Required Report - public distribution

**Date:** 8/1/2006

**GAIN Report Number:** CI6017

CI6017

**Chile**

**Food and Agricultural Import Regulations and Standards**

**Annual**

**2006**

**Approved by:**

![](media/image1.wmf)Christine M. Sloop, Agricultural Attache

Office of Agricultural Affairs

**Prepared by:**

Christine Sloop, Agricultural Attache

**Report Highlights:**

Please note that there are new regulation on Organic products and new
regulation being discussed on GMO products. Also Agriculture and
Livestock Service (SAG) is requiring that Spanish language labels be
applied at point of production on all U.S. beef products.

Includes PSD Changes: No

Includes Trade Matrix: No

Annual Report

Santiago \[CI1\]

\[CI\]

Table of Contents

[Section I. Food Laws 3](#section-i.-food-laws)

[Section II. Labeling Requirements
3](#section-ii.-labeling-requirements)

[General Requirements 3](#general-requirements)

[Requirements Specific to Nutritional Labeling
4](#requirements-specific-to-nutritional-labeling)

[Health Claims 6](#health-claims)

[Organic Labeling 6](#organic-labeling)

[GMO Labeling 6](#gmo-labeling)

[Section III. Packaging and Container Regulations
7](#section-iii.-packaging-and-container-regulations)

[Section IV. Food Additive Regulations
7](#section-iv.-food-additive-regulations)

[Section V. Pesticide and Other Contaminants
7](#section-v.-pesticide-and-other-contaminants)

[Section VI. Other Regulations and Requirements
8](#section-vi.-other-regulations-and-requirements)

[Section VII. Other Specific Standards
9](#section-vii.-other-specific-standards)

[Dr. Hector Escobar 11](#dr.-hector-escobar)

[Section VIII. Copyright and/or Trademark Laws
12](#section-viii.-copyright-andor-trademark-laws)

[Section IX. Import Procedures 13](#section-ix.-import-procedures)

[A. Customs Clearance 13](#a.-customs-clearance)

[B. Clearance for Sale within Chile
14](#b.-clearance-for-sale-within-chile)

[C. Recommended Documents for Facilitating Clearance
14](#c.-recommended-documents-for-facilitating-clearance)

[Appendix I. Government Regulatory Agency Contacts
15](#appendix-i.-government-regulatory-agency-contacts)

[Appendix II. Other Import Specialist Contacts
16](#appendix-ii.-other-import-specialist-contacts)

# Section I. Food Laws

Chile actively participates in the World Trade Organization and the
CODEX Alimentarius Commission. Because Chile is concerned that
unscientific technical trade barriers may adversely affect its exports,
the government supports the standardization of sanitary and
phytosanitary trading regulations.

The Agriculture and Livestock Service (Servicio Agricola y Ganadero -
SAG) of the Ministry of Agriculture has a good record of notifying
changes in plant & animal health legislation to the WTO, partly because
the notification office is located in this ministry. Changes in Ministry
of Health' requirements are reported more sporadically, as these are
communicated through the Ministry of Agriculture's office. SAG is
responsible for enforcing Chile's import regulations concerning
alcoholic beverages, organic foods, animal and plant quarantine, and the
grading and labeling of beef and some processed food products both for
human and animal consumption including petfood, feed and feed
supplements.

The Ministry of Health is responsible for food sanitation, including
meat and poultry and the approval of food ingredients, labels, and
packaging of processed foods. The Ministry is currently bringing Chile's
food sanitation regulations into conformity with CODEX standards.

Decree 977 is posted in both English (unofficial) and Spanish. Also
check the Metropolitan Environmental Health Service's home page (SESMA -
Servicio de Salud Metropolitano del Ambiente) <http://www.sesma.cl/>
under \"Alimentos\" - \"Normativas\" - Reglamento Sanitario de Alimentos
(Chile's Food Sanitary Regulation) for the Spanish version.

In November 25^th^, 2003, the Ministry of Health published a significant
revision of Decree No. 977. The English translation of this document can
be found at the U.S. embassy website,
[http://www.embajadaeeuu.cl/\_temporal/1011/Website/2003/Food%20Law/fasinden.htm](http://www.embajadaeeuu.cl/_temporal/1011/Website/2003/Food Law/fasinden.htm)

# Section II. Labeling Requirements

## General Requirements

(See Title 2, Paragraphs 106 to 112 of Decree 977 in
[http://www.embajadaeeuu.cl/\_temporal/1011/Website/2003/Food%20Law/fasinden.htm]{.underline})

All imported products shall comply will all labeling provisions
hereunder. Any information required hereunder and not included on the
original label, not in Spanish, or not shown as provided hereunder,
shall be added on a label affixed permanently to the container, of
adequate size and location, and including at least the information on
the original label.

