G/SPS/N/SAU/162  
 
26 June 2015  
(15-3311)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
1. Notifying Member: KINGDOM OF SAUDI ARABIA 
If applicable, name of local government involved:   
2. Agency responsible: Saudi Food and Drug Authority (SFDA) 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): Infant Formula for Special Medical Purposes (ICS 
Code: 67.230) 
4. Regions or countries likely to be affected , to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document: The Kingdom of Saudi Arabia/The Cooperation Council 
for the Arab States of the Gulf Draft Technica l Regulation for: "Infant Formula for Special 
Medical Purposes"  Language(s): Arabic  Number of pages: 30 
http://members.wto.org/crnattachments/2015/SPS/SAU/15_2470_00_x.pdf  
6. Description of content: This draft technical regulation applies to Infant Formula for 
Special Medical Purposes as a powder or liquid in order to use in the nutritional purposes 
for infants because of disease, physiological disorder or medical condition after birth to 12 months. 
7. Objective and rationale: [X] food safety, [ ] animal health, [ ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [ ] protect territory from 
other damage from pests.   
8. Is there a relevant international st andard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) CODEX STANDARD (72/2011) for infant formula and 
formulas for special medical pu rposes intended for infants 
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[ ] None 
Does this proposed regulation conform to the relevant international standard?   
[X] Yes   [ ] No If no, describe, whenever possible, how and why it deviates from the 
international standard:   G/SPS/N/SAU/162 
 
- 2 - 
 
  9. Other relevant documents and language (s) in which these are available:  
- COMMISSION DIRECTIVE 2006/141/European Commission of 22 December 2006 on 
infant formulae and follow-on formulae  and amending Directive 1999/21/European 
Commission. 
- Australia New Zealand Food Standards Code - Standard 2.9.1 - Infant Formula 
Products (21.2.2014). 
- Infant formula and follow on (England regulation 2007). 
- Global Standard for the Composition of Infant Formula: Recommendations of an 
ESPGHAN Coordinated International Expert Group 2005. 
- (European Commission) No 1333/2008 of the European Parliament and of the Council 
by establishing a Union list of food additives. 
- Dietary treatment of cows' milk protein allergy in childhood: a commentary by the 
Committee on Nutrition of the French Society of Paediatrics- British Journal of 
Nutrition (2012), 107, 325-338.   
10. Proposed date of adoption (dd/mm/yy) : To be determined. 
Proposed date of publication (dd/mm/yy) : To be determined. 
11. Proposed date of entry into force: [X] Six months from date of publication , 
and/or  (dd/mm/yy) :   
[ ] Trade facilitating measure   
12. Final date for comments: [X] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 25 August 2015 
Agency or authority designated to hand le comments: [ ] National Notification 
Authority, [X] National Enquiry Point. Address, fax number and e-mail address 
(if available) of other body:  
SPS Enquiry point, Saudi food & Drug Authority 
SFDA - 3292 North Ring road Al Nafel Area Unt (1) - Riyadh 13312 - 6288 
Tel: +(966 11) 203 8222, ext. 3331 
Fax: +(966 11) 210 9825 E-mail: SPSEP.Food@sfda.gov.sa 
Website: http://www.sfda.gov.sa  
13. Text(s) available from: [ ] National Notifi cation Authority, [X] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
SPS Enquiry point, Saudi food & Drug Authority  
SFDA - 3292 North Ring road Al Nafel Area Unt (1) - Riyadh 13312 - 6288 Tel: +(966 11) 203 8222, ext. 3331 
Fax: +(966 11) 210 9825 
E-mail: SPSEP.Food@sfda.gov.sa Website: http://www.sfda.gov.sa