GCC STANDARDIZATION ORGANIZATION (GSO) 
 
  
      
Final Draft  
  
  
GSO5/ FDS …./2010  
 
      
 اﻟﻌﺎﻣﺔ  وراﺛﻴﺎًاﻟﻤﺘﻄﻠﺒﺎت  اﻟﻤﺤﻮرة  ﻟﻠﻤﻨﺘﺠﺎت  واﻟﺘﺘﺒﻊ  اﻟﻤﺨﺎﻃﺮ  ﻟﺘﻘﻴﻴﻢ   
GENERAL REQUIREMENTS FOR RISK ASSESSMENT 
AND TRACEABILITY FOR GENETICALLY  MODIFIED 
PRODUCTS  
 
    
                         
   
Prepared by:  
 
Gulf technical committee for standards of food and agriculture products 
___________________________________________________________________________________________________________ 
This document is a draft Gulf  standard circulated for comments, it is therefore, 
subject to change, and may not be referre d it as a Gulf standard, until approved by 
the Board of Directors.  .   Foreword 
  
    
Standardization Organization for G CC (GSO) is a regional Organization 
which consists of the National Standard s Bodies of GCC me mber States. One 
of GSO main functions is to issue Gulf Standards /Technical regulation 
through specialized technical committees (TCs). 
 
GSO through the technical progra m of committee TC No 5  "  The Gulf 
Technical Committee for Food and Ag ricultural Standards Products" has 
prepared this Standard .  The Dr aft Standard has been prepared by 
(KINGDOM OF SAUDI ARABIA      ) 
 
 The draft Standard has been prepared based on re levant ADMO, International 
and National foreign Sta ndards and references. 
 
This standard has been approved as Gu lf (Standard / Technical Regulation)   
by GSO Board of Directors in its meeting No..../....  …….held on    /    /   /  H 
,  /    /   G GSO STANDARD  GSO ...... / 2010
 
 1 GENERAL REQUIREMENTS FOR RISK ASSESSMENT  
AND TRACEABILITY FOR GENETICALLY  
MODIFIED PRODUCTS  
 
 1. SCOPE AND FIELD OF APPLICATION 
  This GSO standard is concerned with  general requirements for risk assessment 
and traceability of GM food Processed  and unprocessed agricultural products , 
the risk assessment and traceability should be fully considered in  the safety of 
each new component in a GM food and c onsiders both the intended effects of 
the genetic modification and the unintended effects.    
 
2. COMPLEMENTARY REFERENCES 
2.1       GSO ……   (General Requirements For Processed Genetically Modified         
Food and Feed)  
2.2 GSO ........(General requirements for genetically modified unprocessed 
agricultural products 
 
3.     DEFINITIONS 
 
3.1      Donor organism  
 Organism from which the transfered DNA is originally derived. 
3.2       Recipient organism 
 Organism into which foreign DNA is introduced. 
3.3       Traceability  
 Tracing GMOs or products produced from  GMOs at all stages starting at 
production stage  and through distribution, c onsumption or  using in agriculture 
production. 
3.4       Hazard 
 Means a biological, chemical or physical agents in or condition of, food or feed 
with the potential to cause an adverse health effect. 
3.5       Risk 
 A function of the probability of an adverse health effect and the severity of that 
effect, consequential to a hazard(s) in food and feeds. 
3.6      Risk Analysis  
 A process consisting of three component s: risk assessment, risk management 
and risk communication. 
 GSO STANDARD  GSO ...... / 2010
 
 2 3.6.1     RISK ASSESSMENT  
 A scientifically based process cons isting of the following steps: hazard 
identification, hazard characterizati on, exposure assessment, and risk 
characterization. 
3.6.1.1     Hazard identification  
 The identification of biological, chem ical, and physical agents capable of 
causing adverse health effects and which ma y be present in a particular food or 
group of foods. 
3.6.1.2     Hazard characterization 
 The qualitative and /or quantitative evaluation of the nature of the adverse 
health effects associated with biological  , chemical and physical agents which 
may be present in food or group of foods. 
3.6.1.3    Exposure assessment  
 The qualitative and /or quantitative evaluation of the likely intake of biological, 
chemical, and physical agents via food as  well as exposures from other sources 
if relevant. 
3.6.1.4    Risk characterization  
 The qualitative and/or quantitative estimation, including attendant 
uncertainties, of  the probability of occurrence and severity of known or 
potential adverse health effects in  a given population based on hazard 
identification, hazard characterization and exposure assessment. 
3.6.2      Risk management  
 The process of weighing policy alternativ es, in consultation with all interested 
parties, considering risk assessment and other factors relevant for the health 
protection of consumers and selecti ng appropriate prevention and control 
options if needed. 
3.6.3      Risk communication: 
 The interactive exchange of inform ation and opinions throughout the risk 
analysis process concerning risk, risk -related factors and risk perceptions, 
among risk assessors, risk managers, consumers ,industry the academic community and other interested partie s including the explanation of risk 
assessment finding and the basis of risk management decisions. 
 