Importers who are importing food products in the Metropolitan Region
(Santiago) should submit labels to the Secretaria Regional Ministerial
de Salud (SEREMI de Salud) Bulnes 194, Santiago for review and approval
prior to importation. For other Regions importers have to submit
requests to their Regional SEREMI de Salud offices. The other principal
ports of entries are:

-   Iquique, contact: <seremisalud1@yahoo.es> , Address: San Martin 255
    Of. 114;

> Iquique; Phone: 56-57-510484.

-   Valparaiso and San Antoni, contact: <secresalud5@123.cl> , Address:
    Melgarejo 669

Piso 6 Valparaiso; Phone: 56-32-218304.

-   Talcahuano, contact: <raguayo@slauddelbiobio.tie.cl> , Address:
    Caupolican 518 Of.

> 510, Concepcion; Phone: 56-41-227044.

Labels must be in Spanish, but the information may be repeated in
another language. Sticker labels may be used, but must first be
approved. Labels must bear the following information:

1\. Name of the food product.

2\. Net content in metric units. Net content stated in units of the
metric system or the international system using the unit symbol or the
complete word. Net content figures shall not be accompanied by any
ambiguous term. Food items packed in a liquid medium shall carry, in
addition to net content, a statement giving the drained weight of the
item in units of the metric system or international system.

3\. Name or company name and address of the manufacturer, packer,
distributor, or importer, as appropriate.

4\. Country of Origin shall be stated clearly on domestic as well as
imported products. \[If processing in Chile results in a change in the
product's physical, chemical, biological or organic properties, it is
considered a local product for labeling purposes. If the product is only
repackaged in Chile, both this fact and the country of origin must be
indicated.\]

5\. Number and date of resolution together with the name of the health
agency responsible for authorizing the establishment processing or
packing the item or authorizing import.

6\. Date of manufacture or packing date. \[A production lot code may be
used.\]

7\. Expiration date, or shelf life (in terms of days, months or years).
Items where processing date is given with the lot key number shall show
duration by stating the expiry date, while items specifying the
processing date may use either expiry date or term of duration. All
items stated to be of "indefinite duration" must show the date when
processed.

8\. List of all ingredients in decreasing concentration, including
quantity or percent.

9.  List of all additives in decreasing concentration.

10\. List of ingredients shall include any food additive used in the raw
materials and other ingredients of a food item and transferred thereto
in sufficient quantity to perform a technological function.

10\. Instructions for storage, including refrigeration, if special
conditions are required for the product to satisfy its minimum duration
period or last to its expiration date.

11\. Instructions for use.

In the case of frequently imported items, where the import and
consumption permits are issued by the same health agency, the health
agency may authorize labeling in the country of origin. The agency must
then publish a resolution authorizing subsequent imports and the label
must show the date and number of the resolution, as well as the name of
the authorizing agency. For food items imported under the above
provision, the package label must have an indelible key number that
shows the production batch or lot and all the other labeling standards.
Import and consumption permits will be issued on an individual batch
basis, each batch being subject to all the controls. Please see Section
IX regarding the requirements for beef.

All food products in container have to be labeled including
institutional packed size. The only exception is for products imported
without a commercial value and a volume of less than 20 kilos. These
products cannot be sold in the local market.

## Requirements Specific to Nutritional Labeling

(See Title 2, Paragraphs 114 to 120 of Decree 977 in
[http://www.embajadaeeuu.cl/\_temporal/1011/Website/2003/Food%20Law/fasinden.htm](http://www.embajadaeeuu.cl/_temporal/1011/Website/2003/Food Law/fasinden.htm)

Nutritional labeling is required for processed food products. In
general, Chile requires less nutritional information on labels than the
U.S. Food and Drug Administration. Nutritional claims must be
scientifically recognized, shall neither encourage unnecessary
consumption nor give the impression that consumption offers protection
against sickness or any debilitating condition, and shall be approved by
the Ministry of Health. A nutritional label must contain the following
information.

1\. Value of energy in calories.

2\. Quantities of protein, available carbohydrates, and fats in grams
(available carbohydrates being understood to mean total carbohydrates
excluding dietary fiber).

3\. Quantity of any other nutrient, dietary fiber, and cholesterol,
concerning which a representation of properties is made. Cholesterol
content shall be included in all food items representing nutritional or
health-related claims in connection with fat or cholesterol.

Values are to be given per 100 g or 100 ml, and per serving. Number of
servings in the container, size of the serving in domestic units and
grams (g) or millimeters (ml) shall be stated.

Values given in the representation of nutrients shall be weighted
average values derived from data specifically obtained from analyses of
products representative of the product subject to representation.

In addition to the above three points nutritional information must
include the following information:

\- when a representation of nutritional properties is made regarding
quantity or type of carbohydrates, total sugars shall be given. Quantity
of starch and other carbohydrate constituents may be shown also. All
this information shall be stated immediately following the
representation of total carbohydrate content.

\- when a representation of nutritional properties regarding dietary
fiber is made, quantity and percentage of soluble and insoluble fiber
shall be shown.

