The National Technical Regulation

THE NATIONAL TECHNICAL REGULATION ACT,
2017
ARRANGEMENT OF SECTIONS
PART I
PRELIMINARY PROVISIONS
Section
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
National Technical Regulation [No. 5 of 2017 119
Single copies of this Act may be obtained from the Government Printer,
P.O. Box 30136, 10101 Lusaka. Price K32.00

hnical Regulation [No. 5 of 2017 119
Single copies of this Act may be obtained from the Government Printer,
P.O. Box 30136, 10101 Lusaka. Price K32.00

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
120 No. 5 of 2017] National Technical Regulation

reign test reports and certification
23. Market surveillance
PART V
GENERAL PROVISION
24. Regulations
120 No. 5 of 2017] National Technical Regulation

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. PART I
PRELIMINARY PROVISIONS
1. This Act may be cited as the National Technical Regulation
Act, 2017, and shall come into operation on a date that the Minister
appoints by statutory instrument. National Technical Regulation [No.

l Regulation
Act, 2017, and shall come into operation on a date that the Minister
appoints by statutory instrument. National Technical Regulation [No.

5 of 2017 121
Enactment
Short title and
commencement
GOVERNMENT OF ZAMBIA
ACT
No. 5 of 2017
Date of Assent:12th April, 2017

5 of 2017 121
Enactment
Short title and
commencement
GOVERNMENT OF ZAMBIA
ACT
No. 5 of 2017
Date of Assent:12th April, 2017

2.

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
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;
122 No.

ental authorisation of a
conformity assessment body to perform specified
conformity assessment activities with a public domain
responsibility;
122 No.

5 of 2017] National Technical Regulation
Act No. 12 of
2011
Act No. of
2017
Act No. of
2017
Act No. of
2017
Interpretation

5 of 2017] National Technical Regulation
Act No. 12 of
2011
Act No. of
2017
Act No. of
2017
Act No. of
2017
Interpretation

“ 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;
National Technical Regulation [No.

, department or agency
with authority and power to develop or oversee the
implementation of a technical regulation;
National Technical Regulation [No.

5 of 2017 123
Act No. 12
of 2011
Act No. of
2017
Act No. of
2017
Act No. of
2017

5 of 2017 123
Act No. 12
of 2011
Act No. of
2017
Act No. of
2017
Act No. of
2017

“ 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 .

on Agreement on Technical Barriers to Trade;
and
“ Zambian National Standard ” means a standard approved
by the Bureau under the Standards Act, 2017 .

124 No. 5 of 2017] National Technical Regulation
Act No. of
2017

124 No. 5 of 2017] National Technical Regulation
Act No. of
2017

3. (1) Despite any other written law, and subject to subsections
(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.

ive, 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
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;
National Technical Regulation [No.

ll be applied in a non-discriminatory
and uniform manner to imported and locally produced
commodities and services;
National Technical Regulation [No.

5 of 2017 125
Principles of
technical
regulation
Application
of Act

5 of 2017 125
Principles of
technical
regulation
Application
of Act

(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.

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
5. (1) There is established the Department of Technical
Regulation in the Ministry responsible for trade to implement the
national technical regulation framework and ensure transparency
and consistency in the development, implementation and
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. 6. (1) The functions of the Department are to—
(a) oversee the review of technical regulations to ensure
compliance with the provisions of this Act and
international standards;
126 No. 5 of 2017] National Technical Regulation
Establishment
of
Department
of
Technical
Regulation
Functions of
Department

international standards;
126 No. 5 of 2017] National Technical Regulation
Establishment
of
Department
of
Technical
Regulation
Functions of
Department

(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.

f 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. National Technical Regulation [No. 5 of 2017 127

ions made by a regulatory
agency, metrology institution, accreditation body or standard setting
body. National Technical Regulation [No. 5 of 2017 127

7. The Public Service Commission shall appoint, as public
officers, the Director for Technical Regulation and such other staff
as are necessary for the proper administration of this Act. 8. (1) A regulatory agency may co-operate with foreign and
international regulatory agencies in the development and
implementation of technical regulations. (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
9. The structure and content of a technical regulation that is
developed by a regulatory agency shall comply with the requirements
specified in this Act. 10.

structure and content of a technical regulation that is
developed by a regulatory agency shall comply with the requirements
specified in this Act. 10.