4.       REQUIREMENTS  
 Without prejudice of what stated in GSO mentioned in items 2/1 and 2/2. The 
assessment of GM foods safety will be carried out on a case-by-case basis. The 
party of export or the exporter should pr ovide the competent national authority 
of the party of  import state prior to the import operation the following: 
  GSO STANDARD  GSO ...... / 2010
 
 3 4.1     History of use 
 In the first part of a safety assessment,  must looks at the hi story of use of the 
conventional food (the recipient or host organism).This includes identifying: 
4.1.1     The edible components of the food.       4.1.2     Food products commonly containing these edible components. 4.1.3     Processing requirements.   4.1.4     The results of toxicity or allergenicity of donor organism.  
4.2     Description of the genetic modification 
         It should provide information on the following : 
4.2.1     Methods used in the genetic modification 4.2.2     Function and regulation of the new genes                    4.2.3     Characterization of the new genes 4.2.4     Stability of the genetic changes 4.2.5     Effect of the new gene on human health  
4.2.1      Methods used in the genetic modification 
 Must provide clear description of methods used in the genetic modification. 4.2.2     Function and regulation of the new genes                    
 The applicant must provide descripti on for the function and regulation of how 
the new genes function in the plant as followed: 
4.2.2.1    The new genes and their products (t hat is the proteins coded for by the new 
genes). 
4.2.2.2    The genetic material that contro ls how, where and when the new genes are 
switched on. 
4.2.2.3    The genetic material that targets any new proteins to specific parts of the cell. 4.2.3    Characterization of the new genes 
 The applicant is required to provide detailed information on the arrangement of 
the new genetic material in the genome (the complete genetic make-up) of the host organism. This includes the following: 
4.2.3.1  The results of standard molecular biological techniques that demonstrate how             
many complete or incomplete copies of the new genetic material are present.  
4.2.3.2   Compares the DNA sequence of the new genetic material in the GM plant's              
genome with that of the original DNA. 
 4.2.3.3   Determining if there are any unexp ected changes in the DNA sequence in the 
plant.  
4.2.4     Stability of the genetic changes  
 The genetic changes in each GM plan t must be stable. The new genetic 
material is considered to have become a stable part of the host genome if they GSO STANDARD  GSO ...... / 2010
 
 4 remain the same over several generati ons of plants produced by conventional 
breeding. This means that the newly introduced traits should be shown to pass from one generation to the next in a normal predictable way, following the 
principles of inheritance. 
4.2.5      Effect of the new gene on human health 
     Must mention any effect of the new gene on human health. 
 
4.3      Characterization of new proteins 
 The safety assessment must include test for nature and function of new proteins 
in GMO.  Standard molecular and bioche mical techniques can be used to verify 
that the size of any new protein is as expected, and to quantify how much new 
protein in particular tissues . 
4.3.1     Nature of the new protein  
 The safety assessment must include test for nature and function of new proteins 
in GMO , since the presence and level of new proteins in particular components 
of GM varieties used as food, or in f ood preparation, may present safety Issues. 
Therefore, assesses this in the parts of GM plants that are actually eaten. It is possible that the new protein is: 
4.3.1.1   Only expressed in n on-edible parts of the plant. 
4.3.1.2   Inactivated, denatured or removed by heat or processing (that is cooking). 
4.3.1.3   Only present at very low levels in the edible part of the plant. 
4.3.2     Potential toxicity of new proteins      
 This part of the assessment examines the potential toxicity of any new proteins 
in the GM food. The applicant must also  supply data demonstrating that new 
proteins do not cause any detectable toxic ity in animal studies. In these studies, 
the purified new protein is given to an imals such as rats, mice and quails at 
high doses (100-1000 times more than a pe rson would expect to eat in a normal 
portion of GM food). The animals are usually observed for a period of time 
(usually 90 days) after being given the protein, to determine whether there are any obvious adverse effects caused by th e new protein. The animals are then 
sacrificed and post-mortems are used to determine any changes in pathology compared to control animals. 
4.3.3     Potential allergenicity of new proteins                         
 In this part of the assessment, look at  whether any new protein present in the 
GM food is likely to cause an allergic reaction in some people. To assess the 
allergenic potential of new proteins, the applicant must provide information on: 
4.3.3.1   Any significant allergens present in the organism that the new proteins came 
from. 
4.3.3.2   Any significant similarity with any known allergens. 
4.3.3.3    Any other physical features characteristic of allergens. GSO STANDARD  GSO ...... / 2010
 
