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POSITION PAPER OF THE REPUBLIC OF LATVIA
Chapter 1: "FREE MOVEMENT OF GOODS" For setting the time frame for the process of adoption and implementation of acquis communautaire the Latvian Government has accepted 1 January 2003 as the date on which Latvia will be prepared for accession to the European Union. Latvia accepts and will fully implement acquis communautaire in the area of free movement of goods and does not require transition period or any delays in this part. By 1 January 2003 Latvia shall be fully prepared to implement all EU key laws in the area of free movement of goods. Where it is possible, Latvia is intended to approximate the legislation with relevant EU legislation and accomplish its implementation as soon as possible and before foreseen accession to the EU. Motor Vehicles EU Acquis relating to Wheeled Road Vehicles and Their Components (sidecars) is fully implemented. Those requirements are defined in the Regulations Nr.30 of the Ministry of Transport from 30 August 1999, which have been elaborated according to the Regulations of the Cabinet of Ministers from 16 March 1999. The requirements of Regulations related to cars and motorbikes entered into force 1 October 1999, but requirements relating to other vehicle categories âÀ“ 1 January 2000. There is established necessary administrative infrastructure âÀ“ the Road Traffic Safety Directorate, which is responsible for development and maintaining of legislation in the area of road traffic safety, and supervision and conformity assessment of road vehicles. It is foreseen to implement EU Acquis related to agricultural and forestry machinery by 31 December 2000. The responsible authority is the Ministry of Agriculture. There is established necessary administrative infrastructure âÀ“ the Baltic Station of Machinery Testing, which will carry out type approval and testing in this area. Foodstuffs The most part of EU Acquis legislation in the area of foodstuffs is implemented in the legislation of Latvia, including "horizontal" directives related to requirements of foodstuff control and hygiene. Such requirements are elaborated in the Law "On Supervision of Food Circulation". It is foreseen that all of "horizontal" directives in the area of foodstuff will be implemented in the year 2000. The further attention will be focused on implementation of "vertical" Directives for certain product groups (mineralwater, fruit juices and similar products, honey, sugars, cocoa and chocolate products etc.), whereas the introduction of them is foreseen by the end of 2002. There is established necessary administrative infrastructure - Latvian Food Centre under supervision of the Ministry of Welfare, State Sanitary Inspection and State Veterinary Inspection. Latvian Food Centre is responsible for development and supervision of legislation. State Sanitary Inspection and State Veterinary Inspection are involved in market surveillance. Chemicals The Law "On Chemical Substances and Chemical Products" was passed on 1 April 1998 and entered into force 1 January 1999. This Law complies with the requirements of European Community Directives related to chemical substances and chemical products. The Law provides such Regulations of the Cabinet of Ministers based on particular requirements of European Community Directives: on classification, packaging and labelling of chemical substances and chemical products (requirements of Directives 67/548/EEC and 88/379/EEC, and amendments to those Directives), on safety data sheets (requirements of Directive 88/379/EEC Article 10, Directives 91/155/EEC and 93/112/EC), on restrictions on the marketing and use of certain dangerous chemical substances and chemical products (requirements of Directive 76/769/EEC and amendments to this Directive), on lists of existing (?Einecs?, according to requirements of Council Decision 85/71/EEC) and notified (?Elincs?, according to requirements of Directive 79/831/EEC) chemical substances, on order of notification of new chemical substances, including risk assessment for new chemical substances (according to requirements Directives 67/548/EEC and 93/67/EEC).
