هيئة التقييس لدول مجلس التعاون لدول الخليج العربية 
GCC STANDARDIZATION ORGANIZATION (GSO)  
 
 
 
 
 
Final Draft  
 
 
 
GSO 05 FDS 1366 / 2016  
 
 
 
اشتراطات عامة لتداول الأغذية المستعملة  
لأغراض طبية خاصة  
General Requirements for Handling of  
Foods for Special Medical  Purposes  
 
 
 
 
 
 
 
 
Prepared by:  
GSO Technical Subcommittee for Organic, Functional and Genetically -
modified Food  
 
This document is a draft Gulf Standard circulated for comments. It is, 
therefore, subject to Alteration and modification, and may not be referred it 
as a Gulf Standard, until approved  by the Board of Directors  
 
 
 
 67.250:ICS  
 Foreword  
 
GCC Standardization Organization (G SO) is a regional Organization  which 
consists of the National Standards Bodies of GCC member States . One of GSO 
main functions is to issue Gulf Standards /  Technical  regulations through 
specialized technical committees (TCs).  
GSO through the technical program of committee TC No. 05-SC3 'GSO 
Technical Subcommittee for Organic, Functional and Genetically -modified Food ' 
has updat ed the GSO standard No. : 1366 / 2002 “ General Requirements for 
Handling of Foods for Special Medical P urposes ”. The draft standard has been 
prepared by Saudi Arabia.  
This standard has been approved as a Gulf (Technical  Regulation) by GSO Board 
of Directors in its meeting No.  ( ), held on   / /    H, / / G. The approved standard 
will replace and  supersede the GSO standard No. ( 1366 /2002 ).GSO STANDARD  GSO 1366 / 2016  
 
 1 GENERAL REQUIREMENTS FOR HANDLING OF  
FOODS FOR SPECIAL MEDICAL PURPOSES  
1. SCOPE  
 This GSO  Standard applies to the general requirements for handling of foods for 
special purposes  in patients over 12 months of age , including the following 
products:  
1.1 Nutritionally complete formulas.  
1.2 Nutritionally incomplete formulas.  
1.3 Formulas for metabolic “genetic” disord ers in patients over 12 months.  
1.4 Oral rehydration solutions.  
2. COMPLEMENTARY REFERENCES  
2.1 GSO 9 “Labeling and prepackage of Foods”.  
2.2 GSO 150 -1 “Expiration periods for Food products - Part 1 : Mandatory expiration 
dates ”. 
2.3 GSO 150 -2 “Expiration p eriods for Food products - Part 2 : Voluntary expiration 
dates”.  
2.4 GSO 654  “General Requirements for Handling of prepackage Foods for Special 
Dietary uses”.  
2.5 GSO 2333 “Requirements for nutrition and health claim in the food” . 
2.6 GSO 2233 “Requirements of nutritional labeling”.  
3. DEFINITIONS  
3.1 Foods for special medical purposes: are categories  of foods for uses that are 
specially processed for  formulated and presented for the dietary management of 
patients and may be used only under medical supervision.  They are intended for 
the exclusive or partial feeding of patients with limited or impaired capacity to take, 
digest, absorb or metabolize ord inary food stuffs or certain nutrients contained 
therein, or who have other special medically - determined nutrient requirements, 
whose dietary uses, or by a combination of the two.  
4. REQUIREMENT  
 Without prejudice to what is given in GSO  Standard item (2 .4), the following shall 
be met in handling of foods for special medical purposes.  
4.1 The formulation shall be based on medical and nutritional purposes.  
4.2 Their use shall be demonstrated, by scientific evidence, to be safe and beneficial in 
meeting the  nutritional requirements of the persons for whom they are intended.  
4.3 The labels, accompanying leaflets and / or other labeling and advertising of all 
types of foods for special medical purposes shall provide sufficient information on 
the nature and pur pose of the food as well as detailed instructions and precautions 
for their use. The format of the information given should be appropriate for the 
person for whom it is intended.  GSO STANDARD  GSO 1366 / 2016  
 
 2 4.4 Foods for special medical purposes shall be dispensed and marketed only b y 
pharmacies, hospitals, medical ce nters and children care centers , (or as per 
appropriate way  that are taken by national  authorities) . 
4.5 Products that are mentioned in item 1.1 shall provide the following:  
 Maximum amount per MJ  Minimum amount per MJ  Nutrient  
 
430 μg retinol equivalents   
84 μg retinol equivalents  Vitamins:  
Vitamin A  
No maximum set  0.15 mg   Thiamin  
No maximum set  0.2 mg  Riboflavin  
No maximum set  2.2 mg niacin equivalents  Niacin  
No maximum set  0.2 mg  Vitamin B 6  
No maximum set  25 μg  Folate  
No maximum set  0.17 μg  Vitamin B12  
No maximum set  5.4 mg  Vitamin C  
6.5 μg or (7.5 μg)*  1.2 μg  Vitamin D 
No maximum set  1 mg alpha -tocopherol 
equivalents  Vitamin E  
No maximum set  1.8 μg  Biotin  
No maximum set  0.35 mg  Pantothenic Acid  
No maximum set  8.5 μg  Vitamin K  
 