 5  
4.4   Compositional analyses 
 Must compare the composition of the conventional food with the GM variety, 
to identity differences in levels of na turally occurring nutrients, anti nutrients, 
toxins and allergens.  
4.4.1    Nutrient analysis 
 The applicant is required to submit the information on the analysis of the 
typical nutrient as followed: 
4.4.1.1   Proximate composition —this refers to the approximate levels of ash, moisture, 
protein. fat, fiber and carbohydrate 
4.4.1.2   Amino acid analysis. 
4.4.1.3   Fatty acid analysis. 
4.4.1.4    Carbohydrate analysis. 
4.4.1.5    Vitamin and mineral analysis. 
 Other compounds present in particular foods may also be measured if they are 
likely to have a significant impact in  the overall diet. For example, the 
assessment would consider isoflavones ( phytoestrogens ) in soybeans. 
4.4.2     Levels of antinutrients 
 Must looks at the levels of any known naturally occurring ant nutrients in the 
food, to check that the genetic modifica tion has not significantly increased their 
levels above the natural range found in  the conventional food.  Processing of 
the foods must also be taken into account, because this may inactivate any antinutriesnts nutrients in the unprocessed food. 
4.4.3     Levels of naturally occurring toxins  
 Must considers the level of any known na turally occurring toxins, to check that 
the genetic modification has not significantly increased levels above the natural range In the equivalent conventional food. 
4.4.4      Levels of naturally occurring allergenic proteins  
 Must submit information  about the levels of any known naturally occurring 
allergens in the food are checked to en sure that the genetic modification has 
not increased the levels above the na tural range found in the equivalent 
conventional food. 
4.5     Nutritional impact 
 Must provide information that a GM food is nutritionally adequate and will 
support typical human growth and wellbeing. This is usually achieved by 
understanding the genetic modification and its  consequences, and analyzing the 
composition of the food. If the compos itional analysis indicates significant 
differences in a number of important nutri ents or other components, or if there 
is concern that the bioavailability of key nutrients may be compromised by the GSO STANDARD  GSO ...... / 2010
 
 6 genetic changes to the food, then feeding studies in animals can determine 
whether the food is nutritionally ad equate. 
4.6    Other safety issues 
         The competent national authority may required other relevant safety issues 
relating to a new GM food on a case-by-cas e basis. In the case of nutritionally 
enhanced food, the nutritional impact of  the changed nutrient profile on the 
human diet would be considered. 
4.7 Domestic classification, if any, of the biosafety level of the living modified 
organism in the country of export. 
4.8 Procedures for emergency and disposal where appropriate. 4.9 The application for GMO approval must include 4.9.1 Any risk assessment and traceability re port that has been supplied to any 
agency for approval. 
4.9.2  The results of any application that has been submitted to any other countries.   
5.     REQUIREMENTS OF TRACEABILITY  FOR GENETICALLY MODIFIED 
PROCESSED AND UNP ROCESS ED AGRICALTRAL PRODUCTS   
5.1  General Requirements 
 The importer must provide the competent national authority with the following 
information before placing foods and feeds on the market:   
5.1.1  The purpose of the importing these GMO products. 
5.1.2  Names and addresses of both importer and  exporter   
5.1.3   A manner for the safe handling, storage, transport and use. 
5.1.4  A credible documentations endorsed by the embassy of imported country of             
origin to indicate that the  product is  been consumed on the country of the 
origin.  
5.2      Special Traceability Requirements  
5.2.1    Traceability requirements  for processed GMO products:  
5.2.1.1   Provide the competent national authority with all information regarding the 
content of the shipment whether the sh ipment contains or has GMO products 
and its special code. 
5.2.1.2   Importer shall make sure the inform ation is given written to the competent 
national authority.  
5.2.1.3   Importer shall have in place systems and standardized procedures to allow the              
holding of the information specified in paragraphs 5.2.1.1 and 5.2.1.2 and the              
identification. 
5.2.2    Traceability requirements  for un-processed agricultural GMO products:  
5.2.2.1   For unprocessed genetically modified agricultural products intended for 
planting or grown  should provide inform ation about the places of planting and GSO STANDARD  GSO ...... / 2010
 
 7 they should be planted in a separate area and far from the areas used for 
planting non-GMO. 
5.2.2.2   The farmer should use only the sp ecified area mentioned in item 5.2.2.1 for 
planting. 
5.2.2.3   For the un-processed GMO agricultural products which used as food or animal 
feed, the importer provide the competent national authority with all information regarding the content of the of GMO which used from GMO and 
all information should be handed to final consumer through the distributors.   
 
 
                         GSO STANDARD  GSO ...... / 2010
 
 8  
 
                                                           REFERENCES 
 
– Cartagena Protocol on Biosafety to the Convention on Biological Diversity. 
– GM foods: safety assessment of genetically modified foos.2005-Food standards 
Australia New Zealand. 
– Guideline for the conduct of food safe ty assessment of food produced using 
recombinant-DNA micro organisms.2003 CAC/GL.46.