Technical regulation in the Republic of Moldova

1. UNITED NATIONECONOMIC COMMISSION FOR EUROPEFirst meeting of regulators from South East European countries Technical regulation in the Republic of Moldova Aurelia Alexandrova, Deputy Heard of General Standardization Division, Department of Standards and Metrology Ljubljana 8 June 2004

2. Oficial dates about Republic of Moldova Oficial name: Republic of Moldova Population: 4228,9thousand Capital: Chisinau, over 750 thousand Political system: The President, Government, Parliament

3. Moldavian Trade Volume with BalkanCountries

4. Moldavian Export-Import in Albania Export Import

5. Moldavian Export-Importin Bulgaria Export

6. Moldavian Export-Import in Bulgaria Import

7. Moldavian Export-Import in Bosnia and Herzegovina Export Import

8. Moldavian Export - Import in Croatia Export Import

9. Moldavian Export-Import in FYR of Macedonia Export Import

10. Moldavian Export-Import in Serbia and Montenegro Export Import

11. Moldavian Export – Import in Romania Export

12. Moldavian Export – Import in Romania Moldavian Export – Import in Romania Export

13. Moldavian Export – Import in Romania Import

14. Moldavian Export-Import in Slovenia Export Import

15. Restrictions of Trade between Moldova and South East EuropeCountries The following trade barriers are known: • A high level of competitiveness on the world market; • Sanitary, fitosanitary and ecological restrictions; • Strict observance of packaging standards; • Appliance of old technological processes and standards by Moldavian companies, which prevents them from producing goods that would meet the requirements of the market; • High requirements to the quality of products; • The fact that Moldova is not famous on the world market; • Lack of trade delegations for promoting the image of the country and informing producers about conditions of access to the markets of countries; • Low purchasing capacity of Moldavian population; • Not corresponding of national standardization systems and conformity assessment system international requirements; • Cultural, linguistic and demographic conditions;

16. Factors,Which Have Defined Priorities of Moldova in Field of Technical Regulation 1. Moldova is member of WTO (on May, 8 2001, in Geneva it was signed the report on the introduction of Republic Moldova in WTO). 2. Orientation of Moldova for integration in EU (It is signed the report between the Republic of Moldova and EU about partnership and co-operation). 3. Necessity of promotion of Moldavian export inEU and Central and the East Europe countries. 4. Maintenanceof Moldavian export markets in NIS countries. 5. Protection of Moldavian market from the inappropriate production imported in Republic Moldova.

17. Stakeholders in Technical Legislation Quality infrastructure: • National Standardization System • National Standardization Body: • Technical Committees; • Standardization services. • National Metrology System: -National Metrology Body; -Metrology services. • National System of Conformity Assessment of products: -National Body of Conformity Assessment of products; • Conformity assessment bodies (26 Body of • certification products; 2 Body of Services certification; • 2 Body of certification of Quality • Managements Systems; 2 Inspection Body; • 156 Test laboratories). • Accreditation System. Ministries (legislator), Responsible for development of technical regulations Market surveillance Industry and trade Consumers

18. Legal and Normative Framework in Moldova for Technical Regulation Development • Law on Standardization Establishes legal, social, economic and organizational basis of standardization, is stated the term “technical regulation” and period for transition to the voluntary application of standards. • Law on Technical Barriers to Trade Establishes juridical bases for elimination of technical barriers to trade during the process of the development, adoption and application of technical regulations, standards and conformity assessment procedures and notification obligations during development of technical regulation and procedures of an estimation of conformity . • Law on Products Conformity Assessment Establishes requirements to structure oftechnical regulation, introduction of the modular approach for the varies phases of the conformity assessment procedures and minimal requirements to notifies bodiesfor work in regulated area.

