Requirements for Food Sanitary Registration in Bolivia

Q.F. Mary Carmen Chuquimia Socpaza
Quality Specialist & Regulatory Affairs Coordinator
SCR Consulting Bolivia

Food Safety is the guarantee that food will not cause harm to the consumer when prepared and/or consumed, without posing health risks. This condition involves several actors (primary producers, food processors, transporters, food traders and final consumers) along the food chain up to the final consumer, all of whom have the responsibility to ensure that food is safe.

The regulation of these products is ruled by SENASAG’s standards, “Servicio Nacional de Sanidad Agropecuaria e Inocuidad Alimentaria” whose objective is to protect the sanitary and productive condition in agriculture, forestry and food safety, in order to contribute to sustainable and durable development, guaranteeing food safety. SENASAG’s National Food Safety Unit is specifically in charge of the evaluation and registration of food products.

The National Food Safety Unit of SENASAG, has the objective of ensuring food safety in the productive and processing stages that correspond to the agricultural sector by regulating good practices in primary production and processing, registration and monitoring and carrying out the certification of food safety of food products for national consumption of export and import.

Sanitary registration is understood as the endorsement issued by SENASAG to all legal and/or natural persons within the food industry, who comply with all the requirements established in SENASAG Administrative Resolution No. 0143/2017 Regulation of Sanitary Registration of Companies in the food industry.

 The Sanitary Registration entitles the natural person and/or legal entity, holder of the same depending on its categorization to produce, fractionate, pack, store, in addition to obtaining the Food Safety Permit for Importation, Prior Authorization for Importation, Food Safety Certificate for Exportation, Free Sale Certificate among other certifications, for its commercialization of the food or foods that are covered by the sanitary registration certificate, for the market level that was granted.

Are subject to the Sanitary Registration all natural and/or legal persons, within the food industry, established in the Bolivian territory and categorized as follows:

• Industrial Processor.
• Semi Industrial Processor.
• Artisanal Processor
• Fractionation and / or Packaging
• Food and Beverage Importers
• Cold storage chambers
• Vegetable product maturation chambers.

In order to register the product, first the label approval process must be carried out, and the requirements to be submitted are the following:

a) General Requirements

1. Request letter for label approval (it is recommended to use the established format).
2. Copy of the NIT (Tax Identification Number), which is the number assigned by the Bolivian Tax Administration to a natural or legal person at the time of registration for any economic activity.
3. Label model approval request form (Form UIA-REGSOL-003).
4. Sworn Statement (Form UIA-INSPETRL-DJUR-001)
5. Label model (It must be the same that will be used for its commercialization), the model must be submitted per product and if there are several presentations, each one of them must be attached, likewise when there are multiple selection labels, the same must be attached for each one of the products to be selected, the label model may be submitted in electronic format according to the established criteria or in Physical format.
6. Copy of the Sanitary Certificate of origin (in case of imported products).

b) Specific Requirements (as applicable)

1. Certificate of conformity on nutritional labeling and graphic system issued by the Health Ministry.
2. Certificate of organic product issued by the competent authority (In case of declaring as organic, ecological or biological product).
3. Certification of awards or recognitions declared on the label.
4. For food supplements and/or foods for special diet, they must also submit the necessary support (Technical Data Sheets, etc.).
5. In the case of products that are, contain or are derived from GMO’s, the supporting documents that guarantee such status must be attached.
6. For food additives, the Technical Data Sheet must be submitted.

c) Payment of the Fee for the Service of Evaluation and Approval of the Information Content on the Labels

The following considerations must be taken into account:

• For products that are presented in different presentations (Colors or designs) or contents (Weight or Volume), but have the same label model in terms of mandatory information, the corresponding fee payment will only be the one applicable to a single product. Therefore, if the label model varies in terms of mandatory information between presentations, the service fee must be paid for each one of them.
• For products with multiple selection label models, the corresponding fee must be paid for each of the duly identified products.

