6. Registration Processes

Animal Feed
Chile

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

6.1 Product Notification

(A) Ingredient/Raw Material

In Chile, animal feeds, including its raw materials, are not subject to Notification or Registration. Animal feeds, feed additives, and raw materials are subject to another procedure called Dossier/Monograph Authorization in which the Resolution issued by the Sub-Department of the Agriculture and Livestock Service (SAG) authorizing the product must be attached during the import process. [1,2]

(B) General Feed

In Chile, animal feeds and feed additives are not subject to Notification or Registration. They are subject to another procedure called Dossier/Monograph Authorization in which the Resolution issued by SAG authorizing the product must be attached during the import process. [1,2]

(B) Category

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

(B) Product

“Formulated Additive” should comply with the requirements in Section 6.1 on “General Feed” above.

6.2 Product Registration/Dossier Authorization

(A) Ingredient/Raw Material

No registration is required for the ingredients that are contained in the imported products unless to import the ingredient itself for subsequent production of animal feed which, in this case, according to the regulation, will require the Dossier Authorization. [Ref 1 - Articles 37, 38, 39]

It is worth mentioning that all additives and ingredients of vegetable and mineral origin in their pure state, i.e. not mixed with other additives or ingredients, are excluded from submitting a dossier. SAG issued positive lists of such additives and ingredients:

• List of authorized additives for the preparation and manufacture of animal feeding stuffs and supplements. [3]
• List and guarantee feed ingredients to be used in the manufacture of animal feeding stuffs or supplements. [4]
  

Mandatory required documents: not applicable for pure additives or ingredients contained in a final product. For raw materials (for subsequent production and not described in the positive list) containing mixed additives/ingredients, it is required to provide the necessary documents as described in (B) below. The cost and timeline will be similar to those described in (B). [2]

(B) General Feed 

In Chile, animal feeds, feed additives, and ingredients (for subsequent production and not described in the positive list) are subject to another procedure called Dossier/Monograph Authorization to which the Resolution issued by SAG authorizing the product must be attached during the import process. 

The presentation of the dossier will follow the following steps and conditions [1 of Article 37 and 39]: 

1.  Each application must be submitted in digital format, in Pendrive, accompanied by the original certificate of free sale or certificate of origin, apostilled or consularized as appropriate.
2. Each product must contain its corresponding application for monographic evaluation, available at www.sag.cl - Pecuaria - Insumos - Alimentación animal - Autorización de productos mediante monografía de proceso (https://www.sag.gob.cl/ambitos-de-accion/atencion-importadores). It must be legible and unamended.
3. For slaughter species (including ruminants) [6], it is important that the application indicates the same name of the product as indicated on the Free Sale Certificate.
4. In the case of feed for non-productive species [5], the dossier must contain all the trade names of the feed in the process line presented according to the certificate of free sale.
5. The interested party (local producer or local importer) shall pay a fee of 5 UTM for each product presented, or process line in the case of food for non-productive species, in accordance with the provisions of Res. Exenta N°7113/2016.
6. During the evaluation process, the Service may require the submission of additional information. This request shall be made by letter or e-mail.
7. If within six months the interested party does not provide all the information required by the Service, the application shall be considered withdrawn, unless the interested party requests an extension of the evaluation in writing. 
8. Once all the information required for product authorization has been submitted and payment has been made, the Service shall issue a decision within a period not exceeding 60 calendar days.
9. If the result of the evaluation of the dossier is satisfactory, the resolution of approval of the dossier is issued. This decision is individual and authorizes the product according to the name on the certificate of free sale and its manufacturing or processing establishment (not its importer, exporter, or consignee).

