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Croatian Government’s Priorities in the Regulatory Area. UNECE Round Table on Regulatory Cooperation in South East Europe Geneva, 22 November 2004. WTO. Year 2000
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Croatian Government’s Priorities in the Regulatory Area UNECE Round Table on Regulatory Cooperation in South East Europe Geneva, 22 November 2004
WTO • Year 2000 • WTO membership/TBT Agreement, Croatia accepted to base its system of technical legislation, standardisation, metrology and conformity assessment on international rules
Stabilisation and Association Agreement with the EU (SAA) • in force since January 2002 • “make necessary measures in order to gradually achieve conformity with Community technical regulations and European standardisation, metrology, accreditation and conformity assessment procedures” (Article 73) • within a period of six years • Candidate country July 2004
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
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
Quality infrastructure • CROATIAN STANDARDS INSTITUTE • CROATIAN ACCREDITATION • CROATIAN METROLOGY INSTITUTE established as public institutions as from 1 January 2005
CROATIAN STANDARDS INSTITUTE Support to technical legislation • Priorities: • to adopt all harmonised European standards • to withdraw all the standards which are not harmonised with European or international standards • Support to the implementation of technical legislation
CROATIAN ACCREDITATATION Activities: • accreditation of testing and calibration laboratories • accreditation of certification bodies, inspection bodies • evaluation and confirmation of the competence of conformity assessment bodies in accordance with technical regulations
Technical requirements and conformity assessment 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
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 fulfilment of the requirements for products
Technical regulations • Based on Law on Technical Requirements for Products and on Conformity Assessment, the Croatian Government adopted a Programme which assigned different ministries with the task of transposition and implementation of the New Approach Directives as regulations • Drafting - complete by the end of 2004
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)
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)
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)
Ministry of the Sea, Tourism, Transport and Development • interoperability of the trans-European high-speed rail system (96/48/EC) • marine equipment (96/98/EC) • recreational craft (94/25/EC) • radio and telecommunications terminal equipment (99/5/EC) • electromagnetic compatibility (89/336/EEC)
Ministry of Environmental Protection, Physical Planning and Construction • construction products (89/106/EEC) • packaging and packaging waste (94/62/EC)
EU support CARDS projects • CARDS 2001 “EU Industrial standards” • CARDS 2003 “Development of accreditation systems and support to national testing and calibration laboratories” • CARDS 2004 “Development of national metrology, standardisation, conformity assessment and accreditation systems”
Transposition Working Groups • Established at ministerial level for the transposition of a particular directive and compilation of technical regulations • Include representatives from ministries, institutions, business and civil society • Technical assistance under the CARDS 2001 project “EU Industrial Standards” is provided to 9 transposition groups
Co-ordination • A Steering Group at high governmental level • Members are all responsible ministers headed by the Deputy Prime Minister responsible for the economy • Enables gathering of all respective date related to the issue of cross-sectorial implementation of directives
Weaknesses • Lack of coordination • No sufficient and adequately trained personnel • Insufficient capacities, in particular of the Ministry of Economy, Labour and Entrepreneurship as a coordinating body • No conformity assessment bodies acting in line with technical regulations
How to address these weaknesses? • Steering group at the Government level • Specialised training of the existing staff through CARDS and PHARE programmes and recruitment of new experts • International cooperation • Reorganisation of the Ministry of Economy, Labour and Entrepreneurship is a priority – Internal Market Directorate
How to address these weaknesses? • Establishment of conformity assessment and accreditation system according to regulations • Upgrading the competence of accreditation and conformity assessment • Ensure financial resources to enable the existing testing laboratories to purchase new equipment
Results • EU directives 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