6. Registration Processes

General Foods
Bolivia

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

In general, the registration of locally manufactured products SENSAG is as follows:

1. Label approval.

2a. For products manufactured in Bolivia: Request for Sanitary Registration for the Manufacturing site, this includes the request for authorization of a product line (see Section 6.4 below) and the inclusion of products to these production lines (See Section 6.2 below).

2b. For imported products: request for Sanitary registration for the company (this includes the request to add products to the Sanitary Registry).

6.1 Product Notification

None.

6.2 Product Registration

There is no product registration required in Bolivia; however, all locally manufactured products must be included in the production line enabled by the entity in charge, SENASAG [1].

Cost

Cost for including product to the production line: variable cost.

Time 

15 business days

Requirements

1. A Request Letter indicating that you wish to include products in production lines already enabled.

2. Application Form and List of ingredients and additives to be used, duly filled out.

3. Letter or Certificate of Label Approval according to the current format.

4. Process flowchart by product group.

7. Copy of the Sanitary Certificate of Origin (or certificate of free sale, or export certificate) of the ingredient to be imported and/or the results of the physicochemical and microbiological analysis of the product(s) to be imported, issued by an official laboratory, if warranted, in the case of food additives and auxiliaries, you must present also the technical sheet of the products to be registered, in which the intended use must be specified. (Only for companies that import their raw materials or inputs)

8. Copy of the documentation that proves that the raw material and the company have the certification issued by a Certification Body (Third party or through the Participatory Guarantee Systems) registered with the National Organic Production Control System of the SENASAG, which supports that the products with such a name respond to that production system. (Only for companies that wish to include products under the name ecological, organic, or biological)

Process 

In-person procedure (there is no online procedure for now):

1. Reception of the file and verification of compliance.
2. Payment for the requested service.
3. Evaluation of the information presented.
4. Evaluation opinion.
5. Preparation of internal communication and data registration in the system.
6. Filing and sending the file to the National Headquarters.

6.3 Other Notes or Requirements

Product Notification

None.

Product Registration

None.

6.4 Manufacturing Site Registration

The manufacturing site must obtain Sanitary Registration, and enable its production lines by food group. The entity in charge of registration is SENASAG [1].

Note: the registration of the manufacturing site must be done jointly with the registration of production lines and products.

1. Cost

• Cost for Health Registration: 797 Bs (113.85 USD)
• Cost for Line Enabling: 3663 Bs (523.28 USD)
• Total amount to cancel = 4460 Bs (637.14 USD) (estimated amount)

2. Time 

2 - 4 months

3. Requirements

1. Application letter (it is recommended to use the established format).

2. Photocopy of the NIT (tax registration certificate).

3. Application Form and List of ingredients and additives to be used, duly filled out.

4. Letter or Certificate of Label Approval according to the current format.

5. Process flowchart by product group.

6. Distribution sketch of the plant's rooms, according to the established format.

7. Plant location sketch, according to the established format.

10. Copy of the Sanitary Certificate of Origin of the product to be imported and/or the results of the physicochemical and microbiological analysis of the product(s) to be imported, issued by an official laboratory if warranted in the case of food additives and auxiliaries, must also submit the technical sheet of the products to the registrar, which must specify the intended use. (Only for processing companies that import their raw materials or inputs)

11. Copy of the documentation that proves that the raw material and the company have the certification issued by a Certification Body (Third party or through the Participatory Guarantee Systems) registered with the National Organic Production Control System of the SENASAG which supports that the products with such a name respond to that production system. (Only for companies that produce products under the name ecological, organic, or biological)

4. Process: in-person procedure

1. Request for information to start the process
2. Delivery of documents
3. Reception of the file and verification of compliance
4. Payment for the requested service
5. Evaluation of the information presented
6. Evaluation opinion
7. Inspection Scheduling
8. Conducting the Inspection
9. Sampling
10. Filling out the inspection compliance form
11. Sending samples to the Laboratory
12. Reception and interpretation of laboratory results
13. Preparation of technical report
14. Review of the technical report and preparation of an opinion
15. Filling data into the system
16. Approval and printing of the Health Registration Certificate
17. Correction of the request for evaluation of food product labels (in case of observation)
18. Registration and printing of the label approval certificate
19. Reception of the digital certificate of approval of food product labels

6.5 Standard/Rules for Manufacturing Site

The rules are in the “Regulation of the Sanitary Requirements for the Preparation, Storage, Transportation, and Fractioning of Foods and Drinks for Human Consumption” [2].

It is based on the provisions of the International Code of Principles General Food Hygiene CAC/1-1969, CODEX.

It establishes the general hygiene standards as well as the health conditions and requirements to which the preparation, storage, fractionation, and transportation of food products must be subject to.

6.6 References

1. RA N° 143 / 2017 Regulation of Sanitary Registration of Companies in the food business - SENASAG 

https://www.senasag.gob.bo/phocadownload/RESOLUCIONES_ADMINISTRATIVAS/INOCUIDAD_ALIMENTARIA/ResAdms2017/RA_143_2017.pdf

2.RA N° 019 / 2003 Regulation of the Sanitary Requirements for the Preparation, Storage, Transportation, and Fractioning of Foods and Drinks for Human Consumption - SENASAG 

https://www.senasag.gob.bo/phocadownload/RESOLUCIONES_ADMINISTRATIVAS/INOCUIDAD_ALIMENTARIA/ResAdms2003/RA_%20019_2003.pdf