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Investigations into the feasibility of a cohort study among workers exposed to diisocyanates to accompany new regulations for diisocyanates under chemicals legislation

Project number: F 2458 Institution: Federal Institute for Occupational Safety and Health (BAuA) / Berufsgenossenschaft Rohstoffe und chemische Industrie (BG RCI) / Institut für Prävention und Arbeitsmedizin der Deutschen Gesetzlichen Unfallversicherung (IPA) Status: Completed Project

Description:

Diisocyanates can cause respiratory and skin conditions. This group of chemicals is produced in large quantities in the EU and used above all in the manufacture of polyurethanes, for paints and foams for example. The REACH restriction proposal for diisocyanates initiated by the Federal Institute for Occupational Safety and Health (BAuA) was submitted to the European Chemicals Agency (ECHA) in October 2016. The objective was to significantly reduce the number of new asthma cases that occur annually as a result of occupational exposure throughout the EU. Binding standards for protective measures and specific training programmes on the safe handling of diisocyanates were to be introduced to achieve this. The REACH restriction on diisocyanates finally adopted as a result of the proposal entered into force in 2020. Following a transition period it will be mandatory for users to receive training as of August 2023.

BAuA advocated the development of a longitudinal study to look at the outcomes of the restriction. This was the purpose of the project conducted between 2018 and 2021 by the Bochum-based Institute for Prevention and Occupational Medicine (Institut für Prävention und Arbeitsmedizin, IPA) with support from BAuA and other cooperation partners. It investigated the feasibility of a cohort study and further study modules with workers exposed to diisocyanates and made preparations for the main study. The principle aim of the feasibility study was to recruit companies with a sufficient number of exposed workers. This would then allow exposure levels and their health impacts to be examined. Visits to businesses all over Germany led to the recruitment of more than thirty companies with over 1,300 exposed workers who would be able to take part in the study. Another aim was to elaborate the study design for the main study. Thanks to the work that has been done, it will now be possible to conduct a prospective cohort study over a period of five years. Furthermore, the effectiveness of the REACH training programmes is to be reviewed with randomised trials at the company level before the mandatory training gets under way. The main study is therefore planned to start in 2022 at the latest.

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