AFDC 1 1 (6527 ) P3 
                                                                                                                          ICS 07.080  
                                                                                                                                                  
DRAFT  TANZANIA STANDARD  
 
 
 
Biotechnology - Genetically modified organisms and derived 
products – Requirements for labelling of food , feed and 
ingredient s. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TANZANIA BUREAU OF STANDARDS  
 
 
 0 Foreword  
This Tanzania standard  provides requirements for label ing of food, feed  and ingr edient derived from 
genetically modified organisms (GMOs) . The labeling provide s clear and factual information to prote ct 
consumer’s health and ensure fair practices in trade. It also helps consumers to make informed choices 
and handling of the products.  The labeling information should be provided in a manner that does not 
mislead consumer s. 
The standard permits verification of claims by several processes including audit tracking (identity 
preservation , traceability ) as well as chemical analysis.  
During the preparation of this standard, reference was made to the following documents:  
 The Environme ntal Management (Biosafety) Regulations, 2009  
 Standard 1.5.2, Food Produced Using Gene Technology Issue 112; Australia New Zealand Food 
Standards Authority  
 Regulation (EC) No 1829/2003 of the European parliament and the Council on Genetically 
Modified Food  and Feed  
 KS 2225: 2009 genetically modified organisms and derived products – Labelling of food and feed  
 The T anzania Food and Drugs Authority, food regulation 2006  
1 Scope  
This Tanzania standard provides  requirements  for labeling of genetically modified  organisms (GMOs) and 
derived products intended for use as food, feed or ingredients . The standard shall not apply to  food, feed 
or their ingredients containing genetically modified organisms a nd derived products in proportions of less 
than 0.9% of the tot al weight of the product.  
2 Normative references  
The following referenced documents are indispensable in the application 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 538/EAS 38  Labelling of pre -packaged foods — General requirements  
TZS 2070, Principles for the risk analysis of foods derived from modern biotechnology -Code of practice  
TZS 2071, Biotechnology - Guideline for the conduct 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  
AFDC 11 (6528) P1  Biotechnology - handling, transfer and use of genetically modified organisms and 
derived products - Code of practice   
 AFDC11 (5385) P1 - ISO 21572:2019 Foodstuffs - Molecular biomarker analysis -Immunochemical 
methods for the detection and quantification of proteins  
TZS 482/  EAS 804  - Claims – General Requirements  
TZS 550/ EAS 805  - Use of nu trition and health claims - Requirements  
FTZS 2414/ISO 24276  Foodstuffs - Methods of analysis for the detection of genetically modified 
organisms and derived products - General requirements and definitions  
FTZS 2411 /ISO 21569  Foodstuffs - Methods of analysis for the detection of genetically modified 
organisms and derived products - Qualitative nucleic acid based methods.  
FTZS 2412/ISO 21570  Foodstuffs - Methods of  analysis for the detection of genetically modified 
organisms and derived products - Quantitative n ucleic acid based methods  
FTZS 2413/ISO 21571  Foodstuffs - Methods of analysis for the detection of genetically modified 
organisms and derived products - Nucleic acid extraction  
3 Terms and d efinitions  
For the purpose of this standard  and in addition to the terms defined  in TZS 538/EAS 38 and AFDC 11 
(6528) P1 , the following definitions shall apply:  
3.1 claim  
any representation which states, suggests or implies that a food has particular qualities relating to its 
origin, nutritional properties, nature, processing, composition or any other quality attributes.   
3.2 Conventional counterpart  
shall be a related organis m/variety, its components and/or products f or which there is experience of 
establishing safety based on common use as food, feed or ingredient.  
3.3 Denomination  
Shall be common, scientific/or commercial name of GMO.  
3.4 Food, feed or ingredient derived from genetically modified organism  
shall be a food, feed, or ingredient produced from, in whole or in part from genetically modified 
organisms.   
3.5 Food/feed additives  
are substances added to food/feed for specific technical and/or functional purposes dur ing processing, 
storing or packaging.  
3.6 Ingredient  
shall mean any substance , including additives and enzymes, used in the manufacture or preparation of 
feed/ foodstuffs  and still present in the finished products even if in altered form.  
3.7 Genetic modification   
 shall be a collection of techniques which are used to alter the heritable gene tic material of living cells or 
organisms in a way that does not occur naturally by multiplication and/or recombination.  
Note: the term genetically modified organism s is synonymous to genetically  engineered organisms  and living 
modified organisms .  
3.8 Label  
shall be any written, printed or graphic matter that is present on the la bel, accompanies the food or feed 
or is displayed near the food  or feed  including that for the purpose of promoting its sale or disposal.  
