In the Name  of God Almighty  
Arab Republic of Egypt  
Presidency of the Republic  
 
 
 
Supplement of t he Egyptian Official Gazette  
(Al-Waqae  Al-Misriyya ) 
 
 
 
 
    Price: EGP 4  
 
  
 Issue  No.185 
 
 
  
    (supplement ) 
  
               Issued on Wednesday , 4th of Dhū al -Ḥijjah 1439 A.H.  
Corresponding to  15th of August 2018 A.D.  
  
  
 Since  
191 A.H. 
        Al-Waqae Al -Misriyya  – Issue No.185 ( supplement) on 15th of August 2018  
 
 
The National Food Safety Authority  
Decree of the Board of Directors No.1 of the year 2018  
On 
The Rules Governing the Registration and Handling of Foods for 
Special Dietary Uses  
Board of Directors (BoD)  
After reviewing the Constitution ; 
Law No.48 of the year 1941 on Combating Fraud and Deception ; 
Decree Law No.95 o f the year 1945 on Supply Affairs ; 
Law No.132 of the year 1950 on Milk and Milk products;  
Law No.21 of the year 1958  on Regulation of Industry ; 
Law No.10 of the year 1966 on Food Control and  Regulating  Handling  thereof ; 
Law No.1 of the year 2017 on the Enactment of the Law of the National Food 
Safety Authority  (NFSA) ; 
Decree of the Minister of Health No.348 of the year 1976 on C onditions and 
Procedures for Registering Foods for Special Dietary Uses as amended by Decree 
No.416 of the year 1994 ; 
Decree of the Minister of Health No.530 of the year 1979 on the Addition of Food 
Preparations  to the Preparations enumerated  in law No.30 of the year 1976;  
Decree of the Minister of Health and Population No.176 of the year  2003;  
Approval of the BoD of NFSA  in the session held on March 20, 2018;  and 
After consulting the State Council ; 
 
Decreed  the following :       Al-Waqae al -Misriyya  – Issue No.185 ( supplement) on 15th of August 2018  
 
 
Clause (1)  
Foods for special dietary uses (FSDU) shall be governed by the provisions of the 
attached technical regulation  issued by the BoD of NFSA .  
Clause (2)  
Any other provision contrary to what is stated in the present decree shall hereby be 
repealed.   
Clause (3)  
This decree  shall be published in the Supplement of the Official Gazette  (Al-
Waqae  Al-Misriyya)  and shall enter into force on the day following the date of 
publication.   
 
Chairman of the Board  
  Dr. Hussein Mansour  
 
 
 
 
 
 
 
 
 
 
       Al-Waqae Al -Misriyya  – Issue No.185 ( supplement) on 15th of August 2018  
 
The Rules Governing the Registration and Handling of Foods for 
Special Dietary Uses  
Article (1)  
The following terms shall , in the appli cation of the provisions of the present  
decree,  have the meanings set forth next to each : 
1- “Foods for special dietary uses (FSDU)”  means  food products that  are 
specially processed, prepared or formulated to satisfy particular dietary 
requirements , or requirements that  exist because of specific diseases  - including 
foods intended for feeding infants and children, diets for use in weight gain or 
reduction , and stimulant, fortified and appetizing foods  – as established by  the 
Code x Alimentarius Commission (CAC).  
2- “Foods for special medical purposes  (FSMP)”  means  a category of FSDU that  
are specially processed or 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, ab sorb or metabolize ordinary foodstuffs or certain nutrients 
contained therein, or who have other special medically -determined nutrient 
requirements, whose dietary management cannot be achieved only by 
modification of the normal diet, by other foods for spe cial dietary uses, or by a 
combination of the two.  
3- “Infant formula and formulas for special medical purposes intended for 
infants ” means  a breast -milk substitute specially manufactured to satisfy, by 
itself, the nutritional requirements of infants durin g the first months of life up 
to the introduction of appropriate complementary feeding.  
4- “Follow -up formula”  means a food intended for use as a liquid part of the 
weaning diet for the infant from the 6th month on and for young children . It is 
prepared fr om the milk of cows or any other animals or any other constituents 
of animal or plant origin , which have been proved to be suitable for infants.  
5- “Processed cereal -based foods for infants and young children”  means foods 
prepared primarily from one or mor e milled cereals, which should constitute at 
least 25% of the final mixture on a dry weight basis.        Al-Waqae al -Misriyya  – Issue No.185 ( supplement) on 15th of August 2018  
 
