croatian government’s priorities in the regulatory area unece round table on regulatory...
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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
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WTO
Year 2000 WTO membership/TBT Agreement,
Croatia accepted to base its system of technical legislation, standardisation, metrology and conformity assessment on international rules
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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
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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
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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
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Quality infrastructure
CROATIAN STANDARDS INSTITUTE CROATIAN ACCREDITATION CROATIAN METROLOGY INSTITUTE
established as public institutions as from
1 January 2005
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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
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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
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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
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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
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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
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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)
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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)
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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)
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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)
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Ministry of Environmental Protection, Physical Planning and Construction
construction products (89/106/EEC) packaging and packaging waste
(94/62/EC)
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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”
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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
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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
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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
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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
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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
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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