G/SPS/N/USA/2534  
 
19 April 2013  
(13-2082)  Page: 1/3  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
NOTIFICATION 
1. Notifying Member:  UNITED STATES OF AMERICA 
If applicable, name of local government involved:    
2. Agency responsible:  U.S. Food and Drug Administration (FDA) 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO;  ICS numbers should be provided in 
addition, where applicable):  Infant formula  HS Code(s):  19. 
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:  Infant Formula: The Addition of Minimum and 
Maximum Levels of Selenium to Infant Formula and Related Labelling Requirements, Proposed rule  Language(s):  English  Number of pages:  10 
Published in Federal Register on April 16, 2013 (78 FR 22442) 
http://www.gpo.gov/fdsys/pkg/FR- 2013-04-16/pdf/ 2013-08855.pdf  
"https://www.federalregister.gov/articles /2013/04/16/2013-08855/infant-formula-the-
addition-of-minimum-and-maxi mum-levels-of-selenium-to-infant-formula-and-related " 
6. Description of content:  The U.S. Food and Drug Administration (FDA) is proposing to 
amend the regulations on nutrient specifications and labelling for infant formula to add 
the mineral selenium to the list of required nutrients and to establish minimum and 
maximum levels of selenium in infant formula.  Products that meet the statutory definition of "infant formula" in section 201(z) of the FD&C Act (21 U.S.C. 321(z)) ("a 
food which purports to be or is represented for special dietary use solely as a food for 
infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk) are subject to this proposed rule. 
7. Objective and rationale:  [X] food safety, [ ] animal health, [ ] plant protection, 
[X] protect humans from animal/plant pe st or disease, [ ] protect territory 
from other damage from pests.    G/SPS/N/USA/2534 
 
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8. Is there a relevant international st andard?  If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or seri al number of Codex 
standard or related text) Standard for infant formula and formulas for spécial 
medical purposes intenteded for infants. CODEX STAN 72-1981,  amended 2011.  
[ ] 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?   
 [ ] Yes   [X] No 
 If no, describe, whenever possible,  how and why it deviates from the 
international standard:  The minimum and maximum levels for selenium in Codex 
Standard (CODEX STAN 72-1981, amended 2011) are 1 microgram (mcg) per 100 
kilocalories (kcal) and 9 mcg /100 kcal, respectively. After considering the scientific reports, FDA is proposing 2.0 mcg selenium/100 kcal as the minimum level for selenium 
in infant formulas.  This proposed minimum level is based on the Institute of Medicine 
(IOM) adequate intake (AI) for selenium for infants 0 to 6 months of age (2.1mcg/day) and the level suggested by the data in the study by Daniels, et a' 2008 (1.9 mcg/100 
kcal) (Ref. 5), rounded to the nearest whole microgram.  The Daniels, et al. study 
demonstrated that infants who consumed infant formula containing 1.9 mcg selenium/100 kcal had plasma and erythrocyte indicators of selenium status that were statistically higher than those of infants consuming formula containing less selenium 
(0.9 mcg/100 kcal) but these levels did not differ from those of infants consuming infant 
formula containing more selenium (3.1 mcg /100 kcal).  Infants consuming the formula containing 3.1 mcg /100 kcal of selenium also had significantly higher urinary excretion 
of selenium.  In the absence of statistically significant changes in plasma and 
erythrocyte indicators of selenium status, the substantially higher urinary excretion of selenium of the infants fed the 3.1mcg selenium formula compared to that of the infants 
fed the 1.9 mcg selenium formula, suggests that a selenium intake of 3.1 mcg/100 kcal 
is likely to be greater than the amount needed to meet an infant's nutritional needs. 
 
Thus, FDA tentatively concludes that 2.0 mcg selenium/100 kcal is an appropriate required minimum for seleni um in infant formulas. 
FDA is also proposing to set a maximum level for selenium in infant formula of 7.0 
mcg/100 kcal. This level is based on the upper level (UL) for infants 0 to 6 months of age established by the IOM, and defined as highest level of daily nutrient intake that is 
l i k e l y  t o  p o s e  n o  r i s k  o f  a d v e r s e  h e a l t h  e ffects in the population of interest.  FDA is 
relying on the IOM's recommendation because the IOM report was the most transparent in terms of the basis for its recommended UL.  Also, unlike the minimum level, there is 
no study that provides direct evidence to establish a maximum level and thus, in 
proposing a maximum level, the agency must rely on a recommendation for an intake level that is likely to pose no risk of adverse health effects. G/SPS/N/USA/2534 
 
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9. Other relevant documents and language (s) in which these are available:   Food 
and Nutrition Board.  Institute of Medicine.  Dietary Reference Intakes for Vitamin C, 
Vitamin E, Selenium, and Carotenoids.  Washington, DC:  National Academy Press, 
p. 21-33; 292-299; 315-316, 2000.   
Food and Nutrition Board.  National Research Council.  Recommended Dietary 
Allowances. 10th Edition.  Washington, DC:  National Academy Press, p. 221, 1989.  
Raiten, D. J., J. M. Talbot, and J. H. Waters, "Assessment of Nutrient Requirements for 
Infant Formulas," Journal of Nutrition,  128: 2059S-2249S, 1998.  
Koletzko, B., S. Baker, G. Cleghorn, U. F. Neto, et al.,"Global Standard for the 
Composition of Infant Formula.  Recommendations of an ESPGHAN Coordinated International Expert Group, " Journal of Pediatric Gastroenterology and Nutrition, 
41:584-599, 2005.   
Daniels, L., R.A. Gibson, K. Simmer, P. Van Dael, M. Makrides, "Selenium Status of Term 
Infants Fed Selenium-Supplemented Formula in a Randomized Dose-Response Trial," American Journal of Clinical Nutrition,  88:70-76, 2008. English 
10. Proposed date of adoption (dd/mm/yy) :  Not applicable to proposed rule.   
Proposed date of publication (dd/mm/yy) :  Not applicable to proposed rule.   
11. Proposed date of entry into force:  [ ] Six months from date of publication , 
and/or  (dd/mm/yy) :  Not applicable to proposed rule. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days  from the date of circulation of the 
notification and/or (dd/mm/yy) :  1 July 2013.  Seventy-five days from date of 
publication in Federal Register 
Agency or authority designated to handle  comments:  [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address 
(if available) of other body:  You may submit comments, identified by Docket No. 
FDA-2013-N-0067 by any of the following methods: 
Submit electronic comments in the following way: Federal eRulemaking 
Portal: http://www.regulations.gov .  Follow the instructions for submitting comments. 
Submit written submissions in the following ways: Fax:  301 827 6870  Mail/Hand 
delivery/Courier (for paper or CD-ROM subm issions):  Mail/Hand delivery/Courier (for 
paper or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  
All submissions received must include th e Agency name and Docket No. FDA-2013-N-
0067 for this rulemaking.  All comments received may be posted without change to 
http://www.regulations.gov , including any personal information provided. For access to 
the docket to read background documents or comments received, go to 
http://www.regulations.gov  and insert the docket number, found in brackets in the 
heading of this document, into the "Search" box and follow the prompts or go to the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852. 
13. Texts available from:  [X] National Notifi cation Authority, [ ] National Enquiry 
Point.  Address, fax number and e-mail address (if available) of other body:   
United States SPS National Notification Auth ority, USDA Foreign Agricultural Service, 
International Regulations and Standards Division (IRSD), Stop 1014, Washington D.C. 
20250; Tel: +(1 202) 720 1301; Fax: +(1 202) 720 0433; E-mail: 
us.spsenquirypoint@fas.usda.go