Required Report - public distribution

**Date:** 8/31/2004

**GAIN Report Number:** E34054

E34054

**EU-25**

**Food and Agricultural Import Regulations and Standards**

**European Union Report**

**2004**

**Approved by:**

![](media/image1.wmf)Stan Cohen

U.S. Mission to the EU

**Prepared by:**

Hilde Brans / Gerda Vandercammen

**Report Highlights:**

This report gives an overview of food laws currently in force in the
EU-25.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Brussels USEU \[BE2\]

\[E3\]

[SECTION 1. FOOD LAWS 3](#section-1.-food-laws)

[SECTION 2. LABELING REQUIREMENTS 5](#section-2.-labeling-requirements)

[A. General Requirements 5](#a.-general-requirements)

[Compulsory Information: 5](#compulsory-information)

[Quinine and Caffeine 6](#quinine-and-caffeine)

[Licorice 7](#licorice)

[Phytosterols & Phytostanols 7](#phytosterols-phytostanols)

[Quantitative Ingredients Declaration (QUID)
7](#quantitative-ingredients-declaration-quid)

[Language Requirements 8](#language-requirements)

[Stick-on Labels 8](#stick-on-labels)

[Samples 9](#samples)

[Labeling of Genetically Modified Foods and Novel Foods
9](#labeling-of-genetically-modified-foods-and-novel-foods)

[B. Medical / Health Claims 9](#b.-medical-health-claims)

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

[C. Product-Specific Labeling 10](#c.-product-specific-labeling)

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

[A. Container Contents 11](#a.-container-contents)

[B. Packaging Waste Management 11](#b.-packaging-waste-management)

[C. Materials in Contact with Foodstuffs
11](#c.-materials-in-contact-with-foodstuffs)

[SECTION 4. FOOD ADDITIVE REGULATIONS
12](#section-4.-food-additive-regulations)

[Processing Aids 13](#processing-aids)

[Flavorings 13](#flavorings)

[SECTION 5. PESTICIDES AND CONTAMINANTS
14](#section-5.-pesticides-and-contaminants)

[Pesticides 14](#pesticides)

[Contaminants 14](#contaminants)

[Residues in Animals and Animal Product
15](#residues-in-animals-and-animal-product)

[SECTION 6. OTHER REGULATIONS AND REQUIREMENTS
16](#section-6.-other-regulations-and-requirements)

[A. Product Inspection and Registration
16](#a.-product-inspection-and-registration)

[B. Certification and Documentation Requirements
16](#b.-certification-and-documentation-requirements)

[AGRIM Certificates 16](#agrim-certificates)

[Health Certificates for Plant Products
17](#health-certificates-for-plant-products)

[Health Certificates for Animal Products
17](#health-certificates-for-animal-products)

[Other Products 17](#other-products)

[Health Certificates for Processed Foods
17](#health-certificates-for-processed-foods)

[SECTION 7. OTHER SPECIFIC STANDARDS
19](#section-7.-other-specific-standards)

[A. Genetically Modified Foods (GMOs)
19](#a.-genetically-modified-foods-gmos)

[B. Novel Foods 19](#b.-novel-foods)

[C. Dietetic or Special Use Foods 20](#c.-dietetic-or-special-use-foods)

[D. Wine, Beer and Other Alcoholic Beverages
21](#d.-wine-beer-and-other-alcoholic-beverages)

[E. Organic Foods 21](#e.-organic-foods)

[F. Vertical Legislation (Breakfast Directives)
22](#f.-vertical-legislation-breakfast-directives)

[G. Animal Products 22](#g.-animal-products)

[H. Frozen Foodstuffs 23](#h.-frozen-foodstuffs)

[I. Irradiated Foodstuffs 23](#i.-irradiated-foodstuffs)

[J. Fruits and Vegetables 23](#j.-fruits-and-vegetables)

[K. Seafood 24](#k.-seafood)

[SECTION 8. COPYRIGHT AND/OR TRADEMARK LAWS
25](#section-8.-copyright-andor-trademark-laws)

[Trademarks 25](#trademarks)

[Protected Geographical Indications
25](#protected-geographical-indications)

[SECTION 9. IMPORT PROCEDURES 26](#section-9.-import-procedures)

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

[APPENDIX II. HOW TO OBTAIN LEGISLATION
28](#appendix-ii.-how-to-obtain-legislation)

[APPENDIX III. EU INITIATIVES 29](#appendix-iii.-eu-initiatives)

#   {#section .unnumbered}

# SECTION 1. FOOD LAWS

The European Union (EU), formerly known as the European Economic
Community (EEC), was created by the Treaty of Rome on March 25, 1957.
Through several accessions, the EU has gradually expanded to become the
world's largest multi-nation trading bloc. Since May 1, 2004, the
European Union comprises 25 member states with over 450 million
consumers. Bulgaria and Romania are set to join the EU in 2007, which
will further raise the EU population by 30 million people.

EU member states: Austria, Belgium, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal,
Slovakia, Slovenia, Spain, Sweden, United Kingdom.

All EU Member countries accept the entire body of EU laws and
obligations associated with the treaties and agreements to which the EU
is a party, including the EU laws and rules pertaining to processed
foods.

Originally created as a customs union, the process of harmonizing
existing Member State legislation has been long and cumbersome and is
still ongoing. While the vast majority of food laws and regulations have
been harmonized throughout the EU, the single EU market is still not a
*fait accompli.* It is important to note that when EU-wide legislation
is incomplete or absent, the laws of Member States apply, often
resulting in different rules in different Member States. The FAIRS
reports prepared by the Offices of Agricultural Affairs in the EU Member
States are excellent sources of information on Member State specific
requirements (<http://www.useu.be/agri/fairs.html>).