Notes: 

1. All additives and ingredients of vegetable and mineral origin in their pure state, i.e. not mixed with other additives or ingredients, are excluded from submitting a dossier.
2. The Dossier authorization is linked to applicant. In the event of changes on the product composition or any information, these must be notified to the SAG for evaluation within 30 working days of their occurrence. A product monograph/dossier authorization is only required to be submitted once, and in the event that another importer wishes to apply for import authorization for that product, that will require a prior notification and approval by SAG. 
3. Only companies with establishment duly notified at SAG can apply for the Dossier authorization (please refer to Section 6.4 on Manufacturing Site Registration).
   

According to Article 37 of Decree N° 4/2016 [1], for the Dossier Authorization of formulated additives, the following information and documents must be submitted in the application:

1. Name or company name of the interested party in Chile.
2. Address and contact information of the interested party in Chile.
3. Name or company name of the production plant.
4. Name of the responsible professional or Technical Director of the production plant.
5. Address and contact information of the producing establishment.
6. Document issued by the competent health authority of the country of origin, which states that the establishment is authorized to produce. This document must not be older than three years unless the certificate itself indicates a period of validity.
7. Generic or commercial name of the product, as appropriate.
8. Product category (additive, formulated additive, supplement, complete or balanced feed, ingredient from animal origin, vegetable ingredient, or mineral ingredient, as appropriate).
9. Qualitative list of additives (for additive, formulated additives, or ingredients), of ingredients and additives, and of their eventual substitutes (for supplements or complete feed) as appropriate. This list must be officialized by the competent sanitary authority of the country of origin.
10. Nature or origin of the raw material.
11. Name, address, and country of origin of the companies supplying the raw materials.
12. Diagram, description of the stages and procedures applied in obtaining the finished product.
13. The physical form of the finished product (powder, granules, pellets, blocks, solutions, among others).
14. Type of commercial presentation (packaging characteristics and net content).
15. Product labeling project, according to the requirements indicated in Article 24 of the Regulation.
16. Guaranteed chemical analysis that is necessary for the use of the product.
17. Background information supporting the shelf life of the product.
18. Species of destination, physiological state of the animal, indications for use, precautions, and warnings, when applicable.
19. Storage conditions of the product.
20. Product safety data sheet, if applicable.
21. Scientific studies, in Spanish or English language, that endorse the specific functional characteristics of products of this type.
22. Certificate of free sale or, alternatively, the export certificate issued by the competent health authority, or whoever corresponds, of the country of origin. This document must not be older than two years unless the certificate itself indicates a period of validity. This must be in original and apostilled/legalized as appropriate. 
23. Proof of payment of the verification and background check fee, before the Service.

The corresponding fee for the Dossier Authorization is 5 UTM (Monthly Tax Unit) equivalent to 312,250 Chilean pesos (389.47 USD approx). As above mentioned, if all the requirements are met, the SAG shall issue a decision within a period not exceeding 60 calendar days. [2]

(B) Category

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

(B) Product

“Formulated Additive” should comply with the product registration requirements under the “General Feed” Section 6.2 above. 

6.3 Other Notes or Requirements

Product Notification

Not applicable.

Product Registration/Dossier Authorization 

(A) Ingredient/Raw Material

Not applicable for pure additives or ingredients contained in a final product. However, raw materials (for subsequent production and not described in the positive list) containing mixed additives/ingredients will need to comply with the additional requirements for dossier authorization by SAG as described in (B) below. [2]

(B) Product

Before applying for the Dossier Authorization, all animal feed importers must notify the SAG of the start of their activities, in accordance with the provisions of Article 7 of the animal feed regulations. This procedure can be done in person at the SAG office that corresponds to their facilities or digitally on the service's website (http://www.sag.cl/ambitos-de-accion/acceso-la- nch-2546of2019). [2]

6.4 Manufacturing Site Registration

General Feed 

Manufacturers (local products), importers, distributors, warehouses, and retail outlets of animal feed, supplements, additives, and ingredients intended for animal feed must apply for the "Notification of commencement of activities for establishments of animal feed products" with the Sub-Department of the Agriculture and Livestock Service (SAG) . [1] 

It is worth mentioning that manufacturing sites abroad only need a document issued by the competent sanitary authority of the country of origin, which states that the establishment is authorized to produce this product. 

