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Technical regulation system of Ukraine (standardization, conformity assessment and accreditation, metrology and metrological activity)

Standardization

The Law of Ukraine On Standardization No. 1315-VII of 05.06.2014 which took effect on 03.01.2015 sets legal and organizational framework of standardization.

The Law of Ukraine On Standardization determines, in particular:

competence of the central executive authority responsible for the formation of state policy in the field of standardization; the central executive authority responsible for the implementation of state policy in the field of standardization; the national standardization body, the supervisory board of the national standardization body, the board of appeals and technical standardization committees (the central executive authority responsible for the formation of state policy in the field of standardization and the implementation of state policy in the field of standardization shall be the Ministry of Economic Development and Trade of Ukraine);

two levels of standardization depending on subject of standardization adopting the standards (the national standards adopted by the national standardization body as well as standards and technical conditions adopted by enterprises, institutions and organizations);

that state policy in the field of standardization is based on well-balanced application of the following principles:

unprejudiced adoption of the national standards on the principles of consensus;

voluntary application of the national standards unless otherwise provided by the regulatory legal acts;

conformity of the national standards to the legislation;

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

adoption of the Code of Good Practice for development, adoption and application of standards and adherence thereto by subjects of standardization according to the WTO Agreement on Technical Barriers to Trade, attached as an annex to the Marrakesh Agreement establishing the World Trade Organization dated April 15, 1994.

For the purpose of implementation of the Law of Ukraine On Standardization, the following documents were approved:

the Methodology of determining the complexity and cost of standardization works (Order of the Ministry of Economic Development and Trade of Ukraine No. 1685 dated 05.10.2016 registered with the Ministry of Justice on 27.10.2016 under No. 1405/29532);

the Regulation on the supervisory board of the national standardization body (Order of the Ministry of Economic Development and Trade of Ukraine No. 76 dated 02.02.2015 registered with the Ministry of Justice on 18.02.2015 under No. 186/26631) and composition of the supervisory board (Order of the Ministry of Economic Development and Trade of Ukraine No. 737 dated 19.05.2017);

the Regulation on the board of appeals and the Procedure for examination of appeals (Order of the Ministry of Economic Development and Trade of Ukraine No. 103 dated 09.02.2015 registered with the Ministry of Justice on 23.02.2015 under No. 208/26653 and No. 209/26654 respectively) and composition of the board of appeals (Order of the Ministry of Economic Development and Trade of Ukraine No. 273 dated 27.02.2017).

According to the Law of Ukraine On Standardization, the European standards shall be adopted as national ones with identical level of conformity.

Ukraine adopted as national standards almost all harmonized European standards in compliance with Annex III to the Association Agreement between Ukraine and the European Union (4055), and partially did not adopt harmonized European standards which application guarantees the presumption of conformity to the European regulations on building products (Regulation No. 305/2011) and radio equipment (Regulation No. 2014/53/EU).

Order of the Ministry of Economic Development and Trade of Ukraine No. 2094 dated 19.12.2016 approved the Methodological Recommendations on the formation of lists of the national standards, which application guarantees the presumption of conformity of products, processes associated therewith, production methods or other objects to the requirements of technical regulations (hereinafter referred to as the Methodological Recommendations).

According to the Methodological Recommendations, the orders of the Ministry of Economic Development and Trade of Ukraine approved 8 lists of the national standards which application guarantees the presumption of conformity of products, processes associated therewith, production methods or other objects to the requirements of technical regulations, which are identical to respective lists of harmonized European standards.

The Ministry approved the lists of the national standards for technical regulations determined as priority for signing the Agreement on Conformity Assessment and Acceptance of Industrial Goods (АСАА), in particular, on:

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

electromagnetic compatibility (2014/30/EU, EMC);

machinery (2006/42/EU, MD).

The Ministry also approved the lists of the national standards for technical regulations on:

safety of non-food products (2001/95/EU);

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

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

safety of toys (2009/48/EU).

The Order of the Cabinet of Ministers of Ukraine No. 1163 dated 26.11.2014 determined that since 03.01.2015 State Enterprise “Ukrainian Scientific Research and Training Center for Standardization, Certification and Quality” (SE “UkrNDNC”) (address: 2, Sviatoshynska St., Kyiv 03115, Ukraine, official website: uas.org.ua) fulfills functions of the national standardization body (NSB).

