Country Product Standards

**\*The majority of information for this document has been copied from
the Bureau of National Affairs website.**

**Suggested Use:** Type in the country of interest (under *Edit*,
*Find*). When at chosen country highlight the part of the document
concerning the country and then do another *Find* search within selected
country information.

**Note:** In general, the country information consists of trade
regulations, requirements and standards for a variety of goods, from
toys to pharmaceuticals, and which body governs over them. It also
contains the information of many helpful contacts within the countries.

Table of Contents

Australia (and Asia) 2-3

Brazil 4-6

Canada 7

Chile 8

China 9-13

Egypt 14-15

France 16-19

Germany 20-22

Hong Kong 23-24

India 25

Iran 26

Italy 27-29

Japan 30-31

Korea 32-34

Mexico 35-36

Philippines 37-38

Poland 39-41

Russia 42-44

Saudi Arabia 45-47

South Africa 48

Spain 49-51

Taiwan 52-55

Turkey 56

United Kingdom 57-58

Link to Major Compliance Marks 68

**Australia**

-   **Australia is a signatory to the Agreement on Technical Barriers to
    Trade**, commonly known as the **Standards Agreement**, negotiated
    under the Tokyo Round of multilateral trade negotiations. The
    agreement is designed to eliminate the use of standards and
    certification systems as impediments to trade.

    -   **The Standards Agreement** does not dictate what the product
        standards must be, but it does call for open procedures in
        adopting standards and sets up a review procedure for settling
        disputes. Signatories are required to publish a notice of their
        proposed standards, to provide copies of these standards, if
        requested, and to allow countries to comment on them. As far as
        international consensus-based standards are concerned, the
        Agreement invites the signatory governments to ensure that the
        standardizing bodies in their countries accept and comply with a
        *\"Code of good practice for the preparation, adoption and
        application of standards\"*, embodied in Annex 3 to the
        Agreement and which is known as the WTO Code of Good Practice.

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-   Standards (both voluntary and mandatory) and certification systems
    promulgated by central governments, state and local governments, and
    private sector organizations are subject to the Standards
    Agreement\'s provisions, although only central governments are
    directly bound by it. The agreement requires that signatories "shall
    ensure that" central government bodies comply fully with its
    provisions. With respect to regional, state, local, and private
    organizations, the agreement requires signatories to "take such
    reasonable measures as may be available to them" to ensure
    compliance.

-   **If exporters have reason to believe that a standard of any
    signatory country unjustifiably impedes their exports**, these
    concerns may be communicated to the Office of Standards Code and
    Information, National Institute of Standards and Technology,
    Building 820, Room 164, Gaithersburg, Md. 20899, (301) 975-4037;
    fax: (301) 926-1559.

-   The specification of industrial standards relating to dimensions,
    terminology, test methods, performance and quality of products, and
    safety or design codes is the responsibility of **Standards
    Australia**. Not only does this organization issue **Australian
    standards regarding materials and products, but it also provides
    standard codes of practice**. Although compliance with these
    standards is not compulsory except in cases where the safety of life
    or property is endangered, many industries voluntarily adopt them
    and customers prefer products that meet these specifications.

    -   **Additional information** is available from Standards Australia
        International Ltd., GPO Box 5420, Sydney, NSW 2001; telephone:
        (61-2) 8206-6000; fax: (61-2) 8206-6001; e-mail:
        <intsect@standards.com.au>.

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-   **Toys:** Subject to the Australian Toy Standard AS1647; the
    standard is essentially voluntary, but participants in the toy
    industry may be prosecuted if found to be misrepresenting their
    products under this standard. Mandatory standards are in place for
    toys intended for children under three years of age.

-   **Drugs and medicines: ** Prescription and non-prescription drugs
    must be approved by the Therapeutic Goods Administration and entered
    in the Australian Register of Therapeutic Goods as a registered or
    listed product.

-   **Drugs and Prescriptions:** All prescription and non-prescription
    drugs containing ingredients that appear in the Standard for the
    Uniform Scheduling of Drugs and Poisons must be registered.
    Registration requires the TGA to evaluate these products for
    quality, efficacy, and safety. Once approved, the product will be
    assigned an AUST R number and included in the Australian Register of
    Therapeutic Goods as a "registered" product.

Some products need only be listed, and they include most
non-prescription and complementary drugs such as herbal, vitamin, or
mineral products. These items must contain only well-known, established
ingredients that have a long history of use and may not contain
substances that appear in the Standard for the Uniform Scheduling of
Drugs and Poisons.

Additional Information on drugs and medical devices is available at:

Therapeutic Goods Administration,

P.O. Box 100

Woden, ACT 2606

telephone: (61-2) 6232-8444; fax: (61-2) 6232-8241.

**Electrical goods: ** Electrical goods must be checked or approved
either with the electricity authority in each state or with the local
supply authority, as appropriate.

**Agricultural goods: ** Imports of seeds, plants, fruit, timber and
wooden articles, and live animals are subject to quarantine. Products
found to be diseased may be returned, treated, or destroyed at the
exporter\'s expense. Meat and poultry imports must originate from a
plant that has been approved for export to Australia.

Comprehensive information regarding quarantine regulations is available
from the Australia Quarantine and Inspection Service, GPO Box 858,
Canberra, ACT 2601; telephone: (61-2) 6272-3933; fax: (61-2) 6239-7351;
e-mail: <importclear@aqis.gov.au>.

**Timber: ** Containers constructed with exposed timber must be
permanently or temporarily treated for pests and diseases in a manner
approved by the Department of Primary Industries and Energy or be
subject to inspection and quarantine by the Australia Quarantine and
Inspection Service. A copy of the treatment certificate from the company
that treated the timber must be presented to AQIS upon request.

**Food regulations: ** Australia and New Zealand harmonized their food
standards in 1995. Standards are promulgated by Food Standards Australia
New Zealand (FSANZ), which replaced the Australia New Zealand Food
Authority as the primary standards body for food products in both
countries effective July 1, 2002.

The Joint Australia New Zealand Food Standards Code officially took
effect Dec. 20, 2002. The new code replaces the Australia Food Standards
Code. For specific standards information, exporters are urged to consult
with their importers or with Food Standards Australia New Zealand,
Macquarie House, 55 Blackall St., Barton, ACT; telephone: (61-2)
6271-2222; fax: (61-2) 6271-2278.

-   Genetically modified foods and food products that contain
    genetically modified ingredients must be specifically approved by
    Food Standards Australia New Zealand

-   For specific information regarding existing foreign agricultural
    standards and testing, packaging, and certification systems,
    exporters should contact the Office of Food Safety and Technical
    Services, Foreign Agricultural Service, U.S. Department of
    Agriculture, South Agriculture Building, Room 5545, 14th Street and
    Independence Avenue S.W., Washington, D.C. 20250, (202) 720-1301;
    fax: (202) 690-0677. The National Center for Standards and
    Certification Information at the National Institute for Standards
    and Technology also maintains extensive files on existing foreign
    non-agricultural standards and their testing and certification
    systems. Further information is available from the **National Center
    for Standards and Certification Information, National Institute for
    Standards and Technology, Building 820, Room 164, Gaithersburg, Md.
    20899, (301) 975-4040; fax: (301) 926-1559**.

Additional information on foreign standards is available to firms in the
United States through the American National Standards Institute, 11 W.
42nd St., New York, N.Y. 10036, (212) 642-4900; fax: (212) 398-0023.

#### Asia

"If you have been selling products in Asia, or are thinking about
expanding your market to reach millions of potential Asian customers,
here are a few facts to ease the process." This is a very helpful
article that overviews the various product certification products
throughout Asia.

<http://www.ul.com/about/otm/otmv8n1/feature.html>

**Brazil**

-   The Brazilian Association for Technical Standards (Associacao
    Brasilera de Normas Tecnicas---ABNT) is the primary standards
    organization. The association develops voluntary standards for all
    sectors in accordance with the National System of Metrology,
    Standardization, and Industrial Quality. The National Institute of
    Metrology, Standardization, and Industrial Quality is the national
    accreditation body.

-   Brazil is a signatory to the Agreement on Technical Barriers to
    Trade, commonly known as the Standards Agreement, negotiated under
    the Tokyo Round of multilateral trade negotiations. The agreement is
    designed to eliminate the use of standards and certification systems
    as impediments to trade.

-   The Standards Agreement does not dictate what the product standards
    must be, but it does call for open procedures in adopting standards
    and sets up a review procedure for settling disputes. Signatories
    are required to publish a notice of their proposed standards, to
    provide copies of these standards, if requested, and to allow
    countries to comment on them.

    -   Government agencies may establish mandatory technical
        regulations for products under their jurisdiction. Products
        subjected to mandatory regulations generally must be tested in
        Brazil by a certification body accredited by the National
        Institute of Metrology, Standardization, and Industrial Quality.

    -   Information is available from:

> Brazilian Association for Technical Standards
>
> Av. 13 de Maio, n° 13, 28° andar
>
> 20003-900 Rio de Janeiro
>
> telephone: (55-21) 3974-2300;
>
> fax: (55-21) 2220-1762
>
> e-mail: <abnt@abnt.org.br>.

Additional information is available from the National Institute of
Metrology, Standardization, and Industrial Quality, Rua Santa
Alexandrina, 416 Rio Comprido, 20261-231 Rio de Janeiro; telephone:
(55-21) 2679-9001; fax: (55-21) 2563-1009.

-   **Food products: ** Certain processed foodstuffs must be registered
    with the Brazilian Sanitary Surveillance Agency (Agencia Nacional de
    Vigilancia Sanitaria---ANVISA) under the Ministry of Health prior to
    being offered for sale in Brazil. The importer or distributor, who
    also must be registered with the agency, must apply for product
    registration. The application for registration must include a
    complete list of ingredients, sample label, and certificate of free
    sale. Registration must be completed within 90 days of application
    and is valid for five years.

Registration is mandatory for the following products: formulated and
sole-substance food additives; artificial sweeteners; mineral, table,
and purified waters; foods with added essential nutrients; infant
formulas; foods for weight control; foods for special diets such as for
pregnant and lactating women, elderly people, and sport participants;
foods with dietary restrictions of nutrients; foods for diets with
controlled sweeteners; certain foods of animal origin; certain
nonalcoholic beverages; technology coadjuvants; liquid compounds for
consumption; ice; new foods and/or new food ingredients; salt; vitamins;
mineral supplements; and canned hearts of palm. Recycled packaging for
food products also must be registered.

-   Additional information is available from:

Brazilian Sanitary Surveillance Agency

SEPN 515, Bl.B, Ed. Omega

70770-502 Brasilia, D.F.

telephone: (55-61) 448-1000.

-   Foreign companies that export **food products of animal origin**,
    including meat, dairy products, and seafood, must register with the
    Department of Animal Origin Products Inspection under the Ministry
    of Agriculture. To register, companies must be inspected and
    approved by the appropriate federal agency. In the United States,
    meat processing plants must be inspected by the U.S. Food Safety and
    Inspection Service; dairy plants, by the U.S. Agricultural Marketing
    Service; and seafood plants, by the National Oceanic and Atmospheric
    Admnistration/National Marine Fisheries Services or the U.S. Food
    and Drug Administration. For meat products, registration also
    requires proof, in the form of a questionnaire completed by
    regulatory authorities in the country of export, that the inspection
    system in the country of export is equivalent to the Brazilian
    system.

    -   Additional information is available from the Ministry of
        Agriculture, Esplanada dos Ministerios, Bloco D, Anexo, 4 andar,
        70043-900 Brasilia, D.F.; telephone: (55-61) 218-2684; fax:
        (55-61) 218-2672.

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-   **Food supplement regulations** cover the sale of nutritional
    supplements and require supplements to contain a minimum of 25
    percent of the recommended daily allowance amounts. Supplements that
    exceed 100 percent of the amounts must be registered as medicine
    with the Ministry of Health, approved by a laboratory in Brazil, and
    sold only in registered pharmacies.

-   **Imports of wine, beer, distilled spirits, and juice** must be
    registered with the Department of Plant Health and Inspection
    Services under the Ministry of Agriculture. The department inspects
    shipments of these products and will test samples for compliance
    with Brazilian standards. Importers and distributors of such
    products also must be registered with the department. For wine,
    registration with the ministry requires the submission of a
    certificate of analysis issued in the country of origin, a
    declaration that the product meets the standards of the country of
    origin, a sample of the label, and a description of the process and
    the names and percentages of ingredients used in producing the item.

-   **Medical products: ** Medical devices and pharmaceuticals,
    including cosmetics, must be registered with the Brazilian Sanitary
    Surveillance Agency; importers and distributors of these products
    also must be registered with the agency. Product registration must
    be requested by the local importer or distributor and must be
    completed within 90 days of application. The following items, as
    appropriate, must accompany the application for product
    registration: complete technical report, including quantitative and
    qualitative formula of the product and information on quality
    control of the production process; list of components or
    ingredients; sample label; and certificate of free sale. The product
    should be patented in Brazil. Exporters are advised to consult
    closely with their representatives in the market and the ministry
    concerning any additional requirements for import authorization.
    Additional information is available from the Brazilian Sanitary
    Surveillance Agency, SEPN 515, Bl.B, Ed. Omega, 70770-502 Brasilia,
    D.F.; telephone: (55-61) 448-1000.

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-   **Medical devices** **and equipment** are categorized as follows:
    diagnostic equipment, therapeutic equipment, medical-hospital
    support equipment, disposable material, implantable devices, and
    in-vitro diagnostic devices. Products are further characterized by
    risk level. Level 1 indicates low risk; level 2, moderate risk; and
    level 3, high risk. Nonsterile products used to support medical and
    laboratory procedures are exempt from the registration requirement,
    as are parts and accessories of such products.

-   **Motor vehicles: ** Under the Traffic Law of 1998, an annual
    vehicle gas and noise emission and maintenance inspection is
    required for all vehicles. Among other things, new automobiles must
    be equipped with catalytic converters. U.S. exporters should consult
    with their customers regarding other import requirements
    necessitated by this program. Additional information regarding the
    vehicle inspection program is available from: Conselho Nacional do
    Meio Ambiente-CONAMA, SAIN, Avenida North, Quadra 604, Edificio Sede
    do Ibama, Sala 54, 70800-200 Brasilia, D.F.; telephone: (55-61)
    225-0564; fax: (55-61) 226-4991; or from the Ministry of Transport,
    Esplanada dos Ministerios, Bloco R, 70000 Brasilia, D.F.; telephone:
    (55-61) 218-6335; fax: (55-61) 218-6315.

-   **Used machinery/instruments: ** Imports of used machinery,
    equipment, tools, dies, containers, or instruments must be of a type
    that cannot be produced in Brazil nor be substituted by Brazilian
    machines or equipment; the Brazilian government must consider these
    goods to be of benefit to the local economy; and the equipment\'s
    age must be less than its life expectancy at the date of the
    importation request. Proof of the age must be provided in a
    technical evaluation and appraisal report prepared by a specialized
    and qualified company of known technical capacity and presented with
    the import request to the Secretariat of Foreign Trade.

Importers of refurbished parts for aircraft and other space equipment
must present an inspection and appraisal certificate issued by a company
authorized by the Federal Aviation Administration and recognized by the
Civil Aviation Department of the Brazilian Air Ministry.

To receive import authorization**, refurbished parts and pieces for
machine and equipment maintenance** must have been refurbished by the
original manufacturer. The refurbished parts and pieces must also have
the same guarantee as new pieces. These refurbished pieces must not be
in production in Brazil, and the importer must present documentation
prepared by the appropriate domestic industry association proving that
the parts are not produced in the domestic market. The import license,
commercial invoice, and packaging must indicate that the products are
refurbished. The manufacturer must provide the prices of new products
that are identical to the ones being imported.

Importation of used cars and consumer goods is prohibited.

-   **Telecommunications equipment: ** The National Telecommunications
    Agency (ANATEL) controls the importation of telecommunications
    equipment. A certificate of technical conformity is required for
    terminal equipment used by the public to access public interest
    telecommunications services; for telecommunications equipment that
    uses the electromagnetic spectrum for transmitting signals,
    including antennas and products characterized as restricted
    radiation radio-communication equipment; and products covered by
    regulations that ensure the interoperability and reliability of
    telecommunications service support networks and that ensure
    electromagnetic compatibility and safety. Certification is based on
    product testing conducted in a laboratory approved by the National
    Telecommunications Agency. Additional information is available from:

National Telecommunications Agency

SAUS Quadra 06, Blocos E e H

70070-940 Brasilia, D.F.

telephone: (55-61) 312-2000 - fax (55-61) 312-2002

e-mail: <fcpt@anatel.gov.br>.

**Other products: ** Imports of arms and ammunition and radioactive
material require a permit issued by the Ministry of the Army. Firearms
may only be imported by foreign firearms representatives who have
registered with and obtained authorization from the ministry.

**Ships and boats** require approval by the National Department of Water
Transportation of the Ministry of Transportation and by the Council of
the Merchant Marine.

The **National Petroleum Agency** (ANP) controls the importation of oil
and petroleum.

**Pet food and animal feeds** must be registered with the Department of
Animal Products Inspection in the Ministry of Agriculture and must
**originate in department-approved manufacturing plants.**

**Imports of flammables, airplanes, dangerous substances, chlorinated
pesticides, insecticides, and other agricultural chemicals** require
special approval.

-   Minimum quality standards have been established for certain
    products, which require a quality certification stamp from an
    independent, internationally respected organ in the country of
    export. Additional information concerning this requirement is
    available from the Ministry of Development, Industry, and Trade.

-   Brazil has adopted the harmonized phytosanitary standards of the
    Southern Cone Phytosanitary Committee. The committee is composed of
    representatives of Argentina, Brazil, Chile, Paraguay, and Uruguay.
    The U.S. Department of Agriculture and the Brazilian Ministry of
    Agriculture have reached bilateral agreement that enables U.S.
    fruit, grain, and seed products to meet the standards.

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-   Members of MERCOSUR are developing a voluntary "green stamp"
    **environmental certification program** for various industries based
    upon ISO 14000 criteria. The MERCOSUR Standards Association has also
    been created within the Common Market Council of MERCOSUR to
    harmonize overall technical standards and industrial regulations in
    an effort to end technical trade barriers within the region,
    facilitate the free circulation of goods, and stimulate economic
    development.

For specific information regarding existing foreign agricultural
standards and testing, packaging, and certification systems, exporters
should contact the **Office of Food Safety and Technical Services,
Foreign Agricultural Service, U.S. Department of Agriculture**, South
Agriculture Building, Room 5545, 14th Street and Independence Avenue
S.W., Washington, D.C. 20250, (202) 720-1301; fax: (202) 690-0677. The
National Center for Standards and Certification Information at the
National Institute for Standards and Technology also maintains extensive
files on existing foreign nonagricultural standards and their testing
and certification systems.

Further information is available from the **National Center for
Standards and Certification Information**, National Institute for
Standards and Technology,  Building 820, Room 164, Gaithersburg, Md.
20899, (301) 975-4040; fax: (301) 926-1559.

Additional information on foreign standards is available to firms in the
United States through the American National Standards Institute, 25 W.
43rd St., Fourth Floor, New York, N.Y. 10036, (212) 642-4900; fax: (212)
398-0023, or at 1819 L St. N.W., Suite 600, Washington, D.C. 20036,
(202) 293-8020; fax: (202) 293-9287; e-mail: <info@ansi.org>.

**Canada**

-   Canada is a signatory to the **Agreement on Technical Barriers to
    Trade**, commonly known as the Standards Agreement, negotiated under
    the Tokyo Round of multilateral trade negotiations. The agreement is
    designed to eliminate the use of standards and certification systems
    as impediments to trade.

    -   The Standards Agreement does not dictate what the product
        standards mustbe, but it does call for open procedures in
        adopting standards and sets up a review procedure for settling
        disputes. Signatories are required to publish a notice of their
        proposed standards; to provide copies of these standards, if
        requested; and to allow countries to comment on them.

    -   Standards (both voluntary and mandatory) and certification
        systems promulgated by central, state, and local governments and
        by private sector organizations are subject to the Standards
        Agreement\'s provisions, although only central governments are
        directly bound by it. The agreement requires that signatories
        "shall ensure that" central government bodies comply fully with
        its provisions. With respect to regional, state, local, and
        private organizations, the agreement requires signatories to
        "take such reasonable measures as may be available to them" to
        ensure compliance.

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    -   If exporters have reason to believe that a standard of any
        signatory country impedes their exports, these concerns may be
        communicated to the Office of Standards Code and Information,
        National Institute of Standards and Technology, Building 820,
        Room 164, Gaithersburg, Md. 20899, (301) 975-4037; fax: (301)
        926-1559.

    -   Under the aegis of the **Standards Council of Canada,** several
        private standards-writing organizations administer technical
        codes and standards for areas ranging from electrical and
        plumbing products to health care technology. The standards
        organizations try to avoid duplication of responsibility, but
        there is some overlap. **Certification generally must be
        obtained by the manufacturer before goods enter Canada**.
        Information on standards is available from the Standards Council
        of Canada, 270 Albert St., Suite 1200, Ottawa, Ontario K1P
        6N7, (613) 238-3222; fax: (613) 569-7808.

    -   The Canadian federal government also has numerous commodity
        standards to safeguard the public welfare. U.S. manufacturers
        and exporters should determine what government standards are
        applicable to their products and receive written notification
        that they are in compliance prior to shipping goods to Canada.

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    -   **Special requirements may exist for the following products:**
        ceramics; certain chemicals; safety glass; toys, children\'s
        furniture, and children\'s sleepwear; fireworks; automobile
        tires; pest control products; any goods that may be considered
        dangerous or hazardous; raw furs; gas-fired appliances,
        equipment, accessories, or components; steel products; textiles,
        buttons, and footwear; radio-transmitting and interference
        equipment; plumbing products; fuel-burning and fuel-handling
        equipment; electrical appliances and equipment; building
        products and structures; fire protection equipment and systems;
        and safety footwear, safety headgear, and safety equipment for
        sports.

    -   Certain **agricultural and food products** must adhere to
        standardized package sizes and minimum type size specifications,
        as well as to labeling requirements outlined below. Some
        agricultural chemicals approved for use in the United States are
        not registered in Canada. Consequently, these products have zero
        tolerance in Canada, and food products containing these
        chemicals in amounts greated than 0.1 parts per million may be
        detained, destroyed, or returned. The use of food additives is
        strictly controlled by Canada\'s Food and Drugs Act and
        Regulations. Products containing food additives that are not
        permitted may be refused entry into the country.

    -   **Fish and fish products** imported into Canada must comply with
        the quality, grade, packing, and labeling requirements of the
        Fish Inspection Act and Regulations. Certain restrictions also
        are in place for the importation of live or raw bivalve
        molluscan shellfish such as mussels, clams, and oysters. In some
        cases, import permits are required and/or provincial
        requirements apply.

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    -   **Honeybees** from the United States, except from the state of
        Hawaii, are prohibited importation into Canada until Dec.
        31, 2004. Further information is available from the Food
        Inspection Agency, 59 Camelot Drive, Nepean, Ontario K1A
        0Y9, (613) 225-2342; fax: (613) 228-6601.

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    -   Specific information regarding existing foreign agricultural
        standards and testing, packing, and certification systems is
        available from the Office of Food Safety and Technical Services,
        Foreign Agricultural Service, U.**S. Department of Agriculture,
        South Agriculture Building, Room 5545, 14th Street and
        Independence Avenue S.W., Washington, D.C. 20250, (202)
        720-1301; fax: (202) 690-0677**. The National Center for
        Standards and Certification Information at the National
        Institute for Standards and Technology also maintains extensive
        files on existing foreign nonagricultural standards and their
        tesing and certification systems. Further information is
        available from the National Center for Standards and
        Certification Information, National Institute for Standards and
        Technology, Building 820, Room 164, Gaithersburg, Md.
        20899, (301) 975-4040; fax: (301) 926-1559.

**Additional information** on foreign standards is available to firms in
the United States through the American National Standards Institute, 25
W. 43rd St., Fourth Floor, New York, N.Y. 10036, (212) 642-4900; fax:
(212) 398-0023, or at 1819 L St. N.W., Suite 600, Washington, D.C.
20036, (202) 293-8020; fax: (202) 293-9287; e-mail: info@ansi.org.

#### Chile

-   The National Standards Institute (Instituto Nacional de
    Normalizacion---INN) develops and publishes voluntary standards in
    response to government or industrial sector requests. The institute
    is the only organization that can submit documents to government
    authorities to make them official standards.

-   Chile is a signatory to the **Agreement on Technical Barriers to
    Trade**, commonly known as the Standards Agreement, negotiated under
    the Tokyo Round of multilateral trade negotiations. The agreement is
    designed to eliminate the use of standards and certification systems
    as impediments to trade.

-   **In general, standards are not mandatory.** In some industries,
    compliance with standards constitutes a "seal of approval." Some
    government agencies have certification programs for products for
    which **certification is mandatory**. Examples of these products are
    **fire extinguishers, electrical and gas products, food and health
    products, items related to industrial safety, and building and
    construction materials.**

    -   **Additional information** is available from **Instituto
        Nacional de Normalizacion, Matias Cousino 64, piso 6, Casilla
        995, Correo 1, Santiago**; telephone: (56-2) 441-0330; fax:
        (56-2) 441-0427; e-mail: inn@inn.cl.

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-   Imports of **firearms** require a permit from a military authority.

-   Prior registration with the Instituto de Salud Publica (Institute of
    Public Health) is required for imports of **pharmaceutical products,
    cosmetics, and most biological and biochemical preparations**.
    Registration of these products generally requires extensive testing
    and analysis of finished samples by designated licensed entities in
    Chile.

-   Standards for pharmaceuticals, cosmetics, nutritional aids, medical
    devices, and pesticides are in effect. Importation, manufacture,
    distribution, sale, or application of agricultural pesticides
    containing pentachlorophenol is prohibited.

-   **Imports considered harmful** to Chilean morals, public health,
    national security, or the environment require special authorization.
    Among the items affected are certain personal security products such
    as **mace sprays, certain chemicals and chemical processes, and some
    media products** that face review and possible censorship. All
    films, videos, and television programs, whether imported or locally
    produced, are reviewed for suitability.

