ANALYSIS OF THE TECHNICAL REGULATION STATE OF COSMETIC PRODUCTS TURNOVER IN UKRAINE

The object of research is the state regulation of the turnover of cosmetic products and some aspects of their implementation in Ukraine. Investigated problem. The issue of import substitution of Ukrainian cosmetic products and the increase in their production and sales in the Ukrainian and foreign markets is an urgent reason for the dynamic development of the cosmetic industry and the diversification of its traditional forms and directions of application. The solution to these problems mainly depends on the level of technical regulation by the state and requires proper legislative support in accordance with the requirements of international standards and EU directives. The main scientific results. The foreign experience of regulatory support and state regulation of the turnover of cosmetic products (CP) is summarized. The problems of technical regulation of cosmetic and medicinal cosmetics in Ukraine are identified. An addition to the draft national technical regulation for cosmetic products is proposed and recommendations for its rational use are given. The prospects of introducing quality management systems at enterprises engaged in activities at all stages of the CP life cycle are determined. Innovative technological product. A model has been developed to improve the current regulatory and technical framework governing the CP turnover in Ukraine, and an algorithm for its implementation is presented. The relevance of methods and means of ensuring the quality, safety and effectiveness of CP by introducing quality management systems at all stages of its life cycle is determined. The scope of the innovative technological product. The developed proposals are recommended for implementation in the system of state regulation of the CP turnover in order to ensure its quality, effectiveness and safety for the health of consumers.


Introduction The object of research
The object of research is the regulatory processes for the turnover of cosmetic products and the technology for their implementation in Ukraine and abroad.

2. Description of the problem
The importance and priority of technical regulation of the CP turnover of cosmetic products in Ukraine is determined by the Association Agreement between Ukraine and the EU [1]. The cosmetic industry of Ukraine is characterized by high prospects for increasing competitiveness and facilitating import substitution. Along with this, ensuring compliance with the laws of the EU countries is a necessary requirement for its effective promotion in the Ukrainian and foreign markets. Now significant attention of scientists and practitioners is paid to the development of the perfumery and cosmetics industry [2,3], to ensure the CP quality and safety [4,5]. The issues of technical regulation of CP turnover are currently not regulated in Ukraine and require research on its compliance with international practice.

3. Suggested solution to the problem
In order to formulate proposals for ensuring proper technical regulation of CP turnover in Ukraine, it is considered advisable to study the experience of countries with a large cosmetic market A B S T R A C T The object of research is the state regulation of the turnover of cosmetic products and some aspects of their implementation in Ukraine. Investigated problem. The issue of import substitution of Ukrainian cosmetic products and the increase in their production and sales in the Ukrainian and foreign markets is an urgent reason for the dynamic development of the cosmetic industry and the diversification of its traditional forms and directions of application. The solution to these problems mainly depends on the level of technical regulation by the state and requires proper legislative support in accordance with the requirements of international standards and EU directives. The main scientific results. The foreign experience of regulatory support and state regulation of the turnover of cosmetic products (CP) is summarized. The problems of technical regulation of cosmetic and medicinal cosmetics in Ukraine are identified. An addition to the draft national technical regulation for cosmetic products is proposed and recommendations for its rational use are given. The prospects of introducing quality management systems at enterprises engaged in activities at all stages of the CP life cycle are determined. Innovative technological product. A model has been developed to improve the current regulatory and technical framework governing the CP turnover in Ukraine, and an algorithm for its implementation is presented. The relevance of methods and means of ensuring the quality, safety and effectiveness of CP by introducing quality management systems at all stages of its life cycle is determined. The scope of the innovative technological product. The developed proposals are recommended for implementation in the system of state regulation of the CP turnover in order to ensure its quality, effectiveness and safety for the health of consumers. and a developed state system for regulating the turnover of such products, as well as conduct a comparative analysis of the legislative framework governing CP turnover in Ukraine and other countries. Based on the results of the study, develop recommendations on the introduction of effective approaches to the practice of regulating the CP turnover in Ukraine.
The aim of research is to develop practical recommendations on the technology for improving and implementing regulatory documents in Ukraine in accordance with international requirements in the field of CP turnover.

Materials and methods
Scientific publications, the Ukrainian and foreign legislative framework on the regulation of turnover of pharmaceutical products, electronic databases of the State Register of Medicines of Ukraine, the weekly Pharmacy and the Compendium directory, and the results of our own research are used as information materials. Methods are applied: analytical, comparative, content analysis and generalization of information.