According to the Law of Ukraine On Standardization, the NSB’s competence includes:

to organize and coordinate development, adoption and abolition of the national standards;

to adopt and abolish the national standards;

to take measures to harmonize the national standards with respective international and regional standards;

to prepare and approve the working program on national standardization;

to coordinate technical standardization committees’ activity and take decisions on establishment and termination of the activity of technical standardization committees.

SE “UkrNDNC” adopted the fundamental national standards:

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

DSTU 1.2:2015 National standardization. Rules of work on national standardization;

DSTU 1.5:2015 National standardization. Rules of development, formulation and presentation of national regulatory documents;

DSTU 1.7:2015 (ISO/IEC Guide 21-1:2005, ISO/IEC Guide 21-2:2005, NEQ) National standardization. Rules and methods for adoption of international and regional regulatory documents;

DSTU 1.8:2015 National standardization. Rules for development of working program on national standardization;

DSTU 1.13:2015 National standardization. Rules for the provision of information to the trade partners of Ukraine;

DSTU 1.14:2015 National standardization. Procedures for the establishment, operation and termination of activity of technical standardization committees.

The fundamental national standards set national terminology; rules for planning, development, formulation and presentation of the national standards; rules and methods for adoption of international and regional standards as national ones; procedures for the establishment, operation and termination of activity of technical committees, which correspond to the international and European standards and provide all the stakeholders with comprehensive information about works on standardization at the national level and guidelines as to fulfillment of Ukraine's international commitments.

Please visit official website of SE “UkrNDNC” (uas.org.ua) to find:

Catalogue of national standards and codes of good practice;

annual working programs for national standardization;

Catalogue of technical standardization committees.

According to the Catalogue of national standards and codes of good practice, as of the beginning of 2019 the national standards fund comprised 21,758 national standards, of which 7,067 are international and 6,824 European standards adopted as national ones.

The national standards can be received from SE “UkrNDNC” in paper and electronic form (on-line standards store: shop.uas.org.ua).

The working program for national standardization for 2019 envisages a total of 2,906 tasks as to development of draft national standards projects, of which 1,720 are harmonized with international and European standards.

A total of 186 technical standardization committees are currently operating in different sectors of the Ukrainian economy. The committees are formed of representatives of public authorities, economic entities and their public associations, employers’ organizations and associations thereof, scientific institutions and educational establishments, scientific, technical and engineering societies, consumer NGOs, trade unions, leading scientists and specialists.

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

Ukraine is:

a qualifying member of the International Standardization Organization (ISO) and the International Electrotechnical Commission (IEC);

a standardization partner of the European Committee for Standardization (СЕN) and the European Committee for Electrotechnical Standardization (CENELEC).

SE “UkrNDNC” as the NSB and the European Telecommunications Standards Institute (ETSI) signed the Memorandum of Mutual Understanding and the Agreement on distribution of documents of ETSI.

SE “UkrNDNC” as the NSB signed bilateral agreements with standardization organizations of other countries: Austria, Georgia, Lithuania, Moldova, Germany, Poland, the United States, Sweden, France, Serbia, Azerbaijan, Canada, Chine and Cyprus.

 

Conformity Assessment and Accreditation

The legislative framework in the field of conformity assessment and accreditation in Ukraine consists of the Laws of Ukraine On Technical Regulations and Conformity Assessment and On Accreditation of Bodies Responsible for Conformity Assessment.

The Law of Ukraine On Technical Regulations and Conformity Assessment sets common legal and organizational grounds for development, adoption and application of technical regulations and procedures of conformity assessment, conducting the conformity assessment in line with the European requirements and provisions of the WTO Agreements on Technical Barriers to Trade.

Adoption of the Law of Ukraine On Technical Regulations and Conformity Assessment, in particular, created the legal basis for harmonization of “vertical (sectorial) legislation”, as defined in Section 2 of Annex III to the Ukraine-EC Association Agreement, since the Ukrainian party takes all necessary measures to sign the Agreement on Conformity Assessment and Acceptance of Industrial Goods (ACAA) pursuant to Articles 56 and 57 of Chapter 3 “Technical Barriers To Trade” of the Ukraine-EU Association Agreement.

Ukraine’s accession to the ACAA will allow placement of goods covered by the Agreement in the internal market of EU and Ukraine without additional testing and conformity assessment procedures.

In 27 sectors described in this Annex, Ukraine, based on respective EU acquis communautaire, adopted 25 technical regulations, of which 24 are binding. Ukraine has yet to develop 2 more technical regulations in relevant sectors (packaging and packaging wastes, high-speed railways).

