Dear readers, We decided to publish all negotiating positions of the Republic of Slovenia for accession to the European Union at a time when the accession process, and especially the negotiations, are coming to a crucial point. In choosing this time, we bore in mind that almost all negotiating chapters have been opened, and that the rest of them are to be opened in the first half of 2000 under the Portuguese Presidency. We have also taken into consideration the fact that the Helsinki European Council, by taking decisions relating to the Intergovernmental Conference on institutional matters and the commaitment that all EU Member States are to be prepared for the accession of new Member States by 2002, set the broad timetable forthe next enlargement. The negotiating positions presented in this publication are the result of 18 months of serious and strenuous work ofall persons engaged in Slovenia's preparations for accession to the EU. By entering the EU, Slovenia has to adopt and implement the acquis which requires the alignment of national legislation, restructuring off ‘public administration, changes in some areas - agriculture, the environment, transport, trade, the economy, international relations as well as in Slovenian citizens' attitudes towards the changing Europe. The negotiating positions are divided into 29 chapters; some of them are very comprehensive and great effort will be required for their proper implementation, They present the regulation of individual sectors in Slovenia, problems anticipated in implementing the acquis and the ways of eliminating inconsistencies - ether through the transitional periods or derogations which Slovenia may request in the negotiations. Our negotiating positions will serve as the grounds for the considered selection of priorities and weighing up of interests which Slovenia seeks to protect as a full EU member. Adhering fo the principle that “nothing is agreed until everything is agreed”, their diplomatic skills in addition to their expert knowledge. the negotiators encounter situations which require the demonstration ofall‘One must also bear in mind that the story of Slovenian legislative alignment and fulfilling the conditions for EW accession is above all an internal story about reforms that will contribute fo Slovenia's membership in the club of modern European states. During the preparatory phase of EU accession, Slovenia thus needs to carry out a host of internal reforms to enable it to align its legislation with the common EU rules. Of all ofthe top six candidate countries for the next EU enlargement, only Slovenia decided to make its ‘negotiating positions public, That decision proved right from the very beginning: non-governmental ‘organisations and social partners have participated in the process of preparing the negotiating positions which has sometimes provided a better and more realistic insight into the current situation. Slovenia is also the only candidate-country whose negotiating positions are discussed and formally approved by the Parliament. The decision to publish al the negotiating positions also involves the commitment that the principle of full transparency of integration will continue to be applied. In my opinion, itis only in this way that we can count ‘on the broader support ofthe public as well as the citizens of the Republic of Slovenia, whose final “YES” vote in the referendum which is to take place before ratification of the Accession Treaty, will eventually round off another success story in Slovenian history. Igor Bavéar Minister of European AffairsPreface experienced a lot of hesitation before I decided to accept the position of the head of the negotiating team for the Republic of Slovenia's accession to the European Union, There were many reasons why I eventually decided to take it up, clearly the most influential of them being the uniqueness of the opportunity and the challenge of testing one’s limits. unknown, Iwas well aware then how demanding this task would be, organisationally challenging, his suspense which so offen makes us go on, in the search for the hitherto professionally rewarding and politically sensitive. And, indeed, it turned out Iwas right. ‘And so, there I was, heading the negotiations for the Republic of Slovenia's accession to the European Union. Negotiations - at frst glance definitely a very promising notion. But not in reality. It is Slovenia which decided to join the European Union and not vice versa, Hence, itis better described as the harmonisation or synchronisation of our system with the system of the European Union, The acquis communautaire - the result 0f°50 years of agreements and compromises made by the leading European countries concerning economic and political power. Can we expect that these achievements will be changed? I don't think so. The most a candidate country can get in negotiations is perhaps a few additions to the acquis or delays in its implementation, And.yet, what is required of a candidate country is a full-scale and efficient adaptation to these previously agreed solutions. The key part of negotiations therefore takes place at home, although this is ‘rue not only for Slovenia but also for the European Union itself. In the Union, this calls for answers as to how to function within a new, enlarged community of nations. And in Slovenia, we should in the first place expand our knowledge about the European Union and accept the way it functions, including all the changes which, once members, become unavoidable. We shouldn't forget that membership of the European Union in fact corresponds with our own aspirations for development into a democratic, safe and economically successful country. A large majority of the present tasks coincide with our goals. You always have to travel before you arrive. Reforms, restructuring, and other changes are never an easy thing to do, In no country. And each country, when ina transition to a developed‘market economy, is faced with resistance resulting from the existing situation, rights, positions. These fears are quite often justified and, what's more, very human. Who is not afraid of change and the unknown? The resistance is, however, overcome by the necessity for change and our fears are being driven away by the good experiences of the current 15 Member States, industrious, entrepreneurial and efficient people decide in favour of membership of the European Union, then this is more a promising opportunity than a new problem, The acquis communautaire, encompassing the whole body of legislation, principles, political orientations and obligations of the Member States, is divided info 31 chapters, and negotiations for membership follow this division, Negotiations in the last two chapters have not yet begun. In view of the anticipated enlargement of the Union, the acquis concerning institutions, the subject of chapter 30, is likely to be further amended and supplemented, whereas the substance of chapter 31 - “other” is not yet known, neither to our friends on the European side nor to us. So, this publication presents to you the Republic of Slovenia's negotiating positions on twenty-nine chapters. Twenty-nine big stories and several more smaller ones. A result of many sleepless nights, numerous days of fruitful work, co-ordination and debate, with the occasional clash of opinion every now and then. Loads of good humour ofallawho fook part in their preparation, a lot of new knowledge and ‘many new friendships. A hallmark of our common journey. Dr. Janez Potoénik Head of the Negotiating TeamTHE NEGOTIATING PROCESS AND PREPARATION OF NEGOTIATING POSITIONS NEGOTIATING POSITIONS [Negotiating positions are documents setting out the position of Slovenia concerning the adoption of the acquis conmunauiaire. They lay down the manner in which Slovenia ‘ill harmonise its legislation with the acquis, Le. how it intends to adopt and implement the legislation that wil bein line wit the acquis an setup al the institutions necessary forts implementation. Slovenia might assess that in some areas it ‘will notbe able to implement the acquis by the anticipated date ofits accession to the European Union, in wiih case it can request transitional period. Ful implementation ofthe coquis in this area can thas be postponed fora certain period oftime. Ifa candidate-country wishes too ‘exemption from implementation ofthe acquis derogation, Requests for transitional periods and derogations have to be propery justified. ‘The structure of each negotiating position depends on the substanceand scope ofthe acquis in each negotiating chapter. Hovrever, ach negotiating postion comprises an introductory part anda justification, The introductory part summarises the situation in a particular chapter atthe time of preparing the sition, the