Required Report - public distribution

**Date:** 8/2/2006

**GAIN Report Number:** EC6009

EC6009

**Ecuador**

**Food and Agricultural Import Regulations and Standards**

**Country Report**

**2006**

**Approved by:**

![](media/image1.wmf)Eugene Philhower

U.S. Embassy

**Prepared by:**

Rene A. Alarcon

**Report Highlights:**

Ecuador\'s food import regulations are based on international standards
such as CODEX, OIE, and the WTO-SPS Agreement. Although rules are
written in consistency with WTO norms, weak institutions, lack of
technological resources, and inefficiency make imports onnerous and
cumbersome. Many regulations allow for interpretation and discretionary
decisions by authorities that are usually political appointees and lack
technical knowledge.

Includes PSD Changes: No

Includes Trade Matrix: No

Annual Report

Quito \[EC1\]

\[EC\]

Table of Contents

[**SECTION I. FOOD LAWS 4**](#section-i.-food-laws)

[The Official Register 4](#the-official-register)

[The Ministry of Agriculture and Livestock (MAG)
4](#the-ministry-of-agriculture-and-livestock-mag)

[Agricultural Development Law 4](#agricultural-development-law)

[Plant Health Law 5](#plant-health-law)

[Animal Health Law 5](#animal-health-law)

[Law of Seeds 5](#law-of-seeds)

[Law for the Formulation, Manufacture, Import, Trade and Use of
Pesticides and Similar Products of Agricultural Use
5](#law-for-the-formulation-manufacture-import-trade-and-use-of-pesticides-and-similar-products-of-agricultural-use)

[Agencies within the Ministry of Agriculture (MAG)
5](#agencies-within-the-ministry-of-agriculture-mag)

[Ecuadorian Animal and Plant Health Service (SESA)
5](#ecuadorian-animal-and-plant-health-service-sesa)

[Domestic and International Trade Office
5](#domestic-and-international-trade-office)

[The Ministry of Public Health (MSP)
6](#the-ministry-of-public-health-msp)

[The Health Code 6](#the-health-code)

[The Sanitary Registration Law 6](#the-sanitary-registration-law)

[Food Regulation 6](#food-regulation)

[The Law of Consumer Defense 7](#the-law-of-consumer-defense)

[Other Institutions Involved in Foreign Trade
7](#other-institutions-involved-in-foreign-trade)

[Ministry of Foreign Trade, Industrialization and Fishing (MICIP)
7](#ministry-of-foreign-trade-industrialization-and-fishing-micip)

[Law of Foreign Trade 7](#law-of-foreign-trade)

[Ecuadorian Normalization Institute (INEN)
7](#ecuadorian-normalization-institute-inen)

[The Ministry of Foreign Affairs 8](#the-ministry-of-foreign-affairs)

[The Ecuadorian Customs Corporation (CAE)
8](#the-ecuadorian-customs-corporation-cae)

[SECTION II. LABELING REQUIREMENTS
8](#section-ii.-labeling-requirements)

[A. General Requirements 8](#a.-general-requirements)

[B. Requirements Specific to Nutritional Labeling
9](#b.-requirements-specific-to-nutritional-labeling)

[Exceptions and Special Dispositions Regarding Mandatory Nutritional
Labeling
9](#exceptions-and-special-dispositions-regarding-mandatory-nutritional-labeling)

[SECTION III. PACKAGING AND CONTAINER REQUIREMENTS
10](#section-iii.-packaging-and-container-requirements)

[SECTION IV. FOOD ADDITIVE REGULATIONS
10](#section-iv.-food-additive-regulations)

[SECTION V. PESTICIDE AND OTHER CONTAMINANTS
11](#section-v.-pesticide-and-other-contaminants)

[SECTION VI. OTHER REGULATIONS AND STANDARDS
11](#section-vi.-other-regulations-and-standards)

[A. The Sanitary Registration 11](#a.-the-sanitary-registration)

[B. Phytosanitary and Health Certification
13](#b.-phytosanitary-and-health-certification)

[Other Requirements 14](#other-requirements)

[C. Registration of [Agricultural and Livestock Inputs]{.mark}
14](#c.-registration-of-agricultural-and-livestock-inputs)

[D. Control of Products at Retail/Wholesale Distribution
14](#d.-control-of-products-at-retailwholesale-distribution)

[SECTION VII. OTHER SPECIFIC STANDARDS
15](#section-vii.-other-specific-standards)

[A. Wine, Beer and Other Alcoholic Beverages
15](#a.-wine-beer-and-other-alcoholic-beverages)

[B. Products Samples and Mail Order Shipments:
15](#b.-products-samples-and-mail-order-shipments)

[SECTION VIII. COPYRIGHT AND/OR TRADEMARK LAWS
16](#section-viii.-copyright-andor-trademark-laws)

[A. Trademarks 16](#a.-trademarks)

[B. Brand Names 17](#b.-brand-names)

[SECTION IX. IMPORT PROCEDURES 17](#section-ix.-import-procedures)

[[Specific Rules for Agricultural Imports]{.mark}
19](#specific-rules-for-agricultural-imports)

[APPENDIX I. GOVERNMENT REGULATORY AGENCY CONTACTS
19](#appendix-i.-government-regulatory-agency-contacts)

[International Trade Under-Secretariat
19](#international-trade-under-secretariat)

[CODEX Committee in Ecuador 19](#codex-committee-in-ecuador)

[MINISTRY OF AGRICULTURE AND LIVESTOCK
20](#ministry-of-agriculture-and-livestock)

[APPENDIX II. OTHER IMPORT SPECIALIST CONTACTS
22](#appendix-ii.-other-import-specialist-contacts)

**FOOD AND AGRICULTURAL IMPORT REGULATIONS AND STANDARDS (FAIRS)**

\"This report was prepared by the Office of Agricultural Affairs of the
USDA/ Foreign Agricultural Service in Quito, Ecuador for U.S. exporters
of domestic food and agricultural products. While every possible care
was taken in the preparation of this report, information provided may
not be completely accurate either because policies have changed since
its preparation, or because clear and consistent information about these
policies was not available. It is highly recommended that U.S. exporters
verify the full set of import requirements with their foreign costumers,
who are normally best equipped to research such matters with local
authorities, before any goods are shipped. FINAL IMPORT APPROVAL OF ANY
PRODUCT IS SUBJECT TO THE IMPORTING COUNTRY'S RULES AND REGULATIONS AS
INTERPRETED BY BORDER OFFICIALS AT THE TIME OF PRODUCT ENTRY.\"

# 

# 

# SECTION I. FOOD LAWS

Ecuador is a member of the World Trade Organization since 1996. Its
Foreign Trade Law prohibits any economic, administrative or technical
practice that may limit or discourage foreign and internal trade, free
competition and local production of goods and services. This law also
allows the application of corrective measures only in cases included in
the World Trade Organization normative.

