Law on Standardization (Draft)

Working document DRAFT

REPUBLIC OF ALBANIA THE PARLIAMENT

LAW No. , dated 2007

STANDARDIZATION

Based on Articles 78 and 83, point 1 of the Constitution of the Republic of Albania, with the proposal of the Council of Ministers, the Parliament of the Republic of Albania

HAS DECIDED:

Chapter One

GENERAL PROVISIONS

Article 1

(1) This Law regulates the conduct of the national standardization activity and the procedure for the establishment, organisation and functioning of the General Directorate of Standardization, hereinafter referred to as “DPS”.

(2) This Law shall define the role of DPS in relation to the notification procedure in the area of standards, for elimination of technical barriers to trade.

(3) This Law does not apply to standards, developed and approved in companies, agencies and sector organisations.

Article 2

For the purpose of this Law, the following meanings shall apply:

(i) “Standardization” means an activity of establishing, with regard to actual or potential problems, provisions for common and repeated use, aimed at the achievement of the optimum degree of order in a given context.

(ii) “Standardization body” means a standardization body recognized at national, regional or international level, which has as a principal function, by virtue of its statutes, the preparation, approval or adoption of standards that are made available to the public.

1 (iii) “National standardization body” means a standardization body recognized at the national level, which is eligible to be the national member of the corresponding international and regional standards organizations.

(iv) “ International standardization organisation” means a standardization body whose membership is open to the relevant national body from every country.

(v) "European Standards Organisations" means CEN (European Committee for Standardization), CENELEC (European Committee for Electrotechnical Standardization) and ETSI (European Telecommunications Standards Institute).

(vi) “ Standard” means a voluntary document, established by consensus and approved by a recognised standardization body, which provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context.

(vii) “International standard” means a standard that is adopted by an international standardization organisation and made available to the public.

(viii) "European Standard" (EN) means a voluntary standard adopted by one of the European Standards Organisations, with an obligation of implementation as an identical national standard in Albania and withdrawal of conflicting national standards and normative documents in Albania.

(ix) "Harmonization Document" (HD) means a voluntary normative document adopted by one of the European Standards Organisations, with an obligation of implementation of the technical content in Albania and withdrawal of conflicting national standards and normative documents in Albania.

(x) "Harmonised Standard" means a European Standard (EN) or Harmonization Document (HD), adopted by one of the European Standards Organisations, following a mandate issued by the European Commission after consultation of Member States, the reference numbers of which have been published in the Official Journal of the European Union.

(xi) "Albanian Standard" means a voluntary document established by consensus, and approved by DPS in accordance with the requirements of this Law, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context. Albanian Standards shall be marked with the initials "S SH".

(xii) "Harmonised Albanian Standard" means an Albanian Standard, transposing a Harmonised Standard in support of regulations, the reference of which has

2 been adopted on a list by the Ministry of Economy, Trade and Energy based on the proposal of DPS and after consultation with the competent Ministries and/or other executive authorities. The list of Harmonised Albanian Standards or any revision thereof shall be published by the Ministry of Economy, Trade and Energy in the Official Gazette. Any legal references to Harmonised Albanian Standards shall be indicative.

(xiii) “Regulation” means a document providing binding legislative rules, which is adopted by an executive authority.

(xiv) “Normative document” means any document that provides rules, guidelines or characteristics for activities or their results and covers such documents as standards, technical specifications, codes of practice and regulations.

(xv) “ Executive authority” means an authority body that has legal powers and rights and is responsible for preparing or adopting regulations.

(xvi) “European Union directive” means a European Union (formerly EC-European Community) legal instruction, binding on all Member States but which must be implemented through national legislation within a prescribed time-scale.

(xvii) “Indicative reference (to standards)” means a reference to standards that states that one way to meet the relevant requirements of a regulation is to comply with the standard(s) referred to in an annex to the regulation.

(xviii) "Standardization document" means a document, adopted by European and international standardization bodies, such as a Technical Specification, Technical Report, Manual or Workshop Agreement, which is generally accessible.

