NATIONAL TECHNICAL REGULATION ACT

Arrangement of Sections

   Section

PART I
PRELIMINARY PROVISIONS

   1.   Short title

   2.   Interpretation

   3.   Application of Act

   4.   Principles of technical regulation

PART II
ADMINISTRATION

   5.   Establishment of Department of Technical Regulation

   6.   Functions of Department

   7.   Director and other staff

   8.   International co-operation on technical regulation

PART III
TECHNICAL 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

   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

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.

[1st January, 2018]

Act 5 of 2017,

SI 86 of 2017.

PART I
PRELIMINARY PROVISIONS

1.   Short title

This Act may be cited as the National Technical Regulation Act.

2.   Interpretation

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 Management Act, 2011;

“Bureau” means the Zambia Bureau of Standards established under the Standards Act, 2017;

“certification” means the formal substantiation that a product, process, service, organisation or individual meets the requirements of a standard;

“commodity” has the meaning assigned to it in the Standards Act, 2017;

“compulsory standard” means a compulsory standard declared under the Compulsory Standards Act, 2017;

“conformity assessment” means the demonstration that a 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;

“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 installation and determination of its conformity with specific 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 market for those goods or services and other goods or 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, 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;

“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;

“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 by the Bureau under the Standards Act, 2017.

3.   Application of Act

   (1) Despite any other written law, and subject to sub-sections (2) and (3), a technical regulation that is developed, implemented 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.   Principles of technical regulation

A technical regulation shall be developed, implemented and maintained in accordance with the following principles—

   (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;

   (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

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