GOVERNMENT OF THE REPUBLIC OF LITHUANIA

GOVERNMENT OF THE REPUBLIC OF LITHUANIA Official translation GOVERNMENT OF THE REPUBLIC OF LITHUANIA RESOLUTION NO. 617 On the Exchange of Information on Standards, Technical Regulations and the Conformity Assessment Procedures 20 May 1999 Vilnius In conformity with the requirements set forth for the compulsory provision of information concerning standards, technical regulations and conformity assessment procedures as laid down in the Europe Agreement which establishes the association between the European Communities and their Member-States, on one side, and the Republic of Lithuania, on the other side, in Directive 98/34/EEC of the European Union, in the Agreement on Trade-Related Technical Barriers of the World Trade Organisation, in the Free Trade Agreements of the Republic of Lithuania and the international agreements, the Government of the Republic of Lithuania has resolved:

1. To approve the Rules Set forth for the Exchange of Information Concerning Standards, Technical Regulations and Conformity Assessment Procedures (attached).
2. To entitle the Lithuanian Standardisation Department under the Ministry of Public Administration Reforms and Local Authorities (hereinafter referred to as the Department) to exchange information on draft standards, technical regulations and conformity assessment procedures with the International Standardisation Organisation and the Information Centre of the European Committee for Electrotechnical Standardisation, the Secretariat of the World Trade Organisation and its members, the European Commission, the European Standardisation bodies, the respective standardisation bodies of the European Union Member States.
3. To establish that: 3.
4. after the Republic of Lithuania becomes a member of the World Trade Organisation, the Department will exchange information on the requirements set forth for the development, adoption and application of standards, technical regulations and conformity assessment procedures as laid down by the World Trade Organisation; 3.
5. after the Republic of Lithuania becomes a members of the European Union or after it signs a separate agreement on this issue, the Department will exchange information on the requirements set forth for the development, adoption and application of standards, technical regulations and conformity assessment procedures as laid down by the European Union;
6. To instruct government institutions, ministries and the departments under the ministries, agencies performing control and accounting functions, inspectorates and other authorities: 4.
7. by 31 may 1999, to submit to the Department copies of all existing documents on technical regulations and conformity assessment procedures; 4.
8. to appoint persons responsible for the implementation of the rules outlined in paragraph 1 and to inform the Department of their appointment.
9. The Ministry of Foreign Affairs shall appoint persons, who would represent the Republic of Lithuania within: 5.
10. the Committee on Trade-Related Technical Barriers of the World Trade Organisation, after Lithuania becomes a member of this organisation; 5.
11. the Stand-by Committee established under the European Commission, which shall address issues related to the implementation of Directive 98/34/EC of the European Union after the Republic of Lithuania becomes a member of the European Union or after a special document is signed on this issue. Acting Minister of Social Affairs and Labour, Acting Prime Minister Irena Degutienė Acting Minister of Public Administration Reforms and Local Authorities Kęstutis Skrebys APROVED by Resolution No. 617 on 20 May 1999 of the Government of the Republic of Lithuania Rules for the Exchange of Information on Standards, Technical Regulations and Conformity Assessment Procedures I. General Provisions
12. These rules regulate the exchange of information on standards, technical regulations and conformity assessment procedures with the Secretariat of the World Trade Organisation, International Standardisation Organisation and the Information Centre of the of the European Committee for Electrotechnical Standardisation (hereinafter referred to as the Information Centre), members to the World Trade Organisation, the European Commission, the European standardisation bodies and institutions of the European Union Members-States, these rules also establish tasks, goals and measures to be carried out by the government institutions, ministries and their departments, authorities exercising control and accounting functions, inspectorates and other authorities (hereinafter referred to as public authorities) in terms of the development, adoption and application of the aforementioned documents according to the Agreement with the World Trade Organisation concerning Trade-Related Technical Barriers and Directive 9834/EC of the European Union concerning the provision of information in the field of technical standards and regulations in accordance with the free trade agreements of the Republic of Lithuania (hereinafter referred to as the agreements) providing for the exchange of information concerning standards and technical regulations and conformity assessment procedures.