Nonetheless, Ecuador maintains both tariff and non-tariff barriers
interfering with agricultural and food imports. Although imports are not
subject to excessive tariffs, technical and safety restrictions are not
always established with the only purpose of protecting human, animal and
plant health. Weak and politically managed institutions often create
inefficiency and sudden changes in the application or interpretation of
rules and requirements involving food and agricultural imports. Some
administrative procedures are cumbersome and require excessive amount of
documents as a way to delay or discourage imports.

Food safety is a shared responsibility in Ecuador. The Ministries of
Agriculture and Health are in charge of controlling the food supply.
Several agencies within these ministries handle the technical and
administrative processes of prior authorization, inspection and control
of local and imported foods and agricultural products. Lately, with the
increasing importance of Biotechnology, the Ministry of Environment has
played a major role in proposing regulations regarding the safe use and
consumption of transgenic products. In April 2006, Ecuador passed a food
security law that prohibits imports use and trade of genetically
modified products for human consumption. However, Ecuador's General
Attorney later qualified this law as inapplicable. Further events on
this regard are expected in the coming months.

## The Official Register

The Official Register (RO) is Ecuador's counterpart of the United States
Federal Register. New laws, application rules, executive decrees,
ministerial agreements or standards issued in Ecuador come into legal
effect on the day after its publication in the Official Register, unless
a specific date had been established for this purpose.

The Official Register is the official legal publication of Ecuador, and
its purpose is to inform stakeholders and the population about any new
laws, decrees, agreements or other legal dispositions. It is a
paper-printed publication sold mainly in Quito, at a price of US\$0.25.
A few private companies also commercialize this publication in
electronic format for a yearly charge of approximately \$200.

## The Ministry of Agriculture and Livestock (MAG)

The Ministry of Agriculture and Livestock is responsible for promoting
harmonic and sustained development of the agricultural and livestock
sectors of Ecuador, through direction and evaluation of agricultural
[and livestock]{.mark} activities. The laws by which this agency is
ruled are mainly the following:

### Agricultural Development Law

This law, published in OR #55 of April 30, 1997, guarantees free imports
and internal trade of agricultural inputs, [improved seeds,]{.mark}
improved plants and animals, machineries, equipment and technology,
except for those qualified by the country of origin as harmful to the
environment.

### Plant Health Law

This law, published in OR #475 of January 18, 1974, is aimed at
preventing and controlling plagues, illnesses and pests that could
affect agricultural crops. This norm establishes regulations, conditions
and prohibitions for imports, exports and local trade and production of
certain plant products.

### Animal Health Law

The Law of Animal Health, published on OR #409 of March 31, 1981, was
enacted to prevent, control and eradicate illnesses in Ecuador's
livestock population. This Law points out that the Ministry of Public
Health, along with the Ministry of Agriculture and Livestock, must
control the quality of animal origin products destined for human
consumption. Also, these two institutions must prohibit trade and call
back harmful products from the market. This law also states the
obligation to obtain prior authorization and a sanitary certificate from
the Ministry of Agriculture for importing and exporting animals and
their products and by-products.

### Law of Seeds

This law is related to all requirements for imports and exports of
seeds. It also mentions the obligation of seed importers and exporters
to register as such with the Ministry of Agriculture and Livestock.
Furthermore, this law [regulates commercialization of seeds and seeds
products.]{.mark}

[]{.mark}

### Law for the Formulation, Manufacture, Import, Trade and Use of Pesticides and Similar Products of Agricultural Use

This law establishes the obligation of every natural person or company
importing, manufacturing or distributing pesticides and similar products
for agricultural use, to register at the Ministry of Agriculture for
such purposes. It also rules transportation, storage, labeling and
advertisement of these products. This legal body also determines
tolerance residue levels for pesticides.

## Agencies within the Ministry of Agriculture (MAG)

### Ecuadorian Animal and Plant Health Service (SESA)

SESA's basic purpose is to ensure good phytosanitary conditions of
agricultural crops and good health of livestock population. It is also
responsible for impeding the entry and spread of exotic pests and
diseases, and for eradicating existing animal diseases and plant pests.
SESA is the Ecuadorian counterpart of APHIS.

Among its duties, SESA must demand the fulfillment of legal norms and
international regional standards (such as Andean Standards) that
regulate imports, exports manufacturing, formulation, distribution,
local trade and end-use of agricultural products, pesticides, and
veterinarian products. This agency issues Health or Phytosanitary
certificates that will allow imports of products and by-products from
animals and plants (including plant breeding material).

### Domestic and International Trade Office

This office, under the supervision of the Undersecretary for Strategic
Management of the MAG, is responsible for gathering and analyzing
agricultural trade and production data in order to suggest policies and
legislation changes. In practice, this office is the administrative
instance in the Ministry of Agriculture in charge of [receiving prior
import authorization requests]{.underline} and passing them onto SESA
for sanitary certification, and to the Undersecretary of Strategic
Management for final approval.

Note: The Prior Authorization requirement for food and agricultural
products is embodied in COMEXI (Foreign Trade Council) Resolution 183,
published in RO Especial Edition #6 of May 5, 2003. This document
provides a positive list of each HTS line subject to prior import
approval from either the Ministry of Agriculture or the Ministry of
Health, depending on the product's degree of processing.

###### Undersecretary for Agricultural Development

Main responsibilities of this office are:

a.  Establish requirements for manufacture, formulation, import and
    trade of fertilizers[, animal feed]{.mark} and seeds.

b.  Control the quality of locally traded fertilizers, [animal
    feed,]{.mark} seeds and vegetal material.