-   **Pharmaceutical products,** including vitamins and minerals used as
    nutritional aids, may be sold only in pharmacies or directly to
    other authorized institutions.

-   **Foodstuffs:**Prior authorization from the Instituto de Salud
    Publica is required for all imported foodstuffs. Detailed quality
    standards for imported foodstuffs have been established, and all
    foodstuffs are subject to sampling and analysis by health
    authorities.

    -   **For specific information** regarding existing foreign
        agricultural standards and testing, packaging, and certification
        systems, exporters should contact the Office of Food Safety and
        Technical Services, Foreign Agricultural Service, **U.S.
        Department of Agriculture, South Agriculture Building, Room
        5545, 14th Street and Independence Avenue S.W., Washington, D.C.
        20250**, (202) 720-1301; fax: (202) 690-0677.

    -   The National Center for Standards and Certification Information
        at the National Institute for Standards and Technology also
        maintains extensive files on existing foreign nonagricultural
        standards and their testing and certification systems. **Further
        information** is available from the **National Center for
        Standards and Certification Information, National Institute for
        Standards and Technology, Building 820, Room 164, Gaithersburg,
        Md. 20899**, (301) 975-4040; fax: (301) 926-1559.

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-   **Additional information on foreign standards** is available to
    firms in the United States through the **American National Standards
    Institute, 25 W. 43rd St., Fourth Floor, New York, N.Y.
    10036**, (212) 642-4900; fax: (212) 398-0023, or at **1819 L St.
    N.W., Suite 600, Washington, D.C. 20036**, (202) 293-8020;
    fax: (202) 293-9287; e-mail: <info@ansi.org>.

-   If exporters have reason to believe that a standard of any signatory
    country unjustifiably impedes their exports, these concerns may be
    communicated to the Office of Standards Code and Information,
    National Institute of Standards and Technology, Building 820, Room
    164, Gaithersburg, Md. 20899, (301) 975-4037; fax: (301) 926-1559.

**China**

-   **Compulsory product certification: ** Products listed in the
    **Catalog of Products Subject to Compulsory Certification**, whether
    imported or produced domestically, must be certified and have the
    official China Compulsory Certification mark (CCC) affixed,
    effective May 1, 2002. Compulsory product certification is a
    comprehensive system of product inspection and approval that
    replaces the certification and marking originally required under the
    Commodities Inspection Law, as well as the safety license and its
    relevant marking.

-   **The catalog includes** the following product classifications:
    electrical wires and cables, switches for circuits and installations
    for protective and connective devices, low-voltage electrical
    apparatus, small power motors, electric tools, welding machines,
    household and similar electrical appliances, audio and video
    apparatus, information technology equipment, lighting apparatus with
    voltage higher than 36 volts, telecommunications terminal equipment,
    motor vehicles and safety parts, motor vehicle tires, safety
    glasses, agricultural machinery, latex products, medical devices,
    fire fighting equipment, and detectors for intruder alarm systems.

-   Imported goods must be approved prior to shipping. The application
    for inspection and certification must be submitted by the exporter
    or the exporter\'s designated agent to the Chinese National
    Certification and Accreditation Administration (CNCA), established
    in September 2001 by the State General Administration for Quality
    Supervision and Inspection and Quarantine (AQSIQ) to oversee the new
    system. Certification is based on product compliance with Chinese
    national standards, when they exist. When there is no applicable
    Chinese standard, certification is based on designated foreign
    standards. Testing and certification are conducted by
    CNCA-designated bodies. Foreign certification bodies may be
    accredited by the CNCA.

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-   **AQSIQ** was established in April 2001 when the State
    Administration for Entry and Exit Quarantine and Inspection was
    merged with the China State Bureau of Quality and Technical
    Supervision. **Additional information is available from AQSIQ at 15
    Fangcaodi Xijie, Chaoyang District, Beijing 100020; telephone:
    (86-10) 6599-4328; fax: (86-10) 6599-4306.**

-   **Information security products certification: ** Imported and
    domestically produced computer software and hardware products used
    for data security or encryption must be tested and certified by the
    China National Information Security Testing Evaluation and
    Certification Center (CNISTEC) under regulations published in
    August 1998. Access control products, proxy servers, authentication
    products, security auditing products, security management products,
    data integrity products, digital signature products, non-repudiation
    products, commercial encryption products, and tempest products are
    among the items requiring certification.

-   **Certification may be obtained** by the product\'s researcher,
    developer, user, or management organization. In order to be tested
    and certified, the applicant must submit two sets of the item in
    question; any related accessories, including floppy diskettes,
    CD-Roms, etc.; complete technical documentation, including the user
    manual; related computer or telecommunication peripheral equipment;
    applicant\'s own test results; and any other documentation deemed
    necessary. The testing process takes approximately three months;
    certification is valid for two years.

    -   **Additional information** is available from the China National
        Information Security Testing Evaluation and Certification
        Center, No. 36 Xinjiang Gongmen, Hai Dian District, Beijing
        100091; telephone: (86-10) 6879-6484; fax: (86-10) 6288-0411.

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-   **Telecommunications equipment license: ** Telecommunications
    products, including wired and wireless equipment, hardware, and
    software, must be licensed by the Telecommunications Administration
    of the Ministry of Information Industry as of Jan. 1, 1999. The
    Telecommunications Administration maintains a catalog of all
    licensed telecommunications equipment; operators are prohibited from
    purchasing equipment not listed in this catalog.

**Licenses** must be obtained by the manufacturer prior to import. The
license application must be submitted to one of two Telecommunications
Equipment License Processing Offices. It must be accompanied by the
company\'s business license; information about the manufacturer,
including a company profile, production conditions, instruments, quality
control system, and after-sale service system; letter of guarantee
signed by the legal representative of the manufacturer; product
description; photographs of the appearance and the internal structure of
the product; user manual; results of any tests performed outside of
China; information about the product\'s commercial application; and
proof of permission to market the product in China. Foreign
manufacturers must submit proof of authorization for a Chinese agent to
apply for the license on the manufacturer\'s behalf.  The license is
**valid for three years** and may be renewed provided an application for
renewal is submitted three months before the license expires.

-   **Additional information** is available from the Telecommunications
    Equipment License Processing Offices at No. 28 Xin Jie Kou Wai
    Dajie, Xi Cheng District, Beijing; telephone: (86-10) 6238-2481;
    fax: (86-10) 6238-2482; and at No. 11 Yuetan Nan Jie, Xi Cheng
    District, Beijing; telephone: (86-10) 6809-4061; fax: (86-10)
    6802-8601.

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-   **Drugs and pharmaceuticals: ** Import of foreign pharmaceuticals,
    including pharmaceutical raw materials and drugs, may require
    special permission from the State Drug Administration. Applications
    for permits may be made directly to the SDA or through municipal or
    provincial public health organizations and medicinal trading
    companies. The following information generally is required: letter
    of patent, clinical data on dosage and side effects, methods of
    quality control, production process, names of active ingredients,
    and literature on pharmacological and toxicological experiments.
    Samples of the product also may be required for clinical validation.

-   **Medical devices: ** Imported medical devices must be registered
    with the State Drug Administration, effective April 10, 2000. The
    application for registration must include a qualification
    certificate for the product\'s manufacturer and the applicant;
    certificate of free sale; technical specifications of the product,
    including test methods; instruction manual for the product; test
    report issued by an SDA-approved testing facility; clinical trial
    reports from more than two trial bases conducted in compliance with
    Chinese regulations on the Provisions on Clinical Trials for medical
    devices; statement issued by the manufacturer guaranteeing that the
    quality of the product to be sold in China is equal to that of the
    product sold in the country of origin; letter of authorization
    designating after-sales service agencies in China, along with a
    letter of commitment and the business licenses from each agency; and
    a statement guaranteeing that the materials submitted with the
    registration application are authentic. Application submissions must
    be in Chinese. The State Drug Administration must accept or reject
    an application for registration within 90 days of receipt.
    Registration of imported devices is valid for four years;
    application for registration renewal must be made six months before
    the registration expires. The renewal application must be
    accompanied by all of the above-mentioned documents, along with a
    report that tracks the product\'s quality over the prior
    registration period.

**A medical device is classified according to** its form of operation,
whether passive or active; its condition for use, whether through
contact with the body or not; and its intended duration, whether
temporary, short-term, or long-term. The State Drug Administration may
require additional information for certain kinds of medical devices.
Also, medical diagnostic x-ray equipment, hemodialysis equipment and
hollow fiber dialysis equipment, blood purification equipment,
electrocardiographs, implantable cardiac pacemakers, and ultrasound
equipment require the approval of the State General Administration for
Quality Supervision and Inspection and Quarantine (see above for
additional information).

-   **Technology imports: ** Regulations governing high technology
    imports require that contracts for importing complete sets of
    equipment, production lines, or key equipment in connection with
    licensing or transfer of patents, trademarks or know-how and other
    technology import contracts be approved by the Ministry of Foreign
    Trade and Economic Cooperation and its provincial branches.

-   **Quarantine and inspection requirement: ** Imports of meat products
    intended for human consumption; goods in transit that contain
    genetically modified organisms; animals including those in transit;
    plants subject to review and approval and their products, as well as
    containers and packaging materials for these products, are subject
    to quarantine inspection upon entry. In general, application for
    inspection and quarantine should include the quarantine permit, the
    original copy of the quarantine certificate issued in the country of
    origin, the place of origin certificate, the trade contract, the
    letter of credit, the bill of lading, the invoice, and other related
    documents. If the reviewing agency requests that a risk assessment
    be performed by experts, the applicant also must provide related
    documents and samples of the product.

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-   An animal and plant quarantine entry permit from the State General
    Administration for Quality Supervision and Inspection and Quarantine
    is required for animals and genetically modified products before the
    contract for the goods is signed or the products shipped.

-   **Applications for the quarantine permit should include the
    following items**: certification that the applicant is a legally
    qualified one; for certain products, a signed contract identifying
    the entity designated by the State General Administration for
    Quality Supervision and Inspection and Quarantine to produce,
    process, or store the product; if the applicant has applied for such
    permits in the past, the quarantine permit from the last
    application, including the verification table; if applicable, an
    application for a permit for temporary quarantine of an entering
    animal; for animals in transit, identification of the transit route,
    provision of an animal hygiene certificate issued in the exporting
    country or region, and the certification document for entry issued
    by an official quarantine department of the importing country or
    region; and, if applicable, approval to import prohibited products
    for scientific research.

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-   An applicant can apply for only one quarantine permit for the same
    product from the same exporting country or region for the same
    consumption or processing intention. If application is made for
    multiple entries or if the product or products require verification,
    the inspection agency must register verification in a table attached
    to the permit. Permits for multiple entries sometimes specify a
    permitted quantity. Permits are valid only for three months or one
    entry. Quarantine permits may not be transferred.

-   Officials of the State General Administration for Quality
    Supervision and Inspection and Quarantine may travel to a country
    exporting meat products to conduct a pre-inspection.

-   An applicant should re-apply for a quarantine permit if the amount
    of the entry product exceeds 5 percent of the permitted quantity, if
    the variety of the product has been altered, or if the port of entry
    or destination or the transportation route has been changed.

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-   **Separate regulations govern imports of fresh fruit.** Fruit
    originating in areas infested by the Mediterranean fruit fly is
    prohibited import until a pest risk analysis has been conducted and
    a quarantine protocol signed between China and the exporting
    country.

-   **Other goods: ** Many imports are subject to more stringent
    standards than domestic products.

-   Certain items, including some steel products, out-of-service ships,
    nonferrous metals, plastic materials, paper, fruit, and cosmetics,
    must undergo an **automatic registration process** and be issued a
    certificate of registration for the import of special commodities.
    The certificate is valid for six months.

-   Producers of animal feeds and feed additives must register with the
    Ministry of Agriculture, which then certifies the product.
    Certification is valid for five years. Exporters should consult
    their customers for additional information.

-   **Food products: ** Foodstuffs are subject to the Food Hygiene Law,
    which governs food additives, containers, and packaging materials,
    among other products. The Food Additive Hygiene Standard provides a
    list of permitted additives and addresses their approved usage.
    Additives not included in the standard are subject to registration
    and approval of the Ministry of Health. The ministry also has
    established maximum residue limits for pesticides and other
    contaminants.

Manufacturers of products listed in the **Catalog of Imported Food
Subject to Enterprise Registration** must be registered with the Chinese
National Certification and Accreditation Administration. Products from
unregistered manufacturers will not be permitted importation. Currently,
the catalog lists only meat, including livestock and poultry meat, meat
products, edible byproducts, and organs.

**The application for registration** must be in English and Chinese, and
must include the name of the manufacturer; status of animal and plant
diseases in the country and region of origin, including regulations on
veterinary sanitation, public hygiene, plant protection, pesticide
residue monitoring, and veterinary medicines; assessment of the
quarantine and sanitary conditions of the manufacturer by the relevant
authorities in the country of origin and guarantee by the authorities
that the manufacturer meets Chinese standards; and supporting documents
about the manufacturer\'s enterprise, including factory layout, workshop
and freezer design, and illustration of production flow.

**Certain grain and feed products are subject to inspection upon
entry.** The regulations apply to grain products not intended for
sowing, including wheat, corn, rice, barley, rye, oat, and sorghum;
beans, including soybeans, mung beans, peas, adzuki beans, broad beans,
and kidney beans; tubers, including potatoes, cassava, and sweet
potatoes; and processed products, including rice, malt, and wheat flour.
Feed products include processed grain and oil byproducts such as wheat
bran, soybean cake, and soy meal. The application for inspection must be
filed by the exporter or the Chinese agent and approved by the relevant
local branch of the State General Administration for Quality Supervision
and Inspection and Quarantine, which then conducts the inspection when
the goods arrive in China.

**Genetically modified products,** including animals and animal
products, plants and plant products, microorganisms, and processed
products made with genetically modified ingredients, require import
approval from the Agricultural Administrative Department of the State
Council. The application for import approval must include the following
items, depending on the product\'s classification and function:
certification that adequate product research has been performed; a list
of precautionary measures that will be applied while the product is
being introduced in China; documents concerning safety test results;
certificate of free sale; and documentation of scientific testing in the
exporting country showing that the product does not harm humans,
animals, plants, microorganisms, and the environment.

-   Genetically modified products are classified according to their
    potential danger to humans, animals, plants, microorganisms, and the
    environment. Class I products present no danger; Class II, low
    danger; Class III, medium danger; and Class IV, high danger.
    Imported products are administered according to their purpose, such
    as testing and research, production, or raw materials. Exporters
    should consult their customers for requirements pertaining to
    specific products.

Information on existing foreign agricultural standards and testing,
packaging, and certification systems is available from the Office of
Food Safety and Technical Services, Foreign Agricultural Service, U.S.
Department of Agriculture, South Agriculture Building, Room 5545, 14th
Street and Independence Avenue S.W., Washington, D.C. 20250, (202)
720-1301; fax: (202) 690-0677. Information on existing nonagricultural
standards and their certification systems is available from the National
Center for Standards and Certification Information, National Institute
for Standards and Technology, Building 820, Room 164, Gaithersburg, Md.
20899, (301) 975-4040; fax: (301) 926-1559.

-   **Additional information** on foreign standards is available to
    firms in the United States through the American National Standards
    Institute, 25 W. 43rd St., Fourth Floor, New York, N.Y. 10036, (212)
    642-4900; fax: (212) 398-0023, or at 1819 L St. N.W., Suite 600,
    Washington, D.C. 20036, (202) 293-8020; fax: (202) 293-9287; e-mail:
    info@ansi.org. Exporters are strongly encouraged to discuss import
    requirements with their Chinese clients, due to the complexity of
    Chinese trade regulations.

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-   This website includes Frequently Asked Questions for China
    Compulsory Certification (CCC) and mark issues. The FAQ's address
    the following topics:

    -   [Spare Parts, Components, and the Exemption
        Process](http://www.mac.doc.gov/China/Docs/BusinessGuides/#q1)

    -   [CNCA Standards and
        Regulations](http://www.mac.doc.gov/China/Docs/BusinessGuides/#q2)

    -   [Sample Testing and Factory
        Inspection](http://www.mac.doc.gov/China/Docs/BusinessGuides/#q3)

    -   [Product Classification and Customs/Border
        Issues](http://www.mac.doc.gov/China/Docs/BusinessGuides/#q4)

    -   [CCC Mark Labeling
        Issues](http://www.mac.doc.gov/China/Docs/BusinessGuides/#q5)

    -   [FAQs on Miscellaneous
        Issues](http://www.mac.doc.gov/China/Docs/BusinessGuides/#q6)

        -   The web address is:
            <http://www.mac.doc.gov/China/Docs/BusinessGuides/cccguide.htm>.

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    -   This website gives the CCC's 19 product groups and the 132
        product categories they are divided into

        -   <http://www.ccc-mark.com/ccc/lists-of-products-subject-to-ccc-mark.html>

            -   If the short descriptions on this page are not
                sufficient, you can do one of two things.

                1.  Review the CNCA's "Implementation Rules" booklets.
                    The 47 booklets each provide a "scope" section,
                    which in some cases provide a more detailed
                    description of which products require the CCC mark

                2.  Review the CNCA's "Announcement 60," a table linking
                    HS codes to products that require the CCC mark (see
                    [www.cnca.gov.cn/board/bianmabiao.htm](http://www.cnca.gov.cn/board/bianmabiao.htm)).
                    This document is only available in Chinese but you
                    may be able to find the HS code and then have a
                    translator translate that section. If you do not
                    know your HS codes, check with your shipping dep't,
                    freight forwarder, or whoever handles your Chinese
                    customs paperwork. Alternatively, contact the
                    Foreign Trade Division of the U.S. Census Bureau.
                    For durable goods, call (301)763-3259. For
                    non-durable goods, call (301)763-3484.

> *(Wineland, et al. " Ask the TIC" Export America April 2003)*

-   **China Compulsory Certification (CCC) general information**

    -   The application process for the CCC mark:

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-   can take sixty to ninety days or longer;

-   requires testing at accredited laboratories in China;

-   generally does not permit self certification or third-party testing
    results;

-   requires submission of numerous technical documents;

-   requires submission of a product sample to a Chinese testing
    laboratory;

-   requires a factory inspection by Chinese officials at the
    applicant\'s expense;

-   requires follow-up inspections every twelve to eighteen months; and

-   can cost several thousand dollars.

The CCC Mark is administered by the Chinese government agency
Certification and Accreditation Administration (CNCA). The following are
steps involved in processing CCC mark applications.

-   **Determine Whether Your Products Require CCC Marking **

-   **Get the Implementing Regulations**

    -   The CNCA has published 47 "Implementation Rules for Compulsory
        Certification." The booklets are available at
        [www.cnca.gov.cn/download/english.html](http://www.cnca.gov.cn/download/english.html)
        The booklets list technical appication requirements for each of
        the product categories. The rules cite numerous "GB Standards,"
        which are mandatory anational standards. Information on
        mandatory standards is available from the following agency:

WTO/TBT National Enquiry Point

Administration of Quality Supervision, Inspection and Quarantine

People's Republic of China

Tel: +86-10-856-22885

Fax: +86-10-856-22884

E-mail: tbt@aqsiq.gov.cn

-   **Consider Your Options for Applying**

    -   If you decide to go through a consulting firm a list of
        companies is available on
        [www.mac.doc.gov/China/Docs/BusinessGuides/cccguide.htm](http://www.mac.doc.gov/China/Docs/BusinessGuides/cccguide.htm)

-   **Apply **

    -   If a company decides to handle the application process they
        should visit the website of the China Quality Certification
        Center
        (CQC):[www.cqc.com.cn/index-e.htm](http://www.cqc.com.cn/index-e.htm)
        at this site, click on the "CCC Aplication On-line Guide." A
        document with instructions on how to apply for the CCC mark.

-   Note Other Chinese Licensing Requirements

*(Wineland, et al. " Ask the TIC" Export America April 2003)*

-   <http://www.etlsemko.com/agmcccmark.htm>

-   <http://www.exportassistance.com/hot_topics/hot_topics.html>

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-   If a company encounters difficulties with the CCC system or has
    trade policy concerns, contact:

> **Timothy Wineland**

## Office of the Chinese Economic Area

> **U.S. Department of Commerce**
>
> Tel: (202)482-5316
>
> Fax: (202)482-1576
>
> E-mail: <Timothy_Wineland@ita.doc.gov>

**Egypt**

-   [EOS]{.underline} -- Egyptian Organization for Standardization and
    Quality Control

    -   <http://www.eos.org.eg/web_en/intro/aboutEos.html>

-   On September 19, 1996, the Ministry of Industry issued Ministerial
    Decree No. 180/1996 whereby all manufacturers and importers are
    required to abide by Egyptian product standards. In cases where no
    mandatory standard exist, the following standards are acceptable:\
    \
    - Egyptian Product Standards (voluntary)\
    - International Standards (ISO/IEC)\
    - European Standards (EN); in the absence of EN standards, British
    (BS), German (DIN), and French (NF) standards may be applied\
    - American Standards (ANS)\
    - Japanese Standards\
    - Codex Standards\
    \
    In the absence of an Egyptian or international standard, authorities
    often will refer to the Analysis Certificate accompanying the
    product.

    -   <http://www.usatrade.gov/Website/CCG.nsf/CCGurl/CCG-EGYPT2002-CH-6:-002735C5>

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-   Egypt is a signatory to the Agreement on Technical Barriers to
    Trade, commonly known as the Standards Agreement, negotiated under
    the Tokyo Round of multilateral trade negotiations. The agreement is
    designed to eliminate the use of standards and certification systems
    as impediments to trade. If exporters have reason to believe that a
    standard of any signatory country unjustifiably impedes their
    exports, these concerns may be communicated to the Office of
    Standards Code and Information, National Institute of Standards and
    Technology, Building 820, Room 164, Gaithersburg, Md. 20899, (301)
    975--4037; fax (301) 926--1559.

-   Egypt is a **member of the African Regional Organization for
    Standardization** (Organisation Regionale Africaine de
    Normalisation), an intergovernmental body designed to harmonize
    standards of member states and to promote standardization in Africa.
    Additional information concerning ARSO is available from the
    Secretary General, African Regional Organization for
    Standardization, P.O. Box 57363, Nairobi, Kenya; telephone: 254 2
    224561; fax: 254 2 218792.

The Egyptian Organization for Standardization and Quality Control in the
Ministry of Industry is responsible for setting product standards;
however, application and enforcement of standards often fall to other
government agencies. Where no product standard has been developed, U.S.
standards are generally acceptable. Additional information about product
standards is available from the Egyptian Organization for
Standardization and Quality Control, 16 Tadreeb El Motdrabeen St.,
Amiria, Cairo; telephone: (2) 2566022; fax: (2) 2593480; telex: 93296
eos un; e-mail: moi@idsc.gov.eg.

-   **Quality inspection**: Many foodstuffs, household appliances,
    transformers, and consumer goods are subject to quality inspection
    on entry into Egypt to ensure the products comply with standards and
    labeling requirements. Effective in February 2000, the General
    Organization for Export/Import Control of the Ministry of Economy
    and Foreign Trade conducts all inspections in consultation with the
    ministries under whose jurisdictions the products fall.

-   **Pharmaceuticals registration:** Pharmaceutical products, including
    cosmetics, medical soaps, medicated pastilles, and toothpastes, must
    be registered with the Ministry of Health; information on chemical
    composition must be provided.

-   **Foodstuffs**: There are quality standards for the manufacture,
    import, and sale of edible vegetable and animal oils and greases;
    preserved tomatoes; tomato pulp, sauces, and juice; molasses; salt;
    soap; and alcoholic beverages. Special regulations also affect the
    importation of butter, raw wool, cod liver oil, whiskey, fruits,
    potatoes, preserved green vegetables, plants, and seeds. Imported
    beef intended for direct human consumption must have less than 7
    percent fat.

-   The Ministry of Health restricts the type and number of **food
    colorings** and **preservatives**, but all **flavorings** accepted
    under the Codex Alimentarius and by the World Health Organization
    are approved for use in Egypt. Not all approved **additives** are
    permitted in all food products. Egyptian standards for **pesticide**
    residues are derived from standards set by the United Nations\' Food
    and Agricultural Organization and World Health Organization.

-   **Imported food products** must have at least **50 percent of their
    shelf life** remaining at the time of import; the time of import is
    considered to be when all customs procedures have been completed and
    the goods released.

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-   **Pesticides**: The Central Agricultural Pesticides Laboratory must
    register all pesticides before they may be used in Egypt. The
    registration application must be accompanied by, among other things,
    field and laboratory evaluation results, a registration certificate
    valid in the country of origin, and a sample label.

-   **Packaged goods**: Packaged goods must be well protected by the
    packaging. The product should fill the package completely. Wooden
    packages require a special certificate (see Documentary Requirements
    above).

-   **Other requirements:** The importation of cotton plants, ginned or
    unginned cotton, cottonseed, and cotton stems is prohibited. The
    transshipment of cotton and cottonseed through Egyptian ports is
    regulated separately. Wooden containers are subject to possible
    fumigation upon arrival in Egypt if any signs of wood borer
    infestation are found.

-   Some **non-food products**, generally medical equipment such as
    catheters and syringes, may be subject to a requirement that at
    least 50 percent of their shelf life remain at the time of import.

-   **For specific information** regarding existing foreign agricultural
    standards and testing, packaging, and certification systems,
    exporters should contact the Office of Food Safety and Technical
    Services, Foreign Agricultural Service, U.S. Department of
    Agriculture, South Agriculture Building, Room 5545, 14th Street and
    Independence Avenue S.W., Washington, D.C. 20250, (202) 720--1301;
    fax: (202) 690--0677. The National Center for Standards and
    Certification Information at the National Institute for Standards
    and Technology also maintains extensive files on existing foreign
    non-agricultural standards and their testing and certification
    systems. Further information is available from the National Center
    for Standards and Certification Information, National Institute for
    Standards and Technology, Building 820, Room 164, Gaithersburg, Md.
    20899, (301) 975--4040; fax: (301) 926--1559.

