , such as the fermentation of microbes to ensure that chemicals are produced in a way that reduces the impact to human health and environment . •
References
1 : https :// ec . europa . eu / environment / pdf / chemicals / 2020 / 10 / Executive _ summary _ FC _ EDC . pdf
2 : https :// ec . europa . eu / info / law / better-regulation / have-your-say / initiatives / 12264-Chemicals- strategy-for-sustainability-
3 : Guidance for the identification of endocrine disruptors in the context of Regulations ( EU ) No 528 / 2012 and ( EC ) No 1107 / 2009
4 : European Commission , 2nd Meeting of Competent Authorities Sub-Group on Endocrine Disruptors ( CASG-ED ) 2nd July 2020
5 : OECD 150 Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption . https :// www . oecd-ilibrary . org / docserver / 9789264304741-en .
6 : 6 V . Ho et al ., Environmental Research , March 2002 , 204 ( A ), 111969
Dr Rosalinda Gioia
PRINCIPAL SCIENTIFIC CONSULTANT
YORDAS GROUP
k + 44 161 250 6217 J r . gioia @ yordasgroup . com j www . yordasgroup . com / hive
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