National Technical Regulation Act, 2017 (No. 5 of 2017)

1. Short title and commencement

2. Interpretation

3. Application of Act

4. Principles of technical regulation PART II ADMINISTRATION

5. Establishment of Department for Technical Regulation

6. Functions of Department

7. Director and other staff

8. International co-operation on technical regulation PART III TECHINICAL REGULATION

9. Structure and content of technical regulation

10. Scope of technical regulation

11. Essential safety requirements

12. Referencing of standards

13. Financing of surveillance by regulatory agency

14. Placement on market of commodities and services

15. Proof of compliance with technical requirements

16. Responsibility for compliance with technical regulation

17. Guidelines for developing and implementing technical regulations Single copies of this Act may be obtained from the Government Printer, P.O. Box 30136, 10101 Lusaka. Price K32.00 120 No. 5 of 2017] National Technical Regulation

18. Review of technical regulation

19. Procedure for developing and implementing technical regulation for emergency situation PART IV CONFORMITY ASSESSMENT SCHEMES

20. Conformity assessment schemes

21. Principal guidelines

22. Foreign test reports and certification

23. Market surveillance PART V GENERAL PROVISION

24. Regulations National Technical Regulation [No. 5 of 2017 121 GOVERNMENT OF ZAMBIA ACT No. 5 of 2017 Date of Assent:12th April, 2017 An Act to provide for the principles of, and a framework for, technical regulation that are compliant with best practice and regional and international obligations to which Zambia is a party; establish the Department of Technical Regulation in the Ministry responsible for trade; provide for the development and implementation of technical regulation for public safety and health, consumer protection and environmental protection; provide technical guidance to regulatory agencies on the development, implementation, administration and review of technical regulations; domesticate the International and Regional Agreements on Technical Barriers to Trade in order to ensure that regulations, standards, testing and certification procedures do not create unnecessary obstacles to trade but implement legitimate policy objectives and measures; and provide for matters connected with, or incidental, to the foregoing. [13th April, 2017 ENACTED by the Parliament of Zambia. Enactment PART I PRELIMINARY PROVISIONS