degree of harmonisation of Slovenian legislation ‘with the acquis, the process of harmonisation of legislation and the institutions for implementation ofthe acquis, as well as any requests for transitional periods or derogations. All ‘these are further elaborated inthe justification part ofthe position paper. Special attention is given to the proper substantiation of requests for a transitional period or ‘derogation Sometimes the substance ofa negotiating position has tobe further clarified with the use of annexes (timetables, analyst, additional information}. ‘The negotiating postion will form the bass of drafting the Accession Treaty which will incorporate all the results of negotiations: harmonisation of Slovenian legisation withthe Agreements of the European Union with third counties, harmonisation of Slovenian legislation with the acquis, transitional periods, derogation, technical adaptations and other measures. PREPARATION OF NEGOTIATING POSITIONS A draftnegotiatng postion i prepared by the working group responsible for each individual chapter (1-31) based on the results of multilateral and bilateral sereenings and te existing situation in that chapter. The working group comprises representatives of various relevant ministries and ofthe Social ‘and Economic Council. Itis headed by a high-ranking official ofa ministry ora government office which covers the basic substance of the negotiating chapter. in addition, external expertsand institutions are invited to take partin preparation of the draft negotiating position, by providing their expert opinion and positions concerning a particular substantive area, When the minister responsible for an individual area confirms the draft negotiating position, pressure groups also become involved in preparation ofthe negotiating postion by submitting thelr opinions and proposals. On the proposal ofthe relevant minister, the draft megotiating position is submitted to the negotiating team. The representatives of the working group and negotiating team then prepare, on the basis of several working meetings and other forms of co-operation (usually around 5 meetings and several discussions, depending onthe complexity ofthe chapter, ‘the proposed negotiating position The negotiating team isin charge ofthe legal and technical eiting ofthe proposed text, it guarantees the consistency of the proposed negotiating positions of all chapters and points out any potential substantive weaknesses, The negotiating positions are prepared ‘with great caution and accuracy since they also serve as aSL delegation, EC delegation, NT working group, (NT) working group fine minis working group lie ministry [Proposed reetatng ton ministers, (OPS) European meeting of government Government RS line ministes, (WT) Mi translation line ministies, (7) National Assembly ree working group, (NT) working group line ministry aaionr clstotong working group, (nt) <—_> working group, (nn) A ision RS to EU Ne H esestng head of working ‘group bs consultation Ds consultation 6D Enlargement, ¥ GDs expert assessment of Negotiating Position oar ‘oman Postion £U Enlargement Working Group preaparation of Common Position) EU [conn Proton COREPER Hoad of NT Accession Conference at Deputies Level y conePER, Accession Conference at Ministerial Level GD Enlargement, GD Enlargement, Foreign Ministries ission ¢a=z= Council EU |¢zmma European Commproposal forthe conclusion ofan international treaty which ‘will be the highest commitment of Slovenia on accession to the European Union, Within the negotiating team, the head of the negotiating team, a member responsible forthe chapterin question, and the editing group of the Department for [Negotiations within the Government Office for European Affairs partcipatein editing the negotiating positon. External experts {in individual chapters are also invited to co-operate in this phase of preparation. Ifthe drafting ofa proposed negotiating position requires inter-ministerial coordination, the so-called “European meeting” of the Governmentis convened for all, the ministers in question, Another important contribution to ‘the negotiating postion is made by the Mision ofthe Republic of Slovenia to the European Union, which provides substantive as well as editorial comments on the negotiating position. ‘The proposed negotiating position is discussed in two government committees (the Committe for Economic Afais ‘andthe Committee fo State Administration and Public Aa) After being adopted by the Government, the negotiating positions are presented to non-governmental organisations ‘and representatives of trade unions. Since the proposed negotiating positions are a basi forthe formation of the ‘Accession Treaty of Slovenia, they are adopted asa proposal for the conclusion of an international treaty. Hence, in accordatice with the Foreign Affairs Act, the Government has to submit them for discussion and approval othe National Assembly. They are discussed by the relevant bodies ofthe National Assembly and eventually approved by the Commitee {orintemational Relations. ‘The negotiating positions are translated into English atthe Department for Negotiations or by the Translation Unit ofthe Government Office for European Affairs. The Negotiating Tearn andthe Government Office for European Ars submit through the Mission in Brussels the English version of the negotiating position to the Council NEGOTIATIONS WITH THE EUROPEAN UNION Based on Slovenia's negotiating position, the European ‘Commission prepares a Draft Common Position and submits itto the Council. After discussing itwith the Member States, the Enlargement Working Group within the Council prepares ‘the Common Position ofthe EU and submits it to Slovenia as ‘basis for discussion at the intergoveramental conference on accession, IPso invited in the Common Position, Slovenia prepares additonal arificationsconceming individual problems ‘exposed in the common position, and submits them to the relevant BU bodies, Negotiating chapters are discussed at the :meetings f intergovernmental conferences on accession at the deputies level (heads of negotiating teams) and at the ‘ministerial level (foreign ministers) At these meetings, which are held separately with each candidate country, the Commitee of Permanent Representatives (COREPER) ofthe Council and ‘candidate county discuss the negotiating positionson both sides, bring their postions on the substance of individual negotiating chapters into line and - provided there are no ‘outstanding issues with regard toa given chapter establish ‘that negotiations on that chapter may be temporarily closed. Due to amendments to and novelties in the acquis after the screening or difficulties with its implementation, these ‘temporarily close chapters may be re-opened. This also reflects the principle applying to the negotiations, which is that “nothing is agreed until everythings agreed’. "REPUBLIC OF SLOVENIA INTERGOVERNMENTAL CONFERENCE ON THE ACCESSION OF THE REPUBLIC OF SLOVENIA TO THE EUROPEAN UNION Negotiating Position of the Republic of Slovenia on Chapter 1 FREE MOVEMENT OF GOODS Ll ‘The Republic of Slovenia accepts the acquis with respect to Chapter 1 - Free Movement of Goods However, the Republic ‘of Slovenia requests @ transitional period and a derogation ‘The Republic of Slovenia does not request a transitional period in the chapter on free movement of goods, except for ‘thefield of pharmaceuticals forhumamn use covered by Directives, ‘65/65/EEC, 75/319/EEC and Regulation 2309/93 and the relating provisions, where the Republic of Slovenia requests & transitional period of five years from the estimated date of accession to the European Union (until 31 December 2007). ‘The Republic of Slovenia doesnot request a derogation fram the aequisin the chapter on free movement of goods, except for the field of dangerous substances (Directives 76/769/EEC and 791117/EEC), where the Republic of Slovenia requests that the existing stricter requirements be retained concerning the limitation ofthe use and trade ofthe following chemicals. orpesticides: atrazine, chlorpirin, methyibromide, paraquat, 2,4,5-Tand carbon tetrachloride a ‘The egilaton ofthe Republic of Slovenia onthe fee movement ‘of goodsis partly in conformity with the aos The Republicof ‘Slovenia will gradually align itslegistation on the freemavement ‘of goods with the acquis, except for the above-mentioned transitional period and derogation, and implement it by 31 December 2002 atthe latest (see Arex). The Republic of Slovenia does not expectancies n the complete adoption ofthe aoquison the free movement of goods. ‘The Republicof Slovenia is preparing the so-called “horizontal legislation” to adequately regulate the elements relevant to ensuring the free movement of goods. The