The main principle of the single market concept is to ensure that all
food products, whether produced in the EU or imported from a third
country, can move freely throughout the EU if they comply with the
requirements. In reality, certain directives allow Member States to make
exceptions e.g. in cases where a country can prove health concerns about
a product intended for import. Free movement can only be guaranteed when
all aspects are covered by harmonized legislation: e.g. a foodstuff may
comply with the labeling directive but may carry a health claim for
which harmonized rules do not yet exist.

Imported products must meet existing Member State requirements in cases
where EU regulatory harmonization is not yet complete.

EU legislation is made up of Directives and Regulations. These are all
translated into the official EU languages. There are twenty official
languages in use in the EU-25. Applicable legislation is currently being
translated in the new languages and is available from the EU website
<http://europa.eu.int/eur-lex/en/accession.html>. **Directives** define
the result that must be achieved but leave to each Member State the
choice of form and methods to transpose the directive into national laws
(usually within 2-3 years after adoption). **Regulations** are binding
in their entirety and automatically enter into force on a set date in
all Member States. Amendments to EU legislation are usually published in
new and separate Directives and Regulations, making it difficult to be
sure of all possible amendments when doing research. When legislation is
referenced in this guide, it is implied that all further amendments also
apply.

The EU has followed a dual approach in harmonizing food laws:
\"horizontal\" legislation that covers aspects which are common to all
foodstuffs (such as additives, labeling, hygiene, etc.) and \"vertical\"
legislation on specific products (e.g., cocoa and chocolate products,
sugars, honey, fruit juices, fruit jams, novel foods, etc.).

In the aftermath of the BSE crisis and several other food scandals, the
EU published its White Paper on Food Safety setting out a legislative
action plan for a pro-active new food policy. The EU's new "Farm to
Fork" approach covers all the sectors of the food and feed chain with
traceability as the basic concept.

In January 2002, the EU adopted the framework regulation 178/2002
setting out the general principles and requirements of EU food law. This
regulation introduces mandatory traceability in the food and feed chain
as of January 1, 2005. The major reform announced in the White Paper
covered the further harmonization of certain areas such as nutritional
and health claims, food fortification and food contact materials and
committed to review and complete the existing legislation with respect
to feed and food hygiene. The final piece of this comprehensive approach
was the design and development of a harmonized EU-wide food and feed
control system, replacing the patchy and fragmented control systems that
are currently in place. Information on the EU's food safety approach is
available on our website at
[www.useu.be/agri/foodsafe.html](http://www.useu.be/agri/foodsafe.html).

Major progress has been made in the realization of the announced
initiatives: all adopted amendments to EU rules are included in this
report; a list of other initiatives, which are still at various stages
of the legislative process, is provided in the Annex.

EU political structures include the permanent bureaucracy of the
Commission, the Council of Member State representatives, and the
European Parliament. All are involved in creating and passing
legislation. For more information on how the EU works, see the website
of the European Commission at http://europa.eu.int/index-en.htm. It is
the task of the European Food Safety Agency (http://www.efsa.eu.int)
established together with the general food law, to provide scientific
advice to the legislators on matters related to food safety.

Enforcement of EU food legislation is done by Member State officials.
Auditing oversight of Member State performance is performed by EU
Commission officials. The EU Commission has the power to initiate legal
action in the European Court of Justice against Member States who are
not complying with EU Directives and Regulations.

Exporters should be aware that there may also be some variation among
Member States in applying EU harmonized legislation. This may result
from the lack of harmonized guidelines for the enforcement of rules; it
may be due to variations in the transitional period needed to adjust to
EU rules; there may be temporary waivers or exemptions --usually called
derogations; in certain cases there may be room for interpretation of EU
harmonized legislation; certain aspects which are not regulated in
detail at EU level may be handled differently in different Member
States, e.g. acceptability of stick-on labels varies among Member
States. Also, there is a wide variation in inspection fees, in
registration fees and in the time required to evaluate dossiers on
products used in the course of the food production process.

Up to date information on EU food import rules as well as general
information on EU import duties and quotas can be found on our website
at [http://www.useu.be/agri/usda.html.]{.underline} The website also
links to additional sources of useful information.

# SECTION 2. LABELING REQUIREMENTS

[www.useu.be/agri/label.html](http://www.useu.be/agri/label.html)

## A. General Requirements

The standard U.S. label fails to comply with EU labeling requirements.

General provisions on the labeling, presentation and advertising of
foodstuffs marketed in the EU are laid down in European Parliament and
Council Directive 2000/13/EC + corrigendum (English version of Annex 3).
It applies not only to foodstuffs intended for sale to the ultimate
consumer but also for supply to restaurants, hospitals and other mass
caterers. Section 7 covers labeling requirements for specific products,
including genetically modified and novel foods.

### Compulsory Information:

\- The name under which the product is sold.

\- The list of ingredients, in descending order of weight. Important
exceptions include added water in foods reconstituted from concentrates,
and cheese, which is covered by special rules. The following ingredients
require a specific statement on the label: GMO's, packaging gases,
sweeteners, aspartame and polyols, quinine and caffeine, phytosterols
and phyostanols and licorice.

