Notifications for Brazil (1991 notifications)

Circular Letter on the Publication of Decree No. 12.031 of 28 May 2024 regarding the Registration of Foreign Manufacturing Establishments, Product Registration, External Access, and Product Importation.This letter explains all the steps required to comply with the procedures established under Decree No. 12.031. The information provided is intended to assist stakeholders in understanding the new requirements and to facilitate compliance.

Draft Ordinance aiming to establish the phytosanitary requirements for the importation into Brazil of seeds of camelina (Camelina sativa) produced in Argentina.

Draft Resolution 1329, 25 April 2025 - previously notified through  G/SPS/N/BRA/2407 - was adopted as Normative Instruction 380, 3 July 2025. The regulation amends the Normative Instruction - IN No 211, of 1 March 2023, which establishes the technological functions, maximum limits and conditions of use for food additives and technology aids authorized for use in foods.

Draft Resolution 1315, 27 March 2025 - previously notified through  G/SPS/N/BRA/2393 - was adopted as Normative Instruction 379, 1 July 2025. The regulation includes the monograph of the active ingredient S25 - STREPTOMYCES GRISEOVIRIDIS on the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservatives, published by Normative Instruction 103 on 19 October 2021 in the Brazilian Official Gazette (DOU - Diário Oficial da União).

This draft resolution proposes the update of the monograph M47 - Melaleuca Alternifolia on the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservatives, which was published by Normative Instruction 103 on 19 October 2021 in the Brazilian Official Gazette (DOU - Diário Oficial da União).

Draft Resolution 1312, 26 February 2025 - previously notified through  G/SPS/N/BRA/2386 - was adopted as Normative Instruction 372, 5 June 2025. The regulation proposes the inclusion of active ingredient O22 - OOENCYRTUS SUBMETALLICUS, on the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservatives, published by Normative Instruction 103 on 19 October 2021 in the Brazilian Official Gazette (DOU - Diário Oficial da União). The final text is available only in Portuguese and can be downloaded at: https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000372&sgl_tipo=INM&sgl_orgao=DC/ANVISA/MS&vlr_ano=2025&seq_ato=000&cod_modulo=134&cod_menu=1696

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

Draft Resolution 1310, 14 February 2025 - previously notified through  G/SPS/N/BRA/2380 - was adopted as Normative Instruction 371, 5 June 2025. The regulation update of active ingredients A14 - ATRAZINE, A66 - INDOLACETIC ACID, B26 - BIFENTRINE, C03 - CARBARYL, C35 - CLOMAZONE, C40 - CHLORFENAPYR, C70 - CHLORANTRANILIPROLE, C88 - CYCLOBUTRIFLURAM, D21 - DIQUATE, E25 - SPIRODICLOFEN, F28 - FENPROPATHRIN, F36 - FLUTRIAFOL, F37 - FENPYROXIMATATE, F42 - FLUROXYPIR MEPTYLIC, F46 - FLUMIOXAZINE, I12 - IMAZAPYR, I18 - ISOXAFLUTOL, M02 - MANCOZEB, M17 - METHOMIL, M32 -METHOXYPHENOZIDE, M40 - MESOTRIONE, M45 - MANDIPROPAMIDE, N08 - NICOSULFUROM, O21 - OXATHYAPIPROLINE, P13 - PROFENOPHOS, P61 - PYROXASULFONE, P65 - PIDIFLUMETOPHEM, S09 - SULFENTRAZONE and T71 - METHYLIC TIENCARBAZONE, on the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservatives, published by Normative Instruction 103 on 19 October 2021 in the Brazilian Official Gazette (DOU - Diário Oficial da União). The final text is available only in Portuguese and can be downloaded at: https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000371&sgl_tipo=INM&sgl_orgao=DC/ANVISA/MS&vlr_ano=2025&seq_ato=000&cod_modulo=134&cod_menu=1696

This draft resolution proposes the updates of 21 Monographs of Active Ingredients of Pesticides, Sanitizing Disinfestants and Wood Preservatives, published through Normative Instruction 103 on 19 October 2021 in the Brazilian Official Gazette (DOU - Diário Oficial da União): A12 - ASULAM, A60 - ABSCISIC ACID, B26 - BIFENTRIN, B55 - EMAMECTIN BENZOATE, C07 - CASUGAMICIN, C32 - CLETODIM, C36 - CYPROCONAZOLE, D36 - DIFENOCONAZOLE, F69 - FLUPYRADIFURONE, G01 - GLYPHOSATE, G05 - AMMONIUM GLUFOSINATE, H07 - HALOXIFOPE-P METHYLIC, I21 - INDOXACARB, I30 - IMPIRFLUXAM, I32 - ISOCYCLOSERAM, M32 - METHOXYFENOZIDE, P34 - PYRIPROXIFEM, P50 - PICOXYSTROBIN, P69 - PINOXADEM, S16 - SAFLUFENACIL and S17 - SOPHORA FLAVESCENS.

