Identification of endocrine system disruptors

PROJECT OVERVIEW

Development of algorithms to identify endocrine system disruptors as part of toxicological assessment of a substance (AL-MES)

In cooperation with the Faculty of Pharmacy, we will conduct a project, Development of algorithms to identify endocrine system disruptors as part of toxicological assessment of a substance.

INFORMATION
  • 1.2.2019―31.7.2020
  • UL, Fakulteta za Farmacijo
  • BiSafe d.o.o.
  • prof. dr. Marija Sollner Dolenc

Project funded by:

  • Public Scholarship, Development, Disability and Maintenance Fund of the Republic of Slovenia
  • Ministry of Health, Chemicals Office of the Republic of Slovenia

The project is co-funded by the Republic of Slovenia and the European Union from the European Social Fund

Objectives of the project:

The main objective of the project is to prepare algorithms to identify potential endocrine disruptors (EDs) allowing the industry to recognise EDs and replace them with safer alternatives.

Endocrine disruptors (EDs) are exogenous substances that alter the function of the endocrine system in humans and animals and consequently cause adverse health effects. In order to restrict their harmful activity, the European Commission adopted two legal acts at the end of 2017:

Commission Delegated Regulation (EU) 2017/2100 and Commission Regulation (EU) 2018/605, which set out scientific criteria for the assessment of endocrine disruptors. Through these regulations, it was requested that endocrine disrupting properties should be determined for all substances used in the manufacture of biocidal products and active substances, safeners and synergists used in the manufacture of plant protection products.

The adopted criteria also upgrade the current possibilities of restricting substances with endocrine disrupting properties under Regulation 1907/2006 REACH, relating to all substances manufactured or imported into the EU, and set criteria to verify potential endocrine disrupting properties also for all other substances used in the industry.  Thus, the industry has both the commitment and the desire to identify EDs in order to ensure safe use of chemicals and allow smooth operation.

Therefore, the industry needs practical solutions and trained professionals able to understand and practically implement the complex Guidance for the Identification of Endocrine Disruptors within Regulations (EU) No. 528/2012 and (EC) No. 1107/2009.

Through mutual exchange of knowledge, experience and good practices, the participants of the project will be able to implement the Guidance requirements into practice.  The project covers five main tasks: selecting toxicology databases, preparing an algorithm to search through toxicological databases, selecting and using computer toxicological models, implementing criteria to assess relevance and suitability of studies, and preparing endocrine potential assessment for the selected substances.