## The Ministry of Public Health (MSP)

The Ministry of Public Health, through the National Control and
Surveillance System, and its dependencies, regulates the entry and
consumption of processed food products, beverages, additives and
pesticides. On regards to food imports, the National Control and
Surveillance System is ruled by the following laws and regulations:

### The Health Code

The health code establishes the obligation of obtaining the Sanitary
Registration prior to import, trade, production, storage or
transportation of processed food, beverages, additives, and pesticides
for domestic, agricultural or industrial use. According to this law, the
Ministry of Public Health (MSP) and its agencies are responsible for the
inspection and control of all processed foods, beverages and food
additives.

### The Sanitary Registration Law

This law regulates the process to obtain sanitary registrations for
imported and locally produced food products and beverages. It affirms
the obligation to obtain the Sanitary Registration prior to importation
and local distribution of food products. It also provides different
requirements for imported products and locally produced products.

### Food Regulation

This set of rules describes all requirements for food products to be
authorized for free sale. It contains information on manufacture
processes, container, packaging and labeling requirements. Moreover, the
food regulation governs the activities of transportation, distribution
and trade of food products.

## 

## 

## The Law of Consumer Defense

Its objective is to guarantee consumer rights to obtain quality,
regularity and fair prices in goods and services. The dispositions of
this law are applicable to all government entities and private companies
(or professionals and business owners) that produce, import, export or
distribute goods and services.

The consumer defense law establishes the obligations and
responsibilities that all goods or services providers have towards
consumers. Among them is the obligation of providing clear, complete and
enough information about their products. It also determines the minimum
necessary information in a label, including price (in local currency)
and indications about the content and weight of the product, expressed
in Standard International Units of Measurement. It states that products
from GMOs must contain all necessary indications about their transgenic
origin in order to alert consumers.

Note: Although this law and all its dispositions are in effect, the
particular requirement for GMO labeling has not been enforced through
application rules or inclusion of such requirement in Ecuador's labeling
requirements. Currently, there is a proposed text for Food Labeling
Rules, which includes the GMO labeling requirement. Ecuador is currently
in the process of notifying this proposed text to the WTO for comment.

## Other Institutions Involved in Foreign Trade

Besides the Ministries of Health and Agriculture, which have the lead in
agricultural and food trade, there are other Ecuadorian institutions
involved that need to be mentioned, as follows:

## 

## Ministry of Foreign Trade, Industrialization and Fishing (MICIP)

MICIP is the government agency responsible for planning, directing,
controlling and executing policies for foreign trade, industrialization,
fishing, small and medium industry and business, and ships. Its mission
is to improve the business environment in Ecuador, and to facilitate
domestic and international [competitiveness]{.mark} of the productive
sectors. This institution is the main player on negotiating multilateral
and bilateral trade agreements.

### Law of Foreign Trade

This law was published in the Official Register #82 on June 9, 1997, and
regulates all activities of MICIP. It also prohibits any practice or
administrative disposition that may limit free competition or obstruct
development of domestic and international trade and production.
Nevertheless, the law allows corrective actions to be applied in the
cases contemplated under the regulations of the World Trade Organization
(WTO). In spite of that, the inefficiency of certain public agencies and
other institutions block an adequate development of import activities.
Examples of this are the actions of the National Health and Tropical
Medicine Institute \"Leopoldo Izquieta Pérez\", co-responsible for the
issuance of the sanitary registration, and those of the Ecuadorian
Customs Corporation (CAE), which administers customs services.

### Ecuadorian Normalization Institute (INEN)

INEN is an agency of the [Ministry of Foreign Trade, Industrialization
and Fishing (MICIP)]{.mark} and is responsible for:

-   Preparing Ecuadorian Technical Standards (NTE), which define the
    characteristics of raw materials, intermediate products and finished
    products marketed in Ecuador. Also, INEN must formulate the methods
    for inspection, analysis, measurement, classification and
    denomination of such materials or products.

-   Administering the [Quality Certification System]{.mark}.

-   Implementing and enforcing the use of the International [Measurement
    System (SI).]{.mark}

-   Inspecting the compliance of the requirements set for in the
    Ecuadorian Technical Standards NTE for imported and local products,
    including labeling requirements.

-   INEN also serves as Ecuador's Point of Contact for CODEX related
    issues.

## The Ministry of Foreign Affairs

The Ministry of Foreign Affairs collaborates with the Office of the
President and coordinates with the Ministry of Foreign Trade and the
Ministry of Agriculture in the formulation of international policies,
direction of international affairs and celebration of agreements and
other international conventions. It is responsible for supporting
commercial negotiations and offering assistance in the solution of
controversies.

## The Ecuadorian Customs Corporation (CAE)

The Ecuadorian Customs Corporation (CAE) administers customs operations.
This agency is responsible for the surveillance and control of the
entrance or departure of people, commodities, and means of
transportation through the borders and ports of Ecuador. It is also
responsible for the collection of import duties and taxes. The Organic
Law of Customs and its application Rule govern CAE's activities.

# SECTION II. LABELING REQUIREMENTS

## A. General Requirements

The Health Code, the Sanitary Registration law, the Food Regulation, and
the Technical Standard NTE INEN 1334-1, provide labeling requirements
for processed food products.

Food containers must have a visible printed or tagged label with certain
minimum information, as detailed below. Imported products with tags in
English and containing the aforementioned minimum information may be
allowed to clear customs, subject to the addition of a tag or sticker in
Spanish before the product is offered in the market. This additional tag
must at least contain expiration date (good through), lot number, the
Sanitary Registration code, the list of ingredients, and name of the
importer reading "Importado por...".

[In addition to the aforementioned requirements, Ecuadorian labeling
standards acknowledge the following guidelines:]{.mark}

[]{.mark}

-   [Labels containing words, pictures or other graphic representations
    introducing the product as having medicinal, therapeutic,
    preventive, curative, nutritional, or especial features; which may
    misrepresent the real nature, origin, composition or quality of the
    product are not allowed.]{.mark}

-   When a product is very small in size and it is not possible to show
    all the information required in a food label, such information must
    be presented in a larger package that contains several units of the
    product. This is case of candy, chocolate, and most confectionery
    products.

-   Imported products may have labels in foreign language, preferably
    with the respective translation in Spanish, in the same form and
    characters, and containing all previously listed requirements. It is
    advisable to apply labels prior to export, because the product has
    to enter the country in its final presentation.

