Scheduled Report - Public distribution

**Date:** 7/30/2007

**GAIN Report Number:** EC7007

EC7007

**Ecuador**

**FAIRS Country Report**

**Annual**

**2007**

**Approved by:**

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

U.S. Embassy

**Prepared by:**

Rene A. Alarcon

**Report Highlights:**

Sections Updated: Section I, Food Laws, has been updated to reflect
recent changes to Ecuador\'s Health Code, which prohibits imports, use
and trade of foodstuffs containing genetically modified organisms.
Although Ecuador\'s food import regulations are generally based on
international standards, the country faces challenges in enforcing its
food regulations. New laws are generally passed without a profound
technical analysis and without a public and international comment
period.

Includes PSD Changes: No

Includes Trade Matrix: No

Annual Report

Quito \[EC1\]

\[EC\]

Table of Contents

[SECTION I. FOOD LAWS 3](#section-i.-food-laws)

[The Official Register 3](#the-official-register)

[The Ministry of Agriculture, Livestock, Aquaculture and Fisheries
(MAGAP)
3](#the-ministry-of-agriculture-livestock-aquaculture-and-fisheries-magap)

[Agricultural Development Law 3](#agricultural-development-law)

[Plant Health Law 3](#plant-health-law)

[Animal Health Law 3](#animal-health-law)

[Law of Seeds 3](#seeds-law)

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

[Agencies within the MAGAP 3](#agencies-within-the-magap)

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

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

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

[The Health Code 3](#the-health-code)

[The Sanitary Registration Law 3](#the-sanitary-registration-law)

[Food Regulation 3](#food-regulation)

[The Law of Consumer Defense 3](#the-consumer-defense-law)

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

[Ministry of Industries and Trade (MIC)
3](#ministry-of-industries-and-trade-mic)

[Law of Foreign Trade 3](#law-of-foreign-trade)

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

[The Ministry of Foreign Affairs 3](#the-ministry-of-foreign-affairs)

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

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

[A. General Requirements 3](#a.-general-requirements)

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

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

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

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

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

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

[A. The Sanitary Registration 3](#a.-the-sanitary-registration)

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

[Other Requirements 3](#other-requirements)

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

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

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

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

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

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

[A. Trademarks 3](#a.-trademarks)

[B. Brand Names 3](#b.-brand-names)

[SECTION IX. IMPORT PROCEDURES 3](#section-ix.-import-procedures)

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

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

[APPENDIX II. OTHER IMPORT SPECIALIST CONTACTS
3](#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 has been 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
legislation also allows the application of corrective measures only in
the instances included in the World Trade Organization normative.

In practice, Ecuador maintains tariff and non-tariff barriers that may
interfere with agricultural and food imports. Although imports are not
subject to excessive tariffs, technical and Sanitary/Phytosanitary (SPS)
restrictions may not always be established with the sole purpose of
protecting human, animal and plant health. Weak institutions often
create inefficiency and there can be sudden changes in the application
or interpretation of rules and requirements. Some administrative
procedures are cumbersome and require excessive documentation.

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 and the Ministry of Health have played a major role in
proposing regulations regarding the safe use and consumption of
transgenic products. Politically-biased decisions, however, are an
important part of Ecuador's rulemaking, especially with regards to
biotechnology and Genetically Modified Organisms (GMOs): In April 2006,
without a scientific basis, Ecuador's Congress passed a food security
law that prohibits the development, use, trade and imports of products
derived from GMOs for human consumption. The legislation was not
enforced because Ecuador's Attorney General qualified this law as
inapplicable. Later, in December of the same year, Ecuador passed a new
Health Code. This legislation included the same prohibitions mentioned
in the prior law plus an article prohibiting Ecuador from accepting food
donations of GMO products for human consumption. To date, this part of
the legislation has not been enforced, mainly because Ecuador does not
have a control and certification system in place.

## The Official Register

The Official Register (RO) is Ecuador's counterpart to 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 their 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, Livestock, Aquaculture and Fisheries (MAGAP)

The Ministry of Agriculture, Livestock, Aquaculture and Fisheries is
responsible for promoting harmonic and sustained development of the
agricultural and livestock sectors of Ecuador, through direction and
evaluation of agricultural and livestock 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, 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 Animal Health Law, published in 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 MAGAP, 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 MAGAP for importing and exporting animals and
their products and by-products.

