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    6. Registration Processes
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    6. Registration Processes

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    Animal Feed
    Brazil


    This section provides information on any product notification or registration and manufacturing site registration processes.

    6.1 Product Notification

    (A) Ingredient/Raw Material

    No product notification for the ingredients that are contained in the imported products unless to import the ingredients themselves (e.g. lysine, soybean oil, and lecithin) for subsequent production of animal feed which, in this case, according to the regulation, will require notification.

    The authority which handles this notification is the Ministry of Agriculture, Livestock and Supply (MAPA). [1,2]

    If raw material itself is imported for subsequent production, then a similar process would apply as in General Feed below.

    Note: All ingredients used must be on the positive list [4]. If not on the positive list, approval from MAPA is required and the process is listed in Section 6.3 (under Approval) below. Ingredients foreseen in the list of substances prohibited in animal feed are NOT allowed [5]. 

    Only ingredients that are imported for subsequent production/commercialization will need to provide the necessary documents for notification with MAPA as listed under "General Feed" below [2,3]. The cost and duration will also be as listed below [7].

    (B) General Feed

    Products different from those requiring registration listed under General Feed in Section 6.2 below are subject to be notified in Brazil (Cadastro in Portuguese). The authority which handles this notification is the Ministry of Agriculture, Livestock and Supply (MAPA). [1,2]

    Notification process [3]:

    • Apply for product notification at SIPEAGRO, available on MAPA's website. After sending the application, it will be distributed and analyzed by the area auditors. Only registered establishments may apply for a product notification.
    • To notify an imported product exempt from registration intended for animal feed, access Produtos > Solicitação > Cadastro > Novo Cadastro.

    There is no need to renew a product's notification (cadastre) since its validity is subject to the validity of the Establishment's registration. According to Article 6 of Decree N°6.296 [1], the Establishment registration is valid for 5 years and can be renewed for similar periods.

    Note: A product can only be notified once. In case another company wishes to import the product, such notification can be transferred (but not extended) to another company that complies with all the requirements that gave rise to the product notification.

    The product notification application requires the importing company to submit the following information [2,3]: 

    1. Product Classification
      1. Area of interest (Animal feed)
      2. Activity (Importing)
      3. Classification/Category (Nutritional additive)
    2. General Data
      1. Número do registro anterior (onde consta: "registro", leia "cadastro") for any previous registration
      2. Denomination/Name
      3. Trademark
      4. Origin
      5. Expiry date
      6. Expiry date of the product (months)
    3. Additional information
      1. Physical form of presentation
      2. Product classification
      3. Species for which the product is intended
      4. Physical nature
      5. Ready to use or for mixing?
      6. Dilution ratio (parts of water to one part of product m/m)
      7. Animal category (depending on the species selected above)
      8. Breeding stage available / Breeding stage selected
    4. Packaging
      1. Type of packaging available
      2. Available packaging material
      3. Packing capacity
      4. Unit of measurement
    5. Data of origin
      1. Company Activity 
      2. Company name
      3. Country of origin
      4. Address
      5. Attach the following files:
        1. Declaration issued by the owner established abroad, empowering the importing company in Brazil to answer before MAPA for all regulatory requirements, including any infractions and penalties and other obligations arising from the importation and marketing of the product.
        2. Official authorization certificate of the establishment that owns and manufactures the product in the country of origin.
        3. Official certificate of registration or authorization of free sale or even, of the authorization of exclusive manufacture for export of the product in the country of origin, specifying the composition.
        4. Declaration issued by the competent authority of the country of origin or by an officially accredited assessment body in the country of origin, that the establishment complies with good manufacturing practice.
    6. Product warning 
    7. Composition 
      1. Basic composition
      2. Raw material group
      3. Raw materials
      4. Basic Composition / Substitute
    8. Raw Material Guarantees
      1. Minimum value / Unit of measurement
      2. Maximum value / Unit of measurement
    9. Indication for use (classification, species, category of animal, raising stage)
    10. Storage method
    11. Mode of use (ready for consumption or for mixing)
    12. Attach documents providing the information above mentioned. 