-   The Solid Waste Management regulation determines that every label
    must promote [recycling]{.mark}, recuperation or re-use of the
    package or container.

-   Ecuadorian standards do not differ significantly from those
    established by the United States; they are based on the Codex
    Alimentarius and FDA (Food and Drug Administration) stipulations. In
    fact, Ecuador's common practice provides for FDA's standards to be
    used in case of inexistence of national (INEN) standards for a given
    product.

## B. Requirements Specific to Nutritional Labeling

The technical standard NTE INEN 1334-2 refers to minimum requirements
for nutritional labeling of processed food products offered as such for
sale. This standard gathers the declaration of nutrients and explains
that the complementary nutritional information is optional.

The bases of this standard are the Codex Alimentarius and the FDA
guidelines, for which, U.S. standards are acceptable. Recommended Daily
Intake (RDIs) is based on the Recommended Daily Intake of nutrients of
the [FAO]{.mark}/ IHO.

[]{.mark}

[]{.mark}

### Exceptions and Special Dispositions Regarding Mandatory Nutritional Labeling

*Foods Containing Insignificant Quantities of Nutrients*

An insignificant quantity is defined as one that allows the declaration
of \"Zero\", except for total carbohydrates values, dietetic fiber and
protein, for which an insignificant quantity is less than one gram.
Examples of exempted products are grain coffee, tealeaves, soluble tea,
and unsweetened coffee; dehydrated vegetables for seasoning, extracts of
flavors and colorings for food.

*Dietetic Supplements*

This exception does not apply for dietetic supplements in the form of
conventional foods, such as breakfast cereals. These products are
subject to all requirements specified in NTE INEN 1334-2

[*Packaged Food*]{.mark}

[]{.mark}

[These products are exempt only if they are shipped in bulk and are not
meant for direct sale to the consumer, but are imported for use in
processing industries. Example: Bulk-packaged sweet corn to be
re-packaged and sold as a vegetable mix.]{.mark}

*Fresh Food Products*

Fresh products (fresh fruits and vegetables) and Seafood (fresh or
frozen fish and seafood) are also exempt.

## SECTION III. PACKAGING AND CONTAINER REQUIREMENTS

The food regulation establishes that food containers must meet the
following conditions:

-   The container must have adequate shape, capacity and closing
    [seal]{.mark} for its contents. No further explanation of what is
    deemed "adequate" in this case.

-   The container should be made of the right materials, in relation
    with the physical-chemical nature of its content.

-   Containers must guarantee proper protection, conservation and
    identification of the product during its shelf life.

The materials used in the containers and packages for a processed food
products should meet the conditions of the E[cuadorian Technical
Standards (NTE) for established for each product or group of
products.]{.mark} Moreover, the Solid Waste Management regulation
asserts that all packaging material and containers must allow
[recycling]{.mark}.

## SECTION IV. FOOD ADDITIVE REGULATIONS

Standards and regulations for food additives are those set for in the
Health Code, the Food Regulation and the technical standard NTE INEN
2074-96. The Food Regulation establishes that food additives are allowed
for importation and in-country sale when:

-   They are innocuous for human health; and,

-   They have obtained the Sanitary Registration.

The technical standard NTE INEN 2074-96 is based in the Codex
Alimentarius standards and the Regulation Code of the Food Drug
Administration (FDA). It establishes a positive list of allowed
additives, regulations for tolerance levels, and a list of prohibited
substances for human consumption. This positive list is periodically
checked and/or modified according to new scientific, technological and
toxicological studies.

The NTE INEN 2074-96 standard, as well as other technical norms are
available for public sale. U.S. exporters can obtain a copy sending a
request to the Ecuadorian Institute of Normalization (INEN[) with
contact information in Appendix I below.]{.mark} However, these norms
are written in Spanish and there are no English copies available.

## SECTION V. PESTICIDE AND OTHER CONTAMINANTS 

The Law of Formulation, Manufacture, Import, Trade and Use of Pesticides
was issued to guarantee the integrity of pesticides, and that
manufacturers, importers and distributors declare their chemical
composition. The Ministry of Agriculture, through the Administrative
Unit of Plant Health of SESA, is the agency in charge of the application
of this law.

Ecuador has not set its own maximum tolerance levels. In fact, it
applies Codex maximum residue limits. Other maximum tolerance levels
established by widely recognized international institutions, such as the
Environmental Protection Agency (EPA), are also accepted.

The Ministry of Agriculture and Livestock (MAG) will temporarily retain
agricultural products suspected of being contaminated with pesticides or
similar products. If analysis and testing carried out by the Ministry of
Agriculture prove such affirmation, products will be destructed and no
compensation will be granted.

## SECTION VI. OTHER REGULATIONS AND STANDARDS 

## A. The Sanitary Registration 

In order to protect consumers' health, the current Health Code
establishes that all national or foreign processed food products and
additives must obtain a Sanitary Registration prior to their importation
and sale in Ecuador. The process for sanitary registrations has been
re-designed, and new laws have been written on this matter. The
June-2001 released Sanitary Registration Law provides the following
guidance:

-   The sanitary registration petition can either be filed by the
    manufacturer or by its Ecuadorian legal representative. In both
    cases, the registration belongs and will be issued to the name of
    the manufacturer, unless specifically requested otherwise.

-   The sanitary registration is valid for ten (10) years. The
    registration fee is approximately \$560 per item, and there is an
    annual maintenance fee of \$170.

The sanitary registration for imported products is granted by
homologation (or equivalence) after 30 calendar days of having filed a
correct application at any office of the National Hygiene Institute
\"Izquieta Perez\" (NHI). Observations will be directed to the applicant
five (5) days after the NHI receives the application. An additional
provision on this topic provides that sanitary registrations for
imported products be automatically issued if the NHI had not justified
its denial in the term of 30 days after the last observation had been
resolved.

Currently, the application must include the following documents:

1.  Request form (obtained at the NHI) including the following
    information:

    1.  Product name in full, including brand name

    2.  Name, and full address of the manufacturer

    3.  Name and address (in full) of the applicant (usually the
        importer)

    4.  Product Description:

        1.  Ingredients list or composition formula (in percentages)
            used in the

> product (including additives), declared by the manufacturer in
> descending
>
> order.