(xix) “ Standardization work programme” means the working schedule of a standardization body, which lists its current items of standardization work.

(xx) “ Consensus” means general agreement, characterized by the absence of sustained opposition to substantial issues by any important part of the concerned interests and by a process that involves seeking to take into account the views of all parties concerned and to reconcile any conflicting arguments.

(xxi) “ State of the art” means developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience.

(xxii) “Fitness for purpose” means ability of a product, process or service to serve a defined purpose under specific conditions.

(xxiii) “ Identical” means identical in both substance and presentation and, if in a different language, it is an accurate translation.

3 (xxiv) “ Implementation” means giving a European Standard the status of an Albanian Standard, either by publication of an identical text or by endorsement, and by withdrawing any conflicting national standards and normative documents in Albania.

(xxv) “ Review” means the activity of checking a standard or standardization document to determine whether it is to be reaffirmed, changed or withdrawn.

(xxvi) “Amendment” means the modification, addition or deletion of specific parts of the content of a standard or standardization document.

(xxvii) “Revision” means the introduction of all necessary changes to the substance and presentation of a standard or standardization document.

Article 3

(1) Standardization is a voluntary, consensus-driven activity, carried out by and for the interested parties themselves, based on openness and transparency, within recognised standardization bodies, leading to the adoption of standards, compliance with which is voluntary.

(2) Standards should have fitness for purpose, have a high degree of acceptability as a result of the full involvement of all relevant interested parties in the standardization process, be coherent with each other and allow for technical innovation and competition.

Article 4

The activity of national standardization shall include:

(i) development of Albanian Standards at national level and their acceptance, approval, publication, dissemination and distribution;

(ii) participation in the development of standards at European and international level, their implementation as Albanian Standards, their publication, dissemination and distribution.

Article 5

Albanian Standards shall be identified by an initial and numerical designation. The initial designation shall consist of the letters "S SH" or a combination of the letters "S SH" and other letter designations, in the cases of implementation of European or International Standards. The numerical designation shall consist of the number of the standard and the year of its approval or implementation. These designations shall not be used for standards, other than Albanian Standards.

4 Article 6

(1) The application of Albanian Standards shall be voluntary.

(2) Albanian Standards are the same for all natural and legal persons, native and foreign, who exercise economic activities in the Republic of Albania.

(3) A regulation, which contains technical requirements, may make reference to Albanian Standards and/or parts of Albanian Standards only when such regulations implement European Union directives. Such standards shall be referred to as “Harmonised Albanian Standards”.

(4) The executive authorities that develop regulations containing references to Albanian Standards and/or parts of Albanian Standards, developed at national level, shall agree the draft regulations with DPS.

(5) A regulation shall make reference to Albanian Standards, which adopt European or international standards, only when they have been implemented by DPS and published as Albanian Standards.

Chapter Two

STRUCTURE AND MANAGEMENT OF THE GENERAL DIRECTORATE OF STANDARDIZATION (DPS)

Article 7

(1) DPS is the national standardization body for the Republic of Albania, with responsibility for standards in all sectors except for those in the telecommunications field.

(2) DPS is a central public institution, with its headquarters in Tirana, reporting to the Minister of Economy, Trade and Energy.

(3) DPS is managed by the General Director, who is appointed and dismissed by the Minister of Economy, Trade and Energy.

(4) The structure and organisation chart of DPS is approved by the Minister of Economy, Trade and Energy.

(5) DPS is a budgetary institution, with its own budget, and is entitled to use the income, which it earns from its services, as defined by agreement with the Ministry of Finance.

Article 8

5 DPS shall conduct its operations in compliance with the laws of the Republic of Albania and the Rules and procedures for national standardization activities which shall be published by DPS.

Article 9

(1) The governing bodies of DPS shall be the Managing Board and the General Director.

(2) The Managing Board shall be regulated by a Decision of the Council of Ministers.