    MAPA does not charge any fees for product notification applications. The timeline for the resolution of this procedure is not specified in the regulation, but it is understood that it will depend on the current demand of applications submitted at MAPA [7].

    (B) Category

    The category of “Nutritional Additive” should comply with the notification requirements in Section 6.1 on “General Feed” above.

    (B) Product

    “Nutritional Additive (Amino Acids)” should comply with the notification requirements in Section 6.1 on “General Feed” above.

    Note: The product of interest in this project is "subject of notification" (or "cadastre" as called in Brazil). This has been verified by checking similar products in the database of products registered and notified (cadastre) in Brazil. [6]

    6.2 Product Registration

    (A) Ingredient/Raw Material

    No registration is required for the ingredients that are contained in the imported products unless to import the following ingredients themselves for subsequent production of animal feed. The following categories are subject to be registered:

    • Adjuvant feeding stuffs intended solely for the feeding of pets with physiological or metabolic disorders;
    • Technological preservative additives indicated for use as silage fermentation aids, also called silage inoculants;
    • Adsorbent technological additives with the indication of use as mycotoxin adsorbent;
    • Zootechnical digestive additives composed of substances that facilitate the digestion of ingested food, acting on certain raw materials intended for the manufacture of products for animal feeding;
    • Zootechnical additives balancing microbiota composed of colony-forming microorganisms or other chemically defined substances that have a positive effect on the flora of the digestive tract;
    • Zootechnical performance-enhancing additives consisting of chemically defined substances that improve performance parameters, excluding antimicrobials;
    • Other zootechnical additives consisting of other substances used to have a positive influence on improving animal performance.

    Products different from those listed above are subject to notification (Cadastro in Portuguese).

    Authority approval for ingredients registration: Department for Livestock Inputs Inspection (DFIP) from the Ministry of Agriculture, Livestock and Supply (MAPA) [1-3]. 

    Only raw materials that fall under one of the above categories and are themselves imported for subsequent production/commercialization, need a similar process, cost, duration, and required documents for registration with MAPA as in General Feed [2,7,8] below.

    Note: All ingredients used must be on the positive list [4]. If not on the positive list, approval from MAPA is required and the process is listed in Section 6.3 (under Approval) below. Ingredients foreseen in the list of substances prohibited in animal feed are NOT allowed [5]. 

    (B) General Feed

    Product registration is required and it will depend on the product. The following categories are subject to be registered:

    • Adjuvant feeding stuff intended solely for the feeding of pets with physiological or metabolic disorders;
    • Technological preservative additives indicated for use as silage fermentation aids, also called silage inoculants;
    • Adsorbent technological additives with the indication of use as mycotoxin adsorbent;
    • Zootechnical digestive additives composed of substances that facilitate the digestion of ingested food, acting on certain raw materials intended for the manufacture of products for animal feeding;
    • Zootechnical additives balancing microbiota composed of colony-forming microorganisms or other chemically defined substances that have a positive effect on the flora of the digestive tract;
    • Zootechnical performance-enhancing additives consisting of chemically defined substances that improve performance parameters, excluding antimicrobials;
    • Other zootechnical additives consisting of other substances used to have a positive influence on improving animal performance.

    Products different from those listed above are subject to notification (Cadastro in Portuguese).

    Authority approval for ingredients registration: Department for Livestock Inputs Inspection (DFIP) from the Ministry of Agriculture, Livestock and Supply (MAPA) [1,2].

    The registration process [8]: 

    • Apply for product registration at SIPEAGRO, available on MAPA's website. After sending the application, it will be distributed and analyzed by the area auditors. Only registered establishments may apply for product registration.
    • To register an imported product intended for animal feed, access: Produtos > Solicitação > Registro > Novo registro

      The product registration will be valid for 5 years and the renewal must be requested up to 60 days before the expiry date through SIPEAGRO. After sending the request this will be distributed and analyzed by the auditors of the area.

    Note: A product can only be registered once. In case another company wishes to import the product, such registration can be transferred (but not extended) to the company that complies with all the requirements that gave rise to the approval of the registration of the product.

