Regulatory Framework

Business Registration and Licensing Authority (BRELA) was formed by The Business Licensing Act No. 25 of 1972 (Cap 208 R.E 2002)  and is mandated to register companies, business names and intellectual property rights such as patents of inventions, industrial designs, trade and service marks and issuance of industrial licenses.  The authority was formed by the following Act:

This is the Act that provides for the licensing of all businesses and for related matters. The Act prohibits any business from operating without a licence. The function of the Act is threefold: i) to regulate businesses; ii) to raise revenue from licensing; and iii) to gather and retain information on businesses. The regulatory objective of the Act is fulfilled through the use of pre-approval. The system of licensing is applied to all firms and individuals, regardless of the size and nature of the business being undertaken.

For further details please visit www.brela.go.tz

The National Environment Management Council (NEMC) is organisation that was established by The Environmental Management Act, No. 20 of 2004  to undertake the environmental enforcement, compliance, review and monitor environmental impact statements, research and awareness raising.

This Act provides for a legal and institutional framework for the sustainable management of the environment; it outlines the principles for management, impact and risk assessment; it provides for the prevention and control of pollution and waste management; it establishes environmental quality standards, compliance and enforcement; and provides for implementation of the National Environment Policy. This is the main law for all issues relating to the environment and health.

Section 81 of the Act imposes an obligation to undertake an Environmental Impact Assessment (EIA) for several projects, including industries involved in processing and manufacturing. A permit or licence to carry out any project or undertaking in accordance with any written law shall not entitle the proposed developer to undertake a project or activity without an environmental impact assessment certificate issued under this Act. The Act empowers the Minister responsible to make a recommendation to the licensing authority that the project should not be licensed or, where the licence has been issued, be cancelled if the project or undertaking does not comply with the environmental standards set by the Act.  

For details please visit  www.nemc.or.tz

Tanzania Revenue Authority (TRA) was established by the Act of Parliament No. 11 of 1995.  In carrying out its statutory functions, TRA is responsible for administering impartially various taxes of the Central Government.

The Income Tax Act, No.11 of 2004 makes provision for the charging, assessment and collection of income tax as well as ascertaining the amount to be charged and matters incidental thereto. Generally, this law and other tax laws provide for compulsory registration. The 4th Schedule of the Act specifies the transactions for which a Taxpayer Identification Number (TIN) is required. This requirement means that upon incorporating or registering a business the party concerned must immediately register with the Tanzania Revenue Authority and produce the TIN prior to securing a licence to undertake the business for which the entity  is established. The Value Added Tax (VAT) obliges person whose taxable turnover exceeds, or the person has reason to believe will exceed, the turnover prescribed in the regulations made under the Act, to make application to be registered within thirty days.

For details please visit www.tra.go.tz

***Tanzania Food and Drugs Authority (TFDA)*** was established by The Tanzania Food, Drugs and Cosmetics Act, No 1 of 2003 for the purpose of regulating the quality, safety and efficacy of food, medicines, cosmetics and medical devices.

This Act provides for the control of food, drugs, medical devices, cosmetics, herbal drugs and poisons. It was enacted to regulate food and food products manufactured and/or imported into the country. The law established the Tanzania Food and Drugs Authority as a regulatory body responsible for national-wide compliance and enforcement of regulations and laws governing food and drugs.

Section 5 empowers the Authority to: i) regulate all matters relating to the quality and safety of food, drugs, herbal drugs, medical devices, poisons and cosmetics; ii) regulate the importation, manufacture, labeling, marking or identification, storage, promotion, sale and distribution of food, drugs, cosmetics, herbal drugs and medical devices; iii) approve and register products regulated under the Act; iv) examine, grant, issue, suspend, cancel and revoke licences or permits issued under this Act; and v) prescribe standards of quality in respect of products regulated under this Act.

Section 18 prohibits any person from manufacturing for sale, selling, and supplying or storing products regulated unless the premises are registered and issued with a licence or permit by the Authority.

Section 22 prohibits a person from manufacturing for sale, selling, supplying, and importing or storing products regulated unless the product is registered and issued with a licence or permit by the Authority.