\- when nutritional properties associated to quantity and type of fatty
acids are specifically represented, quantities of saturated,
monounsaturated, polyunsaturated fatty acids, and cholesterol shall be
given immediately following representation of total fat content.

Representation of nutritional properties, representation of
health-related properties, representation of nutrients, and
supplementary nutritional information shall adhere to the technical
standards issued on the subject by the Ministry of Health, to be
published in the Official Gazette.

When a representation of nutrients is made, vitamins and minerals may
also be listed if present in significant quantities, 5% or more of the
recommended intake for the relevant population. For the population over
four years of age, the Daily Reference Dose (DRD) shall be used for
energy, protein, vitamins, and minerals proposed in the Codex
Alimentarius; for vitamin E, biotin, pantotenic acid, copper, and
selenium, not specified in the Codex Alimentarius, the Reference Daily
Intake (RDI) values proposed by the US Food and Drug Administration
shall be used.

For infants and children under four years of age, pregnant and nursing
women, the relevant RDIs shall be used as Daily Reference Dose. For iron
and vitamin A during pregnancy the Daily Reference Dose shall be 30
md/day for iron and 800 mcg/day for vitamin A, as established in the
Nutritional Guidelines of the Ministry of Health.

Numerical information on vitamins and minerals shall be given in metric
units, international system for 100 g or 100 ml, for one serving, in
percentage of the recommended Daily Reference Dose, and per container if
only one serving is contained therein. In addition, such information
shall be given per serving on the label when the number of servings per
container is shown.

Supplementary nutritional information that may be added to the
representation of nutrients shall be intended to aid consumer
understanding of the nutritional value of the food item concerned and
help consumers to interpret the representation of nutrient(s).

In February 2005, the Ministry of Health published Decree 57, modifying
the nutrition labeling requirements. These changes will take effect
November 6, 2006. The Ministry of Health gave industry 18 months to
adjust to the new requirements. The new nutrition labeling requirements
make the following items mandatory on a label:

-   Calories

-   Fat content

-   Proteins

-   Disposable carbon hydrates

-   Sodium

Additionally, when the fat contents exceed 5 grams per serving the
amounts of saturated, poli saturated and mono unsaturated fats and
cholesterol must be listed on the label.

For additional information on labeling please contact the Labeling
Department of the SEREMI:

Olivares Street \# 1229 8º Floor

SANTIAGO

Phone: 56-2-399-2633

Contact: Ms. Lorena Contreras (<lcontreras@sesma.cl> ) or

Mr. Mauricio Yanez ( <mauricio.yanez@sesma.cl> )

## Health Claims

See Sections II, B and Sections IV and VII.

## Organic Labeling 

Organic products have the same labeling requirements as any other normal
product. There is a mandatory certification requirement to market
organic products in Chile. Law 20089 from 01/17/2006 establishes that
the labels "Organic product, ecological product or biological product"
must be certified.

## GMO Labeling

Biotechnological events modifying certain foods and/or alimentary raw
materials for human consumption and new foods, ingredients, and
alimentary raw materials must be reviewed and specifically approved by
the Ministry of Health at which point the product may be used in
domestic and imported foods. (See Title 1, Paragraphs 3 of Decree 977 in
[http://www.embajadaeeuu.cl/\_temporal/1011/Website/2003/Food%20Law/fasinden.htm]{.underline})

Chile only allows transgenic seeds to be reproduced under strict field
controls especially for export; there are no labeling requirements on
these exported seeds.

Currently there is an initiative from Deputy Health Committee that would
establish mandatory labeling for food and bulk products that were
manufacture with ingredients or additives that had been genetically
modified or were transgenic, the initiative is now on the Senate Health
Committee and is expected to be voted during the year, the language
suggested is "Transgenic product".

# Section III. Packaging and Container Regulations

## 

Plastic packaging materials must not transfer more than 0.05 ppm of
vinyl chloride or acrylonitrile or any other substance utilized in the
manufacture of plastic elements that may be harmful to health.

All plastic utensils, vessels, containers, packing, wrappings, sheets,
film, parts of apparatus, piping, and accessories making contact with
food items and raw materials thereof, shall not contain residual
monomers amounting to more than 0.25% styrene, 1 ppm vinyl chloride, and
11 ppm acrylonitrile. Likewise, all objects made of plastics shall not
release into food more than 0.05 ppm vinyl chloride or acrytonitrile, or
other substance used in plastics manufacture that may be health hazards.

Plastic net bags are customarily used to pack citrus, onions and
potatoes. They are also used for grapes and other fruits. Plastic trays
with plastic film covers are used for a wide variety of fruits and
vegetables.

In Chile recycling is voluntary, there is no mandatory program or symbol
to be used on recyclable containers. The international symbol of three
arrows forming a circle is commonly used by the industry when the
containers are recyclable.

# Section IV. Food Additive Regulations

All additives must comply with the identification, purity and toxicity
evaluation rules in accordance with the Codex Alimentarius. It is
mandatory that additives be indicated on the label with their specific
name, according to the International Numbering System (S.I.N.) and in
decreasing concentration order. The exceptions to this rule are
flavorings, which may be listed in a generic manner without any
ingredient detail.