    The product registration application required by the importing company must be accompanied by a report signed by the responsible technician, containing [2,8]:

    1. Designation of the product by name and commercial brand, if any
    2. Physical form of presentation
    3. Packaging characteristics and form of packaging
    4. Composition
    5. Guarantee levels
    6. Description of the manufacturing process and control of the raw material and finished product
    7. Indications for use and animal species for which it is intended
    8. Instructions for use
    9. Net content expressed in the decimal metric system
    10. Expiry date
    11. Conservation conditions
    12. Name, address, and CNPJ of the establishment that owns the product
    13. Name, address, and CNPJ of the importer, when it is an imported product
    14. Restrictions and other recommendations

    In addition, the application for registration of an imported product must also be accompanied by the following documents and a translation thereof:

    1. Document informing the manufacturer's data abroad
    2. Document that informs the data of the foreign OWNER, if he is not the manufacturer
    3. Declaration issued by the owner established abroad, empowering the importing company in Brazil to respond before MAPA for all regulatory requirements, including any violations and penalties and other obligations arising from product registration
    4. Certificate of official registration of the establishment that owns and manufactures the product in the country of origin (Note: when the owner and manufacturer are different companies, certificates from both are required)
    5. Official certificate of registration or Free Sale Certificate or authorization of exclusive manufacture for export of the product in the country of origin, specifying the composition.
    6. Declaration or certificate of Good Manufacturing Practices from the manufacturing establishment, issued by the competent authority in the country of origin or by an assessment body officially accredited for this purpose in the country of origin
    7. Copy of the original label of the country of origin in the case of imported additives

    MAPA does not charge any fees for product registration applications. The timeline for the resolution of this procedure is not specified in the regulation, but it is understood that it will depend on the current demand of applications submitted at MAPA. [7]

    (B) Category

    The category of “Nutritional Additive” should comply with the product registration requirements under the “General Feed” Section 6.2 above.

    (B) Product

    “Nutritional Additive (Amino Acids)” should comply with the product registration requirements under the “General Feed” Section 6.2 above. 

    In addition, as above-mentioned in Section 6.1 under "Product", the product of interest is subject to notification (not registration). 

    6.3 Other Notes or Requirements

    Product Notification

    (A) Ingredient/Raw Material

    For additives that contain or are produced from Genetically Modified Organisms (GMOs), submit the appropriate documentation for their assessment and legal authorization for use in accordance with current legislation. (Please refer to Section 3 for GMO Regulatory Requirements). [2]

    (B) Product

    Same as (A) above.

    Note: In order to be able to operate in SIPEAGRO and carry out the product notification and the establishment registration procedures, the company must have a "Cadastro de Pessoa Física" (CPF) number, which corresponds to the tax identification number in that country. Only persons and companies legally constituted in Brazil have this CPF number, therefore, only importers can carry out procedures related to products and establishments at MAPA, and therefore in SIPEAGRO. To apply for access and registration of the company in SIPEAGRO, the company must access this link with the same data as the Brazilian government procedures portal. Once enabled in this system, the company will be able to carry out the applications for the corresponding modules. [2]

    Product Registration

    (A) Ingredient/Raw Material

    Same as Product Notification requirements for (A) above (Section 6.3).

    (B) Product

    Same as (A) above.

    Note: In order to be able to operate in SIPEAGRO and carry out the product registration and the establishment registration procedures, the company must have a "Cadastro de Pessoa Física" (CPF) number, which corresponds to the tax identification number in that country. Only persons and companies legally constituted in Brazil have this CPF number, therefore, only importers can carry out procedures related to products and establishments at MAPA, and therefore in SIPEAGRO. To apply for access and registration of the company in SIPEAGRO, the company must access this link with the same data as the Brazilian government procedures portal. Once enabled in this system, the company will be able to carry out the applications for the corresponding modules. [2]


    Approval (inclusion or alteration of the list of raw materials approved by MAPA)

    (A) Ingredient/Raw Material

    For those raw materials not described in the positive list, the interested company must submit the "Applications for inclusion or alteration of raw materials intended for animal feed on the list approved by MAPA".