TFDA has powers under Section 21 to issue manufacturing licences, wholesale licences, retail licences or any other licence or permit as it deems fit, and it can vary any provision, suspend or revoke any licence issued under the Act as provided under section 25.

The Authority has the power to inspect any premises for the purpose of Good Manufacturing practice (GMP), distribution and routine inspection after the product has been in the market (post-marketing surveillance). In order to perform its functions adequately, TFDA has the following regulations;

• Import and Export of Food Regulations, 2006
• Food Hygiene Regulations, 2006
• Fees and charges, 2005
• Treatment and Disposal of Unfit Food, 2006  

For further information on the services provided by TFDA please visit on  www.tfda.or.tz

Tanzania Bureau of Standards (TBS) was formed by Standards Act, Act.No.2 of 2009 and it is mandated  to undertake activities that ensure measures for quality control of products of all descriptions and promotion of standards in industry and commerce.

This Act provides for the standardization of the specifications of commodities and services, the re-establishment of the Tanzania Bureau of Standards and an improvement in the provisions for the functions, management and control of the Bureau, as well as repealing the Standards Act, Cap130.

The law established the Bureau of Standards with the following powers and functions;

1. undertake measures to control the quality of commodities, services and the environment of all descriptions;
2. promote standardization in industry and trade;
3. approve, register and control the use of standard marks in accordance with the provisions of this Act;
4. provide for the inspection, sampling and testing of locally manufactured and imported commodities with a view to determining whether the commodities comply with the provisions of this Act or any other law dealing with standards relevant to those commodities;
5. assist industries in setting up and enforcing quality assurance and environmental management systems and procedures.

The Tanzania Bureau of Standards (TBS) sets standards and acts as  a member of ISO providing International Standards to companies. The Agency certifies the imports and new company’s products introduced into the market for a fee. The Act confers powers on the Bureau of Standards to issue a licence for standard marks. Any mark approved by the Bureau for any commodity or for the manufacture, production, processing or treatment of any commodity will be a standard mark in respect of it and TBS may, in like manner, cancel or amend that mark.

For further details on the services rendered by TBS please visit http://www.tbs.go.tz/

The Government Chemist Laboratory Authority (GCLA) was formed by the Industrial and Consumer Chemicals (Management and Control) Act, No.3 of 2003  for the purpose of providing high quality, cost effective testing/ analytical, advisory, research and consultancy services to the Government, private institutions and the general public on food, drugs, industrial and consumer chemicals and forensic sciences services (that include but not limited to DNA and toxicology).

GCLA is given the power to ensure that any chemical producer complies with the Good Manufacturing Practice (GMP) and undertakes Environmental Impact Assesment (EIA) before undertaking business operations.  This act also empowers the Chemical Laboratory Agency to issue a licence for producing, transporting, importing, exporting, storing and dealing in chemicals for a prescribed fee.

For further details of CGLA please visit www.gcla.go.tz/

Occupational Safety and Health Agency (OSHA)   was formed by   The  Occupational Health and Safety Act No. 5 of 2003:   with the aim of improving the health and well being of workers, and of workplaces. This is achieved by promoting occupational safety and health (OSH) practices in order to prevent occupational injuries and diseases, and ultimately achieve better productivity.

The main objectives of the Act are to repeal the Factories Ordinance, to make provision for the safety, health and welfare of persons at work in factories and other places of work, to provide for the protection of persons other than persons at work against hazards to health and safety arising out of or in connection with the activities of persons at work, and to provide for connected matters. Section 15 the Act provides for the registration of factories or workplaces.

The Chief Inspector is given discretionary powers to enter such particulars in relation to every factory and workplace as he may consider necessary. The Act obliges the owner or occupier of a factory or workplace to register such factory or workplace and obtain a certificate of registration or compliance licence. The Act established the Occupational Health and Safety Agency (OSHA), which checks the company’s premises and inspects the health, safety and dwelling of workers and of workplaces. It inspects the working environment and the equipment used in operational activities. OSHA is responsible for coordinating the provision of health services for employees of these institutions, with technical support from the Regional Secretariat and Ministry of Health.

