Commission Report (2002): Poland

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

Chapter 1: Free movement of goods

Progress since the last Regular Report

Developments in this domain have been variable. Poland has made considerable progress in some areas, whereas in others a step backward has been taken.

In the area of horizontal and procedural measures, Poland adopted in August 2002 an amendment to the Law on Conformity assessment system which, inter alia, addresses the issue of market surveillance. A new standardisation law was adopted in July 2002.

Efforts over the reporting period have focused on the adoption of sector specific legislation, where progress was considerable. In the areas covered by the New Approach Directives, new legislation was adopted aimed at transposing eight Directives: electromagnetic compatibility (EMC), radio equipment and telecommunications terminal equipment, low voltage, simple pressure vessels, toys, personal protective equipment, gas appliances and machinery. The package of pharmaceutical laws (Pharmaceutical Law, Provisions introducing the Law, Law on Medical Products and Law on the Registration Office for Medical, Medicinal and Biocidal Products) entered into force in October 2002 although some provisions, notably concerning data protection, will only come into effect on the date of accession. The Law on Pricing of Pharmaceutical Products of July 2001 entered into force in December 2001. It is partially aligned with the `Transparency' Directive applicable in this field. Some implementing regulations under this act were also adopted. The 2001 law on Chemical Substances and Preparations was amended in July 2002 and a series of implementing Ordinances were adopted under this Law. Some implementing ordinances under the Law on cosmetics were also adopted during the reporting period.

In the field of motor vehicles, the amendment to the Road Traffic Act adopted in September 2001 fully entered into force in June 2002. A series of UN/ECE Regulations became binding in Poland. These further align Poland's legislation to the acquis. One area where alignment with the acquis regressed concerned the re-introduction of an old measure concerning emission levels for second hand vehicles. In the field of construction products, the amendment to the Construction Law adopted in July 2001 partially entered into force in February 2002. Other provisions of the law relating to the use of CE marked products and recognition of EC qualifications for architects will come into force from the day of accession. The amendment creates the framework for the implementation of the Construction Products Directive once the appropriate implementing legislation is adopted. This is also the case for the harmonisation of the acquis related to explosives for civil use, for which the framework legislation was adopted in June 2002. Legislation on drug precursors was adopted in September 2001 and entered into force in January 2002. An Ordinance on the safety and labelling of textiles partially aligning Polish legislation with the acquis was adopted in October 2001 and entered into force in June 2002. Legislation aimed at transposing the acquis on safety checks at external borders was adopted in June 2002.

As regards the issue of food safety and foodstuffs legislation (see also Chapter 7 ­ Agriculture), the Law on materials and products intended to come into contact with foodstuffs, aiming at transposing the corresponding acquis, was adopted in September 2001 and will enter into force in November 2002. The May 2001 Food and Nutrition Act has been amended to ensure further compliance with the acquis. Amendments which entered into force in September 2002 addressed, in particular, the abolition of the pre-market authorisation procedures which still subject foodstuffs to prior ``registration'', ``notification'' or other forms of control, beyond the limits set by the acquis. In June 2002, the Ministry of Health took over the functions of co-ordinator of activities relating to food safety previously undertaken by different ministries and central institutions. The Food and Nutrition Institute developed a Food Safety Strategy the first version of which was adopted in February 2002. It was decided that from January 2003 onwards the control on the commercial quality of agricultural and food products would become the responsibility of the Inspection of Trade Quality of Agricultural and Food Products as well as of the Trade Inspectorate.

