G/TBT/N/USA/1471  
 
16 April 2019  
(19-2519) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UNITED STATES OF AME RICA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Food and Drug Administration (FDA), Health and Human Services 
(HHS) [1497]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Bottled 
water; Waters, including natural or artificial mineral waters and aerated waters, not 
containing added sugar or other sweetening matter nor flavoured; ice and snow 
(HS 2201); Quality (ICS 03.120), Beverages (ICS 67.160), Water quality (ICS 13.060)  
5. Title, number of pages and language(s) of the notified document:  Beverages: 
Bottled Water (5 page(s), in English)  
6. Description of content:  The Food and Drug Administration (FDA or we) is proposing to 
revise  the quality standard for bott led 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 p ackaged 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 U.S. Public Health Service (PHS) for 
community wa ter 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 fro m its source 
water).  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Quality requirements  
8. Relevant documents:   
84 Federal Register (FR) 12975, 3 April 2019; Title  21 Code of Federal Regulations (CFR) 
Part 165. Will appear in the Federal Register when adopted.  
Federal Register notice entitled “Public Health Service Recommendation for Fluoride 
Concentration in Drinking Water for Prevention of Dental Caries” (80 FR 24936, 
1 May 2015)  
Letter to Manufacturers, Distributors, or Importers of Bottled Water with an Update on 
Fluoride Added to Bottled Water – 
https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/b
ottledwatercarbonatedsoftdrinks/ucm444373.htm  G/TBT/N/USA/1471  
 
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  9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  3 June 2019  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://members.wto.org/crnattachments/2019/TBT/USA/19_2195_00_e.pdf