6. Registration Processes

Animal Feed
Argentina

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. Animal feeds, raw materials, feed additives, supplements, etc. require sanitary registration and not a notification.

(B) General Feed

No product notification. Animal feeds, raw materials, feed additives, supplements, etc. require sanitary registration and not a notification.

(B) Category

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

(B) Product

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

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 ingredient itself e.g. lysine, soybean oil, and lecithin for subsequent production of animal feed which, in this case, according to the regulation, will require registration (except for the soybean oil, as it is considered an ingredient for human consumption, therefore it would be exempted). 

According to the regulation, the following are exempted from the obligation to register, provided that there are no restrictions of use specified for animal feeds:

1. Products made-to-order
2. Products obtained by self-consumption processors
3. Raw materials of non-industrialized vegetable origin
4. Ingredients that the National Directorate for Agri-Food Safety and Quality (DNICA) may decide as a result of the risk assessment established in this Technical Standard
5. Products intended for human consumption

Authority approval for ingredients registration: Coordination of Animal Feed Registration of the National Service of Agri-Food Health and Quality (SENASA). 

If raw material itself is imported for subsequent production, then similar process, cost, duration, and required documents would apply as in General Feed below.

Note: There is no positive list of ingredients that can be used in animal feed. Thus, approval is required if used for commercialization.

(B) General Feed

All materials (for B2B and for B2C) must be registered in Argentina prior to commercialization. 

Authority approval for product registration: Coordination of Animal Feed Registration of the National Service of Agri-Food Health and Quality (SENASA). 

The registration process involves the following steps: 

1. The User must send an email to the Coordination of Animal Feed Registration (CRAA) to request the initiation of each registration procedure. For this purpose, the following e-mail account has been set up: craagde@senasa.gob.ar. In the mail, the User must request the Payment Orders indicating:

1. Name of the procedure
2. Firm / Company
3. CUIT/CUIL
4. Tariff Code is indicated in Table 1 of the Instructive. The code corresponding to the Registration of animal feed (production or pet) is IC008

2. The CRAA will issue the Payment Orders and send them by return mail.

3. Presentation of the Procedures: the User shall submit a Compact Disc (CD), in addition to the original printed and signed documents, in order to validate the documentation submitted in electronic format. One CD per product must be submitted. Once this verification has been carried out, the printed documentation will be returned to the User and the CD will be retained. In addition, the receipt of the documentation submitted shall be stamped.

The CD must be enveloped with the following identification / Cover / Label and will be retained for the uploading of the information to the Electronic File:

1. Name of the Procedure
2. Firm/Company name
3. Commercial name of the product
4. CUIT/CUIL (tax identification number)
5. Tariff Code (for this purpose the code is IC008)
6. File and Certificate No.: (for products already registered, e.g. raw materials)

Note: If the electronic documentation does not comply with the format indicated for each Procedure, it will be returned because it is unfeasible to upload to the platforms in force. 

The registration certificate is valid for 10 years from the date of issue. In case of renewal, it must be requested at least 120 calendar days before the expiry of the registration. 

Note: A product can only be registered once. In case the other company wishes to import the product, the Registration Holder of a product can transfer or extend the certificate of use and marketing of the product only to other registered firms (s), which must be authorized through the relevant administrative act.

The current fee for sanitary registration is 36,030.8 Argentinean Pesos. The timeline, according to SENASA RESOLUTION 594/2015 [1] is 60 days (minimum) for the resolution of the sanitary registration. SENASA issued the Tarrif Manual [2] that also clarified that this procedure has a duration of 180 working days, which can be reduced to 60 working days, but will generate additional costs (not described in the tariff manual).

(B) Category

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

Specific requirements/mandatory documents for "Product Registration (Additives, Vitamin Mineral Cores and Premixes of Additives) (Code 2017)" [1]:

1. A single pdf document containing the payment voucher and the payment voucher for the requested installment. 
2. A single pdf document containing the Application for Registration of Additives, Vitamin Mineral Cores, and Premixed Additives and the draft label. 
3. A single pdf document containing the Certificate of Free Sale from the country of origin, signed by the competent Official Authority and translated by a public translator, and the original label of the country of origin.
4. In case of having ingredients of animal origin, a single pdf containing instructions to register imported products with ingredients of animal origin must be submitted. This is in order to determine if the country of origin of the product to be registered has agreed to the International Veterinary Certificate with Argentina. If it is not positive, the product cannot be registered.

