The Ukrainian Markets of Electric Equipment: Impact Assessment of the Technical Regulation Reform
Why the Low Voltage Directive?
Between October 2007 and February 2008, UEPLAC conducts a survey on the economic and administrative impacts of the introduction of the Low Voltage Directive (73/23 EEC) into Ukrainian legislation. This Directive has been chosen as an illustrative example of the technical regulations of the European Union. It is expected that the corresponding Ukrainian technical regulation will enter into force on 1 January 2009, and that Ukraine will fully correspond to the EU norms in this area at around 2011 in the framework of envisaged Agreement of Conformity Assessment and Acceptance of Industrial Products (ACAA) with the European Union.
This Regulatory Impact Assessment Project is a Pilot Project: its lessons should be used in their own capacity (for making decisions on Technical Regulation on Safety Assessment of the Low Voltage Equipment), as well as the methodological materials on impact assessment for the Ukrainian Ministries and Agencies.
Previously, the Low Voltage Directive (LVD) has been chosen as subject of RIAs in potential member countries of the EU. The Governments of these countries have used such assessments to find out the possible consequences of harmonizing their technical legislations with that of the EU.
- In 2000 a RIA has been prepared on the impacts of introducing LVD into the legislation of Lithuania.3
- In 2001 a RIA has been prepared on the impacts of introducing LVD into the legislation of Croatia.4
What is the Low Voltage Directive?
The Low Voltage Directive is a regulation issued by the European Union, providing for conformity assessment rules that apply to low voltage5 electrical equipment. Low voltage electrical equipment is a very wide product group, including most household electrical appliances.
The Low Voltage Directive has been in use for more than 30 years in the EU. It formulates essential safety requirements for electrical equipment, and defines certain procedures for demonstrating the safety of the products, the so-called “conformity assessment procedures”. Compliance by the safety requirements of the Directive is a necessary condition for putting the conformity CE mark on electrical products designed for use within certain voltage limits. Moreover, if a product is marked with the CE mark (and so satisfies the Directive’s requirements), then this must be also a sufficient condition for allowing it to the Single European Market: governments of countries within the Single European Market may not prohibit, restrict or impede the placing on the market and putting into service in their territory of products bearing the CE marking, unless the provisions relating to CE marking are incorrectly applied.
What is the New Approach?
The Low Voltage Directive is one of the 24 so-called New Approach Directives of the EU that have entered in force between 1973 and 1999.6 Each one of the New Approach Directives formulates certain requirements (essential requirements) for specific groups of products, e.g. machines, pressure vessels or lifts, etc.
These Directives limit public intervention on the markets to control of only essential safety characteristics of products, and from another side leave business and industry the greatest possible choice on how to reach compliance with the “essential requirements” of the New Approach Directives aiming to facilitate the free movement of goods:
- Products legally manufactured or marketed in one country should in principle move freely throughout the Community.
- On the other hand, only products fulfilling the essential requirements may be placed on the market and put into service.
New Approach Directives are based on voluntary standards
- The compliance with the harmonized standards, which have been transposed into national standards, is sufficient to consider the products being in compliance with the essential requirements.
- However, for products under the New Approach Directives the application of harmonized standards is not an obligatory condition of conformity assessment. Manufacturers are free to choose any technical solution that provides compliance with the essential requirements (without application of standards).
Comparing Systems of Technical Regulation of the Electrical Equipment Markets in Ukraine and the EU
According to the plans of the Ukrainian Government, the Low Voltage Directive will be transposed into the Ukrainian regulation as a measure to harmonize the system of the Ukrainian technical regulation with the New and Global Approach Directives of the EU. As of 2007, the Ministry of Industrial policy has developed 17 technical regulations (which transpose the norms of the respective EU Directives) and 20 technical regulations are in the drafting process.
As one of the above regulations, in 2003 Ukraine has partially introduced the Low Voltage Directive into its legislation7.
However, still there are serious differences between European and Ukrainian rules. In particular, the present Ukrainian regulation of conformity assessment of low voltage products is used together with the requirement of mandatory certification for a wide range of products. If the Directive will be introduced fully, it will profoundly change the present regulatory practice regarding the safety of electrical equipment. Main differences between the present normative basis and planned technical regulation (according to the Directive) are provided in the table.