Directive 2003/89/EC on allergen labeling abolishes the current "25%
rule", under which it is not necessary to list all the components of
compound ingredients if they make up less than 25% of the final food
product. For example, the label on a food product containing less than
25% mayonnaise does not have to list all the ingredients used in the
mayonnaise. Under the new rules, all potential allergenic ingredients
such as cereals containing gluten, crustaceans, eggs, fish, peanuts,
soybeans, milk and dairy products (including lactose), nuts and nut
products, sesame seeds and sulphite at concentrations of at least 10 mg
per kg, celery, and mustard must be declared on the label. Food labels
will have to comply with the new rules as of 2005 (for more information
see GAIN report E23186). Guidelines for the implementation of this
amendment to the general food labeling directive are available on the
Commission's website at
<http://europa.eu.int/comm/food/food/labellingnutrition/foodlabelling/guidelines.pdf>.

\- Certain ingredients may be designated by the name of the category
rather than the specific name (Annex I to Directive 2000/13/EC). These
include fats, oils (note that peanut oil is also subject to the new
allergen rules), starch, fish, cheese, spices, herbs, gum bases, crumbs,
sugar, dextrose, glucose syrup, milk proteins, cocoa butter,
crystallized fruit, vegetables and wine. Directive 2001/101/EC adds meat
as a category and defines the term \"meat\" for the labeling of
pre-packed meat-based products (for more information see GAIN report
E23004).

\- The quantity of certain ingredients or categories of ingredients
(QUID) -- see below.

\- The net quantity of prepackaged foodstuffs expressed in metric units
(liter, centiliter, milliliter, kilogram or gram).

\- The date of minimum durability: the shelf life is indicated by the
words \"Best before\...\" when the date includes an indication of the
day, or by \"Best before end of\...\" in other cases. The date has to be
given in order of day- month-year. However, for foodstuffs with a shelf
life of less than three months, the day and month of expiry are
adequate; for a shelf life of three to eighteen months the month and
year are sufficient; for more than eighteen months shelf life the year
is sufficient indication. In the case of highly perishable foodstuffs
the date consisting of the day, the month and possibly the year has to
be preceded by the words \"use by.\"

\- Any special storage conditions or conditions of use.

\- The name or business name and address of the manufacturer, packager
or vendor established within the Community.

\- Particulars of the place of origin or provenance in case absence of
such information might mislead the consumer.

\- Instructions for use.

\- The actual alcoholic strength for beverages containing more than 1.2
percent alcohol by volume.

\- A mark to identify the lot to which a foodstuff belongs, determined
by the producer, manufacturer or packager or by the first seller in the
EU. The marking must be preceded by the letter \"L\", except in cases
when it is clearly distinguishable from other indications on the label.
The lot identification is not necessary if the date (day and month) of
minimum durability or \"use by\" date, appears in un-coded form on the
label.

\- Treatments undergone, with specific indications for irradiated foods
and deep-frozen foods (see section 7).

Note: the use of the EAN (European Article Numbering) product coding
system is not regulated by EU law. However, this bar code system is
commonly used in the EU for traceability purposes. Traceability will
become mandatory on January 1, 2005.

**Additives**

\- Annex II to the labeling directive lists the categories of additives,
which must be designated by the name of their category followed by their
specific name or EEC number. The categories are the following: color,
preservative, anti‑oxidant, emulsifier, thickener, gelling agent,
stabilizer, flavor enhancer, acid, acidity regulator, anti‑caking agent,
modified starch, sweetener, raising agent, anti‑foaming agent, glazing
agent, emulsifying salts, flour treatment agent, firming agent,
humectant, bulking agent, propellant gas.

\- Flavorings: Annex III to the labeling directive describes the way of
designating flavorings in the list of ingredients.

\- The presence of sweeteners/aspartame/polyols requires standardized
statements on the label; packaging gases are not considered as additive
but also require a standardized statement.

### Quinine and Caffeine

Commission Directive 2002/67/EC requires the compulsory labeling of
quinine and caffeine used in the production or preparation of foodstuffs
(usually tonic waters and energy drinks). Quinine and caffeine must be
mentioned in the ingredients list, preceded by the term \"flavoring\".
Beverages containing more than 150 mg of caffeine per liter will have to
be labeled with \"high caffeine content\" followed by the caffeine
content expressed in mg/100 ml.

### Licorice

Commission Directive 2004/77/EC, scheduled to come into force on May 20,
2005, lays down rules for the labeling of confectionery and beverages
containing glycyrrhizinic acid and its ammonium salt (licorice).

### Phytosterols & Phytostanols

Commission Regulation 608/2004 lays down labeling requirements for foods
and food ingredients with added phytosterols, phytosterol esters,
phytostanols and phytostanol esters (used to reduce cholesterol levels).
For labeling purposes, they must be designated respectively by the terms
"plant sterols", "plant sterol esters", "plant stanols" and "plant
stanol esters".

### Quantitative Ingredients Declaration (QUID)

Quantitative ingredients declaration (QUID) is compulsory in the
following cases:

\- Where the ingredient or category of ingredients appears in the name
under which the foodstuff is sold:

e.g. \"15% strawberries\" on strawberry ice cream - QUID for
strawberries

\"35% fruit\" on fruit pie - QUID for total fruit content

\- Where the ingredient or category of ingredients is usually associated
with that name by the consumer: e.g. goulash soup - QUID for beef

\- Where the ingredient or category of ingredients is emphasized on the
labeling in words (e.g. \"made with butter\"), pictures (e.g. of a cow
to emphasize dairy ingredients) or graphics (different size, color
and/or style of print).

