L.I. Medved's Research Center of Preventive Toxicology, Food and Chemical Safety, Ministry of Health of Ukraine, Kyiv, Ukraine

Abstract. Objective. Conduct a comparative analysis of legislative decisions, legal framework, methodology, standards in force in the EU and Ukraine, which are aimed at implementing management solutions in the system of ecologizing the production and use of chemically modified products and products based on them in the environment of human habitation.
Materials and Metods of Work. The data of periodic legal, technical, economic and medical scientific publications of Ukraine and the EU countries on the issue of the ecologization of production and use of polymeric materials.
Results. The analysis of the methodology of the concept of the risk assessment of paint and varnish materials, the legislative base, standards and hygienic standards used in the countries of European Union and Ukraine to ensure the safety of paint and varnish materials indicates their significant differences.
Key words: methodology, directives, legislative framework, European Union, standards, paints and varnishes materials.

At present, Ukraine is intensively integrating into the world community. This process resulted in a radical reorganisation of the economy, management of market relations, transformation of relationships that have developed over the decades in all spheres of economic activity. Chemically modified industrial products including those based on polymeric materials came into a particularly common use as a result of the technological nature of production processes and their cheapness. In connection with new technologies, special attention of all advanced countries was attracted by the problem of ensuring the safe use of polymers and materials based on them in the human environment, in particular in building, manufacture of furniture and products for interior finish of residential and public buildings. This is due to the use of a diverse raw materials containing substances of high toxicity in production of these materials: monomers, organic solvents that belong to different hazard classes (classes 2–4). In addition, raw materials may contain highly toxic heavy metals (hazard class 1). In economically developed countries, there is a whole group of materials widely used in building, furniture manufacturing, interior finish. It includes wood-plastic composites based on carbamide resins, in particular furniture and various paint and varnish materials. Such wood-plastic composites and furniture are the source of long-term release of formaldehyde (substance of 2nd hazard class ) into the air of the premises, and paint and varnish materials used for interior finish of walls, furniture, building constructions can pollute the air with harmful substances of 2–4 hazard class [1, 2, 3, 6]. The possibility of air pollution by heavy metal ions is not excluded in case of their content in raw materials used in the technology of production of these materials [1, 2]. For this very reason, nowadays, the study of room aerial environment pollution with harmful substances releasing by wood-plastic composites, furniture and paint and varnish coatings and affecting the health of the population is recognised as a world problem that is in the focus of attention of the WHO, scientists of the EU countries, the USA, etc. [2, 4]. The term “sick building syndrome” has become international. It absolutely specifically characterises the uncomfortable state of health and the whole complex of painful manifestations on the part of various human organs and systems under conditions of residence or work in buildings and premises, the air of which is polluted with harmful chemicals [3, 5, 11]. In this regard, the issues of green production and regulation of the safe use of polymeric materials of building, furniture and paint and varnish purpose in the human environment is a major problem for the protection of the environment and public health in all countries of Europe, the United States and Ukraine. Integration of Ukraine with the EU countries and entry into the free-trade area requires the adaptation of Ukrainian sanitary legislation, methodology, criteria and methodological approaches regarding assurance of safety of industrial products for the population in accordance with the EU requirements. A legislative instrument that establishes mandatory requirements for products in the process of design, manufacturing, sales and disposal is the EU directives (New and Global Approach Directives). This is actually a mechanism of mandatory certification. At the same time, the EU legislation left the right for the EU members to develop their own mechanisms for the implementation of the EU directives with stricter rules. The certification procedure cannot be simplified at the national level. The analysis of the legal framework of the regulatory and safety systems of the European Union products and a number of international organisations speaks for the international legislative recognition of the methodology for assessing the risk to human health as a key tool for justifying the safety standards of products and goods [4]. At the same time, safety assurance is the most important requirement in the production and application of any industrial products. Safety and risk as terms are interrelated. The main distinguishing feature of the EU legal framework regarding this issue is the recognition of safety as the absence of unacceptable risk, and not as the absence of risk in general [4]. According to the WHO recommendations, risk management can be carried out in several ways:

•    Absolute control — risk reduction to zero (this approach is used in case of real possibility of complete prevention of exposure to a particularly dangerous substance by prohibiting its use in the technological production process).
•    Risk reduction to a reasonable maximum technically and economically achievable level.
•    Risk reduction to a level that is perceived as practically zero, that is, a risk acceptable for each individual and society as a whole.