The following Regulations of the Cabinet of Ministers have been adopted: 1) Regulations of the Cabinet of Ministers Nr. 418 of 28 October 1998 "On Procedure for Compilation of and Supplying with Safety Data Sheets", which is into force since 1 January 1999. These Regulations have been elaborated according to Council Directive 91/155/EEC of 5 March 1991, amended with Directive 93/112/EC, which notifies detailed arrangements for systems of specific information relating to dangerous preparations in order to implement requirements of Directive 88/379/EEC Article 10. 2) Regulations of CM Nr.228 of 29 June 1999 "On Procedure of Classification, Packaging and Labelling of Chemical Substances and Chemical Products". The Regulations are worked out in compliance with Council Directives 67/548/EEC and 88/379/EEC and amendments to them enforced by the year 1999. The requirements of Directive 1999/45/EC are not incorporated thereof. The Draft Regulations "On Restrictions on Sale and Use of Dangerous Chemical Substances and Chemical Products" is submitted on consideration to the Committee of the CM and should be reviewed by 10.01.2000. The Draft Regulations are based on Council Directive 76/769/EEC and amendments to it. During the year 2001 it is foreseen to adopt other regulations that complete legislation harmonisation with EU requirements within Acquis. By establishing competent body and the register of chemical substances and chemical products it is foreseen to implement relating requirements by 1 July 2002. The responsible institution in this area is Latvian Environmental Data Centre. Pharmaceuticals The main requirements of EU Directives 65/65/EEC; 75/319/EEC; 89/105/EEC; 92/27/EEC; 92/26/EEC; 91/356/EEC; 92/25/EEC; 92/28/EEC in the area of pharmaceuticals are introduced to the Latvian legislation by Law "On Pharmaceuticals". At present there are enforced following Regulations: "On Registration of Medical Products", "On Classification of Medical Products for Human Use", "On Procedure of Specifying the classification of Medical Products", On Labelling of Medical Products for Human Use", "On Reimbursement of Medicinal Products for Ambulatory Care", "On the Advertising of Medical Products for Human Use". The process of approximation of directives is carried out according to schedule set up by the National Integration Program into European Union. There is foreseen implementation of such requirements: related to medical products derived from human blood human plasma (89/381/EEC), radiopharmaceuticals (89/343/EEC), vaccines, toxins, serums and allergenic products (89/342/EEC), homeopathic medicines (92/73/EEC), clinical research, improvement of advertising surveillance (92/28/EEC), as well as completion of legislation in the areas of manufacturing of medical products (91/356/EEC; 75/319/EEC) and registration (65/65/EEC; 75/319/EEC); market surveillance of medical products (pharmocomitoly matters) (75/319/EEC), colouring matters which may be added to medical products (78/25/EEC), and analytical, pharmatoxicology and clinical protocols and standards in respect of testing and assessment of medical products (75/318/EEEC),
also taking into account amendments thereof. It is foreseen that requirements of Acquis will be implemented by year 2002. The structural reorganisation in the area of pharmaceuticals has been completed and there are no problems of administrative means. In general in the sector of pharmaceuticals and for administration of medical products market the all-necessary institutions are established and operating in Latvia âÀ“ State Pharmaceutical Inspection and State Agency of Medicines. The State Medicines Price Agency is responsible for gradual implementation reimbursement procedure for consuming medical products. Medicines for veterinary use The Law "On Pharmaceuticals" and the Law "On Veterinary Medicine" define the procedure for registration, manufacturing and marketing of medicines for veterinary use. According to the Ordinance of the Ministry of Agriculture of 25 January 1998 "On the Procedure of Assessment and Registration of Veterinary Drugs and Veterinary Pharmaceutical Products" the State Veterinary Service carries out the registration of veterinary medical products. The Ordinance is elaborated in compliance with requirements of EU Directives 81/851/EEC and 65/65/EEC. Expert, who according to "State Veterinary Service's Veterinary Pharmacological Division Statute" is notified by Veterinary Pharmacological Division, carries out assessment of applied documentation of veterinary drugs. The Statute complies with requirements of EU Directive 81/852/EEC. According to requirements of EU Directives 81/851/EEC and 91/412/EEC and the principles of Good Manufacturing Practice there are elaborated drafts regulations of the CM in the area of manufacturing of veterinary medicines that is foreseen to accept in 2000: 1) Since 10 January 1997 the rates of medicines residues in foodstuffs of animal origin are defined by the Order of State Veterinary Service "On Restrictions of Medical Drug Application to Animals and Limits of Drug Residues in Foodstuffs", which implemented the requirements of Council Regulation Nr.2377/90 and amendments thereof. The Order has been revised into the draft regulations of the Cabinet of Ministers "On Mandatory Requirements for Harmless of Drugs for Animal Consumption and Rates of Medical Residues in foodstuffs of Animal Origin". 