AFDC 1 1 (6528 ) P3 
                                                                                                                          ICS 07.080  
                                                                                                                                                  
 TANZANIA STANDARD  
 
 
 
Biotechnology - genetically modified organisms and derived 
products  – Requirements  for handling, trans portation  and 
use. 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TANZANIA BUREAU OF STANDARDS  
 
 
 0 Foreword  
Tanzania embraces science and technology and recognizes the potential benefits of modern 
biotechnology. On the other hand, the country is also aware of the potential harms to humans, animals 
and the environment that could results from inappropriate handling and use  of genetically modifi ed 
organisms (GMOs). Thus, this  Tanzania standard aims at ensuring that all GMOs and derived products 
are handled in accordance with relevant national regulations.  
This Tanzania standard provides guidance for compliance, and a checkl ist for monitoring and inspection 
of genetically modified organisms and derived products to ensure that the handling, transportation and 
use of GMOs do  not cause harm to the environment, and human , plant and animal health.  
This Tanzania standard  provides t he information and records that are required at different stages of 
handling ; transporting, importing, exporting  processing , using (direct use as food or feed, contain ed or 
confin ed), and storing of GMOs. It is meant to guide stakeholders, including the public at large, to 
properly and in a standardized manner handle or use GMOs in the country.  
 During the development of the standard, reference was made to the following documents:  
 Cartagena Protocol on Biosafety to the Convention of Biological Diversity  
 The Environmental Management (Biosafety) Regulations, 2009  
 The National Biosafety Guidelines for Tanzania of 2004  
 DKS 2182 (2012): Code of practice for handling, transfer and use of genetically modified 
organisms and derived products published by Kenya Bur eau of Standards (KEBS).  
1 Scope  
This Tanzania standard prescribes  requirements  for safe handling, transfer and use of genetically  
modified organisms (GMO s) and derived products.  It is applicable to genetically modified organisms and 
derived products intended for contained and confined use, introduction into the environment, placing on 
the market , importation, , transit and export , direct use as food , feed or for processing . This Tanzania 
standard is not applicable to gen etically modified organisms and derived products which are 
pharmaceuticals .  
2 Normative References  
The following referenced documents are indispensable in the appl ication of this Tanzania standard . For 
dated references, only the edition cited applies. For  undated references, the latest edition of the 
referenced document (including any amendments) applies:  
TZS 2070 , Principles for the risk analysis of foods derived from modern biotechnology - Code of practice  
TZS 2071 , Biotechnology - Guideline for the condu ct of food safety assessment of food derived from 
Recombinant DNA plants  - Code of practices  
TZS 2072 , Biotechnology - Guideline for the conduct of food safety assessment of foods produced using 
recombinant -DNA micro -organisms  - code of practice  
TZS 2073 , Biotechnology -Guideline for the conduct of food safety assessment of foods derived from 
recombinant -DNA Animals -Code of practice    
 3 Terms and definitions  
For the purposes of this Tanzania standard , the following terms and definitions should apply:  
3.1 contained use  
means any activity undertaken within a facility, installation, or other physical structure which involves 
genetically modified organisms and/or derived products that are controlled by specific measures that 
effectively limit their contact wit h, and their impact on, the external environment  
3.2 Confinement  
Restriction of an organism and its genetic traits to a specific and defined area of the environment, herein 
called the confined field trial site‟ or the trial site‟.  
3.3 confined use / confin ed field trial (CFT)  
is a restricted environmental  release of a genetically  modified organisms , for research purposes, under 
terms and conditions intended to mitigate the establishment and spread, in the environment, of genetic 
material from organisms  and the interaction genetic material with the environment.  A single confined field 
trial may comprise one, or more, transgenic events of a single species that are subject to the same terms 
and conditions of confinement.  These terms and conditions includ e, but are not limited to, reproductive 
isolation, site monitoring, and post -harvest land use restrictions.   
3.4 Compliance Document Binder (CDB)  
Is a file prepared to keep all records used to document all steps of a contained use and/or confined use 
such as transport, storage, inspection, harvest and disposition, and post -harvest monitoring of genetically  
modified organisms and derived  products . 