Only additives on the positive list found in Title 3, Paragraph II of
Chile's food regulations (Decree 977 in <http://www.usembassy.cl/> under
Embassy, Trade/Food/Agriculture) may be used. The Ministry of Health may
add to this list by further decree, if there is a need.

The addition of substances for therapeutic purposes (pharmaceutical
ingredients) is prohibited. In addition, the use of an additive is
prohibited if it significantly reduces the nutritional value of an
important ingredient (with the exception of dietetic products), conceals
poor quality, or misleads the consumer regarding the quantity or nature
of the food product.

See Section VII for \"fortified\" or vitamin enriched foods.

# Section V. Pesticide and Other Contaminants

Chile follows the Codex guidelines for pesticide residues on food. The
Ministry of Health is responsible for establishing tolerance levels
allowed in food products for pesticide residues, heavy metals, and
mycotoxin and microbiological contamination and enforces the
regulations. Random controls are performed and the office responsible
for these controls is:

Mr. Carlos Pavletic

Ministry of Health

Mac-Iver 459 Piso 8º

Santiago

Tel.: (56 2) 630-0575

Fax: (56 2) 664-9150

E-mail: <cpavletic@minsal.cl>

Maximum tolerance levels are set for all approved pesticides. CODEX
maximum residue limits are accepted for imported food products.

The Ministry of Agriculture's Agricultural and Livestock Protection
Service (SAG) must approve the use of pesticides. This agency regulates
the use of pesticides in Chile. For more information regarding approvals
and/or maximum residue level, contact:

Mr. Arturo Correa B.

Division of Plant Protection

Agricultural and Livestock Protection Service (SAG)

Ministry of Agriculture

Av. Bulnes 216 Of. 603

Santiago, Chile

Tel.: (56 2) 695-0805

Fax: (56 2) 687-9607

A list of approved pesticides can be obtained through SAG's web page
[http://www.sag.gob.cl](http://www.sag.gob.cl/)

Once you open the web page select:

Ambito Agricola

Then select:

Plaguicidas y Fertilizantes

Then select:

Plaguicidas autorizados

Then Download an EXCEL file for a list of approved pesticides, or send
inquiries about pesticides to: <plaguicidas@sag.gob.cl>

You can also see FAS Import Policy Report CI4020 on "Frequently asked
questions about pesticides located on the U.S. Embassy website under
Trade/Food and Agriculture
([http://www.usembassy.cl/OpenDocs/asp/pagDefault.asp?boton=Doc26&argInstanciaId=26&argCarpetaId=278&argTreeNodosAbiertos=(0)&argTreeNodoSel=278&argTreeNodoActual=278](http://www.usembassy.cl/))

# Section VI. Other Regulations and Requirements

(Product Registration, Testing, Certification, Special Documentation or
Conformity Assessment Requirements).

There are no mandatory quality certification standards for fruits and
vegetables. As a result of the U.S.-Chile FTA, U.S. meat grading
standards are now accepted in Chile. Since Chile provides grades for all
parts of animal, be sure to consult both the AMS Verification Program
(<http://www.ams.usda.gov/>) and the FSIA export library
(<http://www.fsis.usda.gov/Regulations_&_Policies/Chile_Requirements/index.asp>)

See Section IX below for meat and poultry or check the Chilean
Agriculture and Livestock Service's webpage (<http://www.sag.cl/> ) for
the requirements.

# Section VII. Other Specific Standards

**1. Consumer Packaging or Municipal Waste Disposal:** Containers and
wrappers used in the distribution of food products must be made or lined
with materials that will resist the transfer of toxic or contaminating
substances that might modify the organoleptic or nutritional nature of
the products. The packaging in immediate contact with the food can not
be recycled.

**2. Weights and Measures:** The net content must be expressed on the
label in units of the metric system. For those food products packed in a
liquid medium, the drained content of the product must also be
indicated.

**3. Vitamin Enrichment Requirements:** The Ministry of Health has
established maximum limits for vitamins and minerals added for food. See
table below. Resolution Nº 393 and Nº 394 dated February 20, 2002 are
the applicable regulations. Beyond these levels, the food becomes a food
supplement and it must receive specific approval from the Ministry of
Health.

+-----------------------------------------------+----------------------+
| ###### Vitamins                               | **% RDA/Serving**    |
+-----------------------------------------------+----------------------+
| **Hydro-soluble vitamins**                    | **50**               |
+-----------------------------------------------+----------------------+
| **Vitamin C**                                 | **100**              |
+-----------------------------------------------+----------------------+
| **E and K oil‑soluble vitamins**              | **100**              |
+-----------------------------------------------+----------------------+
| **A oil‑soluble vitamins**                    | **25**               |
+-----------------------------------------------+----------------------+
| **D oil‑soluble vitamins**                    | **40**               |
+-----------------------------------------------+----------------------+

The above limits do not apply to foods designed for special regimes,
such as foods fortified to address a specific public health need. A
calcium fortification limit is set by the Ministry of Health for each
specific food product, according to the type of calcium salts used and
the target population of the product.

