TECHNICAL REGULATION SYSTEM IN UKRAINE

The legal and organizational principles of standardization are set forth in the Law of Ukraine No 1315-VII of 05.06.2014 on Standardization, which entered into force on 03.01.2015.

In particular, the Law of Ukraine on Standardization:

• sets out the scope of authority of the government agency responsible for formation of the national policy on standardization, the government agency responsible for carrying out the national policy on standardization, the national standardization body, the management board of the national standardization body, the appeals commission and technical standardization committees (the government agency responsible for formation of the national policy on standardization and for carrying out the national policy on standardization is the Ministry for Development of the Economy, Trade and Agriculture);

• sets out two levels of standardization depending on the entity adopting standards (national standards adopted by the national standardization body, and standards and technical specifications adopted by enterprises, institutions and organizations);

• states that the national policy on standardization is based on a balanced application, in particular, of the following principles:

impartial adoption of national standards on the basis of consensus;

voluntary application of national standards, unless otherwise required by regulatory acts;

conformity of national standards with law;

the priority of adopting international and regional standards as national in Ukraine;

adoption and observance by standardization adopting entities of the Code of Good Practice for the Preparation, Adoption and Application of Standards under the Agreement on Technical Barriers to Trade of the World Trade Organization, which represents an annex to the Marrakesh Agreement of 15 April 1994 establishing the World Trade Organization.

The following documents were approved for the purpose of implementing the Law of Ukraine on Standardization:

Methodology of Calculating Labor Intensity and Cost of Standardization Work (Order 1685 of the Ministry of Economic Development and Trade of 05.10.2016, registered with the Ministry of Justice on 27.10.2016 under No 1405/29532);

Rules of Procedure of the Management Board of the National Standardization Body (Order 76 of the Ministry of Economic Development and Trade of 02.02.2015, registered with the Ministry of Justice on 18.02.2015 under No 186/26631), and membership of the Management Board (Order 239-20 of the Ministry for Development of the Economy, Trade and Agriculture of 14.02.2020);

Rules of Procedure of the Appeals Commission, and Procedure of Hearing Appeals by the Appeals Commission (Order 103 of the Ministry of Economic Development and Trade of 09.02.2015, registered with the Ministry of Justice on 23.02.2015 under No 208/26653 and No 209/26654), and membership of the Appeals Commission (Order 273 of the Ministry of Economic Development and Trade of 27.02.2017).

According to the Law of Ukraine on Standardization, European standards are adopted as national with the identical degree of conformity.

Almost all (4055) harmonized European standards have been adopted per EU legislative acts mentioned in Annex ІІІ to the Ukraine-EU Association Agreement, while certain harmonized European standards whose application gives presumption of conformity with European regulations on construction products (Regulation No 305/2011) and radio equipment (Regulation No 2014/53/EU) have not been adopted.

The Order 2094 of the Ministry of Economic Development and Trade of 19.12.2016 approved the Methodological recommendations concerning formation of the lists of national standards the conformity with which gives presumption of conformity of products, related production processes or methods, or other objects with requirements of technical regulations (the “Methodological Recommendations”).

According to the Methodological Recommendations, the Ministry of Economic Development and Trade issued orders approving eight lists of national standards the conformity with which gives presumption of conformity of products, related production processes or methods, or other objects with requirements of technical regulations, which are identical to the corresponding lists of harmonized European standards.

Lists of national standards have been approved for technical regulations defined as priority documents for the purpose of signing the Agreement on Conformity Assessment and Acceptance of Industrial Products (АСАА), in particular, concerning:

• low-voltage electrical equipment (2014/35/EU, LVD);

• electromagnetic compatibility of equipment (2014/30/EU, EMC);

• machinery (2006/42/EC, MD).

• Lists of national standards have also been approved for technical regulations concerning:

• general product safety (2001/95/EC);

• equipment and protective systems intended for use in potentially explosive atmospheres (2014/34/EU, ATEX);

• restriction of the use of certain hazardous substances in electrical and electronic equipment (2011/65/EU, RoHS);

• safety of toys (2009/48/EC);

• legislatively regulated measuring instruments.

The Directive 1163 of the Cabinet of Ministers of Ukraine of 26.11.2014 states that effective 03.01.2015, Ukrainian Research and Training Center for Standardization, Certification and Quality, State Enterprise (SE “UkrNDNC”) (address: vul. Sviatoshynska 2, Kyiv, 03115, Ukraine, official website: uas.org.ua) operates as the national standardization body (NSB).