3.5 Transit  
means transport ation, by whatever means, of a genetically modified organism to Tanzania from any other 
jurisdiction for the purposes of conveying  such genetically modified organism to any third jurisdiction;   
3.6 environment  
means physical factors of the surroundings, human beings, including land, water, atmosphere, soil, 
vegeta tion, climate, sound, odour, aesthetics, fish and wildlife   
3.7 genetically modified organism  
means any organism that possesses a novel combination of genetic material obtained through the use of 
modern biotechnology  
3.8 intentional introduction into the e nvironment  
means any deliberate release of genetically modified organisms other than contained use.  
3.9 modern biotechnology  
Means the application of:   
 a) in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injecti on 
of nucleic acid into cells or organelles, or  
b) fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or 
recombinant barriers and that are not techniques used in traditional breeding and selection.  
3.10 National B iosafety Focal Point  
means  the competent authority designated by the government to coordinate, evaluate, authorize and 
approve applications for contained use, introduction into the environment, importation, placing on the 
market, transit and export of genetically modified organisms  and derived products (GMO)  
3.11 organism  
means any entity able to replicate its own genetic material  
3.12 placing on the market  
means making genetically modified organisms and derived products available for sale  
3.13 permit  
means  a written authority issued by a regulatory agency for the handling, transfer and use of genetically 
modified organisms and derived products  
3.14 derived product  
means anything made of or derived from a genetically modified organism, living or dead  
3.11 regulatory  authority  
means any institution mandated by the laws of Tanzania  with the responsibility of enforcing laws related 
to human, plant, animal, and environmental health and safety.  
3.15 unintentional release  
means a release that takes place without authorization  under the laws of Tanzania and takes place as a 
result of adventitious presence of GMOs with non -GMO shipments imported for direct use as food, feed 
or for processing but excludes an accident;  
3.16 person  
includes both natural and legal  entities and local communities.  
4 General requirements  
4.1 Genetically modified organisms and/or derived products should be handled in a safe manner to 
prevent adverse effects to the environment  and human, animal and plant health  
4.2 All GMOs and derived products related activities and facilities should be approved in accordance with 
the relevant laws of Tanzania  and requirements of relevant regulatory authorities.  
4.3 A person intending to undertake any activity involving the use of genet ically modified organisms 
and/or derived products should:   
 a) Apply for approval by the National Biosafety Focal Point for the intended activity.  
b) Provide risk assessment information necessary  for evaluation of potential risks and/or benefits 
of the parti cular genetically modified organisms and derived products. The information should 
include but not limited to:  
i) Identity and relevant characteristics;  
ii) Quantity and volumes involved;  
iii) Novel traits introduced;  
iv) Donor  of novel traits  
v) Methods of production;  
vi) The intended use;  
vii) Receiving environment;  
viii) Methods for safe handling storage and disposal  
ix) Related risk assessment and risk management.  
x) Means  of detections  
xi) Biosafety  group and level  
4.4 Risk assessment should be evaluated on a case by case basis taking into account any known risk 
posed by potential exposure to the genetically modified organism and /or derived products  in accordance 
with TZS 2073, TZS 2071, TZS 2072, TZS 2070  and relevant  laws in Tanzania.  
NOTE:  The information required for risk assessment may vary with characteristics of the organism and use, 
frequency, and scale of the intended use. Where the information required relates to a product, a requirement to 
submit full studies dossier to demonstrate safety to human and the environment is necessary . 
4.5 Appropriate measures should be maintained to manage risks identified dur ing the risk assessment 
process as described in biosafety regulation in Tanzania.  The measures should include but not limited to 
the following:  
a) Appropriate information and/or training provided for those involved in handling the organisms;  
b) Monitoring procedures applied in such a way that appropriate measures can be taken to 
manage  identified and  unexpected effects during and aft er release;  
4.6 Any person  undertaking contained or confined use an activity involving genetically modified 
organisms should keep and maintain the following records  in compliance  document binder;  
a) Name of person responsible for supervision and safety of the activity;  
b) Qualifications and training of the person nel involved;  
c) A map clearly indicating where the activity is being undertaken;   
 d) Experimental  design  and timeline . 
e) Risk assessments and risk management;  
f) Waste  management;  
g) Contingency  measures in case of unintentional release  
h) Approval to undertake the activity;  
i) Training of staff involved in the activity  
4.7 all records including compliance document binder should be made available to inspectors of the 
National Biosafety Focal Point and relevant regulatory authorities . 