This label approval process may be carried out online through the virtual platform for Label Evaluation and/or Approval or at SENASAG departmental offices. The deadlines for the procedures are detailed according to the flow of labels:

For revision and/or approval of labels in the departmental offices:

• From 1 to 10 labels. Within 5 working days after full compliance with the requirements.
• From 10 to 20 labels. Within 10 working days after compliance with the requirements.
• From 20 to 30 labels. Within 15 working days after compliance with the requirements.

For online label revision and/or approval:

• From 1 to 10 labels. Within 3 working days after full compliance with the requirements.
• From 10 to 20 labels. Within 6 working days after compliance with the requirements.
• From 20 to 30 labels. Within 10 working days after compliance with the requirements.

The approval of the food product label and/or food information is unique and will not expire, and will be shown in the Certificate of Label Approval.

When modifications or changes are made to the mandatory information, the product holder must start a new label approval process according to the procedures detailed above.

It will be considered as an update of labels only when there are modifications in terms of artwork, weight or volume of the same, or involving the change of figures and / or illustrations or layout of the information on labels that previously have the certificate of label approval, for this natural or legal persons wishing to make the update of labels, as long as it does not contravene the provisions of the above regulation, in this case only the notification of update will be made and must wait for the Approval of the Update.

It is also clarified that when there are regulatory changes regarding food labeling or sanitary requirements for food product registration, label and food product evaluations may be subject to a new evaluation.

Once the label approval is done, the interested party will obtain the label approval document and will have access to the Sanitary Registration process. For this purpose, SENASAG will carry out the respective evaluation.

The evaluation of the food product includes the assessment of all the information related to the food product. Including the name of the product, brand name, country of origin, manufacturer, exporter, storage conditions, shelf life of the product, product presentations, details of ingredients and additives, product classification, type of label, sanitary endorsement (if applicable), among other data related to the sanitary condition.

For this procedure the dossier must be composed of the following documents:

1. Application letter (it is recommended to use the established format).
2. Photocopy of the NIT.
3. Application Form and List of Ingredients and Additives to be used properly filled out.
4. Letter or Certificate of Label Approval according to the current format.
5. Location sketch of the warehouse distribution according to the established format.
6. Location sketch of the warehouse location according to the established format (In case a company has more warehouses nationwide, these must be declared in the Registration Application Form for their corresponding authorization).
7. 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 of the country of origin in the case of alcoholic beverages; in the case of food additives and auxiliaries, the product’s technical data sheet must also be submitted.
8. If the company imports products under the denomination of ecological, organic or biological, these must have the certification issued by a Certification Organization registered in the competent authority of the country of origin, which supports that the products with such denomination respond to that system of production.
9. Other documentary requirements in application of specific regulations (Product fortification, authorization or registration of other entities such as the Ministry of Productive Development and Plural Economy).

The documents must be submitted in a Green folder labeled with the name of the applicant company, contact person and telephone number, in duplicate.

The evaluation time is 30 working days and in case observations are generated, from the date of correction, the evaluation time will be carried out within 15 working days. The Sanitary Registration is valid for 5 years from the date of issuance.

It is important to point out that the submission of these requirements must be in Spanish.

Therefore, according to what is indicated in this article, the processes to obtain the Sanitary Registration of Food products do not have to be complicated, since the requirements correspond to legal documents of a company duly registered in Bolivia and technical documents common in other countries in the regulation of this type of products, so that compliance with the standard and being updated on all obligations to be fulfilled as natural and / or legal persons within the food industry can ensure the sanitary quality and safety of the food that will reach the consumer.

So with all this documentation, obtaining the sanitary registration for foods marketed in Bolivia, will ensure that these have been produced under appropriate hygienic conditions and that its components do not represent a harm to the providing assurance to consumers; being that the holder of the Sanitary Registration assumes responsibility for the sanitary quality and safety of the food or beverage released for marketing; this sanitary registration is therefore synonymous of safety, providing assurance to consumers of food and beverages, since not obtaining the sanitary registration represents a risk to the health of the Bolivian population, because its quality, safety, efficacy and effectiveness cannot be guaranteed.