Article 10

(1) Technical Committees on standardization shall be working bodies of DPS, responsible for specific designated areas of standardization.

(2) Technical Committees shall be established and dissolved by DPS.

(3) Participation in Technical Committees shall be voluntary.

(4) Participation in Technical Committees shall be open to all interested parties.

Article 11

(1) Technical Committees shall:

(i) develop and adopt drafts of Albanian Standards and standardization documents;

(ii) propose to the General Director for approval drafts of Albanian Standards and standardization documents;

(iii) participate in the development of European and International Standards and standardization documents in their respective areas and their implementation as Albanian Standards.

(2) The Rules and procedures of work of the Technical Committees shall be regulated in the Rules and procedures for national standardization activities.

Chapter Three

ORGANISATION OF NATIONAL STANDARDIZATION ACTIVITIES

Section One

Aims and Principles of the General Directorate of Standardization (DPS)

Article 12

The aims of DPS are to:

(i) assist the development and competitiveness of the Albanian economy in the context of growing international economic integration by ensuring sustainable development;

(ii) harmonise national standards with European and International Standards as a prerequisite for improving the quality of products, processes and services and for reducing and gradually eliminating technical barriers to trade;

(iii) contribute to legislation in respect to the requirements for the preservation and improvement of the quality of life, safety and health, environmental and consumer protection, thus ensuring unified requirements.

Article 13

In order to achieve its aims, DPS shall respect the following generally accepted principles:

(i) the right to voluntary participation and contribution by all interested groups in developing and approving for adoption Albanian Standards;

(ii) consensus (i.e. general agreement) of participants in standardization work on the technical content of standards;

(iii) precedence of public over the private or personal interests of participants in standardization work;

(iv) transparency of work and access of the public to Albanian Standards;

(v) interoperability of Albanian Standards;

(vi) adoption of best practice;

(vii) adoption of the latest “state of the art” European and international standards as Albanian Standards;

(viii) respect for the rules of the European and international standardization organisations.

Section Two

Purposes and competencies of the General Directorate of Standardization (DPS)

Article 14

DPS shall:

(i) develop, approve and amend the rules and procedures of work on national standardization activities;

(ii) prepare and propose methodological guidance and instructions for the elaboration of standards, approved within agencies, branches of industry and companies;

(iii) prepare, approve and publish the standardization work programme in accordance with the interests of standardization stakeholders;

(iv) develop, accept and approve or implement, confirm, amend or withdraw Albanian Standards and Albanian standardization documents;

(v) distribute draft Albanian Standards, Albanian Standards, draft Albanian standardization documents and Albanian standardization documents;

(vi) distribute draft European Standards, European Standards, draft international standards, international standards, draft foreign national standards and foreign national standards;

(vii) delegate the distribution rights for draft Albanian Standards, Albanian Standards, draft Albanian standardization documents and Albanian standardization documents to a third party within the territory of the Republic of Albania or in other territories where Albanian is recognised as an official language;

(viii) compile and maintain a database of standards and standardization documents;

(ix) compile and maintain a stock of national, international, European and foreign national standards and a specialised library;

(x) provide information services according to the requirements of domestic and foreign entities which exercise economic activities in the Republic of Albania;

(xi) discharge the standardization-related duties resulting from the World Trade Organization Agreement on Technical Barriers to Trade and European Union Directive 98/34/EC of 22 June 1998 (amended by Directive 98/48/EC of 20 July 1998) laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services;

(xii) undertake with other standardization bodies the exchange of standards and cooperate with national standardization bodies from other countries in the field of standardization;

8 (xiii) organise training courses, seminars, conferences, and other events for promoting increased participation in national standardization activities;

(xiv) publish an official bulletin and a catalogue of Albanian Standards;

(xv) publish an annual report of its activity;

(xvi) encourage studies, publications, experience and research dealing with standardization and related activities. This shall include encouraging and coordinating initiatives of a scientific, technical, applicable and cultural character that have demonstrable links with standardization;

(xvii) propose legal and regulatory acts on the activities it covers;

(xviii) propose tariffs to the Ministry of Finance for the price of services carried out for third parties.