13. For the purpose of these rules the following meanings shall apply: product – any industrially manufactured product and any agricultural product, including fish products; technical specifications – a specification contained in a document which lays down the characteristics required of a product such as level of quality, performance, safety or dimensions, including the requirements applicable to the product as regards the name under which the product is solved, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures. The term “technical specification” also covers requirements for agricultural, cattle breeding, fishing products and for the products related with the aforementioned products during the initial stage of processing, as well as for food and medical products and medical preparations intended for human and animal consumption, as well as production methods and processes where these have an effect on their characteristics; other requirements – a requirement, other than a technical specification, imposed on a product for the purpose of protecting consumers or the environment, which affects its life cycle after it has been placed on the market, such as conditions of use, recycling or disposal where such conditions can significantly influence the composition or nature of the product or its marketing; standard – a technical specification approved by a recognised standardisation authority for repeated or continuous application with which conformity is not compulsory and which is one of the following: international standard – a standard adopted by an international standardisation organisation and made available to the public or the European standard – a standard adopted by a European standardisation body and made available to the public; national standard – a standard adopted by a national standardisation authority and made available to the public; standards programme – a work programme of a recognised standardisation authority listing the subjects on which standardisation work is being carried out; draft standard – a document containing the text of the technical specifications concerning a given subject which is being considered for adoption in accordance with the national standards procedure as that document stands after preparatory work and as circulated for consideration; European Standardisation Body- European Committee on Standardisation, European Committee for Electrotechnical Standardisation, European Telecommunication Standards Institute technical regulation – a legal document which contains a reference to technical specifications and other requirements the observance of which is compulsory in the case of production, marketing, importation or use of a product. Technical regulations also include: laws, regulations or administrative provisions of a member state which refer wither to technical specifications or other requirements or to professional codes or codes of practice the conformity of which confers the presumption of conformity with the obligations imposed by the aforementioned laws, regulations or administrative provisions; agreements to which a public authority is a contracting party and which provide in the public interest for conformity with technical specifications of other requirements, including public procurement tender specifications; technical specifications or other requirements which are linked to fiscal or financial measures the conformity of which affect the consumption of products. Technical specifications or other requirements linked to national social-security systems are not regarded as technical regulations; draft technical regulation – a legal document which contain the text of technical specification or other requirement being at the stage of preparation at which substantial amendments can still be made. conformity assessment procedures – any directly or indirectly applicable procedures which assess the conformity with the requirements of technical regulations and standards. Conformity assessment procedures include taking test, testing and control procedures; assessment, checking and conformity assurance; registration, accreditation and confirmation as well as combinations thereof;
14. A standard, technical regulation and conformity assessment procedures within these rules mean a standard, technical regulation and the conformity assessment procedures as related to products.
15. In the process of the exchange of information on standards, technical regulations and conformity assessment procedures, the terms of a standard and technical regulations may be used as defined in the international agreements which are signed by the Republic of Lithuania. II. Actions Taken by the Department and other Public Authorities as related to the Requirements set forth by the World Trade Organisation concerning the Development, Adoption, Application and Exchange of Information on Standards, Technical Regulations and Conformity Assessment Procedures
16. The department and other public authorities shall ensure: 5.
17. that the development of standards, technical regulations or conformity assessment procedures shall follow the international standards or parts thereof which are already enforced or are in the process of development except for the cases when these standards preclude the achievement of legitimate national goals (like enforcement of national security, prevention of fraudulent activities, safety insurance, health care and environmental protection) or due to the possible essential changes in climate or other geographical factors or technological problems. It should not be thought that the international trade is hindered by whatever activities related to the standardisation which aims at achieving the aforementioned legitimate national goals and which is in line with the international standards; 5.
18. that standards, technical regulations, conformity assessment procedures developed, adopted and applied in Lithuania create no unnecessary impediments to international trade; 5.
19. the exchange of information on standards, technical regulations, conformity assessment procedures with the members of World Trade Organisation and other states parties to the agreements seeking: 5.3.
20. to eliminate barriers to international trade which could stem from standards, technical regulations and conformity assessment procedures enforced; 5.3.
21. to ensure publicity concerning standards, technical regulations and conformity assessment procedures which are in the process of development; 5.3.3 to provide a possibility to all member of the World Trade Organisation and the states parties to other agreements to submit their comments concerning standards, technical regulations and conformity assessment procedures enforced in Lithuania; 5.3.
22. to provide a possibility to the public authorities of the Republic of Lithuania and other interested legal persons and enterprises without legal persons rights to submit their comments on standards, technical regulations and conformity assessment procedures developed by the members of the World Trade Organisation and states parties to other agreements.
23. The Department shall: 6.
24. develop every six months the programmes concerning standards in Lithuania (including those in the process of development and standards adopted six months prior to the preparation of the programme); 6.