**4. Novel Foods:** These types of products do not have any specific
labeling requirements; they have to comply with the same regulations as
any other food product.

**5. Dietetic or Special Use Foods:** Chilean food regulation defines
food for special diets as food specially prepared or processed to meet
particular nutrition demands owing to specific physical, physiological,
or metabolic conditions. The composition should be substantially
different from ordinary food of similar nature, if any. Synthetic
ingredients replacing lipids, carbohydrates, diet fiber, and other
nutrients used in such food shall, for authorization purposes, adhere to
technical standards issued on the subject by the Ministry of Health.
Such foods are required to carry a statement of nutritional and health
properties, as provided hereunder.

 

In additional to nutritional information and general labeling,
description of essential characteristics of the product should be stated
close to the name of the food. The total quantity of specific nutrients
or other components whereto the essential characteristic is due that
makes such food appropriate for a special diet should be stated per 100
g or per 100 ml or per serving.

 

Food for weigh control should state in their nutritional information the
phrase "Food for weigh control". The same happens with low-fat and/or
low-calorie foods, which besides the main designation of the food name
and the nutritional information, it should state the category or
essential characteristic of the food as "low-..." or "...-free".

See Title 28, Paragraph 8 of Decree 977 regarding infant formula,
regarding commercial preparations of children's food, food for
low-sodium diets, cereal-based processed foods for children, food for
low-sodium diets, gluten-free diets, for weight-control diets, and low
fat and low calorie food products in
[www.usembassy.cl](http://www.usembassy.cl/) under Embassy,
Trade/Food/Agriculture.

**6. Food Sanitation Laws/Guidelines:**

Decree No. 725, 1968.

Decree No. 2763, 1979.

Decree No. 977, August 6^th^, 1996.

Decree No. 807, February 3^rd^, 1998.

Decree No. 1844, November 10^th^, 1998.

Decree No. 855, July 31^st^, 1999.

Decree No. 475, January 13^th^, 2000.

Decree No. 897, February 8^th^, 2000.

Decree No. 824, March 9^th^, 2000.

Decree No. 90, April 28^th^, 2000.

Decree No. 165, May 26^th^, 2000.

Decree No. 238, May 26^th^, 2000.

Decree No. 287, February 28^th^, 2002.

Decree No. 253, January 20^th^, 2003.

Decree No. 79, June 24^th^, 2003.

Decree No. 81, July 24^th^, 2003.

Decree No. 115, November 25^th^, 2003.

**7. Fish and Seafood:** See Titles 12 (fish) and 13 (shellfish) of
Decree 977 in <http://www.usembassy.cl/> under Embassy,
Trade/Food/Agriculture.

**8. Animal Quarantine:** The Ministry of Agriculture, Department of
Livestock Protection, enforces strict salmonella testing on imports of
fresh and frozen poultry as a quarantine measure. If any samples of a
shipment are found to be positive for salmonella, the shipment may not
enter the country. Also there are animal health and sanitary strict
requirements including materials that can be used during processing.
Cooked poultry meat may enter Chile under the conditions specified in
Regulation No. 1597 of June 4, 1997, issued by the Division of Livestock
Protection, SAG. Currently the plant must be inspected and approved by
SAG. However, under the US -- Chile FTA both technical services are
working on an equivalency agreement that would allow each agency to
certify plants to export to each country.

The most current requirements for poultry and processed poultry products
can be found on the Ministry of Agriculture, Department of Livestock
Protection Service's (SAG) web page: <http://www.sag.gob.cl/> . Also see
"poultry and poultry products requirements" translated in Import
Requirements SAG: Poultry Processed Meat, Cooked Poultry Meat , Poultry
Meat, Dairy Products and Pet Food on the U.S. embassy website
[http://www.usembassy.cl/\_temporal/4148/Website/Resolutions/Certificate%20Report.htm](http://www.usembassy.cl/_temporal/4148/Website/Resolutions/Certificate Report.htm)

The current red meat import requirements are available on SAG's web
page. Resolution \# 833, which establishes the Sanitary Requirements for
Imports of Red Meat (beef), states that:

-   the bovine meat being imported must be covered by an official
    certificate issued by the corresponding sanitary authority in the
    country of origin (the US Food Safety Inspection Service
    \[www.fsis.usda.gov\] in the United States), in which it is
    indicated the zone and the place of origin of the animal, the name
    of the slaughter house and its number, the identification of the
    product, the specie of the animal, the number of boxes in the
    shipment, the quality and grade of the meat, the name of the cuts,
    the identity of the exporter and importer and the means of
    transport. The grading certificate has to be attached to the health
    certificate.