In accordance with this concept for risk assessment accepted in the EU, the main legislative document for the management of chemicals and compounds is EU Regulation No. 1907/2006 on Registration, Evaluation, Authorisation and Restriction of Chemicals, REACH regulation, which became effective from July, 2007 [10]. According to REACH, paint and varnish materials can not contain heavy metals: cadmium, cobalt, chromium, molybdenum and others, as well as compounds, for example, pigments containing them [10, 13]. Thus, lead carbonates (CAS No. 598-63-0, CAS No. 1319-46-6) and lead sulphates (CAS No. 7446-14-2, CAS No. 15739-80-7) cannot be used in paint and varnish materials. Such an approach to risk reduction by bringing it to zero during the production and use of paint and varnish materials is carried out on the basis of legislative measures provided that there are real possibilities that exist in the EU countries. To ensure safety regarding the release of volatile organic compounds from paint and varnish materials, approaches are used to heavily regulate their content in the composition of these materials. This is due to the fact that volatile organic compounds (monomers, solvents and other aromatic substances) are permanently released into the air of the premises posing a real threat to public health. This approach is reflected in the legislative documents: Directive No. 1999/13/EC and Directive No. 2004/42/EC, according to which the content of organic solvents in paint and varnish materials decreased by 2–13 times [8, 9, 13]. Such paint and varnish materials enter the EU market since January 01, 2010. In connection with the entry of Ukraine into the free-trade area, in order to enhance the competition of domestic industrial products and goods of European countries, it is necessary to use the EU recommendations on the safety of chemically modified materials, volatile organic and heavy metals. In 2014–2015 in Ukraine, the production of water-dispersible paint and varnish materials increased significantly, which was 60 % of the total production volume of these products in 2015. Despite the positive dynamics in decreasing the volumes of production and use of materials based on organic solvents, their part in the Ukrainian market remains significant, about 40 %. A significant defect of sanitary legislation of Ukraine in the field of safety use of heavy metals during production of paint and varnish materials is the lack of their regulations in the existing regulatory documents. This is due to the fact that most of the regulatory documents regarding paint and varnish materials were adopted before 1992, but are still valid, despite their inconsistency with modern international requirements for the direct regulation of the safety of these materials [16, 17, 18, 19, 20]. Therefore, there is an urgent need in Ukraine to develop appropriate technical regulations. Thus, at the meeting of the working group with the participation of the manufacturers of paint and varnish materials, the Ministry of Economic Development and Trade of Ukraine, representatives of the Ministry of Ecology and Natural Resources of Ukraine and the Ministry of Health, the first draft of the Technical Regulations On the Limitation of the Content of Volatile Organic Compounds in Certain Categories of Paint and Varnish Materials was considered. Legislative approval of this draft of the Technical Regulations will facilitate the introduction of strict regulation of content and limitation of the use of volatile organic compounds in the production of paint and varnish materials in Ukraine.

In November 21, 2017, the Ministry of Economic Development and Trade of Ukraine issued the draft order On Approval of the Technical Regulation on the Limitation of Emissions of Volatile Organic Compounds Due to the Use of Organic Solvents in Certain Paint and Varnish Materials and Vehicle Refinishing Products.

Approximation of approaches for harmonisation of chemical safety of paint and varnish materials stipulates the task of adapting the quantitative characteristics of harmful substances and EU standards used for risk assessment in the EU countries and Ukraine. The maximum permissible levels of chemical air pollutants recommended in the EU are not standards as such. Before converting them into legally binding standards, it is necessary to consider not only the safe limits of the maximum permissible chemical pollutants for human health, but also a whole range of factors: prevailing levels of exposure, technical attainability, control methods, strategy for reducing the level of chemical pollutants, as well as specific social and economic and cultural conditions of the country. In addition, the standard-setting procedure may be affected by the possibility of their compliance. Therefore, in the end, all of the above can contribute to the adoption of a standard above or below the appropriate recommended maximum safe level (MSL).

In addition, when justifying a standard, the cost-benefit ratio can be taken into account.

Such a methodical approach corresponds to the principle of technical regulation when justifying standards for the content of harmful substances released from finished products and fully complies with the WHO recommendations regarding reducing the risk to a reasonable maximum technically and economically achievable level [4]. Thus, as standards for emission of chemical pollutants into the air of a room from the products, that level of concentration is considered which has been adopted by regulatory bodies as mandatory and is used for certification of industrial products.

The results of consideration of all the necessary factors can form the basis for the justification of several standards. For example, the adoption of a standard aimed at complete effect elimination adopted as a promising goal and a less stringent standard as an intermediate one, which can be achieved within a shorter period. If the standard applied to the product meets the main essential requirements of the specific EU Directive of the New Approach, then the standard is classified as harmonised (European EN standards). In 2013, France adopted new hygienic standards relating to paint and varnish, building and finishing materials. These standards are designed to assess the environmental safety. After the issuance of French Decree No. 2011-321 dated March 23, 2011, mandatory labelling of all paint and varnish, building and finishing materials is necessary regarding the content of harmful volatile substances in the premises during their use. The new decree applies to all materials for interior finishing of the building: covering for floor, walls, ceilings, insulation, paint, varnish, filling, etc.