19. Legal and Normative Framework in Moldova for Technical Regulation Development • The Government Decision on Transition to the Voluntary Standardization Establishes central authorities (ministries, departments and agencies), responsible for development of technical regulations in specific areas. Department of Standardization and Metrology coordinates the activity related to technical regulation development. Mandatory standards of National Standardization System • Moldavian Standard SM 1-13 “Principals and methodology of standardization. Technical regulation. General principles” Establishes the general principles of technical regulation development, requirements for the basic structural elements of technical regulation, the responsibility during development. • Moldavian Standard SM 1-17 “Principals and methodology of standardization. Rules and procedures of notifications preparation in conformity with Agreement on Technical Barriers to trade” It is developed according to Recommendations of World Trade Organizationnotification requirements.

20. Rules for the National Adoption of ISO, IEC, EN Standards and of National Standards of the Other States as Moldavian National Standards Mandatory standards of National Standardization System • Moldavian Standard SM 1-12 “Principals and methodology of standardization. Adoption of international standards in Moldavian standards” (according toGuide ISO/IEC 21:1999) • Moldavian StandardSM 1-20 “Principals and methodology of standardization. Order of application of other states normative documents in Republic Moldova ” • Moldavian StandardSM 1-21 “Principals and methodology of standardization. Adoption of European standards in Moldavian standards”

21. The Responsibility During Development of Technical Regulation Role of Ministries • Development of technical regulation • Implementation of EU Directives • Export promoting • Withdrawal conflicting regulation • Implementation of standards • Technical regulations-referred standards Role of Department of Standardization and Metrology: • Coordination the activity of technical regulation development • Standardization development Technical work • Affiliation to ISO membership

22. In the Republic of Moldova the following are considered as technical regulations: Legislations acts, Decrees of the President and Decision of the Government, containing requirements for products; Normative acts of public authorities, in whose competence is establishing mandatory requirements for products; Medical standards, medical and biological requirements, sanitary norms, sanitary and hygienic norms and rules; Norms and rules in construction field; Norms and rules in field of environment, energy, transport, and telecommunication; Norms and rules in field of industrial security;  Norms and rules in field of labour safety; Other documents with mandatory technical requirements in respective field. Technical regulation objects to which obligatory demands can be applied: Products Processes of production Operations Storage Transportation Marketing Utilization Technical Regulation in Moldova

23. Safety and compatibility On main group of products Safety and compatibility On main group of products Safety and compatibility On main group of products Safety and compatibility On main group of products Safety and compatibility On main group of products Safety and compatibility On main group of products Safety and compatibility On main group of products National Program on Technical Regulation Development (over 74 technical regulations) Horizontal technical regulations General product safety (Directive 2001/95/EC) Liability for detective product (Directive 85/374/EEC) • The priority of technical regulations: • Safety of main group of food staff ; • Safety of main group of industrial products; • Sanitary –veterinary norms for milk and • meat products; • Safety on tobacco and tobacco articles; • Norms and rules in transport field; • Safety of pharmaceutical products; • Safety of cosmetic products; • Safety of textile; • Labelling of food and industrial products; • Packing Modules for the various Phases of the conformity Assessment procedures (Directive 85/374/EEC)

24. Main Problems Impeding Regulatory Work on National and Regional Level 1. Insufficient experience in development of technical regulations which transposes EU Directives. 2. Insufficient experience in identifying the essential requirements (There is a necessity of experts, which would be able to specify requirements for each group of products. But it is also important the knowledge of standardization bases, the knowledge of conformity assessment for each group of products, knowledge of horizontal technical regulations) . 3. The necessity to improve the Conformity Assessment System of Products (it’s necessary to apply conformity assessment procedures based on modular approach, the technical regulation body must develop technical regulations for groups of products, which would set essential requirements, procedures of conformity assessment and market surveillance. Conformity Assessment bodies must switch to the conformity assessment procedures, which are established in technical regulation). These and other problems in Moldova will be realized on the basis of the Law onProducts Conformity Assessment, which wasapplied in January, 2004 and now replaces theLaw on Certification which was in force. 4. The language barriers in applying International and European standards, as well as European directives.