(1) A technical regulation shall —
(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-
128 No. 5 of 2017] National Technical Regulation
Director and
other
staff
International
co-operation
on
technical
regulation
Structure and
content of
technical
regulation
Scope of
technical
regulation

irector and
other
staff
International
co-operation
on
technical
regulation
Structure and
content of
technical
regulation
Scope of
technical
regulation

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
of risk to causing harm, contain the minimum 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.

(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
compliance with the requirements for a commodity or service where
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
the surveillance functions of the regulatory agency shall be clearly
detailed in the technical regulation. National Technical Regulation [No. 5 of 2017 129
Essential
safety
requirements
Referencing
of
standards
Financing
of
surveillance
by
regulatory
agency

National Technical Regulation [No. 5 of 2017 129
Essential
safety
requirements
Referencing
of
standards
Financing
of
surveillance
by
regulatory
agency

(2) The supplier shall be responsible for financing the
conformity assessment services provided by the designated or
acceptable conformity assessment service providers. 14. A commodity and service falling under a technical regulation
shall be placed on the market if the commodity and service —
(a) does not endanger public safety or health or plant or animal
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. 15. (1) A supplier shall provide proof of compliance with a
conformity assessment scheme as provided under Part IV. (2) A supplier shall, in all cases, be required to compile and
retain the required technical documentation including the declaration
of conformity. 16. (1) Subject to subsection (2), a supplier or service provider
of a commodity or service, or a representative of the supplier or
service provider, shall ensure that the commodity or service complies
with the requirements of a technical regulation.

presentative of the supplier or
service provider, shall ensure that the commodity or service complies
with the requirements of a technical 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. 17. (1) A regulatory agency shall—
(a) before developing a technical regulation, ensure that the
technical regulation is justified based on evidence and
the nature of the problem; and
(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;
130 No. 5 of 2017] National Technical Regulation
Placement
on
market of
commodities
and services
Responsibility
for
compliance
with
technical
regulation
Guidelines
for
developing
and
implementing
technical
regulations
Proof of
compliance
with
technical
requirements

compliance
with
technical
regulation
Guidelines
for
developing
and
implementing
technical
regulations
Proof of
compliance
with
technical
requirements

(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.

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
the date that a technical regulation became effective, cause the
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
the environment or human and animal life and health, in consultation
with Cabinet, by statutory instrument, adopt and publish a technical
regulation intended to deal with the threat, without following the
procedure specified in section 17. National Technical Regulation [No. 5 of 2017 131
Review of
technical
regulation
Procedure
for
developing
and
implementing
technical
regulation
for
emergency
situation

al Regulation [No. 5 of 2017 131
Review of
technical
regulation
Procedure
for
developing
and
implementing
technical
regulation
for
emergency
situation

(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
20. (1) Where a formal assurance of conformity with a technical
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.

ment 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. 21. (1) A conformity assessment scheme shall enable the
regulatory agency to ensure that commodities and services placed
on the market conform to the requirements of the relevant technical
regulation. 132 No. 5 of 2017] National Technical Regulation
Conformity
assessment
schemes
Principal
guidelines

requirements of the relevant technical
regulation. 132 No. 5 of 2017] National Technical Regulation
Conformity
assessment
schemes
Principal
guidelines

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.

hall 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
commodities may be accepted by the regulatory agency if —
(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
and services placed on the market to ensure that they comply with
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. Foreign test
reports and
certification
Market
surveillance

134 No. 5 of 2017] National Technical Regulation
PART V
GENERAL PROVISION
24. The Minister may, by statutory instrument, make regulations
for the better carrying out of the provisions of this Act.
Regulations