Directive on the general safety of products (92/58/EEC) wilbe transposed into the legislation of the Republic of Slovenia by the Law on the General Safety ofProduets tobe adopted and implemented by 31 December 1999 at the latest. By the adoption of the new ‘Law on Technical Requirements for Products and Conformity Assessment (draft tle) and the new Law on Standardisation, the current Law on Standardisation (Official Gazette ofthe RS, [No 1/95), which serves asa bass for isuing some of technical regulations, will cease to apply. The Law on Technical Requirements and Conformity Assessment (draft tit}, to be adopted by 30 Jume 2000 and fully implemented by 30 June 2002, willay down the necessary general principles in forcein ‘the EU Members States to permit the free movement of goods. This law willao serve asa legal basis forssuing regulations on technical requirements for selected products inthe feds for ‘Which special law does not (or willnot) exist. With the entering {nto force ofthe law the ministries willhave a legal basis for preparing technical regulations to permit transposition ofthe Community directive ether from the so-called old approach or ‘new approach directives) The new Law on Standardisation wil regulate the field of standardisation Iwill be adopted by 30, June 2000 and fully implemented by 30 Jume 2002 at the latest. The detaited sequencing of the adoption and implementation ofthe necessary legisationis given in AnmexI. Inthe Republic of Slovenia, most ofthe institutions necessary for the efficent implementation ofthe acquisin the chapter on the fire movement of goods are in place. However, forte eficint ‘implementation ofthe acquis the Republic of Slovenia wil setup some ne institutions: (type approval boy testing laboratories and organisations fr assessing compliance with regulationsin the eld of agricultural and forestry tractors; Ofie for Chemicals, inthe field of chemicals i a national organisation in the field of explosive substances for civil use i) a national organisation for technical approval and notified conformity assessment bois inthe field of constuction product, andy) Publi Procurement Office. In addition, the existing institutions willbe reinforced 13Chapter FREE MOVEMENT OF GOODS (new reruitments, personnel training) to ensure a moreeffcent operation of the existing institutions and performing of functions within the public administration (ministries, inspection services, offices, etc) ‘Special attention willbe pa to ensure the independence and ceceney of selected activites cnet an inet afeting the implementation of technical regulations, induding market survellance To this end the Standardsand Metrology Institute ‘of Slovenia (SMS) willbe institutionally reorganised, im terms oF ‘organisational changes of activites curently unk the competence ofthe SiS, such as standardisation, accreditation, metrology, conformity assessment (system approach), type approval of chides Thenew organist wllensureindepndencin desir making in performance of these activities. ‘The changes will be undertaken in two phases. n the ist phase, selected activities within the SMIS will be given, independence a regards decision-making. This wil be settled ‘by 30 June 1999, In the second phase, the organisational separation of selected activites wil take place as fllows: 1. thefied of metrology and preciousmetals wil be organised ‘within the pubic administration; 2. thefield of acretation willbe organised in an independent institution; '3._ the field of standardisation and an information centre wll bbe organised in an independent institution; 4, thefield of ype approval of vehicles willbe organise n the ffamenorkof the publicadminisratio in thereevant ministry. ‘Amore detailed status and organisational scheme ofthe above ‘mentioned institutions and activities wll be defined by 30, June 1999 at the latest. Reorganisation will be phased out by 30 June 2002 at the latest, with different sequencing for selected fies. ‘The conformity assessment activities relating to system regulation ofthis field and curently carried out hy the SMIS will ~inthe framework ofthe public administration ~ fell under the competence of the ministry responsible forthe intemal market and the free movement of goods (nist of EeonomicRetatons and Development - MERD). The MERD willbe responsible for defining and monitoring ofthe policy implementation in the field of the free movement of goods, which includes: = ensuring compliance of technical legal acts (awsand other regulations) rating to products subject tothe requirements of safe operation and use, and ~ ensuring the market surveiance as regards compliance ‘with technical legal ats relating to products. ‘The transfer ofthese activities from the SMIS to the Ministry ‘of Economic Relations and Development will take place by 31 ‘March 1999, Tithe process of harmonisation and implementation of legistation, induding the establishment and reinforcement of institutions, the Republic of Slovenia expects technical and financial assistance from the EU (See Annex 1. 1, MOTOR VEHICLES Existing legislation inthe Republic of Slovenia ‘The legislation of the Republi of Slovenia on motor vehicles isparty in conformity with the acquis: ~ inthe field of road vehicles, the Republic of Slovenia has ‘an established type approval system thats comparable to ‘that applicable in the EU buts based on specific technical regulations of UN/ECE which are mainly considered ‘equivalent to individual BEC directives. As regards technical compatbily, almost harmonisation hasbeen achieved ‘Mos of the institutions required for efficient functioning of the system are in place ~ inthe eld ofagicultural and foresty tracts, the Republic of Slovenia does not have national technical legislati and the whole system fas yt to be established. Harmonisation of legislation with the acquis ‘The Republic o Slovenia wil fully adopt te acquis eating to rotor vehiclesas follows: = inthe field of road vehicles, new Regulations on Motor ‘Vehicles wil be prepared which willfully transpose the system applicable in the EU. The necessary regulations be adopted by 30 June 2001, The new system will be fully implemented by 31 December 2001 or by the date of ‘Slovenia's accession tothe EU due tothe fact that some of the activities can only be applied to Member States. = inthe fed of agricultural and forestry tractors, Regulations on agricultural and forestry tractors willbe adopted. The necessary regulations will be adopted by 30 June 2001. ‘The acquis in this field willbe fully implemented by 31 December 2002 orby the date of Slovenia's accession to the EU due to the fact that some ofthe activities can only bbe applied to Member States. Institutional framework forte implementation of harmonised legislation Inthe Republic of Slovenia, al theelevantinsttutions regarding road vehicles arein place. With egand to agpicultural and forestry tractors thenetwork of relevant institutions will be established as fllows:a type approval body by 30 September 2000, testing laboratory by 30 Jume 2002 and organisations in charge of| ‘monitoring conformity with regulations by 30 June 2002, All tesebodies wll become filly operational by 31 Decenber2002 2, FOODSTUFFS Existing legislation inthe Republic of Slovenia The legislation of the Republic of Slovenia on foodstuffs comprises the Law on the Wholesomeness of Foodstuffs and Items of General Use (Official Gazette ofthe SFRY, No 55) 87 anc 59/85) and the Law on the Health Control of Foodstus(Oficial Gazette ofthe SRS, 17175 and 42/86), which serve as legal basis for technical regulations on foodstuffs issued by the Ministry of Health and ensure the health control of foostull;ithe Law on Standardisation (Offical Gazette of ‘theRS, 1/95) and the Law on the Quality Control of Agro and ood Products in Foreign Trade (Official Gazette ofthe SFRY, ‘No 26/75, 70/78, 54/86 and 30/91), which serve as a legal basis for technical regulations on foodstufs issued by the ‘Ministry of Agriculture, Forestry and Food and ensure quality control of foodstuf i the Veterinary Law (Official Gazette of the RS, No 82/94, 21/95, 16/96) which serves as a legal basis for issuing technical regulations in the field of special requirements for foodstuffs of animal origin and ensures, contzol over foodstuffs of animal origin, ‘The legislation of the Republic of Slovenia on foodstullsis parly in conformity withthe acquis (the legislation governing ‘the contto ofthe safety of foodtuffsand consumersprotection {is well aligned with the acquis, except forthe requirements, ‘concerning testing laboratories in terms of their accreditation and the qualification of administrative bodies for theofficial contro of foodstuffs tobe carried outa al phases of production and trade as regards requirements