\- Where the ingredient or category of ingredients is essential to
characterize a foodstuff and to distinguish it from similar products.

The QUID declaration must be indicated in or immediately next to the
name under which the product is sold, unless a list of ingredients is
voluntarily indicated on the label in which case the quantity may appear
in the list. The quantity of the ingredient, expressed as a percentage,
must correspond to the quantity of the ingredient(s) actually used in
the preparation of the product.

The QUID requirement DOES NOT apply to constituents
[naturally]{.underline} present in foods and which have not been added
as ingredients e.g. caffeine (in coffee) and vitamins and minerals (in
fruit juices). QUID declarations are not needed in a number of cases,
e.g. when products state the drained net weight or where an ingredient
is used for purposes of flavoring. QUID declarations CANNOT replace
nutrition labeling.

Commission Directive 1999/10/EC provides for exemptions from the QUID
requirement:

\- When the wording \"with sweeteners\" or \"with sugar(s) and
sweetener(s) accompanies the name under which a foodstuff is sold.

\- When the addition of vitamins and minerals is subject to nutrition
labeling.

\- When foodstuffs are concentrated or dehydrated.

General guidelines have been drawn up to help Member States and industry
organizations implement the principle of QUID. A copy of these
guidelines are available on our website at
[www.useu.be/agri/label.html](http://www.useu.be/agri/label.html).

### Language Requirements

As a general rule, labeling has to be in a language easily understood by
consumers; this is in practice the official language(s) of the member
state. As an exception to the general rule, it is also allowed to use:

\- Another language provided it can easily be understood by consumers.

\- Other means depicting the content (e.g. pictures).

Multi-language labeling is allowed throughout the EU.

Language labeling requirements in practice:

  ----------------------------------- -----------------------------------
  **EU Member State**                 **Language**

  Austria                             

  Belgium                             French AND Dutch, German also
                                      recommended

  Czech Republic                      Czech

  Denmark                             Danish

  Estonia                             Estonian

  Finland                             Finnish

  France                              French

  Germany                             German

  Greece                              Greek

  Hungary                             Hungarian

  Ireland                             British English

  Italy                               Italian

  Latvia                              Latvian

  Lithuania                           Lithuanian

  Luxembourg                          French or German

  Malta                               Maltese or English or Italian

  Netherlands                         Dutch

  Poland                              Polish

  Portugal                            Portuguese

  Slovakia                            Slovak

  Slovenia                            Slovene

  Spain                               Spanish

  Sweden                              Swedish

  United Kingdom                      British English
  ----------------------------------- -----------------------------------

### Stick-on Labels

EU legislation does not contain any reference to the use of stick-on
labels. It is up to individual Member States whether to accept stick-on
labels.

### Samples

EU legislation covers all foods destined for consumption. It does not
contain any specific labeling requirements or exceptions for samples.
Exporters are advised to consult the member state FAIRS reports for
specific information
([www.useu.be/agri/fairs.html](http://www.useu.be/agri/fairs.html)).

### Labeling of Genetically Modified Foods and Novel Foods

Section 7.A of this report is entirely dedicated to the regulatory
review and commercialization of genetically modified foods in the EU and
provides information on EU labeling requirements for genetically
modified foods and their derivatives. The words \"produced from
genetically modified \...\" or \"genetically modified\" as a footnote or
specification following the ingredient have to be used to indicate the
presence of the GM soy and corn proteins and all GM additives and
flavorings that are currently on the market.

## B. Medical / Health Claims

Medical claims, attributing to a foodstuff the property of preventing,
treating or curing human diseases, are explicitly prohibited in the EU
general labeling directive. The directive does not provide any guidance
on which health claims (e.g.\"Aids Digestion\") are allowed and which
not. As a result, many EU Member States have developed separate
initiatives in this area. However, the EU has proposed new rules on
health claims made on foods and will draw up a list of authorized health
claims (for more information see GAIN reports E23199, E23172 and
E23136).

### Requirements Specific to Nutritional Labeling

Nutrition labeling is not mandatory in the EU unless a nutrition claim
is made on the label or in advertising messages. \"Nutrition labeling\"
means any information on the label that relates to energy value and to
the following nutrients: protein, carbohydrate, fat, fibre, sodium,
vitamins and minerals present in significant amounts. A \"nutrition
claim\" means any representation or advertising that claims that a
foodstuff has particular nutritional properties and is only allowed if
it relates to the energy value and/or nutrients referred to above.
Nutrition labeling rules are laid down in Council Directive 90/496/EEC.

Where nutritional labeling is provided, the information to be given
should consist of either group 1 or group 2 in the following order:

  ----------------------------------- -----------------------------------
  **Group 1**                         **Group 2**

  \- the energy value                 \- the energy value

  \- the amount of protein,           \- the amount of protein,
  carbohydrate and fat                carbohydrate, sugar, fat,
                                      saturates, fibre and sodium
  ----------------------------------- -----------------------------------

The energy value and the proportion of nutrients must be declared in
specific units per 100 grams or per 100 milliliters. Information on
vitamins and minerals must be expressed as a percentage of the
recommended daily allowance (RDA).

The information on the label must be presented in tabular form with the
numbers aligned or if space does not permit, in linear form in a
language easily understood by the purchaser.

The EU has proposed new rules on harmonizing nutrition claims made on
foods by introducing a list of definitions (for more information see
GAIN report E23172 and E23136).