According to the Law of Ukraine on Standardization, the scope of authority of NSB includes, in particular:

organizing and coordinating efforts aimed to develop, adopt and repeal national standards;

adopting and repealing national standards;

overseeing harmonization of national standards with the corresponding international and regional standards;

preparing and approving national standardization programs;

coordinating activity of technical standardization committees, and making decisions to establish and dissolve technical standardization committees.

SE “UkrNDNC” has adopted the following fundamental national standards:

• DSTU 1.1:2015 (ISO/IEC Guide 2:2004, MOD) “National standardization. Standardization and related activities. Glossary of terms”;

• DSTU 1.2:2015 “National standardization. Rules of national standardization procedures”;

• DSTU 1.5:2015 “National standardization. Rules for development, layout and issuance of national normative documents”;

• DSTU 1.7:2015 (ISO/IEC Guide 21-1:2005, ISO/IEC Guide 21-2:2005, NEQ) “National standardization. Rules and methods of adopting international and regional normative documents”;

• DSTU 1.8:2015 “National standardization. Rules for development of a national standardization program”;

• DSTU 1.13:2015 “National standardization. Rules for issuing notices to trade partners of Ukraine”;

• DSTU 1.14:2015 “National standardization. Procedures of establishment, work procedures and procedures of dissolution of technical standardization committees”.

The fundamental national standards establish national terminology; rules for planning, development, layout and issuance of national standards; rules and methods of adopting international and regional standards as national standards; procedures of establishment, work procedures and procedures of dissolution of technical committees conformant with international and European and which provide all stakeholders with comprehensive information concerning standardization work at national level and guidelines on fulfillment of Ukraine’s international commitments.

The official website of SE “UkrNDNC” (uas.org.ua) contains, in particular:

the Catalogue of National Standards and Codes of Good Practice;

annual national standardization programs;

the Catalogue of Technical Committees of Ukraine (TC).

According to the Catalogue of National Standards and Codes of Good Practice, 26,227 national standards have been adopted as of early 2020, including 8,137 international and 9,111 European standards adopted as national standards.

National standards can be purchased from SE “UkrNDNC” in paper and electronic form (online standards store: shop.uas.org.ua).

The 2020 national standardization program envisages 2,043 assignments concerning development of draft national standards, including 1,104 standards harmonized with international and European standards.

173 technical standardization committees are presently operating in Ukraine in various sectors of the national economy, which include representatives of public authorities, businesses and business associations, employer organizations and associations, R&D and educational institutions, scientific technical and engineering societies, consumer organizations, labor unions, lead scientists and specialists.

According to the Law of Ukraine on Standardization, NSB represents Ukraine in international and regional organizations for standardization.

Ukraine is a:

full member of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC);

affiliate member of the European Committee for Standardization (СЕN) and the European Committee for Electrotechnical Standardization (CENELEC).

SE “UkrNDNC” as the NSB has signed a Memorandum of Understanding with the European Telecommunications Standards Institute (ETSI) and the Agreement on Dissemination of ETSI Documents.

SE “UkrNDNC” as the NSB has entered into bilateral agreements with organizations for standardization of other countries, including Austria, Georgia, Lithuania, Moldova, Germany, Poland, United States, Sweden, France, Serbia, Azerbaijan, Canada, China and Cyprus.

Conformity assessment and accreditation

The legislative framework regulating conformity assessment and accreditation in Ukraine consists of the Law of Ukraine on Technical Regulations and Conformity Assessment and the Law of Ukraine on Accreditation of Conformity Assessment Bodies.

The Law of Ukraine on Technical Regulations and Conformity Assessment sets out the uniform legal and organizational principles of developing, adopting and applying technical regulations and conformity assessment procedures, performing conformity assessments according to European requirements and the WTO Agreement on Technical Barriers to Trade.

The passage of the Law of Ukraine on Technical Regulations and Conformity Assessment created, in particular, a legislative basis for adaptation of “vertical (sectoral) legislation” defined in the part two of Annex ІІІ to the Ukraine-EU Association Agreement, because pursuant to Articles 56 and 57, Chapter 3 “Technical barriers to trade” of the Ukraine-EU Association Agreement, the Ukrainian party takes all actions necessary to sign the Agreement on Conformity Assessment and Acceptance of Industrial Products (АСАА).

The accession of Ukraine to АСАА would allow the products covered by this Agreement to be marketed in the EU’s internal market and the domestic market of Ukraine without additional tests and conformity assessment procedures.

Out of the 27 sectors mentioned in this Annex, Ukraine has adopted 25 obligatory technical regulations on the basis of the relevant EU legislative acts. Two technical regulations still need to be developed for the packaging and packaging waste sector and for the high-speed railways sector.