2.  Elaboration date

3.  Expiration date or maximum consumption time

> Note: Since exporters usually do not know when the first shipment
> would take place, or what lot of products will be exported, these two
> requirements are only intended for declaring a maximum time of
> consumption in the label. For example, if the product is good for 6
> months, then Production date may be declared as January 1, 2005 and
> Expiration date as June 1, 2005. The dates are not relevant, but the
> period of time in which the product is good for consumption.

4.  Packaging Information: must declare type of container, and content

> expressed in units of the International Measurements System (SI).

5.  Conservation conditions

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5.  Applicant's signature accompanied by the signature of the product's
    technical

> representative in Ecuador (a food chemist or food engineer registered
> at the
>
> Ecuadorian Ministry of Health)

2.  The applicant must include a copy of his/her identification document
    (in the case of a natural person), or a certificate of company
    registration accompanied by the legal representative's appointment
    (in the case of a company).

3.  The Certificate of Free Sale issued by a competent health authority
    in the exporting country. This document must list the products to be
    registered and must state that the products are authorized for free
    sale and consumption in the country of origin. In the United States,
    this document can be obtained at the Health Services Department of
    your state.

4.  Product analysis certificate, which may be issued by the
    manufacturer or the competent health authority in the country of
    origin. A certificate of quality from a quality control laboratory
    would be ideal.

5.  A legalized letter signed by the manufacturer regarding the
    following:

    1.  The representation of the product in Ecuador. This document must
        appoint an

> exclusive representative in Ecuador, who would be authorized to
> register, import
>
> and distribute the product.

2.  The ownership of the sanitary permit. The manufacturer must state
    its decision

> regarding who will own the sanitary registration; the manufacturer or
> the
>
> importer. In case this statement is not included, it will be
> understood that the
>
> manufacturer owns the sanitary registration of its products.

6.  Product's label or tag draft (original and copy).

7.  Invoice for payment of registration fees (approximately \$560 per
    item).

**Notes:**

-   All documents and certificates written in languages other than
    Spanish must be translated.

-   All official certificates and documents must be either notarized or
    legalized by the Consul of Ecuador in the exporting country.

-   It is recommended that Sanitary Registrations are filed in the INH
    offices in Quito rather than in Guayaquil, due to administrative and
    compliance problems the INH-Guayaquil.

-   A new Sanitary Permit will be necessary in the following events:

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```
-   If there is a change in the product composition.

-   The product needs a different conservation process.

-   There is a substantial modification of the following additives:
    colorings, flavorings, sweeteners, conservation agents, and
    nutritional additives.

-   Changes in the nature of the container

-   Change of manufacturer.

**IMPORTANT:** The Sanitary Registration law provides an exemption of
the Sanitary Registration for food products and ingredients to be used
by restaurants and food industries. However, health authorities are not
enforcing this particular provision. The U.S. Embassy is currently
requesting clarification on the issue.

## B. Phytosanitary and Health Certification

Under the law, importers of []{.mark}plant and animal products and by
products are required to obtain a Phytosanitary Certification or a
Health Certification (depending on the case), prior to importation. Out
of the law, prior administrative authorization must also be requested
for importation of most commodities, seeds, animals, and plants. To be
valid, such authorization requires two signatures or approvals, one from
SESA (which represents the Phytosanitary or Helath Certificate) and one
from the Under Secretary of Strategic Management of the Ministry of
Agriculture, a political appointee.

The request must be filed at the Domestic and International Trade
Directorate of the Ministry of Agriculture in Quito, accompanied by the
following documentation:

-   [The Unique Import Document]{.mark} (DUI) (See Section IX. Import
    Procedures)

-   Note of Requisition (original and three copies)

-   Pro-forma Invoice (original and three copies)

-   \"Prior Import Authorization\" form (original and three copies)

-   For importation of animals and other products of animal origin, the
    importer must include a payment receipt of the import fee at the
    National Agricultural Development Bank (BNF)

An individual or collective PEDIGREE certificate must be included for
importation of pets and breed animals. The Pedigree Certificate will be
analyzed and checked by the [Under Secretariat for Agricultural
Development]{.mark} in Quito, or by the [Undersecretary of the Coastal
Region]{.mark} in Guayaquil, depending on the case.

The [Ecuadorian Animal and Plant Health Service]{.mark} (SESA) will
check the documentation and will issue the phytosanitary or health
permit, depending on the product. If the documents were not correct,
SESA will return the application to the Domestic and International Trade
Directorate indicating that such import is not authorized.

In the phytosanitary and health permits, SESA will indicate the
treatment and conditions to be met by the product in order to enter the
country, depending on pre-established phytosanitary and health norms.

If the product is granted a phytosanitary or health certificate, the
documents will be pending the signature and final approval by the Under
Secretary of Agriculture for Policy, Trade and Investment. In the last
instance, this authority will decide if the product can be imported or
not, even after having passed the technical examination of SESA.

### Other Requirements

There are additional requirements specific for imports of plants and
plant breeding material:

-   The product must be free of soil and products in animal or vegetal
    decomposition.

-   Use of poor quality, re-used, infected or infested packaging
    material is prohibited.

-   The [plant breeding]{.mark} material must come from a country or
    area known to be free of pathogens or diseases exotic to Ecuador.

-   Given the case, SESA shall request the product to be accompanied by
    a Fumigation Certificate or Quarantine Treatment, signed by the
    competent authority of the country of origin.

In the case of animal imports, the following requirements must be met:

-   Animals must come from zones in which no infect-contagious illnesses
    affecting the specie were detected, during a specific period of time
    previous to the shipment. Ecuador follows OIE standards on this
    issue.

-   Animals must have been opportunely immunized with all the vaccines
    required by Ecuador through SESA authorities.

-   Results of laboratory tests and exams carried out to investigate the
    presence of infectious and contagious illnesses should be negative,
    and;

-   Animals should have received treatment against parasites, and they
    should be in good physical conditions without clinic symptoms of
    infectious or contagious illnesses.

## C. Registration of [Agricultural and Livestock Inputs]{.mark}

Natural Persons or Companies importing and/or producing [agricultural
and livestock inputs]{.mark} (seeds, plants and plant breeding material,
[improved]{.mark} animals, semen, fertile eggs and embryos) must be
registered with SESA or in the Under Secretariat for [Agricultural
Development]{.mark} at MAG. The validity of the registration is
indefinite, but it can be canceled because of non-compliance with the
dispositions stated in the Law of Seeds and in its respective
regulation.