-   Animals must come from an area free of Foot and Mouth Disease,
    Bovine Pest, Bovine Contagious Pleuropneumonia and BSE.

-   Animals and products must comply with the requirements in
    Resolutions #3138, which establishes the requirements for approving
    production facilities in the country of origin and Resolution #1150,
    which is an amendment to the general requirements of importing
    animals and by-products.

-   In the case of beef, the product must be labeled according to Decree
    239/1993 of the Ministry of Agriculture, in Spanish at the point of
    production. The resolution also establishes that a label has to be
    inserted on each cut (between the meat and the plastic) and another
    in the box. Further conversation with the authority concluded on the
    possibility to put the label of the cut outside the plastic.

To get the import requirements from SAG's web page go to
[www.sag.gob.cl](http://www.sag.gob.cl/) and under Imports, click on:

"Sistema de importaciones agricolas" for plants

"Sistema de importaciones pecuarias" for livestock

"Establecimientos pecuarios habilitados" for authorized facilities

For additional information from SAG you can contact:

# Dr. Hector Escobar

Bulnes 140

Santiago, Chile

Tel.: (56 2) 341-1417

E-mail: <hector.escobar@sag.gob.cl>

**9. Wine, Beer and Other Alcoholic Beverages:** The wine and alcoholic
beverage industries are regulated by the Servicio Agrícola y Ganadero.
Labels on wine may indicate origin, variety of grape, and year of
harvest when at least 75% of the grapes used to produced the wine fit
the description used. The expression *\"Estate Bottled*\" or similar
expressions may be used when the wine comes from grapes grown on lands
owned or rented by the vineyard and located in the same geographical
area as the denomination of origin. SAG's authority to enforce the
labeling law is found under law No. 18.455. For further information,
contact:

Antonio Aluanlli

Servicio Agrícola y Ganadero

Departmento Proteccion Agricola

Subdepartamento Vinas y Vinos

Av. President Bulnes No. 140

Santiago

Phone: (56-2) 696-6490

Fax: (56-2) 696-6480

Email: [vinas@sag.minagri.gob.cl]{.underline}

Wine, beer and other alcoholic beverages of domestic and/or import
origin are subject to a tax which is 27% for alcoholic beverages (i.e.
liquor, whisky, etc.) and 15% for wine and beer. Additionally all
alcoholic beverages are subject to a 19% Value Added Tax.

**10. Organic Foods and Health Foods:** The market for organic foods
within Chile is small, but domestic production is growing. With a view
toward developing the industry, the National Institute of Standards
(Instituto Nacional de Normalizacion) in 1999 established Norma NCh2439,
which establishes the voluntary principles or rules for the production
(with set periods for certification), packaging, labeling and sale of
organic products for export. Norma Nch 2079, approved in March 2000,
establishes the general criteria for the accreditation of organizations
certifying products as \"organic.\" A law establishing the criteria for
the organic certification is being discussed at this moment in Congress
and will have to be passed before the end of December, when the
authorization for external organic certification companies (American,
European) will expire, per Chile's Free Trade Agreements with the United
States and the European Union. The Agriculture and Livestock Service
(Servicio Agrícola y Ganadero -- SAG) regulates organic production and
certification, they can be reached at:

Contact: Gonzalo Narea

Servicio Agrícola y Ganadero

Av. Bulnes 197 Piso 3º

Santiago

Tel.: (56 2) 698-6517

E-mail: <gonzalo.narea@sag.gob.cl>

**11. Product Samples:** A sample is considered of no commercial value
when its weight does not exceed 20 kilograms of solid product. In the
case of additives, or granulated products, the limit is 250 grams. In
the case of higher quantities for personal use or for laboratory
samples, these must be certified through a notary public letter. This
letter is necessary for Customs clearance.

**12. Irradiated Foods:** Chile permits the irradiation of food
products. See Title 6 of Decree 977 for further information
(<http://www.usembassy.cl/>). The irradiation of foods shall be done in
conformity with the Code of Good Irradiation Practices of the
International Consultative Group for Irradiation of Foods established
under the auspices of the Food and Agricultural Organization of the
United Nations (FAO), the International Atomic Energy Agency and the
World Health Organization. When more than 5% of a product's ingredients
have been treated with radiation or ionizing energy, the label must
indicate very close to the product name the treatment employed, using
phrases such as: *\"treated with ionizing energy\", \"processed with
ionizing energy\"* or *\"preserved with ionizing energy\"*. It may also
carry the logo or symbol, internationally acknowledged for these
effects. Decree 977 does not limit the use of radiation to particular
food products.

# Section VIII. Copyright and/or Trademark Laws

Chile belongs to the World Intellectual Property Organization, and
patents, trademarks, industrial designs, models, and copyrights are
protected in Chile by the provisions of the International Convention for
the Protection of Industrial Property (the Paris Convention).

However, Chile\'s intellectual property regime is currently not
WTO/TRIPS compliant.