As regards the development of Poland's administrative capacity in this area, the gradual improvement that began in previous years has continued during the period under consideration. Activities to prepare the relevant bodies for carrying out market surveillance tasks have started. The Polish Committee for Standardisation has intensified its efforts to meet the conditions for entry into the European Standardisation organisations CEN and CENELEC. The role of the national information point implementing provisions of the Agreement on technical barriers to trade (WTO/TBT) was strengthened in the light of its future role under the `Information' Directive regarding the notification of standards. In November 2001, the Polish Accreditation Centre officially joined the European co-operation for Accreditation (EA) and preparations for the signature of all Multilateral Agreements on Accreditation within EA (EA MLAs) are being undertaken. A series of bodies have applied to become `notified' or `competent' bodies under several New Approach Directives. In the area of chemical products, the Inspector for Chemical Substances and Preparations was appointed in November 2001. The Office for Chemical Substances became operational as of January 2002. In February 2002, new tasks in this field were also attributed to a range of bodies including the Sanitary Inspectorate, the Environmental Protection Inspectorate, the border guard and the customs authorities. In the field of pharmaceuticals and by way of a decision of the Ministry of Health adopted in November 2001, a Bureau for the organisation of the Registration Office for Medical, Medicinal and Biocidal products was set up, aiming at putting in place the technical and administrative basis for the creation of the Office.

In the non-harmonised area, an inter-ministerial team to analyse Polish legislation in terms of its compliance with Articles 28--30 of the EC Treaty was established on the basis of a Decision taken in March 2002. Where difficulties are identified the team is mandated to propose decisions to insert as appropriate mutual recognition clauses. The amendment to the Law on Conformity Assessment is important in this respect, introducing as it does, the concept of mutual recognition into Polish law.

During the course of the year a number of laws which have been adopted demonstrate that the current procedures for verifying compatibility with the acquis requires strengthening. Both the Law on Alcohol Advertising and the Law amending the Act on Unfair competition contain provisions which appear to be in contradiction with the acquis concerning the free movement of goods.

In the field of public procurement, amendments to the Law on Public Procurement from June 2001 entered into force in October 2001 and January 2002 respectively. The provisions on equal access for EC firms will enter into force from the date of accession. A further important adjustment related to the requirement that the contracting authority specify the use of Polish standards transposing European standards, or in their absence, European or international standards. Implementing legislation was also adopted and entered into force during the reporting period.

Overall assessment

The adoption of the horizontal and procedural measures and the establishment of the necessary institutional infrastructure allowing for the implementation of New Approach legislation started slowly but has progressed significantly over the last couple of years. Without prejudice to an assessment of the recently adopted laws, the legal framework for implementing the New Approach directives appears now to be in place.

Drafts of implementing legislation transposing the remaining New Approach Directives are in preparation and cover notably: equipment used in explosive atmospheres (ATEX), pressure equipment, recreational crafts, lifts, cableway installations, construction products, non-automatic weighing instruments, medical devices, active implantable medical devices and in vitro diagnostic medical devices. The transposition of the Directive on explosives for civil uses still requires implementing legislation under the recently adopted Law on explosives for civil uses.

On completion of this legislative programme, the old system of mandatory certification, which depended largely on `mandatory standards' will be abolished. At present 644 Polish standards are still mandatory. As regards the Old Approach Directives, similar efforts are required and, indeed, are underway. In the field of motor vehicles, Poland is close to full alignment with the EC acquis on motor vehicle type approval. Further implementing legislation is also under preparation for the implementation of the package of pharmaceutical legislation and the 2001 Law on cosmetics. In the case of the pharmaceutical legislation in particular, implementation is being closely monitored to ensure that the new system does not allow de facto discrimination against imported pharmaceutical products. Full alignment with the acquis on pre-packaging requires some implementing legislation to be adopted under the 2001 Law on pre-packed goods. Alignment in the field of legal metrology is on track but needs to be further pursued. The October 2001 Ordinance on the safety and labelling of textiles will still need to be amended. This is also the case with the legislation on safety of toys. The footwear acquis was implemented some time ago. Work is in progress in the fields of glass and wood. Legislation on cultural goods to ensure alignment remains to be adopted. Amendments to the Law on arms and ammunition are required.

