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Technical regulation system in Ukraine (standardization, conformity assessment and accreditation, scientific and applied metrology)

Standardization

The legal and organizational principles of standardization are set in the Law of Ukraine “On Standardization”, which entered into force on 03.01.2015.

In particular, the Law of Ukraine “On Standardization” sets:

  • scope of authority of the central executive body responsible for formation of the state policy in the field of standardization, the central executive body responsible for implementation of the state policy in the field of standardization, the National Standardization Body, the Steering Committee of the National Standardization Body, the Appeals Commission and technical standardization committees (the central executive body responsible for formation of the state policy in the field of standardization and for implementation of the state policy in the field of standardization is the Ministry of Economy of Ukraine);  
  • two levels of standardization depending on the standardization 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 provided for byregulatory acts;

compliance of national standards with legislation;

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

adoption and adherence by standardization entities of the Code of Good Practice for the Development, Adoption and Application of Standards according to the World Trade Organization Agreement on Technical Barriers to Trade, which is an Annex to the Marrakesh Agreement on the Establishment of the World Trade Organization of April 15, 1994.

The following documents were approved for the purpose of implementing the Law of Ukraine “On Standardization”:

Decree of the Cabinet of Ministers of Ukraine of 26.11.2014 № 1163-p “On Determination of the State Enterprise which Performs the Functions of the National Standardization Body”;

Regulations on the Steering Committee of the National Standardization Body (Order of the Ministry of Economic Development and Trade of Ukraine of 02.02.2015 № 76 “On Approving the Regulations on the Steering Committee of the National Standardization Body”, registered in the Ministry of Justice of Ukraine on 18.02.2015 under № 186/26631);

Order of the Ministry of Economy and Trade of Ukraine of 08.09.2021 № 508 “On Approving the Composition of the Steering Committee of the National Standardization Body”; 

Regulations on the Appeals Commission and the Procedure for Consideration of Appeals by it (Order of the Ministry of Economic Development and Trade of Ukraine of  09.02.2015 № 103 “On Regulations on the Appeals Commission and the Procedure for Consideration of Appeals”, registered in the Ministry of Justice of Ukraine on 23.02.2015 under № 208/26653 and № 209/26654, with amendment Order of the Ministry of Economy of Ukraine of 28.01.2022 № 209, registered in the Ministry of Justice of Ukraine on 18.02.2022 under № 228/37564), and composition of the Appeals Commission (Order 273 of the Ministry of Economic Development and Trade of 27.02.2017 № 273);    

Methodology of Calculating Labor Intensity and Cost of Standardization Works (Order of the Ministry of Economic Development and Trade of Ukraine of 05.10.2016 № 1685 “On Approving the Methodology of Calculating Labor Intensity and Cost of Standardization Works”, registered in the Ministry of Justice of Ukraine on 27.10.2016 under № 1405/29532);

According to the Law of Ukraine “On Standardization” the European standards are adopted as national with the identical degree of conformity.

Almost all harmonized European standards have been adopted under the acts of European legislation defined by Annex III to the EU – Ukraine Association Agreement, while certain harmonized European standards, application of which provides for a presumption of conformity with European regulations on construction products (Regulation № 305/2011) and radio equipment (Regulation № 2014/53/EU) have not been adopted.

The Order of the Ministry of Economic Development, Trade and Agriculture of Ukraine of 22.01.2021 № 125 (registered in the Ministry of Justice of Ukraine on 10.02.2021 under № 173/35795) approved the Rules for the formation of Lists of national standards for the purposes of applying technical regulations (the “Rules for the formation of lists of national standards”).  

According to the Rules for the formation lists of national standards, the Ministry of Economy of Ukraine issued orders approving twenty five lists of national standards, compliance with which provides for a 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 the harmonized European standards.

Lists of national standards have been approved for technical regulations defined as priority ones 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);
  • legally regulated measuring instruments.

The Decree of the Cabinet of Ministers of Ukraine as of 26.11.2014 № 1163-p “On Determination of the State Enterprise which Performs the Functions of the National Standardization Body” defines that State Enterprise “Ukrainian Scientific, Research and Training Center on Standardization, Certification and Quality Problems” (the “UkrNDNC”) (address: vul. Sviatoshynska 2, Kyiv, 03115, Ukraine, official website: uas.gov.ua) will perform functions of the National Standardization Body (NSB).

According to the Law of Ukraine “On Standardization”, the scope of powers of the NSB includes, in particular:

organization and coordination regarding development, adoption, examination, revision, cancellation and revalidation of national standards, codes of best practice and changes to them;

adoption, cancellation and revalidation of national standards, codes of  best practice and changes to them;

taking measures for harmonization of national standards and codes of best practice with relevant international, regional standards and codes of best practice;

development of national standards and amendments to them in coordination with central executive body that implements state policy in the field of standardization;

preparation and approval of program for national standardization works;

establishment and disbanding of technical committees for standardization, determination of scope of its activity;

coordination of activity of technical committees for standardization;

ensuring and promoting cooperation in the field of standardization between manufacturers, suppliers, consumers of products and relevant authorities;

encouraging of small and medium entrepreneurship to participate in development of national standards and codes of best practice, ensuring access of these entities to the texts of such documents.

Works on national standardization (SE “UkrNDNC”are performed according to the Law of Ukraine “On Standardization” and a set of fundamental standards, in particular:

  • DSTU 1.2:2015 National standardization. Rules of works on national standardization;
  • DSTU 1.5:2015 National standardization. Rules of development, formulation and presentation of national normative documents;
  • DSTU 1.7:2015 National standardization. Rules and methods for adoption of international and regional normative documents;
  • DSTU 1.8:2015 National standardization. Rules for Development of Working Program on National Standardization.