## D. Control of Products at Retail/Wholesale Distribution

The Ministry of Health has the obligation of controlling processed food
products and additives offered for sale in the Ecuadorian market. If a
product does not meet the minimum quality standards, or does not have a
Sanitary Registration, it could be immediately confiscated and/or
destroyed.

The Ministry of Public Health in coordination with the Ministry of
Agriculture, will control the products of animal origin destined to
human consumption and will prohibit or retire from trade those resulting
harmful to human health.

The Ministry of Agriculture and Livestock, through employees of the
Plant Health Directorate of SESA or other designed persons may inspect
commercial or industrial facilities storing and selling seeds to verify
the health status of the [plant breeding material]{.mark}. If plant
pests or outbreak infectious diseases are in place, the staff can
declare \"Observation Zone\" or \"Quarantine\" depending on the
seriousness of the case, and if it is necessary they can order the
incineration of the infected material.

[]{.mark}

# SECTION VII. OTHER SPECIFIC STANDARDS

## A. Wine, Beer and Other Alcoholic Beverages

Imports of alcoholic products, including beer require prior
authorization from the Ministry of Health and the products must have
been priory registered with the sanitary authority. Imports of these
products must meet INEN regulations PyM 1992-20, PyM 1992-17, PyM 1992-
21 for containers. Alcoholic products and beer must necessarily show the
following information on their front label:

\"Importado por (Name of the representative or importing company)\",
alcohol content per volume, and the capacity of the bottle in cubic
centimeters.

Also the following health advisory note has to be included:

\"Advertencia: El consumo excesivo de alcohol causa graves daños en su
salud y perjudica a su familia. Ministerio de Salud Pública\", that must
be written in the principal or secondary label, meeting disposition 1828
of the Decree dated June 10^th^, 1994.

Alcoholic products and imported beers sold in the national market which
do not fulfill these requirements, will be considered as smuggled into
the country.

## B. Products Samples and Mail Order Shipments: 

Samples Import and Export regulations establish that these are exempt
from the payment of [import duties]{.mark}, Value- Added Tax (IVA) and
Special Consumption Tax (ICE), when the CIF value does not exceed from
US\$ 500 or its equivalent in other currencies. Merchandise exceeding
this value will pay (for the excess) the established tariff for imports.

Samples without commercial value must meet the following requirements in
order to obtain this exemption:

-   They must be sent by the manufacturer itself, its representative or
    the authorized exporter;

-   The [addressee]{.mark} shall be a company or an importer habitually
    dedicated to this commercial activity.

-   The documentation (commercial invoices, transportation invoices or
    others concerning the shipment), shall contain annotations
    demonstrating the products are samples without commercial value;
    and,

-   Samples must show legends, signs or impressions identifying
    themselves as samples without commercial value and forbidding sale.
    In case of doubt, the Customs Administration may mark the samples
    with perforations, seals and others in order to impede their sale.

Correspondence and small packages (up to 2 Kilograms) are also exempt of
taxes. Other types of packages and international postal [cargo]{.mark}
leaving or entering the country, with or without commercial purposes and
made by any type of mail agency, are subject to the payment of the
corresponding taxes, in relation to the CIF value.

In the same way, small packages, other packages and postal
[cargo]{.mark} and samples without commercial value, exempt or not of
taxes, whose CIF values do not exceed \$160 will be dispatched by
[customs]{.mark} through a simplified declaration.

Imports or exports by mail of products such as: narcotics, explosives,
tobaccos, liquors, inflammable products and other dangerous or
contaminant substances are forbidden.

# SECTION VIII. COPYRIGHT AND/OR TRADEMARK LAWS

The Law of Intellectual Property, published in the Official Register on
May 19^th^ of 1998, regulates and guarantees the intellectual property
acquired according to the law. Basically, this law refers to inventions,
trademarks, commercial logos and models, commercial and industrial
secrets, brand names, distinctive appearances of businesses and
commercial establishments and any other intellectual creation for
agricultural, industrial or commercial use. It also includes vegetal
obtainment. Dispositions of this law apply to both Ecuadorians and
foreigners, residing or not in the country.

## A. Trademarks 

The trademark registration application should be filed at the National
Institute of Intellectual Property (IEPI). The first request to register
a trademark presented in a member country of the World Trade
Organization, the Andean Community, or the Paris Agreement for the
Protection of Industrial Property, will grant the applicant the priority
right for a period of six months until the same trademark application is
filed in Ecuador. This request should not refer to different or
additional products than those contained in the first request.

A trademark's register will have a ten-year validity from the date of
its concession and it can be renovated. A trademark's renovation has to
be requested at the same agency, six months prior to its expiration.

-   They must be sent by the manufacturer itself, its representative or
    the authorized exporter;

-   The [addressee]{.mark} shall be a company or an importer habitually
    dedicated to this commercial activity.

-   The documentation (commercial invoices, transportation invoices or
    others concerning the shipment), shall contain annotations
    demonstrating the products are samples without commercial value;
    and,

-   Samples must show legends, signs or impressions identifying
    themselves as samples without commercial value and forbidding sale.
    In case of doubt, the Customs Administration may mark the samples
    with perforations, seals and others in order to impede their sale.

Correspondence and small packages (up to 2 Kilograms) are also exempt of
taxes. Other types of packages and international postal [cargo]{.mark}
leaving or entering the country, with or without commercial purposes and
made by any type of mail agency, are subject to the payment of the
corresponding taxes, in relation to the CIF value.

In the same way, small packages, other packages and postal
[cargo]{.mark} and samples without commercial value, exempt or not of
taxes, whose CIF values do not exceed \$160 will be dispatched by
[customs]{.mark} through a simplified declaration.

Imports or exports by mail of products such as: narcotics, explosives,
tobaccos, liquors, inflammable products and other dangerous or
contaminant substances are forbidden.

## B. Brand Names

Brand names can be registered at the [National Institute of Intellectual
Property]{.mark}, for which the same procedure for registration of
trademarks is necessary. This registration represents a presumption for
the [holder's]{.mark} benefit. However, the right for exclusive use is
created by the public and continuous use in trade, at least for six
months of the brand name. Brand names will be protected without the
obligation of registration. The registration of a brand name does not
have a maximum validity time.

