Cosmetic products as an object of technical regulation of the ministry of health. Development of a methodology for the implementation of the technical regulations
Keywords:technical regulation, cosmetic products, Technical regulations for cosmetic products, standards, quality management system
From 2021, cosmetic products are subject to technical regulation of the Ministry of Health, which is responsible for ensuring the implementation of Technical Regulations, approval of guidelines for their application, national standards in accordance with the requirements of Technical Regulations. It was adopted in early 2021. For the first time in Ukraine, the technical regulations for cosmetic products apply to cosmetic products the principles of technical regulation, powers to comply with which are vested in the relevant Ministry of Health.
The aim of this work is to develop a methodology for implementing the Technical Regulations for cosmetic products as an object of authority of the Ministry of Health.
As research materials the processes of technical regulation of cosmetic products are studied, logical, investigation methods of research, and also a method of the content analysis are used.
Results. An analysis of the practice of regulating the circulation of cosmetic products in a number of foreign countries, identified and systematized potential risks in the implementation of the principles of its technical regulation. Based on the analysis of causal relationships in the process of implementing the requirements of the Technical Regulations for cosmetic products, the methodology of its practical application is proposed.
Conclusions. The tendencies of regulatory policy in relation to cosmetic products in a number of foreign states and Ukraine are established. The analysis of the main provisions of the Technical Regulations for cosmetic products is carried out and the methodology of its introduction is developed
Annual growth of the global cosmetics market from 2004 to 2020. Available at: https://www.statista.com/statistics/297070/growth-rate-of-the-global-cosmetics-market/
Cosmetics Market. Available at: https://www.loreal-finance.com/en/annual-report-2020/cosmetics-market-2-1-0/
Lebedynets, V. O., Kazakova, I. S. (2020). The analysis and determination of prospects for the development of the market of medicinal cosmetic products in Ukraine. Social Pharmacy in Health Care, 6 (2), 44–60. doi: http://doi.org/10.24959/sphhcj.20.185
Pro zatverdzhennia Tekhnichnoho rehlamentu na kosmetychnu produktsiiu (2021). Postanova Kabinetu ministriv Ukrainy No. 65. 20.01.2021. Available at: https://zakon.rada.gov.ua/laws/show/65-2021-%D0%BF#Text
Regulation (EC) No 1223/2009 (2009). European parliament and of the council of 30 November 2009 on cosmetic products. Official Journal of the European Union, L 342/59– L 342/209.
Kovalova, O. M., Tsyhulova, O. M., Shumilo, O. M., Dieieva, O. O. (2016). Bezpeka kosmetychnykh tovariv v Ukraini. Medyko-pravovi aspekty ta suchasna koniunktura na vnutrishnomu rynku. Kyiv: FOP «Klymenko», 447.
Baitsar, R. I., Kordiiaka, Yu. M. (2015). Aktualni problemy ta perspektyvy rozvytku kosmetychnoi haluzi. Visnyk Natsionalnoho universytetu "Lvivska politekhnika". Avtomatyka, vymiriuvannia ta keruvannia, 821, 44–49.
Burd, N. B., Heorhiiants, V. A., Polovko, N. P., Hryzodub, O. I. (2016). Likuvalna kosmetyka v Ukraini: realii ta perspektyvy. Farmatsevtychnyi zhurnal, 6, 41–44.
Popko, O. V. (2016). Unifikatsiia vymoh tekhnichnoho rehuliuvannia parfumerno-kosmetychnoho rynku Ukrainy z normamy YeS: tovaroznavchi aspekty. Instytutsionalizatsiia protsesiv yevrointehratsii: suspilstvo, ekonomika, administruvannia. Rivne, 198.