25. announce in the bulletins issued by the Department the information about draft technical regulations and conformity assessment procedures, which were developed in the Republic of Lithuania and communicated to the Secretariat of the World Trade Organisation, as well as the information concerning the standards programmes in Lithuania; 6.
26. publicise announcements concerning draft technical regulations and conformity assessment procedures of the members of the World Trade Organisation and states parties to other agreements; 6.
27. forward notifications to the following institutions concerning standards programmes in Lithuania: 6.4.
28. the Information Centre; 6.4.
29. the institutions specified in other agreements according to the established procedure; 6.
30. submit upon the request of the members of the World Trade Organisation and the states parties to other agreements the copies of standards programmes in Lithuania or copies of draft standards; 6.6 handle all information related with the comments received concerning draft standards in Lithuania which are in the process of development, as well as comments of the Republic of Lithuania concerning draft standards developed by members of the World Trade Organisation and the states parties to other agreements; 6.7 submit notification on draft technical regulations and conformity assessment procedures in Lithuania to: 6.7.
31. to the Secretariat of the World Trade Organisation; 6.7.
32. to the institutions specified in other agreements according to the established procedure; 6.
33. submit upon the request of the members of the World Trade Organisation and the states parties to other agreements copies of technical regulations and conformity assessment procedures; 6.
34. submit to the interested legal persons of the Republic of Lithuania and enterprises without legal persons rights notifications received from the Secretariat of the World Trade Organisation concerning the suggestions on technical regulations and conformity assessment procedures as well as notifications received from the states parties to other agreements; 6.
35. obtain from the members of the World Trade Organisation, upon the request of the interested legal persons of the Republic of Lithuania and enterprises without legal persons rights, unabridged texts of draft technical regulations and conformity assessment procedures; 6.
36. handle information related with the comments received concerning draft technical regulations and conformity assessment procedures in Lithuania which are in the process of development, as well as comments received from the public authorities of the Republic of Lithuania concerning technical regulations and conformity assessment procedures developed by members of the World Trade Organisation and the states parties to other agreements; 6.
37. communicate to the Secretariat of the World Trade Organisation information about the bilateral and multilateral agreements concluded by the Republic of Lithuania concerning standards, technical regulations and conformity assessment procedures with reference to which products they are applicable and accompanied by a brief description of the agreement; 6.
38. submit to the member of the World Trade Organisation and legal and natural persons thereof, as well as to the states parties to other agreements upon their inquiry information about the standards, technical regulations and conformity assessment procedures which are already approved or are in the process of development in Lithuania, and upon their request prepare copies of these documents for their attention in the Lithuanian language. The production and delivery of the copies of these documents is charged in the amount established by the Department and not exceeding the amount of charges levied from legal persons of the Republic of Lithuania and enterprises without the legal persons rights. 6.
39. provide to the legal persons of the Republic of Lithuania and enterprises without the legal persons rights upon their request the information concerning national standards, technical regulations and conformity assessment procedures which are approved or in the process of development by the members of the World Trade Organisation.
40. Public authorities shall: 7.
41. communicate information to the Department on the technical regulations and conformity assessment procedures drawn up in breach of the requirements for international standards and capable of exerting a considerable impact on trade by submitting a filled-in report in the established form of the Department (questions in the “c” section will be covered in the event of submission of reports to the European Commission only) and draft technical regulations or conformity assessment procedure stored in a floppy disk, in the Lithuanian language, 90 days beforehand the planned adoption date of the document so that the members to the World Trade Organisation might submit comments; 7.
42. inform the Ministry of Foreign Affairs on the draft documents referred to in paragraph 7.1 by submitting the fully printed text of a draft technical regulation; 7.
43. offer consultations on the comments of members to the World Trade Organisation for the Secretariat or member of this Organisation at their request; 7.
44. in working out a definitive draft technical regulation or conformity assessment procedure, take the comments of the members to the World Trade Organisation and states parties to other agreements into account; 7.
45. adopt technical regulations and conformity assessment procedures that were communicated to states parties to other agreements under the provisions of these agreements. 7.
46. forward the adopted and published text of the technical regulations or conformity assessment procedure to the Department; 7.