1. This Act may be cited as the National Technical Regulation Short title and Act, 2017, and shall come into operation on a date that the Minister commencement appoints by statutory instrument. 122 No. 5 of 2017] National Technical Regulation Interpretation 2. In this Act, unless the context otherwise requires — “ accreditation ” means third party attestation for a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks; “ adverse ” has the meaning assigned to it in the Environmental Act No. 12 of Management Act, 2011; 2011 “ Bureau ” means the Zambia Bureau of Standards established under the Standards Act, 2017; Act No. of “ certification ” means the formal substantiation that a product, 2017 process, service, organisation or individual meets the requirements of a standard; Act No. of “ commodity ” has the meaning assigned to it in the Standards 2017 Act, 2017; “ compulsory standard ” means a compulsory standard declared under the Compulsory Standards Act, 2017; Act No. of “ conformity assessment ” means the demonstration that a 2017 product, process, system, person or body meets the specified requirement; “ conformity assessment procedure ” means a procedure used, directly or indirectly, to determine that relevant requirements of a technical regulation or standard are met, and includes a procedure for sampling, testing, inspection, evaluation,verification, assurance of conformity, registration, accreditation and approval or a combination of these procedures; “ conformity assessment scheme ” means the rules, procedures and management for carrying out a conformity assessment; “ Department ” means the Department of Technical Regulation established under section 5; “ designate ” in relation to conformity assessment service providers, means the governmental authorisation of a conformity assessment body to perform specified conformity assessment activities with a public domain responsibility; National Technical Regulation [No. 5 of 2017 123 “ Director ” means the Director of Technical Regulation appointed under section 7; “ environment ” has the meaning assigned to it in the Environmental Management Act, 2011; “ inspection ” means the examination of a product,process or Act No. 12 installation and determination of its conformity with specific of 2011 requirements or, on the basis of professional judgement, with general requirements; “ ISO ” means the International Organisation for Standardisation; “ legal metrology ” has the meaning assigned to it in the Metrology Act, 2017; “ market ” in relation to any goods or services, includes a Act No. of market for those goods or services and other goods or 2017 services that are substitutable for, or otherwise competitive with, the goods or services; “ market surveillance ” means random checks and audits of, or taking samples and gathering of information with regard to, products and services available on the market and in warehouses; “ metrology ” has the meaning assigned to it in the Metrology Act No. of Act, 2017; 2017 “ national quality infrastructure ” means the totality of the institutional framework, whether public or private, the output of which includes metrology, standards, inspection, testing, certification and accreditation; “ pre-market approval ” means the scientific and regulatory review of a commodity, by the regulatory agency responsible for enforcing standards to which that commodity is subject, in order to establish that commodity’s safety and effectiveness before its approval for the market; “ process ” means a method of operation, manufacturing, production, storage, transportation, disposal or combination of these processes; “ product ” has the meaning assigned to it in the Standards Act, 2017; Act No. of 2017 “ production method ” means the mechanical or chemical steps used to create an object, usually repeated to create multiple units of the same item and generally involves the use of raw materials, machinery and human resource to create a product; “ regulatory agency ” means a Ministry, department or agency with authority and power to develop or oversee the implementation of a technical regulation; 124 No. 5 of 2017] National Technical Regulation “ relevant Minister ” means the Minister under whose portfolio a regulatory agency falls; “ service ” means any work or doing work for remuneration and at the request of a recipient of the service, and includes the process used for delivering the service; “ service provider ” means a person who supplies a service to which a technical regulation applies; “ standard ” means a document, approved by a recognised body, which provides for common and repeated use of the rules, guidelines or characteristics for products and their related processes or production methods, with which compliance is not mandatory, and includes terminology, symbols, packaging, marking or labelling requirements as they apply to a product or process; “ supplier ” means the manufacturer, merchant, distributor, importer or agent who places a product, process or service onto the market; “ SADC ” means the Southern African Development Community; “ technical regulation ” means a document which lays down commodity or service characteristics or their related processes and production methods, including administrative provisions, with which compliance is mandatory, and includes terminology, symbols, packaging, marking or labelling requirements as they apply to a commodity or service or their related processes; “ technical regulation framework ” means the manner in which technical requirements, the conformity assessment system, regulatory authority mandates and sanctions are applied in the development and implementation of technical regulation; “ trade ” means the buying, selling or exchange of goods and services; “ WTO TBT Agreement ” means the World Trade Organisation Agreement on Technical Barriers to Trade; and “ Zambian National Standard ” means a standard approved Act No. of by the Bureau under the Standards Act, 2017 . 2017 National Technical Regulation [No. 5 of 2017 125

3. (1) Despite any other written law, and subject to subsections Application (2) and (3), a technical regulation that is developed, implemented of Act or maintained by a regulatory agency shall comply with the requirements of this Act. (2) The provisions of this Act do not apply to a law, standard or technical regulation relating to national security the disclosure of which is prejudicial to the interests of the State. (3) The mandatory requirements for a commodity or service, and the method and scheme for assessing its conformity, which is contained in a technical regulation are exhaustive, have direct effect throughout the Republic and shall be amended by the introduction of an amendment or supplement to the technical regulation.