2) The Draft regulations specifying prohibited medical substances according to requirements of EU Regulations and Directives (1445/95, 1798/95, 1311/96, 2701/94, 17/97, 270/97, 156/98, 1570/98), as well as medical products which are limited in use for farm animals (96/22/EC). Cosmetics, glass, textiles, footwear and wood EU requirements included into Directives 73/44/EEC and 96/73/EC concerning quantitative analysis of textile fibre mixtures, Directive 96/74/EC, amending Directive 97/37/EC, concerning textile names and Directive 94/11/EC concerning labelling of footwear are implemented Latvian legislation. There are elaborated Draft Regulations of the Cabinet of Ministers on cosmetics, glass and woods. In the area of cosmetics the Regulations of the Cabinet of Ministers Nr.218 are into force since 1 September 1998 (accepted 9 July 1998). Responsible authority âÀ“ the Ministry of Welfare. In the area of glass âÀ“ the Draft regulation is submitted to the Cabinet of Ministers and came into force since 7 February 2000. The administrative institution in the areas of cosmetics, glass, and textile âÀ“ Consumer Rights Protections Centre, in the area of wood âÀ“ State Forest Department. New Approach Metrology âÀ“ there are adopted the mandatory directives in the area of legal metrology by enforcing the Law "On Uniformity of Measurements" and supporting Regulations of the Cabinet of Ministers thereof. The infrastructure in the area of legal metrology is also established (by means of Latvian National Metrology Centre, calibration and verification laboratories). However it is essential to upgrade and expand technical equipment and national measurement standards basis in compliance with requirements of European Union legislation. The Regulations of the Cabinet of Ministers on pre-packaged goods will be elaborated by February 2001. The responsible authority is the Ministry of Economy. Machinery âÀ“ the draft regulations "On Safety of Machinery" that regulates this area has been elaborated and accepted by the Cabinet of Ministers 12 July 1999 and at present they are under consideration in Cabinet of Ministers. The regulations entered into force 1 July 2000. Personal protective equipment âÀ“ the EU legislation of this area is fully implemented. Requirements are elaborated in the Regulations of the Cabinet of Ministers "Regulations on Personal Protective Equipment", accepted 12 December 1998 and enforced 1 December 1999. Lifts âÀ“ the draft regulations "On Lifts" are submitted to the Cabinet of Ministers. The regulations entered into force 1 July 2000. Electrical equipment âÀ“ EU legislation in this area is fully implemented (electromagnetic compatibility and electro safety). The requirements are elaborated in the Regulations of the Cabinet of Ministers "On the Electrical Safety of Equipment" and "On the electromagnetic compatibility of apparatus" accepted in April and May of 1998 and entered into force 1 July 1999. Electrical equipment in explosive atmospheres âÀ“the draft regulations "Equipment and protective systems intended for use in potentially explosive atmospheres" are submitted to the Cabinet of Ministers 22 July 1999. It is foreseen that the regulations will entry into force by 1 July 2003. Toys âÀ“ the draft regulations are under consideration in the Cabinet of Ministers. Recreational crafts âÀ“ the legislation is under development and will be adopted by year 2000. Responsible authority is the Ministry of Transport Maritime Department. Aerosol dispensers- the legislation in this area will be implemented by year 2000; it is foreseen that the regulations would entry into force in 2002. Gas appliances âÀ“ EU legislation in this area is adopted in full. Requirements are implemented in the Regulations of the Cabinet of Ministers Nr.202 " Regulation on household appliances burning gaseous fuels", which were accepted 1 June 1999 and are not in force yet. Pressure vessels âÀ“ Ministry of Welfare has elaborated draft regulations "On Pressure equipment and their accessories", which currently is under consideration in the Cabinet of Ministers. It is foreseen that the regulations will entry into force by 1 January 2001. Simple pressure vessels - EU legislation in this area is adopted in full. Requirements relating to simple pressure vessels are implemented in the Regulations of CM Nr.92 "On Simple Pressure Vessels", which were accepted 9 March 1999 and came into force 1 January 2000. Medical devices âÀ“ the Order Nr.359 of Ministry of Welfare of 5 November 1997 "Registration Rules of Medical devices and goods" (amended