Results
The experience of regulating CP turnover in the EU countries, as well as in the USA, Japan, India and China, is studied. The main regulatory documents governing the CP turnover in these countries, where there is a high level of development of the cosmetics industry, are analyzed [6][7][8][9][10]. The research results are given in Table 1. Regulation of requirements for the design, review and approval of special-purpose personal cosmetics Guidelines on the procedure for registration and approval of import CP of non-special purpose, 2016 Regulation of requirements for the design, review and approval of imported non-special purpose CP  Regulation of the list of substances that are prohibited and restricted for use in cosmetics According to the results of studies, in countries with a developed cosmetic market, significant attention from the state is paid to the quality, safety and effectiveness of CP. All stages of the product life cycle are regulated by the relevant regulatory legal acts (for example, criteria, methods for assessing and monitoring the quality, safety and effectiveness of CP).
If there is a declaration of a therapeutic effect in the CP, their status is defined as "medicinal cosmetics" (USA, India), "quasi-cosmetics" (Japan), and "special cosmetics" (China). In this case, the legislator regulates the need to prove the therapeutic and cosmetic effect of the product by determining its compliance with the requirements of certain standards.
Special requirements for the CP safety are distinguished by EU countries, in whose territory the CP turnover is regulated by Regulation No. 1223/2009 of the European Parliament and the European Council for Cosmetic Products [9,10]. The objects of systematic monitoring on the part of the authorized bodies are all links of CP turnover on the market.
An important area of industry control over CP in the world is cosmetological supervision (cosmetovigilance) -monitoring the CP safety in the process of their practical application. The process of monitoring the results of the use of products involves the interaction of the responsible person of the manufacturer, distributor, medical/pharmaceutical representative and the consumer of CP.
The information base on undesirable effects resulting from the CP use is generally accessible and forms a system of safe and high-quality cosmetic market. If there is a serious risk to the health of consumers, which requires urgent action, the authorized body will take the necessary measures to prohibit or restrict sales of CP in the market or to extract such products from points of sale.
The key to the correct operation of all parts of the CP turnover system is the implementation of quality management principles in accordance with the requirements of relevant good practices (development, production, laboratory research, storage, transportation, etc.) and quality system standards.
In Ukraine, regulation of CP turnover is determined by a number of regulatory legal acts, which should be investigated in accordance with the legal status of this category of products.
According to the requirements of DSTU 2472:2006 "Perfume and cosmetic products. Terms and definitions", CP status is defined in Ukraine, and according to the Law of Ukraine "On Medicines" dated 04.04.1996 No. 123/96-BP -the status of medicinal cosmetic products (MCP). A combination of cosmetic and medicinal properties is MCP characteristic.
An analysis of the features of technical regulation of the CP and MCP turnover in accordance with the requirements of current regulatory documents is given in Table 2. According to the results of the analysis of the Ukrainian legislative base, in the consumer market of Ukraine there are two categories of products -CP and MCP, the legislative regulation of which has certain features. The MCP turnover is regulated by general requirements in the field of healthcare and is controlled by the Ministry of Health (MH) of Ukraine. CP is defined as a category of non-food products, the turnover of which is controlled by the State Service for Food Safety and Consumer Protection.

Discussion
According to the results of the study, it was established that international experience in regulating the turnover of cosmetic products proves the need for a systematic approach to ensuring its quality, safety and effectiveness. In a number of countries, such as the USA, Japan, India, and China, categories of cosmetic products that can have medicinal properties are defined, and in proving, along with cosmetic, a therapeutic effect [6][7][8][9][10]. The analysis of regulatory documents governing the CP turnover in Ukraine indicates that the requirements for their quality and safety do not meet international standards, outdated regulatory and technical documents continue to apply. The current regulatory framework does not provide for the regulation of the processes of creation, research, registration, post-marketing control of cosmetic products. CP sanitary-hygienic examination procedure does not meet international standards. For MCP there is no regulation of the criteria and methods for assessing cosmetic effectiveness [11,12]. These factors do not contribute to the harmonization of industry legislation with the requirements of European directives and may pose a potential threat to consumer health.
Thus, the Ukrainian legislative framework requires urgent system improvement, but the necessary changes are taking place very slowly. In fulfillment of Ukraine's obligations regarding the implementation of EU legislation into national legislation, the Ministry of Health of Ukraine back in 2013 developed a draft Technical Regulation for Cosmetic Products (hereinafter -Regulation). The draft Regulation is again posted on the website of the Ministry of Health of Ukraine on January 23, 2020 for public discussion. The analysis of the document [13] shows the need for its specific supplement in order to comply with European standards and current trends in the development of the cosmetics industry. In particular, it is recommended that the requirements for state market supervision be specified, namely: monitoring compliance with the principles of good practice in organizing production by industry enterprises. It should also include a requirement for the competent authority to apply the necessary measures to prohibit or limit the entry of CP to the market or to withdraw them from sales on the basis of the facts of non-compliance. The following should be considered the conditions for the above actions: the presence of a serious risk to the health of consumers; neglect by the responsible person of appropriate measures for a specified period of time.
For the effective implementation of the Regulation, the question arises of the implementation of its requirements in Ukraine, namely: the creation of a Ukrainian regulatory framework, the adaptation of documents and the definition of competent organizations that will ensure control over their implementation. Based on the analysis of the current national legislative framework and the experience of foreign countries in regulating the CP turnover, recommendations are developed for the implementation of the Regulations, the implementation algorithm of which is shown in Fig. 1.  Fig. 1. Algorithm for the implementation of the provisions of the Regulation on cosmetic products It can be argued that for the implementation of the Regulation it is necessary to apply a complex of multi-vector management actions, it requires combining the efforts of both authorized state bodies and industry public organizations, as well as all participants in the cosmetic market as a whole. The use of these technologies for the implementation of the Regulation is aimed at its effective implementation in order to ensure compliance with international standards.

Conclusions
The peculiarities of regulating the turnover of cosmetic and medicinal cosmetic products in different countries of the world are established. International experience of technical regulation of the CP turnover are investigated, features of legislative support for the quality, safety and effectiveness of CP and MCP in Ukraine are described. Inconsistencies of the existing Ukrainian regulatory framework for the technical regulation of the CP turnover with international approaches are identified. An analysis of the draft national technical regulation for cosmetic products is carried out, recommendations are given for its improvement and an algorithm for implementing its provisions.
The problems of import substitution of Ukrainian CP and the increase in their production and sales in the Ukrainian and foreign markets are relevant in the context of the dynamic development of the cosmetics industry. The solution to this problem directly depends on the level of technical regulation of CP turnover and requires proper legislative support in accordance with the requirements of international and European standards and directives.
Given the foregoing, promising is the continuation of work on the development of regulatory documents governing the standardization of cosmetic products, given the experience of interna- tional technical regulation and the development of the modern cosmetic market. The use of quality management systems at all stages of CP turnover allows to provide a systematic approach to their standardization and quality control, to guarantee consumers the proper efficiency and safety of products in accordance with international standards.