4. A technical regulation shall be developed, implemented and Principles of maintained in accordance with the following principles: technical regulation (a) a technical regulation shall not be prepared, adopted or applied in order to create an unnecessary obstacle to international trade, but to facilitate the trade; (b) a technical regulation shall be developed and implemented where it is necessary for the protection of human health or safety, animal or plant life or health, the prevention of deceptive practices and environmental protection; (c) technical regulation shall comply with the requirements of international and regional agreements to which Zambia is a party; (d) technical regulation shall comply with the national technical regulation framework, the functions of regulatory agencies and conformity assessment systems and sanctions; (e) technical regulation shall take into account the national economic interest, related processing technology or intended end-uses of products and the level of scientific and technical development; (f)the requirements of any technical regulations shall not create barriers to entrepreneurial activities to a greater degree than is minimally necessary for achieving its purposes; (g) technical regulation shall be applied in a non-discriminatory and uniform manner to imported and locally produced commodities and services; 126 No. 5 of 2017] National Technical Regulation (h) conformity assessment systems and technical regulation shall not serve as disguised protection against imported commodities and services; (i) conformity assessment systems governing imported products and services shall not be less favourable than those accorded to domestic products and services; (j)international, regional and national standards and norms, where available and applicable, shall be used as the basis for technical regulation; (k) the national quality infrastructure shall be used and suppliers shall choose their conformity assessment service providers who are technically competent and acceptable to, or so designated by, regulatory agencies; (l) regulatory agencies shall not, as far as is practicable and consistent with international practice, provide or participate in providing conformity assessment for commodities or services that they are mandated to inspect and control; (m) accreditation, certification and inspection bodies shall be independent from suppliers; and (n) technical regulations shall not be maintained if the circumstances or objectives giving rise to their adoption no longer exist or if the circumstances or objectives can be addressed in a less trade-restrictive manner. PART II ADMINISTRATION Establishment 5. (1) There is established the Department of Technical of Regulation in the Ministry responsible for trade to implement the Department of national technical regulation framework and ensure transparency Technical and consistency in the development, implementation and Regulation maintenance of technical regulations in accordance with the requirements of this Act. (2) The Minister may, by statutory instrument, appoint a Government department to perform the functions of the Department or agency on such terms and conditions as the Minister may determine. Functions of 6. (1) The functions of the Department are to— Department (a) oversee the review of technical regulations to ensure compliance with the provisions of this Act and international standards; National Technical Regulation [No. 5 of 2017 127 (b) audit technical regulations proposed by regulatory agencies to ensure that they comply with the national technical regulation framework; (c) co-ordinate the development of technical regulations by— (i) facilitating consensus among the regulatory agencies for purposes of this Act; and (ii) minimising overlaps in technical regulation for commodities and services among the regulatory agencies; and (d) review the compliance of the relevant authorities with the obligations under international and regional agreements relating to technical regulation that Zambia has ratified. (2) The Department shall, in implementing its functions under subsection (1) — (a) act as the notification point for Zambia with regard to technical regulation; (b) manage the regional and international trade agreement notification points; (c) facilitate Zambia’s participation in the WTO TBT Agreement and relevant regional committees; (d) promote good regulatory practices; (e) conduct training for officers responsible for technical regulation in regulatory agencies; (f) provide information related services on technical regulations; and (g) disseminate information to assist local companies and entrepreneurs to overcome technical barriers to trade. (3) The Department may — (a) develop and implement technical regulations; (b) provide conformity assessment services; and (c) accredit and designate conformity assessment service providers. (4) Except as provided for in subsection (1), the Department shall not exercise any authority over decisions made by a regulatory agency, metrology institution, accreditation body or standard setting body. 128 No. 5 of 2017] National Technical Regulation Director and 7. The Public Service Commission shall appoint, as public other staff officers, the Director for Technical Regulation and such other staff as are necessary for the proper administration of this Act. International 8. (1) A regulatory agency may co-operate with foreign and co-operation international regulatory agencies in the development and on technical implementation of technical regulations. regulation (2) International co-operation on technical regulation under subsection (1) may include— (a) information sharing; (b) enforcement of standards; (c) reciprocal recognition of standards; or (d) any other matter in respect of which co-operation may be granted under this Act. (3) A request for international co-operation by a foreign or international regulatory agency shall be made to the relevant regulatory agency in the prescribed manner and form. PART III TECHNICAL REGULATION Structure and 9. The structure and content of a technical regulation that is content of developed by a regulatory agency shall comply with the requirements technical regulation specified in this Act. Scope of 10. (1) A technical regulation shall — technical regulation (a) define the range of the commodities and services that are covered by the technical regulation; (b) clarify the nature of the hazards that it is intended to prevent; (c) avoid a proliferation of technical regulations for the same commodities or services related to similar hazards; (d) indicate the sequence and details of pre-market testing and certification, product approval and post-market surveillance, as relevant; (e) indicate the arrangement of information on the designated conformity assessment service providers; and (f)identify the regulatory agency and its powers and responsibilities regarding pre-market approvals and post- National Technical Regulation [No. 5 of 2017 129 market surveillance. (2) A technical regulation shall state that the supplier is responsible for providing proof that the commodity or service falling within the scope of a technical regulation meets its requirements. (3) A technical regulation shall provide for a process of appeal by suppliers who are aggrieved with, or are adversely affected by, a decision of the regulatory agency concerned.

