1.

Notifying Member: BRAZIL

If applicable, name of local government involved:

2.

Agency responsible: The 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): Environment. Health protection. Safety (ICS code(s): 13)

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: Draft Resolution 1217, 23 November 2023. Language(s): Portuguese. Number of pages: 13

Draft: http://antigo.anvisa.gov.br/documents/10181/6684489/CONSULTA+PUBLICA+N%C2%BA+1217+GGALI.pdf/b0a83969-dddf-41a3-acb3-dfc68bb1cbaa

Comment form: https://pesquisa.anvisa.gov.br/index.php/661129?lang=pt-BR

*Will be available for comments on 4 December 2023.

6.

Description of content: This draft resolution proposes a Normative Instruction which stablishes the conditions for optimized procedure of assessment applications review of foods by the admission of introductory documentation issued by a Counterpart Foreign Regulatory Authority.

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?

[ ] 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 after the end of the consultation period.

Proposed date of publication (dd/mm/yy): To be determined after the end of the consultation period.

11.

Proposed date of entry into force: [ ] Six months from date of publication, and/or (dd/mm/yy): To be determined after the end of the consultation period.

[ ]      Trade facilitating measure

12.

Final date for comments: [ ] Sixty days from the date of circulation of the notification and/or (dd/mm/yy): 2 March 2024

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:

International Affairs Office

Brazilian Health Regulatory Agency - Anvisa

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:

International Affairs Office

Brazilian Health Regulatory Agency - Anvisa

Tel: +(55 61) 3462 5402/5404/5406

E-mail: rel@anvisa.gov.br