which foodstuffs have to ‘meet in terms of safety and health and which are set out in specific regulations and directives on food adkitives, processing ‘ids, materials and articles in contact with foodstus, and contaminants, the applicable legislation ofthe Republic of Slovenia has not followed the technical progress and expert findings on which the relevant EC directives are based. Harmonisation oflegistation withthe acquis To implement the aoquis on foodstfs the Republic of Slovenia ‘will: (adopt the Law onthe Safety of Foodstufs, Materials and ‘ticles Coming Contact with Foodstlls by 3! December 1999, (which wi replace the existing Law on the Wholesomeness of Foodstuffs and tems of General Use andthe Law on the Health Control of Foods); i adopt the Law on Agficalture by 31 December 2000 which wil serveas alegal ss forissung technical regulations conceming consumers protection and the fee movement of goods in the intemal market, which isunder the competence of Minis of Agicule, Forestry and Food cumenly regulated by the Law on Standerdsaton; il) onthe basis ofthe above two laws, gradually adopt and implement secondary legislation relating to foodstufis by 31 December 2002, withthe aim to protect public health and consumers as wells to ensure the iee movement of goods in the internal market ce Annex). ‘The Republic of Slovenia expects that upon accession to the EU the registration of agro-food products in blocks will be Permitted, as was the ease with the acceding countries in the last round ofenlargement, Harmonisation of legislation ofthe Republic of Slovenia withthe acquis also means the termination ‘ofsome ofthe existing so-called “recipe legsation” governing ‘the quality of foodstuffs. The Republic of Slovenia produces some traditional foods .¢ Karstsmoked ham "Krai pou’, some Slovenian semi-soft cheeses, etc. on the bass ofthe so- called “recipe egisation’ In theperiod from 1 January 1999 to 31 December 2002, the Ministry of Agriculture, Forestry and Food will adopt and implement the legislation on special agro-food products, compatable tothe relevant EU legislation (Regulations 2081) ‘92 and 2082/92) This legislation wil allow the Republic of Sloveniato market products which meet ational requireents in the EU internal market, as is minimally required by the horizontal and vertical directives governing foodstuff. Institetiona framework forthe implementation of harmonised legislation ‘Toimplementthe acquis on foodstuls, the Republic of Slovenia ‘wil reinforce and train the staff in the existing inspection bodes forthe implementation ofleisation inthe sense of the official control of foods reinforce the professional staffing ‘and technical capacity of the existing testing laboratories to meet the accreditation requirements under EN 45001, ad (i) reinforce the institutions designed to offer expert support to official contol inspectors when solving health-related problems of foodstuffs and ensuring consumer protection 3. CHEMICALS DANGEROUS SUBSTANCES Existing legislation in the Republic of Slovenia ‘The legislation of the Republic of Slovenia on dangerous substances is partly in conformity with the acquis: () the system for the classification, packaging and labelling of dangerous substancesis partly in conf the acquis; ‘the main diferenceis that, inthe applicable legislation ofthe Republicof Slovenia, dangerous substances are classified into three groups of txicity according to acute toxicity, whilst in the EU there are fifteen groups; moreover, different clas fication criteria are applied the present administrative bodies are qualfed only to cany out task laid dow by the applicable legislation ofthe Republic of Slovenia. Consequently, the ‘Minis of eatth, which isesponsile for the implementation oflegisiation, and the Health Inspectorate ofthe Republic of Slovenia responsible frits contro areassuch not fly qualified to implement future legislation. Harmonisation of legislation wth the acquis ‘The Republic of Slovenia wil align it legislation on dangerous stubstances with the acquis (Directives 67/548/EEC, 76/769/ EECand 79/117/EEC) by adopting the aw on Chemicals and relevant secondary legislation. The aw on Chemicals willbe ‘adopted and implemented by 31 Decermber 1999, The acquis ‘willbe Filly implemented by 31 March 2001 (see Annex 156 Chapter: FREE MOVEMENT OF GOODS Institutional framework forthe implementation of harmonised legislation To implement the harmonised legislation, the Republic of Slovenia will adoptthe Law on Chemicals whereby itwill:() «stablish a body responsible for chemical safety - Office for Chemicals, i reinforce the supervisory body fr the imple- mentation of the law and secondary legislation - Health Inspectorate ofthe Republic of Slovenia i) qualify anadequate numnber of expert inthe institutions responsible for providing risk assessment of chemicals and other professional tasks, supporting te relevant body, under the co-ordination of the Institute for Heath Protection ofthe Republicof Slovenia, ‘The Republic of Slovenia will also ensure that an adequate number of experts is trained to offer advice to small and ‘medium sized enterprise onthe implementation ofreguations. Request for derogation from the acquis: ‘With regard tothe implementation ofthe acquis on dangerous substances the Republic of Slovenia requestsa derogation in thesense of right to retain the existing stricter requirements, on the tettory of the Republic of Slovenia concerning the prohibition ofthe use ofthe following chemicals or pesticides: atrazine, chlorpicrin, methylbromide, paraquat, 24,5-T and ‘carbon tetrachloride, As regards atrazine the Republic of Slovenia ‘wishes to retain the general ban on the trade and use of one- ‘component preparations on the basis of pure active atrazine substance and ban on the use of preparationsin which atrazine isone ofthe component parts, in the water-protected areas. AS regards other dangerous substances, the Republic of Slovenia, ‘wishes to retain thebanon the trace and use ofthese substances. ‘The Republic of Slovenia cannot agree to accept health and ‘environmental standards inthis field that are lower than those achieved 30 fa, The Republicof Slovenia constantly endeavours to reduce the use of pesticides and other dangerous substances: the Law on Trade in Poisons oF 1991 prohibited ors limited theuse of some pesticides and other dangerous substances; i) the Decree sued by te Heath Ministerin 1996 further proibitel orliitedtheuse of pesticides i the Law onthe Health Protection ‘ofPants of 1994 contibuted to greater concer about the rational use of pesticides; (iv the assessment of the risks of pesticides to rman and the environment isin accordance with the Law on ‘Trade in Poisons ands under the responsibility ofthe Ministry cof Health, The heath and environmental policy of the Republic of Slovenia adheres to the principle of replacing more dangerous chemicals by the less dangerous ones, As regards the above- mentioned chemicals ess dangerous altematives are available. ‘The reasons forthe prohibition and limitation ofthe use of the above-mentioned pesticides or chemicals le in theirtoxicand co-toxicreaction when use in the environment of Slovenia, Which otremely vlnerabl in the ecological sense, witaround 40 ofthe Kast vary porous transi) where most water supplies come from groundwater and Karst water sources. Ong to unfavourable natural conditions for agriculture - around 70% oF tela as ess favoured contions for agrcature relieves, high altitudes climate and peology conditions remoteness etc), intensive agriculture inthe Republicof Slovenia is only passible on theplains, wih mostly sandy sols and groundwater servos. Given the fact that 579 ofthe users of public water-supply systems obtain ther drinking wate from groundwater sources and 38% fom Karst source, and only 54 from surface and other sources, and that public systems provide water to 75% oF ‘the population, the once abouttheuse ofdangeroussubstances| ‘sofia importance. Another factor contibutingto theproibion and imitation ofthe use of dangerous chemicals wasthe results of monitoring f pesticides and other chemicals in the water sources. Another ctor of increasing importance as regards the limitation of theuseofpesticidesin the environments the concer forthe preservation of bio-dvensity, which still very high nthe Repuilicof Slovenia also because of the rational us of dangerous substances, DANGEROUS PREPARATIONS AND DETERGENTS, GOOD LABORATORY PRACTICE Existing legisation in the Republic of Slovenia ‘The legislation of the Republic of Slovenia on dangerous preparations is party in conformity with the acquis () the system for the classification, packaging and labelling of dangerous preparations is partly in conformity with the acquis, except