    This application must be done through the new system SIPEAGRO. The requests must be instructed according to the script in Annex I of Normative Instruction 03, of 25/01/2021 [9] - ROUTE FOR REQUEST FOR INCLUSION OR CHANGE OF RAW MATERIALS which includes the following:

    1. Suggested name for the raw material
    2. Category (ingredient or additive)
    3. Classification (if the category is "additive", inform subcategory: technological, sensory, zootechnical, etc.) and its functional group (probiotic, prebiotic, adsorbent, palatable, etc.)
    4. Characteristics of the raw material:
      1. Origin or Source of obtaining
      2. Detailed descriptive memorial of the manufacturing process, describing the physical or chemical processing and informing the name of the chemical agents and the temperature to which the original material was subjected, if applicable.
      3. Physical aspects (micronized, powder, liquid, granulated, pelletized, extruded, paste, lyophilized, laminated, block, flour, bran, broken, pressed, whole, etc.)
      4. Purity of the active ingredient/principal(s)
      5. Presence of possible contaminants
      6. GMO Status if the raw material is GMO or derived from GMOs as defined by Law 11.105 of March 24, 2005. If so, inform if it has already been evaluated by CTNBio.
    5. Animal species(s) for which it is intended
    6. Restriction (if there is any restriction for the use of a particular animal species)
    7. Purposes of use (e.g. as a source of protein, fiber, or other nutrients, or responsible for certain functionality other than nutritional for the animal or food)
    8. Data on the safety of use
    9. Intended guarantee levels
    10. Additional information

    For further details on each requirement, access the regulation of reference. [9]

    (B) Product

    Not applicable. The approval is only for raw materials (ingredients and additives). 

    6.4 Manufacturing Site Registration

    General Feed

    According to Article 6 of Decree N° 6.296 [1], all establishments that produce, manufacture, manipulate, fractionate, import, and market products intended for animal feed must be registered with the Ministry of Agriculture, Livestock and Supply (MAPA). The application must be made in SIPEAGRO. After submitting the application, it will be analyzed by the auditors in the area. The request must contain the following information: 

    1. Business name
    2. Registration in the National Register of Legal Entities - CNPJ
    3. State registration
    4. Location of the establishment
    5. Activity to be carried out
    6. Category, identifying the nature of the products and processes involved
    7. Technical responsible, indicating his training and registration in the relevant professional council

    The following documents must be attached [1]:

    1. Copy of the CNPJ registration card;
    2. Copy of the state registration card;
    3. Copy of the social instrument and contractual changes duly registered with the competent body, with an indication of the address and objective consistent with the activity to be carried out;
    4. Descriptive memorial of the establishment, with a specification of the facilities and equipment, mentioning the details of the type and capacity of the main equipment of the production lines or ways of obtaining, the installed production capacity, and the production flowchart of each production line;
    5. Floor plan of the buildings in scale 1:100 (one per hundred) with a legend indicating sectors and facilities of the industry and arrangement of equipment, in color, with legend and identification of the areas, flow of personnel, raw material, and production;
    6. Plan of the land, on the scale 1:1000 (one per thousand), with an indication of the position of the construction in relation to public roads, confronting, natural courses, and alignment of the land;
    7. Annotation of technical responsibility in the respective professional council;
    8. Environmental license or authorization issued by the competent body; and
    9. License for location issued by the municipal agency or equivalent agency of the Federal District. 

    MAPA does not charge any fees for establishment registration applications. The timeline for the resolution of this procedure is not specified in the regulation, being understood that it will depend on the current demand of applications submitted at MAPA. [11]

    Category

    The category of “Nutritional Additive” should comply with the manufacturing site registration requirements outlined in the “General Feed” Section 6.4 above.

    Product

    “Nutritional Additive (Amino Acids)” should comply with the manufacturing site registration requirements outlined in the “General Feed” Section 6.4 above.