In view of certain changes in the European legislation, according to which a number of EU directives have been revised and set forth in new wordings, the adopted technical regulations are being now revised in order to bring them in line with new versions of the EU directives.

Ukraine has adopted a total of 73 technical regulations (the list of adopted technical regulations is posted on the official website of the Ministry of Economic Development and Trade of Ukraine in section “Activity”, sub-section “Technical Regulation” → “Technical Regulations”), of which 67 technical regulations were developed on the basis of the EU acquis communautaire, including directives of New and Global Approaches, of which 60 are already binding.

At present, the infrastructure of designated bodies responsible for assessment of products conformity to the requirements of technical regulations consists of 108 accredited bodies (the list of designated bodies is posted on the official website of the Ministry of Economic Development and Trade of Ukraine in section “Activity”, sub-section “Technical Regulation” → “Lists of Designated Bodies Responsible for Conformity Assessment” → “Registry of Designated Bodies Responsible for Conformity Assessment to the Requirements of Technical Regulations” and “List of Designated Bodies Responsible for Conformity Assessment”).

The National Accreditation Agency of Ukraine (hereinafter referred to as the NAAU) is governed by the Law of Ukraine On Accreditation of Bodies Responsible for Conformity Assessment.

The NAAU is a government organization established and controlled by the Ministry of Economic Development and Trade of Ukraine, which is engaged in non-commercial economic activity.

The NAAU conducts accreditation of bodies responsible for conformity assessment in the following directions:

  testing and calibration laboratories;

  management systems certification bodies;

  personnel certification bodies;

  inspectorates;

  product certification bodies;

  medical laboratories;

  professional testing providers.

Potential customers having an access to accreditation services can be bodies responsible for conformity assessment irrespective of their ownership form.

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

The NAAU has acquired the status of signatory of the Bilateral Recognition Agreement with the European Cooperation for Accreditation (EA) for accreditation of products certification bodies, management systems and personnel, inspectorates, testing and calibration laboratories.

The NAAU has also acquired the status of a qualifying member of the International Laboratory Accreditation Cooperation (ILAC) and a signatory of the ILAC Mutual Recognition Agreement (MRA) for accreditation of calibration and testing laboratories, inspectorates.

The NAAU is also a member of the International Accreditation Forum (IAF) and a signatory of the IAF Multilateral Recognition Arrangement (IAF MLA) in the areas of accreditation –certification of products, personnel, management systems.

More information about NAAU’s activity is available at: www.naau.org.ua.

The perspective key activities of the Ministry of Economic Development and Trade of Ukraine in the area of conformity assessment and accreditation for the nearest future include:

1. Recognition of technical regulation system of Ukraine at the international level (preparation for signing of the АСАА for particular types of products between Ukraine and the EU).

2. Adoption of new and revision of adopted technical regulations of Ukraine in order to bring them in compliance with the EU acquis communautaire.

3. Development of the efficient infrastructure of designated bodies responsible for assessment of product conformity to requirements of technical regulations.

4. Expansion of the range of services provided by the NAAU and assistance in recognition of the national system of accreditation at the European and international levels.

Achievement of these objectives will facilitate an increase in the level of social stability and welfare of the country, further development of trading and investment cooperation with the EU countries, as well as removal of technical barriers to trade.

 

Metrology and Metrological Activity

The legislative framework in the area of metrology and metrological activity shall be governed by the Law of Ukraine On Metrology and Metrological Activity (hereinafter referred to as the Law) developed on the basis of a document of the International Organization of Legal Metrology OIML D1 “Revision of the law on metrology”.

To implement the Law, a total of 41 regulatory and legal acts have been adopted.

The Law and the regulatory and legal acts determine the scope of legally regulated metrology, measurement units, requirements to national standards, measuring instruments, calibration thereof and conformity assessment, as well as metrological supervision.

All the aforementioned legislative acts have been developed on the basis of international and European requirements – the documents of the International Organization of Legal Metrology (OIML) and the European cooperation in the area of legal metrology (WELMEC) as well as respective EU acquis communautaire.

Adoption of the Law created a legislative background for harmonization of “vertical (sectoral) legislation”, as defined in Section 2 of Annex III to the Association Agreement between Ukraine and the European Union, since the Ukrainian party takes all necessary measures to ensure conformity of the metrology system of Ukraine to metrology systems of the EU countries pursuant to Articles 56 and 57 of Chapter 3 “Technical Barriers To Trade” of the Ukraine-EU Association Agreement.

