Development of the national list of carcinogens, mutagens and reprotoxicants and its implementation in the regulation of the circulation of chemicals over the territory of the Russian Federation and member states of the Eurasian economic union

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Abstract

Introduction. Highly hazardous chemicals that can cause distant and specific effects in the human body and various representatives of natural biota are circulating on the market. To develop effective measures to minimize the risk of chemicals exposure and to inform the general public in the countries of the European Union, the United States and many other countries, national lists of substances that are potentially dangerous due to one or another type of effect on the body are being created. There are no lists of chemicals with reprotoxic and mutagenic effects in the Russian Federation and the Eurasian Economic Union. There is also a need to update the list of substances with carcinogenic properties.

The aim of the study. Creation of lists of chemicals with reprotoxic, mutagenic and carcinogenic effects, based on a single international harmonized approach to the assessment, hazard classification and labelling of these highly hazardous substances.

Materials and methods. To achieve this goal, an analysis of the information was carried out on about two thousand substances included in the regulatory legal acts of the Russian Federation and the European Union, as well as on a huge array of data from domestic and foreign sources of information, using the principles of evidence-based medicine.

Results. Based on the obtained data, lists of chemicals with reprotoxic, mutagenic and carcinogenic were formed. The list of chemicals according to the danger of impact on reproductive function and development of offspring, which consists of substances classified into two classes, as well as compounds that affect through lactation. Seventy-five substances were assigned to class 1, 46 were included in the second class, and 16 substances were allocated to a separate class that influences the newborn through lactation. The list of mutagenic effects included 589 chemical substances, and due to the lack of epidemiological data, the analysis did not allow any of the substances to be attributed to hazard class 1A, 438 substances were classified to hazard class 1B, 151 substances were classified to hazard class 2. As a result of the analysis, a list of carcinogens was formed, among which 133 substances were assigned to the 1st class, and 244 were classified to the 2nd hazard class.

Conclusion. These lists, to implement the Technical Regulations of the Eurasian Economic Union “On the Safety of Chemical Products” (TR EAEU 041/2017), were included in Annex No. 7 of the Procedure for Forming and Maintaining the Register of Chemicals and Mixtures of the Eurasian Economic Union, and also formed the basis for coding production and consumption waste according to these effects.

Contribution:

Khamidulina Kh.Kh. — concept and design of the study, collection and processing of material, editing, approval of the final version of the article, responsibility for the integrity of all parts of the article;

Rabikova D.N. — concept and design of the study, collection and processing of material, writing a text.

Conflict of interest. The authors declare no conflict of interest.

Acknowledgement. The study had no sponsorship.

About the authors

Khalidya Kh. Khamidulina

Russian Register of Potentially Hazardous Chemical and Biological Substances-Branch of Federal Scientific Center of Hygiene named after F.F. Erisman of the Federal Service for Supervision in Protection of the Rights of Consumer and Man Wellbeing; Russian Medical Academy of Continuing Professional Education

Author for correspondence.
Email: noemail@neicon.ru
ORCID iD: 0000-0001-7319-5337

MD, PhD, DSci., professor, Director of the Russian Register of Potentially Hazardous Chemical and Biological  ubstancesBranch of Federal Scientific Center of Hygiene named after F.F. Erisman of the Federal Service for Supervision in Protection of the Rights of Consumer and Man Wellbeing, Mytishchi, 141014, Russian Federation; Head of the Department of Hygiene of the Russian Medical Academy of continuing professional education, Moscow, 123993, Russian Federation.

e-mail: director@rosreg.info

Russian Federation

Dinara N. Rabikova

Russian Register of Potentially Hazardous Chemical and Biological Substances-Branch of Federal Scientific Center of Hygiene named after F.F. Erisman of the Federal Service for Supervision in Protection of the Rights of Consumer and Man Wellbeing; Russian Medical Academy of Continuing Professional Education

Email: noemail@neicon.ru
ORCID iD: 0000-0003-3965-7600
Russian Federation

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