4.8 A written approval from National Biosafety Focal Point ; stipulating appropriate conditions for 
movement should be issued for any genetically modified material whether for import, export, transit, 
environmental relea se or for placing on the market. Such material should be:  
a) Packaged in accordance with prevailing national regulation and guidelines , applicable international 
agreements, standards and conventions.  
b) Labelled in accordance with the relevant laws in Tanz ania and accompanied by the following 
information:  
i) Nature, identity and quantity of contents;  
ii) Country or locality where collected, developed, manufactured, reared or cultivated;  
iii) Description of any potential risk  
iv)Name, address and telephone number of supplier, owner, importer, shipper, forwarding agent;  
v) Name, address and telephone of individual and institution of consignee;  
vi)Name of transporter(s);  
vii) Approval number authorizing movement;  
viii) Intended use;  
ix) Date of movement;  
x) Re gulatory status in country of origin;  
xi) Declaration that the information provided is factual  
4.9 There shall be no authorization for the import or export of GMOs or their products that are banned by 
the laws of the exporting or as the case may be, importing country.  
4.10 a person intending  to introduce GMOs and/or derived products into the environment should obtain 
permit from National Biosafety Focal Point .   
 Note: a person  should bear in mind that,  at any time, in light of new scientific information on potential adverse effects 
to human health and the environment, NBFP may review and change a decision regarding any activity involving 
genetically modified organisms and derived products.  
5 Specific re quirements  
In addition to general requirements the following requirements should apply.  
5.1 Contained use  
5.1.1  A person intending to conduct a contained use activity should on application, provide information 
necessary for risk assessment of potential ris ks and/or benefits of the particular genetically modified 
organism and derived products. The information should be as may be prescribed by the National 
Biosafety Focal Point including but not limited to the following:  
a) Name and contact address of applica nt; 
b) Location where contained use activities should be undertaken;  
c) Nature and identity of genetically modified organism;  
d) The nature and purpose of activities;  
e) Scale of operation and quantity of organisms to be used  
f) Description of proposed con tainment measures and verification of their functioning;  
g) Description of any potential risk;  
h) A description of remedial measures to be undertaken in the event of any accident and 
unexpected events;  
i) Training and supervision of personnel carrying out the activity;  
j) Plans for waste management;  
k) Plans for safety and health of personnel;  
l) Relevant information from previous uses.  
5.1.2  Appropriate risk management measures for contained use should be based on the type of organism  
whereby a person should adhere to biosafety level requirements .  
5.1.3  A person intending to undertake contained use activities should ensure that:  
a) Institutional  biosafety committee is in place.  
b) All facilities adhere to principles of good operational practices, and good occupational safety and 
hygiene.  
c) The level of containment is in accordance with the requirements of the relevant regulatory institutions  
5.1.4 Records and reports on activities involving genetically modified material shou ld be maintained within 
the facility. These should include but not limited to plans and procedures for:   
 a) Safe handling;  
b) Harvesting;  
c) Storage;  
d) Transportation;  
e) Use;  
f) Packaging and labelling;  
g) Disposal;  
h) Contingency procedures.  
5.1.5 Geneti cally modified materials intended for transportation for contained use should be packaged in 
three levels consisting of:  
a) Primary package;  
b) Secondary package; and  
c) Tertiary containers.  
5.1.6 In addition to the information required in 4.8 (b), genetic ally modified organisms intended for 
contained use should be labelled to provide:  
a) Specific identity, traits and/or characteristics;  
b) Biosafety level  
c) Methods and conditions for safe handling, storage, transport, use and disposal.  