11. (1) Technical regulations shall, taking into account the degree Essential of risk to causing harm, contain the minimum safety requirements safety requirements for commodities and services, but shall not specify or predict the technical solutions for doing so. (2) The safety requirements for commodities and services shall be precisely worded in order to — (a) create legally binding and enforceable obligations; (b) facilitate the development and reference of the appropriate standards; and (c) enable the assessment of conformity of commodities or services.

12. (1) A technical regulation may, in order to facilitate Referencing of compliance with the requirements for a commodity or service where standards a standard exists or has been established for the commodity or service to which the technical regulation relates, reference the standard or list of standards or specify the official publication listing of the standards for purposes of conformity. (2) The reference of the standards shall include, as a minimum, the number, title, scope and publisher of the standards. (3) The standards referred to in this section may be a Zambian National Standard published by the Bureau, a regional standard published by regional bodies or an international standard published by international standards bodies. (4) Compliance with a referenced standard confers a presumption of conformity of the commodity or service with the requirements of the technical regulation.

13. (1) The obligations of the State and the supplier in financing Financing of the surveillance functions of the regulatory agency shall be clearly surveillance detailed in the technical regulation. by regulatory agency 130 No. 5 of 2017] National Technical Regulation (2) The supplier shall be responsible for financing the conformity assessment services provided by the designated or acceptable conformity assessment service providers. Placement 14. A commodity and service falling under a technical regulation on shall be placed on the market if the commodity and service — market of commodities (a) does not endanger public safety or health or plant or animal and services life or health; (b) does not give rise to consumer exploitation; (c) does not have adverse effects on the environment when undertaken, installed and maintained; and (d) is used for the purpose for which it is intended. Proof of 15. (1) A supplier shall provide proof of compliance with a compliance conformity assessment scheme as provided under Part IV. with technical (2) A supplier shall, in all cases, be required to compile and requirements retain the required technical documentation including the declaration of conformity. Responsibility 16. (1) Subject to subsection (2), a supplier or service provider for of a commodity or service, or a representative of the supplier or compliance service provider, shall ensure that the commodity or service complies with technical with the requirements of a technical regulation. regulation (2) A regulatory agency shall, in conducting market surveillance, hold the supplier, seller or marketer responsible for compliance of the commodity or service with the technical regulation applicable to the commodity or service. Guidelines 17. (1) A regulatory agency shall— for developing (a) before developing a technical regulation, ensure that the and implementing technical regulation is justified based on evidence and technical the nature of the problem; and regulations (b) in developing a technical regulation, ensure conformity with relevant laws and guidelines for developing regulations that impact on business. (2) A regulatory agency shall, when consulting stakeholders during the development of the technical regulations, provide the following information: (a) a full description of the commodity or service which will be the subject of the technical regulation; National Technical Regulation [No. 5 of 2017 131 (b) the justification or the necessity of its development and implementation; (c) information on the adoption of international, regional or national standards as the basis for the technical regulation, including reasons for non-adoption, if any; and (d) the envisaged conformity assessment systems. (3) A regulatory agency shall submit the technical regulation to the Department for review for compliance with the national technical regulation framework and with international and regional obligations. (4) A regulatory agency shall, after clearance by the Department, submit the draft technical regulation, including the outcome of the review by the Department to the relevant Ministry for consideration and publication. (5) The Department shall notify the secretariat of the international and regional organisations as required by the relevant international and regional agreements regarding the technical regulation.