    6.4.1 Standard/Rules for Manufacturing Site

    General Feed

    MAPA Normative Instruction No. 4/2007 - Technical Regulation on the Hygiene and Sanitary Conditions and Good Manufacturing Practices for Establishments Manufacturing Products for Animal Feed. [10]

    Category

    The category of “Nutritional Additive” should comply with the standards/rules outlined in the “General Feed” Section 6.4.1 above.

    Product

    “Nutritional Additive (Amino Acids)” should comply with the standards/rules outlined in the “General Feed” Section 6.4.1 above.

    6.4.2 Other Notes or Requirements for Manufacturing Site Registration

    Only local companies can apply for manufacturing site registration. Please refer to the note in Section 6.3 (B).

    6.5 References

    1. Decree Nº 6.296 of 2007. Regulation of Law Nº 6.198 of 1974, which provides for the compulsory inspection and supervision of products intended for animal feeding.

    http://www.planalto.gov.br/ccivil_03/_Ato2007-2010/2007/Decreto/D6296.htm


    2.Normative Instruction MAPA 13/2004. Technical regulation on additives for products intended for animal feed

    https://sistemasweb.agricultura.gov.br/sislegis/action/detalhaAto.do?method=visualizarAtoPortalMapa&chave=133040692


    3. SIPEAGRO MANUAL. Cadastre of imported product exempt from registration intended for animal feed

    https://www.gov.br/agricultura/pt-br/assuntos/insumos-agropecuarios/insumos-pecuarios/alimentacao-animal/arquivos-alimentacao-animal/manual_cad_prod_edicao1_PUBLICADO_EM_14AGO20.pdf


    4. List of raw materials (ingredients and additives) approved by MAPA for use in animal feed

    https://www.gov.br/agricultura/pt-br/assuntos/insumos-agropecuarios/insumos-pecuarios/alimentacao-animal/listageral13032023.pdf


    5. List of substances prohibited in animal feed 

    https://www.gov.br/agricultura/pt-br/assuntos/insumos-agropecuarios/insumos-pecuarios/arquivos-de-insumos-pecuarios/Substnciasproibidas20.02.2020.pdf


    6. LIST OF PRODUCTS FOR ANIMAL FEED REGISTERED AND CADASTRE IN THE MAP 

    https://www.gov.br/agricultura/pt-br/assuntos/insumos-agropecuarios/insumos-pecuarios/alimentacao-animal/Planilhadeprodutoecadastrodeproduto020123.xlsx


    7. QUESTIONS AND ANSWERS. Registration and Notification (cadastre) of feed products

    https://www.gov.br/agricultura/pt-br/assuntos/insumos-agropecuarios/insumos-pecuarios/alimentacao-animal/arquivos-alimentacao-animal/pmf_reg_ren_alt_canc_produto_edicao1_PUBLICADOEM_09jul202.pdf


    8. SIPEAGRO MANUAL. Product Registration 

    https://www.gov.br/agricultura/pt-br/assuntos/insumos-agropecuarios/insumos-pecuarios/alimentacao-animal/arquivos-alimentacao-animal/copy_of_COD_10_20REGISTRODEPRODUTOS.pdf


    9. Normative Instruction N° 3/2021 that establishes the ingredients and additives authorized for use in animal feed and makes other arrangements.

    https://www.in.gov.br/en/web/dou/-/instrucao-normativa-mapa-n-3-de-25-de-janeiro-de-2021-300362840


    10. MAPA Normative Instruction No. 4/2007 Technical Regulation on the Hygiene and Sanitary Conditions and Good Manufacturing Practices for Establishments Manufacturing Products for Animal Feed

    https://www.gov.br/agricultura/pt-br/assuntos/insumos-agropecuarios/insumos-pecuarios/alimentacao-animal/arquivos-alimentacao-animal/legislacao/instrucao-normativa-no-4-de-23-de-fevereiro-de-2007.pdf/view


    11. QUESTIONS AND ANSWERS. Doubts regarding the registration of establishments and the use of SIPEAGRO for registration

    https://wikisda.agricultura.gov.br/manual_estabelecimentos_aa/cod_03_20_7edregistroestab_anexoi.pdf


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