Article 15

DPS represents the Republic of Albania in the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC).

Article 16

DPS is responsible for preparing the notifications, referenced in Annex 3 to the World Trade Organization Agreement on Technical Barriers to Trade and submit them to the ISO/IEC Information Centre in Geneva, Switzerland.

Article 17

DPS shall respond to enquiries about Albanian Standards from interested parties from members of the World Trade Organization, and provide information regarding Albanian Standards, which have been adopted or proposed for adoption.

Article 18

(1) DPS shall notify the Commission of the European Union, the European Standardization Organisations and the national standardization bodies of the European Union Member States, and make available upon request, that part of its standardization work programme which relates to the adoption or change of national standards, or of international standards, which are not implemented in an identical manner.

(2) DPS shall make available to the Commission of the European Union, the European Standardization Organisations and the national standardization bodies of the European

9 Union Member States, upon request, the drafts of the standards under paragraph 1 above and shall ensure them an opportunity for providing opinions and comments.

Article 19

DPS, in conformity with the Rules and procedures for national standardization activities, shall comply with the requirements, shown in the rules of work of the European Standardization Organisations, for postponement or termination of work on national standards, which could have an impact on harmonisation at a European level.

Section Three

Development, adoption and approval of Albanian Standards

Article 20

Any natural and/or legal person may submit a proposal, with justification, to DPS for the development and approval of an Albanian Standard.

Article 21

The proposal under Article 20 above shall be justified in terms of:

(i) the goals to be attained by the proposed standard;

(ii) economic factors and impact;

(iii) provision of financing and expertise;

(iv) possible application of the standard for the purposes of conformity assessment;

(v) relation to other standards.

Article 22

(1) The General Director of DPS shall forward the proposal to the appropriate Technical Committee – or, where there is no Technical Committee, the Expert Working Group on Standardization – for review under the criteria established in Article 21 above.

(2) Following a decision to elaborate an Albanian Standard, DPS shall assign its actual development to the appropriate Technical Committee.

(3) If a proposal for a standard approved for development falls within an area of standardization where no Technical Committee has been established, DPS shall designate a Working Group of experts to develop by consensus the draft of the Albanian Standard.

10 Article 23

(1) The Technical Committees and Working Groups shall adopt the draft Albanian Standards after consensus has been achieved and shall submit them to the General Director for ratification as Albanian Standards.

(2) Consensus shall be achieved when there is an absence of sustained objections on substantive issues by any interested party after taking into consideration the views of all parties and all diverging viewpoints.

(3) Albanian Standards shall enter into force after ratification of the General Director and publication of the designations under Article 5 above and their titles in the DPS official bulletin.

Article 24

The procedure for development, adoption and ratification of Albanian Standards shall be regulated by the Rules and procedures for national standardization activities.

Section Four

Implementation of European and International Standards as Albanian Standards

Article 25

DPS is responsible for ensuring full implementation of all rules and decisions taken by the European Standards Organisations relating to their national members and affiliates.

European and international Standards shall be implemented in the Republic of Albania solely by adoption as Albanian Standards and withdrawal of conflicting standards and normative documents.

Article 26

(1) European Standards shall be implemented in an identical way as Albanian Standards:

(i) by adoption, approval and issue of an identical text of the standard in the Albanian language or in the official languages of the European Standardization Organisations; or

(ii) by endorsement as Albanian Standards.

(2) Confirmation of endorsement as Albanian Standards shall be done by issue of a national endorsement sheet and by announcement in the DPS official bulletin.

11 (3) By the implementation of European Standards, any conflicting Albanian Standards or other normative documents, approved at national level, shall be withdrawn.

Article 27

International Standards shall be implemented at the initiative of Technical Committees on standardization, upon proposal by natural and/or legal persons.