### Seeds Law

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 MAGAP. 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 for Agricultural Use

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

## Agencies within the MAGAP

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

SESA's basic purpose is to ensure good phytosanitary conditions for
agricultural crops and good health for livestock populations. It is also
responsible for preventing 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
veterinary products. This agency issues Health or Phytosanitary
certificates that 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 MAGAP, 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
entity in the MAGAP in charge of [receiving prior import authorization
requests]{.underline} and passing them onto SESA for sanitary
certification, and to the Undersecretary for Strategic Management for
final approval.

**Note:** *The Prior Authorization requirement for food and agricultural
products is embodied in COMEXI (Foreign Trade Council) Resolution 383 of
June 11, 2007. This document provides a positive list of 100
agricultural products subject to prior import authorization by the
MAGAP. This ruling applies only for products originating outside the
Andean Community of Nations. This may constitute a violation of WTO
non-discrimination principles.*

###### 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 vegetable material.

## The Ministry of Public Health (MSP)

The Ministry of Public Health, through the National Control and
Surveillance System, and its branches, regulates the entry and
consumption of processed food products, beverages, additives and
pesticides. With regard 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 Health Code of 2006 also prohibits the development, use,
trade and imports of foodstuffs derived from Genetically Modified
Organisms (GMOs), and provides for the labeling of such products. It
also prohibits Ecuador from receiving food donations containing GMOs,
and establishes an interagency system for GMO control. To date, the
GMO-related provisions of this law have not been enforced.

### 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 manufacturing
processes, container, packaging and labeling requirements. Moreover, the
food regulation governs the activities of transportation, distribution
and trade of food products.

## The Consumer Defense Law

Its objective is to guarantee consumer rights to obtain quality,
consistency 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 to provide clear, complete and
sufficient information about their products. It also determines the
minimum information necessary for 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 information 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 requirements in Ecuador's
labeling requirements.

## 

## 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 Industries and Trade (MIC)

MIC is the government agency responsible for planning, directing,
controlling and executing policies for trade, industrialization and
investments. 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 in 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 MIC. 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 the appropriate 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 MIC 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 compliance with 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 approval 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 the 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 set the following guidelines:]{.mark}

[]{.mark}

-   [Labels containing words, pictures or other graphic representations
    introducing the product as having medicinal, therapeutic,
    preventive, curative, nutritional, or special 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 the case for candy, chocolate, and most
    confectionery products.

-   Imported products may have labels in a 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 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
provided by 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, tea leaves, soluble tea,
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" is included.

-   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 processed food
products should meet the conditions of the E[cuadorian Technical
Standards (NTE) 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 by sending a
request to the Ecuadorian Institute of Normalization (INEN[), whose
contact information is included 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 Plant Health
Administrative Unit of SESA, is the agency in charge of the application
of this law.

Ecuador does 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 (MAGAP) 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 excessive residues, products will be
destroyed 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 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 to and will be issued in 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 has not justified
its denial within the 30 day term after the last observation has 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 for
> consumption on the label. For example, if the product is good for six
> months, then the 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 is.

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)

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2.  The applicant must include a copy of his/her identification document
    (in the case of an individual), 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 with 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 Health 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 for 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.

-   In such a situation, SESA may 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 infectious or contagious
    illnesses affecting the species were detected, during a specific
    period of time previous to the shipment. Ecuador follows OIE
    standards on this issue.

-   Animals must have been appropriately 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.

-   Animals should have received treatment against parasites and they
    should be in good physical condition, without clinical 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 with the Under Secretariat for [Agricultural
Development]{.mark} at MAGAP. 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 MAGAP, controls the
products of animal origin destined for human consumption and will
prohibit or remove those that are harmful to human health.

MAGAP, through employees of the Plant Health Directorate of SESA or
other designated 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 infectious diseases
are found, the staff can declare the facilities as \"Observation Zones\"
or \"Quarantined\" depending on the seriousness of the case and, if
necessary, 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 previously registered with the sanitary authority. Imports of these
products must meet INEN regulations PyM 1992-20, PyM 1992-17, and 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 on the principal or secondary label, meeting disposition 1828
of the Decree dated June 10, 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: 

Import and Export regulations governing samples 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
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.