3.9 Unique identifier  
shall be a simple numeric or alphanumeric code which serves to ide ntify a GMO on the basis of the 
authorised transformation event from which it was developed and providing  the means to retrieve specific 
information pertinent to that GMO.  
4 General requirements  
4.1 Labelling of food, feed or ingredients containing genetically modified org anisms or products derived 
from genetically modified organisms shall be conside red after they have un dergone appropriate food 
safety assessment in accordance with TZS 2070, TZS 2071, TZS 2072 and TZS 2073  
4.2 Food, feed or ingredient derived from genetically modified organism s offered to the consumer shall be 
autho rized for use in Ta nzania  in accordance with AFDC 11 (6528) P1 . 
4.3 Any person offering food, feed or ingredient derived from genetica lly modified organisms for sale shall 
demonstrate that it has been authorized  in accordance with section 4.2. 
4.4 Claims about single -ingredient foods as well as to ingredi ents in a multi -ingredient food shall  
a) be permitted pursuant to the scope of th is standard  
b) be clear , informative, not false, and not misleading;  
c) comply with all requirements of section 5.2; 
d) refer  to ingredient(s) in a multi -ingredient food rather than to the multi -ingredient food itself; 
(For examples, see Appendix A: Claim Statements, par agraph . A2.1)  
e) contain a reference to an external, readily accessible source of further information, such as  a 
,Quick Response (QR) code, toll-free telephone number or a Web -page address, unless all the 
mandatory information required accompanies the claim;  
f) be accompanied by an explanatory statement if the claim alone is likely to result in 
misunderstanding or  misinformation;  
g) be presented in a manner so that the claim is grouped together with any explanatory 
statements and sources of additional information. Explanatory text shall be placed in close 
proximity to the claim with no intervening material . 
h) be b ased upon a percentage by weight as offered for sale unless otherwise stated;   
 i) not imply directly or indirectly an improvement that does not exist nor exaggerate the aspect of 
the food to which the claim relates;  
j) not imply that the food is endorsed or  certified by an independent third -party organization, when 
it is not;  
k) not be made using absolute terms such as free or 100% or all;  
l) use such terms as entirely, completely and absolutely with care. When claims are modified by 
these terms, allowances for unintentional or unverifiable food or ingredients, as described in 
sections 6, cease to exist; (For examples, see Appendix A: Claim Statements, par. A1.3)  
m) comply with TZS 538 on use of signs or emblems , symbols and  abbreviations n) be re -
assessed an d updated as necessary to reflect changes in technology or other circumstances that 
could alter the accurac y of the claim;  
o) use the terms genetically modified (name of product), (derived) from genetically 
engineered /modified  (name of product), or the term  product of genetic modification , which refers 
to either of the preceeding terms and shall conform, in intent, to the examples and guidance 
found in Appendix A: Claim Statements;  
5 Specific requirements  
5.1 Claims that food  are products of genetic engineering  
5.1.1 Claims about Single -Ingredient Foods (For examples, see Appendix A: Claim Statements, 
paragraph ( A2.3) 
5.1.1.1 If a claim is made that a single -ingredient food is a product of genetic engineering /modification , it 
must comply with the requirements of sub-clause 4.4 of this standard.  
5.1.1.2 Claims that a single -ingredient food is a product of genetic engineering shall be made only when 
more than 9 9% of the source of the single -ingredient food is a product of genetic 
engineering/modification . 
5.1.2 Claims about Ingredient(s) in a Multi -Ingredient Food (For examples, see Appendix A: Claim 
Statements, par. A2.3 and A2.4) 
5.1.2.1 If a claim is made that an ingredient is a product of genetic engineering/modification or is a 
mixture of products of and not of genetic engineering/modification , it must comply with the requirements 
of sub-clause 4.4 of this standard . 
5.1.2.2 Claims that an ingredient in a multi -ingredient food is a product of genetic 
engineering/modification shall be made only when more than 9 9% of the source of the ingredient is a 
product of genetic engineering/modification . 
5.2. Verification  of claims  
5.2.1 Prior to making a claim, verification methods shall be used to confirm the validity of the claim.   
 5.2.2  A person making a claim in accordance with this standard shall ensure compliance with the 
requirements in sub-clause 4.4 and sub-clause 5.1 of this standard , as appropriate and shall be 
responsible for securing data  necessary for the verification of the claim.  
5.2.3 Verification for claims about foods that are and are not products of genetic engineering/modification 
may include but are not limited to testing, detection methods, inspection, and audit tracking. No clai m is 
permitted if it cannot be verified.  
5.2.4 Claims  shall be verified in accordance with FTZS 2414, FTZS 2411, FTZS 241 3, FTZS 2412  and 
AFDC11 (5385) P1 . 