# SECTION IX. IMPORT PROCEDURES

In order to clear customs, the following procedure must be carried out:

-   If the FOB value of the imported goods exceeds US\$ 4000, the owner,
    consignee or [consigner]{.mark}, personally or through a customs
    agent, must present the declaration in the [Unique Import]{.mark}
    Document (DUI).

-   The Unique Import Document (DUI) should be filed and revised by any
    bank or financial society acting on behalf of the Central Bank of
    Ecuador. After establishing the importer's identity, the bank or
    financial society will accept the document within the following two
    working days.

-   The approved DUI form does not have a validity limit time, it is
    indefinite, except in goods with restrictions. In this case, the
    validity time is determined by the authorizations or import
    licenses.

-   The declaration must be presented in the customs, anytime between
    seven days before to fifteen days after the arrival of the goods.
    This [customs declaration]{.mark} must be accompanied by the
    following documents:

    1.  Note of Requisition (mandatory)

    2.  Authorizations or licenses (if needed): If the type of good
        demands it, it is necessary to obtain authorizations in a
        Ministry or other public entity depending on the case (See
        Section VI. Other Regulations and Requirements above).

    3.  Insurance Certificate (if needed).

    4.  Import Verification Request (if needed): Only for goods which
        FOB value exceeds US\$4000. The request has to be filled and
        then delivered to the verification company (SGS, Bureau Veritas,
        Cotecna o ITS) along with the requisition note.

    5.  Certificate of Inspection (Certificado de Inspeccion):This
        certificate is issued by the verification company after having
        previously issued the SVI, and only in goods exceeding FOB value
        of US\$4000. According to the Law, if a good enters Ecuador
        without the CI, it cannot be nationalized.

    6.  Certificate of Origin (if needed)

    7.  Shipment [Manifest (mandatory)]{.mark}

    8.  Bill of Lading (mandatory)

    9.  Commercial Invoice (Factura Comercial) (mandatory)

    10. Customs Declaration of Value (DAV) (mandatory): Is an oath that
        the consigned value is the real one.

Note: Import documents do not need to be translated into Spanish.

-   The import declaration has to be presented in the respective customs
    district, which will verify the data and confirm compliance with all
    requirements. If there are no observations, the declaration will be
    accepted, and the district will assign a validation number so the
    procedure may continue. Once the declaration is accepted, it is
    final and cannot be amended.

-   The next step is documental revision or visual examination of the
    goods, to establish its nature, quantity, value and its tariff
    classification.

-   In the visual examination, the verification company checks the
    merchandise, verifies that the security seal has not been violated
    and compares the declaration with the actual load. If everything is
    correct, the documental revision takes place. If it is not equal,
    the verification company will make sure that the difference is
    within the tolerance margin (maximum 10% of the taxes) and the
    importer will pay the same upon the totality. Taxes are paid upon
    the real quantity, but if the difference exceeds 10%, it is
    considered illegal.

-   The physical examination generally takes more time than predicted,
    for which it is recommended to calculate a 30% more of the budget
    established for customs clearance. It is calculated that 70% of the
    [containers]{.mark} arriving at the port of Guayaquil stay there
    more than 15 working days.

-   The verification company also carries out the document revision.
    This consists in verifying that what was declared is equal to what
    the accompanying documents of the DUI stated. If there are no
    observations, the customs district will authorize the payment of
    tariffs, which will be done through one of the authorized banks for
    this matter. Subsequently, customs will proceed to confirm this
    payment and will authorize the delivery of the merchandise.

-   Were there an obstacle for tax payment, the [Ecuadorian Customs
    Corporation]{.mark} (CAE) demands a guarantee of 20% of the total
    amount to be paid with a time limit of 60 days.

-   If in the declaration and document delivery, only the commercial
    invoice is missing, for example, the merchandise can be taken out
    with a guarantee, but the term is only 30 days to present a new
    invoice to the CAE. However, if the Certificate of Origin is
    missing, it is better to leave the merchandise in Customs until the
    certificate arrives.

-   Claims upon any customs administrative act, can be presented to the
    manager within 20 days after it was carried out or notified.

## [Specific Rules for Agricultural Imports]{.mark}

The Inspection in the Country of Origin of agricultural product
shipments is a requirement established in the law. Verification
companies hired for this purpose will carry out this inspection.

Imports of agricultural and livestock products (except industrialized
products) can only arrive at seaports and airports here SESA has
displayed animal and plant quarantine officers, according to the Law of
Animal Health and the Law of Plant Health.

**Airports:** Quito and Guayaquil

**Sea Ports**: Guayaquil, Manta, Esmeraldas and Puerto Bolívar.

**Land Ports**: Tulcan, Macara and Huaquillas.

When the merchandise arrives, a SESA inspector will check and examine
the documents, and will inspect the product itself to confirm the
phytosanitary condition. Products in good condition will be granted a
[merchandise entry license]{.mark}.

# 

# APPENDIX I. GOVERNMENT REGULATORY AGENCY CONTACTS

**[[MINISTRY OF FOREIGN TRADE, INDUSTRIALIZATION AND
FISHING]{.underline}]{.mark}**

[]{.mark}

Address: Av. Amazonas y Eloy Alfaro

[Ministerial Office]{.underline}

Phone: 593-2-290-6127/ 593-2-254-3893

Fax: 593-2-250-5073

Contact: *Minister*- Tomás Peribonio

### International Trade Under-Secretariat

Phone: 593-2-256-6784

Fax: 593-2-250-4922

Contact: Under-Secretary- Susana Naranjo

[[International Trade Directorate]{.underline}]{.mark}

Phone: 593-2-254-1854

Contact: *Director*- Econ. Fabián Andrade Egas

Website: [www.micip.gov.ec](http://www.micip.gov.ec/)

# CODEX Committee in Ecuador

President: Dra. Ligia Tamayo

Phone: 593 2 254 2565

**[MINISTRY OF PUBLIC HEALTH]{.underline}**

Address: Juan Larrea 445, A Building, 3^rd^ Floor.