Similarly, small packages, other packages and postal [cargo,]{.mark} and
samples without commercial value, exempt or not of taxes and 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, 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
material. Dispositions of this law apply to both Ecuadorians and
foreigners, residing in the country or not.

## 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.

## B. Brand Names

Brand names can be registered at the [National Institute of Intellectual
Property]{.mark}, for which the same procedure used for registration of
trademarks must be applied. However, the right to exclusive use is
created by the public and continuous use in trade (for at least 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 time limit; 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 at 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 from 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 whose
        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 for 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 the declaration
    does not match the load, 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 appropriate taxes based on
    the actual quantity shipped. However, if the difference exceeds 10%,
    the shipment will be considered illegal.

-   The physical examination generally takes more time than predicted,
    hence it is recommended to increase, by 30%, 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.

-   Where there is 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.

## []{.mark}

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

The Inspection in the Country of Origin of agricultural product
shipments is a requirement established by 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 where 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

# 

[]{.mark}

[[MINISTRY OF INDUSTRIES AND COMPETITIVENESS]{.underline}]{.mark}

[]{.mark}

Address: Av. Amazonas y Eloy Alfaro

[Ministerial Office]{.underline}

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

Fax: 593-2-250-7549

Contact: *Minister*- Econ. Raul Sagasti

### 

[International Trade Under-Secretariat]{.underline}

Phone: 593-2-256-6784

Fax: 593-2-250-4922

Contact: Under-Secretary- Genaro Baldeon

[]{.mark}

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

Phone: 593-2-254-1854

Contact: *Director*- Jeanneth Mariño / David Sotomayo

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

[CODEX Committee in Ecuador]{.underline}

President: Dra. Hipatia Nogales

Phone: 593-2-256-7232 ext. 134

[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. Caroline Chang.

[National Health Director]{.underline}

Contact: Dra. Nancy Vasconez

Phone: 593-2-297 2900 ext. 2954

Fax: 593-2- 254 3588

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

[Food Control Directorate]{.underline}

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

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

Gen

[MINISTRY OF AGRICULTURE AND LIVESTOCK]{.underline}

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

Minister: Ing. Carlos Vallejo

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*- Dr. Carlos Nieto

Phone: 593-2-254-4476

Fax: 593-2-222-8448 ext. 102

*Plant Quarantine Directorate*

Contact: Ing. Edwin Caseres

Phone: 593-2-254 8823 ext. 131

Fax: 593-2-222-8448 ext. 130

*Animal Health*

Contact: Dr. Alex Andrade

Phone: 593-2-254 8823 ext. 136

Fax : 593-2-222-8448 ext. 133

*Agricultural Products Control and Register Division*

Contact: Ing. Liliana Guaman

Pho (5932) 254-3319

Fax: 593-2-222-8448

E-mail: direcsesa@mag.gov.ec

[Domestic and International Trade Directorate]{.underline}

Contact: Dr. Carlos Romero

Phone: (5932) 396 0203

Fax: (5932) 222 8011

fffF

[Under Secretariat for Strategic Agriculture Development]{.underline}

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

Fax Phone: (5932) 396-0201

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 E8-29 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 N14285 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*-Francisco Hernandez

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*- Econ. Santiago León]{.mark}

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

[Phone: 593-4-250-0100]{.mark}

[Fax: 593-4-248-4251]{.mark}

[]{.mark}

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

[Contact: *District Manager*- Ec. Fabian Ronquillo]{.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*- Manuel Jacho]{.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- Econ. Patricio Troya

Address: Pasaje Amazonas y Río Arajuno.

Phone: 593-2-244-4033

Quito, Ecuador

[District Manager Office:]{.underline}

Contact: *Regional Manager*- Jorge Ernesto de la Torre Cisneros

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

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

Quito, Ecuador

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

[NATIONAL INSTITUTE OF INTELLECTUAL PROPERTY]{.underline}

Contact: National President - Dr. Alfredo Corral

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*- Dr. Marco Armas.

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

[Department of Patents]{.underline}

Contact: *Director*- Ing. Martha Carvajal

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 Specialist

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

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

e-mail: Agquito@fas.usda.gov

Quito, Ecuador.