 
6- “Canned baby foods”  means foods intended primarily for use during the 
normal infant's weaning period and also for the progressive adaptation of 
infants and children to ordinary food. They may be either in ready -to-eat form 
or in dry form requiring reconstitution with water or milk only. They do not 
include products covered by items (4) and (5).  
7- “Food supplements”  means food products that are intended to supplement the 
normal diet , contain  concentrated sources of nutrients (vitamins and minerals) 
or other components with nu tritional and physiological effects  alone or in 
combinations, and are marketed in forms such as solutions, capsules, powder s, 
tablets, capsules, ampoules, drops, or in any other similar forms that are 
designed to be taken in measured small -unit quantities but are not in a 
conventional food form.  
8- “Container”  means any packaging of food for delivery as a single item and 
includes wrappers. A container may enclose several units or types of packages 
when such is offered to the consumer.  
9- “Label”  means tag,  brand, mark, pictorial or descriptive matter, written, printed, 
stencilled, marked, embossed or impressed on, or attached to  a container of 
food or placed in close proximity to  foods offered for sale.  
10- “Essential nutrients”  means any substance normally consumed as a 
constituent of food in order to provide energy and which is needed for growth, 
development and maintenance of life. Any nutrient deficiency can lead to 
symptoms, biological or physiological changes.  
11- “Fortific ation”  means the addition of one or more essential nutrients to a food 
whether or not it is normally contained in the food, for the purpose of 
preventing or correcting a deficiency of one or more nutrients in the population 
or specific population.  
12- “Sub stitute food”  means a food prepared to resemble a common food in 
appearance, texture, taste and smell and is intended to be used as a complete 
or partial replacement for the food it resembles.  
       Al-Waqae Al -Misriyya  – Issue No.185 ( supplement) on 15th of August 2018  
 
13-  Claims:  
(a) “Nutrition claim”  means any representation , which states, suggests or 
implies that a food has particular nutritional properties , including but not 
limited to the energy value and to the content of protein, fat and 
carbohydrates, as well as the content of vitamins and minerals , to meet the 
requirements  stated in  items (1) and (2).  
 (b) "Health claim " means any representation, which states, suggests, or 
implies that a relationship exists between a food or a constituent of that 
food and health.  
14- “Expiration date” means the period d uring which a product maintains  its 
basic characteristics and remain s palat able, acceptable and marketable  until 
the end of this period  under any stated pack aging, transportation and storage 
conditions,  and after which one of its characteristics begins to deteriorate, in 
accordance with the standard of the CAC . 
15- “Food a dditives”  means substances added to a food during manufacture, 
processing, preparation, treatment, packing, packaging  or transport for 
technological purposes  or functions or for producing actual or possible 
effects on food.  
  These substances  are not normally consumed as a food by itself and not 
normally used as a typical ingredient of the food, whether or not it has 
nutritive value. The term does not include contaminants or substances added 
to food for maintaining or improving nutritional qua lities.  
16- “Food additives  carried over into  food s”: food additives not authorized in 
food ingredients and raw materials may be used in or added to a food if the 
raw material or ingredient is carried over unintentionally into the food . The 
food additives in this case are called “ food additives carried over into foods” 
and must  be included in the lists of the authorized food additives.  In 
addition , the food additives carried over into foods may not  be used in infant 
formula or complementary foods.  
17- “Warnings”  means the warnings issued by the CAC , the European legislation 
or the international legislative bodies, for instance (if aspartame is added to a       Al-Waqae al -Misriyya  – Issue No.185 ( supplement) on 15th of August 2018  
 