47. notify the Department of bilateral and multilateral agreements with other states relating to technical regulations, standards or conformity assessment procedures, indicating to which products the agreement is applicable, and submit a short description of the agreement;
48. Public authorities may adopt technical regulations or conformity assessment procedures non-complying with Paragraph 7.1 of the present provisions in those cases where these documents should be prepared as the matter of urgency for reasons of public health, safety, and the environmental protection or the prevention of fraudulent activities pursuant to the requirements of national security.
49. Public authorities, relevant legal persons and enterprises without legal person rights have a right to submit to the Department comments on the draft standards technical regulations and conformity assessment procedures of members to the World Trade Organisation and states parties to the other agreements.
50. The Department in co-operation with a public authority, which is responsible for the adoption of relevant technical regulations and conformity assessment procedures in the Republic of Lithuania, and fifteen days prior to the deadline for the submission of comments, shall summarise the comments received from the above institutions referred to in paragraph 9 of these Regulations, and on behalf of the Republic of Lithuania shall express its opinion to the member to the World Trade Organisation or the states parties to other agreements.
51. Public authorities, legal and natural persons have a right to obtain information on national standards, technical regulations, conformity assessment procedures, approved or prepared by the members to the World Trade Organisation or states parties to other agreements. This information might be obtained from the Department in the established order or directly from the relevant information services of the members to the World Trade Organisation or states parties to other international agreements with their addresses published in the Department bulletin. III. Actions of Department and Public Authorities Relating to the Development, Adoption, Application and Exchange of Information on the European Union Standards and Technical Requirements
52. The Department shall: 12.
53. communicate information to the European Commission, European standardisation bodies and national standardisation bodies of the European Union Member States on every new subject for standardisation included in the Lithuanian standards programmes; the information shall indicate that: 12.1.
54. the draft Lithuanian standard will transpose an international standard without being identical or equivalent to the international standard; 12.1.
55. it will be a new Lithuanian standard; 12.1.
56. it will amend a Lithuanian standard; 12.
57. submit a whole Lithuanian standards programme or a part thereof to the European Commission upon its request; 12.
58. communicate all draft standards to the European Commission, European standardisation bodies and national standardisation bodies of European Union Member States upon their request; 12.
59. publish information in the Department bulletin on Lithuanian draft standards; 12.
60. keep informed the European Commission, European standardisation bodies and national standardisation bodies of European Union Member States on a regular basis of the actions taken as response to any comments of the European Union Member States relating to Lithuanian drafts; 12.
61. not object to a subject for standardisation in its work programme being discussed at European level in accordance with the rules laid down by the European standardisation bodies and undertake no action which may prejudice a decision of the European standardisation bodies in this regard; 12.
62. refrain in particular from any Lithuanian standards adopted in breach of the provisions of paragraphs 12.1-12.5 of these rules; examine the current Lithuanian standards within five years from the adoption of these rules and replace them in accordance with the requirements referred to in paragraphs 12.1-12.5 of these rules; 12.
63. grant the national standardisation bodies of European Union Member States the right to be involved passively (by providing comments) or actively (by sending observers) in the planned standardisation activities; 12.
64. ensure that during the preparation of a European draft standard in the European Union, the standardisation bodies do not take any actions which could prejudice the harmonisation intended and, after its approval, that they do not adopt any new or revised Lithuanian standard which is not completely in line with an existing European standard; This provision shall not apply to the work of a standardisation institutions undertaken at the request of public authorities to draw up a relevant standard for specific products for the purpose of enacting technical regulations for such products. The Department shall communicate this request as a draft technical regulation, in accordance with paragraph 12.10.1 of the present rules when a public authority states the grounds for its enactment; 12.
65. communicate to the European Commission: 12.10.
66. any draft technical regulation, except where it merely transposes the full text of an international or European standard, in which case the Department shall furnish information regarding the relevant standard, on the basis of which a technical regulation is developed; 12.10.
67. a brief statement of the grounds which make the enactment of such a technical regulation necessary, where these have not already been made clear in the draft; 12.10.
68. the basic legislative provisions relating to a draft regulation, where it is necessary to assess the effect of the draft regulation on the free movement of goods;
71. all changes to the draft technical regulation in question; 12.10.
72. information of the actions taken as response to any comment of the European Commission and the European Union Member States made concerning draft technical regulation, and the definitive text of a technical regulation;
75. the comments of the public authorities of the Republic of Lithuania on the draft technical regulations of European Union Member States;
76. Public authorities shall: 13.
77. from 2004, refrain from application by reference to a Lithuanian standard which was not communicated to the European Commission, European standardisation bodies and the national standardisation institutions of the European Union Member States in accordance with the requirements referred to in paragraphs 12.1-12.5 of these rules; 13.