forthe fat that, under the leistation of the Republic of Slovenia, dangerous preparations are classified in three groups of toxicity according to acute toxicity, whilst in the EU there are fifteen groups; moreover, different classification criteria ae applied in the Republic of Slovenia. i the existing administrative bodies are qualified only to camry out tasks lad down by the applicable legislation. Consequently, the Ministry of Felt, which isesponsiblefor implementation oflegsation, and the Health Inspectorate of the Republic of Slovenia responsible for its control are as such not fly qualified for the implementation ofthe future legislation. ‘The good laboratory practice isnot yet regulated by legal acts. However, certain tasks relating to the establishment of a system of control have been undertaken and such asystem will, ‘beset up after appropriate legislation has been putin place. ‘The legislation ofthe Republic of Siovenia on detergents is partly in conformity with the acquis Harmonisation of legislation with the acquis Tobringitslegistation into ine wth the acquis on dangerous preparations (Directives 88379/EEC and 78/631/EEC), detergents (Directives 73/405JEEC and 73/404JEEC) and good laboratory practic Directive 87/18]BEC and 88/320)EEC) the Republic of Slovenia will adopt and implement the Lavon‘Chemicals by 31 December 1999 and the relevant secondary legislation regulating the above-mentioned fields by 31 December 2002 (se Annex Institutional framework forthe implementation of harmonised legislation To implement the harmonised legislation, the Republic of Slovenia will by adopting the Law on Chemicals, (establish an institution responsible for chemical safety the Office for Chemicals, (i) reinforce the supervisory body for the {implementation of the law and secondary legislation - the “Health Inspectorate ofthe Republic of Slovenia, ii) qualify an adequate number of experts in the institutions responsible for providing risk assessment of chemicals and for other professional tasts supporting the relevant body, under the co- ‘ordination ofthe institute for Health Protection ofthe Republic of Slovenia, iv) qualify an adequate numberof assessors to ‘be exployed in the Office for Chemicals who wil be capable of monitoring good laboratory practice. FERTILISERS Existing legislation in the Republic of Slovenia. The legislation of the Republic of Slovenia on fertilisers is partly in conformity withthe acquis. Harmonisation ofegislaton withthe acquis ‘The Republicof Slovenia wil align its legisationon fertilisers with the acquis gradually by 31 December 2002 by adopting ‘new Law on Fertilisers and relevant secondary legislation (Gee Annex which wil transpose the provisions ofthe relevant, directives. Upon accession to the EU, no obstacles tothe free ‘movement of frtlises wth the label "EEC fertilisers willbe {imposed in the Republic of Siovenia, Accorting tothe Slovenia's interpretation ofthe provisions of Directive 76]116/EEC, certain fertilisers produced in the Republic ofSlovenia which do not meet the norms required to ‘obtain an “EEC fertilisers” label but meet the minimum requirement set out by the national legislation canbe lin circulation after accession to the EU, ass the case in other ‘Member States. These are in the frst place special mineral ‘ertlisersin smaller packages intended for gardening purposes. Institutional framework forthe implementation of harmonisedlegisation ‘The Republic of Slovenia does not need to establish new institutions forthe implementation of harmonised legislation on erties The Republi of Slovenia wll enforce thestafing and technically improve the existing testing laboratory (to ‘eet the accreditation criteria under EN 45001, to apply new testing methods as set out in Directive 77/535/EEQ). ‘DRUG PRECURSORS Existing legislation in the Republic of Slovenia ‘The legislation ofthe Republic of Slovenia on drug precursors, {snot in contradiction with the acquis, The Regulation on the amendments tothe Regulation on classification of goods Into the types of exports and imports (Official Gazette of RS, No 3/95) stipulates that substances included in the UN Convention against illegal traffic in drugs and psycho-tropic substances of 1988 (Convention No 88) are only permitted to be imported or exported on the basis of an export or impor license issued by the Ministry of Health. According. to instructions issued by the Ministry of Health on the basis, ofthis regulation, an import license issued by the importing, country i required to export substances from Group I, and ‘an open permit for multiple imports or exports can be issued for substances from Group I. Other issues relating to the traffic and production of drug precursors willbe regulated by special law which is being prepared, Harmonisation legislation vith the acquis ‘The Republic of Slovenia will harmonise its legislation on drug precursors withthe aequishy the Law on Drug Precursors, which will transpose all the relevant elements ofthe acquis (Council Regulation (EEC) No 3677/90 as amended). The law will regulate n greater detail the issues relating to the surveillance of imports, exports and domestic trade in drug. precursors Moreover, the Law will () regulate the process of ‘supplementing and changing thelist of drug precursors in line with the changes adopted by the EU or the UN Drug Commission, (i lay down the requirements for legal entities ‘engaged in the production and trade in drug precursor, regulate the issuing licenses or permits for trade or production, (Gi) regulate the procedure for exports orimpors of precursors fiom Groups 1,2 and 3, (\ stipulate special surveillance over ‘rade with counties for which evidence exit that precursors are used forthe illegal production of drugs, by asystem of ‘import licenses or by informing the relevant authorities inthe Importing countries, (i regulate the records and reporting, ‘methods, (vi lay down the methods used fr inspection and (vi set out penalties The law will be adopted by 31 December 2001 and implemented by 31 December 2002. Institutional framework forthe implementation of hharmonisedlegistation ‘oimplement the Law on Drag Precursor, the Republic of Slovenia will reinforce the staffing and improve the technical capacity ofthe existing Service for Precursors operating in the framework of the Ministry of Health, wich wl ensure (i the issuing oflcenses and permit for rade and in production of drug precursors, (i) the exchange of information with importing or exporting countries and with the EU, i regular 7chapec 1 FREE MOVEMENT OF GOODS inspections and (Wv) the work of an expert group (drug precursors comtanssion] to be responsible for implementation, ofthelaw. EXPLOSIVES Existing legislation in the Republic of Slovenia, ‘The legislation ofthe Republic of Slovenia on explosives for civil use is not in conformity with the acquis (Directive 93/15) EQ. The existing legislation sets outa system of permits and a list which are only partly known in the EU; the control system is also different in Slovenia, The trade permits issued bbyan administrative body, while the esting of new explosive substances is carried out by a special commission in an authorised laboratory, whichis, however, not accredited. The system of standards is not defined. Each substance which ‘meets the criteria isplaced on thelist of explosive substances, allowed tobe traded and used inthe Republic of Slovenia, All ‘ests are practically free of charge. Technical experts on ‘explosive substances and standardisation take par in issuing permits and testing. ‘Harmonisation ofegislation with the acquis “The legislation of the Republic of Slovenia on explosives for civil use willbe aligned with the aequis (Directive 93/15/EEC) and fll implemented by 31 December 2002 (ee Annex. Instittional framework forthe implementation ofthe hharmonisedlegisiation ‘The Republic of Slovenia will set up a national authority responsible for explosive substances for civ useby 31 Decemiber 2002, which will camry out all the task stipulated in Directive 93/15/BEC and make the necessary preparations for the institutional framework for assessing the appropriateness of explosives. 