6. Registration Processes
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6. Registration Processes
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Animal Feed
Mexico
This section provides information on any product notification or registration and manufacturing site registration processes.
6.1 Product Notification
(A) Ingredient/Raw Material
Ingredients contained in the final products (not medicated) do NOT require registration or notification.
There is no positive list of ingredients/additives for use in products intended for animal feeding. If the ingredients of interest correspond to vitamins, minerals, amino acids, or carbohydrates from plant or synthetic origins, or fish by-products (fishmeal, fish oil, etc.), for oral administration are of low risk, this exemption of registration/notification is applicable.
Note: The only approval/validation of ingredients is required for those GMO-derived ingredients as described in Section 3.2.2 about GMO regulatory requirements.
[1,2,3]
(B) General Feed
Products containing vitamins, minerals, amino acids, or carbohydrates, or a combination thereof, of plant or synthetic origin and which are administered orally do NOT require notification or registration. These products are "deregulated".
These products are considered low risk so they only must comply with the following requirements to be produced or imported to Mexico:
- The "Notice of Operation of the Establishment" in Mexico, and
- In the specific case of imported products, with those requirements established for the import of "Feed additives, food supplements, and food supplements for animal use or consumption exempted from registration or authorization" (refer to Section 7.2 on Customs Procedure)
Note: Products such as finished feed or premixtures, containing ingredients and meals of animal origin, which may contain premixtures and active ingredients or pharmaceutical additives in accordance with national regulations must apply for authorization (please see "General Feed" in Section 6.2 below).
This is handled by The National Service for Health, Safety and Agri-Food Quality (SENASICA).
[1,2,3]
(B) Category
The category "Finished products containing only vitamins, minerals, amino acids, or a combination of these and for oral administration" should comply with the requirements in Section 6.1 on “General Feed” above.
(B) Product
"Products containing amino acids" should comply with the requirements in Section 6.1 on “General Feed” above.
6.2 Product Registration/Authorization
(A) Ingredient/Raw Material
No registration is required. Ingredients are assessed in the final product.
Note: The only approval/validation of ingredients is required for those GMO-derived ingredients as described in Section 3.2.2 about GMO regulatory requirements.
[1,2,3]
(B) General Feed
Product authorization is required for the above-mentioned products such as finished feed or premixtures, containing ingredients and meals of animal origin, which may contain premixtures and active ingredients or pharmaceutical additives in accordance with national regulations.
Notes:
- Products containing ingredients and meal of animal origin must come from establishments or plants approved by the health authority. For imported products from USA, Mexico, and USA recognize each other's Meat Plant Inspection Systems.
- Although this procedure is called authorization, it is like a registration, but cannot be called registration since the registration procedure is applied for other veterinary products such as medicines, biological products, etc., having much broader requirements and more restrictive control based on the risk they pose.
The authority that handles this authorization is the National Service for Health, Safety and Agri-Food Quality (SENASICA).
The authorization process involves the following steps:
- Complete the file with the requirements
- Enter your dossier in SENASICA
- Pay the fee
- Receive the application number
The authorization certificate is valid for 5 years and must be renewed before its expiry date (no minimum time indicated).
Notes: The authorization is linked to the importing establishment, so any company wishing to import the product must carry out its own authorization procedure with the authorities. In other words, the authorization limits its right only to the company that applied for authorization.
This also applies to products exempted from registration/authorization. In administrative terms, any company wishing to import a deregulated product, no matter if it is already imported by another company, must comply with all the requirements and procedures established in the local regulation.