 
food product, a phrase indicating that it c ontains source of phenylalanine  
should be on the label).  
18- “Allergens”  means the allergens  determined and enumerated  in the latest 
publications of the CAC  and international legislation.  
19- “Infants”  means a person not more than 12 months of age.  
20- “Young children”  means a person from 12 months up to 36 mont hs of age.  
Article (2)  
The following food products shall, in the appli cation of the provisions of 
the present  decree , be d eemed to be FSDU : 
1. infant formula and formulas  for special medical purposes intended for 
infants , (breast -milk substitute s) and formulated complementary foods ; 
2. processed cereal -based foods for infants and young children ; 
3. canned baby foods ; 
4. foods  intended for persons  with s pecial physiological conditions;  
5. FSMP;  
6. foods that are  marketed with health clai ms as stated in items 1, 2 and 7 of 
Article (1) of the present regulation , and as established by  the CAC  and 
international legislation;  
7. low-energy diets (800 – 1200 kcal)  and very low energy diets  (400 – 800 
kcal) used in weight control or reduction  and presented as a total or 
partial replacement for daily food , with the exception of the pre packaged 
foods  put up for sale as conventional foods;  
8. high-energy diets  for use in  weight gain ; 
9. low-sodium  foods , inclu ding salt substitutes that bear  health  claims;  
10. foods to which  vitamins or mineral s are added by (15%) or more  of the  
reference value per 100 g of solids , or by (7.5%) of the refere nce value 
per 100 ml of liquids;  
11. foods to which prebiotics , or other fortifying substances, compounds or 
elements are added  in the light of international legislation;  
12. foods containing stimulant, forti fying and appetizing substances;  
13. food s upplements provided that they do not contain any substances with a 
therapeutic pharmacological effect;        Al-Waqae Al -Misriyya  – Issue No.185 ( supplement) on 15th of August 2018  
 
14. food s upplements for athletes , and foods intended for intense muscular 
effort ; 
15. individual he rbs and spices  or mixture s thereof  bearing health claims ; and 
16. prepacked artificial sweeteners ( table sugar substitutes).  
Article (3)  
The provisions of the present  decree  may not apply to the following products ; 
however, they are subject to the rules governing the handling of common 
food s: 
1. individual h erbs and spices or mixture s thereof  not bearing health claims ; 
2. low-calorie foods not intended for specific groups of population (such as 
sugar -free or l ow-calorie foods and beverages);  
3. foods that are by their nature deemed a source of vitamins , minerals , or other 
elements or nutrients;  
4. foods that contain  vitamins and minerals  less than (15%) of the reference 
value per  100 g of solids , or (7.5% ) of the reference value per 100 ml of 
liquids and other nutrients , in accordance with international legislation;  
5. fiber-reinforced products that contain less than 3 g per100 g (30 g daily) 
or10 % of the daily intake reference value (DIRV) ; 
6. natural  bottled drinking water and mineral bottled drinking water;  or 
7. low-sodium foods , including salt substitutes not bearing health  claims.  
Article (4)  
The label  of the pre packaged FSDU  shall bear  a label indicating  the following 
information : 
1. the name of FSDU ; 
2. a list of ingredients in descending or ascending order;  
3. ingredients, additives , and nu trients that may cause food allergies ; 
4. authorized food additives , and flavorings  except for processing  aids;  
5. net weight or size; 
6. names and address es: 
a. the name, address  and brand of the producer shall , if any, be indicated  
on the food container , 
b. in case of imported products, the name and address of the importer, as 
well as the  country of origin  shall be indicated ; furthermore,  the name       Al-Waqae al -Misriyya  – Issue No.185 ( supplement) on 15th of August 2018  
 