According to the Law and DSTU 1.14:2015 “National standardization. The Procedures for the establishment, activity operation and disbanding of the technical committees for standardization” technical committees are established for the purpose of organization and implementation of works on international, regional and national standardization.

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, working procedures and procedures of dissolution of technical committees conformant with international and European and which provide all stakeholders with comprehensive information concerning standardization works at national level and guidelines on fulfillment of Ukraine’s international commitments.

The official website of the SE “UkrNDNC” (uas.gov.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, 27 336 national standards have been adopted, including 18 674 international and European standards adopted as national ones.

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

The National Standardization Program 2022 envisages 2 715 assignments concerning development of draft national standards, including 1 767 standards harmonized with international and European ones.

164 technical committees for standardization are presently operating in Ukraine in various sectors of 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” the 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);

a Companion Standardization Body of the European Committee for Standardization (СЕN) and the European Committee for Electrotechnical Standardization (CENELEC).

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

Within the framework of international and regional cooperation, the NSB has concluded license agreements with:

  • American Society for Testing Materials (ASTM);
  • Deutsches Institut für Normung (DIN);
  • European Telecommunications Standards Institute (ETSI);
  • International Electrotechnical Commission (IEC).

SE “UkrNDNC” as the NSB has entered into bilateral agreements with standardization bodies of other countries, including Austria, Georgia, Lithuania, Moldova, Germany, Poland, United States, Sweden, France, Serbia, Azerbaijan, Canada, China, Czech Republic, Turkey 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 the 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 EU – Ukraine  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 will 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 101 technical regulations; 89 of these technical regulations were developed on the basis of EU legislative acts including New and Global Approach Directives, and 93 of them are already obligatory.

As of today, the infrastructure of designated bodies responsible for assessing product conformity with technical regulations is comprised of 81 accredited bodies.

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

The NAAU is a governmental agency established and overseen by the Ministry of  Economy of  Ukraine, which conducts noncommercial economic activity.

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

testing and calibration laboratories;

management system certification bodies;

personnel certification bodies;

inspection bodies;

product certification bodies;

medical laboratories;

professional test providers.

verification bodies.

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

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

As of today, the NAAU has the status of a 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.

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

In addition, the 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 the 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 of Economy of  Ukraine 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 the 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 Metrology and Metrological Activity”, 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, verification 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 the EU member states.

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

  • central executive body responsible for formation and implementation of the state policy in the field of metrology and metrological activity (the Ministry of  Economy of Ukraine);
  • central executive body responsible for implementation of the state policy in the field of metrological surveillance (the State Service of Ukraine on Food Safety and Consumer Protection);
  • four scientific metrological centers: National Scientific Center “Institute of Metrology”, Kharkiv; State Enterprise “Ukrmetrteststandart”, Kyiv; State Enterprise “Scientific and Research Institute “Systema”, Lviv; State Enterprise “Ivano-Frankivskstandardmetrology”, Ivano-Frankivsk;
  • 24 state enterprises subordinated to the Ministry of  Economy of Ukraine and conducting metrological activity (located in every region of Ukraine);
  • Service of Universal Time and Reference Frequencies, Service of Reference Materials of Composition and Properties of Substances and Materials, Service of Standard Reference Data on Physical Constants and Substances and Materials. Properties. The NSC “Institute of Metrology” was designated as the Main Center Service of Universal Time and Reference Frequencies and as the Methodological Research Center of the Service of Reference Materials of Composition and Properties of Substances and Materials, and SE “Ukrmetrteststandart” was designated as the Methodological Research Center of the Service for Service of Standard Reference Data on Physical Constants and Substances and Materials. Properties;
  • metrology services of other central executive bodies and state-owned bodies, enterprises and organizations;
  • conformity assessment bodies of measuring instruments and verification laboratories. These bodies and laboratories are designated and authorized by the Ministry of Economy of Ukraine for their performance as third parties of conformity assessment and verification of measuring instruments.

As of today, 14 bodies responsible for assessment of conformity of measuring instruments with technical regulations have been designated and 69 verification laboratories have been authorized.

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

Technical Regulations on Non-Automatic Weighing Instruments, developed on the basis of the 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 Regulations on Measuring Instruments, developed on the basis of the 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 Legally Regulated Measuring Instruments, which covers the categories of legally regulated measuring instruments in Ukraine not covered by the technical regulations developed on the basis of the MID and NAWI Directives.

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

According to the Law, legally regulated measuring instruments in operation shall be subjected to metrological surveillance.

Metrological surveillance includes inspections of condition and compliance of measuring instruments with the rules for operation, compliance with periodical verification requirements, and the use of authorized measurement units when operating measuring instruments.

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

Metrological surveillance also applies to inspect the conformity of legally 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 in:

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

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

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

As of today, the list of national measurement standards of Ukraine comprises 83 national primary measurement standards of measurement units, and 308 CMCs 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 as:

  • a Member State of the General Conference on Weights and Measures (CGPM) since 2018 (had the status of an Associate State since 2002);
  • a Member State of the International Organization of Legal Metrology (OIML) since 2021 (had the status of a Corresponding Member since 1997);
  • a Member State of the Euro-Asian Cooperation of State Metrological Institutions (COOMET) since 1992;
  • a member of the European Association of National Metrological Institutions (EURAMET) since 1998 as a LO-NMI, Liaison Organisation: National Metrology Institute.

The main prospective areas of scientific and applied metrology-related activity in the nearest future include:

  1. Harmonization of all regulatory acts with the Law of Ukraine “On Metrology and Metrological Activity”.
  2. Creation, improvement and comparison of national measurement standards.

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

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