Quito, Ecuador

Ministerial Office

Phone: 593-2-223-2713 / 593-2-255-6984

Fax: 593-2-256-9786

Contact: Minister-Dr. José Guillermo Wagner.

[Food Control Directorate]{.underline}

Fax/ Phone: 593-2-297-2900 ext. 2773

Contact: Dra. Magda Saltos Fax/Phone: 593-2-297-2900 ext. 2770

[General Health Director]{.underline}

Contact: Dra. Doris Quiroz

Phone: 593-2-252-1277

Fax: 593-2- 250-4322

Web-site: [www.msp.gov.ec](http://www.msp.gov.ec/)

#### [MINISTRY OF AGRICULTURE AND LIVESTOCK]{.underline}

Address: Av. Amazonas y Eloy Alfaro, MAG Building, Quito

Minister: Ing. Pablo Rizzo

Phone: 593-2-250-4433 / 593-2-256-5450

Fax: 593-2-250-0873

F

[[Ecuadorian Animal and Plant Health Service (SESA)]{.underline}]{.mark}

Contact: *Director*- Ing. Abel Viteri

Phone: 593-2-254-4476

Fax: 593-2-222-8448

*Plant Quarantine Directorate*

Contact: Ing. Edwin Caseres

Phone: 593-2-254 8823

Fax: 593-2-222-8448

*Animal Health*

Contact: Dr. Alex Andrade Phone: 593-2-254 8823

*Agricultural Products Control and Register Division*

Contact: Ing. Carlos Navas

Phone: (5932) 254-3319

Fax: 593-2-222-8448

E-mail: direcsesa@mag.gov.ec

[Domestic and International Trade Directorate]{.underline}

Contact: Dr. Carlos Romero

Fax/ Phone: (5932) 222-8011

[Under Secretariat for Agriculture Development]{.underline}

[Contact:]{.mark} *Under Secretary: Ing. Guillermo Ortega*

Fax Phone: (5932) 255-0502

Website: [www.mag.gov.ec](http://www.mag.gov.ec/)

Quito, Ecuador

[**[ECUADORIAN INSTITUTE OF NORMALIZATION (INEN)]{.underline}**]{.mark}

Director: Felipe Urresta

Address: Baquerizo Moreno No. 454 y Almagro

Phone: 593-2-250-1885

Fax: 593-2-256-7815

[International Normalization Directorate]{.underline}

Contact: Ing. Gustavo Jimenez Phone ext.: 232

[Consumer Control Directorate]{.underline}

Contact: Ing. Enrique Troya Phone ext.: 210

e‑Mail:

Web‑site: [www.ecua.net.ec/inen](http://www.ecua.net.ec/inen)

Quito, Ecuador

**[NATIONAL HEALTH AND TROPICAL MEDICINE INSTITUTE \"LEOPOLDO IZQUIETA
PEREZ\"]{.underline}**

Address: Iquique 2045 y Yaguachi / Quito, Ecuador

Contact: *Director*- Marcelo Chiriboga

Phone: 593-2-255-2715

Fax: 593-2-256-8041

E-mail: mhchiriboga@hotmail.com

Office in Guayaquil:

Address: Julian Coronel 905 y Esmeraldas / Guayaquil, Ecuador

Contact: *Director*- Luiggi Martini

Phone: 593-4-228-1542/ 228-0414/ 228-2281

Fax: 593-4-229-3189

E-Mail: dirnainh@telconet.net

[]{.mark}

[]{.mark}

**[ECUADORIAN CUSTOMS CORPORATION (CAE)]{.underline}**

[[General Manager Office]{.underline}:]{.mark}

[Contact: *General Manager*- Ing. Rafael Conte]{.mark}

[Address: Av. 25 de Julio Km 4, vía a Puerto Marítimo.]{.mark}

[Phone: 593-4-248-0640]{.mark}

[Fax: 593-4-248-8894]{.mark}

[]{.mark}

[[District Manager Office:]{.underline}]{.mark}

[Contact: *District Manager*- Ec. Mario Miranda]{.mark}

[Address: Sea Port]{.mark}

[Phone: 593-4-248-1166 / 248-1879]{.mark}

[Guayaquil, Ecuador]{.mark}

[]{.mark}

[[Aero Cargo Deputy Manager Office]{.underline}:]{.mark}

[Contact: *District Manager*- Cristian Ledwon]{.mark}

[Address: Airport \"Simón Bolívar\".]{.mark}

[Phone: 593-4-228-7834 / 228-7827]{.mark}

[Guayaquil, Ecuador]{.mark}

[]{.mark}

[[Regional Deputy Manager Office for Customs Quito:]{.underline}]{.mark}

Contact: *Regional Manager*- Dr. Eduardo Guerrero Mortola

Address: Av. 10 de Agosto 1665, 4^th^ floor

Phone: 593-2-321-5024 / 321-5025

Quito, Ecuador

[District Manager Office:]{.underline}

Contact: Regional Manager- Dr. Patricio Suárez

Address: Pasaje Amazonas y Río Arajuno.

Phone: 593-2-244-4033

Quito, Ecuador

[Website: [www.corpae.com](http://www.corpae.com/)]{.mark}

**[NATIONAL INSTITUTE OF INTELLECTUAL PROPERTY]{.underline}**

Contact: National Director -- Dr. Cesar Dávila Torres.

Address: Av. Republica 396 y Diego de Almagro

Phone: 593-2-250-8000, ext. 302

Fax: 593-2-250-8027

[www.iepi@interactive.net.ec]()

[Department of Trademarks]{.underline}

Contact: *Director*- Lcda. Elizabeth Ribadeneira.

Phone: 593-2-250-8000, ext. 235

[Department of Patents]{.underline}

Contact: *Director*- Bioquímica Lilia Garrido Torres

Phone: 593-2-250-8000 ext. 230

Fax: (5932) 254-3894

Quito- Ecuador

# 

# APPENDIX II. OTHER IMPORT SPECIALIST CONTACTS

**U.S. EMBASSY QUITO**

*USDA/ Foreign Agricultural Service*

Address: Av. Colombia #1573 y Queseras del Medio, 3^rd^ floor

René A. Alarcón, Agricultural & Marketing Specialist

Phone: (5932) 256-4147 / 252-9088

Fax: (5932) 250- 6283/ 250-4888

e-mail: Agquito@usda.gov

Quito, Ecuador.