-   **Additional information** on foreign standards is available to
    firms in the United States through the American National Standards
    Institute, 11 W. 42nd St., New York, N.Y. 10036, (212) 642--4900;
    fax: (212) 398--0023.

**France**

-   **Description of EU standards harmonization process:**

The task of drawing up specific technical standards on the basis of
mandates from the EU Commission is delegated to three European regional
standards organizations---CEN (European Committee for Standardization),
CENELEC (European Committee for Electrotechnical Standardization), and
ETSI (European Telecommunications Standards Institute). First
consideration in standards development is given to existing standards
drawn up by the ISO or by the International Electrotechnical Commission.

There are ongoing efforts to harmonize product standards in the EU, but
widely differing standards, testing, and certification procedures
continue to exist in member countries for both industrial and consumer
products. Once the harmonization process is completed, however,
domestic, as well as imported, goods will have to meet established EU
standards.

If a proposed standard duplicates an existing common European standard
established by the Comite Europeen des Normes (CEN), the CEN standard
becomes the French standard. If International Standards Organization
quality assurance standards (ISO9000) are prepared subsequent to the
issuance of CEN standards and if they differ from the CEN standards, the
ISO standards will prevail, and the French national standard will be
modified to conform.

The end result of the standards harmonization process in the EU will be
a hierarchical system, with national standards being traceable via the
CEN to the ISO, thereby providing the basis for mutual recognition of
national standards. When a national standard is published, previously
accepted industry standards are superseded. When an EU (CEN) standard is
issued, the national standard is superseded, and when an ISO standard is
issued the EU or CEN standard is superseded.

**Many products sold in the European Union require a CE mark** that
certifies that the products conform to the legal requirements of EU
directives published in the Official Journal of the European Community.
The directives cover essential safety or other performance requirements
in the general interest. If more than one directive applies to a product
the product must comply with all appropriate provisions in all of the
applicable directives in order to receive the CE mark. Once a product
receives the CE mark it may circulate freely within the EU. Many
consumers in EU member states perceive the CE mark as being a quality
mark.

-   **Among the product categories covered by the mark** are machinery,
    toys, construction products, personal protection equipment,
    non-automatic weighing machines, medical devices, gas appliances,
    hot water boilers, and telecommunications terminal equipment.
    Manufacturers can self certify some products. For these items, the
    manufacturer should identify applicable directives and national,
    European Union, or international standards to be used in determining
    whether the product meets legal requirements. Once the relevant
    directives have been identified, the manufacturer can test the
    product to determine its conformance to appropriate legal
    requirements, affix the CE mark to the product, and construct a
    technical file that will be available for inspection with the
    authorized representative or importer in the EU. Some products such
    as medical devices and dangerous machines require additional testing
    by a laboratory that has been designated as "competent" by the
    European Union.

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-   **More detailed information** concerning this requirement is
    available in Directive 93/44/EEC, dated Jan. 1, 1997. Information is
    also available from the U.S. Department of Commerce, International
    Trade Administration, Office of European Union and Regional
    Affairs, (202) 482--5276 or 482--4494; fax: (202) 482--2897; or the
    National Center for Standards and Certification Information at the
    National Institute for Standards and Technology (see address below).
    See also Documentary Requirements above for additional information.

    -   **Directives have been adopted for consumer-ready agricultural
        products** concerning food labels, pre-packaged and frozen
        foods, substances in contact with food, food additives, dietetic
        foods, protection of geographic designations and designation of
        origin, food contaminants, aflatoxins, and novel foods.
        Regulations are either in force or scheduled for implementation
        related to noise levels for machinery, airplanes, motor
        vehicles, and other apparatus.

    -   **The EU has adopted maximum allowable residue levels for a list
        of pesticides**. However, pesticides that are not on the EU list
        are subject to the regulations of individual member states.

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    -   EU regulations also require that **imported wines** be produced
        only with those oenological practices that are authorized for
        the production of EU wines. Although U.S. wines have been
        permitted entry in the past under EU regulatory exemptions,
        exporters should consult their clients in the market concerning
        current requirements.

    -   In June 1997, the United States and the European Union accepted
        a package of mutual recognition agreements that allows U.S.
        products or processes to be assessed for conformity to EU
        testing, inspection, and certification requirements in the
        United States. Products of EU member states will likewise be
        evaluated against U.S. requirements. The agreements include
        network and electromagnetic compatitiblity for
        telecommunications, medical devices, electrical safety for
        electrical and electronic products, recreational craft,
        pharmaceuticals, veterinary medicines, and industrial fasteners.
        The agreements will be phased in and fully implemented
        gradually. Additional information concerning MRAs is available
        from the U.S. Department of Commerce, International Trade
        Administration, Office of European Union and Regional Affairs,
        Washington, D.C.

    -   **U.S. exporters experiencing problems related to the
        application of the mutual recognition agreements may contact the
        National Institute of Standards and Technology by telephone at
        888--591--8378 or by e-mail at <oiaa@nist.gov>.**

    -   France is a signatory to the **Agreement on Technical Barriers
        to Trade**, commonly known as the Standards Agreement,
        negotiated under the Tokyo Round of multilateral trade
        negotiations. The agreement is designed to eliminate the use of
        standards and certification systems as impediments to trade.

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-   If exporters have reason to believe that a standard of any signatory
    country unjustifiably impedes their exports, these concerns may be
    communicated to the Office of Standards Code and Information,
    National Institute of Standards and Technology, Building 820, Room
    164, Gaithersburg, Md. 20899, (301) 975--4037; fax: (301) 926--1559.

    -   **All goods entering France should conform** to French or
        European Union standards. Conformity is mandatory for all
        products satisfying publicly funded contracts, as well as for
        all machinery, tools, household appliances, sporting equipment,
        toys, etc. Conformity is generally optional for other goods
        satisfying private contracts. However, products that meet French
        and EU standards have increased marketability.

    -   **The Association Francaise de Normalisation (AFNOR)**
        coordinates all work and research relating to standardization.
        AFNOR works closely with professional, industrial, and
        governmental organizations that perform the technical work
        including testing. AFNOR prepares new and revised standards,
        subjects them to public inquiry, and finally submits them to the
        relevant ministry for approval.

    -   Compliance with approved standards is mandatory in contracts and
        projects involving public funds, but they are usually optional
        in the private sector. However, if a standard is mentioned
        expressly in the contract, its application is legally binding.
        Ministerial approval of a standard may include a decision to
        make it mandatory, especially when it has a special bearing on
        public safety and business integrity. Certain products, such as
        household appliances, scientific instruments, and builders\'
        hardware, for which specific standards have been established,
        may receive the national standard mark ("NF") if they comply
        with these standards.

        -   **AFNOR** controls the highly regarded **NF mark**. AFNOR
            also issues the "NF Environment" label, which certifies that
            a specific product meets the level of quality commensurate
            with an NF mark and that it is environmentally friendly. "NF
            Environment" labels can be issued for paints, lubricants,
            trash bags, household chemicals, heating equipment,
            cosmetics, insulating materials, and paper.

        -   **Information on the NF or NF Environment marks** is
            available from AFNOR, Tour Europe, 92049 Paris La Defense
            Cedex 7; telephone: (1) 42--91--55--55; fax: (1)
            42--91--56--56; e-mail: international@email.afnor.fr.

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    -   **Professional associations also issue quality labels**, and
        each association has its own criteria for issuance of its label.
        Exporters may obtain a list of these associations from the
        Conseil National du Patronat Francais (CNPF), 31, avenue
        Pierre-ler-de-Serbie, 75784 Paris Cedex 16; telephone: (1)
        40--69--44--44; fax: (1) 47--23--47--32. These labels are not
        mandatory but are considered very desirable.

    -   **For specific information regarding existing foreign
        agricultural standards** and testing, packaging, and
        certification systems, exporters should contact the Office of
        Food Safety and Technical Services, Foreign Agricultural
        Service, U.S. Department of Agriculture, Room 5545-S,
        Washington, D.C. 20250, (202) 720--1301; fax: (301) 690--0677.
        The National Center for Standards and Certification Information
        at the National Institute for Standards and Technology also
        maintains extensive files on existing foreign non-agricultural
        standards and their testing and certification systems. Further
        information is available from the National Center for Standards
        and Certification Information, National Institute for Standards
        and Technology, Building 820 Room 164, Gaithersburg, Md.
        20899, (301) 975--4040; fax: (301) 926--1559.

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    -   **Additional information on foreign standards** is available to
        firms in the United States through the American National
        Standards Institute, 11 W. 42nd St., New York, N.Y. 10036, (212)
        642--4900; fax: (212) 302--1286.

    -   **Automotive standards**: All automobiles and certain types of
        automotive equipment imported into and sold in France must
        conform to French standards. Among other things, these standards
        stipulate that all cars be equipped with specific antitheft
        devices and safety belts and that tractors with wide trailers be
        fitted with wing mirrors. Additional regulations and
        instructions pertain to the carbon monoxide emission levels of
        vehicles, suitability of tires to different types of vehicles,
        braking systems, turn signals, etc.

Standard requirements are in effect for forklift trucks, work trucks,
coupling devices of trailer caravans, and safety belts and holding
systems fitted on any car put up for sale.

EU automobile emissions standards and motorcycle noise level standards
also are in effect.

-   **Toys:** Children\'s toys and other accessories containing
    polyvinyl chloride are prohibited importation into EU countries
    effective Nov. 10, 1999.

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-   **Foodstuffs**: The use of food colorings is regulated. Only those
    colorings on the permitted list may be used in foodstuffs.

Standards are in effect for certain foodstuffs dealing with the content
and use of nitrates and nitrate-reduction methods in the manufacture of
cheeses; nitrate content of fruit, vegetables, and byproducts; the total
fat content of processed and unprocessed starch; and specifications for
clove powder.

Quality and nutritional standards are in effect for baby foods.

Special regulations on the labeling of canned and frozen foodstuffs are
in effect. Regulations are also in effect for sugar products, cocoa, and
chocolate intended for human consumption; special conditions and
procedures also exist for the importation of game shot for human
consumption.

Deep frozen prepacked **fish** must be packaged in specific sizes.

Shipments of **perishable goods,** including deep frozen foodstuffs,
fish products, prepared frozen dishes, and minced meat are subject to a
temperature limit of -20°C.

**Alcohol and spirits, certain dietetic foods and preparations for
infants, butter, and semolinas and pastas are subject to special quality
standards**. Regulations specify the approved methods for laboratory
analyses used to determine whether the products conform to the
standards. A number of food colorings are prohibited in foodstuffs. The
use of amaranth in foodstuffs other than caviar or imitation caviar is
prohibited.

The use of **tricalcium phosphate** as an anti-agglomerate in certain
powdered preparations for non-alcoholic fruit drinks is subject to
special regulations. Sorbic acid and its calcium, sodium, and potassium
salts are regulated in certain specified sweet confectionery.

Other regulations define **milk-based dietetic foodstuffs**, list
additives that may be used in such, and set down labeling and biological
purity requirements.

Specific criteria for the purity of emulsifying, stabilizing,
thickening, and gelling agents have been established, and conditions for
the sale of food and drink for animal and human consumption have been
outlined.

Regulations relative to the use of eat-by dates and production batch
numbers on drinks and foodstuffs, other than those liable to
deterioration, also are in effect.

**Vitamins and nutritional supplements** are considered food items
rather than pharmaceuticals. There are strict guidelines for the
importation of such products and exporters should consult their contacts
in the market concerning regulations applicable to specific products.

-   **Veterinary drug imports**: Imports of veterinary medicaments are
    subject to authorization by the Ministry of Health. The products
    must conform to the definitions of veterinary medicaments as given
    in the amended Public Health Code. Serum and vaccine imports also
    must be authorized.

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-   **Pharmaceuticals**: Before they can be marketed in France,
    pharmaceuticals must be certified by the Ministry of Health.
    Application for certification must be submitted only by a company
    incorporated under French law and which employs a pharmacist
    responsible for distribution of the pharmaceutical. Documents
    submitted with the application must be in French and must be
    verified and approved by an expert appointed by the French
    government. These must include technical and analytical studies, a
    pharmaco-kinetic study, a toxicology study, and studies against
    placebos for proof of the product\'s efficacy and the level of
    people\'s tolerance for it. Raw materials used in the manufacture of
    the product also must be checked by the authorities.

Special regulations apply to imports of veterinary drugs. French law
prohibits the use of substances having an estrogen action in veterinary
products administered to animals whose flesh or produce is intended for
human consumption, except when used to control the oestrous cycle in
female animals.

-   **Cosmetics regulations**: Poisonous substances may be allowed in
    cosmetic and hygienic products provided their concentration by
    weight does not exceed the limit established for each type of
    product. Exporters should contact their importers for further
    details on the regulations.

A decree listing poisonous substances that may be used in the
manufacture of cosmetics is in effect.

EU cosmetics regulation covers beauty products and products used for
personal hygiene but not pharmaceutical specialties and medicinal
products that have cosmetic effects but that are intended mainly to
protect against disease or to correct abnormal conditions requiring
medical attention. It prescribes labeling requirements and provides that
information concerning the composition of cosmetics be made available to
competent authorities to ensure protection for the consumer. It also
contains a list of authorized coloring agents and substances and
coloring agents that are authorized provisionally.

-   **Other items**: Specific regulations are in effect for a number of
    other items, including honey, bees and beeswax, medical equipment
    and supplies, foodstuffs, pesticides, aerosols, live animals, plant
    products, telecommunications equipment, machinery, construction
    equipment, household appliances, building equipment, toys, tobacco
    products, and chemicals and hazardous substances, among others.

**Germany**

-   Germany\'s regulations and bureaucratic procedures are complex and
    can prove to be a hurdle for foreign exporters unfamiliar with the
    local environment. Health and safety standards, when strictly
    applied, can restrict market access for many products.

-   The European Union issues directives to harmonize safety standards
    for industrial products marketed in member countries. During a
    transition period, national requirements must be met. After the
    transition period, the European Union-wide "CE" mark will supersede
    all other compliance requirements, provided the products in question
    are covered by an EU directive. Existing German standards will
    likely form the basis for eventual EU standards.

    -   Additional information is available from the **Office of EU and
        Regional Affairs, International Trade Administration, U.S.
        Department of Commerce, Washington, D.C. 20230**, (202)
        482-4496; fax: (202) 482-2155.

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-   **Germany is a signatory to the Agreement on Technical Barriers to
    Trade**, commonly known as the Standards Agreement, negotiated under
    the Tokyo Round of multilateral trade negotiations. The agreement is
    designed to eliminate the use of standards and certification systems
    as impediments to trade.

-   **German buyers may require additional performance or quality
    marks**, which are not necessarily legally required, but which
    greatly enhance a product\'s chances to be marketed. Both EU
    requirements and the standards for a German quality or performance
    mark will, in many cases, require a product to be modified. Even if
    the product does not require modification, it will require testing
    and certification before it can be marketed. Important marks are the
    "gepruefte Sicherheit" (GS) mark, which means "safety tested," for
    mechanical products and the "Verband Deutscher Elektrotechniker"
    (VDE) mark for electrical components.

-   **The German organization responsible for the GS mark** is the
    Deutscher Industrie Normenausschuss (DIN) (German Standards
    Institute). Testing is conducted by the Technischer
    Ueberwachungsverein e.V. (TUV) (Technical Inspection Association).
    There are separate TUV outlets with specific testing
    responsibilities in most of the German states. TUV outlets are
    private companies set up by various German states to inspect and
    test products for compliance with German safety standards.
    Individual TUVs also have been authorized by the German Government
    to test products for compliance with EU legislation, and some have
    established representative offices in the United States.

    -   Although the VDE license deals with electrical products instead
        of mechanical products, the same process of certification can be
        followed. TUV tests for both the VDE license and the GS license.

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-   **Food products: ** The German Law on Weights and Measures contains
    provisions establishing standard sizes for containers of prepackaged
    foods, as well as labeling and gauging requirements for
    consumer-ready containers.

    -   The vast majority of food laws of EU member states have been
        harmonized into EU law, but vitamins, minerals, and other
        physiological substances are still awaiting harmonization.
        However, because of the EU single market principle, all food
        products imported legally into one member country can also be
        distributed in all other member countries.

    -   **Food products are governed by the German Food Law**, which
        consists of about 230 different ordinances. Enforcement of the
        food law is the responsibility of the states. Exporters to this
        market should be aware that in some instances, minor infractions
        to the food law may be tolerated in one state but not in
        another. Major violations are prosecuted, however. Imported and
        domestic goods are constantly checked by government laboratories
        at the point of sale, and products that pose a risk to public
        health are publicized, along with the brand name and the
        importer or producer.

    -   **Product registration is not required for foods** in Germany.
        In some cases, however, German inspection agencies at the point
        of entry may require the importer to arrange for further
        inspection of an imported product to satisfy the importer\'s
        legal duty to exercise due care and diligence. The importer may
        even be required to engage a food chemist to determine if the
        product is free of illegal substances and residues.

    -   **The German Food Law prohibits all food additives** and other
        substances that are not specifically approved for use. The use
        of food additives, food coloring substances, artificial
        sweeteners, and preservatives is regulated by the Food Additives
        Ordinance. With the exception of a smaller number of additives
        approved for general use, most food additives are approved only
        for specific purposes and for specific foods under specified
        conditions.

        -   The definition of a food additive is fairly broad.
            "Technical aid substances" are substances required only
            during the processing of a food product and are tolerated if
            either totally removed or technically unavoidable during the
            processing.

        -   The following vitamins may be added freely to any type of
            food and must be shown in the list of ingredients; however
            they need not be listed as food additives. They are E 301
            sodium-L-ascorbate, E 302 potassium-L-ascorbate,
            calcium-L-ascorbate, E 304 ascorbyl palmitate,
            thiamin-chloride-hydrochloride, thiamin nitrate,
            riboflavin-5-phosphate-sodium, pyridoxin-hydrochloride,
            sodium-and-calcium-D-pantothenate,
            alpha-and-beta-tocopherylacetate,
            alpha-and-beta-tocopherysuccinate, nicotinic acid (niacin),
            and nicotinic acid amid.

        -   The following vitamins can only be added to specific foods
            with given limitations: vitamin-A-acetate,
            vitamin-A-palmitate, ergocalciferol, cholecalciferol, and
            cholecalciferol-cholesteric.

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    -   EU regulations have established maximum residue limits for
        certain pesticides and contaminants, including nitrates in
        lettuce and spinach and aflatoxins in peanuts, nuts, dried
        fruits, cereals, and milk. As of April 5, 2002, limits are in
        place for lead, cadmium, mercury, and
        3-monochloropropane-1,2-diol (3-MCPD) in a wide range of food
        products; for aflatoxin in spices; and for ochratoxin A in
        cereals and dried vine fruits. Maximum levels of dioxin take
        effect July 1, 2002, for vegetable oils and for products of
        animal origin.

    -   **Food irradiation** rules are not yet harmonized among EU
        countries. An EU directive issued in 1999 permits dried aromatic
        herbs, spices, and vegetable seasonings to be treated with
        ionizing rays, while another 1999 directive provides for the
        establishment of a positive list of foodstuffs that could be
        irradiated. Under German regulations, ultraviolet rays may be
        used to sterilize drinking water, fruit surfaces, and hard
        cheese during storage.

    -   **Cereal-based foods and baby foods** for infants and young
        children, infant formula and follow-on formula, foods intended
        for use in energy-restricted diets for weight reduction, and
        dietary foods for special medical purposes are subject to
        special restrictions. Applicable EU directives have established
        requirements concerning product composition and hygiene, quality
        of raw materials, additives, labeling, sampling procedures, and
        analysis methods. A February 2001 EU directive specifies those
        substances, including vitamins, minerals, and amino acids, that
        may be added to these products for specific nutritional
        purposes.

    -   New functional foods with specific health related properties and
        other "novel" (non-traditional and new to the market) foods
        require special approval.

    -   **Seafood products** from the United States may be imported only
        from U.S. firms approved by the Food and Drug Administration.
        Fish foods with mercury content of more than 1 ppm are
        prohibited.

    -   The German Federal Ministry of Health, in close coordination
        with the Ministry of Agriculture, is responsible for monitoring
        compliance with German Food Law regulations. Further information
        is available from **Bundesministerium fuer Gesundheit (Federal
        Ministry of Health), Abteilung 4, Am Probsthof 78a, D-53121
        Bonn;** telephone: (49-228) 441-0; fax: (49-228) 941-4900;
        e-mail: info@bmg.bund.de.

-   **Cosmetics: ** EU cosmetics regulations cover beauty products and
    products used for personal hygiene but not pharmaceutical
    specialties and medicinal products that have cosmetic effects but
    that are intended mainly to protect against disease or to correct
    abnormal conditions requiring medical attention. The regulations
    prescribe labeling requirements and provide that information
    concerning the composition of cosmetics be made available to
    competent authorities to ensure protection for the consumer. Lists
    of prohibited substances, restricted substances, authorized coloring
    agents, and substances and coloring agents authorized provisionally
    are included

-   **Pesticides: ** Pesticides must be authorized by the Federal
    Biological Research Center for Agriculture and Forestry. The
    importer, distributor, or manufacturer must guarantee that the
    product meets the legal requirements established under the Act for
    the Protection of Crop Plants. Additional information is available
    from the Department for Plant Protection Products and Application
    Techniques, Federal Biological Research Center for Agriculture and
    Forestry, Messeweg 11/12, 38104 Braunschweig; telephone: (49-53)
    1299-3401; fax: (49-53) 1299-3002/3; e-mail: <AP@bba.de>.

-   **Motor vehicles: ** Certain standards are in effect for motor
    vehicles. Cars are subject to emission standards in the European
    Union, and noise standards are in effect for motorcycles.

-   **Packaging materials: ** Germany is considered to be in the
    forefront of European environmental legislation, including that on
    packaging. The German government established the Duales System
    Deutschland (DSD) to certify product packaging materials that could
    be recycled, reused, or otherwise legally disposed of by retailers
    or distributors independent of the existing public waste disposal
    system.

    -   The "green dot" system of recycling is in wide use in Germany.
        The "green dot" is a recycling symbol found on virtually all
        retail products. This is not a legal requirement, but it is
        almost impossible to market a product in Germany without the
        "green dot." Typically, the producer or the importer will pay a
        license fee to use the "green dot," dependent on the type and
        amount of packaging, and provide the exporter with the necessary
        information for use of the symbol.

-   **Construction equipment: ** EU regulations limiting the noise level
    of certain construction equipment provide a standard level of noise
    acceptability for all member countries. Items subject to these
    regulations include compressors, tower cranes, welding generators,
    power generators, and power hand-held concrete breakers and picks.

-   **Other items: ** Regulations are in effect controlling the maximum
    residual levels of herbicides, pesticides, and other chemicals
    permitted in foodstuffs of vegetable origin. Other regulations are
    in effect for the importation of dangerous substances such as
    explosives, corrosives, and poisons, etc.

-   If exporters have reason to believe that a standard of any signatory
    country unjustifiably impedes their exports, these concerns may be
    communicated to the **Office of Standards Code and Information,
    National Institute of Standards and Technology, Building 820, Room
    164, Gaithersburg, Md. 20899**, (301) 975-4037; fax: (301) 926-1559.

-   **Additional information** is available from Technischer
    Ueberwachungsverein e.V., Langemarckstrasse 28, 45141 Essen;
    telephone: (49-201) 825-5000; fax: (49-201) 825-4000; e-mail:
    info@rwtuev.de. The TUV also may be contacted in the United States
    at TUV Essen Laboratories, 6 Brighton Road, Clifton, N.J.
    07012, (201) 773-8880; fax: (201) 773-8834.

Information also is available from VDE at Verband Deutscher
Elektrotechniker e.V., Stresemannallee 15, 60596 Frankfurt/Main;
telephone: (49-69) 63080; fax: (49-69) 6308273.

For specific information regarding existing foreign agricultural
standards and testing, packaging, and certification systems, exporters
should contact the Office of Food Safety and Technical Services, Foreign
Agricultural Service, U.S. Department of Agriculture, South Agriculture
Building, Room 5545, 14th Street and Independence Avenue S.W.,
Washington, D.C. 20250, (202) 720--1301; fax: (202) 690--0677. The
National Center for Standards and Certification Information at the
National Institute for Standards and Technology also maintains extensive
files on existing foreign non-agricultural standards and their testing
and certification systems. Further information is available from the
National Center for Standards and Certification Information, National
Institute for Standards and Technology, Building 820, Room 164,
Gaithersburg, Md. 20899, (301) 975-4040; fax: (301) 926-1559.

Additional information on foreign standards is available to firms in the
United States through the American National Standards Institute, 11 W.
42nd St., New York, N.Y. 10036, (212) 642-4900; fax: (212) 398-0023.

Hong Kong

-   The Hong Kong Safety Institute (HKSI) was established by the Hong
    Kong Standards and Testing Centre (STC) to formulate, develop,
    implement and launch the Hong Kong Safety Mark Scheme. Hong Kong
    Safety Mark symbolizes the compliance with relevant Hong Kong
    product safety regulations and gives immediate access to the Hong
    Kong market.

    -   It covers the following products:

    -   Food products

    -   Health supplement products

    -   Proprietary Chinese Medicine

    -   Cosmetics and toiletries

    -   Household products and detergents

    -   For further information visit
        <http://www.hkstc.com/servicesproducts/srv_psc.asp>

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-   **Special requirements under the Consumer Protection Law** are in
    effect for many goods. Children\'s toys are subject to specific
    safety standards. Information is available from the Trade and
    Industry Department, 700 Nathan Road, Kowloon; telephone: (852)
    23985649; fax: (852) 23989173; e-mail: tidenq@tid.gcn.gov.hk

-   Pharmaceuticals: Pharmaceutical products, including vitamins, must
    be registered with the Department of Health. As a general rule,
    medicines to be taken internally should have a package size of no
    more than 500 tablets or capsules or 500 milliliters. The
    application for registration must be accompanied by the following:

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-   specifications and detailed qualitative and quantitative composition
    of the finished product;

-   certificate of analysis of a representative batch of the finished
    product;

-   method of analysis;

-   certified copy of the manufacturer\'s license;

-   original or certified copy of a certificate of free sale;

-   prescribed number of product samples for laboratory analysis;

-   one original or prototype outer package and one container label for
    each package size;

-   clinical papers for unusual combinations of drug ingredients and to
    support indications and claims that are not well-documented in
    pharmacopeias;

-   information on manufacturing facilities and evidence of good
    manufacturing practices; and

-   stability test data (see below for additional information).