## C. Product-Specific Labeling

For a number of products, specific labeling requirements have been
established in addition to the general requirements described above.
These include:

\- genetically modified foods

\- novel foods

\- foodstuffs for particular nutritional uses including dietetic and
baby/infant foods

\- beef

\- wine

\- spirit drinks

\- organic foods

\- cocoa and chocolate products, sugars, honey, fruit juices and similar
products, preserved milk

\- coffee extracts and chicory extracts, fruit jam, jellies, marmalades
and chestnut puree

\- fresh fruits and vegetables

\- meat, eggs, dairy products, spreadable fats

\- seafood

More details on above products can be found in Section 7.

# SECTION 3. PACKAGING AND CONTAINER REQUIREMENTS

[www.useu.be/agri/packaging.html](http://www.useu.be/agri/packaging.html)

## A. Container Contents

Unlike the other requirements covered by this guide, requirements in the
Directives concerning container contents of pre-packaged products set
out below are not a prerequisite for marketing a foodstuff. However, if
these requirements are satisfied, free movement throughout the EU is
guaranteed.

The maximum tolerable error between the actual content and the quantity
indicated on the label, and methods to check this are fixed in Council
Directive 76/211/EEC, as amended. A small \"e\" of at least 3 mm on the
label guarantees that the actual content corresponds to the quantity
indicated. The size of the figures indicating the quantity depends on
the nominal quantity:

-   nominal quantity greater than 1000 g or 100 cl: at least 6 mm high

-   greater than 200 g/20 cl but less than 1000 g/100 cl: at least 4 mm

-   greater than 50 g/5 cl but less than 200 g/20 cl: at least 3 mm

-   less than 50 g/2 cl: 2 mm. The quantity must be followed by the unit
    of measurement.

Container sizes have been prescribed for butter, fresh cheeses, salt,
sugar, breakfast cereals, pasta, rice, dried fruits and vegetables,
coffee, frozen fruits and vegetables, fish fillets, fish fingers, ice
cream, preserved fruits and vegetables and products sold in metal
containers. (Council Directive 80/232/EEC)

## B. Packaging Waste Management

Member States are required to take measures to reduce packaging waste
and must introduce systems for reuse, recovery and recycling of
packaging materials (Council Directive 94/62/EC). To facilitate
collection, reuse and recovery including recycling, an identification
system for packaging has been drawn up (Commission Decision 97/129/EC).
Its use is voluntary. A well-known and widely used recycling program is
the German "green dot" system. Fore more information see
[www.gruener-punkt.de](http://www.gruener-punkt.de/).

## C. Materials in Contact with Foodstuffs

Council Directive 89/109/EEC specifies the common rules for all
materials that come into contact with foodstuffs and provides for the
adoption of specific directives including lists of authorized
substances, conditions of use, migration limits, purity standards. To
date, specific directives have been developed for vinyl chloride,
certain epoxy derivatives, plastics, regenerated cellulose film,
ceramics. In the case of ceramics, migration limits have been
established for two of their constituents, namely lead and cadmium.
Materials must bear an indication "for food use", which can be replaced
by the specific symbol designed in Council Directive 80/590/EEC.

Exporters are advised to verify if a Member State follows EU provisions
as Member States are allowed to authorize provisionally the use of
certain substances not listed in one of the specific directives and, for
reasons of public health, they may also restrict or temporarily prohibit
the use of certain materials authorized by the specific directives. The
\"EU Practical Guide\" explaining these directives can be downloaded
from
[www.useu.be/agri/packaging.html](../www.useu.be/agri/packaging.html)[.]{.underline}

# SECTION 4. FOOD ADDITIVE REGULATIONS

[www.useu.be/agri/additive.html](http://www.useu.be/agri/additive.html)

Council Directive 89/107/EEC provides for the establishment of EU
harmonized positive lists \--lists of what is permitted\-- of a wide
range of food additives. All food additives not included in the positive
lists are prohibited except for those new food additives that receive a
temporary two-year authorization by Member States. Most food additives
may be used only in limited quantities in certain foodstuffs. Food
additives for which no quantitative limits have been established
(maximum level established at "quantum satis") must be used according to
good manufacturing practice. This means using only as much as necessary
to achieve the desired technological effect. Processing aids and
flavorings fall outside of the scope of this directive.

Substances added to foodstuffs as nutrients such as minerals, trace
elements, vitamins do not fall under the scope of this directive and
continue to be subject to Member States legislation.

The lists of authorized food additives and their conditions for use are
published in three directives:

1\) European Parliament and Council Directive 94/35/EC on **sweeteners**
for use in foodstuffs. The annex to this directive lists maximum usable
doses for sweeteners in selected foodstuffs.

2\) European Parliament and Council Directive 94/36/EC on **colors** for
use in foodstuffs.

Annex I: list of permitted food colors. Only substances listed in this
annex may be used

Annex II: foodstuffs which may not contain added colors

Annex III: foodstuffs to which only certain permitted colors may be
added

Annex IV: colors permitted for certain uses only

Annex V: colors permitted in general and the conditions of use
therefore.

3\) European Parliament and Council Directive 95/2/EC, as amended, the
so-called **miscellaneous additives** directive on food additives other
than colors and sweeteners.

Annex I: list of food additives permitted for use in foodstuffs (excl.
those listed in Annex II) following the \"quantum satis\" principle

Annex II: list of foodstuffs in which only a limited number of additives
of Annex I may be used. These include cocoa and chocolate products,
fruit juices and nectars, jam and jelly, dehydrated milk and cream,
fruits and vegetables, rice, oils and fats, certain cheeses, minced
meat, bread and pasta, wines and beer

Annex III: list of conditionally permitted preservatives and
antioxidants

Annex IV: list of other permitted additives

Annex V: list of permitted carriers and carrier solvents

Annex VI: list of additives permitted in foods for infants and young
children

These lists can be downloaded from our additives webpage.