The framework legislation for food safety is in place, but further analysis is required to determine whether any adjustments will be required so as to bring the legislation fully in line with the acquis. Transposition and implementation of implementing legislation under these framework laws is still at an early stage and efforts need to be intensified significantly if Poland is to be fully in line before accession. Regarding the administrative capacity in this field, further co-ordination between the Ministries and other bodies involved in food safety is required. The decision of the Ministry of Health establishing from September 2002 an inter-ministerial task force for food safety is an encouraging first sign in this respect. Progress has been made in the development of institutional structures for the official control of genetically modified and novel foods and further efforts are needed to set up equipment and analytical controls. Special efforts also need to be devoted to the area of official control of food hygiene, contaminants and pesticide residues. The process of setting up adequate laboratories, developing and validating analytical methods and the training of staff should be accelerated. It is not foreseen that HACCP principles will be implemented before accession: an earlier application would however give both economic operators and inspectors a longer period of time in which to adjust to the EC principles of food safety. For the Rapid Alert System in particular, Poland still needs to designate a single contact point and further develop documented procedures for the operation of the system. The Ministry of Health which, with the assistance of the Food and Nutrition Institute, has become the co-ordinator for all food safety related matters requires a significant increase in qualified staff.

Staff increases are envisaged for the Ministry of Economy, the Office for Chemical Substances and the Registration Office for Medical, Medicinal and Biocidal Products (to become operational from October 2002 with the entry into force of the `set' of pharmaceutical laws). Particular attention will need to be given to the further development of a well-functioning market surveillance system. New qualified staff should be hired in the Office of Competition and Consumer Protection, which, in line with the draft amendment to the Law on Conformity Assessment, will become the supervisory body for market surveillance.

In the non-harmonised area, efforts need to be intensified. The Ministry of Economy requires additional resources if it is to identify and abolish potential barriers to trade. A national contact point for the implementation of the EC Decision on the notification procedure for measures potentially creating obstacles to the free movement of goods is required upon accession.

As noted, Poland has replaced its previous, discriminatory system on the setting of prices for pharmaceuticals for human use. However, the system put in place by the new legislation is not fully transparent and further analysis is required to assess its alignment with the acquis and, in particular, that there are no de facto discriminatory provisions.

On public procurement, alignment has been greatly improved by recent legislative developments. A series of Ordinances, inter alia on documents, competition, tender commission and rules of procedure in appeals, need to be adopted to reach full alignment with the acquis in this area. Further strengthening of the Public Procurement Office should be envisaged.

Conclusion

In its 1997 Opinion, the Commission concluded that serious efforts would be needed to put in place a sufficiently developed system enabling the full and effective implementation of the acquis in this area. The areas identified as having seen inadequate progress and where there was a particular need to accelerate, develop and complete the programme of approximation were New Approach Directives, automotive sector, chemicals (detergents and dangerous substances), foodstuffs and pharmaceuticals. In this context the Opinion recalled the importance of implementing legislation necessary in order to implement the general legislative framework and accompanying infrastructure independent of the government.

Since the Opinion, considerable progress has been made over the last two to three years notably by putting in place the framework legislation needed and by developing further the institutional infrastructure needed for its implementation. To date a high level of transposition of the acquis has been achieved in relation to the primary legislation and administrative capacity has reached a reasonable level.

Negotiations on this chapter have been provisionally closed. A transitional arrangement was granted for medical devices. Furthermore, Poland was granted a transitional arrangement until the end of 2008 for the renewal of market authorisations for existing pharmaceutical products. Poland is generally meeting the commitments it has made in the accession negotiations.

In order to complete preparations for membership, Poland should now focus on finalising its alignment efforts, in particular by the adoption of outstanding implementing legislation, particularly in the field of foodstuffs and public procurement. Poland should also strengthen its administrative capacity, in particular in the non-harmonised area, in the field of market surveillance and in the field of food safety.

---

Next: Chapter 2: Free movement of
Up: 3.1. The chapters of the
Previous: 3.1. The chapters of the