5.2 Confined  use/field trial  
5.2.1  Appropriate risk management measures for con fined use /field trial  should be based on the type of 
organism. The appropriate measures should include but not limited to the following:  
a) Plant  
i) Applying reproductive isolation,  
ii) Controlling persistence or dispersal of reproductive structures such as propagules or seeds,  
iii) Destroying volunteer plants after harvest.  
b) Animal  
i) Confining by appropriate means e.g. fences, filters, islands, ponds.  
ii) Applying reproductive isolati on by using sterile animals.  
iii) Isolation from feral animals of the same species.   
 iv) Controlling persistence or dispersal of reproductive structures such as larvae and eggs.  
c) Micro -organism  
i) Using organisms with impaired ability to grow or persist i n the environment;  
ii) Minimizing gene transfer;  
5.2.2 In addition to the information in 5.1, a person intending to undertake a confined  use/field  trial 
activity, should on application for confined field trial provide information as may be prescribed by th e 
National Biosafety Focal Point including but not limited to the following:  
a) Description of genetically modified organism including the name of the donor organism, 
recipient organism(s), inserted genes, marker genes, and traits;  
b) Purpose and scale of trial/use; 
c) Geographical description and location of release;  
d) Proximity to human residence and activity;  
e) Method and frequency of trials /uses ; 
f) Time and duration of trial /use; 
g) Expected environmental conditions during trial /use; 
h) Likelihood of  trans -boundary movement;  
i) Proposed risk management measures including verification of their functioning;  
j) Subsequent treatment of site;  
k) Potential impact on the environment;  
l) Methods and plans for monitoring the genetically modified organism and d erived product;  
5.2.2  The safety of the genetically modified organism and/or derived products should be evaluated in 
accordance with the relevant Tanzania standards  and national regulations on risk assessment as may be 
prescribed by the National Biosafety Focal Point and/or relevant regulatory institutions . 
5.3 Import  
5.3.1  A person intending to import any genetically modified organisms and/or derived products should on 
application for approval, provide information as may be prescribed by the National Biosafety Focal Point 
including, but not limited to the following:  
a) Name address and contact details of the importer and exporter  
b) Origin, name and taxonomic status of recipient organism  
c) Unique identifiers; describing traits introduced or m odified and characteristics of the organism  
d) Intended dates of transboundary movement   
 e) Port of entry,  
f) Intended use of genetically modified organisms or derived product in Tanzania , 
g) Authorized  use of genetically modified organisms and/or derived p roducts in the country of 
export,  
h) Quantity or volume to be imported,  
i) Risk assessment report in accordance with Tanzania standard and existing laws and 
regulations  in Tanzania   
j) Methods and plans for safe handling, storage, transport, use, and dispo sal 
k) Previous approval status regarding the genetically modified organism and/or derived products.  
5.3.2  The import consignment should be labelled to clearly identify the nature of modification  and 
intended use.  
5.3.3  The import consignment should also b e accompanied by documentation as may be prescribed by 
the National Biosafety Focal Point . This should include but not limited to:  
a) A written approval from National Biosafety Focal Point ; stipulating appropriate condition(s) for 
importation  
b) Permit of importation from the relevant regulatory agency.  
c) Permits from exporting country  e.g. phytosanitary certificate.  
5.4 Environmental release  
5.4.1  Any genetically modified organisms and/or derived products intended for environmental release or 
placing o n the market should comply with  specific product requirements for food safety, human health, 
animal health, plant health, environmental safety, variety release, efficacy, registration, certification and 
quality, as may be appropriate and in accordance with national  requirements and the existing laws, 
regulations and standards in Tanzania . 
5.4.2  A person intending to place on the market any genetically modified organisms and/or derived 
products should on application for approval for environmental release or pl acing on the market, provide 
information as may be prescribed by the National Biosafety Focal Point including but not limited to the 
following:  
a) Name of product, nature and/or traits of the genetically modified organism contained therein  
b) Name and cont act details of product applicant  
c) Name and contact details of manufacturer or distributor in Tanzania  
d) Country, scope and date of authorization  
e) Regulatory status within the country of export in case of imports (e.g. prohibited, restricted, 
approved for release) and if banned, the reasons for the ban  
f) Unique identifier   
 g) Intended use  
h) Links to information on the genetically modified organism and derived products  
i) A risk assessment and management consistent with international and national requirements , 
j) Environmental  impact assessment  
k) Monitoring  plan and strategies.  