5.2.5 The verification shall be fully documented, and the documentation shall be retained by the claimant 
for the purposes of information disclosure.  
5.2.6 Retention of documents shall be for the period that the claim for the food or ingredient is being 
made, and for a reasonable period thereafter, taking into account the patterns of use of the food.  
5.2.7 Where there are no methods already in existence, the person making the claims may develop a 
method, provided it meets the other requirements of this standard  and is subject for approval by 
regulatory authority . 
5.3 Prohibitions on Claims  
5.3.1  Claims which cannot be substantiated  
5.3.2  Claims that are not in conformity with the suitability of the food, feed o r ingredient in conformity with  
TZS 550  
5.3.3  Claims which could give rise to doubt about the safety of similar food o r which could arouse  or 
trigger fearto  consumer s 
5.4 Labeling requirements  
5.4.1 Labeling of food, feed, or ingredients containing or derived from GMOs  shall be consistent with the 
requirements of TZS 538/EAS 38 , TZS 482  and TZS 550 . Also shall comply with national regulations.  
5.4.2 Where food, feed or ingredient containing or derived from ge netically modified organisms is 
displayed for sale, labelling shall include the statement “genetically modified”.  The labeling shall be clearly 
indicated .  
5.4.3 The language on the label shall be “ Kiswahili ” or Kiswahili and English ”. A second language may be 
used depending on the designated market.  
5.4.4 Labelling information shall indicate a change in composition,  nutrition al value, intended use, and 
any other characteristics or properties which the food, feed, or ingredient de rived from genetically 
modified organism differs from the conventional counterpart.  
5.4.4 .1 Where a food or feed consists of a single ingred ient or where there is no  list of ingredients; the 
words “genetically modified” or “produced from genetically modified (name of the ingredient or organism) 
shall b e in the labelling information. For example;  
“Soybean  (genetically modified)”   
 “Maize flour pr oduced from genetically modified (maize)”  
“Soy protein isolate (genetically modified)”  
5.4.4 .2 Where a food or feed consists of more than one ingredient the words “ genetically modified” or 
“produced from genetically modified (name of the ingredient) shall appear on the list of ingredients to 
indicate the ingredient that is gen etically modified. For example:  
Ingredients:  
i. Soy protein isolate (genetically modified)  
ii. Maltodextrin  
iii. Vegetable oil  
iv. Emulsifier  
v. Water  
5.4.4 .3 Where food, feed or ingredient derived from  genetically modified  organism contains a new factor 
known to cause allergic response in particular sections of the population, the presence of the allergen 
shall be declared in the labelling information.  
5.4.4 .4 Where the origin of genetic material used in the modification s may raise objections based on 
religious or cultural dietary restrictions, such origin may be declared.  
5.4.4 .4 Where there is common knowledge on the identity of the product by way of a unique identifier or a 
denomination or any other internationally accepted identifier, that identity may be indicated.  
APPENDIX A: CLAIM STATEMENTS  
Introduction  
This appendix contains explanatory text and examples of claims that are acceptable and unacceptable 
according to the standard.  
The examples provided are meant to be illustrative of the consideration discussed in each section, and 
unless otherwise noted, are not meant to take into consideration all the requirements of the standard.  
This Appendix does not contain an exhaustive list  of the requirements of the standard and is therefore not 
meant to serve as a replacement for the text of the standard.  
A1. Use of terms  
A1.1 Product of genetic engineering/modification - The expression product of genetic 
engineering/modification refers to  food consisting of organisms that have undergone genetic 
engineering/modification and to foods derived from these organisms. Care must be taken when using the 
terms genetic engineering/modification , genetically engineered /modified , or from genetically 
engineered /modified . 
Examples:  
These potatoes are a product of genetic engineering (GE) /modification , this maize  oil is a product of 
genetic engineering/modification , and soybean  oil (from a GE/non -GE blend of soybean ) are acceptable 
claims if they are made in accordance with the standard. Genetically engineered /modified  maize  oil, 
however, is unacceptable, since it is the maize  that is actually genetically engineered /modified .  
 A1.2 Use of terms other than those identified in this Standard  - Certain terms are  not used in this 
standard. For example, claims that a food does not contain genetically modified  (GMO) are misleading in 
many cases, since most foods do not contain organisms. Seeds, nuts, and micro -organisms such as live 
bacterial cultures in yogurt are exceptions. It is also important to consider whether acronyms such as 
GEO are commonly understood by the consumer, before using them in claims.  
Examples:  
Non-GEO maize  starch and non -GEO soybean  oil are unacceptable statements, since neither maize 
starch nor soybean  oil are, or contain, organisms.  