According to the Law, the national metrology service of Ukraine consists of:

central executive authority responsible for the formation and implementation of state policy in the area of metrology and metrological activity (the Ministry of Economic Development and Trade of Ukraine);

central executive authority responsible for the implementation of state policy in the area of metrological supervision (the State Service of Ukraine for Food Safety and Consumer Protection);

4 scientific metrological centers: National Scientific Center “Institute of Metrology” (Kharkiv); State Enterprise “Ukrmetrteststandart” (Kyiv), State Enterprise “Scientific and Research Institute “System” (Lviv); State Enterprise “Ivano-Frankivskstandartmetrologia” (Ivano-Frankivsk);

24 state enterprises managed by the Ministry of Economic Development and Trade of Ukraine and engaged in metrological activity (located in every region of Ukraine);

Service of Universal Time and Reference Frequencies, Service of Standard Samples of Composition and Properties of Substances and Materials, Service of Standard Reference Data on Physical Steels and Properties of Substances and Materials. National Scientific Center “Institute of Metrology” is determined as the main center of the Service of Universal Time and Reference Frequencies as well as the scientific and methodological center of the Service of Standard Samples of Composition and Properties of Substances and Materials; SE “Ukrmetrteststandart” – the methodological center of the Service of Standard Reference Data on Physical Steels and Properties of Substances and Materials;

metrological services of other central executive and public authorities, enterprises and organizations;

bodies responsible for assessment of conformity of measuring instruments and calibration laboratories. The aforementioned bodies and laboratories shall be designated and authorized by the Ministry of Economic Development and Trade of Ukraine and to fulfill tasks acting as third parties on the conformity assessment and calibration of measuring instruments.

At present, there are 9 designated bodies responsible for assessment of conformity to the requirements of technical regulations for measuring instruments as well as 59 authorized calibration laboratories.

Requirements to measuring instruments (hereinafter referred to as the MI) available on the Ukrainian market and/or introduced into Ukraine are set 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 EU member states regarding introduction of non-automatic weighing instruments (NAWI) into the market;

Technical Regulation on measuring instruments developed on the basis of Directive 2014/32/EU on the harmonization of the laws of the EU member states regarding introduction of measuring instruments (MID) into the market;

Technical regulation on legally regulated measuring instruments that covers the categories of legally regulated measuring instruments in Ukraine not covered by technical regulations developed on the basis of MID and NAWI directives.

According to the Law, legally regulated MI used in Ukraine shall be subject to compulsory periodical calibration. The list of such MI is approved by the Ukrainian Government and consists of 80 MI categories.

Legally regulated MI being used shall be subject to metrological supervision according to the Law.

The supervision involves examination of the condition and verification of adherence to the rules for using MI, meeting the requirements to periodical calibration, using the permissible measurement units when using MI.

The metrological supervision is also provided to verify conformity of legally regulated MI to the requirements of aforementioned technical regulations and the number of packaged goods.

According to the Law, the metrological requirements to packaged goods are set by:

Technical Regulation on bottles used as measuring tanks developed on the basis of Directive 75/107/EEC;

Technical Regulation on some goods packaged by mass and volume in ready-made packaging developed on the basis of Directive 76/211/EEC;

Order of the Ministry of Economic Development and Trade of Ukraine No. 969 dated 05.07.2017 On Metrological Requirements to Packaged Goods registered with the Ministry of Justice of Ukraine under No. 934/30802 on 28.07.2017.

At present the list of national etalons of Ukraine consists of 73 state primary etalons of measurement units and a total of 275 SMS-lines on measuring and calibration capacities of national etalons are included in the database of the International Bureau of Weights and Measures (BIPM).

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

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

Eurasian Cooperation of State Metrological Institutions (COOMET), a qualifying member since 1992;

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

International Organization of Legal Metrology (OIML), a corresponding member since 1997.

The perspective key activities of the Ministry of Economic Development and Trade of Ukraine in the area of metrology and metrological activity for the nearest future include:

1. Harmonization of all regulatory and legal acts with the Law of Ukraine On Metrology and Metrological Activity. At present the list consists of 121 regulatory and legal acts and is not exhaustive.

2. Creation, improvement and verification of national etalons.

3. Taking measures for acquiring Ukraine’s qualifying membership in the International Organization of Legal Metrology (OIML).

Fulfilling the aforementioned tasks will contribute to raising the level of social stability and welfare of the country, further development of trade and investment cooperation with the EU countries, as well as removal of technical barriers to trade.

Ministry for Development of Economy,
Trade and Agriculture of Ukraine
01008, Ukraine, Kiyv city,
Grushevsky str., 12/2