[1,2,4]
List of mandatory required documents [1,4]:
The following must be filed as corresponding requirements for the authorization of animal feed containing ingredients and meal of animal origin:
- An "Escrito libre" addressed to the Directorate of Services and Livestock Certification, containing:
- Name or company name
- Address of the interested party
- Phone number and, if applicable, fax number
- Email, if applicable
- Federal Taxpayer Registry Number (RFC) or Unique Population Registry Key (CURP)
- Signed by the interested party or Legal Representative
- Indicate the petition that is made, the facts or reasons that give reason for the petition, the administrative body to which they are addressed and the place and date of their issuance
- The following documents must be attached:
- Product authorization application form for duplicate products
- Draft text of the product label and packaging in duplicate
- Analysis or quality control document issued by the manufacturing company
- Reports of testing results issued by an official, approved or authorized laboratory
- Certificate of Good Manufacturing Practices
- Product dossier for authorization containing:
- Specifications of the finished product describing the qualitative and quantitative formulation
- Description of primary and secondary packaging
- Manufacturing protocol
- Analytical technique of the finished product
- Information on the use in the species(s) for which the product is to be applied
The authorization procedure has a cost of 1,117 Mexican pesos and takes about 20 days according to the procedure description. [4]
(B) Category
The category of "Finished products containing only vitamins, minerals, amino acids, or a combination of these and for oral administration" is exempted from registration/authorization.
Note: Any company wishing to import a deregulated product, no matter if it is already imported by another company, must comply with all the requirements and procedures established in the local regulation.
(B) Product
"Products containing amino acids" should comply with the requirements under "Category" in Section 6.2 above.
6.3 Other Notes or Requirements
Product Notification
Not applicable.
Product Registration/Authorization
(A) Ingredient/Raw Material
Not applicable.
(B) Product
None.
6.4 Manufacturing Site Registration
General Feed
For establishment for local production and for those for the storage of imported products, the Notice of Operation of the Establishment (i.e. Registration of establishment) is required and handled by the National Service for Health, Safety and Agri-Food Quality (SENASICA). [5]
All establishments in Mexico, for manufacturing or for storage of imported products, must apply for the "Notice of Operation of the Establishment". The notice is the one identified as SENASICA-01-018 - Modality A [6]. For this purpose, the following documents must be submitted:
- Certificate of incorporation or official identification (depending on whether it is a natural or legal person)
- Proof of address
- Tax identification number
- "Escrito libre" signed by the legal representative or natural person promoting the procedure, stating the activities that will be carried out by the establishment
Note: The simple copy of the certificate of the Responsible Veterinarian who assists in the establishment will not be required for establishments for storage and commercialization of finished food products for animal consumption. However, for manufacturing sites, this requirement must be attached. [3]
The Notice of Operation of the Establishment is free of cost and takes 10 working days after receipt of the application for its authorization. [6]
Category
The category of "Finished products containing only vitamins, minerals, amino acids, or a combination of these and for oral administration" should comply with the manufacturing site registration requirements outlined in the “General Feed” Section 6.4 above.
Product
"Products containing 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
Establishments shall implement the measures described in the Manual of Good Manufacturing Practices for Animal Feed Products. This applies to manufacturing and storage sites (imported products). [7]
Category
The category of "Finished products containing only vitamins, minerals, amino acids, or a combination of these and for oral administration" should comply with the standards/rules outlined in the “General Feed” Section 6.4.1 above.
Product
"Products containing 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
None.
6.5 References
1. Regulation of the Federal Animal Health Law, 2012
2. SENASICA's AGREEMENT/2010. By which non-medicated products for animal use or consumption that are deregulated are specified (Official Gazette of the Federation 29/11/2010)
3. Animal health requirements for the importation of goods "Feed additives, food supplements and food supplements for animal use or consumption exempted from registration or authorisation" - Combination code: 099-14-985-USA-USA
https://sistemasssl.senasica.gob.mx/mcrz/moduloConsulta.jsf
4. Authorisation of products for animal use or consumption
https://catalogonacional.gob.mx/FichaTramite?traHomoclave=SENASICA-01-024-A
5. SENASICA - Deregulated products:
6. SENASICA-01-018 Notice of commencement of operations
https://www.gob.mx/senasica/documentos/senasica-01-018-modalidad-a-aviso-de-inicio-de-funcionamiento
7. Manual of Good Manufacturing Practices for Animal Feed Products
https://www.gob.mx/cms/uploads/attachment/file/503904/MBPM_ALIMENTOS_EDICI_N_NOV_2019.pdf
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