Article 28

The procedure for implementation of European and International Standards as Albanian standards shall be regulated in the Rules and procedures for national standardization activities.

Section Five

Development, adoption and approval of Albanian standardization documents

Article 29

(1) Albanian standardization documents shall be standardization documents which have been developed and approved or implemented by DPS.

(2) Albanian standardization documents shall be identified by a letter and numerical designation. The letter designation shall consist of the letters [SD – Standardization Document – in Albanian] or a combination of the letters [SD – Standardization Document – in Albanian] and other letter designations, in the cases of adoption of European or international standardization documents. The numerical designation shall consist of the number of the standardization documents and the year of their approval or adoption. These designations shall not be used for standardization documents, other than Albanian standardization documents.

(3) Albanian standardization documents shall not be developed, adopted and ratified under the procedure of Sections Three and Four above, without adhering to the principle of general agreement under Article 23, paragraph 2.

Section Six

Confirmation, amendment, revision and withdrawal of Albanian Standards and Albanian standardization documents Article 30

(1) DPS shall conduct periodic reviews on the current state of Albanian Standards.

12 (2) Confirmation, amendment, revision or withdrawal of an Albanian Standard or an Albanian standardization document shall take place in conformity with the Rules and procedures for national standardization activities.

Section Seven

Copyright and distribution rights

Article 31

DPS shall be the sole holder of the copyright in Albanian Standards and Albanian standardization documents.

The copyright of format and content of any Albanian Standard or standardization document shall vest in DPS and any person who, without written authorisation from DPS, publishes, reproduces or records in any manner or form, any document or part thereof in respect of which copyright vests in the DPS shall be in breach of this law and [reference to Albanian national Copyright Law].

Article 32

DPS shall have the exclusive right to publish, reproduce, distribute and sell Albanian Standards and Albanian standardization documents. DPS may appoint agents or distributors acting for the sale or distribution of Albanian Standards and Albanian standardization documents.

Article 33

Protection of the copyright of DPS in Albanian Standards and Albanian standardization documents shall be in accordance with the procedures of the [reference to Albanian national Copyright Law].

Chapter Four

FINANCING

Article 34

Revenue for the DPS operational budget shall be derived from:

(i) a subsidy from the state budget, approved by the Ministry of Finance for the respective year;

(ii) membership fees, paid by DPS members, in accordance with an agreement between DPS and interested parties;

13 (iii) the sale of standards and standardization documents;

(iv) the provision of services, including information and training;

(v) participation in European, international and other donor programmes and/or projects with special-purpose funding;

(vi) donations or grants from natural and legal persons, international funds, institutions and persons.

Chapter Five

TRANSITIONAL AND CONCLUDING PROVISIONS

Article 35

Standards, which were approved or adopted under the procedure of applicable legislation prior to entry into force of this Law, shall retain their validity.

Article 36

The Council of Ministers is charged to enact the following Decisions enforcing the implementation of this Law:

(i) "On the creation and functioning of the Board of the General Directorate of Standardization";

(ii) "The provision of information in the field of technical standards, technical regulations and conformity assessment procedures" which transposes the World Trade Organization (WTO) Agreement on Technical Barriers to Trade;

(iii) "The approval of the WTO code of good practice for the preparation, adoption and application of standards" which transposes the WTO Code of Good Practice for the preparation, adoption and application of standards, which forms Annex 3 to the WTO Agreement on Technical Barriers to Trade;

(iv) "The provision of information in the field of technical standards and regulations and of rules on information society services" which transposes European Union Directive 98/34/EC of 22 June 1998 (amended by Directive 98/48/EC of 20 July 1998) laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services with regard to the provision of information in the field of technical standards and regulations and of rules on Information Society services.

Article 37

14 The Law “On Standardization” no. 8464, dated 11.03.1999, and any other regulatory provisions amending this Law, are repealed.

Article 38

This Law comes into force 15 days following its publication in the “Official Gazette”.

THE CHAIRMAN