Processed Food

HEALTH LICENSE/REGISTRATION

Processed Food

1 Concept

2 Services

3 Registration – Requirements

4 GMP Certificate homologation – Requirements

5 Health License exceptions

6 Health License / Sanitary Registration NOT Requirement Certificate

7 Product classification Certificate

8 Health License Validity

1. Concept

It is any natural or artificial food material that is for human consumption has been subjected to technological operations necessary for its transformation, modification, and conservation, which is distributed and marketed in containers labeled under a trademark determined. The term processed food extends to alcoholic and non-alcoholic beverages, table waters, condiments, spices, and food additives.

2. Services

Sanitary Notification / Health License for Foreign Processed Foods.

Legal and Technical Holding

Modification of Sanitary Notification / Health License for Foreign Processed Foods.

Re-registration of Sanitary Notification / Health License for Foreign Processed Foods.

Health License / Sanitary Registration NOT Requirement Certificate

Health risk level Categorization

Preparation of nutritional tables

Elaboration of labels according to the Technical Regulations for Food Labeling.

3. Registration

  1. Legalized Free sale certificate (FSC) or Export Certificate of the origin country.
  2. Legalized authorization from the foreign manufacturer or from the owner of the product to the legal holding in Ecuador, to submit the registration process. This document must be translated into Spanish.
  3. Description of the product development process.
  4. Physical and chemical specifications of the packaging material
  5. Organoleptic and physicochemical specifications for the product, established by the manufacturer.
  6. Original label
  7. Description and interpretation of the batch code
  8. Declaration of the qualitative-quantitative formula of the final product
  9. For organic products, the corresponding certification granted by the competent authority of the origin country of the product must be presented. The document must be legalized.
  10. Stability study stating the proposed shelf life of the food and its storage conditions; signed by the technical manager.
  11. Label design for Ecuador commercialization, which must have the following information:
  • Product name
  • Brand
  • Net content
  • Ingredients
  • Conservation instructions
  • Date of elaboration
  • Date of Expiry
  • Bach
  • Made by with address.
  • Warnings
  • Imported by
  • Graphic system
  • Nutritional information

4. Documents Required

Good Manufacturing Practices certificate or Food Safety Certification issued by the National Health Authority of the origin country, duly authenticated by the Consul of Ecuador in the origin country or apostilled, as appropriate.

Scope of the conformity assessment body accredited, which must be duly authenticated by the Consul of Ecuador in the origin country or apostilled, as appropriate.

Location of the processing plant or food processing establishment.

Declaration of the certified lines, type of food, list of processed foods and each of the presentations of the processed foods that will be marketed in the country.

Certification of the foreign manufacturer or owner of the product, in which the holder of the certificate of Good Manufacturing Practices is authorized to register and commercialize the food products in the country, which must be duly authenticated by the Consul of Ecuador in the original country or apostilled, as appropriate.

Once the GMP certificate homologation has been obtained, the processed foods will be registered under the certified production line, whose Sanitary Notification will have a validity corresponding to the Good Manufacturing Practices Certificate registered. Once the Good Manufacturing Practices certificate is renewed, the Sanitary Notifications of processed foods according to the certified production line will be automatically re-registered (FREE OF GOBERMENT FEE CHARGE).

5. Food that not required license

Food products in their natural state such as: fresh fruits and vegetables and other products.

Food products of animal origin whether they are raw, chilled, or frozen, including cut products; as long as they have not been subjected to technological transformation, modification and conservation processes. Eggs in their natural state and honey are included.

Dried grains in any presentation, except parboiled rice.

Seeds such as sesame, sunflower, zambo seeds and other similar ones that have not been subjected to any technological process of transformation, modification, and conservation.

Nuts in the shell (such as walnuts).

Food raw materials in general, food additives and semi-finished products without the purpose of direct sale to the final consumer.

Samples of no commercial value intended for market studies and interlaboratory tests, research, development, laboratory tests and trials.

Bakery and pastry products that, due to their compositional characteristics, are for daily or immediate consumption.

Ready packed meals for daily consumption, the packaging of which will include the date of preparation.

6. Health License 

Service that verifies if the processed food products require or not require sanitary registration / health license for the distribution, commercialization, and import.

7. Product Classification

Process directed to informing the user about the category to which the product belongs, which requires obtaining health registration for subsequent marketing.

8. Health License Validity

The License will be valid for 5 years, counted from the date of its issue and may be renewed for equal periods. (Re-registration).

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