An important difference from U.S. legislation is the use of flour
bleaching agents: chlorine, bromates and peroxides are not allowed in
the EU.

Specific information on authorized additives can be obtained from our
office. Upon request, our office can also provide a multilingual list of
all food additives.

Labeling requirements for additives and flavorings are laid down in
directive 2001/13/EC (general labeling directive), regulation 50/2000/EC
(GM additives) and directive 89/107/EEC. The addition of a new food
additive to the EU positive list is a lengthy process. However, any
Member State can allow the domestic use of a new food additive on their
territory for a two-year period. Companies are advised to submit an
application to the Member State where they want to start using a new
additive and simultaneously to the Commission. Procedures on obtaining
the 2-year waiver differ from one Member State to another, and the time
necessary to obtain approval also can vary significantly. The procedure
for inclusion of an additive in the positive list requires that a
dossier be sent to the European Food Safety Agency (EFSA) and to the
Commission. EFSA reviews a substance and has to give a positive opinion
before the Commission can propose the addition to the positive list.

### Processing Aids

A list of extraction solvents allowed in the production of foodstuffs
and food ingredients, along with their conditions of use has been
established in Council Directive 88/344/EC.

### Flavorings

In an initial step to harmonize the use of flavorings in the EU, the
European Commission has compiled a register of all flavoring substances
authorized in the different EU Member States. The register can be
downloaded from the Internet in pdf-format at
<http://europa.eu.int/comm./food/food/chemicalsafety/flavouring/list_en.pdf>.
Once the EU-wide harmonized positive list has been finalized, foreseen
by July 2005, only those flavorings listed will be allowed.

# SECTION 5. PESTICIDES AND CONTAMINANTS

[www.useu.be/agri/pesticides.html](http://www.useu.be/agri/pesticides.html)

The legislation on pesticides and contaminants is partially harmonized
in the EU. Enforcement of both EU and remaining Member State rules is
done at the Member State level.

### Pesticides

EU pesticide legislation has not been fully harmonized yet and is under
review. Community maximum residue levels (MRL's) take into account the
work done by Codex Alimentarius and by the OECD but exceptions exist. An
overview of all compounds for which harmonized MRL's have been developed
are available from our website. The complete list of MRL/commodity
combinations can be downloaded from the Commission's website at
[http://europa.eu.int/comm/food/plant/protection/pesticides/index_en.htm]{.underline}.
Pesticide MRL's for processed or composite products are based on the
MRL's for the raw agricultural ingredients.

Harmonized sampling plans have been developed for the official control
of residues (Commission Directive 2002/63/EC).

For the registration of a new pesticide in the EU, including the
establishment of an MRL, an application needs to be prepared and
reviewed by the relevant authorities and committees at Member State and
EU level based on the rules set out in Directive 91/414. Pesticides that
were already on the EU market when this directive was adopted have been
undergoing a review. The currently ongoing legislative initiatives in
the area of pesticides will have two main end results: MRL's will become
harmonized throughout the EU and the number of active substances will be
drastically reduced. MRL's for unapproved substances will be set at
levels that essentially exclude them from use. For pesticides which are
not or no longer authorized at Community level, an import tolerance may
be requested. Application dossiers are first submitted to a rapporteur
Member State. The complete procedure is described on the Commission's
website at
[http://europa.eu.int/comm/plant/protection/resources/working_en.pdf]{.underline}.

Compounds for which there is no harmonized MRL yet remain subject to
Member State legislation.

### Contaminants

EU harmonized levels are in force for a number of contaminant/product
combinations. They are available in the annex to Commission Regulation
466/2001, as amended (see table below). Harmonized sampling plans have
been developed for the official controls of these levels.

+-----------------------------------+-----------------------------------+
| Amendments to Commission          |                                   |
| Regulation 466/2001               |                                   |
+-----------------------------------+-----------------------------------+
| Aflatoxins in nuts, dried fruit,  | Commission Regulation 257/2002    |
| cereals, maize, spices and milk   |                                   |
|                                   | Commission Regulation 472/2002    |
|                                   |                                   |
|                                   | Commission Regulation 2174/2003   |
+-----------------------------------+-----------------------------------+
| Ochratoxin A in cereals, cereal   | Commission Regulation 472/2002    |
| products, dried vine fruit        |                                   |
+-----------------------------------+-----------------------------------+
| Nitrate in lettuce and spinach    | Commission Regulation 563/2002    |
+-----------------------------------+-----------------------------------+
| Aflatoxin, Ochratoxin A, nitrate  | Commission Regulation 683/2004    |
| in infant foods                   |                                   |
|                                   | Commission Regulation 655/2004    |
+-----------------------------------+-----------------------------------+
| Dioxins                           | Commission Regulation 2375/2001   |
+-----------------------------------+-----------------------------------+
| Heavy metals, lead, cadmium,      | Commission Regulation 221/2002    |
| mercury                           |                                   |
+-----------------------------------+-----------------------------------+
| Patulin                           | Commission Regulation 1425/2003   |
+-----------------------------------+-----------------------------------+
| Inorganic tin                     | Commission Regulation 242/2004    |
+-----------------------------------+-----------------------------------+

Member States requirements continue to apply for a number of other
contaminants including heavy metals, certain other mycotoxins, and
radioactive elements.

