Commission Report 2002 (Slovakia)

• Progress since the last Regular Report
• Overall assessment
• Conclusion

Chapter 1: Free movement of goods

Progress since the last Regular Report

Since the last Regular Report, Slovakia has continued to make good progress in this area, with further legislative alignment in particular in the fields of the New and Global Approach and public procurement.

In the area of horizontal and procedural measures, amendments to the already existing framework legislation on technical requirements for products and on conformity assessment entered into force in November 2001, thus further aligning with the acquis. This legislation governs the method for determining technical requirements; the development, approval and issuance of Slovak technical standards; procedures for conformity assessment; rights and obligations of manufacturers, importers and those placing products on the market; and certain aspects of market surveillance. A new, separate law covering market surveillance, effective from April 2002, has established the legal basis for the enforcement of CE marking.

Further progress can be reported as regards the adoption of sector-specific legislation. In the areas covered by New Approach Directives, government ordinances for the transposition of the EC Directives on simple pressure vessels, lifts, medical devices, active implantable medical devices and in-vitro diagnostic medical devices were adopted in the reporting period. Furthermore, amendments to existing governmental ordinances were also adopted with respect to machinery, explosives for civil use, electrical equipment used within certain voltage limits, gas appliances, electromagnetic compatibility, equipment for use in explosive atmospheres, hot water boilers, refrigerators and freezers, marine equipment, non-automatic weighing instruments and personal protective equipment. Most of the New Approach Directives have now been transposed.

Further progress was also made in the sectors covered by Old Approach Directives. In the field of chemicals, following the entry into force of the new Act on Chemical Substances and Preparations in June 2001, a number of implementing regulations transposing EC Directives were adopted. In the field of pharmaceuticals, a government decree on the registration of medicines, which transposes the acquis on marketing authorisations, entered into force in January 2002. An amendment to the 1998 Act on Medicines and Medical Devices entered into force in December 2001, thereby introducing ten year data exclusivity for high technology medicinal products. Decrees aimed at transposing the acquis on labelling the composition of textiles, glass and footwear entered into force in 2002. No further progress can be reported as regards motor vehicles.

As regards the issue of food safety and foodstuffs legislation (see also Chapter 7 - Agriculture), there was some progress, notably the removal of some provisions related to the pre-market approval procedures in place in Slovakia. At the same time, the Ministry of Agriculture issued a decree introducing compulsory notification of all manufactured and imported foodstuffs. This measure contradicts the objective of a proper incorporation of the Community acquis into the Slovak system and will therefore need to be brought in line. Amendments to the Food Act provided for the establishment of the State Veterinary and Food Administration (SFVA). In addition, an inter-sectoral Food Safety Commission was created to enhance co-ordination between the various institutions involved in the food safety area.

An Act on the Return of Unlawfully Removed Cultural Goods was adopted in June 2002 aimed at implementing the two Directives in this field from accession. As regards the transposition of the acquis on firearms, no particular progress can be reported.

As regards the development of Slovakia's administrative capacity for the implementation of horizontal and procedural measures and sector-specific legislation, further improvements can be noted. In the field of standardisation, the Slovak Institute for Standardisation (SÚTN) achieved full membership of the European Committee for Electrotechnical Standardisation (CENELEC) in June 2002. Harmonisation with EC standards has surpassed the 80% required for membership of the European Committee for Standardisation (CEN). According to the Slovak authorities, in the sectors proposed for inclusion in the Protocol to the Europe Agreement on Conformity Assessment and Acceptance of Industrial Products (PECA), the adoption rate of harmonised standards is 100%. A government ordinance for the transposition of the EC Directive laying down a procedure for the provision of information in the field of technical standards and regulations was adopted in July 2002. No progress can be reported on the measures to be taken with regard to the EC Regulation concerning the checks for conformity with the rules on product safety in the case of products imported from third countries. Although this Regulation will be directly applicable from the date of accession, Slovakia needs to set up the necessary enforcement structures well before accession.

Since the last Regular Report, some further progress has been made as regards the non-harmonised area, mainly as concerns information procedures. However, limited progress can be reported as regards the systematic screening of legislation for provisions that might not be compatible with Articles 28 to 30 of the EC Treaty.

In the area of public procurement two amendments to the Act on Public Procurement were adopted in the reporting period, the latest in July 2002. This second amendment,expected to enter into force at the beginning of 2003, is intended to improve transparency in selection and award procedures and further clarify certain aspects related to review procedures, dealing, for example, with the award of damages by the Public Procurement Office and the possibility of legal appeals against its decisions. The amendment also aim to tackle some of the other previously identified shortcomings such as excessively broad exceptions from the law, the exclusion of bodies governed by public law, the inadequate coverage of purchasing entities in the field of utilities, the requirement to have `entrepreneur' status and the need to abolish discriminatory provisions in favour of underdeveloped regions.

