Endocrine disrupting chemicals (EDCs) are chemicals that alter the function of the endocrine system and have a negative affect on human and animal health. They may be of synthetic or natural origin. Exposure can occur due to various sources, such as pesticide residues or consumer products that are used or present in our daily lives. In recent decades, there has been an increased interest in chemicals that act on the endocrine system. This interest has led regulators worldwide to consider whether potential EDCs should be identified and evaluated for their effects on human and wildlife health and what harmonized criteria could be used to make such an assessment.
The Master's thesis summarizes the regulatory guidelines in Europe, the US (United States of America) and Japan. We focused on the beginnings of setting up a health risk assessment system for EDC, the current strategy, guidelines and the required test methods. In addition to comparing these three parts of the world, we described how they deal with the problem globally by harmonizing procedures, where we focused on the Organization for Economic Co-operation and Development (OECD).
We have found that there are differences in legislation between Europe, the US and Japan, starting with the very definition of EDC itself and the programs introduced for EDC detection. While in Europe there are two lists with proven 66 substances and suspected 564 substances, in the USA they have a list of proven 45 substances with endocrine action and in Japan a list that lists 67 substances with suspected endocrine function. Different regulatory bodies are also responsible for each part of the world - in Europe the main body dealing with EDC is the European Chemicals Agency (ECHA), in the USA the Environmental Protection Agency (EPA) and in Japan, the Ministry of the Environment of Japan. In the field of test guidelines, all three parts of the world are striving for harmonization and are therefore involved in the work of the OECD. The main objective of this organization is to harmonize test approaches, regulate regulations and develop new test guidelines in the field of EDC nationally and internationally. Tests consisting of methods in silico, in vivo and in vitro are developed within the OECD document of the OECD Conceptual Framework for Testing and Assessment of Endocrine Disrupters, which consists of five stages. The OECD has already made significant progress in this area. An example of the use of these tests in a regulatory framework exists within the US Endocrine Disruptor Screening Program (EDSP), which uses validated tests and models to determine endocrine disruption. The European Commission has also made significant progress in regulating this area, since after many years of debate, at the end of 2017, it adopted two pieces of legislation: Commission Delegated Regulation (EU) 2017/2100 (2) and Commission Regulation (EU) 2018/605 (3), which set out the scientific criteria for EDC evaluation. They requested that all substances used in the production of biocidal products, as well as the active substances, safeners and synergists used in the production of plant protection products, should be verified as having no EDC properties. This builds on the existing possibilities of limiting substances with these properties under REACH Regulation 1907/2006, which applies to all substances manufactured or imported into the EU, and sets criteria for verifying the potential properties of EDCs for all other substances used in different purposes. In the future, we can expect these scientific criteria to be taken into account globally.
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