PROJECT OVERVIEW
Selection and preparation of the dossier for a potentially neurotoxic chemical using in-silico methods for the purpose of European chemical legislation REACH implementation (V1-1914)
In cooperation with the National Institute of Chemistry and the Faculty of Pharmacy, we conduct project selection and preparation of the dossier for a potentially neurotoxic chemical, using in-silico methods for the purpose of implementing the European chemical legislation REACH.
INFORMATION
- PROJECT DURATION: 1.11.2019―31.10.2020
- PROJECT LEAD BY: National Institute of Chemistry
- PROJECT PARTNERS: BiSafe d.o.o., Faculty of Pharmacy at the University of Ljubljana
- PROJECT HEAD: doc. dr. Marjan Vračko - Grobelšek
Project funded by:
Objectives of the project:
The European legislation REACH describes the registration, evaluation and potential authorisation of chemicals manufactured or imported on the European Union market.
At the Union level, European Chemicals Agency (ECHA) is responsible for the implementation of this regulation. Article 57 of REACH lays down the criteria for selecting substances to be included in Annex XIV, better known as Substances of Very High Concern (SVHC). SVHC thus covers substances that are carcinogenic, mutagenic and toxic to reproduction as well as persistent, bio-accumulative and toxic and very persistent, very accumulative substances and endocrine-disrupting substances.
In addition, under Article 57(f), SVHC are also classified as substances which have scientifically been proven to have serious effects on human health or the environment, equivalent to the effects of the above substances. This last group also covers neurotoxic effects, which are the subject of our study. Our fundamental objective was to select a substance (‘priority setting’) for which there is scientific evidence of its neurotoxic action, and to prepare an Annex XV dossier for submission to ECHA.
The candidate compounds will be selected among high-quantity compounds registered under REACH, with a focus on solvents. The proposed ECHA dossier means combined efforts from science, industry and regulators. The research results in this field will help raise awareness on potential risk resulting from exposure to selected groups of substances and their metabolites via air, food, drink and water among lay and professional public.
In this way, they will significantly contribute to the preparation of relevant guidelines, directives and regulations at national, European and global levels, resulting in significant contribution to public health protection.
Poleg teh pa člen 57(f) med SVHC uvršča tudi snovi, za katere je znanstveno dokazano, da imajo lahko resne učinke na zdravje ljudi ali okolje, ki so enakovredni učinkom prej naštetih snovi. V to zadnjo skupino sodijo tudi nevrotoksični učinki, ki so predmet naše raziskave. Naš temeljni cilj je izbrati eno snov (‘priority setting’), za katere obstajajo trdni znastveni dokazi, da učinkuje nevrotoksično ter pripraviti dosje XV za predložitev ECHA.
Kandidatne spojine bomo izbirali izmed visoko tonažnih spojin registranih skladu z Uredbo REACH, pri čemer se bomo osredotočili na topila. Predlagani dosje za ECHA pomeni sintezo naporov znanosti, industriji in regulatorjev. Rezultati raziskovanj na tem področju bodo pripomogli k zavedanju o potencialnem tveganju zaradi izpostavljenosti izbranim skupinam snovi in njihovim presnovkom preko zraka, hrane, pijače in vode tako v laični kot strokovni javnosti.
Na ta način bodo zelo pomembno pripomogli tudi k pripravi relevantnih smernic, direktiv in uredb na nacionalni, evropski in svetovni ravni, kar bo pomembno prispevalo k varovanju javnega zdravja.