4, PHARMACEUTICALS ‘PHARMACEUTICALS FOR HUMAN USE Existing legislation in the Republic of Slovenia ‘Thelegislation ofthe Republicof Slovenia on pharmaceuticals for human use i partly in conformity with the acquis. Harmonisation of legislation withthe acquis ‘When harmonising its legislation on pharmaceuticals for hhuman use with the acquis, the Republic of Slovenia will separate pharmaceuticals fiom medical devices and introduce ‘changes soas to harmonise marketing authorisation approval procedures for medicinal products. The Republic of Slovenia will bring its legislation into line with the acquis by the Law ‘on Medicinal Products and Medical Devices to be adopted by 31 December 1999 and implemented by 31 December 2000, ‘except for the provisions for which a transitional period is required, and theby the relevant secondary legislation to be adopted by 31 December 1999 and implemented by 31 December 2000, except for some provisions ofthe Regulations on the marketing authorisation approval procedures for medicinal products (1 December 2007) (see Annex D. The Republic of Slovenia wil gradually implement the harmonised legislation in the five-year period after planned accession tothe EU, in light ofthe request for transitional period. ‘According tothe interpretation ofthe Republic of Slovenia, the measures with retroactive effect - harmonisation of procedures and contents ofthe already submitted documents ‘on the basis of which the marketing authorisations for medicinal products were granted, which in fact mean a revision ofthe whole pharmaceutical matket before the accession to the EU - are expectations which go beyond the scope of, requirements of the aoguis. ‘nsttutional framework forimplementaion of harmonised legislation ‘Toimplement the acquis on pharmaceuticals for human use theRepublicof Slovenia il reinfore the staffing ofthe Agency for Medicinal Products which spar of the Ministry of Health, as well as the inspection services and the institutions with control and analysis functions. Request fora transitional period ‘The Republic of Slovenia requests a transitional period offive years starting on the date of foreseen accession to the EU. (lasting until 31 December 2007) as regards the implementation ‘of the aegis on pharmaceuticals for human use relating to the provisions of Directives 65/65/EEC and 75/319/EEC and Regulation 2309/93 and related regulations. Te transitional period is necessary to ensure that Slovenia's pharmaceutical industry is granted a consistent transition permitting harmonisation withthe requirements ofthe acqusin the way interpreted by the European Comission ‘According to the interpretation ofthe Republic of Slovenia, the requirement for the harmonisation of marketing authorisation procedure and harmonisation ofthe contents of ‘the documentation on the basis of which a medicinal product, is evaluated will only apply to pharmaceuticals entering the Slovenian market after the adoption of the acquis. -Accoreing tothe interpretation of the Republic of Stovenia, a renewal of marketing authorisation will not be possible ‘without the documentation that isin ine with the provisions of the acquis relating to the renewal of a marketing authorisation. ‘The Commission expects that by the time of EU accession a holder ofa marketing authorisation submits notonly thedata,required for renewal ofa marketing authorisation buta complete primary documentation, revised in ine with te criteria ofthe ‘acquis, which was submitted for initial assessment of a Pharmaceutical and was inline with regulations applying at thattime, According tothe interpretation of the Republic of Slovenia, this isa requirement with retrograde effect and goes beyond ‘the obligations deriving from the adoption ofthe acquis.To meet this requirement, which isan enormous administrative, professional and financial projec, the Republic of Slovenia. needs transitional period offive years starting onthe foreseen date of accession tothe EU. To complete this revision by the date of EU accession is beyond the ability ofthe Slovenia's ‘Phannaceatical industry. The renewal of marketing authorisation {sa five-year cyce. The domestic pharmaceutical industry needs two cycles of renewals of authorisations to carry out the requited revision in two parts, following its print lst. According tothe interpretation of the Republic of Slovenia, the requirements relating to a complete revision of initially suibmitted docamentation and explained asnecessary to enable the principle ofthe free movement of goods do not apply to national registrations (pharmaceuticals which are notsold in ‘more than one Member State) because in this event the free movement of goods principle does a priori not apply. Ikis not before full accession tothe EU that the Slovenia's pharmaceutical industry will be able tobe directly involved in ‘the procedures of mutual recognition of marketing authorisations ‘with an alm to ease the access to the EU market and will ‘therefore use the transitional period for gradual adaptation ‘PHARMACEUTICALS FOR VETERINARY USE Existing legislation in the Republic of Slovenia ‘The legistation ofthe Republic of Slovenia on pharmaceuticals for veterinary useis notin conformity with the acquis. Hemonisation of legislation withthe acquis ‘The legal provisions on pharmaceutical for veterinary use ‘hich have been prepared and are aligned with the acquis will, be ncomporated asa separate chapter into the Law on Medicinal Products and Medical Devices, to be adopted by 31 December 1999 and iniplemented by 31 December 2000. The relevant secondaty legislation will be adopted and gradually ‘implemented by 31 December 2002 see Annex D Institutional framework forthe implementation of ‘harmonised legislation ‘To implement the acquis on pharmaceuticals for veterinary use the Republic of Slovenia will reinforce the staffingin the ‘existing institutions (Veterinary Administration of the Ministy ‘of Agriculture, Forestry and Food) and increase the capacity of the existing laboratories, 5. COSMETICS Existing legisaton inthe Republic of Slovenia ‘Thelegislaton ofthe Republic of Slovenia on cosmetics ie. the applicable legislation goveming the wolesomenessoffoodtuls and ites of general use, which also covers cosmetics is partly Jn confornity with the acquis In particular as regards the directives incorporating the lists of permitted, conditionally peritted and prohibited substances in cosmetic products and defining the methods of analyses to examine the structure in lightoftswholesomeness, the existinglegilation ofthe Republic ‘of Stoveniahas ed to follow the echnical and expert progress ‘which these directives have taken into account. Harmonisation of etsation with the acquis Toimplementthe acquis on cosmetics (Directives 76/768/EEC and 96/45/80) the Republic of Slovenia will gradually adopt and implementthe harmonised regulation on cosmetic products by30June 2002, Institutional framework forthe implementation of ‘harmonised legislation ‘The Republic of Slovenia will ensure efficient control over costietic products on the market, reinforce the staffing and improve and modemise the technical capacity ofthe existing ‘esting laboratories to meet the requirements of accreditation ‘under EN 45001, 6. LEGAL METROLOGY AND PRE-PACKAGING LEGAL METROLOGY Existing leoisation in the Republic of Slovenia ‘The legislation ofthe Republic of Slovenia on metrology is parlly in conformity with the acquis. The Republic of Slovenia hasan established legal metrology system which is comparable to the system of old approach of selected directives. As for contents, the national regulations are largely in conformity ith te OIML recommendations The Standards and Metrology Institute of Slovenia (SMS) isthe body responsible for legal metrology. Harmonisation of legislation withthe acquis ‘The Republic of Slovenia will adopt the new legislation on legal metrology in conformity with the acquis by 30 June 2001 and will implement it ally by 31 December 2001 (see ‘Annex Certain provisions ofthis legislation, however, will notente into force before the Republic of Sloventa becomes a full member ofthe EU. = To harmonise the legislation with the old approach directives, the supplemented and amended secondary legislation will be adopted by 30 Sune 2001 8Chapter: FREE MovENLENT OF GOODS = to harmonise the legislation with the new approach directives (NAWD, amendments to certain provisions of. the Law on Metrology will be adopted by 30 June 2000 and amendments to horizontal secondary legislation will bbe adopted by 30 June 2001 and fully implemented by 31 December 2001 (see Annex, Institutional framework forthe implementation of harmonised legislation To implement the harmonised legislation, the Republic of Slovenia does not need to establish new institutions. However, the Republic of Slovenia has to carry out certain status and organisational changes in the Standards and Metrology Institute (changes are under way; see Point III in the {introductory text) and reinforce the existing institutions. PRE-PACKAGING Existing legislation inthe Republic of Slovenia ‘Thesystem forcontolling the quantities and labelling ofpre- packaged products in the Republic of Slovenia is an integral partof the system of legal metrology regulated by the Lawon, Metrology. The legislation ofthe Republic of Slovenia on pre- packaging snot lly n conformity