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-   **A stability test** is required effective Jan. 2, 2001, to support
    shelf-life claims for all finished pharmaceutical products. For the
    test, a combination of 30°C/70 percent relative humidity should be
    used, although other temperature-humidity-duration conditions may be
    used if necessary. An accelerated stability test, using a
    combination of 40°C ± 2°C/75 percent relative humidity ± 5 percent
    relative humidity, also is acceptable.

-   For **new chemical entities**, one gram to two grams of the new
    ingredient may be required to undergo laboratory analysis. Clinical
    documentation; chemical, biological, and pharmaceutical evaluations;
    and pharmacalogical and toxicological evaluations also must be
    provided.

-   Products that contain only Chinese traditional medicines, drugs
    imported for use as inputs by pharmaceutical manufacturers, products
    intended for re-export, and products imported directly by a
    registered medical practitioner, dentist, or veterinarian for the
    treatment of a particular person or animal are exempt from
    registration requirements. Chinese traditional medicines are
    regulated by the Chinese Medicine Council and must be registered
    under the Chinese Medical Ordinance.

-   **Additional information about pharmaceutical product registration**
    is available from the Pharmaceuticals Registration and Import/Export
    Control Section, Department of Health, Wu Chung House, 18th Floor,
    213 Queen\'s Road East, Wanchai; telephone: (852) 29618781;
    fax: (852) 28360071.

-   **Food products:** Imports of meat, poultry, game, frozen
    confections, milk and milk beverages, and marine products are
    subject to regulations issued by the Food and Environmental Hygiene
    Department. Shipments are inspected by the department upon arrival
    in Hong Kong, and samples are taken for analysis if the importer
    cannot produce an official health certificate issued in the country
    of origin. The department issues a "release letter" once the
    inspection or analysis is complete; without this letter, the
    shipment cannot clear customs.

**Meat, poultry, and game** require an import license issued by the
department. The license application must include a valid health
certificate issued by the appropriate authorities in the country of
origin.

**For frozen confections, milk, and milk beverages**, the importer must
submit to the Food and Environmental Hygiene Department the full name
and address of the processing plant in the country of origin, the law
governing the production of the product in the country of origin, sample
containers or wrappers with labels, and a certificate of heat treatment
documenting the method used to pasteurize or sterilize the product and
showing the chemical and bacteriological quality of the product. The
manufacturer must provide additional information on the heat treatment
method and facilities, including production equipment and water supply
in the processing plant. For frozen confections, the importer must
submit detailed information concerning ingredients, coloring agents,
stabilizers, and sweeteners, including their amounts. For milk and milk
beverages, the manufacturer must provide a statement confirming the
product\'s approximate shelf-life.

**Hong Kong\'s food laws list permitted preservatives and restrict the
use of some preservatives to specified foods in specified amounts.**

**Food additives are prohibited when:** they are intended to disguise
defective raw materials; enhance the color, odor, flavor, or shelf-life
while causing substantial damage to or reduction of nutrients; and
simplify or facilitate food processing in order to bypass proper
processing practices and good hygienic standards. Additives that may
pose a health hazard also are prohibited. Vitamins and minerals intended
to enrich a product\'s nutritional value are not considered to be
additives; neither are seasoning substances such as salt, herbs, or
spices.

**Pesticide residues** may not exceed maximum levels established in the
Codex Alimentarius.

Food products and live animals intended for food use **may not contain
the chemicals** clenbuterol, salbutamol, hexoestrol,
diethylstilboestrol, dienoestrol, chloramphenicol, and avoparcin, under
regulations that took effect Dec. 31, 2001. The regulations also
established maximum residue limits for 10 other chemicals: cloxacillin,
cicloxacillin, ampicillin, amoxycillin, benzylpenicillin, sulfonamides,
chlortetracycline, oxytetracycline, doxycycline, and tetracycline.

**Additional information about food product requirements** is available
from the Food and Public Health Branch, Food and Environmental Hygiene
Department, Queensway Government Offices, 43rd Floor, 66 Queensway, Hong
Kong; telephone: (852) 28675570 or 28680000; e-mail:
enquiries@fehd.gov.hk.

-   For specific information regarding existing foreign agricultural
    standards and testing, packaging, and certification systems,
    exporters should contact the Office of Food Safety and Technical
    Services, Foreign Agricultural Service, U.S. Department of
    Agriculture, Room 5545-S, Washington, D.C. 20250, (202) 720-1301;
    fax: (202) 690-0677. The National Center for Standards and
    Certification Information at the National Institute for Standards
    and Technology also maintains extensive files on existing foreign
    non-agricultural standards and their testing and certification
    systems. Further information is available from the National Center
    for Standards and Certification Information, National Institute for
    Standards and Technology, Building 820, Room 164, Gaithersburg, Md.
    20899, (301) 975-4040; fax: (301) 926-1559.

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-   **Additional information on foreign standards** is available to
    firms in the United States through the American National Standards
    Institute, 11 W. 42nd St., New York, N.Y. 10036, (212) 642-4900;
    fax: (212) 398-0023.

-   Hong Kong is a signatory to the **Agreement on Technical Barriers**
    to Trade, commonly known as the Standards Agreement, negotiated
    under the Tokyo Round of GATT multilateral trade negotiations. The
    agreement was designed to eliminate the use of standards and
    certification systems as impediments to trade.

-   If exporters have reason to believe that a standard of any signatory
    country unjustifiably impedes their exports, these concerns may be
    communicated to the Office of Standards Code and Information,
    National Institute of Standards and Technology, Building 820, Room
    164, Gaithersburg, Md. 20899, (301) 975-4037; fax: (301) 926-1559.

**India**

-   India is a signatory to the Agreement on **Technical Barriers to
    Trade**, commonly known as the Standards Agreement, negotiated under
    the Tokyo Round of multilateral trade negotiations. The agreement is
    designed to eliminate the use of standards and certification systems
    as impediments to trade.

-   If exporters have reason to believe that a standard of any signatory
    country unjustifiably impedes their exports, these concerns may be
    communicated to the Office of Standards Code and Information,
    National Institute of Standards and Technology, Building 820, Room
    164, Gaithersburg, Md. 20899, (301) 975-4037; fax: (301) 926-1559.

-   **Agricultural products:** Imports of primary agricultural products
    are subject to the approval of the Ministry of Agriculture and
    Cooperation.

-   **Food products:** Food products are subject to guidelines laid out
    in the Prevention of Food Adulteration Act. The PFA Act specifies
    detailed standards for ingredients including additives, flavors,
    colors, pesticide residue, and fat content. Under July 2001
    regulations, food products must have at least 60 percent of their
    shelf-life remaining at the time of import.

-   **Pharmaceuticals**: Imported pharmaceuticals must be registered
    with the Ministry of Health under regulations that take effect Jan.
    1, 2003. Exporters of pharmaceuticals to India also must be
    registered. Registration is valid for three years and may be
    renewed.

The registration application for a drug intended to be marketed in India
must indicate the following information about the product: name; dosage
form; formulation composition; test specifications, including active and
inactive ingredients; pharmacological classification and indications for
which the product is to be used; patent status; and name of the
manufacturer of the raw materials. In addition, the following data must
be submitted: chemical and pharmaceutical data; animal pharmacology;
animal toxicology; human/clinical pharmacology trials (Phase I);
exploratory clinical trials (Phase II); confirmatory clinical trials
(Phase III), including published review articles; bio-availability,
dissolution, and stability data; regulatory status in other countries;
and marketing information, including proposed product monograph and
sample labels and packaging. Information on the product\'s raw
ingredients also must be submitted, including manufacturing method,
quality control parameters and/or analytical specification, stability
report, and animal toxicity data.

**Applicants intending to market fixed-dose combination drugs** must
submit, in addition to the above, therapeutic justification such as
authentic literature in journals and textbooks, data on
pharmacokinetics/pharmacodynamics combination, and any other data
concerning the safety and efficacy of the combination.

Foreign drug manufacturers intending to conduct clinical trials in India
must submit a similar application.

-   Additional information is available from the Ministry of Health and
    Family Welfare, Nirman Bhavan, Maulana Azad Marg, New Delhi 11001;
    telephone: (91-11) 3018863; fax: (91-11) 3014252.

-   **Electrical appliances:** The manufacture, sale, and distribution
    of household electrical appliances must conform to specified Indian
    standards. Mining equipment and other equipment for use in places
    where flammable gases exist are subject to special regulations.

-   **Toys**: The Bureau of Indian Standards finalized toy standards in
    April 2001. The standards cover areas such as flammability and
    physical, mechanical, and toxicological properties.

-   **Other products**: Standards drafted by the Bureau of Indian
    Standards affect a number of other commodities in the areas of
    agricultural and food products, civil engineering, chemicals,
    medical instruments, electronics and telecommunications, marine
    cargo movement and packaging, consumer products, textiles,
    electro-technical mechanical engineering, and metals. Many of these
    standards have been adopted by government agencies and other local
    industries, and U.S. exporters may want to become familiar with some
    of them. The BIS is in the process of harmonizing Indian standards
    with international standards.

-   **Additional information** is available from the Bureau of Indian
    Standards, Manak Bhavan, 9 Bahadur Shah Zafar Marg, New Delhi
    110002; telephone: (91-11) 3237991; fax: (91-11) 3239399; e-mail:
    bis@vsnl.com.

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-   **For specific information** regarding existing foreign agricultural
    standards and testing, packaging, and certification systems,
    exporters should contact the Office of Food Safety and Technical
    Services, Foreign Agricultural Service, U.S. Department of
    Agriculture, South Agriculture Building, Room 5545, 14th Street and
    Independence Avenue S.W., Washington, D.C. 20250, (202) 720-1301;
    fax: (202) 690-0677. The National Center for Standards and
    Certification Information at the National Institute for Standards
    and Technology also maintains extensive files on existing foreign
    non-agricultural standards and their testing and certification
    systems. Further information is available from the National Center
    for Standards and Certification Information, National Institute for
    Standards and Technology, Building 820, Room 164, Gaithersburg, Md.
    20899, (301) 975-4040; fax: (301) 926-1559.

-   **Additional information** on foreign standards is available to
    firms in the United States through the American National Standards
    Institute, 11 W. 42nd St., New York, N.Y. 10036, (212) 642-4900;
    fax: (212) 398-0023.

> **Iran**

-   ISIRI, the Institute of Standards and Industrial Research of Iran,
    is appointed by Ministerial Decree to control the quality of
    imported and exported goods.

    -   <http://www.sgs.com/sgs/psc/psc_serv.nsf/pages/ISIRI+Mandatory+Standards+Program>

-   The **Institute of Standards and Industrial Research** is
    responsible for establishing and implementing national standards and
    ensuring that imported and domestically produced goods are in
    compliance. The institute maintains numerous laboratories throughout
    the country and periodically tests products to ensure that they do
    not contain any harmful ingredients and are not otherwise
    misrepresented by the supplier. Fees are assessed for the tests.

    -   **Additional information** is available from the Institute of
        Standards and Industrial Research, P.O. Box 14155--6139, Tehran;
        telephone: (261) 226031; fax: (261) 225015.

    -   **For specific information regarding existing foreign
        agricultural standards and testing, packaging, and certification
        systems**, exporters should contact the Office of Food Safety
        and Technical Services, Foreign Agricultural Service, U. S.
        Department of Agriculture, South Agriculture Building, Room
        5545, 14th Street and Indpendence Avenue S.W., Washington, D.C.
        20250, (202) 720--1301; fax: (202) 690--0677. The National
        Center for Standards and Certification Information at the
        National Institute for Standards and Technology also maintains
        extensive files on existing foreign non-agricultural standards
        and their testing and certification systems. Further information
        is available from the National Center for Standards and
        Certification Information, National Institute for Standards and
        Technology, Building 820, Room 164, Gaithersburg, Md.
        20899, (301) 975--4040; fax: (301) 926--1559.

    -   **Additional information on foreign standards** is available to
        firms in the United States through the American National
        Standards Institute, 11 W. 42nd St., New York, N.Y. 10036, (212)
        642--4900; fax: (212) 398--0023.

    -   **Alcoholic beverages:** Import of alcoholic beverages is
        restricted by the Ministry of Commerce to the amount necessary
        for the attraction of foreign tourists.

    -   **Ships and equipment**: Imports of ships and shipping equipment
        require prior approval from the Ports and Shipping Authority
        and, in some cases, the Ministry of War.

    -   **Packing materials**: Packing materials, including tape and
        labels for packing goods, are prohibited import if they bear a
        foreign trademark.

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-   **Hazardous products:** A wide range of products considered
    potentially hazardous to public health and safety may not be
    imported without prior approval of the Ministry of Commerce after
    consultation with appropriate authorities. For example, the Ministry
    of Agriculture is consulted in the case of poisonous chemicals used
    for plant pest control and weed control. The Ministry of Health has
    stringent rules governing all pharmaceuticals, narcotics, poisons,
    and other substances being imported for medical purposes.

-   **The import of foodstuffs, beverages, cosmetics, and toiletries**
    is subject to the prior approval of the Ministry of Health.
    Cosmetics and toiletries are subject to special regulations issued
    by the ministry. When applying for permission to import such items,
    the manufacturer must furnish samples, together with details of
    composition. Permits normally are valid for three years.

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-   **Application for registration of orders for the following goods
    will not be accepted unless prior approval is obtained**: meat
    products; fish and fowl products; milk and milk products;
    nutriments; all fruit products; edible vegetable products; edible
    fats and oils; cereal products; sweet and hard sugar; alcoholic and
    non-alcoholic drinks; sherbets; pickles and related products; cocoa
    and products thereof; disinfectants and insecticides; cosmetics and
    strengthening materials thereof; hygiene and sanitary articles;
    containers and packings of articles of food, drinks, and toiletries;
    vessels for preparing, manufacturing, or cooking articles of food,
    drinks, and toiletries; and spare parts for refrigeration equipment
    used in food, drinks, and toiletries.

-   **Other requirements:** Certain items such as pharmaceuticals and
    goods imported by the Ministry of the Post, Telegraph, and Telephone
    require a special permit for customs clearance.

Italy

-   **Description of EU standards harmonization process:**

    -   **See beginning of France article for detailed description**

-   In Italy, information on standards is available from the Ente
    Nazionale Italiano di Unificazione, Via Battistotti Sassi 11/b,
    I--20133 Milano; telephone: 2--70--02--41; fax: 2--70--10--61--49;
    e-mail: uni@uni.unicei.it.

-   U.S. exporters experiencing problems related to the application of
    the mutual recognition agreements may contact the National Institute
    of Standards and Technology by telephone at 888--8378 or by e-mail
    at **<oiaa@nist.gov>.**

-   Information on existing foreign agricultural standards and testing,
    packaging, and certification systems is available from the Office of
    Food Safety and Technical Services, Foreign Agricultural Service,
    U.S. Department of Agriculture, South Agriculture Building, Room
    5545, 14th Street and Independence Avenue S.W., Washington, D.C.
    20250, (202) 720--1301; fax: (202) 690--0677. Information on
    existing non-agricultural standards and their testing and
    certification systems is available from the National Center for
    Standards and Certification Information, National Institute for
    Standards and Technology, Building 820, Room 164, Gaithersburg, Md.
    20899, (301) 975--4040; fax: (301) 926--1559.

-   **Additional information on foreign standards** is available to
    firms in the United States through the American National Standards
    Institute, 11 W. 42nd St., New York, N.Y. 10036, (212) 642--4900;
    fax: (212) 398--0023.

-   Italy is a signatory to **the Agreement on Technical Barriers to
    Trade**, commonly known as the Standards Agreement, negotiated under
    the Tokyo Round of multilateral trade negotiations. The agreement is
    designed to eliminate the use of standards and certification systems
    as impediments to trade.

    -   If exporters have reason to believe that a standard of any
        signatory country unjustifiably impedes their exports, these
        concerns may be communicated to the **Office of Standard Code
        and Information, National Institute of Standards and Technology,
        Building 820, Room 164, Gaithersburg, Md. 20899**, (301)
        975-4037; fax: (301) 926--1559.

-   **Motor vehicles**: Automobile emissions standards for cars and
    noise level standards for motorcycles and construction equipment are
    in effect. In addition, other standards affecting reverse gears and
    speedometers, braking devices, statutory plates and inscriptions,
    and anchorages for motor vehicle safety belts apply to motor
    vehicles and trailers.

-   **Toys:** Children\'s toys and other accessories containing
    polyvinyl chloride are prohibited importation into EU countries
    effective Nov. 10, 1999.

-   **Food and beverages:** If a food product is imported into one EU
    country, it can be transshipped to Italy if it has a label written
    in Italian and does not present a public or animal or plant health
    risk. Foodstuffs imported directly into Italy are subject to complex
    regulations governing production, packaging, transportation, and
    sale. The basic law regulating the hygiene and sanitary
    characteristics of foodstuffs is the Statute 283 of April 30, 1962,
    along with the enforcement rule, Presidential Decree 327 of March
    26, 1980. Importers should check with their Italian customers for
    information on specific products. The following regulations also
    apply. Organic or chemical additives in starch used in the
    preparation of foodstuffs are regulated by a ministerial decree.

The use of other **chemical additives** in foodstuffs also is regulated
by ministerial decree. The amount of potassium iodide permitted in the
production and selling of kitchen salt (sodium chloride) is 2 g per 100
kg of salt. The package must show the amount of potassium iodide added
to the salt.

Certain other regulations governing the use of **chemical additives** in
foodstuffs cover preparations for puddings and ice creams, extracts for
juices and syrups, blends from which fermentation chemicals can be
obtained, and labeling requirements of foodstuffs intended for household
use. A number of coloring materials are prohibited use in the processing
of foodstuffs, in paper and wrappings or packings for foodstuffs, and in
articles for personal or household use.

All **frozen food products** must be frozen evenly and quickly (maximum
time of four hours). Trucks used to transport the products must meet
specific standards. Temporary thawing at any point is not permissible.
Frozen products must be put on sale in original, sealed packaging that
protects the product from contamination. Frozen foods may not be
imported unless they come from qualified plants recognized by Italian
health authorities. There are also special labeling requirements for
frozen foods.

The importation, production, and sale of defatted and reconstituted soya
flour and products using this flour are permitted subject to the
following regulations: the amounts of added flavoring and natural and
artificial colorings are regulated; the amount of monosodium glutamate
permissible is limited to 4 percent; other non-meat foodstuffs may be
added; products based on this flour may not be advertised as substitutes
for other foodstuffs and must not claim dietetic properties; and special
labeling requirements apply (see below).

**Food and meat products** (excluding canned meat, sausage, and salami)
may include up to 30 percent protein in the form of **soya protein.**
Each 100 grams of meat extender using soya flour and protein
concentrates must be supplemented with 10 mg iron, 2 mg thiamine, 0.8 mg
riboflavin, and 5 mg vitamin B12.

**Aluminum sulphate and aluminum ammonium sulphate** are approved for
use in the pasteurization treatment of egg albumen in Italy. The
permitted quantity is 300 g per 1,000 liters of egg albumen. Regulations
are in effect for packages, containers, and utensils intended to come in
contact with foodstuffs or with other substances intended for personal
use.

Special regulations are in effect regarding the production and sale of
cocoa and chocolate products for human consumption.

-   Containers of non-alcoholic beverages are required to carry a
    special seal if the product is intended for retail sale. A
    ministerial decree outlines which products require the seal, where
    it must be placed on the containers, and the size of the letters to
    be used. See also LABELING below.

Whiskey, brandy, and similar alcoholic beverages must be bottled in
specific metric sizes, namely, 10, 25, 50, 75, 100, 150 and 200
centiliters.

The solvents that can be used and the amounts of caffeine allowed in raw
or roasted coffee and in soluble extracts (desiccated or freeze dried)
of coffee also are regulated. The words "decaffeinated coffee" must be
shown on the label with the specification "caffeine not more than 10
percent" for raw or roasted coffee and "caffeine not more than 30
percent" for desiccated or freeze dried coffee extracts.

Special rules are in effect for the production and trading of
**decaffeinated tea**.

An EU regulation requires that **imports of wine**, grape must, and
grape juice be accompanied by a certificate issued by an agency in the
exporting country and, if for human consumption, an analysis report
drawn up by a body or service designated by the country in which the
product originated.

-   The use of saccharin and artificial sweeteners in foodstuffs and
    beverages, except dietetic products, is prohibited. Authorization
    from the Ministry of Health is required for their use in dietetic
    foods.

-   **Potatoes** to be shipped to most European markets must be treated
    with growth inhibitors to prevent sprouting. In addition, Italy
    requires that imported potatoes be inspected during the growing
    season.

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-   **Cosmetics**: EU cosmetics regulations cover beauty products and
    products used for personal hygiene but not pharmaceutical
    specialities and medicinal products that have cosmetic effects but
    that are intended primarily to protect against disease or to correct
    abnormal conditions requiring medical attention. The regulations
    prescribe labeling requirements and provide that information
    concerning the composition of cosmetics must be made available to
    competent authorities to ensure protection for the consumer. They
    also contain a list of prohibited substances, a list of restricted
    substances, a list of authorized coloring agents, and lists of
    substances and coloring agents that are authorized provisionally.

The use of boric acid and its derivatives in cosmetics and medicinal and
pharmaceutical products is limited by a ministerial decree. The use of
placenta and gestagene/estrogen substances in cosmetics is prohibited.
Extracts of placenta are permitted, however, provided they are devoid of
estrogen or gestagene. The use of benzoil peroxide in cosmetics is
prohibited.

**Italian Legislative Decree 126 of April 24, 1997, provides a
definition of cosmetics**, as well as rules for the production and
distribution of cosmetics. Companies manufacturing cosmetics that will
be imported into Italy must establish and maintain the following
information needed to evaluate the safety of the product and prove its
effectiveness: the complete formula of the product, including quality
and quantity information; the chemical, physical, and microbiological
specifications of the base products and finished products, along with
information concerning their compliance with purity and microbiological
requirements; the production methods used and how they comply with good
manufacturing practices as set forth by EU regulations; the evaluation
of the safety to human health of the finished product; the name and
address of the person responsible for the evaluation data; all
information pertaining to possible side effects; and documented proof of
the effectiveness of the product, if justified by the nature of the
product.

The product should not cause any damage to human health when used under
normal circumstances or when used under conditions that are easily
foreseeable.

-   **Forest products:** EU regulations require that sawn lumber must be
    kiln dried to below a 20 percent moisture content expressed as a
    percentage of dry matter, and logs must be stripped completely of
    bark and be free from Bursaphelenchus xylophilus (pine wood
    nematode). See also Documentary Requirements above.

-   **Other goods:** Standards and other regulations are in effect for a
    number of goods; other goods, including medical equipment and
    supplies, must be registered with the relevant ministry such as the
    Ministry of Health. These include cotton textiles, concrete,
    synthetic detergents, medical equipment, electrical goods,
    industrial equipment, hair dyes, insecticides, toys, and footwear

#### Japan

-   Japan\'s VCCI Mark (Voluntary Control Council for Interference by
    Information Technology Equipment) is administered by VCCI for
    information technology equipment (ITE) sold in Japan. VCCI
    requirements are EMC only and based entirely on CISPR 22. The VCCI
    Mark is voluntary, although most ITE equipment sold in Japan show
    the VCCI Mark. Product quality is a perception gained by displaying
    the VCCI Mark

    -   <http://www.percept.com/pages/compliancemarks.html#Japan>

-   **Industrial standards: ** The principal agency for establishing
    standards in Japan is the Japan Industrial Standards Committee
    (JISC), an agency of the Ministry of Economy, Trade, and Industry.

    -   Additional information is available from the Japan Industrial
        Standards Committee, Technical Regulation, Standards, and
        Conformity Assessment Policy Unit, Ministry of Economy, Trade,
        and Industry, 1-3-1 Kasumigaseki, Chiyoda-ku, Tokyo 100--8921;
        telephone: (3) 3501-9471; fax: (3) 3580-8637; e-mail:
        <jisc_iso@jsa.or.jp>

-   **Agricultural standards: ** The Japanese Agricultural Standard
    (JAS) applies to beverages; processed foods; forest products;
    agricultual commodities; livestock products; oils and fats; products
    of the fishing industry; and processed goods made from agricultural,
    forestry, and fishing industry raw materials. The Ministry of
    Agriculture, Forestry, and Fisheries administers the system,
    specifying product quality standards for relevant products, product
    definitions for items covered by JAS, and methods of measurement and
    determination of quality. The JAS mark, indicating compliance with
    the applicable standard, is an important quality assurance for
    forest products. Specific JAS marks exist for various types of
    plywood, paneling, flooring boards, lumber, and timber.

-   **Automobile standards:** the Ministry of Transport inspects a
    sample vehicle and establishes standards for that type of vehicle
    based on the inspection;

-   **Consumer products: ** Under the Consumer Product Safety Law, many
    products must bear the mandatory quality "S" mark. Each product must
    be tested and granted type approval, and the manufacturing
    facilities must be inspected and approved for quality control by a
    laboratory so designated by the Ministry of Economy, Trade, and
    Industry. METI has authorized Underwriters Laboratories and the
    United States Testing Company to perform product testing and factory
    inspections prior to the granting of the "S" mark. In the case of
    carbonated beverages, however, the manufacturer may verify that its
    product and facilities are in compliance with the consumer law and
    need not submit to independent testing.

    -   Consumer products may also be subject to additional voluntary
        quality marks that meet the technical and safety standards of
        Japanese industry associations.

    -   **The "SG" mark**, affixed by Japan\'s Consumer Product Safety
        Association, applies to furniture, sporting goods, household
        goods, and items for infants and children, except toys, which
        are covered by the "ST" mark.  Although U.S. manufacturers of
        these products are not required to obtain the "SG" mark, its
        existence may enhance the image of the product(s) with Japanese
        consumers. In addition, in the event of an accident attributed
        to a defect in a product bearing the "SG" mark, the Japan
        Consumer Product Safety Association will provide financial
        compensation to the consumer for the manufacturer.