All household items: furniture, upholstery fabrics, everyday items, etc. release one or another level of pollutants into the air. For the environmental labelling of this type, the level of volatile substances is measured according to the most dangerous and common compounds: organic solvents, monomers, formaldehyde, acetaldehyde, toluene, styrene, xylene, etc. Since January 01, 2012, this type of labelling is mandatory for all kinds of paint and varnish products and finishing materials supplied to the market. Now, all enterprises that produce products for its further use as paint and varnish products, building materials, furniture must undergo such an inspection on the level of their environmental safety. The resulting evaluation should be placed on the product so that the buyer can immediately obtain important information. The standard has several levels, from C to A+, which are characterised by the degree of hazardous substance release into the air. Wherein:

•    A+ is the best estimate (the amount of hazardous substances released is insignificant or absent at all)
•    A is good (safe level of emission of harmful substances)
•    B is satisfactory (the amount of released substances does not exceed the permissible limit)
•    C is the worst estimate (large amount of hazardous substances released).

In Ukraine, the current state of the problem on the regulation of the safety of chemically modified products, materials based on polymers (building, paint and varnish and other materials) is carried out in accordance with the existing concept [1, 7]. The hygiene concept for the use of polymeric materials in a residential environment is a systematic approach to identifying and assessing the components of unfavourable factors that determine the potential danger of polymeric materials in human environments and under certain exposure conditions that lead to the formation of pre-pathological conditions or morbidity of the population, which can be excluded by the development and application of a goal-oriented system of hygienic regulation of production, the use of polymer materials, handling them after the expiration period, as well as their disposal and destruction. It follows from the concept that: Effective provision of safe use of polymer materials is possible through the development and implementation of a set of preventive measures that cover all stages of the life cycle of materials and products and determine the adoption of certain management decisions.

In Ukraine, the most important criteria for assessing the chemical safety of industrial products are hygienic standards, which also serve as a legal basis for the state control. The main distinguishing feature of the methodology for solving the issue of chemical safety of chemically modified materials in Ukraine is the full recognition of the approaches to the establishment of the daily average threshold level value in accordance with the zero risk concept. It is assumed that there is a certain limiting concentration of a harmful substance, below which staying in a certain area (indoors, residential area) is absolutely safe for different population segments for an infinitely long period.

This explains the significant difference in the quantitative values of domestic standards — the daily average threshold level value for a number of priority chemical pollutants of the air in premises compared to the EU standards established in accordance with the risk assessment based on technical regulation, which is presented in the Table.

Thus, it is necessary to develop approaches and criteria that help avoid errors to implement the harmonization of domestic hygiene standard — the daily average threshold level value for a specific substance — with the EU standard.

All of the above indicates that the presence of Ukraine in the free-trade area and successful competition of domestic chemically modified products, including paint and varnish materials, requires the adaptation of existing legislative documents, legal framework, methodological approaches used in Ukraine to ensure the safety of this product for public health.

CONCLUSIONS.

1. The conducted analysis of the methodology of the concept of the risk assessment of paintwork materials, legal framework, standards and hygienic regulations used in the EU countries and Ukraine to ensure safety of paint and varnish materials indicates their significant differences.

2. The most important tasks to solve the problem of adaptation of Ukrainian methodology and legal framework to the EU countries are the following: the development of new technologies for the production of paint and varnish materials, which allow exclusion of the use of highly toxic compounds and heavy metals, which pollute the air of premises with harmful substances of 1st hazard class; to strictly limit the content of organic solvents, which are sources of harmful substances of 2nd hazard class, in paint and varnish materials.

These developments should be included to the production of paint and varnish products by implementing the relevant Technical Regulations taking into account their compliance with the European ones.

3. It is necessary to develop and implement an appropriate regulatory framework into sanitary legislation in order to adapt the quantitative values of hygienic standards — the daily average threshold level value for harmful substances released from the paint and varnish materials into the air — valid in Ukraine to the EU standards.

REFERENCES

1. Dyshinievych N. Ie. Influence of polymeric materials and hazard criteria / N. Ie. Dyshinievych // SES profilaktychna medytsyna. – 2006. – No. 3. – P. 54–59.

2. Workgrouprepord: Indoor Chemistry and Health / C. J. Weschler, J. R. Wells, D. Poppendieck [et al.] //Environ Health Perspect. – 2006. – Mar; 114 (3). – P. 442–446.

3. Dyshinievych N. Ie. Polymer building materials and the sick building syndrome / N. Ie. Dyshinievych, R. E. Sova // Environment and health. Work book. – Kyiv, 1998. – P. 247–257.