Beg, M. R. (2020). Cosmetic-Regulations, Research Marketing challenges and global compliance: An overview. doi: http://doi.org/10.31219/osf.io/d8tzu
Lores, M., Celeiro, M., Rubio, L., Llompart, M., Garcia-Jares, C. (2018). Extreme cosmetics and borderline products: an analytical-based survey of European regulation compliance. Analytical and Bioanalytical Chemistry, 410 (27), 7085–7102. doi: http://doi.org/10.1007/s00216-018-1312-3
Monteiro Rodrigues, L., Fluhr, J. W. (2019). EEMCO Guidance for the in vivo Assessment of Biomechanical Properties of the Human Skin and Its Annexes: Revisiting Instrumentation and Test Modes. Skin Pharmacology and Physiology, 33 (1), 44–60. doi: http://doi.org/10.1159/000504063
Amberg, N. (2018). Environmentally conscious consumer behaviour in the cosmetics markets of the United States and Еurope. Available at: https://www.researchgate.net/publication/338233673_ENVIRONMENTALLY_CONSCIOUS_CONSUMER_BEHAVIOUR_IN_THE_COSMETICS_MARKETS_OF_THE_UNITED_STATES_AND_EUROPE_in_ESZTERHAZY_KAROLY_EGYETEM_GYONGYOSI_KAROLY_ROBERT_CAMPUS_ESZTERHAZY_KAROLY_UNIVERSITY_A_TUDOMAN
Eixarch, H., Wyness, L., Sibanda, M. (2019). The Regulation of Personalized Cosmetics in the EU. Cosmetics, 6 (2), 29. doi: http://doi.org/10.3390/cosmetics6020029
Legislation. Available at: https://ec.europa.eu/growth/sectors/cosmetics/legislation_en
Inspection of Cosmetics. Available at: https://www.fda.gov/cosmetics/cosmetics-compliance-enforcement/inspection-cosmetics
China Releases New Guidelines on Cosmetic Safety Assessments (2021). Available at: https://www.sgs.com/en/news/2021/05/safeguards-06121-china-releases-new-guidelines-on-cosmetic-safety-assessments
Hu, A. (2021). CSAR Subsidiary Regulations: China Finalizes Standards for Cosmetic Efficacy Claim Evaluation. Available at: https://cosmetic.chemlinked.com/news/cosmetic-news/csar-subsidiary-regulations-china-finalizes-standards-for-cosmetic-efficacy-claim-evaluation
Hu, A. (2021). Japan Сosmetic Regulation. Available at: https://cosmetic.chemlinked.com/cosmepedia/japan-cosmetic-regulation
Guidance on Skin Irritation Asseessment System for Quasi-Drugs and cosmetics safety Asseessment (2021). Available at: https://cosmetic.chemlinked.com/database/view/1241#documents-list
Sarma, P., Kumar, H., Medhi, B. (2017). Cosmetovigilance in India: Need of the day. Indian Journal of Pharmacology, 49 (5), 341–343. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5830843/#idm140273848653776title
Pro tekhnichni rehlamenty ta otsinku vidpovidnosti (2015). Zakon Ukrainy No. 124-VIII. 15.01.2015. Available at: https://zakon.rada.gov.ua/laws/show/124-19#Text
Tekhnicheskii reglament Tamozhennogo soiuza «O bezopasnosti parfiumerno-kosmeticheskoi produktsii» TR TS 009/2011 (2011). Available at: https://docs.cntd.ru/document/902303206
Kazakova, I., Lebedynets, V. (2020). Analysis of the technical regulation state of cosmetic products turnover in Ukraine. ScienceRise, 2, 39–46. doi: http://doi.org/10.21303/2313-8416.2020.001279
Kazakova, I., Lebedynets, V., Kovalenko, S., Kazakova, V. (2021). Research of the activities of the enterprises of the perfume and cosmetic industry of Ukraine. EUREKA: Health Sciences, 2, 44–55. doi: http://doi.org/10.21303/2504-5679.2021.001700
How to Cite
Copyright (c) 2021 Iryna Kazakova, Svitlana Kovalenko, Viacheslav Lebedynets, Daria Bondarenko, Viktoriya Kazakova
This work is licensed under a Creative Commons Attribution 4.0 International License.
Our journal abides by the Creative Commons CC BY copyright rights and permissions for open access journals.
Authors, who are published in this journal, agree to the following conditions:
1. The authors reserve the right to authorship of the work and pass the first publication right of this work to the journal under the terms of a Creative Commons CC BY, which allows others to freely distribute the published research with the obligatory reference to the authors of the original work and the first publication of the work in this journal.
2. The authors have the right to conclude separate supplement agreements that relate to non-exclusive work distribution in the form in which it has been published by the journal (for example, to upload the work to the online storage of the journal or publish it as part of a monograph), provided that the reference to the first publication of the work in this journal is included.