l) Protocol  for detection of GMO event after general release.  
m) Measures to take in case of  unintended use.  
n) Instructions and conditions of use, storage, handling and disposal  
o) Proposed packaging  and labeling   
5.4.3  Any genetically modified organisms and/or derived products intended for environmental; release or 
placing on the market as food or feed should be evaluated for food safety in accordance with the following 
Tanzania  standards:  
a) TZS 2070  
b) TZS 2071  
c) TZS 2072   
d) TZS 2073  
5.4.4  Genetically modified organisms and/or derived products intended for environmental release or 
placing on the market should be labelled in accordance with AFDC 11 (6527) P1  
5.4.5  Manufacturer(s) , importer(s) or distributor(s) of genetically modified organism and derived products 
should in their premises maintain records of permits for placing on the market of the specific genetically 
modified organism and/or derived products being handled.  
5.5 Tr ansit  
5.5.1  A person intending to transport through Tanzania  genetically modified organisms and derived 
products, which are not destined for use in Tanzania  should apply for a written approval for such transit 
from the National Biosafety Focal Point.  
On ap plication  for transit , the following information should be provided including but not limited to:  
a) Name, address and contact details of the exporter;  
b) Name, address and contact details of the importer; and/or agent within receiving country;  
c) Name and  identity of genetically modified organisms contained therein  
d) Intended date(s) of proposed entry and exit from Tanzania ; 
e) Intended use of organism and/or derived product in receiving country;  
f) Quantity or volume of consignment;   
 g) Manner in which co nsignment will be transferred from the port of entry to port of exit;  
h) Methods  for safe handling, storage, transport, and use including packaging, labelling, 
documentation, disposal and contingency procedures;  
i) Approval status in the exporting country  
5.5.2 All transit consignments containing genetically modified organisms and/or derived products should 
be accompanied by the following documentation and a declaration from the exporting country regarding 
the safety of the consignment to human health and e nvironment:  
a) A letter of consent from the relevant National Authority of the receiving country, addressed to 
the National Biosafety Focal Point in Tanzania .  
b) A copy of the import permit issued by the receiving country indicating the quantities or volu me 
of the consignment from exporting country and that may contain genetically modified material.  
c) Methods  for packaging and handling of genetically modified organisms and/or derived products 
imported through conveyor shipment should comply with the relevant international and national 
requirements for repackaging and handling of conveyor shipped commodities.  
5.5.3 Transportation  of GMO within the country shall be in accordance with National biosafety regulations.  
5.6 Export  
A person intending to export genetically modified organism and derived products from Tanzania  should 
submit to NBFP  a written consent gran ted by a relevant Authority of the country to which the genetically 
modified organism and derived products are destined, to the effect that the relevant authority has no 
objection to the intended exportation.  
A person who export genetically modified organi sm and derived products  shou ld obtain written approval 
from NBFP and keep record of documents relating to export and may submit to relevant regulatory 
authorities if needed for trade facilitation.  
Note 1: The presentation of the advance informed agreement by an exporter shall in no way absolve the 
exporter from complying with any other laws governing foreign trade.    
Note 2: The submission of the advance informed agreement shall not preclude the country of  the exporter 
from taking into account other considerations before approving the export . 
5.7 direct use as food or feed or food processing  
5.7.1  In addition to the information given  (transit, import, release ) the following should apply to GMO and 
their derived products to be used as food, feed or food processing.  
a) Declaration that products are direct use as food or feed or food processing.  
b) Approved use of the GMO,  
c) Genetically modified food and feed assistance introduced into the United Republic shall comp ly 
national regulations.  
d) Food and feed consignment involving grain that contain GMOs shall be milled prior to distribution 
to the beneficiaries.   
 e) Food and feed in transit that contain GMO should be clea rly identified and labelled in accordance 
with AFDC 11 . 
5.7.2  A person intending to use GMO and their derived products as food, feed or food processing in 
Tanzania should obtain a written consent granted by NBFP .