The U.S.-Chile FTA requires Chile to accede to several international IPR
agreements, e.g., the Patent Cooperation Treaty (1984) and the Trademark
Law Treaty (1994). In general terms, the FTA provides that full
implementation of the agreement's various IPR obligations must be
completed by each country within two to five years. Under the terms of
the FTA, Chile also agreed that trademark applications can be opposed
and that procedures for preventing or canceling the registration of a
mark that is similar or identical to a well-known trademark will be
established. In the past, foreign companies wishing to begin operations
in Chile have often found individuals or companies have already
registered their trademarks in Chile. Chilean courts have been
supportive in cases where trademarks have been \"stockpiled,\" but gone
unused, but less so in cases where investments were made in use of the
trademark. In either case, proceedings have been lengthy (2-4 years) and
expensive (\$5,000-\$10,000+). In fact, for the sake of expediency, some
firms have preferred to negotiate with the infringer in lieu of going to
court. The FTA ought to improve the situation, but U.S. firms should
still register their trademark as soon as they have any intention of
doing business in Chile.

Ownership of the trademark is not prejudiced by lack of use in cases
where the

registered party makes use of the mark in other countries, and
trademarks may be

perpetually registered in periods of ten years at a time. Firms wishing
to register their

trademarks should do so with the Ministry of Economy, Departamento de
Propiedad

Industrial, Tel: (56-2) 688-3124 or on the web at <http://www.dpi.cl/>

Since 1992, Chilean law has set copyright protection at the author's
life plus 50 years. The U.S.-Chile FTA should strengthen copyright
protection in Chile. It stipulates that authors, performers and
producers have exclusive rights to authorize or prohibit reproductions
of their work, and that the term of protection is not less than the life
of the author and 70 years after the authors death, or not less than 70
years from the end of the year of the first publication of the work, if
the term is not based on the life of a person. As part of the FTA, the
Government of Chile also confirmed its commitment to use only legitimate
computer software. With implementing legislation and good enforcement,
the FTA should, therefore, help U.S. companies who have been suffering
estimated annual losses of some \$50 million due to copyright
infringement in Chile.

The U.S.-Chile FTA will also require Chilean authorities to adjust
patent terms to allow for unreasonable delays encountered in granting
the patent. Data exclusivity is

guaranteed for 5 years for pharmaceuticals and 10 years for agricultural
chemicals.

The FTA seeks to beef-up IPR enforcement as well. In civil proceedings,
the rights

holder will now be able to request destruction of goods that have been
found to be

pirated or to bear counterfeit marks. Rights infringers can be liable
for actual damages or statutory damages where actual damages are
unknown. Law enforcement is given the authority to seize suspected
counterfeit or pirated goods, as well as the equipment used to produce
such goods.

# Section IX. Import Procedures

## A. Customs Clearance 

A local agent or importer is absolutely necessary to clear food products
for sale and distribution in Chile. Food shipments must obtain a
Certificate of Use and Disposal from the Ministry of Health on a
case-by-case basis before the product is released by customs for sale in
Chile. The Ministry of Health has 100% inspection requirement and a high
percentage of sampling and analysis although their processing time is
relatively efficient and the cost for the service is nominal. The U.S.
government is working with the Ministry of Health to develop a database
that will facilitate trade and reduce duplicate testing analysis.

The procedure for obtaining permission to import food products begins in
the Health Service Office at the port of entry. For example, if the port
of entry is "Comodoro Arturo Merino Benitez" airport (Santiago's
International Airport), clearance is handled by SESMA (Metropolitan
Environmental Health Service, web site: www.sesma.cl).

The first step is to request "customs destination approval", which
authorizes the retrieval of the products from Customs and their transfer
to bonded storage, where they must be stored intact and separate from
other goods pending sampling and inspection by health authorities.
Obtaining "customs destination approval" usually takes 72 hours (3
working days). Forms should be obtained from the Customer Service Office
(Oficina Atención al Usuario) of SESMA, located in Av. Bulnes 194,
Santiago, from Monday through Friday, between 8:30 to 15:00. Fees are
assessed by weight in kilograms. For more information check SESMA's
homepage [www.sesma.cl]{.underline} under \"Alimentos\" -
\"Fiscalización\".

Required Documents:

1\. The original and five (5) copies of the Customs Destination Form
#2003 ("Solicitud Certificado Destinacion Aduanera").

2\. A photocopy of the resolution certifying to the sanitary condition
of the warehouse to which the products will be moved upon leaving
customs.

3\. Air waybill, ocean bill of lading, or product invoice.

## B. Clearance for Sale within Chile

The Health Service Office of the region where the products are being
stored conducts the sampling and testing of products. Depending on the
potential health risk and the necessary tests involved, this process may
take up to 4 weeks but usually only takes about 7 days.