4. Guidelines on air quality in Europe (edited by S. L. Avaliani, V. M. Zakharov, S. G. Dmitriiev, N. N. Gerasymov) – Second edition. – M.: Ves mir, 2004. – 312 p.

5. Hygienic and clinical aspects of the sick building syndrome and perspectives of public health protection / N. G. Prodanchuk, N. Ie. Dyshinievych, G. M. Balan [et al.] // Sovremennye problemy toksikologii. – 2006. – No. 3. – P. 4–12

6. Sheftel V. O. Toxicology of polymer materials / V. O. Sheftel, N. Ie. Dyshinievych, R. E. Sova. – Kyiv: Zdorove. – 1988. – P. 3-32.

7. Prodanchuk M. G. Substantiation of the necessity of making the criteria for evaluating the human-friendly use of polymeric building materials consistent with the international requirements / M. G. Prodanchuk, N. Ie. Dyshinievych, Ie. A. Bahlii // Suchasni problemy toksykolohii. – 2003. – No. 3. – P. 4–9.

8. On the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain activities and installations: Council Directive dated March 11, 1999 No. 1999/13/EC. – Available at: http://zakon2.rada.gov.ua/laws/show/994_923.

9. On the limitation of emissions of volatile organic compounds due to the use of organic solvents in decorative paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC: European Parliament and Council Directive dated April 21, 2004 No. 2004/42/EC. – Available at: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32004L0042&from=EN

10. EU Directive No. 1907/2006/EC REACH. – Available at: https// engtime.ru/statyi/raznoe/i-gryanul-reach.html

11. Toxicological and hygienic significance of polymeric materials as a source of low intensity chemical factor in the human environment / V. F. Shylina, N. Ie. Dyshinievych, Ie. L. Perehuda, T. S. Oboronova // Suchasni problemy toksykolohii. – 2011. – No. 5 (55). – P. 165.

12. Hygienic aspects of the problem of harmonization of basic principles for the safe use of polymeric materials in human environment with the European standards (analytical review) / N. G. Prodanchuk, N. Ie. Dyshinievych, V. G. Herasymova [et al.] // Meditsina. – 2011 – No. 4.

13. Dudla I. Harmonization of safety requirements for paint and varnish materials in Ukraine and the EU // Problemy bezpechnosti tovariv. – 2016. – No. 1. – P. 222–233.

14. Draft of the Technical Regulations On the Limitation of the Volatile Organic Compounds Content in Certain Categories of Paint and Varnish Materials. – Available at: http://auvlp.org.ua/news/id-37

15. 1999/10/EC: Commission Decision of 18 December 1998 establishing the ecological criteria for the award of the Community eco-label to paints and varnishes (notified under document number C(1998) 4257) (Text with EEA relevance) s //Official Journal of the European Communities. – OJL S. – 9.1.1999. – P. 77 – 82.

16. GOST 6465-76. Enamels ПФ-115. Specifications. – Intro. 1977 – 01 – 07. – M.: Izdatelstvo standartov, 1976. – 15 p.

17. GOST 926-82. Enamels ПФ-133. Specifications. – Intro. 1983 – 01 – 01. – M.: Izdatelstvo standartov, 1982. – 7 p.

18. GOST 15907-70. Varnishes ПФ-170 and ПФ-171. Specifications. – Intro. 1971 – 01 – 01. – M.: Izdatelstvo standartov, 1970. – 7 p.

19. GOST 5470-75. Lacquers of ПФ-283 and ГФ-166. Specifications. – Intro. 1976 – 01 – 07. – M.: Izdatelstvo standartov, 1975. – 8 p.

20. GOST 25129-82. Primer ГФ-021. Specifications. – Intro. 1983 – 01 – 01. – M.: Izdatelstvo standartov, 1982. – 9 p.

21. Maximum permissible concentrations of chemical and biological substances in the atmospheric air of populated areas, approved: a.i. Chief Sanitary Doctor of Ukraine dated March 3, 2015.

22. French Regulations No.2011-321 dated March 23, 2011 On labelling of construction products, floorings, wall coverings, paints and varnishes regarding their volatile pollutant emissions, available at: https://www.legifrance.gouv.fr/eli/decret/2011/3/23/DEVL1101903D/jo

23. Research protocols of Cerutti ST. Available at: http://www.potolok-art.ru/potolki-emissions-dans-air-interieur.html

24. State Sanitary Rules and Regulations on Polymer and polymer-based materials, products and constructions, used in building and furniture manufacturing. Hygienic Requirements. Approved by the Order of the Ministry of Health of Ukraine No. 1139 dated December 29, 2012.

Надійшла до редакції 25.12.17