This draft resolution excludes citrus from monograph I19 - Imazalil on the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservatives, which was published by Normative Instruction 103 on 19 October 2021 in the Brazilian Official Gazette (DOU - Diário Oficial da União).

Art. 1 – Ordinance SDA/Mapa No. 1.237, of 28 January 2025, published in the Official Gazette (D.O.U.) No. 24, Section 1, page 1, of 4 February 2025, shall come into force with the following amendments:"Art. 1 ................................................................................ Sole paragraph. The phytosanitary requirements are established for the following species: Impatiens balsaminaImpatiens flaccidaImpatiens wallerianaImpatiens hawkeri, and their interspecific hybrids."

Draft Ordinance aiming to establish the phytosanitary requirements for the import of seedlings and cuttings (Category 4) of lucky bamboo (Dracaena sanderiana) produced in China.

This draft resolution proposes the inclusion of active ingredient  O23 - OCIMUM BASILICUM on the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservatives, which was published by Normative Instruction 103 on 19 October 2021 in the Brazilian Official Gazette (DOU - Diário Oficial da União).

Draft Ordinance aiming to establish the phytosanitary requirements for the importation into Brazil of of propagating material (Category 4) of Lobelia erinus and Lobelia x speciosa of any origin.

This draft resolution proposes the inclusion of active ingredient  W01 - Willaertia Magna on the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservatives, which was published by Normative Instruction 103 on 19 October 2021 in the Brazilian Official Gazette (DOU - Diário Oficial da União).

Ordinance establishing the phytosanitary requirements for the importation of cut flowers (Category 3) of peony (Paeonia spp.) produced in Chile.

This draft resolution proposes the inclusion of active ingredient  B73 - BETAINE on the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservatives, which was published by Normative Instruction 103 on 19 October 2021 in the Brazilian Official Gazette (DOU - Diário Oficial da União).

Draft Resolution 1308, 24 January 2025 - previously notified through  G/SPS/N/BRA/2373 - was adopted as Normative Instruction 366, 16 May 2025. The regulation proposes the inclusion of active ingredient P76 - PSEUDOMONAS GLYCINIS on the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservatives, published by Normative Instruction 103 on 19 October 2021 in the Brazilian Official Gazette (DOU - Diário Oficial da União). The final text is available only in Portuguese and can be downloaded at: https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000366&sgl_tipo=INM&sgl_orgao=DC/ANVISA/MS&vlr_ano=2025&seq_ato=000&cod_modulo=134&cod_menu=1696

Draft Resolution 1307, 24 January 2025 - previously notified through  G/SPS/N/BRA/2372 - was adopted as Normative Instruction 363, 16 May 2025. The regulation proposes the inclusion of active ingredient M47.2 - MALALEUCA ALTERNIFOLIA EXTRACT on M47 - MALALEUCA ALTERNIFOLIA on the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservatives, published by Normative Instruction 103 on 19 October 2021 in the Brazilian Official Gazette (DOU - Diário Oficial da União). The final text is available only in Portuguese and can be downloaded at:https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000363&sgl_tipo=INM&sgl_orgao=DC/ANVISA/MS&vlr_ano=2025&seq_ato=000&cod_modulo=134&cod_menu=1696

Draft Resolution 1309, 24 January 2025 - previously notified through  G/SPS/N/BRA/2374 - was adopted as Normative Instruction 365, 16 May 2025. The regulation proposes the inclusion of active ingredient T78 - TRICHODERMA VIRIDE, on the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservatives, published by Normative Instruction 103 on 19 October 2021 in the Brazilian Official Gazette (DOU - Diário Oficial da União). The final text is available only in Portuguese and can be downloaded at:https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000365&sgl_tipo=INM&sgl_orgao=DC/ANVISA/MS&vlr_ano=2025&seq_ato=000&cod_modulo=134&cod_menu=1696