18. (1) The Department shall, not later than five years from Review of the date that a technical regulation became effective, cause the technical regulation relevant regulatory agency to review whether the technical regulation still complies with the principles stated in section 4 and with current international or regional standards, norms and rules. (2) Where the circumstances or purposes that caused the development and implementation of the technical regulation change or cease to exist, the Department shall cause the relevant regulatory agency to initiate the appropriate procedures for revision or withdrawal of the technical regulation.

19. (1) The relevant Minister may, where there is a threat to Procedure for the environment or human and animal life and health, in consultation developing with Cabinet, by statutory instrument, adopt and publish a technical and implementing regulation intended to deal with the threat, without following the technical procedure specified in section 17. regulation for emergency situation 132 No. 5 of 2017] National Technical Regulation (2) The statutory instrument referred to in subsection (1) shall state the justification for the technical regulation. (3) A technical regulation promulgated under this section shall not remain in force for a period exceeding one year from the date of its publication. (4) The relevant regulatory agency shall, while implementing a technical regulation for purposes of this section, develop an appropriate technical regulation in the manner prescribed in section 17. (5) A technical regulation passed under this section shall cease to have effect on the promulgation of the appropriate technical regulation. (6) The Department shall notify the secretariat of the international and regional organisations as required by the relevant international and regional agreements regarding the technical regulation. PART IV CONFORMITY ASSESSMENT SCHEMES Conformity 20. (1) Where a formal assurance of conformity with a technical assessment schemes regulation is required, a regulatory agency shall, where practicable — (a) formulate and adopt conformity assessment schemes based on international best practice; and (b) ensure that the conformity assessment services are provided in the most cost effective way. (2) A regulatory agency shall maintain a database of designated conformity assessment service providers. (3) Zambia shall recognise the accreditation body or bodies providing accreditation services in the technical regulation domain as part of the international mutual recognition mechanisms. Principal 21. (1) A conformity assessment scheme shall enable the guidelines regulatory agency to ensure that commodities and services placed on the market conform to the requirements of the relevant technical regulation. National Technical Regulation [No. 5 of 2017 133 (2) A regulatory agency shall, in selecting the appropriate conformity assessment scheme, take into consideration the — (a) appropriateness of the scheme for the type of commodity or service; (b) nature of the risks involved; (c) economic infrastructure of the sector; (d) type and importance of local production or importation mechanisms; (e) level of State surveillance; (f) technical capability of the national quality infrastructure; and (g) other requirements as prescribed by statutory instrument. (3) A regulatory agency shall not impose a conformity assessment scheme that is or is likely to be onerous relative to the objectives of the relevant technical regulation.

22. A foreign test report and certification for imported or local Foreign test reports and commodities may be accepted by the regulatory agency if — certification (a) an agreement of mutual recognition has been negotiated between the regulatory agency and the conformity assessment provider in the foreign country; or (b) the regulatory agency is of the opinion that the foreign conformity assessment service provider’stechnical competency has been adequately demonstrated through accreditation and that the risk of accepting the test reports and certification unilaterally is acceptable.

23. (1) A regulatory agency shall monitor the commodities Market and services placed on the market to ensure that they comply with surveillance the relevant technical regulation. (2) Pre-market approval of a commodity or service by a regulatory agency shall only be considered if the risk of failure and the consequential damage of the failure is so high that market surveillance alone is inadequate. 134 No. 5 of 2017] National Technical Regulation PART V GENERAL PROVISION Regulations 24. The Minister may, by statutory instrument, make regulations for the better carrying out of the provisions of this Act.