At the same time, due to changes in the European legislation resulting in the revision of a number of EU directives, the adopted technical regulations are presently being revised for the purpose of harmonizing them, to the maximum possible extent, with the revised versions of EU directives.

In total, Ukraine has adopted 84 technical regulations (an up-to-date list of adopted technical regulations is available on the website of the Ministry for Development of the Economy, Trade and Agriculture at https://bitly.su/HJdBy); 79 of these technical regulations were developed on the basis of EU legislative acts including New and Global Approach Directives, and 81 of them are already obligatory.

As of today, the infrastructure of designated bodies responsible for assessing product conformity with technical regulations is comprised of 105 accredited bodies (an up-to-date list of designated conformity assessment bodies is available on the website of the Ministry for Development of the Economy, Trade and Agriculture at https://bitly.su/1qNZM.

The National Accreditation Agency of Ukraine (NAAU) is governed by the Law of Ukraine on Accreditation of Conformity Assessment Bodies.

NAAU is a government agency established and overseen by the Ministry for Development of the Economy, Trade and Agriculture of Ukraine, which conducts noncommercial economic activity.

NAAU is responsible for accreditation of conformity assessment bodies in the following areas:

test and calibration laboratories;

management system certification bodies;

personnel certification bodies;

inspection bodies;

product certification bodies;

medical laboratories;

professional test providers.

Potential orderers having access to accreditation services may include conformity assessment bodies regardless of form of ownership.

Accreditation of conformity assessment bodies by NAAU is recognized at European and international levels.

As of today, NAAU has the status of signatory of the European Cooperation for Accreditation (EA) Bilateral Recognition Arrangements concerning accreditation of product, management system and personnel certification bodies, inspection bodies, and test and calibration laboratories.

NAAU also has the status of full member of ILAC, and became a signatory of ILAC MRA concerning accreditation of test and calibration laboratories and inspection bodies.

In addition, NAAU is a member of the International Accreditation Forum (IAF) and a signatory of the International Accreditation Forum Multilateral Recognition Arrangements (IAF MLA) concerning accreditation of product, management system and personnel certification bodies.

Detailed information about NAAU is available on the agency’s website at www.naau.org.ua.

The main prospective areas of conformity assessment and accreditation-related activity of the Ministry for Development of the Economy, Trade and Agriculture in the nearest future include:

1. International recognition of Ukraine’s technical regulation system (taking preparatory measures to sign АСАА between Ukraine and the EU for certain products).

2. Adopting new and revising existing technical regulations of Ukraine for the purpose of harmonizing them with EU legislative acts.

3. Developing an efficient infrastructure of designated bodies responsible for assessing product conformity with technical regulations.

4. Expanding the scope of services provided by NAAU, and supporting European and international recognition of the national accreditation system.

The attainment of these objectives would help increase social stability and wellbeing of the country, further develop trade and investment cooperation with EU member states, and eliminate technical barriers to trade.

Scientific and applied metrology

The legislative framework regulating scientific and applied metrology consists of the Law of Ukraine on Scientific and Applied Metrology (the “Law”), which was developed on the basis of the International Organization of Legal Metrology (OIML) document D1 “Considerations for a Law on Metrology”.

41 regulatory acts were adopted pursuant to the Law.

The Law and regulatory acts define the scope of legislatively regulated metrology, units of measurement, requirements to national etalons and measuring instruments, calibration and assessment of conformity of these instruments, and metrological oversight.

All the aforementioned legislative acts were developed on the basis of international and European requirements: documents of the International Organization of Legal Metrology (OIML) and European Cooperation in Legal Metrology (WELMEC), and the applicable legislative acts of the European Union.

The passage of the Law created a legislative basis for adaptation of “vertical (sectoral) legislation” defined in the part two of Annex ІІІ to the Ukraine-EU Association Agreement, because pursuant to Articles 56 and 57, Chapter 3 “Technical barriers to trade” of the Ukraine-EU Association Agreement, the Ukrainian party takes all actions necessary to harmonize Ukraine’s metrology system with metrology systems of EU member states.