by the Order Nr.26 of the Ministry of Welfare of 30 January 1998) has been worked out according to Article 8 point 4 of the Law on Medical Treatment. The Order applies to all suppliers of medical devices and goods in Latvia apart from holding and business form. The Order incorporates the requirements of EU directives 93/42/EEC (on medical devices), 90/385/EEC (on approximation of legislation relating to active implantable medical devices) and 84/539/EEC (on approximation of legislation relating to electro-medical equipment used in human or veterinary medicine) and does not contradict with requirements of Directive 98/79/EEC. Construction products âÀ“ EU Directive 89/106/EEC on approximation of legislation relating to construction products currently is under implementation process in Latvia. Implementation is carried out in the framework of general legislation in the area of conformity assessment, which is regulated by the Law "On Conformity Assessment" and following regulations of the Cabinet of Ministers: 1. Regulations Nr.463 of 24 December 1996 "On authorisation of testing and calibration laboratories, certification and inspection bodies in the mandatory area"; 2. Regulations Nr.464 of 24 December 1996 "On procedure of recognition in Republic of Latvia of conformity assurances and approvals issued abroad in mandatory area"; 3. Regulations Nr.465 of 24 December 1996 "Arrangements for accreditation of testing and calibration laboratories, certification bodies and inspection bodies". Conformity assessment in this sector is regulated by Building Law Article 25, which defines obligatory conformity assessment for construction products included in mandatory area. The following legal acts of the Cabinet of Ministers define procedure on conformity assessment of construction products: Regulations Nr.295 of 05.08.97 "Procedure of conformity attestation of building materials and construction products in mandatory area" Regulations Nr.133 from 14.03.98 "Amendments to the Regulations of the Cabinet of Ministers Nr.295 of 05.08.97 "Procedure of conformity attestation of building materials and construction products in mandatory area"" (list of products of mandatory area); Decree of the Cabinet of Ministers Nr.313 of 17.06.98 "On authorization of institutions for conformity assessment of building materials and construction products in mandatory area".
Currently the work is focused on two sectors: standardisation technical committees (TCK), particularly TC for Building Materials provides adoption of CEN harmonised standards and development of Latvian national standards (LVS) for construction products where are not developed CEN standards yet; in order to specify conformity assessment procedure for building materials in mandatory area due to their type, purpose for use, risk degree and importance for national economy, there are under preparation amendments to the Regulations Nr.295 of 5 August 1997. The amendments will implement EU Commission decisions relating to enforcement of EU Directive on construction products Article 20 (there is proposed technical assistance of PHARE programme).
It is foreseen that the draft legal act on Commission decisions relating to implementation of Article 20 of European Directive on construction products will be prepared by the end of 1999 and approved by the Cabinet of Ministers in year 2000. Draft Regulations of the CM, which would implement Commission Decisions from 1998 and 1999, will be elaborated in 2001 and enforced by year 2002. The Ministry of Environmental protection and regional development is responsible for implementation of European Directive on construction products. According to the point 14 of Regulations Nr.295 of the CM Ministry of Environmental protection and regional development elaborates and submits to the Cabinet of Ministers proposals on construction products in mandatory area and their safety requirements. In accordance with the point 12 of these regulations Ministry of Environmental protection and regional development submits to the CM proposals on authorisation of institutions for conformity assessment of building products in mandatory area. According to Decree Nr.313 there are two certification bodies and 14 testing laboratories are authorized to carry out conformity assessment in mandatory area. The State Construction Inspectorate (particularly Assessment Board for Construction Products) carries out inspection. Latvian manufacturers of construction and building products and professional association participate in implementation of conformity assessment system in this area. Latvian Association for Building Products Manufacturers has taken part in development of legislation in this area since 1996. Currently manufacturers and professional associations participate in Standardisation TC. Implementation infrastructure: Market surveillance: CRPC âÀ“ for consumer products, State Labour Inspection âÀ“ for industrial products, State Metrology Inspection âÀ“ for measure instruments.