A1.3 Modi fying Statements - Care should be taken when using such terms as entirely, completely, and 
absolutely. Claims that are modified by these terms ignore the allowances for unintentional or unverifiab le 
food or ingredients described in sub-clause 4.4  and 5.1. Claims using such terms should not be made 
when ingredients in a multi -ingredient food are of unverifiable origin, or when it cannot be verified that 
there are no unintentionally present and/or un declared products of, or not of, genetic 
engineering/modification in this food.  
Examples:  
Made entirely from non -genetically engineered /modified  ingredients and ingredients used are absolutely 
not genetically engineered /modified  are unacceptable claims if some of the ingredients used are of 
unverifiable origin.  
This maize  is completely non -genetically engineered /modified  and these maize  chips contain absolutely 
no genetically engineered /modified  ingredients are also unacceptable claims if it could not be verified that 
there is no product of genetic engineering/modification unintentionally present in these foods.  
A2. Guidance related to specific sections of the standard  
A2.1 Claims about  ingredients in a multi-ingredient food - A statement that a multi -ingredient food is or is 
not a product of genetic engineering/modification is misleading, since it is actually the ingredients that are 
or are not products of genetic engineering/modification . 
Examples:  
This cake is not a product of genetic engineering, non -genetically engineered pizza, and genetically 
engineered /modified  potato chips are unacceptable statements.  
These chips are made from potatoes that are not a product of genetic engineering/modification and made 
with oil from soybean  that is a product of genetic engineering/modification are acceptable statements.  
A2.2 Explanatory statements in some cases, explanatory statements are required to ensure that a claim 
is truthful and not misleading. In other cases, a manufacturer may want to provide further details. Any 
information provided in such statements must also be truthful and not misleadin g, must meet all the 
requirements of sub-clause 4.4  and 5.3, and must apply specifically to the food being labelled, unless 
given an appropriate context.  
Examples:  
Soybean  oil from soybean  genetically engineered /modified  to increase crop yield, maize : prod uct of 
genetic engineering/modification , this type of maize  requires less pesticide use, and our potatoes are  
 genetically engineered /modified  to reduce our use of pesticide are acceptable statements about why 
genetic engineering/modification was used as lo ng as they are truthful and not misleading. Scientific data 
about specific crops may be required to support claims that, for example, pesticide use was reduced for 
the crop being sold.  
Identity preservation systems are used to ensure that the soybeans we u se are not genetically 
engineered /modified  and non -genetically engineered /modified  maize  (tested) are also acceptable 
statements about the methods used to verify claims that foods are not products of genetic 
engineering/modification provided that they are truthful and not misleading.  
Soybean  oil. Product of genetic engineering/modification . Contains no genetically engineered /modified  
material is an acceptable statement for a product of genetic engineering/modification that contains no 
genetically engineered /modified  material  
High fructose maize  syrup. Product of genetic engineering/modification . Contains less than 0.1 % 
genetically engineered /modified  material is an acceptable statement for a product of genetic 
engineering/modification that contains less th an 0.1 % genetically engineered /modified  material.  
A2.3 Claims about  Foods that are products of genetic engineering/modification  
In addition to the considerations described above, the choice of appropriate expressions for claims about 
single -ingredient foods and ingredients that are products of genetic engineering/modification will depend 
on how much of the specific food has been pr oduced through genetic engineering/modification . 
Examples:  
Papaya (product of genetic engineering/modification ) and genetically engineered /modified  potatoes are 
acceptable claims only if the food is obtained from sources (for example, a farmer's crop) that  are more 
than 9 9% product of genetic engineering/modification . 
Potatoes (partly a product of GE), tomatoes (combination of GE and non -GE), and squash (mixed non -
GE and GE sources) are acceptable claims when between 1% and 9 9% of the source of the food or 
ingredient is a product of genetic engineering/modification . 
A2.4 Claims about ingredients in a multi-Ingredient food  
A2.4.1  when  a claim is made that one or more ingredients in a multi -ingredient food are products of 
geneti c engineering/modification or are a mixture of products of and not of genetic 
engineering/modification , the standard requires  
a) That the manufacturer undertake steps to investigate the origin of all ingredients  of the multi -ingredient 
food as offered for  sale, and  
 b) That all known ingredients that are products of genetic engineering be identi fied in the list of 
ingredients.  
Example:  
The following is an acceptable claim and format. (The percentages listed refer to the weight of ingredients 
in the product  as offered for sale. These are included here for instructional use and are not a requirement 
of the standard.)   
 Maize  chips snack food: ingredients: maize  Footnote 1 (70%), hydrogenated soybean  oil Footnote 2 
(25%), seasonings (4%), calcium hydroxide  
FOOTN OTES  
Footnote 1 - Not products of genetic engineering/modification . 
Footnote 2 - From GE/non -GE crops.