For further details on OSHA please visit www.osha.go.tz

Occupational Safety and Health Agency (OSHA)   was formed by   The  Occupational Health and Safety Act No. 5 of 2003:   with the aim of improving the health and well being of workers, and of workplaces. This is achieved by promoting occupational safety and health (OSH) practices in order to prevent occupational injuries and diseases, and ultimately achieve better productivity.

The main objectives of the Act are to repeal the Factories Ordinance, to make provision for the safety, health and welfare of persons at work in factories and other places of work, to provide for the protection of persons other than persons at work against hazards to health and safety arising out of or in connection with the activities of persons at work, and to provide for connected matters. Section 15 the Act provides for the registration of factories or workplaces.

The Chief Inspector is given discretionary powers to enter such particulars in relation to every factory and workplace as he may consider necessary. The Act obliges the owner or occupier of a factory or workplace to register such factory or workplace and obtain a certificate of registration or compliance licence. The Act established the Occupational Health and Safety Agency (OSHA), which checks the company’s premises and inspects the health, safety and dwelling of workers and of workplaces. It inspects the working environment and the equipment used in operational activities. OSHA is responsible for coordinating the provision of health services for employees of these institutions, with technical support from the Regional Secretariat and Ministry of Health.

For further details on OSHA please visit www.osha.go.tz

Weights and Measures Agency (WMA) was formed by The Weights and Measures Act, 1982 with a mandate to provide protection to consumers in relation to legal metrological control which includes legal control of measuring instruments, metrological supervision and metrological expertise in trade, health, safety and environment.

This Act revises and consolidates the laws relating to weights and measures and provides for the introduction of the International System of Units (SI) and related matters. According to section 11-(1), unless otherwise permitted by this Act, every contract, bargain, sale or deal made, whereby any work, goods, wares, merchandise or other thing is or are to be, or is or are done, sold, delivered, carried, measured, computed, paid for or agreed by weight or measure, shall be made and had according to one of the relevant units of measurement specified in the First, Second, Third, Fourth, Sixth, Seventh and Eighth Schedule to this Act or to some multiple thereof.

Section 9 empowers the Minister to procure and cause to be maintained standard equipment, which he may from time to time determine as being proper and necessary for the verification of standards of weights and measures. The duties of an assizer shall be:

• to carry out verification of weights, measures, weighing and measuring instruments;

• to care for and maintain any working standards which may be entrusted to his care;

• to keep records and make such reports as the Commissioner may require;

• to give effect to the directions of the Commissioner; and

• generally to exercise such other powers and duties as may be conferred or imposed by this or any other Act or by regulations made under this Act.

For details please visit www.wma.go.tz

Tanzania Atomic Energy Commission (TAEC) was established by the Act of Parliament referred to as the Atomic Energy Act No. 7 of 2003. Tanzania Atomic Energy Commission is the official government body responsible for all atomic energy matters in the United Republic of Tanzania.  The mandate of TAEC is to:

1.  Provide Regulatory and Radiation Protection Services,

2.  Coordinate, monitor, and

3.  Promote peaceful use of nuclear technology in the country.  

This Act established the Tanzania Atomic Energy Commission (TAEC) and provides for its functions in relation to controlling the use of ionizing and non-ionizing radiation sources and promoting the safe and peaceful use of atomic energy and nuclear technology. The Commission is empowered to issues various licences upon application being made to the Commission on the prescribed form and the prescribed fee being paid, subject to such conditions or limitations as may be deemed fit or necessary to impose. Section 5 empowers TAEC to regulate the safe and peaceful use of atomic energy, promote and expand the contribution of atomic energy and nuclear technology to health and prosperity throughout the United Republic of Tanzania. Section 30 provides for the mandatory requirement for any manufacturer, importer and exporter of foodstuffs specified in the relevant regulations to obtain a radioactivity analysis certificate from the Commission before the said food is imported into the country or exported from the country or distributed for human and animal consumption.

For details please visit www.taec.or.tz