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