A comparison of the legal environment of conformity assessment of electrical products
What is regulated |
Legal framework in Ukraine as of 2007 |
Legal framework in the European Union |
Range of electrical products under mandatory certification |
Mandatory certification of a wide range of electrical products is in force.8 This includes the whole spectrum of household electrical devices. Accordingly, before putting such products on the Ukrainian market, a certification has to be obtained from a notified body, or “product certification body”. |
For low voltage electrical products there is no mandatory certification regime, with the exception of the following products:
- Electrical equipment for use in an explosive atmosphere.
- Electrical equipment for radiology and medical purposes.
- Electrical parts for goods and passenger lifts.
- Electrical meters.
- Plug and socket outlets for domestic use.
- Electrical fence controllers.
- Radio-electrical interference apparatus.
- Specialized electrical equipment, for use on ships, aircraft or railways.
For low voltage products that are not under the above list of exceptions, the option of compliance assessment made by the manufacturer is offered. |
Role of standards in conformity assessment of electrical products |
The system of DSTU and GOST technical standards are sufficient to prove the conformity of electrical products within the Ukrainian system of certification. However, only a subset of these standards are harmonized in the sense of the Low Voltage Directive, and only a subset of the standards under the LVD are introduced into the Ukrainian system.
If a manufacturer or an importer company wants to prove the conformity of its electronic equipment, he or she must use the set of existing Ukrainian technical standards. Although the manufacturer is free to choose from the set of existing standards, the present Ukrainian regulatory regime offers no alternative to using standards. In this sense the application of standards is mandatory (obligatory). |
Products are presumed to conform to the safety requirements of the Low Voltage Directive where the equipment has been manufactured in accordance with technical standards which are harmonized with the Directive. The Directive refers to more than 800 harmonized standards that can be applied in a voluntary way to prove conformity. This means that conformity assessment with the help of standards is a sufficient way of demonstrating the safety of an electrical product.
However, safety demonstration does not require any obligatory application of the relevant standards. The goods can be manufactured in conformity with the essential requirements of the Directive on safety of products without applying harmonized, international or national standards. In such cases the manufacturer must include in the technical documentation a description of the technical solutions adopted to make the products compliant with the Directive provisions on low voltage equipment.9 |
Conformity Assessment Modules that are relevant for electrical products |
Conformity Assessment Modules are administrative procedures to prove product conformity.10 The Ukrainian legislation has recently introduced the concept of Conformity Assessment Modules.11 The Ukrainian technical regulation regarding low voltage equipment requires the participation of a notified body (i.e. a product certification organization) to carry out tests or to supervise the tests carried out by the manufacturer. For most electrical products this requirement is expressed as a mandatory application of Module AA. |
For products under the LVD only Module A (Internal Production Control) is applicable. This means that the involvement of a notified body is optional.. The following conformity assessment actions are to be made autonomously by the manufacturer or with the assistance of a notified body:
- to create a Technical File (covering the design, manufacture and use of the electrical equipment)
- to make the EU declaration of conformity
- and to put a CE mark on the product.
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Product marking, certification and its consequences to market access |
The UkrSEPRO Certificate of Conformity system was introduced by Ukraine Government in 1993, obliging to certify a number of products. The UkrSEPRO system is regulated by the Law of Ukraine “On conformity assessment” and guarantees that product conforms to the safety requirements established by national law. For putting electrical products on the market, producers and importers are obliged to obtain this certificate. For products subject to mandatory certification the original or certified copy of an UkrSEPRO Certificate of Conformity is required for customs clearance at the Ukrainian border as well as for sale and / or marketing within the country. |
Products within the scope of LVD must bear a CE marking in the European Community which is a manufacturer's self declaration of conformity. Under the law, a manufacturer is obliged to be able to support its claim with proof that the product meets the essential health and safety requirements of the Directive. This test data can be obtained from a third party, or manufacturers can provide it themselves. The CE mark is placed on the product by the manufacturer or his authorized representative established in the Community. The CE mark is placed on the electrical equipment, or if that is not feasible, on the packaging, the instructions for use, or the guarantee.