withthe acquis. Control hasnot been established yetofthe quantities and labelling of pre-packaged products. The Standards and Metrology Institute of Slovenia isthe body responsible for pre-packaging, Harmonisation of legislation withthe acquis ‘The legislation ofthe Republic of Slovenia on pre-packaging will be harmonised with the acquis by the adoption of an Order on pre-packaging (based on the Law on Metrology), which will lay down in greater detail the methods of control ss wellas measuring and other requirements needed to establish a fimetioning system to monitor the quantities and labelling of pre-packaged products. The Order will be adopted by 31, December 1999 and flly implemented by 31 December 2001. Institutional framework for the implementation of bhormonised legislation ‘To implement the harmonised legislation on pre-packaging, the Republic of Slovenia will reinforce the staffing ofthe exsing metrology institution, 7. ELECTRICAL EQUIPMENT ‘LOW VOLTAGE DIRECTIVE (1VD} Existing legislation in the Republic of Slovenia ‘The legislation of the Republic of Slovenia regarding the Low Voltage Directive is notin conformity with the acquis. Hormonisaton of egislaton withthe acquis ‘The Republicof Slovenia wll harmoniset legislation regarding the Low Voltage Directive with the acquis and filly implement itby 31 December 1999 -by the Order on electrical equipment designed for use within certain voltage limits (Gee Annex D, Institutional framework forthe implementation of. ‘harmonisedteislation ‘The Republic of Slovenia wil establish institutional framework {orimplementation of harmonised legislation in accordance ‘with the contents of Chapter 10 of this document: The Republic of Slovenia will ensure the proper operation ofthe relevant institutions necessary for the implementation of the acquis regarding the Low Voltage Directive. DIRECTIVE ON ELECTROMAGNETIC COMPATIBILITY (EMC) Existing legislation in the Republic of Slovenia ‘The legislation ofthe Republic of Slovenia isin conformity ‘ith de Directive 89/336/EEC on Electromagnetic Compt, except for mark of conformity forthe electrical devices and the “notified body’. The Directive on Electromagnetic Compatibility isin the Republicof Slovenia covered by Article 28 ofthe Law on Telecommunications (Offical Gazette ofthe RS, No 35/97) and the Regulation on Electromagnetic Compatibility (Oficial Gazette of the RS, No 61/97). Harmonisation of legislation with the acquis ‘The implementation of the Directive on Electromagnetic Compatibility will be achieved by 31 December 1999 on the basis of the already adopted legislation ofthe Republic of, Slovenia on electromagnetic compatibility. Institutional framework forthe implementation of harmonised legislation ‘The Republic of Slovenia wil establish institutional framework forimplementation of harmonised legislation in accordance with the contents of Chapter 10 of this document, Slovenia doesnot need to setup any new institutions or administrative bodies to implement the Directive on Electromagnetic Compatibility. Pursuant to the provisions of the new Law on ‘Telecommunications, which is to be implemented by 31 ‘December 2000, an independent National Regulatory Authority will be putin place by this dat, which will also bein charge of the field of electromagnetic compatibility. In order to implementthe legislation effectively, te Republic of Slovenia ‘will ensure proper functioning of other institutions necessary for implementation of the acquis on EMC.ELECTRICAL EQUIPMENT USED IN POTENTIALLY EXPLOSIVE ATMOSPHERES (ATEX) ‘Existing legislation in the Republic of Slovenia ‘The legislation ofthe Republic of Slovenia on equipment used in potentially explosive atmospheres (ATEX) is partly in conformity with the acquis Harmonisation of legislation with the acquis ‘The Republic of Slovenia will bring its legislation on ATEX in line with the acquis (Directive 94/9/EQ) and implement itby 31 December 1999 -by an Order on equipment and protecting systems for use in potentially explosive atmospheres (see Annex D. Institutional framework forthe implementation of harmonised legislation ‘TheRepublicof Slovenia wil establish institutional framework for implementation of harmonised legislation in accordance ‘with the contents of Chapter 10 ofthis document. The Republic of Slovenia will ensure proper functioning ofthe institutions necessary for implementation ofthe acquis on ATEX. 8, TOYS sting legislation inthe Republic of Slovenia The legislation ofthe Republic of Slovenia on the safety of toys, which incorporated in the Law onthe Wholesomeness of Foodstuffs and Item of General Uses partly in conformity ‘with the acquis. In the frst place, the fulfilment of health requirements s monitored ina similar way as for foodtufs: ‘nparcuay the chemical, mechanical and hygiene requirements of tysare monitored, but this doesnot involve a more complex control of safety requirements as applicable in the EU. The new approach directive principe self certification or ype approval and the issue of certificate by a relevant authority - ‘Snot transposed to the applicable legisation ofthe Republic of Siovenia, Harmonisation oflegisation wth the acquis ‘To harmonise its legislation with the acquis (Directives 88/ S79[EEC and 93/6/EEQ, the Republic of Slovenia will adopt ~ ‘on the basis of @ new Law on Technical Requirements for Products and Conformity Assessment (draft title) - and fully ‘implement the relevant secondary legislation regarding the safety of toys by 31 December 2002 (see Annex 1). Institutional framework for the implementation of harmonised legislation ‘The Republicof Slovenia will establish institutional framework {or implementation of harmonised legislation in accordance with the contents of Chapter 10 ofthis document, To implement the acquis on toys the Republic of Slovenia will ensure the efficent control of toys on the market, improve the staffing, technical and expert capacity and nominate the notified body out of existing institutions (laboratories), which will be in charge of issuing type certificates fr toys. 9.1. MECHANICAL DEVICES ‘MACHINERY Existing legislation in the Republic of Slovenia ‘The legislation ofthe Republic of Slovenia on machinery is notin conformity with the acquis. Harmonisation oftegislation withthe acquis ‘The Republicof Slovenia wil align its estan on machinery ‘with the acquis and implement itby 31 December 1985 by a Decree on Machinery (See Annex Institutional framework forimplementation of harmonised legislation ‘The Republic of Slovenia wil establish institutional framework for implementation of harmonised legislation in accordance ‘with the contents of Chapter 10 of this document. The Republic ‘of Slovenia will ensure the proper operation of the institutions necessary forthe implementation ofthe acquis on machinery. UFTS Existing legislation in the Republic of Slovenia ‘The legislation of the Republic of Slovenia on lifts is not in conformity with the acquis. Harmonisation oflegisation with the acquis ‘The Republic of Sloventa wil align its legislation on its with ‘he acquis and implement tas follows: adopt and implement ‘the regulation on certificates and production of wire ropes, chains and hooks by 31 December 2001; adopt and implement {he regulations on lifts by 31 December 2002 (ee Annex!) Institutional framework forthe implementation of harmonised legislation The Republic of Slovenia will establish institutional framework ‘or implementation of harmonised legislation in accordance with the contents of Chapter 10 of this document. The Republic of Slovenia will ensure the proper operation ofthe relevant institutions necessary for the implementation of the acquis on lifts. 212 Chapters: FREE MoVENENT OF GOODS 9.2. PERSONAL PROTECTIVE EQUIPMENT (PPE) Existing legislation in the Republic of Slovenia ‘The legislation ofthe Republic of Slovenia on personal protective cequipmentis notin conformity with the acquis. Harmonisation oftegisation with the acquis ‘The Republic of Slovenia wl implement the aguis on personal protective equipment by 31 December 2001, To align its legislation with the acquis the Republic of Slovenia will adopt secondary legislation laying down the requirements for the producers of personal protective equipment by 31 December 1999 and implementit by 31 December 2001, Institutional amework forthe implementation of ‘harmonised legislation ‘The Republic of Slovenia willetablish institutional framework for implementation of harmonised legislation in accordance ‘with the contents of Chapter 10 ofthis document. The Republic ‘of Slovenia will ensure the proper operation of the relevant institutions necessary for the implementation ofthe acquis ‘on personal protective equipment. 