Croatia n Government’s Priorities in the Regulatory Area

1. CroatianGovernment’s Priorities in the Regulatory Area UNECE-SIDA “South East Europe Regulatory Project” Ljubljana, 8 June 2004

2. WTO membership • TBT Agreement • Code of good practice

3. Stabilisation and Association Agreement with the EU (SAA) • “make necessary measures in order to gradually achieve conformity with Community technical regulations and European standardisation, metrology, accreditation and conformity assessment procedures” (Article 73) • a period of six years

4. National Strategy for Technical Harmonisation with the EU • January 2003 • Separation of the relevant functions of the State Office for Standardisation and Metrology • responsibilities for the transposition and implementation of new approach and old approach directives

5. Horizontal IssuesLegislative framework • September/October 2003 • Law on Technical Requirements for Products and on Conformity Assessment • Law on Standardisation • Law on Accreditation • Law on General Product Safety • Law on Metrology

6. Standardisation • Independent institution - 1 January 2005 • Priority: to adopt all harmonised European standards • To withdraw all the standards which are not harmonised with European or international standards • Voluntary participation and application of Croatian standards

7. Accreditation • Independent national accreditation body as a public institution - 1 January 2005 • Necessary infrastructure already exists within State Office for Standardisation and Metrology which acts as the National Accredition Service

8. Technical requirements and conformity assessment The new Law on Technical Requirements for Products and Conformity Assessment • Defines methods to determine technical requirements for products • Conformity assessment procedures in line with corresponding New Approach Directives • Adoption of technical regulations

9. Technical requirements and conformity assessment • Rules for affixing and use of the CE conformity marking (93/465/EEC) • A form of the conformity marking to be affixed to products will be defined in a separate regulation • Market surveillance with regard to the fullfilment of the requirements for products

10. Technical regulations • Croatian Government is currently adopting an Implementation Programme which will assign different ministries with the task of transposition and implementation of the New Approach Directives into Croatian legislation • Drafting of technical regulations is planned to be completed by the end of 2004

11. Ministry of Economy, Labour and Entrepreneurship • low-voltage electrical equipment (73/23/EEC) • simple pressure vessels (87/404/EEC) • machinery (98/37/EC) • lifts (95/16/EC) • personal protective equipment (89/686/EEC)

12. Ministry of Economy, Labour and Entrepreneurship • appliances burning gaseous fuels (90/396/EEC) • pressure equipment (97/23/EC) • efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (92/42/EEC) • energy efficiency requirements for household electric refrigerators and freezers(96/57/EC)

13. Ministry of Health and Social Welfare • safety of toys (88/378/EEC) • medical devices, general (93/42/EEC) • active implantable medical devices (90/385/EEC) • in vitro diagnostic medical devices (98/79/EC)

14. Ministry of the Sea, Tourism, Transport and Development • electromagnetic compatibility (89/336/EEC) • recreational craft (94/25/EC) • radio and telecommunications terminal equipment (99/5/EC) • cableway installations for persons (2000/9/EC)

15. Ministry of Environmental Protection, Physical Planning and Construction • construction products (89/106/EEC) • packaging and packaging waste (94/62/EC) • interoperability of the trans-European high-speed rail system (96/48/EC) • marine equipment (96/98/EC)

16. Conformity assessment • Through the implementation of these directives, relevant procedures laid down in the directives will be introduced in the Croatian conformity assessment system.

17. Transposition Working Groups • Established at ministerial level for the transposition of a particular directive and compilation of technical regulations • Include representatives from business and civil society • Technical assistance under the CARDS 2001 project “EU Industrial Standards” is provided to 9 transposition groups

18. Co-ordination • A Steering Group at high governmental level • Members are all responsible ministers headed by the Deputy Prime Minister resonsible for the economy • Enables gathering of all respective date related to the issue of cross-sectorial implementation of directives

19. Weaknesses • No adequately trained personnel • Insufficient capacities, in particular of the Ministry of Economy, Labour and Entrepreneurship, as notified body responsible for technical legislation • No conformity assessment bodies acting as notified bodies

20. How to address these weaknesses? • Specialised training of the existing staff through CARDS programme • Recruitment of new experts for technical legislation • Reorganisation of the Ministry of Econoy, Labour and Entrepreneurship is a priority – Internal Market Directorate

21. How to address these weaknesses? • Enhance the capacities of current certification bodies in line with the requirements of the European notified bodies • Inform producers about the new legislation • Ensure financial resources to enable the existing testing laboratories to purchase new equipment

22. Results • EU standards adopted and implemented • Trained and competent personnel • Market operators familiar with regulations and standards in their export markets and able to compete • Limitation of obstacles to international trade and facilitated market access