 
and address of the producer  may be written  in English or French if 
writing in Arabic is difficult , and 
c. in case of packaging , the name and address of the packer shall be 
indicated ; 
7. country of origin (production);  
8. batch/lot identification ; 
9. expiration date; 
10.  product -specific s torage instructions ; 
11.  in case of domestic  production, any of the following  phrases (Made in 
Egypt, Made in A.R.E., or equivalent) shall be used;  and 
12.  nutrition al data/facts. 
Nutritional facts/values shall be declared  on the label  as follows:  
1. the declaration of nutritive  value  shall be numerical ; however, the use of  
additional means of presentation  may also be used;  
2. information on e nergy value  shall be  expressed  in Kilocalorie s (kcal)  or in 
Kilojoule s (KJ) per 100 g rams  or per 100 ml  of the food as sold and per 
specified quantity of the food as suggested for consumption ; 
3. information on a mounts of protein, carbohydrate s and fat present in food 
shall be expressed in Grams (g) per 100 g  or per 100 ml of the food as sold 
and per specified quantity of the food as suggested for consumption ; 
4. information on a mounts of essential and non -essential amino acids or 
essential fatty acids  may be expressed similarly in metric units as 
appropriate;  
5. information on a mounts  of vitamins and essential minerals present  in the 
food shall be  expressed in metric units per 100 g or per 100 ml of the food as 
sold and per specified quantity of the food as suggested for consumption ; 
6. where it is appropriate, the quantities of nutrients may be expressed in terms 
of percentage s of the relevant internationally recognized r ecommended daily 
allowance s; 
7. information on osmolality or  osmolarity , or acid-base balance of a product  
shall be provided  when  appropriate ; and  
8. the nature of the animal or plant proteins , or protein hydrolysates shall be  
declared.  
In case of FSMP, a ll the aforementioned information in addition to  a prominent 
statement  “USE UNDER MEDICAL SUPERVISION ” shall be made in Arabic        Al-Waqae Al -Misriyya  – Issue No.185 ( supplement) on 15th of August 2018  
 
besides any other languages , and shall be marked in a conspicuous place in such a 
way as to be easily visible and clearly legible.  Furthermore, food preparation 
directions  (including other ingredients required to be added for the use of the food) 
shall be declared on the label . 
The label of any food  that has been treated with ionizing radiation shall bear a 
written statement indicating that treatment  and shall appear in close proximity to 
the name of the food.  
Article (5)  
Nutrition  and health  claims may not be used if they : 
a) are false, ambiguous or misleading;  
b) give rise to doubt about the safety of food or the nutrit ional adequacy  of 
other foods;  
c) encourage  to or condone excess consumption of  a food;  
d) state or imply that a balanced and varied diet cannot provide  appropriate  
quantities  of nutrients  in general ; or 
e) refer to changes in bodily functions, which  could give rise to doubt in the 
consumer , either textually or through pictorial, graphic , or symbolic 
representations.  
The following may not constitute nutrition claims : 
- substances in the list of ingredients,  
- nutrients as a mandatory part of nutrition labelling , or 
- quantitative or qualitative declaration  of certain nutrients on the label  if 
required  by the relevant standards  and technical rules.  
Article (6)  
FSDU , whether domestically  manufactured or imported,  may not be handled nor  
advertised unless registered and licensed for handling by NFSA.  
Article (7)  
No FSDU may be manufactured , process ed or  prepared  except in licensed factories  
that meet hygienic  requirements of food factories provided that hygienic  
requirements for producing foods  intended for infants and young children  are 
fulfilled . 
       Al-Waqae al -Misriyya  – Issue No.185 ( supplement) on 15th of August 2018  
 
 
 
 
Article (8)  
No FSDU may be advertised by word of mouth, by picture , or in writing in any 
kind of mass media  unless NFSA is notified of the advertisement text a week prior 
to advertising.  
No FSMP may be advertise d to the public . 
Breast -milk substitutes may not be advertised by any mean s. 
Article (9)  
FSDU shall be registered as follows:  
The r egistration, follow -up and submission of the scientific file shall be paper -
based or via the NFSA website and e-mail.  
The documents required for registration shall be determined by virtue of a decree  
of the NFSA chairman.  
Registration process may not exceed a 60 -day term as of date of receipt of the 
required documents in full , and a 30 -day term in case of registration by 
notification.  
FSDU l icense shall be  valid for a five-year term as of date of  registration and  
obtaining  a license for handling provided that the requirements and specific ation s 
of the registered product  are met.  
Registration by notification shall  be made for the  FSDU handled in the  country  of 
origin provided  that said country has food safety management systems (FSMS) 
consistent with the FSMS applied  in Egypt, has a Certificate of Free Sale , and 
submit s all the docu ments required for registration . 
Upon dully fulfilling the terms and specifications  of the product registered, the re -
registration shall be made by notification.  
NFSA  shall issue a list of FSDU , FSMP , and dietary supplements that are subject 
to regis tration under  the present  regulation.  
A database of all registered FSDU companies and factories shall be created.        Al-Waqae Al -Misriyya  – Issue No.185 ( supplement) on 15th of August 2018  
 