(B) Product

“Nutritional Additive (Amino acid)” should comply with the product registration requirements under the “General Feed” Section 6.2 above. Additionally, the below applies:

Specific requirements/mandatory documents for "Product Registration (Additives, Vitamin Mineral Cores and Premixes of Additives) (Code 2017)" [1]:

1. A single pdf document containing the payment voucher and the payment voucher for the requested installment. 
2. A single pdf document containing the Application for Registration of Additives, Vitamin Mineral Cores, and Premixed Additives and the draft label. 
3. A single pdf document containing the Certificate of Free Sale from the country of origin, signed by the competent Official Authority and translated by a public translator, and the original label of the country of origin.
4. In case of having ingredients of animal origin, a single pdf containing Instructions to register imported products with ingredients of animal origin must be submitted. This is in order to determine if the country of origin of the product to be registered has agreed to the International Veterinary Certificate with Argentina. If it is not positive, the product cannot be registered.

6.3 Other Notes or Requirements

Product Notification

Not applicable.

Product Registration

(A) Ingredient/Raw Material

Only ingredients that are imported for subsequent production will need to comply with the requirements for registration with SENASA as listed in (B) below.

(B) Product

Any company or a person applying for product registration, both the importing company and its establishment, must be duly registered and authorized, as the product registration will be linked to the registration number of the establishment in the surveillance and product control systems in Argentina. Details on the establishment registration are listed below. 

Registration of companies in the National Register of Animal Feed Firms (for both local and importers) must be done at the TAD [3]. To access the TAD you must have a CUIT number (tax identification number). The documentation to be submitted includes: 

Own plants: 

• Payment voucher for the tariff
• Payment voucher for the term of the procedure 
• Note declaring the Legal Responsible of the Firm 
• Accreditation of legal personality 
• Supporting documentation of the property or plant declared in the form

Processing/fractionation/storage in third-party plants (already registered):

• Fee payment voucher
• Payment voucher in accordance with the requested term. 
• Note declaring the Legal Responsible of the Firm 
• Copy of the third-party Plant Authorization Provision, granted by the Coordination for the Control of Animal Feed Establishments (COFIAL)
• Accreditation of the Legal Personality (optional)
• Letters of commitment between the Firm and the Plant

6.4 Manufacturing Site Registration

General Feed

Not for the manufacturing site abroad, but all storage sites for imported products must be registered at SENASA. To register a storage establishment at SENASA, the importer must also have a company in Argentina since the CUIT number (tax identification number) is required to start this procedure in the Argentinean Distance Processing Platform (TAD) [1]. 

Only a Free Sale certificate is needed to indicate GMP compliance. Otherwise, if not available, a GMP certificate is issued by the local authority of the country of origin.

Note: The importer's establishment, including storage sites in Argentina, needs to be registered at SENASA.

The Coordination of Animal Feed Establishment Controls is from SENASA but the application must be done only at TAD. 

According to the Tariff Manual [2] the corresponding fee for Code IC 007 - Registration / Rehabilitation / Modifications to the Register of Animal Feed Establishments (Processors, Fractionators and/or Warehouses/Storage) is 24,031.8 Argentine Pesos and this procedure has a duration of 90 working days, which can be reduced to 45 working days, but will generate additional costs (not described in the tariff manual).

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 acid)” 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

Article 9 of SENASA RESOLUTION 594/2015 [1] provides for the implementation of the GMP in any establishment involved in the animal feed activities, and the corresponding schedule for implementation. As well as, Annex 1 of SENASA RESOLUTION 594/2015 (Item 5) describes all the applicable rules for the GMP implementation, stating that "all establishments must have a Manual of Good Manufacturing Practice. The manual should be written incorporating the principles and criteria set out in this Technical Standard and in the Codex Alimentarius Code of Practice on Good Animal Feeding CAC/RCP 54-2004".

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 acid)” 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