G/SPS/N/BRA/1583  
13 December 2019  
(19-8596) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original : English  
 
  
NOTIFICATION  
1. Notifying Member:  BRAZIL  
If applicable, name of local government involved:   
2. Agency responsible:  Brazilian Health Regulatory Agency (ANVISA)  
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): 84133090 (desalinated sea water); ICS Code(s): 13  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading part ners  
[ ] Specific regions or countries:   
5. Title of the notified document:  Resolution - RDC number 316, October 17th, 2019 . 
Language(s):  Portuguese . Number of pages:  4 
Resolution: 
http://portal.anvisa.gov.br/documents/10181/5668701/RDC_316_2019_.pdf/b372fba0 -
11be-4681-84f5-a7529694c550  
6. Description of content:  This resolution establishes the sanitary technical requirements 
for desalinated, potable, and bottled seawater. This regulation will be also notified to the 
TBT committee.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[X] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.  The objective of the regulation is to establish requirements 
for the use of seawater for human consumption. Before being released for c onsumption, 
the seawater must be desalinated, and it must be also potable, which means that such 
water must contain the quantity of  mineral salts established by the resolution and must 
not contain certain chemical and biological substances that can risk h uman health.  
8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : General Standard for Bottled/Packaged Drinking 
Waters (Other Than  Natural Mineral Waters)  
[ ] 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  G/SPS/N/BRA/1583  
 
- 2 - 
 
  If no, describe, whenever possible, how and why it deviates from the 
international standard:  The scientific methodology used by Brazil to establish the 
composition of packaged waters is cons istent with international best practice. Countries 
set the composition of waters according to the needs applicable to their region, given that 
pests, diseases and environmental factors vary. This means that Brazilian composition for 
waters may differ from Codex standards.  
9. Other relevant documents and language(s) in which these are available:  
Resolution - RDC number 240, July 26th, 2018. Available in Portuguese 
at: http://portal.anvisa.gov.br/documents/10181/3898888/RDC_240_2018_COMP.pdf/2
1a18be6 -6104-405e-96a7-3b5939958620  
Resolution - RDC number 27, August 6th, 2010. Available in Portuguese 
at: http://portal.anvisa.gov.br/documents/10181/2718376/%281%29RDC_27_2010_C
OMP.pdf/74d15d32 -7665-4477-9785-49111cfd7 a23  
10. Proposed date of adoption (dd/mm/yy) : 18 October 2019  
Proposed date of publication (dd/mm/yy) : 18 October 2019  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : 18 October 2019  
[ ] Trade facilitat ing measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable  
Agency or authority designated to handle comments: [  ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:   
Assessoria de Assuntos Internacionais - AINTE  
International Affairs Office  
Agência Nacional de Vigilância Sanitária - Anvisa  
Brazilian Health Regulatory Agency  
Tel: +55 (61) 3462-5402/5404/5406  
E-mail: rel@anvisa.gov.br  
13. Text(s) available from: [  ] National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
Assessoria de Assuntos Internacionais - AINTE  
International Affairs Office  
Agência Nacional de Vigilância Sanitária - Anvisa  
Brazilian Health Regulatory Agency  
Tel: +55 (61) 3462 -5402/5404/5406  
E-mail: rel@anvisa.gov.br