Article (10)  
Registration and  licensing for handling  of FSDU  enumerated hereinbefore 
shall  be made subsequent to paying the following  fees:  
- EGP 10.000 ( ten thousand Egyptian pounds ) for FSDU , and 
- EGP 15.000 ( fifteen thousand Egyptian pounds ) for formula s intended for 
children, and foods for athletes . 
FSDU  shall be  handled in markets in accordance with  the product -specific storage 
and handling conditions approved by NFSA . 
No FSMP  may be handled outside pharmacies , or hospitals.  
Article (11)  
NFSA may, f or the purpose of controlling FSDU, take the following 
procedures : 
- taking s amples in the light of risk analysis rules, and  
- taking s amples randomly from the FSDU  display areas to ensure that such 
samples are consistent  with the data and information recorded  in the 
registration file.  
For the purpose of analyzing samples, NFSA may  take the following 
procedures : 
a) sending  samples taken from raw materials and products to be analyzed in the 
accredited  laboratories to ensure  that the registration requirements  are 
fulfilled in compliance with the mandatory  technical regulations and the 
applicable standards ; 
b) the permissible microbiological limits for FSDU  shall be in compliance  with 
the applicable legislation and standards  and shall be within  the following 
limits, whichever is less:  
- free of Salmonella /25g, 
- free of Staphylococcus aureus /25g, 
- free of Enterobacteriaceae /g (for infant formula s as well as  dried and 
canned baby foods ), 
- free of Bacillus cereus /g (for infant formula s and dried and canned 
baby foods) , 
- free of Enterobacter sakazakii /25g, and  
- free of Listeria monocytogenes /25g;       Al-Waqae al -Misriyya  – Issue No.185 ( supplement) on 15th of August 2018  
 
 
c)the maximum residue limits (MRL) for pesticide s shall be in compliance  
with international legislation ; 
d)the veterinary drug residues shall be in compliance with international 
legislation; and  
e) the maximum pollutant limits  shall be in compliance  with international 
legislation.  
Article (12)  
FSDU producers and importers shall submit an application for registration to 
NFSA as follows:  
a) applicant c ompanies that have currently registered products shall submit an 
application for registration to NFSA and shall bring the original  valid license  
issue d by the Minis try of Health  (MOH ) in order  for NFSA to grant a new 
license  for the validity period remaining on t he MOH license under the rules 
provided for in the present regulation ; 
b) applicant c ompanies that  have unregistered products (new  products / re-
registration)  shall submit an application for registration to NFSA  in the light 
of the  rules provided for in the  present regulation;  
c) applicant c ompanies  that have  products under registration by MOH shall 
submit a request to NFSA for completing  the registration procedures. T hese 
cases shall be examined separately  and in accordance with the rules provided 
for in the present regulation; and  
d) in respect of  imported  FSDU , the MOH license  shall  remain  valid for a 
three -month term  as of  date of publication of the present  decree pending  
adjustment.  
Article (13)  
FSDU production inputs  subject to the present rules shall be released from customs 
by virtue of a valid license issued by NFSA.  
Printed in the General Organization  for Government Printing  
Chairman of Board of Directors  
Eng.: Emad Fawzy Farag Mohamed        Al-Waqae Al -Misriyya  – Issue No.185 ( supplement) on 15th of August 2018  
 
Deposit No. at Dar El Kotob 268/201 8 
25124/2018 - 16/8/2018 - 1809