  ----------------------------------- -----------------------------------
  Sampling & Analysis Methods for     
  Official Controls                   

  Aflatoxin                           Commission Directive 98/53/EC

  Ochratoxin A                        Commission Directive 2002/26/EC

  Dioxins                             Commission Directive 2002/69/EC

  Heavy metals & 3-MCPD               Commission Directive 2001/22/EC

  Patulin                             Commission Directive 2003/78/EC

  Tin                                 Commission Directive 2004/16/EC
  ----------------------------------- -----------------------------------

### Residues in Animals and Animal Product

The monitoring of residues in animals and animal products is addressed
separately in Council Directive 96/23/EC. This directive includes the
monitoring of the above-mentioned pesticide residues but includes also
the monitoring of residues of veterinary drugs and a wide range of other
contaminants and undesired substances such as residues of growth
promotants. The prohibition of the use of hormones in meat production is
addressed in Council Directive 96/22/EEC. The U.S. residue monitoring
plan for honey was considered insufficient by the EU and as a result,
the imports of honey were banned. The import restriction on honey is
expected to be dropped in the fall of 2004.

# SECTION 6. OTHER REGULATIONS AND REQUIREMENTS

## A. Product Inspection and Registration

Member States are responsible for carrying out inspections on a regular
basis and in cases where non-compliance is suspected*.* Products can be
checked at import or at all further stages of marketing. In case of
non-compliance, the EU hygiene directive (Com. Reg. 93/43/EEC) allows
the Commission to suspend imports from third countries or introduce
special conditions for products from the third country concerned,
applicable on the entire EU territory.

Criteria for laboratories conducting food controls have been harmonized
but it is the Member States' responsibility to designate laboratories
that are allowed to perform analyses (Council Directives 89/397/EEC and
93/99/EEC).

Specific detailed inspection requirements exist for animal products.
Inspections are done under supervision of a veterinarian at a limited
list of ports and border inspection posts. Fresh fruits and vegetables
are subject to phytosanitary controls and are checked for compliance
with EU-harmonized marketing standards (see section 7.J).

Product samples have to comply with the food regulations applicable in
the EU. Exemptions exist for meat and meat products, for which a waiver
may be obtained from the listing requirement described below.

Inspection fees differ from one Member State to another. Measures in
case of non-compliance also vary widely, ranging from non-admittance of
a product to forced destruction. This may be a decisive factor in
choosing a port of entry for products where problems are more likely.

Generally, there is no EU requirement to register imported foods except
for the introduction of novel foods (see section 7.B). The
person/company introducing a novel food has to submit a request to the
authorities in the Member States where the product will be marketed and
a copy of this request has to be sent to the Commission's Health and
Consumer Protection Directorate. Importers of organic products (see
section 7.E) are required to notify the competent regulatory authority
of the Member State of their activity. The introduction of foodstuffs
with particular nutritional uses (see section 7.C) needs to be notified
to the Member State where the food is sold. Exporters of
vitamin-enriched foods or nutritional supplements are especially advised
to check for the existence of specific Member State registration or
notification requirements.

## B. Certification and Documentation Requirements

### AGRIM Certificates

The EU requires import licenses (AGRIM certificates) for most
agricultural products for which it provides market support, including
grains, milk, meat, olive oil, most fruits and vegetables, wine and
sugar. In order to obtain a license, an application form must be
submitted and a security fee must be paid to the issuing Member State.
Licenses vary in validity with most expiring three months after the
month of issuance.

### Health Certificates for Plant Products 

([www.useu.be/agri/plantcertif.html](http://www.useu.be/agri/plantcertif.html))

Phytosanitary certificates are required under the EU's Plant Health
Directive 2000/29/EC. Imports of fresh fruits and vegetables and
unprocessed nuts must be accompanied by a U.S. Department of Agriculture
phytosanitary certificate or PPQ577, issued by an official Animal and
Plant Health Inspection Service (APHIS) inspector. The certificate is
used to certify that the commodities have been inspected and that they
comply with the importing country's phytosanitary regulations.

For more information see
[www.aphis.usda.gov/ppq/pim/exports/certificates&forms.htm](http://www.aphis.usda.gov/ppq/pim/exports/certificates&forms.htm).

### Health Certificates for Animal Products 

([www.useu.be/agri/certification.html](http://www.useu.be/agri/certification.html))

Animal products imported into the EU or transiting through the EU need
to be accompanied by a veterinary certificate. EU harmonized health
certificates are mandatory for meat, poultry, dairy, eggs, gelatin and
seafood.

The European Community is well advanced in the process of harmonizing
legislation on imports of animal products. This is a three‑stage process
that starts with the recognition of a country to export a certain animal
product. The U.S. is recognized by the EU for nearly all animal
products, except honey. However, as a result of the EU's hormone ban and
the rejection of chlorine as an anti-microbial treatment, U.S. exports
of beef and poultry to the EU have been blocked. For more information
see [www.useu.be/agri/ban.html](http://www.useu.be/agri/ban.html) and
[www.useu.be/agri/pltryexp.html](http://www.useu.be/agri/pltryexp.html).

In a second stage, lists of EU approved establishments are drawn up in
recognized countries. Various U.S. agencies, including FSIS, APHIS, AMS,
and FDA are involved in the listing process. Contact information for the
agencies issuing export certificates is available from our website.
Establishments are subject to EU inspections prior to listing and/or to
occasional EU audits after listing. Exporters should be aware that
getting a plant listed can take several months. Lists can be accessed
through
[www.useu.be/agri/estab.html](http://www.useu.be/agri/estab.html). At
present, the following food products must come from an EU-approved
establishment: red meat, meat products, farmed & wild game meat,
ratites, animal casings, milk & milk products, fish & fishery products
and gelatin.