Overall assessment

Despite some progress in the non-harmonised area, the situation is still unclear as regards legislation in conflict with Articles 28-30 EC. The Slovak authorities should ensure that all legislation that is not compatible with Articles 28 to 30 of the EC Treaty is amended by the date of accession. More information on transposition measures and enforcement arrangements concerning other related legislative instruments is still awaited.

As regards sector-specific legislation for areas covered by New Approach Directives, transposition is almost complete, with most of the relevant Directives transposed. Work remains with regard to the pressure equipment and, transportable pressure vessels Directives. In the area of Old Approach Directives, the acquis on chemicals, cosmetics, legal metrology, pre-packaging and wood has been largely transposed. However, further progress is required in the pharmaceuticals area, where alignment of price controls still needs be achieved and the central procedure for registration and the procedure for the mutual recognition of registrations need to be implemented by the date of accession. The renewal of existing marketing authorisations for pharmaceuticals should also be completed. Also, transposition of the motor vehicles acquis is outstanding.

In terms of transposition of the foodstuffs acquis, Slovakia is behind schedule. Additional efforts are needed to achieve full transposition and to guarantee the quality of the implementing provisions. Further steps are also necessary in order to dismantle the authorisations, registrations and other forms of control prior to marketing in all instances where such procedures are not provided for by Community law. As for novel foods, there is currently no official approval system in place for specifically novel foods, including genetically modified foodstuffs, nor any specific legislation in force.

As for administrative capacity, Slovakia's standardisation and accreditation bodies have been in place for some years and continue to function well. The Slovak National Accreditation Service (SNAS) is a member of the European co-Operation for Accreditation (EA) and will participate fully in the multilateral agreement (MLA) from the end of 2002. In June 2002, the Slovak Institute for Standardisation (SUTN) became a full member of CENELEC and formal membership of CEN is scheduled for the end of 2002. In the past year, Slovakia has increased the personnel capacity of the Slovak Trade Inspectorate, the Centre for Chemical Substances and Preparations and the State Institute for Drugs Control. Reorganisation of market surveillance structures has also taken place following adoption of the new Act on state control of the internal market in consumer protection issues. Such efforts at reinforcing capacity should be sustained. In all industrial sectors, the relevant administrative infrastructure for application of the acquis must be in place and functioning effectively by the date of accession, if not before.

In the area of foodstuffs, further reinforcement of administrative capacity is required, despite the progress made. As the mandate of the newly established State Veterinary and Food Administration remains ambiguous, co-ordination between the various services is vital. The use of laboratories needs to be streamlined and their personnel trained, partly so as to be able to put in place the necessary structures and procedures in line with the EC acquis. Clear guidelines and procedures need to be set up to operate fully a rapid alert system for food and feed and the creation of a commission for crisis management is awaited. The national contact point also needs to be designated and an adequate network with IT equipment established. The compliance of food producers with Hazard Analysis Critical Control Point Systems (HACCP) principles remains a major challenge and a plan of action for their implementation would be welcome.

As regards safety checks on products at external borders, Slovakia still needs to establish appropriate customs and market-surveillance infrastructure, as well as effective administrative co-operation between competent authorities.

As regards the transposition of the acquis on firearms, a new law on weapons and ammunition aimed at ensuring full compatibility with the acquis is under preparation. The foreseen transposition measures will need to be examined, including as concerns the establishment of national procedures for the exchange of information and issuance of European firearms passes.

As regards public procurement, despite the fact that the Public Procurement Office is functioning well and is carrying out its tasks in a very proactive way, further efforts should still be made towards guaranteeing a wider and more regular monitoring and control system and towards increasing the quality and number of inspections. Infringements committed by procuring entities seem to be still quite common, especially at the level of municipalities. Further efforts are needed to ensure transparency and enforcement of current rules at all levels of government and in all sectors. In performing the review procedures, steps should be taken to reinforce total independence and adequate capacity of the Office.

Conclusion

In its 1997 Opinion, the Commission concluded that Slovakia was progressively taking on the full acquis related to the free movement of goods but that the slow progress in legislative alignment and in implementing a compatible system of voluntary standardisation and conformity assessment reflected weaknesses in compliance with the provisions of the Europe Agreement. It was nevertheless noted that it was not expected that the free circulation of goods would be a major obstacle at the point of accession.

Since the Opinion, progress has generally been good. Transposition of the acquis is reasonably advanced and administrative capacity largely in place.

Negotiations on this chapter have been provisionally closed. Slovakia has not requested any transitional arrangements in this field. Slovakia is generally meeting the commitments it has made in the accession negotiations in the free movement of goods area.

In order to complete preparations for membership, Slovakia's further efforts should now focus on alignment in the field of motor vehicles, where the exact form of the transposition is yet to be determined following decentralisation of competencies, and in the area of pharmaceuticals as outlined above. Furthermore, a special focus on food safety and foodstuffs legislation and implementation is required, as is the completion of systematic screening of legislation in the non-harmonised areas and removal of legislation contrary to the acquis. More generally, continued improvements to administrative capacity should be made.

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