9.3, MEDICAL DEVICES ‘MEDICAL DEVICES FOR USE IN HUMAN MEDICINE Existing legislation in the Republic of Slovenia ‘Thelegislation of the Republic of Slovenia on medical devices for usein human medicine relating to Directives 93/42/EEC and 90/385/EEC, is not in conformity with the acquis. Harmonisation ofegisation withthe acquis ‘When harmonising its legistation withthe aoqus, the Republic of Slovenia will separate medical devices from pharmaceuticals andl apply the principles ofthe new approach directives. Tae process of harmonisation will include the adoption of the Law (on Medicinal Products and Medical Devices which wll regulate medical devices separately, and adoption of the relevant secondary legislation. The Law on Medicinal Products and ‘Medical Devices willbe adopted by 31 December 1999 an fll implementation ofthe harmonised legislation will be achieved by the estimated date of accession tothe EU (31 December 2002) (see Annex D, Institutional framework forthe implementation of ‘harmonised legislation ‘The Republic of Slovenia wil establish institutional framework forimplementation ofharmnonised lgsation in accordance with the contents of Chapter 10 ofthis document To implement tne aoquson medical devies fr human use, the Republi of Slovenia willrinforce the staffing ofthe Agency for Medicinal Products of the Republic of Slovenia asa competent body within the Ministry of Healt, the inspection body and the notified bodies. MEDICAL DEVICES FOR VETERINARY USE Existing legislation in the Republic of Slovenia ‘The legisation ofthe Republic of Slovenia on medical devices, for veterinary use is notin conformity with the acquis. Harmonisation of legislation with the acquis ‘The Republic of Slovenia will align its legislation on medical devices for veernary use with the acquis by the Law on Medicinal Products and Medical Devices to he adopted by 31 December 1999, The necessary secondary legislation wil be adopted and implemented gradually by 31 Decernber 2002 ee Ane Institutional framework forthe implementation of harmonised legislation ‘Toe Republic of Slovenia wil establish institutional framework {or implementation of harmonised legislation in accordance ‘with the contents of Chapter 10 ofthis document. To implement the aogus, the Republic of Slovenia will reinforce the staffing ofthe existing institutions (Veterinary Administration ofthe Ministry of Agriculture, Forestry and Food) and increase the techincal capacity ofthe existing testing laboratories 9.4. APPLIANCES BURNING GASEOUS FUELS Existing legislation in the Republi of Slovenia ‘Toe legislation ofthe Republic of Slovenia on appliances burning gaseous fuels is notin conformity with the acquis. Harmonisation ofegislaton withthe acquis ‘The Republic of Slovenia wil align tslegislation on appliances bbuming gaseous fuels with the acquis an implement itby 31 December 1999 by an Order on appliances burning gaseous fuels (See Annex I Institutional framework forthe implementation of. ‘harmonised legislation ‘The Republic of Sloveni willestablish institutional framework for implementation of harmonised legislation in accordance vith the contents of Chapter 10 ofthis document Tae Republic of Sloventa will ensure the proper operation ofthe relevant institutions necessary forthe implementation ofthe aequis, on appliances buming gaseous fuels. 9.5. PRESSURE VESSELS Existing legislation in the Republic of Slovenia ‘The legislation ofthe Republic of Slovenia on pressure vessels isnotin conformity with the acquis.Harmonisation of legislation with the acquis ‘The Republic of Slovenia wil align its legislation on pressure vessels with the angus and implement it as follows: adopt and implement an Order on pressure equipment, Order on common provisions for pressure vessels and Order on simple pressure vessels by 31 December 2001; adopt and implement ‘the Order on aerosol dispensers by 31 December 2002 (see Annex D. Institutional framework forthe implementation of harmonised legislation ‘The Republic of Slovenia will establish institutional framework {or implementation of harmonised legislation in accordance with the contents of Chapter 10 ofthis document. The Republic of Slovenia will ensure the proper operation ofthe relevant institutions necessary forthe implementation ofthe acquis on pressure vessel. 9.6, CONSTRUCTION PRODUCTS Existing legislation in the Republic of Slovenia ‘The legislation ofthe Republic of Slovenia on construction products is not fully in conformity with the acquis. The legislation of the Republic of Slovenia on the construction ‘works and the in-built construction products is based on the Law on the Construction, which in ts secondary legislation Jays down two sub-systems of technical regulations. The fist regulates the field of construction products and the second, hich s more comprehensive, the field of construction works Constraction proicts are farther regulated by certain technical regulations (orders, regulations) applied on the bass of the applicable Law on Standardisation, The acquis clretly regulates the fed of construction products, ‘with te Directive on Construction Products (CPD) No 89/106) BECand numerous Commission decisions. There i, however, no regulations directly governing the field of construction ‘works. Inview ofthe very specific production and marketing of construction products, the harmonisation of technical regulations and the preparation of harmonised technical specifications (hTS) relating to the CPD is still under way ‘within the EU, After ten years of existence ofthe CPD, only ‘wo types of construction products can be given the "CE rmatking’ Hence, almost al trade in construction products within the EU is regulated by the general provisions of Articles 30-36 ofthe Treaty establishing the European Community. Harmonisation oflegisation with the acquis The Republic of Slovenia will align its legislation on construction products with the aequis by 31 December 2002, tothe exten available in the EU at that time, ‘The Republic of Slovenia is in aspecificposition as regards the harmonisation ofits legislation with the acquis. On the ‘one hand, Slovenia lacks an adequate body of technical specifications necessary forthe creation and operation of clicient legislation in the field of construction products and ‘works. On the other hand, the drafting of HTS in the EU isl at a very eatly stage. Therefore, as long as the final harmonisation of technical regulations in the field of ‘onstruction productsis not achieved in the EU, the Republic ‘of Slovenia will on the domestic market apply its own conformity assessment systems equivalent to the systems applied in the trade in construction products within the EU. Asregards the transposition ofthe CPD toits legislation, the Republic of Slovenia would like to stress the following: ~The barmonisition of technical regulations on constuction products inthe Republi of Slovenia depend on the previous harmonisation within the EU. The dynamics ofhammonisation will bea long-lasting process, following the dynamics of harmonisation within the EU, ie. preparation of KTS for ‘each separate type of construction products, = During the period ofharmonisation the Republic of Slovenia, ‘wil in ts trade in construction produets with Member ‘States, apply the principe of reciprocity in conformity assessment procedures. Any potential levelling of procedures will not be considered a breach ofthe ban on restricting existing measures of trade ensuing from the Europe Agreement establishing an association between ‘he Buropean Communities and their Member States acting within th framework ofthe European Union of the one part and the Republic of Slovenia of the other part Article 26, Paragraph 2). Tis regime can only be introduced on the basis of an agreement wit the EU and will apply only fora specific construction product until the relevant HTS has been implemented, Institutional framework forthe implementation of harmonised legislation ‘The Republic of Slovenia wil establish institutional framework forimplementation of harmonised legislation in accordance With the contents of Chapter 10 ofthis document. To implement ‘the acquis on construction products, the Republic of Slovenia, will setup a national organisation for technical approval by analogy with EOTA (the Ministry responsible forthe CPD is ‘an observer member in EOTA). The notified conformity assessment bodies under the CPD will be appointed by the Republicof Slovenia in the framework ofa general scheme of conformity assessment systems in Slovenia, Given the complexity ofhimonising technical regulations inthe field of construction and the present situation as regards their harmonisation within the EU, the Republic of Slovenia request that its representatives become involved in the work ‘of selected EU bodies on the CPD as soon as possible. 23