G/SPS/N/USA/3056  
 
5 April 2019  
(19-2181) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member:  UNITED STATES OF AME RICA 
If applicable, name of local government involved:   
2. Agency responsible:  Food and Drug Administration  
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):  HS Code(s): 2201; ICS Code(s): 67  
4. Regions or countries likely to be affected, to the extent relevan t or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Beverages: Bottled Water, Proposed Rule . 
Language(s):  English . Number of pages:  5 
https://www.govinfo.gov/content/pkg/FR -2019-04-03/pdf/2019 -06201.pdf  
https://members.wto.org/crnattachments/2019/SPS/USA/19_1970_00_e.pdf  
6. Description of content:  The Food and Drug Administration (FDA) is proposing to revise 
the quality standard for bottled water to specify that bottled water to which fluoride is 
added by the manufacturer may not contain fluoride in excess of 0.7 milligrams per liter 
(mg/L). This action, if finalized, will revise the current allowable levels for fluoride in 
domestically packaged and imported bottled water to which fluoride is added. We are 
taking this action to make the quality standard regulation for fluoride added to bottled 
water consistent with the recommendation by the US Public Health Service (PHS) for 
community water systems that add fluoride for the prevention of dental caries . 
This action, if finalized, will not affect the allowable levels for fluoride in bottled water to 
which fluoride is not added by the manufacturer (such bottled water may contain fluoride 
from its source water).  
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 standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  G/SPS/N/USA/3056  
 
- 2 - 
 
  [ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:    
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: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : To be determined.  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 1 June 2019  
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:   
Yinqing Ma, Center for Food Safety and Applied Nutrition (HFS -317), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20 740, +(1 240) 402 2479  
13. Text(s) available from: [  ] National Notification Authority, [  ] National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
Text can be found in the Federal Register, Vol. 84, No. 64, page 1297 5 or on the internet 
at: https://www.govinfo.gov/content/pkg/FR -2019-04-03/pdf/2019 -06201.pdf