    -   **The "ST" or Safety Toy mark**, affixed by the Toy Safety
        Control Administration, a self-regulatory commission composed of
        toy manufacturers, consumers, and health professionals,
        indicates that toys meet the voluntary safety standards of the
        industry. Since Japanese retailers are strongly committed to
        carrying domestic and imported toys with the "ST" mark, it is
        recommended that exporters comply with this standard. No U.S.
        organizations are currently authorized to test and approve toys
        for the "ST" mark. An English language manual describing the
        application and approval process of the "ST" marking system is
        available from the Japan Toy Association, 4-22-4
        Higashi-Komagata, Sumida-ku, Tokyo, 130-8611; telephone: (3)
        3829-2513; fax: (3) 3829-2549

    -   The "ECO" mark is a voluntary mark used to endorse
        environmentally friendly products to Japanese consumers. Use of
        the "ECO" mark on applicable products is recommended because
        Japanese consumers will choose to purchase products bearing it,
        even if prices are a little higher than similar products without
        the mark. Covered product categories include solar-powered
        products, non-CFC aerosols, biodegradable oil for two-cycle
        engines, soap made from cooking oil, recycled paper products,
        home composters, recycled plastic products, and recycled wood
        fertilizers.

-   **Food Regulations**: information on imports of food products is
    available from the Ministry of Health, Labor, and Welfare, 1-2-2
    Kasumigaseki, Chiyoda-ku, Tokyo 100-8045; telephone: (3) 3503-1711.

-   **Electrical appliances: ** Standards are in effect for consumer
    electrical appliances and commercial electrical apparatus under the
    Electric Appliance and Material Control Law. Appliances that use
    high voltage or high temperatures require type approval before they
    can be marketed in Japan. In order to receive the "T" mark, or type
    approval, both the products and their facilities must be inspected
    by METI-designated testing laboratories. Certification is provided
    by the Japan Electrical Testing Laboratory, 5-14-12 Yoyogi,
    Shibuya-ku, Tokyo 151; telephone: (3) 3466-9203; fax: (3) 3466-9204.
    In the United States, Underwriters Laboratories can help U.S.
    exporters obtain certification but is not authorized to certify U.S.
    products for the Japanese market.

-   **Telecommunications equipment:** including digital cordless
    telephone equipment, frame-relay equipment, wireless data
    communications terminals, etc., must adhere to the
    Telecommunications Business Law and the Radio Law. The Japan
    Approvals Institute for Telecommunications Equipment grants approval
    for goods required to comply with the Telecommunications Business
    Law. Information is available from the Japan Approvals Institute for
    Telecommunications Equipment, Isomura Building, Third Floor, 1-1-3
    Toranomon, Minato-ku, Tokyo; telephone: (3) 3591-4300; fax: (3)
    3591-4355. Goods required to comply with the Radio Law must be
    approved by the Telecom Engineering Center, 5-7-2 Yashio,
    Shinagawa-ku, Tokyo; (3) 3799-0051; fax: (3) 3799-1313.

Products new to Japan, including but not limited to foods, cosmetics,
and agricultural chemicals, must be submitted for tests conducted by
designated government or government-approved laboratories and testing
centers. This is time-consuming and in some instances expensive.
However, approval is necessary before importation and sale in Japan will
be authorized.

-   Information about standards in Japan is available from the Standards
    Information Service, First International Organizations Division,
    Economic Affairs Bureau, Ministry of Foreign Affairs, 2-2-1
    Kasumigaseki, Chiyoda-ku, Tokyo 100-8919; telephone: (3) 3581-3813;
    fax: (3) 3503-3136, and the Standards Information Service,
    Information Services Department, Japan External Trade Organization,
    2-2-5 Toranomon, Minato-ku, Tokyo 105-8466; telephone: (3)
    3582-6270; fax: (3) 3589-4179.

**Korea**

-   **Inspection**: All live animals, animal products, fresh food, and
    certain processed food products are subject to inspection as part of
    the quarantine procedures to which they must also submit. (See
    Documentary Requirements, above.) In addition, certain items such as
    chocolate products and other consumer goods considered luxury goods
    are subject to general inspection and testing procedures in which
    quality, box-sealing conditions, and other factors are evaluated.
    These procedures can result in an additional three to six weeks
    until the goods clear customs, despite the fact that technically the
    goods are not subject to any restrictions under Korean law.

-   **Food products:** The Ministry of Health and Welfare administers
    the Food Sanitation Act, which serves as the basis for all food
    safety regulations; however, the Korea Food and Drug Administration
    maintains standards for food and food additives. The KFDA also
    inspects and tests imported food products. Most food products are
    subject to the provisions of the Korea Food Code. In addition to
    covering general standards, the food code contains specific
    requirements for 148 food categories, along with maximum residue
    levels for chemicals, antibiotics, hormones, etc. The KFDA also is
    responsible for implementing the Food Additive Code, which contains
    a list of permitted chemical, natural, and mixed additives.
    Additional information is available from the Ministry of Health and
    Welfare, Health Industry Policy Division, 1 Jungang-dong, Gwachon
    City, Kyonggi Prov. 427-760; telephone: (82-2) 503-7585; fax: (82-2)
    503-7590, and from the Korea Food and Drug Administration, 5
    Nokbeon-dong, Eunpyung-ku, Seoul 122-704; telephone: (82-2)
    380-1733; fax: (82-2) 388-6392.

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-   **The Ministry of Agriculture and Forestry** is responsible for
    meat, poultry, and dairy product standards under the Livestock
    Product Processing Control Act, the Plant Protection Act, and the
    Agricultural and Fishery Product Quality Control Act. The ministry
    coordinates with the National Veterinary Research and Quarantine
    Service, the National Agricultural Product Qualtiy Management
    Service, and the National Plant Quarantine Service to inspect and
    test imported agricultural products. Additional information is
    available from the Ministry of Agriculture and Forestry,
    International Agricultural Bureau, 1 Jungang-dong, Gwachon City,
    Kyonggi Prov. 427-760; telephone: (82-2) 500-2656; fax: (82-2)
    507-2095.

-   **New-to-market goods** require laboratory testing and must be
    accompanied by a list of all the ingredients by percentages;
    subsequent shipments are subject to random sampling.

-   **Korea accepts manufacturer\'s use-by dates for most goods.
    Manufacturer\'s dates are not accepted, however, for sterilized milk
    and certain other dairy products and bottled water.**

-   A product is considered **organic** and may be labeled as such if
    the raw materials meet quality standards specified in the
    **Environmental Agricultural Promotion Act,** packaging is made of
    biodegradable material, organic and inorganic materials are stored
    and processed separately, and the manufacturing process meets
    specific mechanical, physical, and biological standards. Organic
    certification may be granted by an organization authorized in the
    country of export or by a recognized international body.

-   **For specific information regarding existing foreign agricultural
    standards and testing, packaging, and certification systems,
    exporters should contact the Office of Food Safety and Technical
    Services,** Foreign Agricultural Service, U.S. Department of
    Agriculture, South Agriculture Building, Room 5545, 14th Street and
    Independence Avenue S.W., Washington, D.C. 20250, (202) 720-1301;
    fax: (202) 690-0677. The National Center for Standards and
    Certification Information at the National Institute for Standards
    and Technology also maintains extensive files on existing foreign
    non-agricultural standards and their testing and certification
    systems. Further information is available from the National Center
    for Standards and Certification Information, National Institute for
    Standards and Technology, Building 820, Room 164, Gaithersburg, Md.
    20899, (301) 975-4040; fax: (301) 926-1559.

-   **Additional information on foreign standards** is available to
    firms in the United States through the American National Standards
    Institute, 11 W. 42nd St., New York, N.Y. 10036, (212) 642-4900;
    fax: (212) 398-0023.

-   **Medical devices**: Medical equipment must be registered with the
    Korea Food and Drug Administration and may be imported only by
    licensed importers that have been certified by a KFDA-authorized
    body. Product registration is issued only to local firms, therefore
    foreign manufacturers must obtain the required approval through
    their Korean distributors. All medical devices must be approved for
    sale in the country of manufacture before the KFDA will permit them
    to be marketed in Korea.

Medical devices are categorized as Class I, Class II, and Class III,
with Class III products posing the highest potential risk. All
categories require the manufacturer to submit a certificate of free sale
(an original U.S. Food and Drug Administration Certificate to Foreign
Government). Class I products require pre-market notification whereby
the KFDA reviews all product documentation but does not test the device
independently. The application for pre-market notification must include
the following information: local importer\'s company name, address, and
business license number; local importer\'s company representative and
resident registration number; the product\'s trade name, model name, and
classification name; list of product\'s raw materials; product\'s
external appearance and internal structure; manufacturing methods;
intended effects; usage instructions and precautions; packaging;
labeling information; and the name of the foreign manufacturer.

Class II and Class III medical devices require pre-market approval
whereby the KFDA conducts a technical review of the documentation
followed by a product type test in an authorized local laboratory. The
application for pre-market approval must include the following
information: local importer\'s company name, address, and business
license number; local importer\'s company representative and resident
registration number; foreign manufacturer\'s name and address; country
of manufacture; trade name, model name, and classification name of the
device; raw materials, including a list of ingredients or components and
a breakdown by percentage of each; information on the product\'s
external appearance, internal structure, and size; manufacturing
methods; product\'s effectiveness and purpose; usage instructions and
precautions; packaging; storage methods; validity period; and standards
and test methods.

During the technical review process, a separate safety and efficacy
review is required for any **product with new-to-market features**. The
following data must be submitted: information on the origin, discovery,
and background of the product\'s development; information on the
determination of the product\'s structure and physicochemical and
biological properties; stability and toxicity data; pharmacological
action; clinical study report; information on previous use in foreign
countries; comparative analysis with products currently available on the
market; functional performance; electromagnetic interference; and
electrical, mechanical, biological, radiation, and other safety
information.

The laboratory conducting the type test for a Class II or Class III
product may accept foreign test reports in lieu of conducting a separate
test. There is no comprehensive list of Korean standards or test
methods, and the KFDA has established standards for fewer than 100 of
its 950 classifications. Test laboratories may accept international
standards or equivalents, and will review and accept corporate
proprietary standards on a case-by-case basis. Commonly, Korean
importers will request from the foreign manufacturer a number of test
reports, including reports on biological safety, electrical safety, and
performance, in order to expedite type testing.

Once approved, Class II and Class III medical devices are subject to
additional local quality assurance testing before they may be marketed
in Korea. Local testing may be waived if the manufacturer complies with
recognized quality system regulations; compliance is usually indicated
on the certificate of free sale.

-   **Additional information** is available from the Korea Food and Drug
    Administration, Medical Devices and Radiation Health Department, 5
    Nokbun-dong, Eunpyung-ku, Seoul 122-704; telephone: (82-2) 380-1754;
    fax: (82-2) 351-3726; e-mail: m_kfda@kfda.go.kr.

-   **Pharmaceuticals**: Pharmaceutical products, including drugs and
    cosmetics, are regulated by, and must be registered with, the Korea
    Food and Drug Administration. This agency does not distinguish
    between U.S. prescription and non-prescription drugs and nutritional
    supplements; all are subject to the same rigorous testing
    requirements. Imports of cosmetics may be tested by authorized
    importers; only new-to-market products require testing.

-   **Chemicals**: Manufacturers and importers of chemical products must
    submit detailed information on the composition of their products to
    the Korean Ministry of Environment. Proprietary product
    formulations, however, need not be provided.

-   **Agricultural goods**: There is a green card system for reporting
    on pesticide residues in imported agricultural products. Under this
    system, imported agricultural products treated with pesticides may
    be imported under a simplified inspection procedure, if information,
    including the date and kind of pesticides used on the products
    during cultivation, storage, and transportation, is declared in
    advance.

-   **Heavy equipment:** Imports of heavy equipment are subject to
    special regulations, including type approval. Under the Revised
    Special Business Deregulation Law a waiver is granted to certain
    types of construction equipment, including some loaders, cranes,
    tractors, rock drilling equipment, bulldozers, forklifts, scrapers,
    rollers, road stabilizers, concrete spreaders, asphalt mixing
    plants, crushers, air compressors, pile drivers and extractors,
    gravel plants, and dredgers.

-   **Other goods:** Korea is a signatory to the GATT Standards
    Agreement. The agreement is designed to eliminate the use of
    standards and certification systems as impediments to trade.

-   **The Standards Agreement** does not dictate what the product
    standards must be, but it does call for open procedures in adopting
    standards and sets up a review procedure for settling disputes.
    Signatories are required to publish a notice of their proposed
    standards, to provide copies of these standards, if requested, and
    to allow countries to comment on them.

-   If exporters have reason to believe that a standard of any signatory
    country unjustifiably impedes their exports, they may communicate
    these concerns to the Office of Standards Code and Information,
    National Institute of Standards and Technology, Building 820, Room
    164, Gaithersburg, Md. 20899, (301) 975-4037; fax: (301) 926-1559.

-   Information is also available from the Korean Agency for Technology
    and Standards, 2 Chungang-dong, Gwachon City, Kyonggi Province
    427-010; telephone: (82-2) 507-4369; fax: (82-2) 503-7977; e-mail:
    standard@ats.go.kr.

Mexico

-   Cigarette stamp: All cigarettes imported into Mexico must have a
    special Mexican stamp affixed to the package.

-   **Product registration**: Certain items such as pharmaceuticals,
    some foods, medical equipment and supplies, pesticides, fertilizers,
    and other products containing toxic substances are subject to prior
    authorization from the Secretaria de Salud y Asistencia before the
    products may be imported. Information on the registration
    requirement for specific products is available from the Office of
    Mexico at the International Trade Administration, U.S. Department of
    Commerce, Washington, D.C. 20230. Inquiries should contain a
    complete product description, including the Harmonized System
    commodity classification number, if known.

-   **If the product requires prior authorization**, the Mexican
    importer must submit the original and one copy of the following
    documents to SSA: an application form obtained from the Ministry of
    Health, a certificate of origin or sanitary certificate, a
    certificate of free sale, a physical/chemical analysis or
    microbiological analysis, the original product label and back label
    (in Spanish, in the form in which they will appear when the product
    is marketed in Mexico), and the invoice or pro forma invoice.

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-   Documents should be submitted to Secretaria de Salud, Direccion
    General de Medicamentos y Tecnologia para la Salud, Monterrey 33,
    Col. Roma, 06700 Mexico, D.F.; telephone: (52-55) 5208-3064; fax:
    (52-55) 5255-0590. For information on requirements for certificate
    of origin, sanitary certificate, and other documents, see
    Documentary Requirements above.

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-   **Authorization to import** is signified by the granting of a
    Ministry of Health (SSA) registration number. This registration
    number must appear on the label of each product imported.

-   **Import verification inspection**: From Oct. 12, 2002, import
    verification inspections for meat and poultry under the animal
    health law must be conducted in Mexico.

-   **Health authorization**: Certain agricultural products, animals and
    animal products, and unprocessed foods require an additional health
    import authorization from the Secretariat of Agriculture (SAGARPA),
    regardless of whether or not an import license is required. As of
    Feb. 20, 2003, the SAGARPA health import authorization must be
    presented to Mexican customs officials at the point of entry. It
    states what health certificates, tests, or other materials must be
    presented to Mexican health authorities at the entry point. The
    sanitary authorization is valid for a specific time period or for a
    specific volume, whichever occurs first. The importer should be
    consulted about product-specific regulations. For information on
    sanitary certificates, see Documentary Requirements above.

-   **Environmental authorization**: Certain goods, including the
    following, must be certified by the Instituto Nacional de Ecologia,
    a branch of the Secretaria de Medio Ambiente, Recursos Naturales y
    Pesca: residues from metals such as iron, zinc, copper, aluminum,
    nickel, and lead; residues from organic and inorganic chemicals;
    fertilizers, plastics, rubber, pigments, paint, explosives,
    cosmetics, glues and other adhesives, used storage drums, and used
    tires. Additional information is available from the Instituto
    Nacional de Ecologia, Periferico Sur 5000, Col. Insurgentes
    Cuicuilco, Coyacan, 04530 Mexico D.F.; telephone: (52-55) 5424-6418
    or 5628-0600; fax: (52-55) 5424-5485.

-   **Ministry of Health notification:** Certain food products,
    cosmetics, alcoholic beverages, toiletries, and any other products
    that do not contain toxic substances only require a notice of
    importation or aviso to be made at the time of importation. The
    notice is made by the exporter\'s authorized Mexican representative
    through the customs broker at the time of importation. The Mexican
    representative or importer must either fill out an application
    available from the Ministry of Health (SSA) or provide a letter
    containing the information described below. The notice must
    accompany each shipment.

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-   The letter to SSA must include the name of the exporter, the country
    of origin, the name of the importer(s), the port of entry, the name
    and address of the warehouse where the product will be stored, the
    Harmonized System number, and the quantity and value of the product
    to be imported. A table format is preferred for the latter. In
    addition, the letter should specify whether the shipment is the
    first to Mexico of this product.

-   **The letter or application** form must be accompanied by any one of
    the following documents: sanitary certificate, certificate of
    origin, certificate of free sale, physical/chemical analysis, or
    microbiological analysis.

-   The customs broker should **submit the documents to the following
    address**: Secretaria de Salud, Departamento de Control Sanitario de
    Productos y Servicios, Monterrey 33, Col. Roma, 06700 Mexico, D.F.;
    telephone: (52-55) 5514-0761.

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-   **Quality standards**: Many products must comply with established
    quality standards, called **Normas Oficiales Mexicanas (NOMs).** As
    of May 6, 2002, there were 731 NOMs in place. The Federal Law on
    Metrology and Standardization specifies the methods by which NOMs
    are developed and compliance is assessed and requires that NOMs be
    revised every five years. Compliance with NOMs must be certified by
    the government agency that issued the NOM or by an authorized
    independent certification body before goods will be allowed entry
    into the country.

-   **To obtain the NOM certificate**, the importer must submit samples
    (generally no more than three) of each model of the product to an
    accredited Mexican laboratory for testing. The laboratory will run
    the tests and will submit the results to the Mexican Bureau of
    Standards (Direccion General de Normas or DGN) or to a
    DGN-accredited private certification body, which will in turn issue
    the certificate. NOM certification is valid for one year and may be
    renewed. Different and new models require separate certifications,
    and separate certificates are required for multiple importers of the
    same product. Samples used for certification purposes may not be
    sold to, or used by, the public.

-   **Products** that are identified during the certification process as
    being **unique or highly specialized** are limited to 25 units per
    import permit.

-   **Under NAFTA, Mexico was required to recognize conformity
    assessment bodies in the United States and Canada** on terms no less
    favorable than those applied in Mexico. Each Mexican government
    agency has its own compliance assessment process to determine
    compliance with its NOMs, however. U.S. manufacturers and/or
    importers are allowed to hold title to NOM certificate of compliance
    issued by the Secretariat of Economy and to assign it to as many
    distributors in Mexico as necessary to cover the market. However,
    this process is costly and does not apply to NOMs issued by other
    agencies.

-   In addition to mandatory standards, there are numerous **voluntary
    standards known as Normas Mexicanas** or NMXs. These voluntary
    standards become mandatory for importation purposes when they are
    referred to in a NOM. The practice in Mexico is to update and
    develop new NOMs using and quoting existing NMXs.

-   **Additional information on quality standards** is available from
    the Direccion General de Normas, Secretaria de Economia, Av. Puenta
    de Tecamachalco No. 6, Lomas de Tecamachalco, Naucalpan de Juarez,
    53950 Edo. de Mexico; telephone: (52-55) 5729-9300; fax: (52-55)
    5520-9715, and from the relevant government ministry. Information
    also is available from the Office of Mexico at the International
    Trade Administration, Department of Commerce, Washington, D.C.
    20230.

-   Mexico is a signatory to the **Agreement on Technical Barriers to
    Trade**, commonly known as the Standards Agreement, negotiated under
    the Tokyo Round of multilateral trade negotiations. The agreement is
    designed to eliminate the use of standards and certification systems
    as impediments to trade.

    -   The Standards Agreement does not dictate what the product
        standards must be, but it does call for open procedures in
        adopting standards and sets up a review procedure for settling
        disputes. Signatories are required to publish a notice of their
        proposed standards, to provide copies of these standards, if
        required, and to allow countries to comment on them.

    -   Standards (both voluntary and mandatory) and certifications
        systems, promulgated by the central governments, state and local
        governments, and private sector organizations are subject to the
        Standards Agreement\'s provisions, although only central
        governments are bound directly by it. The agreement requires
        that signatories "shall ensure that" central government bodies
        comply fully with its provisions. With respect to regional,
        state, local, and private organizations, the agreement requires
        signatories to "take such reasonable measures as may be
        available to them" to ensure compliance.

-   If exporters have reason to believe that a standard of any signatory
    country **unjustifiably impedes their exports**, these concerns may
    be communicated to the Office of Standards Code and Information,
    National Institute of Standards and Technology, Building 820, Room
    164, Gaithersburg, Md. 20899, (301) 975-4037; fax: (301) 926-1559.
    This office will facilitate the transmission of U.S. comments to the
    government of the foreign country concerned.

-   **For special information regarding existing foreign agricultural
    standards and testing, packaging, and certification systems,**
    exporters should contact the Office of Food Safety and Technical
    Services, Foreign Agricultural Service, U.S. Department of
    Agriculture, South Agriculture Building, Room 5545, 14th Street and
    Independence Avenue S.W., Washington, D.C. 20250, (202) 720-1301;
    fax: (202) 690-0677. The National Center for Standards and
    Certification Information at the National Institute for Standards
    and Technology also maintains extensive files on existing foreign
    nonagricultural standards and their testing and certification
    systems. Further information is available from the National Center
    for Standards and Certification Information, National Institute for
    Standards and Technology, Building 820, Room 164, Gaithersburg, Md.
    20899, (301) 975-4040; fax: (301) 926-1559.

-   **Additional information** on foreign standards is available to
    firms in the United States through the American National Standards
    Institute, 25 W. 43rd St., Fourth Floor, New York, N.Y. 10036, (212)
    642-4900; fax: (212) 398-0023, or at 1819 L St. N.W., Suite 600,
    Washington, D.C. 20036, (202) 293-8020; fax: (202) 293-9287; e-mail:
    <info@ansi.org>.

#### Philippines

-   **Import permits** are required for imports of meat, fishery
    products, fresh produce, planting seeds, and plants. The Deparment
    of Agriculture regulates these products. The United States has been
    largely prequalified to ship these goods to the Philippines.

-   **Regulations for meat imports** were revised effective Sept.
    27, 2000. For meats, the import permit consists of a veterinary
    quarantine clearance issued by the Bureau of Animal Industry and is
    valid for 30 days to 60 days, depending on the geographical location
    of the country of origin. Shipments must not be dated earlier than
    the date of issuance of the VQC. Canned meats and meat products must
    be shipped not later than one year prior to their expiration date;
    fresh, chilled, and frozen meats must be shipped at the earliest
    date possible prior to their expiration date. **Additional
    information is available from the Bureau of Animal Industry, Visayas
    Avenue, Diliman, Quezon City; telephone: (63-2) 927-0971 or
    926-6883; fax: (63-2) 926-6866.**

-   **Fishery products** are permitted entry only upon approval by the
    Department of Agriculture, under an administrative order that took
    effect Oct. 31, 1999. A required quarantine certificate is issued by
    the Bureau of Fisheries and Aquatic Resources. **Additional
    information is available from the Bureau of Fisheries and Aquatic
    Resources, Arcadia Building, Quezon Avenue, Quezon City; telephone:
    (63-2) 372-5043; fax: (63-2) 372-5048; e-mail:
    acamacho@vlink.net.ph.**

-   For **fresh produce, planting seeds, and plants**, the Bureau of
    Plant Industry issues permits. Fresh fruit from Texas is not
    permitted because of the fruit fly. Additional information is
    available from the Bureau of Plant Industry, San Andres, Malate,
    Manila; telephone: (63-2) 525-7857 or 525-7909; fax: (63-2)
    521-7650; e-mail: bpinir@info.com.ph.

-   **Local inspection for standards compliance** is required for a
    number of products, including **cosmetics, medical equipment,
    lighting fixtures, electrical wires and cables, cement, pneumatic
    tires, sanitary wares, and household appliances**. For other goods
    U.S. manufacturers\' self-certification of conformance is generally
    accepted.

-   **The Bureau of Product Standards** is a government body authorized
    to promote quality through product certification and quality
    management system certification. It offers the following services to
    importers and manufacturers: (1) A PS quality mark may be affixed to
    products manufactured in compliance with national or international
    standards following rigid testing and assessment of the product in
    accordance with standards set by the bureau. (2) Import commodity
    clearance may be issued to importers of commodities conforming to
    national and international standards. (3) By adoption of the
    International Standards Organization 9000 series, established
    standards may be applied in the services and manufacturing sectors,
    with foreign certification bodies doing joint quality system
    assessment. (4) Only the modern metric system (SI units) can be used
    for measurement. Importation of non-metric measuring devices,
    instrumentation, and apparatus is prohibited without prior clearance
    from the bureau.

-   For specific information regarding existing **foreign agricultural
    standards and testing, packaging, and certification systems**,
    exporters should contact the Office of Food Safety and Technical
    Services, Foreign Agricultural Service, U.S. Department of
    Agriculture, South Agriculture Building, Room 5545, 14th Street and
    Independence Avenue S.W., Washington, D.C. 20250, (202) 720-1301;
    fax: (202) 690-0677. The National Center for Standards and
    Certification Information at the National Institute for Standards
    and Technology also maintains extensive files on existing foreign
    nonagricultural standards and their testing and certification
    systems. Further information is available from the National Center
    for Standards and Certification Information, National Institute for
    Standards and Technology, Building 820, Room 164, Gaithersburg, Md.
    20899, (301) 975-4040; fax: (301) 926-1559.