According to the Law, the national metrological service of Ukraine includes:

• the government agency responsible for formation of, and for carrying out the national policy on scientific and applied metrology (Ministry for Development of the Economy, Trade and Agriculture of Ukraine);

• the government agency responsible for carrying out the national policy on metrological oversight (State Service of Ukraine for Food Safety and Consumer Protection);

• four metrological research centers: Institute of Metrology, National Research Center, Kharkiv; Ukrmetrteststandart, State Enterprise, Kyiv; Systema Research and Development Institute, State Enterprise, Lviv; Ivano-Frankivskstandardmetrology, State Enterprise, Ivano-Frankivsk;

• 24 state enterprises subordinated to the Ministry for Development of the Economy, Trade and Agriculture of Ukraine and conducting metrological activity (located in every region of Ukraine);

• Time Synchronization and Etalon Frequencies Service, Service for Standard Samples of Composition and Properties of Substances and Materials, Service for Standard Reference Data Concerning Physical Constants and Properties of Substances and Materials. The Institute of Metrology NRC was designated as the Main Center of the Time Synchronization and Etalon Frequencies Service and as the methodological research center of the Service for Standard Samples of Composition and Properties of Substances and Materials, and Ukrmetrteststandart SE was designated as the methodological research center of the Service for Standard Reference Data Concerning Physical Constants and Properties of Substances and Materials;

• metrology services of other government agencies and public bodies, enterprises and organizations;

• measuring instrument conformity assessment bodies and calibration laboratories. These bodies and laboratories are designated and authorized by the Ministry for Development of the Economy, Trade and Agriculture of Ukraine to perform engagements concerning measuring instrument conformity assessment and calibration as third parties.

As of today, 14 bodies responsible for assessing conformity of measuring instruments with technical regulations have been designated and 63 calibration laboratories have been authorized.

The requirements to measuring instruments marketed and/or commissioned in Ukraine are set forth in three technical regulations:

Technical Regulation on Non-automatic Weighing Instruments, developed on the basis of Directive 2014/31/EU on the harmonization of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (NAWI);

Technical Regulation on Measuring Instruments, developed on the basis of Directive 2014/32/EU on the harmonization of the laws of the Member States relating to the making available on the market of measuring instruments (MID);

Technical Regulation on Legislatively Regulated Measuring Instruments, which covers the categories of legislatively regulated measuring instruments in Ukraine not covered by the technical regulations developed on the basis of MID and NAWI Directives.

According to the Law, legislatively regulated measuring instruments operated in Ukraine shall be subjected to obligatory regular calibration. The list of the said measuring instruments is adopted by the government and consists of 80 measuring instrument categories.

According to the Law, legislatively regulated measuring instruments in operation shall be subjected to metrological oversight.

Metrological oversight includes checks of the condition and compliance with the rules for operation of measuring instruments, compliance with regular calibration requirements, and the use of authorized units of measurement when operating measuring instruments.

The rules for use of units of measurement and for writing the names and designations of units of measurement and symbols defining the main SI units were approved by the Order 914 of the Ministry of Economic Development and Trade of 04.08.2015, registered with the Ministry of Justice on 25.08.2015 under No 1022/27467 and developed on the basis of Council Directive 80/181/EEC.

Metrological oversight also applies to check the conformity of legislatively regulated measuring instruments with requirements of the aforementioned technical regulations and in terms of the quantity of prepackaged products in the packages.

According to the Law, metrological requirements to packaged products are set forth in:

the Technical Regulation on Bottles Used as Measuring Containers, developed on the basis of Directive 75/107/EEC;

the Technical Regulation on the Making-up by Weight or by Volume of Certain Prepackaged Products, developed on the basis of Directive 76/211/EEC;

Order 969 of the Ministry of Economic Development and Trade of 05.07.2017 establishing metrological requirements to prepackaged products, registered with the Ministry of Justice of Ukraine on 28.07.2017 under No 934/30802.

As of today, the list of national etalons of Ukraine comprises 83 national primary etalons of units of measurement, and 308 SMS-lines concerning measurement and calibration features of national etalons were included to the database of the International Bureau of Weights and Measures (ВІРМ).

Ukraine is represented in the following international and regional organizations for metrology:

• General Conference on Weights and Measures (СGPM), a full member since 2018;

• Euro-Asian Cooperation of National Metrological Institutions (COOMET), a full member since 1992;

• European Association of National Metrology Institutes (EURАMET), a partner organization since 1998;

• International Organization of Legal Metrology (OIML), a full member since 2021.

The main prospective areas of scientific and applied metrology-related activity of the Ministry for Development of the Economy, Trade and Agriculture in the nearest future include:

1. Harmonization of all regulatory acts with the Law of Ukraine on Scientific and Applied Metrology.

2. Creation, improvement and verification of national etalons.

The attainment of these objectives would help increase social stability and wellbeing of the country, further develop trade and investment cooperation with EU member states, and eliminate technical barriers to trade.