420 mg or (600 mg)*   
84 mg or (120 mg)* Minerals:  
 Calcium 
No maximum set  18 mg  Magnesium  
No maximum set  1.2 mg  Iron 
No maximum set  72 mg  Phosphorus  
3.6 mg  1.2 mg  Zinc 
1.2 mg  0.12 mg  Manganese  
1.25 mg  0.15 mg  Copper  GSO STANDARD  GSO 1366 / 2016  
 
 3 84 μg  15.5 μg  Iodine  
No maximum set  3 μg Chromium  
No maximum set  7 μg Molybdenum  
25 μg  6 μg Selenium  
 
No maximum set   
72 mg  Electrolytes:  
Sodium  
No maximum set  190 mg  Potassium  
No maximum set  72 mg  Chloride  
* This amount applies only to products intended for children aged one to ten years.  
5. LABELING  
 Without prejudice to what is given in GSO  standards mentioned in items (2.1 and 
2.6), the following shall be declared on the label:  
5.1 Name of the product followed by a statement indicatin g the medical purposes that 
it is intended for.  
5.2 compositional c hanges in the product that  make it appropriate for this medical 
condition.  
5.3  Phrase describes the nature and type of the product according to item (1).  
5.4 Information on energy value shall be expressed in kj and kcal per 100 g or 100 ml 
as sold as well as per scientific quantity of the food as suggested for consumption.  
5.5 The amounts of protein, carbohydrate and fat in the food shall be expressed in g 
per 100 g or per 100 ml as sold,  as well as per specific quantify of the food 
suggested for consumption.  
5.6 The amounts of vitamins and essential minerals shall be expressed in metric units 
per 100 g or per 100 ml as sold, as well as per specific quantity of the food 
suggested for consu mption.  
5.7 The quantity of nutrients shall be expressed in terms of percentages of the relevant 
international recognized recommended daily allowances.  
5.8 Information on osmolality or osmolarity and / or in acid -base balance shall be 
given when appropria te. 
5.9 When serving sizes are normally used, information described in sections 5/2 to 5/5 
shall be given only per serving as quantified on the label or per portion provided 
that the number of servings or portions contained in the package is stated.  
5.10 The nature of the animal and plant proteins or protein hydrolyses.  
5.11 Foods for special medial purposes in which the essential charesterstic involves a 
specific modification of the content or the nature of proteins, fats or carbohydrates GSO STANDARD  GSO 1366 / 2016  
 
 4 shall bear a description of this modification and information on the amino acid fatty 
acid or carbohydrate profile, when necessary.  
5.12 A prominent statement “USE UNDER MEDICAL SUPERVISION” shall appear 
on the label in bold letters in an area separated from other writ ten, printed, or 
graphic information.  
5.13 Adequate directions for the preparation including the requirement to add other 
ingredients, for the use of the food and its strong and keeping after the container 
has been opened, shall be included on the label.  
5.14 An additional prominent warning statement consisting of an explanatory statement 
shall appear on the label in bold letters in area separated from other writing, printed 
or graphic information if the food for special medical purposes a health hazard 
when consumed by individuals who do not have the diseases, disorders or medical 
condition for which the food is intended.  
5.15 A statement that product is not be used for parenteral administration.  
5.16 A prominent statement indicating whether the product is or is not intended as the 
sole source of nutrition.  
5.17 A complete statement concerning adequate precautions, known side effects, 
contraindications, and product drug interactions, as applicable.  
5.18 A statement specifying the nutrient(s) which have been reduced, deleted increased 
or otherwise modified, relative to normal requirement, and the rational for the 
reduction, deletion, increase or other indication.  
5.19 If the product has been formulated for specific age group, it shall carry a prominent 
stateme nt to this effect.  
5.20 Lactose claims in relation to food for special medical purposes:  
5.20.1  A claim to the effect that a food for special medical purposes is lactose free may 
be made if the food contains no detectable lactose.  
5.20.2  A claim to the eff ect that a food for special medical purposes is low lactose may be 
made if the food contains not more than 2 g of lactose per 100 g of the food.  
5.20.3  If a claim in relation to the lactose content of a food for special medical purposes 
is made the label o n the package of food must include the average quantity of the 
lactose and galactose in the food, expressed per given quantity of the food.  
 GSO STANDARD  GSO 1366 / 2016  
 
 5 References :  
- Codex Standard f or The Labelling of and Claims for Foods for Special 
Medical Purposes Codex Stan 180-1991  
- FSANZ Standard 2.9.5 Food for Special Medical Purposes . 
- FDA Medical Foods Program – Import And Domestic : 
http://www.fda.gov/downloads/Food/ComplianceEnforcement /UCM0733
39.pdf