-   **Additional information on foreign standards** is available to
    firms in the United States through the American National Standards
    Institute, 25 W. 43rd St., Fourth Floor, New York, N.Y. 10036, (212)
    642-4900; fax: (212) 398-0023, or at 1819 L St. N.W., Suite 600,
    Washington, D.C. 20036, (202) 293-8020; fax: (202) 293-9287; e-mail:
    info@ansi.org.

-   The Philippines is a signatory to **the Agreement on Technical
    Barriers to Trade**, commonly known as the Standards Agreement,
    negotiated under the Tokyo Round of multilateral trade negotiations.
    The agreement is designed to eliminate the use of standards and
    certification systems as impediments to trade.

-   If exporters have reason to believe that a standard of any signatory
    country unjustifiably impedes their exports, these concerns may be
    communicated to the Office of Standards Code and Information,
    National Institute of Standards and Technology, Building 820, Room
    164, Gaithersburg, Md. 20899, (301) 975-4037; fax: (301) 926-1559.

-   **Information is available from the Philippine Bureau of Product
    Standards,** Department of Trade and Industry, Trade and Industry
    Building, Third Floor, 361 Senator Gil J. Puyat Ave., Makati, Metro
    Manila; telephone: (63-2) 890-5227; fax: (63-2) 890-5129; e-mail:
    bps@dti.gov.ph.

-   **Product registration:** Processed foods, food supplements,
    pharmaceuticals, medical devices, diagnostic reagents, cosmetics,
    and hazardous household substances must be registered with the
    Philippine Bureau of Food and Drugs (BFAD) and receive the
    Certificate of Product Registration. Depending on the product,
    registration may require submission of the following: letter of
    application from the manufacturer or distributor; certificate of
    agreement between the manufacturer and distributor; certificate of
    brand name clearance; complete product formulation; technical
    specification of the finished product and all ingredients;
    description of the methods, facilities, and controls used to
    manufacture and package the item; quality control procedures and
    analytical test methods for the finished product; shelf-life
    estimate with appropriate justification; unattached labels and
    labeling materials; samples for laboratory analysis; certificate of
    analysis; certificate of free sale; and proof of payment of
    registration and testing fees. The Certificate of Product
    Registration is valid for two years and may be renewed for three
    years; the renewal application must be submitted three months before
    the expiration date to avoid additional fees.

-   **In order to import products requiring the Certificate of Product
    Registration**, the importer must have a valid license issued by the
    Bureau of Food and Drugs. The license includes a list of acceptable
    foreign suppliers and the products they may supply. In order to be
    included on this list, the foreign supplier must provide a
    Certificate of Good Manufacturing Practice and a certificate of
    agreement between the manufacturer and the importer; both documents
    must be authenticated by a Philippine Consulate.

-   Imported or locally produced **antibiotics** and
    **antibiotic-containing products** in all forms are subject to batch
    certification before they can enter the country or be released for
    sale.

-   Imports of **in vitro diagnostic reagents** require a report of test
    procedures and expected performance specifications. HIV test systems
    must have an evaluation report from an internationally recognized
    HIV reference laboratory.

-   The registration application for pharmaceuticals must include the
    product\'s suggested retail price. New drugs must have a full report
    of clinical and preclinical trials and a protocol for monitored
    release scheme. Drugs known to have bioavailability problems must
    have a report on any bioavailability studies undertaken. An initial
    conditional approval may be issued for drug products that have a
    valid registration but that are produced under a new manufacturer or
    have improved packaging. For drugs packaged in plastic containers,
    the registration application must include samples of the containers
    and closures along with data to substantiate their safety, including
    information on the components of the plastic used and results of
    chemical, physical, and biological tests on the material.

-   For **cosmetics** that claim to be hypoallergenic,
    dermatologist-tested, mild or gentle, noncomedogenic, nonirritating,
    for sensitive skin, or antibacterial, a full report must be provided
    of the clinical studies undertaken to justify the claims. A full
    report also is required for cosmetic products that claim to
    strengthen hair, prevent dandruff, penetrate deeply, help repair
    hair or split ends, and help increase and maintain cellular renewal.

-   **Food products** must have a certificate from the supplier that the
    flavor components are safe and suitable for human consumption.

**Food products are classified as Category I or Category II products**.
Category I products include bakery and related products; nonalcoholic
beverages and beverage mixes; candies and confectionery products;
coffee, tea, and nondairy creamer; condiments, sauces, and seasonings;
culinary products; gelatin, dessert preparations, and dessert mixes;
dairy products; dressings and spreads; flour, flour mixes, and starch;
fish and other marine products; prepared or processed fruits,
vegetables, and edible fungi; meat and poultry products; and noodles,
pastas, and pastry wrappers. These goods do not require laboratory
analysis and instead require only an affidavit of undertaking stating
that the product\'s ingredients and additives are permitted under BFAD
regulations and that the item is in compliance with BFAD and Codex
Alimentarius labeling standards. The necessary form is supplied by the
BFAD. The importer must supply three copies of the list of goods to be
imported, broken down by product classification; a copy of the sales
invoice; and a sample of each item in commercial form with a copy of the
label. A colored picture may be supplied in lieu of an actual sample.
Although laboratory analysis of the product is not required, random
samples may be selected and tested by the BFAD at the importer\'s
expense.

Category II food products include alcoholic beverages, food supplements,
herbal tea, bottled drinking water, foods for infants and children,
foods for special dietary use, transgenic food products, and ethnic
foods containing indigenous ingredients not common in the Philippines.

-   **Additional information** is available from the Bureau of Food and
    Drugs, Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa
    City 1781; telephone: (63-2) 807-0721; fax: (63-2) 842-5606; e-mail:
    bfad@bfad.gov.ph.

#### Poland

-   Effective in January 1997, **imported goods**, including food and
    agricultural products, **must be inspected for compliance with
    Polish quality standards**. The Centralny Inspektorat Standaryzacji
    is charged with ensuring the quality of products offered on the
    Polish market. Quality standards are in effect for many goods; in
    many cases, these standards apply to goods imported or transhipped
    and stored temporarily in Poland. Food and agricultural products,
    for example, are subject to standards established by the Polish
    Committee on Norms; they contain a wide range of requirements,
    including product age limitations, freezing and storage
    requirements, and residue limits.

-   **Approval Procedure:** l imported products must be approved for
    sale or use on the Polish market. **Only firms registered in Poland
    such as the importing firm can order product testing**. In order to
    test or register a new product, as well as to receive approval for a
    new additive not on the approved additives list, the appropriate
    sanitary station must be contacted. Importers generally will be
    required to submit samples of products or equipment for testing,
    regardless of whether foreign or international certificates had been
    previously issued, as well as detailed documentation on the
    products. In addition, they must adhere strictly to all requests by
    relevant inspection agencies. Testing can take from two weeks to two
    months.

Once an application and supporting materials have been submitted, the
inspecting agency will make a positive or negative recommendation for
import to the appropriate Polish ministry. When the import of a specific
product is approved, further imports of that product may be made free of
additional regulations. However, if some of the ingredients are
questioned, additional information may have to be submitted to the state
hygiene office (Panstwowy Zaklad Higieny). If approved by PZH,
permission still must be granted by the chief sanitary inspector (Glowny
Inspektor Sanitarny) for the product to be sold on the Polish market.
GIS approves all goods for sale on the Polish market. GIS requires the
following documentation: a written request for approval for the products
to be sold in Poland, a copy of PZH documentation, and a copy of
registration documents of the Polish importer (the importing firm must
be officially registered in Poland).

-   In addition to the approval procedure, some products, particularly
    those that come in contact with or **that can affect the health of
    the consumer**, must undergo registration once imported. In the case
    of **hazardous materials**, the importer must receive permission to
    use the product before applying for a concession to import the
    product into Poland.

-   **Regulations** covering the registration, packaging, and labeling
    of **genetically modified organisms and products containing GMOs are
    in effect**. The regulations have no minimum tolerance levels for
    foods containing GMOs. However, a new regulation approved in June
    2001 and expected to take effect at the beginning of 2002 will
    permit a 1 percent tolerance level for GMO ingredients in products.

-   **All pharmaceuticals** must be registered with the Instytut Lekow
    of the Ministry of Health and Social Welfare and approved for sale
    in Poland. All food and food products must conform to sanitary and
    other requirements before importation is permitted.

-   Imported products also must be checked by **the Polish Sanitary
    Station SANEPID**. It is the responsibility of the importer to
    submit a report on each shipment of imported goods to the state
    sanitary station. The report should include the following
    information: name of the product, name of the producer, names of the
    exporter and importer, quantity along with number of cases or
    pallets, date of production, date and port of entry, and means of
    transportation (e.g., truck, registration number, etc.). Reportedly,
    it is very difficult to obtain SANEPID\'s approval for importation
    of ecological products into the Polish market. Details of these
    regulations should be obtained from Polish importers before
    shipment.

-   Poland has a **positive-additives list** which identifies which
    additives are permitted for use in foodstuffs. A positive-residue
    list also is in effect. Both lists are similar to ones used in the
    European Union but not identical

-   **Diagnostic apparatus and medical equipment** for which there are
    no national or industrial standards and that are not on the list of
    domestically produced medical goods may be imported only by the
    Ministry of Health and Social Welfare.

-   Special requirements are in effect for the import of certain
    **agricultural products**. A phytosanitary permit from the Plant
    Quarantine Inspection Service of the Ministry of Agriculture and
    Food Economy is required for all live plants, fresh fruits,
    vegetables, grains, and seeds. Any shipment containing prohibited
    organisms such as fungi, viruses, bacteria, insects, mites, and
    weeds is prohibited. Imports of live animals, meat, meat products
    and offal, semen, and embryos must be covered by a veterinary
    permit. Veterinary permits for breeding livestock, semen, and
    embryos are not issued unless a positive opinion for the importation
    is received from the Central Animal Breeding Office. Some goods are
    subject to inspection upon importation.

-   The following goods are subject to veterinary controls and special
    import requirements from Oct. 1, 1999: live animals, eggs for
    hatching, egg products, live fish, canned fish, mammals, birds, sea
    animals, meat products, canned meats, milk and milk products,
    cheeses, skins, bones, blood, milk protein for animal feed, and pet
    food. There are quality standards for storage conditions of meat and
    meat products and validity of the products, depending on conditions
    and temperature of storage.

-   **Imported poultry meat processed by the following methods is not
    permitted to enter Poland for local consumption**, further
    processing, or re-export: mechanically separated, cleaned by
    chemical methods, or preserved with polyphosphorants. In addition,
    there are very strict rules on how poultry may be packaged. Among
    other things, poultry packed in a single block of ice is prohibited.
    In the absence of unit packaging such as shrink-wrapped trays or
    polyethylene bags, imported poultry parts must at least be
    layer-packed, with pieces separated by layers of plastic film so
    that the parts can be separated easily for inspection purposes.

-   **Imported food and agricultural products** must be inspected for
    compliance with Polish quality standards. The sanitary inspection of
    food is carried out by the State Sanitary Inspection Agency; the
    Central Office of Standardization of the Ministry of Foreign
    Economic Relations verifies the inspection. The Ministry of
    Agriculture and Food Economy is responsible for veterinary and
    phytosanitary inspection of imported food articles. The State
    Commission of Drugs of the Ministry of Health and Social Welfare
    verifies the quality of imported drugs for the protection from and
    treatment and diagnosis of, diseases.

-   A new law concerning the health and nutrition aspects of food
    products was adopted on May 11, 2001, covering production, storage,
    handling, labeling, etc. Some aspects of the law will take effect in
    2002 and others on Jan. 1, 2004. The provisions of this law will
    further align Polish regulations with those of the European Union.

-   **Safety standards:** The Polish Center for Certification and
    Control is responsible for organizing and supervising testing and
    certification systems. Hazardous domestic or imported materials and
    those that affect life, health, and the environment are subject to
    certification by authorized certifying units in accordance with
    Polish standards and must be marked with the center\'s registered
    safety symbol.

![](media/image1.png){width="0.15625in" height="0.15625in"} Poland has
an extensive system of standards and certification requirements to
protect consumer interests. These standards do not appear to be in
harmony with any international norms. Many of these standards are
obligatory and must be certified by accredited Polish testing agencies.
Safety certification requirements, which were introduced Jan. 1, 1997,
apply to a large number of manufactured goods, requiring them to be
certified and to bear the safety sign (the letter "B" in a triangle)
before they can be sold on the Polish market. The "B" stands for
"bezpieczenstwo" or "safety" in Polish. Final implementation of the
safety certification requirement, with fines of up to 100 percent of the
value of products for noncompliance, took effect Jan. 1, 1999.

-   Poland is cooperating with the European Union to adopt EU principles
    in the field of standards and conformity of Polish laws to those
    regulating these matters within the EU. The EU and Poland agreed
    that the Polish testing laboratories and other institutions issuing
    certificates will be checked in view of their conformity to European
    directives. After the testing bodies are checked and the results are
    positive, a list of these institutions will be published. All
    products then tested by these bodies will be automatically accepted
    in the EU as well as in Poland without any additional procedures.

-   **The regulations are administered by Polskie Centrum Badan i
    Certyfikacji (PCBC), ul. Klobucka 23A, 02699 Warsaw**; telephone:
    (48-22) 8579916; fax: (48-22) 6471222. The PCBC is responsible for
    certification of certain products.

-   **When applying for safety certification from PCBC Warsaw,**
    companies must complete an application form and a manufacturer\'s
    questionnaire. These documents may be obtained directly from PCBC
    Warsaw. A technical description and detailed information on the
    construction and content of the product must accompany the
    application. If a product has received the European Union CE mark or
    other international product certification, copies of the certifying
    documents should also be supplied with the application.

    -   Upon receipt of the required documents, PCBC Warsaw will provide
        the applicant with a list of appropriate laboratories authorized
        to perform tests on the product. The applicant must then supply
        the product to one of the laboratories. After completion of
        necessary tests by the laboratory, the applicant must supply
        PCBC Warsaw with the test results. PCBC Warsaw then will review
        the test results and inform the applicant if any further
        documents must be provided in order to complete the process.

    ```{=html}
    <!-- -->
    ```
    -   **Building Products:** When introduced into the Polish market,
        building products must have documentation certifying that they
        are in conformity with existing standards. They also must
        receive technical approval, a document issued by designated
        research and development institutes. After receiving technical
        approval, some building products may still need the "B"
        certificate. This requires another certification process which
        can take considerable time to complete; however, official
        regulations specify that this process should not exceed three
        months. Certificates are available only at the PCBC. U.S.
        exporters of these products should consult their Polish
        customers for additional information.

    -   **Other standards:** Polish standards describing a wide range of
        products have been developed by a central institution, the
        Polish Committee for Standardization (PKN), over the years.
        These standards have a P.N. prefix. Through its ministries, the
        government of Poland decides which of these standards are
        obligatory. Also, ministerial regulations clarify what standards
        a particular product must meet to be admitted into Poland.
        Information is available from the Polish Committee for
        Standardization, ul. Elektoralna 2, P.O. Box 411, PL-00-950
        Warsaw; telephone: (48-22) 6205434; fax: (48-22) 6205434;
        e-mail: intdoc@pkn.pl.

    -   Standards worked out by industry branches or industrial
        associations were marked **BN**. Initially, they were only valid
        for specialists in the particular branch of industry to which
        they applied. Over the years, however, many of these standards
        received national status and were listed together with the
        national standards. The prefixes **P. N.** and BN still exist.

    -   **For specific** information regarding existing foreign
        agricultural standards and testing, packaging, and certification
        systems, exporters should contact the Office of Food Safety and
        Technical Services, **Foreign Agricultural Service, U.S.
        Department of Agriculture, South Agriculture Building, Room
        5545, 14th Street and Independence Avenue S.W., Washington, D.C.
        20250, (202) 720-1301; fax: (202) 690-0677**. The National
        Center for Standards and Certification Information at the
        National Institute for Standards and Technology also maintains
        extensive files on existing foreign non-agricultural standards
        and their testing and certification systems**. Further
        information is available from the National Center for Standards
        and Certification Information, National Institute for Standards
        and Technology, Building 820, Room 164, Gaithersburg, Md.
        20899, (301) 975-4040; fax: (301) 926-1559.**

    -   Additional information on foreign standards is available to
        firms in the United States through the American National
        Standards Institute, 11 W. 42nd St., New York, N.Y. 10036, (212)
        642-4900; fax: (212) 398-0023.

**Russia**

-   The Russian law \"On Certification\" and \"On Protection of
    Consumer\'s Rights\" and related Government regulations impose
    strict safety requirements on imported cosmetic products in Russia.

    -   View this website for more specifics and contact information
        <http://www.bisnis.doc.gov/bisnis/isa/9903csm.htm>

-   An American company with prospective Russian buyers should start the
    certification process for its products by submitting a broad range
    of required documents and data to a Russian-accredited certification
    center.

    -   For a more details visit
        <http://permanent.access.gpo.gov/lps3997/9608cert.htm>

-   Russia has an official certification called \"GOST R Certification
    System\" (GOST refers to State standards; whereas R means Russia).
    This certification system is administered by the Russian State
    Committee on Standardization, Metrology, and Certification
    (Gosstandart). Gosstandart oversees and develops industry mandatory
    and voluntary certification programs.

    -   <http://www.percept.com/pages/compliancemarks.html#Japan>

-   [Gosstandart accepts testing protocols from]{.underline}
    Underwriters Laboratories, the International Electrotechnical
    Commission System for Conformity Testing and Certification of
    Electrical Equipment (IECEE) for electrical equipment, and the
    International Electrotechnical Commission Quality Assessment System
    for Electronic Components (IECQ) for electrical components.

-   **[Many products also require certification by a specific industry
    body]{.underline}**

    -   [Ministry of Agriculture]{.underline} for food products

    -   [Ministry of Health]{.underline} for medical devices and
        pharmaceuticals

    -   [State Communications Committee]{.underline} for
        telecommunications equipment and services

    -   [State Mining and Industrial Inspectorate]{.underline}
        GOSGORTECHNADZOR for equipment for the mining, oil, and gas
        industries

    -   [Veterinary Department]{.underline} for animal Products

    -   **[Sanitary certificate:]{.underline} ** Certain agricultural
        substances, including livestock, meat, plant materials, seeds,
        fresh fruits and vegetables, and biological substances, may
        require sanitary certificates.

        -   Food products, additives, and preservatives must be covered
            by hygiene certificates. The State Committee on Sanitation
            and Epidemic Control (Goskomsanepidemnadzor), which is the
            agency responsible for sanitary and hygiene regulations,
            issues the certificates for children\'s foods, food
            additives, and non-traditional forms of unprocessed foods,
            as well as for food products purchased under international
            agreements. Certificates normally are issued through the
            agency\'s Moscow certification laboratories but may also be
            handled through testing centers in the United States such as
            Control Union Inspection Inc. or the U.S. Testing Company
            Inc. Certificates for other food products may be issued by
            local departments of Sanepidemnadzor.

        -   More information may be obtained from the Animal and Plant
            Health Inspection Service, U.S. Department of Agriculture,
            4700 River Road, Riverdale, Md. 20737, (301) 734-7885;
            fax: (301) 734-6402 (Veterinary Services) and (301)
            734-8537; fax: (301) 734-5786 (Plant Protection and
            Quarantine).

        -   Exporters should obtain information directly from the
            importer prior to shipment because of the complexity of
            sanitary and health regulations. Information also can be
            obtained from the appropriate ministry of the Russian
            government.

-   **Most goods**, whether imported or domestically produced, are
    **subject to safety certification** and inclusion in the state
    register by Gosstandart (the Russian State Standards Committee), a
    state certification center, or a foreign company authorized by
    Gosstandart.

-   **Gosstandart is the primary Russian standards organization**, and
    it decides whether a product is accepted in the state register. If a
    product is not included in the state register, the company will have
    to provide the required documents before registration can take place
    allowing the goods to be imported. (See Documentary Requirements
    above for additional information on certification procedures.)

Gosstandart certifies products according to Russian government standards
rather than international standards. U.S.-made drugs and biological
products approved by the U.S. Food and Drug Administration for safety
and efficacy standards may be imported into Russia without additional
testing. Russia also is establishing reciprocal standardization with
other countries and has pledged to cooperate on improving and
simplifying mutual recognition of certification, testing, and quality
assurance.

While Gosstandart and its authorized agents are the chief sources for
certification in Russia, other agencies are involved in certification of
certain products, such as the Ministry of Agriculture for food products,
the Ministry of Health for medical devices and pharmaceuticals, the
State Communications Committee for telecommunications equipment and
services, and the State Mining and Industrial Inspectorate
GOSGORTECHNADZOR for equipment for the mining, oil, and gas industries.

-   **Testing protocols from certain other bodies**, including Control
    Union Inspection Inc., U.S. Testing Company, Underwriters
    Laboratories, IECEE for electrical equipment, and IECQ for
    electrical equipment and components, are accepted by Gosstandart and
    help to expedite certification by the Russian agency. Certificates
    normally are issued through the agency\'s Moscow certification
    laboratories.

-   **Food products: Foodstuffs must be registered prior to
    importation.**

> **The following meat products may not be imported from the United
> States** to Russia: ground red meat packaged in bulk form or in meat
> patties; beef products originating from animals raised in states where
> there are outbreaks of vesicular stomatitis; ground poultry in
> consumer size packages, mechanically deboned poultry meat, and
> giblets; and poultry products from birds grown in selected counties in
> states affected by an outbreak of laryngotracheitis.

**Raw and processed meat** products intended for export to Russia must
comply with USDA standards and regulations. Imports of raw pork and raw
poultry must be processed or packed in plants that have been approved
for the specified product by the Russian Ministry of Agriculture. A list
of approved plants is available from the U.S. Food Safety and Inspection
Service, Technical Service Center, Export Division, 106 S. 15th St.,
Suite 904, Omaha, Neb. 68102, (402) 221-7400; fax: (402) 418-8914.

Fully cooked pork products, fully cooked poultry products, and heat
treated but not fully cooked poultry products, pork casings, and beef
and beef products may originate from any federally inspected facility.
Processed food products must comply with the general import requirements
discussed above. In addition, if the products contain meat or poultry,
they must comply with all requirements for importing meat and poultry
products. Fish and seafood products must be from plants approved by the
U.S. Food and Drug Administration. Special import requirements also may
apply to certain processed foods and beverage products.

-   All **genetically modified food products**, including genetically
    modified raw materials, such as soy and some fruits and vegetables,
    and genetically modified food additives, distributed or sold in
    Russia must be registered in the RF Register of GM Food Products. In
    addition, all food products, additives, and preservatives must be
    certified. The State Committee on Sanitation and Epidemic Control
    (Goskomsanepidemnadzor) certifies children\'s foods, food additives,
    nontraditional forms of unprocessed foods, and food products
    purchased under international agreements and is responsible for
    Russia\'s sanitary and hygiene regulations. Additional information
    is available from Goskomsanepidemnadzor, Vadkovskiy per. 18/20,
    Moscow; telephone: (7-095) 973-27-48; fax: (7-095) 200-02-12.

-   **Hygienic regulations** that became effective Sept. 1, 2002, cover
    the permissible levels of hazardous chemical compounds, including
    pesticides and biologic objects, in foodstuffs; the level of animal
    growth stimulants and medical drugs in foodstuffs; the content of
    nitrogen-containing substances in some foods; the oxidative
    deterioration indices in fatty products; any radionuclide content;
    the parasitological parameters of potable water safety; and the
    microbiological parameters of food safety and nutrition. Foods for
    children\'s consumption shall take into consideration the
    children\'s age. The hygienic regulations also include criteria for
    food for consumption by pregnant and nursing women. U.S. exporters
    should consult with their importers to determine how to comply with
    the hygienic rules.

-   **Medical devices**: All medical devices imported into Russia must
    be registered with the Ministry of Health. Registration usually
    requires clinical trials. The registration certificate is issued by
    the State Inspectorate for the Quality Control of Drugs and Medical
    Equipment, Ministry of Health, 3 Rakhmanovsky per., Moscow 101432;
    telephone: (7-095) 973-13-94; fax: (7-095) 925-01-28. Registration
    applications and forms may be obtained from the Department of
    Testing and Registration of New Foreign Medical Equipment, Ministry
    of Health, 3 Rakhmanovsky per., Moscow 101432; telephone: (7-095)
    927-29-55, 927-28-91, or 927-29-48; fax: (7-095) 200-02-12.

-   Certain types of **imported medical devices and equipment** also
    must be accompanied by safety certificates. The main testing and
    certification body is Gosstandart, which also develops basic
    policies for certification. Gosstandart maintains and updates lists
    of goods subject to certification and metrological control and
    authorizes testing institutes to issue certificates of safety. See
    also Documentary Requirements above.

-   **Gosstandart may be contacted at 9 Leninsky Prospekt, 117049
    Moscow; telephone: (7-095) 236-62-08; fax: (7-095) 236-62-31;
    e-mail: <info@gost.ru>.**

-   **Pharmaceuticals**: All drugs and biological products must be
    registered with the Ministry of Health in the name of the
    manufacturer and/or an authorized representative. In addition, the
    pharmaceutical or substance must be registered and listed with the
    local food and drug administration in the country of origin by the
    manufacturer. Drug registrations are handled by the Bureau of
    Registration of New Pharmaceuticals and Medical Equipment, Ministry
    of Health, 3 Rakhmanovsky per., Moscow 101432; telephone: (7-095)
    973-16-35; fax: (7-095) 973-16-35.

-   **Documents required for registration** include an application, a
    product description, and certification/approval papers. Trading
    companies seeking product registration must present a letter from
    the manufacturer authorizing them to do so. Registration is valid
    for five years.

-   **In addition to registration, an importer must obtain a Russian
    quality certificate for pharmaceuticals**. Since certification and
    registration procedures are similar, an applicant may present copies
    of tests and analyses carried out during registration to the
    certification body. This information normally is sufficient for
    certification without additional testing, or it may reduce testing
    to a minimum. Gosstandart authorizes a number of organizations to
    certify pharmaceuticals, but many companies prefer to act through
    the Inspectorate of Quality Control of Drugs and Medical Equipment
    in the Ministry of Health. The inspectorate also can provide
    information on testing laboratories that can provide certificates of
    conformity for drugs. See also Documentary Requirements above.