78. forward to the Department the full draft technical regulation, together with the statement of the grounds and basic legislative provisions of the draft concerned, should they be necessary to asses the implications of the draft technical regulation, and the filled-in report in the prescribed form of the Department; if a draft technical regulation complies with the whole text of an European or international standard, the Department shall be kept informed by public authorities on the European or international standard concerned, indicating the necessity of adoption of this technical regulation; 13.
79. where a draft technical regulation seeks to limit the marketing or use of a chemical substance, preparation or product on grounds of public health or of the protection of consumers or the environment, forward a communication with a short description of the chemical substance, preparation or product concerned, or references of all relevant data relating to the substance, and communicate the anticipated effects of the measure on public health and the protection of the consumer and the environment, together with an analysis of the risk carried out as appropriate in accordance with the general principles for the evaluation of chemical substances as referred to in legislation that comply with the European Union regulations; 13.
80. postpone the adoption of a draft technical regulation: 13.4.
81. for three months in every case from the date of receipt by the European Commission of the communication; 13.4.
82. for four months from the date of receipt by the European Commission of the communication if the draft is related to the agreement where a public authority is a contracting party and which envisages to follow technical specifications or other requirements for the benefit of the public; 13.4.
83. for six months if the European Commission or other Member State delivers a detailed opinion, in three months from the date of receipt of the European Commission of the communication, to the effect that the measure envisaged may create obstacles to the free movement of goods within the internal market of the European Union. Lithuania shall report to the European Commission on the action it proposes to take on this detailed opinion. 13.4.
84. for twelve months if the European Commission for three months from the date of receipt of the communication: 13.4.4.
85. announces its intention to propose or adopt a directive, regulation or decision on the matter; 13.4.4.
86. announces its findings that the draft technical regulation concerns a matter which is covered by a proposal for a directive, regulation or decision; 13.4.
87. for eighteen months if the Council of Europe adopts a common position during the standstill period referred to in paragraph 13.4.4 of these rules; 13.
88. take the comments of the European Union or the European Union Member States into account as far as possible;
90. submit to the Department the definitive text of a technical regulation; 13.
91. record a reference, as prescribed by the legislation of the Republic of Lithuania, confirming that a technical regulation was developed in accordance with the requirements of Directive 98/34/EC of the European Union;
92. Paragraph
93. 4 of these rules shall not apply where public authorities are obliged to adopt: 14.
94. a technical regulation if, for urgent reasons, relating to the protection of public health or safety, the protection of animals or the preservation of plants, they must urgently to prepare technical regulations in a very short space of time without any consultations being possible. Following the preparation of technical regulations referred to in paragraph 14.1 of these rules, a public authority shall give in the communication to the Department the reasons which warrant the urgency of the measures taken; 14.
95. within their competence laws prohibiting the manufacture of a product as they do not impede the free movement of goods; 14.
96. within their competence legislation with respect to technical specifications or other requirements relating to the fiscal or financial aspect of the measure;
97. Paragraph 13.4 of these rules shall not apply to those laws or agreements of the public authorities by means of which authorities: 15.
98. comply with binding European Community acts, which result in the adoption of technical specifications; 15.
99. fulfil obligations arising out of international agreements, which result in the adoption of technical specifications in the European Community; 15.
100. make use of safeguard clauses provided for in binding European Union acts; 15.
101. take urgent measures that prevent the selling or use of a hazardous product within the territory of the state in accordance with the laws of the Republic of Lithuania; 15.
102. restrict themselves to implementing a judgement of the Court of Justice of the European Communities;
104. restrict themselves to amending a technical regulation at the request of the European Commission, with a view to removing a technical obstacle to trade;
105. Public authorities may not postpone for twelve months those agreements in which a public authority is a contracting party and which envisage to comply with technical specification or other requirements for the benefit of the public.
106. Public authorities have a right to submit comments to the Department or a detailed opinion on the draft technical regulations of the European Union Member States in the procedure prescribed by paragraphs 9 and 10 of these rules;
107. When a Lithuanian draft technical regulation forms part of documents which are required to be communicated at the draft stage under another European Community act, a public authority may make a communication under that other act, provided that it formally indicates that the said communication also constitutes a communication under the requirements of Directive 98/34/EC of the European Union, and forward a copy of the communication to the Department.