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Draft
Resolution number 1243, 20 March 2024
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Draft
Resolution 1243, 20 March 2024 - previously notified through G/SPS/N/BRA/2267
- was adopted as Normative Instruction 367, 5 June 2025. The regulation
establishes composition and quality requirements, content and nutritional
claims and list of authorized constituents for infant formulas, transitional
foods and cereal-based foods for infants and young children, formulas for
enteral nutrition and diet therapy formulas for inborn errors of metabolism.
The
final text is available only in Portuguese and can be downloaded at:
_https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000367&sgl_tipo=INM&sgl_orgao=ANVISA/MS&vlr_ano=2025&seq_ato=222&cod_modulo=134&cod_menu=1696
https://members.wto.org/crnattachments/2025/SPS/BRA/25_03953_00_x.pdf
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This addendum concerns a:
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[ ] Modification
of final date for comments
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[X] Notification of adoption,
publication or entry into force of regulation
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[ ] Modification
of content and/or scope of previously notified draft regulation
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[ ] Withdrawal
of proposed regulation
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[ ] Change
in proposed date of adoption, publication or date of entry into force
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[
] Other:
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Comment period: (If the addendum extends
the scope of the previously notified measure in terms of products and/or
potentially affected Members, a new deadline for receipt of comments should
be provided, normally of at least 60 calendar days. Under other
circumstances, such as extension of originally announced final date for
comments, the comment period provided in the addendum may vary.)
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[X] Sixty
days from the date of circulation of the addendum to the notification and/or (dd/mm/yy): 18 August 2025
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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:
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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
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Text(s) available from: [] National Notification Authority, [X]
National Enquiry Point. Address, fax number and e-mail address (if available)
of other body:
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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
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