-   In most cases**, vitamins and biologically active additives** are
    registered and certified in the same manner as drugs. In some cases,
    however, a hygiene certificate issued by the Institute of Nutrition
    of the Russian Academy of Medical Sciences may be sufficient. That
    institute can be reached at 2/14 Ustinsky Proezd, Moscow 109240;
    telephone: (7-095) 298-18-59; fax: (7-095) 298-18-72.

-   **Tobacco and alcohol**: Imported alcoholic beverages and tobacco
    products are required to be accompanied by specific information
    about the country of origin, the importer, and the customshouse
    through which the goods have been cleared before they can be sold
    within the country. Fines of up to 5,000 times the minimum monthly
    wage may be levied for noncompliance.

-   **Information on existing foreign agricultural standards and
    testing, packaging, and certification systems** is available from
    the Office of Food Safety and Technical Services, Foreign
    Agricultural Service, U.S. Department of Agriculture, South
    Agriculture Building, Room 5545, 14th Street and Independence Avenue
    S.W., Washington, D. C. 20250, (202) 720-1301; fax: (202) 690-0677.
    Information on existing nonagricultural standards and their testing
    and certification systems is available from the National Center for
    Standards and Certification Information, National Institute for
    Standards and Technology, Building 820, Room 164, Gaithersburg, Md.
    20899, (301) 975-4040; fax: (301) 926-1559.

-   Additional information on foreign standards is available to firms in
    the United States through the American National Standards Institute,
    11 W. 42nd St., New York, N.Y. 10036, (212) 642-4900; fax: (212)
    398-0023.

**Saudi Arabia**

-   The [Saudi Arabian Standards Organization](http://www.saso.org.sa/)
    (SASO) was established pursuant to the Royal Decree No. M/10 dated
    March 3, 1992. Acting under this decree, the SASO and the Ministry
    of Commerce (MOC) have implemented the [International Conformity
    Certification Program](http://www.iccp.com/) (ICCP), a mandatory
    product testing and certification scheme for a wide range of
    products imported into the Kingdom of Saudi Arabia.

    -   [Regulated products consist of]{.underline} certain food and
        agricultural items, some electronics and related goods,
        automobiles and certain automotive parts, chemical products, and
        various other commodities including cigarettes, cement, aluminum
        products, gold bullion, gold and silver jewelry, and household
        fire extinguishers.

    -   <http://www.ul.com/international/saudi.html>

    -   The application for registering or listing a regulated product
        is available through the SASO Americas Regional Licensing
        Center, 7070 Codman Hill Road, Boxborough, Mass. 01719,
        800-441-7276; fax: 978-635-1620; e-mail: <rlc1@etl.semko.com>

-   **[Food Products]{.underline}** are tested in Saudi Arabia by the
    Quality Control Department of the Ministry of Commerce or by SASO
    laboratories. If Saudi authorities are satisfied that the applicable
    standards have been met, they will issue a certificate of conformity
    and a consignment release order.

-   **The Saudi Arabian Standards Organization is the primary unit
    responsible for establishing product quality and safety standards**.
    Mandatory standards are in effect for many products. Quality control
    laboratories at ports of entry may reject products that are in
    violation of existing law. U.S. companies may request additional
    information concerning requirements from the Saudi Arabian Standards
    Organization, P.O. Box 3437, Riyadh 11471; telephone: (966-1)
    452-0000; fax: (966-1) 452-0086; e-mail: sasoinfo@saso.org.

-   **Certain regulated products** such as electronics, chemical goods,
    automobiles and automotive parts, chemical and various other
    products are subject to special certification requirements involving
    registration in the country of origin and preshipment inspection to
    verify their compliance with applicable Saudi safety and quality
    standards. Regulated food products are tested at the port of entry
    by the Quality Control Department of the Ministry of Commerce or by
    a SASO laboratory to determine their compliance with Saudi standards
    (see Documentary Requirements for additional information).

-   Saudi Arabia is taking steps to bring its national product standards
    into conformity with those of **the International Standards
    Organization** and to coordinate the development of these standards
    with other members of the Gulf Cooperation Council. The council has
    established some unified standards through the Gulf Standards
    Organization.

-   **Food products**: Food imports must comply with strict shelf-life
    regulations. Specific information regarding shelf-life requirements
    is available from the Saudi Arabian Standards Organization. Food
    items with a shelf life of one year or more after production will be
    denied entry if more than six months have elapsed. Food items with
    less than one year of shelf life will be denied entry if more than
    half of the shelf life has elapsed or three months have passed,
    whichever is shorter. However, food items whose expiration date
    falls within less than two months of the date of production are
    exempted from these requirements.

Numerous regulations apply to food preservatives and additives and
generally are based on the Codex Alimentarius. Foodstuffs may contain
only those flavors, colors, emulsifiers, stabilizers, thickeners, and
sweeteners that are specified in Gulf Cooperation Council standards.
Maximum limits for pesticides and other contaminants, including
antioxidants, aflatoxins, and radioactive substances, also have been
established.

**Imported food products are subject to random testing** upon entry to
determine compliance with regulations governing genetically modified
organisms. Food products may not contain genetically modified animal
ingredients; however, modified plant ingredients are permitted.
Foodstuffs containing less than 1 percent genetically modified plant
ingredients are considered nonmodified.

-   **Meat and animal byproducts** imported into Saudi Arabia must be
    processed in plants that have implemented the Hazard Analysis and
    Critical Control Point (HACCP) as a system of production process
    control, effective June 7, 2003..

-   **Foods must be packaged** in containers of food grade quality that
    protect the food against contamination, degradation, moisture,
    environmental conditions, and transportation hazards. Food
    containers must not appear to be in the shape of a pharmaceutical
    product. Special regulations for plastic containers limit the
    concentration of a vinyl chloride monomer to a maximum of 1
    milligram per kilogram (0.01 milligram per kilogram if the package
    is made of polyvinyl chloride).

-   **Health foods and supplements must be registered with the Ministry
    of Health** (see information on pharmaceuticals below).

-   **The Saudi Arabia Food and Drug Authority** was established March
    10, 2003, to handle all aspects of food and drug safety regulations.
    A five-year transition period is in effect, during which time the
    responsibilities for food and drug safety currently handled by the
    Saudi Arabian Standards Organization, the Ministry of Commerce, the
    Ministry of Health, and the Ministry of Agriculture are to be
    consolidated. The authority is expected to assume full
    administrative duties by March 2008.

-   **Pharmaceuticals**: All drugs, including herbal medicines and
    health food products, must be registered with the Ministry of Health
    before they may be marketed in Saudi Arabia. Only a Saudi agent may
    handle the registration process, which typically takes from six
    months to 18 months. The exporter must provide necessary
    documentation, including certificates of free sale and analysis and
    evidence of good manufacturing practice. The exporter also must
    supply the following information about the product: registration
    number and date; date of marketing in the country of origin; trade
    and/or generic name; full composition, including the quantity and
    scientific name of active and inactive ingredients; therapeutic
    category, if applicable; statement that the composition of the
    product to be exported to Saudi Arabia is the same as that marketed
    in the country of origin; list of countries in which the product is
    currently sold; percentage of alcohol in the finished product, and
    justification of that percentage; and the source of any animal-based
    ingredients. The full specifications, methods of analysis, stability
    study, and storage conditions must be included. Six samples of the
    product normally are required along with abstracts of scientific
    references and periodicals testifying to its safety and efficacy.

-   **Additional information** is available from the Ministry of Health,
    P.O. Box 21217, Riyadh 11176; telephone: (966-1) 401-5555; fax:
    (966-1) 402-9897.

-   **The Food and Drug Authority** established March 10, 2003, will
    gradually assume responsibility for drug safety and regulation. The
    authority is expected to be fully operational by March 2008.

-   **Motor vehicles:** Motor vehicles and automotive spare parts are
    subject to mandatory standards. In July 2000, the Saudi Arabian
    Standards Organization approved a series of mandatory standards
    applicable to used vehicles.

-   **Appliances**: Household electrical appliances must be accompanied
    by Arabic instruction manuals. Electrical products should conform to
    Saudi Arabia\'s power system of 127/220 volts, 60 hertz; however,
    SASO will accept products that operate at 120 volts, 60 hertz.

-   **Plants**: All shipments of plants will be inspected upon arrival
    in Saudi Arabia, with costs to be borne by the importer. Soil, sand,
    and specified plant pests are prohibited. Plant propagative
    materials such as cuttings, seedlings, and bulbs must be shipped in
    peat moss certified to have been sterilized in the country of
    origin. Firms that wish to ship plants in artificial materials other
    than peat moss should verify in advance from the Plant Protection
    Branch, Ministry of Agriculture, Riyadh, that the artificial
    material will be acceptable.

-   **Agricultural equipment**: The Ministry of Agriculture requires
    registration by a local agent of agricultural equipment and
    chemicals being introduced to Saudi Arabia for the first time. Dairy
    equipment or any supplies or structural components such as on-farm
    silos, fencing, etc., are not required to be registered. The local
    agent must present a signed distributor agreement with the supplying
    company, price information, and five sets of technical
    specifications when applying for product registration of on-farm
    agricultural machinery. Distributors will be allowed to import up to
    five of the units being registered for sale to identified buyers.
    Regular import approval will be granted if the initial users
    experience no problems with the machinery after one agricultural
    season or 500 hours of operation. The ministry will establish an
    acceptable price level after review of pricing information and
    technical specifications. Suppliers should give careful
    consideration to initial pricing, since there are no provisions for
    automatic review of price levels; once established, prices may not
    be easily changed.

-   **Additional information** is available from the Ministry of
    Agriculture, Airport Road, Riyadh 11195; telephone: (966-1)
    401-6666; fax: (966-1) 403-1415.

For specific information regarding existing foreign agricultural
standards and testing, packaging, and certification systems, exporters
should contact the Office of Food Safety and Technical Services, Foreign
Agricultural Service, U.S. Department of Agriculture, South Agricultural
Building, Room 5545, 14th Street and Independence Avenue S.W.,
Washington, D.C. 20250, (202) 720-1301; fax: (202) 690-0677. The
National Center for Standards and Certification Information at the
National Institute for Standards and Technology also maintains extensive
files on existing foreign nonagricultural standards and their testing
and certification systems. Further information is available from the
National Center for Standards and Certification Information, National
Institute for Standards and Technology, Building 820, Room 164,
Gaithersburg, Md. 20899, (301) 975-4040; fax: (301) 926-1559.

-   **Additional information on foreign standards** is available to
    firms in the United States through the American National Standards
    Institute, 25 W. 43rd St., Fourth Floor, New York, N.Y. 10036, (212)
    642-4900; fax: (212) 398-0023, or at 1819 L St. N.W., Suite 600,
    Washington, D.C. 20036, (202) 293-8020; fax: (202) 293-9287; e-mail:
    <info@ansi.org>.

South Africa

-   **Foodstuffs**: The sale, manufacture, and importation of most
    foodstuffs are regulated. Imported food products must meet
    phytosanitary, veterinary, legal, and labeling requirements. The
    Trade and Metrology Act sets measurement standards and outlines
    inspection procedures to ensure the products meet specified
    requirements. Before imported food is allowed to enter the South
    African market, it is inspected at the port of entry. Some
    requirements must be met by the exporter before the shipment occurs,
    but it is the responsibility of the importer to be aware of the
    requirements and to ensure compliance with the regulations. Some
    imports, including genetically modified organisms, require special
    permission to be imported into the country.

The Foodstuffs, Cosmetics and Disinfectants Act, 1972, governs the
maximum limits for veterinary medicine and stock remedy residues that
may be present in foodstuffs, as well as regulations on microbiological
standards for foodstuffs and related matters. In addition, the maximum
limits for pesticide residues and chemicals that may be present in
foodstuffs are regulated.

The regulations relating to the grading, packing, and marking of **honey
and mixtures intended for sale** in South Africa are applied under the
Agricultural Products Standards Act, 1990. Imported honey must also
comply with relevant requirements prescribed by the Department of
Health\'s Foodstuffs, Cosmetics, and Disinfectants Act, 1972, and the
Department of Agriculture\'s Agricultural Pests Act, 1983.

**Fresh fruit** imports from the United States generally are prohibited;
only fresh grapes and citrus fruit from certain areas are permitted, and
these imports are subject to quarantine and inspection requirements.

The South African Bureau of Standards issues national standards
specifications, codes of practice, and standard methods for many
products sold in the country. A specification may be a description of a
commodity or a description of the manner of manufacture, in which case,
the components, material or substance, characteristics, and other
relevant aspects are included.

-   Some goods may be eligible to bear the applicable certification mark
    as evidence to the consumer that the commodity is manufactured in
    accordance with the mark specification. In some cases, the
    Department of Trade and Industry, on the recommendation of the SABS,
    may declare a specification to be compulsory in order to promote and
    maintain standardization and quality when safety, health, consumer
    protection, or the environment is concerned. The compulsory
    specification is administered by SABS on behalf of the department.
    Some imported goods may be subject to inspection on entry into the
    country in order to ensure that the goods are in accordance with
    applicable regulations.

-   **The Plastic Bag Regulations** of May 2000 prohibit carry bags of a
    thickness of less than 30 microns from Jan. 1, 2001, and bags with a
    thickness of less than 80 microns from June 1, 2001.

**Information on standards** is available from the **South African
Bureau of Standards, Private Bag X191, Pretoria, 0001**; telephone: (12)
4286925/6 or 4286561; fax: (12) 3441568; e-mail: info@sabs.co.za.

-   For specific information regarding existing foreign **agricultural
    standards and testing, packaging, and certification systems**,
    exporters should contact the Office of Food Safety and Technical
    Services, **Foreign Agricultural Service, U.S. Department of
    Agriculture, South Agriculture Building, Room 5545, 14th Street and
    Independence Avenue S.W., Washington, D.C. 20250, (202) 720-1301;**
    fax: (202) 690-0677. The National Center for Standards and
    Certification Information at the National Institute for Standards
    and Technology also maintains extensive files on existing foreign
    non-agricultural standards and their testing and certification
    systems. Further information is available from the National Center
    for Standards and Certification Information, National Institute for
    Standards and Technology, Building 820, Room 164, Gaithersburg, Md.
    20899, (301) 975-4040; fax (301) 926-1559.

-   **Additional information** on foreign standards is available to
    firms in the United States through the American National Standards
    Institute, 11 W. 42nd St., New York, N.Y. 10036, (212) 642-4900;
    fax: (212) 398-0023.

Spain

-   The **quality of imported goods** must correspond to the description
    shown on import documents, declarations, licenses, and labels or
    packages. Inspection for quality is conducted by the Customs
    Inspection Service (or SOIVRE---Servicio Oficial de Inspeccion y
    Vigilancia del Comercio Exterior) and takes place before customs
    clearance.

-   The task of drawing up specific technical standards on the basis of
    mandates from the EU Commission is delegated to **three European
    regional standards organizations**---CEN (European Committee for
    Standardization), CENELEC (European Committee for Electrotechnical
    Standardization), and ETSI (European Telecommunications Standards
    Institute). First consideration in standards development is given to
    existing standards drawn up by the ISO or by the International
    Electrotechnical Commission

-   There are ongoing efforts to harmonize **product standards in the
    EU**, but widely differing standards, testing, and certification
    procedures continue to exist in member countries for both industrial
    and consumer products. Once the harmonization process is completed,
    however, domestic, as well as imported, goods will have to meet
    established EU standards.

-   **If a proposed standard duplicates an existing common European
    standard** established by the Comite Europeen des Normes (CEN), the
    CEN standard becomes the Spanish standard. If International
    Standards Organization quality assurance standards (ISO9000) are
    prepared subsequent to the issuance of CEN standards and if they
    differ from the CEN standards, the ISO standards will prevail, and
    the Spanish national standard will be modified to conform.

    -   The end result of the standards harmonization process in the EU
        will be a hierarchical system, with national standards being
        traceable via the CEN to the ISO, thereby providing the basis
        for mutual recognition of national standards. When a national
        standard is published, previously accepted industry standards
        are superseded. When an EU (CEN) standard is issued, the
        national standard is superseded, and when an ISO standard is
        issued the EU or CEN standard is superseded.

**Many products sold in the European Union require a CE mark** that
certifies that the products conform to the legal requirements of EU
directives published in the Official Journal of the European Community.
The directives cover essential safety or other performance requirements
in the general interest. If more than one directive applies to a
product, the product must comply with all appropriate provisions in all
of the applicable directives in order to receive the CE mark. Once a
product receives the CE mark, it may circulate freely within the EU.
Many consumers in EU member states perceive the CE mark as being a
quality mark.

-   **Description of EU standards harmonization process:**

    -   **See beginning of France article for detailed description**

    -   **U.S. exporters experiencing problems** related to the
        application of the mutual recognition agreements may contact the
        National Institute of Standards and Technology by telephone at
        888--591--8378 or by e-mail at oiaa@nist.gov.

    -   Spain has established specific certification requirements for
        certain products. This certification procedure is referred to as
        "**homologation**" and involves cumbersome product testing by
        approved laboratories. The Spanish government publishes a list
        of approved laboratories for testing and certification each
        year. Although most of the local homologation requirements and
        testing standards are gradually disappearing as Spanish
        legislation conforms to EU directives, certain homologation and
        other special requirements remain for some products, including
        computer keyboards and screens, dot matrix printers,
        teleprinters, medical equipment, electric typewriters,
        telecommunications equipment, motor vehicles, bicycles, pleasure
        boats, and gas connectors. **Generally, a product that meets the
        standards and certification requirements of any other EU country
        may be imported into and sold in Spain without further
        testing**. Applications for homologation are processed by the
        Ministry of Industry and Energy.

    -   Spain is a signatory to the **Agreement on Technical Barriers to
        Trade**, commonly known as the Standards Agreement, negotiated
        under the Tokyo Round of multilateral trade negotiations. The
        agreement is designed to eliminate the use of standards and
        certification systems as impediments to trade.

        -   The Standards Agreement does not dictate what the product
            standards must be, but it does call for open procedures in
            adopting standards and sets up a review procedure for
            settling disputes. Signatories are required to publish a
            notice of their proposed standards, to provide copies of
            these standards, if requested, and to allow countries to
            comment on them.

    -   If exporters have reason to believe that a standard of any
        signatory country **unjustifiably impedes their exports**, these
        concerns may be communicated to the Office of Standards Code and
        Information, **National Institute of Standards and Technology,
        Building 820, Room 164, Gaithersburg, Md. 20899**, (301)
        975--4037; fax: (301) 926--1559. This office will facilitate the
        transmission of U.S. comments to the government of the foreign
        country concerned.

    -   The **Spanish Standards Certification Association** is
        responsible for developing voluntary standards and certification
        programs. It represents Spain in international standards bodies.
        Standards information is available from AENOR (Asociacion
        Espanola de Normalizacion y Certificacion), Genova, 6, ES--28004
        Madrid; telephone: (1) 4326000; fax: (1) 3104976; e-mail:
        aenor@aenor.es.

    -   **For specific information regarding existing foreign
        agricultural standards and testing, packaging, and certification
        systems**, exporters should contact the Office of Food Safety
        and Technical Services, Foreign Agricultural Service, U.S.
        Department of Agriculture, South Agriculture Building, Room
        5545, 14th Street and Independence Avenue S.W., Washington, D.C.
        20250, (202) 720--1301; fax: (202) 690--0677. The National
        Center for Standards and Certification Information at the
        National Institute for Standards and Technology also maintains
        extensive files on existing foreign non-agricultural standards
        and their testing and certification systems; further information
        is available from the National Center for Standards and
        Certification Information, National Institute for Standards and
        Technology, Building 820, Room 164, Gaithersburg, Md.
        20899, (301) 975--4040; fax: (301) 926--1559.

    -   **Additional information on foreign standards** is available to
        firms in the United States through the American National
        Standards Institute, 11 W. 42nd St., New York, N.Y. 10036, (212)
        642--4900; fax: (212) 398--0023.

    -   **Electrical products**: Electrical products that operate in a
        voltage range of 50 to 1,000 volts alternating current or 75 to
        1,500 volts direct current must meet the EU low voltage
        directive. There are three accepted forms for proof of
        conformity with this regulation---a mark issued by an authorized
        EU agency, a certificate issued by an approved EU authority, or
        a declaration issued by the manufacturer. The declaration by the
        manufacturer must self-certify that the products are
        manufactured with good engineering practices and that they will
        not endanger the safety of persons, domestic animals, or
        property when properly installed and maintained and when used in
        applications for which it was made.

    -   **Used equipment:** Used equipment, materials, and goods may be
        imported. However, these items are subject to the same safety
        standards as the corresponding new product. There may be
        additional regulations pertaining to certain types of used
        equipment such as computers and peripherals

    -   **Toys**: Children\'s toys and accessories containing polyvinyl
        chloride are prohibited importation into EU countries effective
        Nov. 10, 1999.

    -   **Foodstuffs**: The primary Spanish legislation governing food
        products is the 1974 Food Code (Codigo Alimentario), as amended
        by subsequent Spanish decrees, orders, specific food product
        technical sanitary regulations (Regulamentos Tecnico
        Sanitarios), and European Union legislation that has been
        incorporated into Spanish legislation. Human consumption
        standards are in effect for the preparation, residual content,
        and storage of virtually all classes of foodstuffs. The
        following imported items are subject to registration in the Food
        Register (Registro): drinking water; baby food; low calorie
        products to control weight; diet food for special medical use;
        low sodium foods, including low sodium or no sodium salt;
        non-gluten foods; special foods for athletes; foods for
        diabetics; food products enriched with vitamins, minerals, or,
        ginseng; and other food products for special uses. A special
        form, along with the product label, should be submitted to the
        Registro.

Royal Decree 1472/89 and its amendment, Royal Decree 151/94 establishes
container size standards for a number of packaged food products. These
laws incorporate the requirements of EU directives 316/88 and 676/89.

-   **Vitamins and food supplements:** Many products sold as vitamins
    and food supplements in the United States are classified as drugs in
    Spain, and their sale and importation is restricted. The Ministry of
    Health must review all vitamins, health food supplements, and
    natural products to determine if the vitamin and mineral content
    exceeds the amount allowed by law or if they contain hormonal
    products, which are also classified as drugs. In general, all drugs
    must be registered with and approved by the ministry.

Firms that manufacture vitamins and health food products must provide
the ministry with technical data on the product\'s composition. If the
product is approved as a dietetic, it receives a registration number and
can be imported. Registration generally takes at least several months.

**Vitamins and health food products** may be exported to Spain while
under review by the ministry. However, if the product is classified as a
non-dietetic, it may no longer be sold and must be removed from shops.
Customs authorities are informed that further imports of the product are
forbidden.

Spain has incorporated the EU Directive 398/89 on dietetic products into
Royal Decree 1809/1991. The directive requires member states to review
products that were formerly classified as **dietetic** products to
determine if they should be reclassified under EU standards as drugs.

-   **Wines**: All wine importers must be registered at a customs
    register, the Registro Especial de Gestion Aduanera. The register in
    Madrid is located at Direccion General de Aduanas, Ministerio de
    Economica y Hacienda, Guzman El Bueno, 132; 28003.

-   **Cosmetics and pharmaceuticals**: Beauty products and products used
    for personal hygiene are subject to European Council regulation. The
    regulation prescribes labeling requirements and provides that
    information concerning the composition of cosmetics be made
    available to competent authorities to ensure protection for the
    consumer. It also contains a list of prohibited substances, a list
    of restricted substances, a list of authorized coloring agents, and
    a list of substances and coloring agents that are authorized
    provisionally.

-   **Pharmaceutical veterinary specialties:** All pharmaceutical
    veterinary specialties, including serums and vaccines and
    prophylactic and biological products for livestock, must be examined
    by a customs veterinary inspector. If the customs veterinary
    inspector finds anomalies of any kind that could affect the potency
    and/or condition of the products, a report to this effect will be
    submitted to the directorate-general for a decision on the course of
    action to be taken. Any items marketed without conforming to these
    regulations may be confiscated, and legal proceedings may be taken
    against the offending parties.

-   Pesticides:: All pesticides must be registered at the Ministry of
    Agriculture, Subdirectorate of Agricultural Production Means, before
    they are allowed to go on sale. Either the importer or the
    manufacturer may apply for registration of the product, and the
    applicant becomes the owner of the registration. The Spanish
    importer must be a registered phytosanitary services company.

The registration application must include information on the
manufacturer, country of origin, name of the product, its ingredients
and composition, packing form, and product applications. The applicant
should attach to the application evidence that the production plant is
registered in the country of origin, as well as the manufacturer\'s
statement of product characteristics and composition, and the product
technical report. Once application for registration is made, the
ministry acknowledges receipt of the materials and either indicates that
the registration process has begun or requests additional information.
The importer is authorized to bring samples of the product into the
country at this stage.

Spanish legislation pertaining to pesticides is found in royal decrees
3349/83, 162/91, 443/94, and in Annex II of Decree 280/1994, as amended.
Decree 3349/83 contains the technical and health regulations governing
the manufacture, trade, and use of pesticides. Decree 162/91 is an
update of 3349/83 and includes labeling requirements. Decree 443/94 is
an amendment to previous legislation. Annex II of decree 280/1994
indicates the maximum allowable pesticide residue by compound for groups
of vegetable products. In addition to the aforementioned legislation,
decree 2163/94 implements EU Directive 414/91 on phytosanitary products.
The EU directive governs the sale of phytosanitary products in the union
and determines which active substances are permissible for phytosanitary
use. Its purpose is to prevent damage to human or animal health or the
environment.

Packaging of pesticides is governed by laws 11/1997 and 10/1998, both of
which implement EU Directive 94/62 on packages and packaging waste.
Although the law does not require that industrial packages be part of an
integrated packaging system, the Spanish Association of Pesticide
Manufacturers (AEPLA) has established a system for its members.
Exporters may wish to contact the Asociacion Empresarial para la
Proteccion de las Plantas, Almagro 44--4D, 28010 Madrid; telephone: (91)
310--0238; fax: (91) 319--7734; e-mail: aepla@teleline.es.