The application for the "Notification of commencement of activities for establishments of animal feed products" can be carried out online through the SAG's online procedures platform (https://sag.cerofilas.gob.cl) or in person at the SAG's offices. For this procedure, the following requirements must be considered [2]:

1. Complete the form of "notification of commencement of activities for establishments of products intended for animal feed". The document must be submitted in duplicate originals, signed and stamped by the owner or his legal representative.
2. Document issued by the Internal Tax Service (SII) accrediting the start of activities with the line of business reported to the SAG.
3. Municipal permit.
4. To carry out this procedure online you must have a ClaveÚnica that allows companies to operate in the SAG's platform. Only local companies can apply for this ClaveÚnica since the RUC number (Tax Identification Number) is required. 

Once the application has been evaluated, its resolution will be notified to the company by e-mail and through the SAG's platform where the certificate can be downloaded for display on the site, as well as for other procedures.

According to the Web section on "Notification of commencement of activities for establishments of animal feed products", this procedure is free of charge. No timeline is described. [7,8]

Category

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

Product

The product “Formulated Additive” 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

According to Articles 9, 10, and 11 of Decree 4/2016 [1], animal feed-producing establishments, shall develop and implement a self-control program based on the quality assurance guidelines established in Resolution No. 5,025/2009 [9], in order to ensure animal health, food safety, and traceability. The establishment's self-control program shall be documented and available so that it is possible to reconstitute the production process of each batch of product. [10]

Category

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

Product

The product “Formulated Additive” 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. Decree 4/2016.  Regulation of animal feed. Type Version: Single 05 January 2018

https://www.bcn.cl/leychile/navegar?idNorma=1104854

2. Guide to the preparation and presentation of monographs on the production process of animal feed products

https://www.sag.gob.cl/sites/default/files/guia_elab_monografias_prod_importados_alim_animal_vs7-30-3-2021_0.pdf

3. List of authorized additives for the preparation and manufacture of animal feedingstuffs and supplements.

https://www.bcn.cl/leychile/navegar?idNorma=249643

4. List and guarantee of feed ingredients to be used in the manufacture of animal feedingstuffs or supplements.

https://www.bcn.cl/leychile/navegar?idNorma=279502

5. Application forms for: Non-productive species

https://www.sag.gob.cl/sites/default/files/solicitud_evaluacion_monografia_especies_no_productivas_24-4-2020.docx

6. Animals for slaughter

https://www.sag.gob.cl/sites/default/files/solicitud_evaluacion_monografia_animales_abasto_24-4-2020.docx

7. SAG - Application for Notification of Commencement of Activities for Animal Feedstuffs Establishments

https://www.chileatiende.gob.cl/fichas/42413-comunicacion-de-inicio-de-actividades-para-establecimientos-de-productos-de-alimentacion-animal

8. Online modality (Through Unique Key)

https://accounts.claveunica.gob.cl/accounts/login/?next=/openid/authorize%3Fclient_id%3Deb838855f2344f65a4c925df80cdcad5%26redirect_uri%3Dhttps%253A%252F%252Fcerofilas.sag.gob.cl%252Flogin%252Fclaveunica%252Fcallback%26scope%3Dopenid%2Brun%2Bname%26response_type%3Dcode%26state%3DUDxLCyPzrYmNeDCOuvqJWFo07CMfw8qvTuw658rC

9. Resolution No. 5.025/2009. Establishes the scope of the Quality Assurance Program in factories or manufacturers of animal feed and supplements and factories of ingredients of animal origin intended for animal feed

https://www.bcn.cl/leychile/navegar?idNorma=1005988

10. SAG - National production of animal feed - Control programs

https://www.sag.gob.cl/ambitos-de-accion/produccion-nacional-de-alimentos-para-animales-programas-de-control