Conformity assessment bodies âÀ“ competent and authorised by the CM bodies, testing and calibration laboratories, certification bodies and inspection bodies. Adoption of European standards âÀ“ State non-profit limited liability company "Latvijas Standarts". Horizontal and procedural activities At present time the legislation is almost harmonised with acquis. General legislation in the areas of standardisation and conformity assessment is in place in Latvia. The new draft laws on liability of producer and safety of products are elaborated in compliance with acquis. The draft laws build the framework for implementation of EU directives in particular branches. The Standardisation development program is developed and approved by the CM, the realisation of which will provide adoption of necessary EU standards. Directive 98/48/EC Realisation of requirements of Directive are provided by the Ordinance of the Cabinet of Ministers Nr.12 of 28 October 1997 "On order, how the Ministry of Economy coordinates exchange of information in the area of technical barriers to trade and sanitary and phytosanitary measures". State non-profit limited liability company "Latvijas Standarts" carries out compiling and disseminate information received from WTO Secretariat and provides WTO Secretariat with relative information about Latvia. Whereas Latvia is not EU Member State, Latvia is not obliged to provide Commission with corresponding information. So far information exchange with EU has been performed with assistance of WTO Secretariat. Latvia is ready to perform realisation of requirements of this directive upon accession to the EU. Public procurement Public procurement system is operating in Latvia since 1 January 1997. The principles of public procurement system are compatible with EU Directives 92/50/EEC; 93/36/EEC; 93/37/EEC; 89/665/EEC and 97/52/EC. The Law "On Works, Supplies, Lease and Services Procured by Entities Operating in the Public Utilities Sector", which is developed according to EU Directives 93/38/EEC; 92/13/EEC and 98/4/EC, was accepted 4 November 1999 and entered into force 1 July 2000. The opening of the Purchase (Supplies) Surveillance Office is delayed. The Office duties are to perform preventive actions including cease of public procurement process in order to complete performance of public procurement process in time. Therefore in the second part of year 2000 there will be completed the framework (by means of legislation and institutions) to ensure conformity of Latvian public procurement system with EU one. Articles 28-30 (ex Articles 30-36) Latvian legislation approximation with acquis and adoption of it will be enforced upon the accession of Latvia into EU. The relative institutions for realisation of relative legislation are in place. Latvia accepts in full objectives, which are included in Articles 28-30 (ex Articles 30-36) and forming part of acquis in the area of Free movement of goods. Since 1 January 1995 there are not into force any quantitative limits on import and export of products of Latvian and European Union origin. Since 1 January 1995 there are no introduced either new quantitative limits on import or export of goods or activities with equivalent meaning, and existing restrictions or equivalent activities are not strengthened. European Agreement can not preclude such limits or prohibitions on import, export or transit of goods, which are considered relating to public moral, politics or safety, protection of human or animal health and life, protection of national resources or art, historical or archaeological values, protection of intellectual, industrial or commercial property; or regulations relating to gold or silver. Latvia accepts requirements related to quantitative limits defined by acquis and European Agreement. In order to accept requirements of acquis and European Agreement relating to activities with equivalent meaning, Latvia has done all necessary preparations. The numbers of entrepreneur activities, which require licence, has been gradually reduced. At present this number is reduced from 118 to 67. According to the Regulations of the Cabinet of Ministers Nr.348 of 7 October 1997 "On Licensing of Certain Entrepreneur Activities" licences are required for banking, insurance, trade of excise goods (such as petrol, tobacco, sugar, spirits etc.), as well for weaponry, explosives, radioactive materials. Council Regulation 2679/98 Latvia accepts in full and is ready to enforce Council Regulation 2679/98 upon the accession to EU. Council Regulation 339/93 Latvia accepts in full and is ready to enforce Council Regulation 339/93 upon the accession to EU. Requirements of the regulation are incorporated in following legal acts: 1. Law "On Pharmaceutics", in force since 08.05.1997;
2. Law "On Border", in force since 01.07.1997;
3. Law "On Veterinary Medicine", in force since 30.06.1992;
4. Law "On Supervision of Food Circulation", in force since 06.03.1998;
5. Law "On Protection of Consumer Rights", in force since 01.04.1999;
6. Draft Law "On Safety of Goods and Services" Control and surveillance is carried out by following institutions: 1. Sanitary Border Inspection
2. Consumer Rights Protection Centre
3. State Pharmacy Inspection
4. State Veterinary Inspection
5. Customs Council Regulation 3052/98 Latvia accepts in full and is ready to enforce Council Regulation 3052/98 upon the accession to EU. In order to ensure the enforcement of the Regulation Latvia will elaborate necessary amendments in the legislation by the year 2002. The Ministry of Economy is responsible for this sector. Taking into account into all mentioned above the Republic of Latvia does not raise any requirements and would propose the negotiations in the area of Free movement of goods to regard as closed.
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