-   **Hazardous substances:** Before any hazardous substance can be
    placed on the EU market, the following information must be provided:
    identity of the substance, production data, physiochemical
    properties, and data relating to toxicological and ecotoxicological
    studies. This information will be examined by the authority to
    ensure that the substance conforms to existing regulations.

Motor vehicles and machinery: EU noise standards are in effect for cars
and motorcyles, as well as for certain power construction equipment,
such as compressors, tower cranes, welding generators, and jackhammers
and picks used to break concrete.

-   Other items: A number of other goods imported into Spain are subject
    to special requirements governing their manufacture, importation,
    sale, and use. These include alcoholic beverages, motor vehicles,
    construction equipment, and dangerous goods. Exporters should
    consult closely with their Spanish customers for specific
    information

Taiwan

-   The Bureau of Standards, Metrology, and Inspection under the
    Ministry of Economic Affairs is responsible for publishing relevant
    standards for imported goods. The standards, known as the Chinese
    National Standards, are generally in conformity with international
    standards. Under the Commodity Inspection Law, more than 1,000 types
    of commodities are subject to inspection by the BSMI. Most of these
    products are foodstuffs and agricultural goods, followed by
    mechanical, electrical, chemical, and mineral products. Information
    is available from the Bureau of Standards, Metrology, and
    Inspection, 4 Chinan Road, Sec. 1, Taipei; telephone: (886-2)
    23431700; fax: (886-2) 23560998.

-   Foodstuffs: The Department of Health is responsible for the
    administration of food safety controls. The public health bureaus of
    the local governments are responsible for the implementation and
    enforcement of the Food Sanitation Law and its regulations and for
    ensuring that safe and good-quality products are available to the
    public. The local bureaus are also responsible for the regulation of
    production, packaging, labels, methods of distribution, and storage
    of items. All food products, imported or domestically produced, are
    subject to examination and certification by the Department of Health
    before they can be released for sale. The Department of Health may
    make surprise inspections or examinations of samples selected from
    production facilities, warehouses, or retail stores to determine
    whether or not the quality standards set are being complied with. If
    the standards are not met, the producer or importer is responsible
    for the recall and destruction of the product.

-   Special regulations govern the importation and use of food
    additives. Artificial additives must not exceed established
    tolerance levels and must comply with requirements established by
    the Department of Health concerning acceptable use. New-to-market
    additives must be approved by the Department of Health, which
    requires the following items to be submitted along with the
    application: animal safety test data, information about the
    acceptability of the additive in other international markets,
    evaluation report stating that the additive is necessary to
    manufacture the product, analysis method, and specifications.

-   Fresh fruits and vegetables must comply with pesticide tolerance
    levels established by the Department of Health. Upon arrival in
    Taiwan, fresh produce is subject to mandatory random inspection by
    the Bureau of Standards, Metrology, and Inspection.

-   Imported fruit juices are subject to purity standards and soft
    drinks, to standards on preservatives. Turkey, pork, and game meats
    are subject to limits on microbiological and chemical residues.
    Routine tests are conducted on many agricultural food products to
    determine compliance with existing regulations.

-   **Nutritional claims** that use terms such as "rich in," "low,"
    "free," "fortified," or "excellent source of" to describe nutrient
    content must meet detailed criteria established in the Regulation on
    Nutrition Claims for Packaged Food, effective Sept. 1, 2002. Under
    the regulation, nutritional claims are divided into two categories.
    The first, "appropriate intake needed," applies to nutrients for
    which excessive intake would adversely affect health and includes
    calories, fat, saturated fatty acids, cholesterol, sodium, and
    sugar. The second category, "supplementary intake may be taken,"
    covers nutrients for which insufficient intake would adversely
    affect health and includes dietary fiber; vitamins A, B1, B2, C, and
    E; calcium; and iron.

-   **Health foods**, defined as food products that provide certain
    nutrients or are clinically proven to promote overall health, are
    **subject to the 1999 Health Food Regulation Law**. Under the law,
    manufacturers may not claim that their products are therapeutic or
    preventive in nature. All health food products must be licensed by
    the Bureau of Food Sanitation under the Department of Health. The
    license is valid for five years; application to extend the validity
    period must be submitted three months prior to expiration. The
    manufacturer must present the following items to the Department of
    Health:

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-   One original and one duplicate copy of the ingredient list, product
    specifications, and nutrient analysis issued by the manufacturer
    within one year of the product\'s production.

-   A certificate of free sale or related clinical trial reports.

-   A summarized diagram of the manufacturing process.

-   An official certificate attesting to the legitimacy of the
    manufacturer.

-   Two copies each of the original label, outer packaging, inserted
    instructions, and Chinese label. If the product is sold in varying
    sizes, separate sets of these items must be supplied for each size.

-   A copy of the applicant\'s business license.

-   A sample of the whole, intact product. If the product is sold in
    varying sizes, a separate sample is required for each size.

-   Other relevant documents specific to the nature of the product,
    e.g., protein test method for high protein products.

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-   If packaged in bulk and intended to be repackaged after arriving in
    Taiwan, a letter from the manufacturer authorizing the product to be
    repackaged; the original letter of agreement between the
    manufacturer and the local repacking company, together with a copy
    of the latter\'s business license and factory license; nutrient
    analysis report for the repackaged product; two copies each of the
    packaging design, Chinese label, and inserted instructions for the
    repackaged product; photographs of the originally packed product;
    and a sample of the repackaged product are required.

-   **Dietary supplements**, including herbal supplements, in tablet or
    capsule form must be licensed by the Department of Health, which
    requires the following items along with the application form:

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-   One original plus one duplicate copy of the product ingredient list
    issued by the original manufacturer within one year of production.
    The list must specify raw materials and additives, including the
    composition of the capsule shell for hard capsules and softgels.

-   Original copy of the product\'s laboratory test report issued by the
    original manufacturer within one year of production. The report must
    include test results for ingredients, including additives, and
    microbes.

-   An official certificate attesting to the legitimacy of the original
    manufacturer.

-   A duplicate copy of the applicant\'s business license.

-   A photograph of the packaged product.

-   A sample of the intact product. If the product is packaged in a
    number of different sizes, a sample of each size must be provided.
    If the sample is packaged in bulk or is intended to be repackaged
    after it has been imported, a sample containing 20 tablets or
    capsules may be supplied.

-   Further laboratory testing may be required. Once issued, the license
    is valid for five years. Application to extend the license validity
    may be submitted three months prior to its expiration.

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-   Genetically modified soybean and corn products must be registered
    with the Department of Health, effective Jan. 1, 2003, in order to
    be imported for food use. All varieties of genetically modified
    soybean and corn products presently on the market in Taiwan must be
    registered with the department before April 30, 2002. Application
    for registration must include background information about the
    applicant and about the genetically modified food product, a
    one-kilogram sample of the product, list of references and relevant
    research papers about the product, and a safety assessment on the
    product along with a separate synopsis of the assessment. The safety
    assessment must include specific information about the genetically
    modified organism, processing methods, adverse effects, toxicity,
    and reproductive, mutagenic, and carcinogenic effects. Registration
    is valid for five years; application for renewal may be filed three
    months prior to expiration.

-   **Additional information regarding food products** is available from
    the Bureau of Food Sanitation, Department of Health, 100 Ai-Kuo East
    Road, 12th Floor, Taipei; telephone: (886-2) 23938209; fax: (886-2)
    23929723.

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-   **Pharmaceuticals**: Pharmaceutical products, including prescription
    and non-prescription drugs and high-dosage vitamin A, E, and D
    supplements, must be registered with the Department of Health. The
    registration process can take up to 24 months for new products.
    Effective in February 2000, high-dosage vitamins A, E, and D are
    defined as containing 10,000 international units (IUs), 1,000 IUs,
    and 4,000 IUs of the specified vitamin, respectively. All other
    vitamins, including multi-vitamins are considered food products.

The following items must be submitted by the exporter\'s agent in Taiwan
along with the registration application for pharmaceuticals: two samples
of the outer packaging, one copy of the written guarantee, one sample of
the inner package adhesive label, original documentation of the
manufacturing permit issued by authorities in the country of origin,
certification that sterile drugs have undergone the necessary process
for sterilization and aseptic filling, two copies of specification and
analysis methods, two copies of inspection results, and a power of
attorney.

**Additional information** is available from the Bureau of
Pharmaceutical Affairs, Department of Health, 100 Ai-Kuo East Road, 11th
Floor, Taipei; telephone: (886-2) 23969265; fax: (886-2) 23971548.

-   **Medical devices:** Most medical devices must be registered with
    the Department of Health. The registration process generally takes
    about six months. Licenses are granted only to individual products
    and not to product lines. Second- and third-generation versions of
    previously approved products must be registered again.

The following items must be submitted by the exporter\'s agent in Taiwan
along with the registration application: letter of authorization
designating the exporter\'s agent; certificate of free sale; seven
copies of a leaflet giving the manufacturer\'s name and address and
stating the name, structure, specification, usage, and administration of
the device; two copies of a quality control record, including the
testing methods and results; a sample of the device, if feasible; and a
sample of the label and instructions for use, in Chinese. Evidence of
good manufacturing process must be supplied; an agreement between the
United States and Taiwan permits the U.S. Food and Drug Administration
to fulfill this requirement by providing establishment inspection
reports to Taiwan\'s Department of Health upon request.

Applications for newly developed devices, previously approved devices
with new intended purposes, and special devices such as implantable
appliances and contact lenses require two copies of the clinical report.

Registration applications for electrical equipment must include two
copies of the circuit and testing records and two sets of instructions
for operating security.

Two copies of the operating records of the automatic measurement
adjustment are required for automatic temperature adjusting equipment,
and two copies of testing records and a certificate of radiation leakage
are required for radioactive equipment.

**Additional information** is available from the Bureau of
Pharmaceutical Affairs, Department of Health, 100 Ai-Kuo East Road, 11th
Floor, Taipei; telephone: (886-2) 23210151; fax: (886-2) 23971548.

-   Cosmetics: Cosmetic products may not contain mercury or mercury
    compounds, bithionol, dichlorophen, halogeno-salicylanilide,
    hydroquinone monobenzyl ether, pilocarpine, boric acid, sodium
    perborate, sodium borate, methyl alcohol, chlorofluoro carbons
    (freon), acetylethyl tetramethyl tetralin (AFTT), cell or tissue
    products of human origin, hexachlorophene, hydroxy-8-quinoline and
    its sulfates, methylene chloride, musk ambrette, 6-methyl coumain,
    vinyl chloride, or tretinoin. Ingredients intended to act as
    preservatives, including benzoic acid, are limited to specified
    amounts per 100 grams. Alcohol, lead, cadmium, and arsenic are
    permitted only in limited amounts.

All eye makeup and cosmetics that contain medicated ingredients or that
make medical claims must be licensed by the Department of Health. The
manufacturer\'s agent in Taiwan must submit, in addition to the
registration application, the following items: letter of authorization
designating the agent to act on the supplier\'s behalf; product formula;
certificate of free sale; three product samples; four samples of the
outer package label; product description in Chinese, including the
product\'s name, weight or capacity, purpose or use, instructions for
use, precautions, and shelf life; certificate of quality, indicating the
color and appearance of the product; test results, which should cover
active and inactive ingredients; product specifications, with a 10
percent tolerance granted against the test results; and an assessment
report identifying each active ingredient in the finished product and
the procedure for verifying active ingredients and calculating their
proportions.

**Additional information** is available from the Bureau of
Pharmaceutical Affairs, Department of Health, 100 Ai-Kuo East Road, 11th
Floor, Taipei; telephone: (886-2) 23210151; fax: (886-2) 23971548.

-   **Automobiles**: All gasoline-powered vehicles must be designed to
    run on unleaded gasoline.

-   **Industrial equipment:** Industrial equipment, including
    air-conditioning and refrigeration equipment, electric hand tools,
    and synthetic rubber gloves, is subject to inspection and testing to
    verify energy efficiency and capacity and/or safety before they can
    clear customs. Inspections are carried out by the Bureau of
    Standards, Metrology, and Inspection, which then issues inspection
    approval labels for the goods. Inspection involves the destruction
    of one sample of each product for the first one or two shipments
    each year and non-destructive testing of samples from subsequent
    shipments.

-   **Other items:** Special approval from the appropriate government
    agency is required for the importation of some goods, including
    radio and telegraph equipment, farm products (including processed
    foods), domestic animals (including meat and dairy products), plants
    and plant products, measuring devices and meters, books and sound
    recordings, narcotics, pharmaceuticals, certain vegetables, and
    cinema films.

-   **Agricultural products:** Animal and plant products are regulated
    by the Council of Agriculture and are inspected by the Bureau of
    Animal and Plant Health Inspection and Quarantine upon entry into
    Taiwan.

-   For specific information regarding existing foreign agricultural
    standards and testing, packaging, and certification systems,
    exporters should contact the Office of Food Safety and Technical
    Services, Foreign Agricultural Service, U.S. Department of
    Agriculture, South Agriculture Building, Room 5545, 14th Street and
    Independence Avenue S.W., Washington, D.C. 20250, (202) 720-1301;
    fax: (202) 690-0677. The National Center for Standards and
    Certification Information at the National Institute for Standards
    and Technology also maintains extensive files on existing foreign
    non-agricultural standards and their testing and certification
    systems. Further information is available from the National Center
    for Standards and Certification Information, National Institute for
    Standards and Technology, Building 820, Room 164, Gaithersburg, Md.
    20899, (301) 975-4040; fax: (301) 926-1559.

-   **Additional information on foreign standards** is available to
    firms in the United States through the American National Standards
    Institute, 11 W. 42nd St., New York, N.Y. 10036, (212) 642-4900;
    fax: (212) 398-0023.

> Turkey

-   **The Turkish Standards Institute (TSE)** sets standards for
    products manufactured in, or imported into, Turkey. Most major
    companies seek TSE certification for their products. This
    certification helps to ensure manufacturers fair competition and
    assures the consumer of the quality of the goods. About 95 percent
    of the approximately 15,500 standards in effect are compatible with
    international standard requirements; about 1,100 of them are
    mandatory for goods ranging from foodstuffs to medical equipment.

TSE must approve imports of goods subject to mandatory standards.
Foreign companies may apply for TSE certification for the manufacture of
goods they export to Turkey. TSE may be contacted at Turk Standartlari
Enstitusu, Necatibey Caddesi No. 112, 06100 Bakanliklar, Ankara;
telephone: (90-312) 4170020; fax: (90-312) 4254399; e-mail:
<yevrenosoglu@tse.org.tr>.

-   Imports of **organic chemicals** including those used to produce
    medicines and medical products, chemicals used in the cleaning and
    food industries, vaccines for both human beings and animals, live
    animals and plants, grains, plant seeds, and hormones must be
    approved by the Directorate General of Curative Care Service in the
    Ministry of Health.

-   **Products requiring after-sales service** such as motor vehicles,
    household electrical goods, office equipment (computers), TV and
    video equipment, telephone-answering machines, heaters, gas-fired
    burners, lathes, and wireless equipment must be approved by the
    Ministry of Trade and Industry. Under a July 2001 regulation,
    importers of passenger cars, buses and minibuses, small trucks, and
    tractors are required to own and operate two maintenance facilities
    and contract with at least 18 additional facilities throughout the
    country. Motorcycle/moped importers must own and operate one
    facility and contract with at least nine others. In addition, motor
    vehicle importers must import spare parts equal to 3 percent of the
    total FOB value of the shipment.

-   **Telecommunications equipment** such as automatic data processing
    machines, electrical apparatus for line telephony or telegraphy, and
    telephone answering machines need type-approval by the Turkish
    telecommunications authority (Turk Telekom); and frequency-related
    products require the approval of the Directorate General of Wireless
    Affairs.

-   A control certificate from the Ministry of Environment is required
    for importers of **goods considered detrimental to the
    environment**, including hard coal, lignite, petrocoke, petroleum,
    arsenic, mercury, lead sulfides and carbonates, fluorocarbons,
    certain chemicals, and scrap metals. Foodstuffs must be approved by
    the Ministry of Agriculture and Rural Affairs. Application for
    approval must be accompanied by a pro forma invoice; analysis report
    issued on the exporter\'s letterhead or by a government agency
    stating the product\'s physical, chemical, microbiological, and
    heavy metal specifications; certificate stating the product is
    dioxin-free; and sample label. In addition to these items, the
    application for consumer-ready products must include a certificate
    of free sale; for alcohol products, a statement from the producer
    that the Turkish importer or distributor is authorized to market the
    product; and for special foods such as diet foods, vitamins, and
    baby food, a written declaration from the importer that the product
    will not be advertised in a misleading manner. Frozen seafood
    products need not provide the analysis report.

-   **Food products** are subject to the Turkish Food Codex, Turkish
    Food Law, and Turkish Food Regulation. The codex includes a list of
    approved additives and colorings and stipulates conditions under
    which they may not be used. Certain products, including honey,
    non-emulsified vegetable and animal oils, sugar, and dried pasta,
    may not include additives. Baby foods, eggs and egg products, bakery
    products, tomato paste and sauces, processed fruits and vegetables,
    meat, and many other foodstuffs may not contain food coloring. Baby
    foods may not contain artificial sweeteners. The codex also sets the
    maximum level of pesticides, contaminants, and hormones permitted in
    food products.

**Additional information concerning food standards** is available from
the Ministry of Agriculture and Rural Affairs, General Directorate of
Protection and Control, Akay Cad. 3, Ankara; telephone: (90-312)
4185834; fax: (90-312) 4166523

-   For specific information regarding existing foreign agricultural
    standards and testing, packaging, and certification systems,
    exporters should contact the Office of Food Safety and Technical
    Services, Foreign Agricultural Service, U.S. Department of
    Agriculture, South Agriculture Building, Room 5545, 14th Street and
    Independence Avenue S.W., Washington, D.C. 20250, (202) 720-1301;
    fax: (202) 690-0677. The National Center for Standards and
    Certification Information at the National Institute for Standards
    and Technology also maintains extensive files on existing foreign
    non-agricultural standards and their testing and certification
    systems. Further information is available from the National Center
    for Standards and Certification Information, National Institute for
    Standards and Technology, Building 820, Room 164, Gaithersburg, Md.
    20899, (301) 975-4040; fax: (301) 926-1559.

-   Additional information on foreign standards is available to firms in
    the United States through the American National Standards Institute,
    11 W. 42nd St., New York, N.Y. 10036, (212) 642-4900; fax: (212)
    398-0023.

**United Kingdom**

-   **Description of EU standards harmonization process:**

    -   **See beginning of France article for detailed description**

-   **In the United Kingdom, the British Standards Institution has
    prepared standards** for virtually all manufactured goods and has
    established production, testing, installation, and operational
    standards. British standards approved goods can be identified by a
    "kite" symbol and the letters "BS" followed by four digits. American
    industry-specific standards and Underwriters\' Laboratory approvals
    may be accepted as an assurance of product quality if no relevant
    British standard exists. However, if a national, EU, or ISO standard
    is adopted, this acceptance is invalidated.

    -   Products that meet British standards are described as conforming
        to **BS (number),** but they cannot be described as being BS
        (number) approved unless they are tested for conformity by BSI
        or a BSI-approved laboratory and a certificate of conformity is
        issued. Testing and certification by BSI or a BSI-approved test
        laboratory entitle the vendor to attach a "kite" mark or tag to
        the product as evidence of its approved status.

    -   **Additional information concerning BSI programs**, services,
        requirements, and procedures is available from the British
        Standards Institution, 389 Chiswick High Road, London, W4 4AL;
        telephone: (44-20) 8996-9000; fax: (44-20) 8996-7400; e-mail:
        info@bsi.org.uk. BSI has established an office in the United
        States at 12110 Sunset Hills Road, Suite 140, Reston, Va.
        20190, (703) 437-9000; fax: (703) 43- 9001; e-mail:
        inquiry@bsiamericas.com.

-   **Imported motor vehicles** that have not been type-approved for
    conformance to British or EU standards must undergo the Single
    Vehicle Approval Test to insure that they are designed and
    constructed to meet British safety and environmental standards. The
    test applies to imported cars and and light passenger vehicles with
    not more than eight seats, light goods vehicles with a maximum gross
    weight of not more than 3,500 kilogram, personal vehicles imported
    into the United Kingdom by persons intending to reside there, kit
    cars and other amateur built vehicles, and low volume vehicles such
    as ambulances and hearses. From Aug. 1, 2001, there are two kinds of
    Single Vehicle Approval Tests: standard and enhanced. The standard
    test is used only for personally imported vehicles and left-hand
    drive vehicles. The enhanced test applies to all other imports that
    have not been type-approved. Additional information is available
    from the Department of Transport, Vehicle Standards and Engineering
    1, Zone 2/01, Great Minster House, 76 Marsham St., London SW1P 4DR;
    telephone: (44-20) 7944-2094; fax: (44-20) 7944-2069; e-mail:
    rvs1.detr@gtnet.gov.uk.

-   The EU has adopted maximum allowable residue levels for a list of
    **pesticides**. However, pesticides that are not on the EU list are
    subject to the regulations of individual member states. Additional
    information is available from the Pesticides Safety Directorate,
    Mallard House, 3 Peasholme Green, York YO1 7PX; telephone: (44-1904)
    455-775; fax: (44-2904) 455-733; e-mail:
    p.s.d.information@psd.defra.gsi.gov.uk.

Pesticides and other imported goods that have environmental impact must
meet national target levels for residue and pollutant control. Exporters
should consult their customers in the market concerning provisions
affecting specific products. Additional information is also available
from the Environment Agency, Rio House, Waterside Drive, Aztec West,
Almondsbury, Bristol BS32 4UD; telephone: (44-1454) 624-400; fax:
(44-1454) 624-409.

-   **Water conservation measures** apply to lavatory and shower
    products, swimming pools, ponds, power hoses for washing
    automobiles, and other appliances and products that rely on water
    for their operation.

-   Regulations are either in force or scheduled for implementation
    related **to noise levels** for machinery, airplanes, motor
    vehicles, and other apparatus.

-   EU regulations require that **imported wines** be produced only with
    those oenological practices that are authorized for the production
    of EU wines. Although U.S. wines have been permitted entry in the
    past under EU regulatory exemptions, exporters should consult their
    clients in the market concerning current requirements.

-   **Directives have been adopted for consumer-ready agricultural
    products** concerning food labels, pre-packaged and frozen foods,
    substances in contact with food, food additives, dietetic foods,
    protection of geographic designations and designation of origin,
    food contaminants, aflatoxins, and novel foods.

-   **The Food Standards Agency** was established on April 1, 2000, to
    oversee all aspects of food safety and standards in the United
    Kingdom. The agency monitors food safety and compliance with food
    laws and establishes standards for the enforcement of food
    regulations. Additional information is available from the Food
    Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH;
    telephone: (44-20) 7276-8000; fax: (44-20) 7238-6330; e-mail:
    helpline@foodstandards.gsi.gov.uk.

-   In June 1997, the United States and the European Union accepted a
    package of mutual recognition agreements that allows U.S. products
    or processes to be assessed for conformity to EU testing,
    inspection, and certification requirements in the United States.
    Products of EU member states will likewise be evaluated against U.S.
    requirements. The agreements include network and electromagnetic
    compatibility for telecommunications, medical devices, electrical
    safety for electrical and electronic products, recreational craft,
    pharmaceuticals, veterinary vaccines, and industrial fasteners. The
    agreements will be phased in and fully implemented gradually.
    Additional information concerning MRAs is available from the U.S.
    Department of Commerce, International Trade Administration,
    Washington, D.C.

-   U**.S. exporters experiencing problems** related to the application
    of the mutual recognition agreements may contact the National
    Institute of Standards and Technology by telephone at (888) 591-8378
    or by e-mail at oiaa@nist.gov.

-   **For specific information regarding existing foreign agricultural
    standards** and testing, packaging, and certification systems,
    exporters should contact the **Office of Food Safety and Technical
    Services, Foreign Agricultural Service, U.S. Department of
    Agriculture, South Agriculture Building, Room 5545, 14th Street and
    Independence Avenue S.W., Washington, D.C. 20250**, (202) 720-1301;
    fax: (202) 690-0677. The National Center for Standards and
    Certification Information at the National Institute for Standards
    and Technology also maintains extensive files on existing foreign
    non-agricultural standards and their testing and certification
    systems. Further information is available from the National Center
    for Standards and Certification Information, National Institute for
    Standards and Technology, Building 820, Room 164, Gaithersburg, Md.
    20899, (301) 975-4040; fax: (301) 926-1559; e-mail: ncsci@nist.gov.
    Information on proposed EU standards also is available on the
    center\'s hotline at (301) 921-4164.

-   **Additional information** on foreign standards is available to
    firms in the United States through the **American National Standards
    Institute, 11 W. 42nd St., New York, N.Y. 10036**, (212) 642-4900;
    fax: (212) 398-0023.

-   The United Kingdom is a signatory to the **Agreement on Technical
    Barriers to Trade**, commonly known as the Standards Agreement,
    negotiated under the Tokyo Round of multilateral trade negotiations.
    The agreement is designed to eliminate the use of standards and
    certification systems as impediments to trade.

If exporters have reason to believe that a standard of any signatory
country unjustifiably impedes their exports, they may communicate these
concerns to the National Institute for Standards and Certification
Information, National Institute of Standards and Technology, Building
820, Room 164, Gaithersburg, Md. 20899, (301) 975-4037; fax: (301)
926-1559.

-   Major Compliance Marks

    -   CE Mark

    -   FCC Logo

    -   UL Mark

    -   TUVGS Mark

-   Country Marks

    -   Argentina

    -   Australia-New Zealand

    -   China

    -   Czech Republic

    -   Japan

    -   Korea

    -   Mexico

    -   Poland

    -   Russia

    -   Taiwan

        -   [**http://www.percept.com/pages/compliancemarks.html#cemark**](http://www.percept.com/pages/compliancemarks.html#cemark)

**Additional information on foreign standards is available to firms in
the United States through the American National Standards Institute, 11
W. 42nd St., New York, N.Y. 10036, (212) 642-4900; fax: (212)
398-0023.**