Products bearing the CE mark lawfully enjoy free circulation within the Single European Market. Governments of countries within the Single European Market may not prohibit, restrict or impede the placing on the market and putting into service in their territory of products bearing the CE marking, unless the provisions relating to CE marking are incorrectly applied |
Certification by third party of imported products |
Certification by third party of a wide range of imported electrical products is mandatory, even if bearing CE marks. |
Certification by third party of imported products bearing CE mark is not mandatory. |
Institutional environment of product quality and conformity |
In Ukraine the quality and conformity infrastructure shows a high level of centralization in performing the following functions:
- consumer protection (i.e. market surveillance),
- notification (i.e. delegating the right of product certification to certain bodies),
- standardization
- and certification.
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According to the principles of the Single European market, the following five functions should be performed by independent institutions:
- consumer protection (i.e. market surveillance),
- notification (i.e. delegating the right of product certification to certain bodies),
- accreditation
- standardization
- and certification.
Only market surveillance and notification are public functions, whereas in typical EU member states accreditation and standardization are the tasks of civil organizations.
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Downloadable documents
In the framework of regulatory impact assessment study, UEPLAC conducts a poll of the enterprises working in electrotechnical field of Ukraine. If You represent a company which works in electrotechnical sector of Ukraine (production, export, import of electrotechnical equipment and goods), we ask You to kindly respond on our questionnaire on evaluation of the regulatory burden caused by technical regulation.
Directive 2006/95/EC (electrical equipment designed for use within certain voltage limits)12
Guidelines of the European Commission
International experience
We would be grateful for your feedback
1 T he Regulatory Impact Assessment is being prepared in accordance with the Resolution of the Cabinet of Ministers “On Approving the Methodologies on Impact Assessment and Review of the Regulatory Act’s Efficiency” dated 11 March 2004 No 308 and in accordance with the Law of Ukraine “On Fundamentals of Public Regulatory Policy in Business Sphere” dated 11 September 2003 N 1160-15.
2 In accordance with the simplified structure of RIA as applied in the EU (Source: the European Commission: “Impact Assessment Guidelines” and “Annexes to Impact Assessment Guidelines” dated 15 June 2005 with March 2006 update.
3 Regulatory Impact Analysis of the Introduction of the Low Voltage Directive (73/23/EEC) into the Croatian Law. A Case Study of the Harmonisation of EU Technical Legislation. Pilot Study. Prepared by Dr. Peter Futo, Consulting and Research for Industrial Economics, Budapest. Ivona Štritof and Toni Lukšić. Ministry for European Integration, Zagreb 2001. Supported by Department for International Development, United Kingdom.
4 The Impacts of a "Free Movement of Goods" Directive. Pilot Study. Regulatory Impact Analysis. of the Introduction of the Low Voltage Directive into Lithuanian Law. Vilnius, May 2000 Prepared by Dr. Peter Futo, Consulting and Research for Industrial Economics, Budapest and Agne Seselgyte, Local Expert, SEIL, Vilnius. Supported by PHARE SEIL Project - Support to the European Integration of Lithuania.
5 Electrical equipment designed for use within the following voltage limits: between 50 and 1000 Vac or between 75 and 1500 Vdc.
6 Guide to the implementation of directives based on the New Approach and the Global Approach. European Commission, 2000. ISBN 92-828-7500-8.
7 Order of the State Committee of Ukraine for issues of technical regulation and consumer policy of 31 December 2003 No. 284 „On approval of the Technical Regulations relating to conformity verification of safety of low voltage equipment”.
8 List of products which are subjects to obligatory certification in Ukraine (27 November 2006).
9 Guidelines on the Application of Directive 2006/95/EC (Electrical Equipment Designed for Use Within Certain Voltage Limits) August 2007
10 Guide to the implementation of directives based on the New Approach and the Global Approach. European Commission, 2000. ISBN 92-828-7500-8.
11 Resolution of the Cabinet of Ministers of Ukraine of 7 October 2003 N 1585 «On approval of the Technical regulations on conformity assessment modules and requirements relating to the national conformity sign marking, which are used in technical regulations»
12 As a result of codification, directive 73/23/EC changed number on 2006/95/EC in December 2006. At the same time, the text of the codified version is identical to 73/23/EC.
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