Committee on Technical Barriers to Trade - Notification - Brazil - Antimicrobial active pharmaceutical ingredients

NOTIFICATION

The following notification is being circulated in accordance with Article 10.6

 

1.

Notifying Member: BRAZIL

If applicable, name of local government involved (Articles 3.2 and 7.2):

2.

Agency responsible:

Ministry of Agriculture and Livestock - MAPA

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:

4.

Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Antimicrobial active pharmaceutical ingredients

5.

Details of notified document(s) (title, number of pages and languages, means of access): SDA/MAPA Ordinance No. 1.419, 3 October 2025; (2 page(s), in Portuguese)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

6.

Description of content: Public Consultation that prohibits the registration, import and use of products containing antimicrobial active pharmaceutical ingredients reserved for human use by the World Health Organization - WHO, in animal species used in human food and provides other measures.

Technically substantiated suggestions should be sent via the Regulatory Acts Monitoring System - SISMAN, of the Secretariat of Agricultural Defense - SDA/MAPA, via the LINK:

https://sistemasweb.agricultura.gov.br/sisman/

7.

Objective and rationale, including the nature of urgent problems where applicable: Quality requirements

8.

Relevant documents:

1) Brazilian Official Gazette 191 on 07 October 2025, section 1, page 5

9.

Proposed date of adoption: On the date of its publication

Proposed date of entry into force: On the date of its publication

10.

Provision of comments

Final date for comments: 20 November 2025

[ ] 60 days from notification

Contact details of agency or authority designated to handle comments regarding the notification:

Ministry Agriculture and Livestock (MAPA)

Esplanada dos Ministérios –Edifício Sede -Bloco D Brasília –DF / Brazil

CEP: 71.632-100

Phone.: +(55) 61 3218-2828