Required Documents:

1\. Original and one copy of the Import Approval Form, #2004,
("Certificado de Uso y Disposición " see the form at the U.S. Embassy
website [www.usembassy.cl](http://www.usembassy.cl/) under Trade/ Food
and Agriculture under Import Regulation SAG or
[http://www.usembassy.cl/\_temporal/4148/Website/Resolutions/Certificate%20Report.htm](http://www.usembassy.cl/_temporal/4148/Website/Resolutions/Certificate Report.htm)).

2\. For fresh and raw seafood: A cholera-free certificate, if cholera is
detected in the country of origin.

3\. For meats: The sanitary certificate must include a declaration that
the meat is free of hormones.

4\. For all meats and poultry, the product must comply with the
regulations of the Ministry of Health, for example, trichinae for pork
or salmonella for poultry. Pease see the individual product requirement
on the U.S. embassy website under Trade Food and Agriculture
(<http://www.usembassy.cl/OpenDocs/asp/pagDefault.asp?boton=Doc26&argInstanciaId=26&argCarpetaId=278&argTreeNodosAbiertos=(0)&argTreeNodoSel=278&argTreeNodoActual=278>)

## C. Recommended Documents for Facilitating Clearance

1\. A certificate of analysis of microbiological quality, and/or
physical chemical analysis.

2\. A Health Certificate and/or Certificate of Free Sale issued by a
recognized public health department in the country of origin confirming
that the product is fit for human consumption, is sold freely throughout
the country, and if processed, describing the product.

3\. A technical sheet.

4\. Labels or empty containers or packages.

5\. For irradiated foods:

a\) A certificate indicating the dosage level and a description of the
packaging.

b\) A certificate issued by the competent government agency authorizing
the plant to irradiate food products.

c\) A certificate recognizing that the plant is included in the
international inventory of irradiation plants.

Certificates issued in the country of origin should be completed in or
translated into Spanish. Fees for sampling and conducting tests are
calculated according to product weight in kilograms.

# Appendix I. Government Regulatory Agency Contacts

WTO Entry Points

Sanitary/Phytosanitary (SPS)

Servicio Agricola y Ganadero (SAG)

Departamento de Asuntos Internacionales

Avenida Bulnes 140, piso 5

Santiago

Tel.: (562) 345-1576 / (562) 345-1571

Fax: (56 2) 345-1578

E-mail: [rrii@sag.gob.cl]{.underline}

Website: <http://www.sag.cl/>

**Technical Barriers To Trade (TBT)**

Direccion de Relaciones Economicas Internacionales

Ministerio de Relaciones Exteriores

Alameda Bernardo O'Higgins 1315, 2 piso

Santiago

Tel.: (56 2) 696-0043

Fax: (56 2) 696-0639

**Enforcement of Food Regulations**

Departamento de Programas del Ambiente

Departamento Salud Ambiental

Ministerio de Salud

Mac-Iver 459, piso 8

Santiago

Tel.: (56 2) 630-0575

**Sampling and Inspection of Imported Foods**

Servicio de Salud Metropolitano del Ambiente (SESMA)

Av. Bulnes 174

Santiago

Tel.: (56 2) 383-1302 / 383-1359

Fax: (56 2) 639-3339

Website: <http://www.sesma.cl/>

**Compliance with Pesticide Residue Regulations**

Division Proteccion Agricola

Servicio Agricola y Ganadero (SAG)

Ministerio de Agricultura

Av. Bulnes 140, piso 3

Santiago

Tel.: (56 2) 698-8205

Website: <http://www.sag.cl/>

Mr. Carlos Pavletic

Ministry of Health

Mac-Iver 459 Piso 8º

Santiago

Tel.: (56 2) 630-0575

Fax: (56 2) 664-9150

E-mail: <cpavletic@minsal.cl>

**Chilean Standards**

Instituto Nacional de Normalizacion - INN

Matias Couseno 64, piso 6

Santiago

Tel.: (56 2) 445-8800

Fax: (56 2) 441- 0427

E-mail: [info@inn.cl]{.underline}

Website: <http://www.inn.cl/>

# Appendix II. Other Import Specialist Contacts

Analysis of Products for Compliance with Existing Food Regulations

Chilean Institute of Public Health

Avenida Marathon No, 1000, Ñuñoa

Santiago

Tel.: (56 2) 350-7477

Fax: (56 2) 350-7578

E-mail: <oirs@ispch.cl>

Website: <http://www.ispch.cl/>

Instituto de Nutricion y Tecnologia de los Alimentos - INTA

Universidad de Chile

Av. El Libano 5524

Casilla 138 Correo 11

Santiago

Tel.: (56 2) 978-1411 / 978-1400

Fax: (56 2) 221-4030

Website: <http://www.inta.cl/>

U.S. Embassy

Office of Agricultural Affairs

U.S. Embassy

Andres Bello 2800 - Las Condes

Santiago

Tel.: (56 2) 330-3704

Fax: (56 2) 330-3203

E-mail: [AgSantiago@usda.gov](mailto:fas_stgo@rdc.cl)

Website: [www.usembassy.cl](http://www.usembassy.cl/) (under Embassy,
Trade/Food/Agriculture)

#