An importer must give at least 24 hours notice of intent to import
animal products to the competent Member State authority and to the
Border Inspection Post (BIPs) at the port or airport of entry. As part
of the process of the 2004 accession, existing BIPs at the eastern land
borders of Germany, Austria and Italy have been closed and new border
Inspection Posts in the new member states have been approved. The list
of EU Border Inspection Posts can be found on our website at
[www.useu.be/agri/borderposts.html](http://www.useu.be/agri/borderposts.html).

### Other Products

For certain products the Community has not yet completed harmonization
of import requirements. In these cases import regulations are still
under the control of the individual Member States. This often results in
the Member States maintaining different sets of lists of third
countries, lists of establishments, certificate requirements, and
inspection programs.

### 

### Health Certificates for Processed Foods 

([www.useu.be/agri/foodcertif.html](http://www.useu.be/agri/foodcertif.html))

### 

All animal products imported into the EU need animal or public health
certification. For processed foods containing animal product, the
situation is more complicated because there is no legislation specifying
the percentage of dairy, egg, red meat or poultry meat that a foodstuff
must contain to necessitate certification. However, the specific EU
legislation applicable to the animal product in question contains
certain provisions on certification.

**Red meat & poultry meat:** Products containing [any
amount]{.underline} of red meat or poultry meat must be certified.

**Egg products & dairy:** Certification of products containing egg
products or dairy products depends on the composition of the product in
relation to the definitions in the relevant Community legislation. As a
rough guideline, if foodstuffs contain more than 50 percent of egg
products/dairy products, the Commission believes they should be
considered as such. More details are available from our website.
Further, the competent authorities of the importing EU Member State
should be contacted for their interpretation of the Commission's
guidelines.

Although there are no harmonized EU certificates for processed foods
such as canned vegetables, soup broths, etc., EU member states often
require that shipments be accompanied by a certificate signed by U.S.
officials. Exporters should check with their importer or with the Office
of Agricultural Affairs in the importing Member State which
documentation is required.

# SECTION 7. OTHER SPECIFIC STANDARDS

## A. Genetically Modified Foods (GMOs) 

([www.useu.be/agri/GMOs.html](http://www.useu.be/agri/GMOs.html))

On April 18, 2004, the EU implemented regulations 1829/2003 on
"Genetically Modified Food & Feed" and 1830/2003 on "Traceability and
Labeling of GMOs". These new regulations repeal Regulations 1139/98 on
the labeling of foodstuffs derived from Round-Up Ready soybeans and
Novartis Bt-176 corn, 49/2000 on adventitious contamination and 50/2000
on GM additives and flavorings.

The traceability rules require all business operators to transmit and
retain information on GM products enabling them to identify both the
supplier and the buyer of the GM product.

All food products containing or consisting of GMOs, produced from GMOs
or containing ingredients produced from GMOs must be labeled even if
they no longer contain detectable traces of GMOs. The allowable
adventitious presence level for EU-approved varieties of GMOs is set at
0.9 percent. Above this level all products must be labeled. For GM
varieties that received a positive EU risk assessment but are not yet
formally approved, the adventitious presence level is set at 0.5
percent. A list of these varieties is available at
<http://europa.eu.int/comm/food/food/biotechnology/gmfood/events_en.pdf>.

The wording to be used on GM food labels is as follows:

\- Where the food consists of more than one ingredient, the words
"genetically modified" or "produced from genetically modified \[name of
ingredient\]" must follow in brackets immediately after the ingredient
concerned. A compound ingredient with a GM component should be labeled
"contains \[name of ingredient\] produced from genetically modified
\[name of organism\]".

\- Where the ingredient is designated by the name of a category (e.g.
vegetable oil), the words "contains genetically modified \[name of
organism\]" or "contains \[name of ingredient\] produced from
genetically modified \[name of organism\]" must be used.

\- Where there is no list on ingredients, the words "genetically
modified" or "produced from genetically modified \[name of ingredient\]"
must appear clearly in the labeling.

The designations may appear in a footnote to the ingredients list,
provided they are printed in a font at least the same size as that of
the list of ingredients or, where there is no list of ingredients,
clearly on the labeling.

A list of products that require labeling under the new rules and
examples of specific wording to be used on labels are available on our
website at
[www.useu.be/agri/GMOs.html](http://www.useu.be/agri/GMOs.html).

## B. Novel Foods 

([www.useu.be/agri/novelfood.html](http://www.useu.be/agri/novelfood.html))

The Novel Food Regulation 258/97 lays down detailed rules for the
authorization of novel foods and novel food ingredients, including foods
derived from or containing or consisting of GMOs. It defines novel foods
as foods and food ingredients that were not used to a significant degree
in the EU before May 15, 1997. The new regulations on GM food provide
for a separate regime to deal with the authorization and traceability of
novel foods and novel food ingredients that consist of or contain or are
derived from GMOs. Pre-market approval of non-GM novel foods will
continue under European Parliament and Council Regulation 258/97. Non-GM
categories of novel foods consist of food and food ingredients:

\- with a new intentionally modified primary molecular structure, or

\- consisting of, or isolated from, micro-organisms, fungi or algae, or

\- consisting of, or isolated from plants or animals, except for foods
and food ingredients obtained by traditional propagating or breeding
practices with a history of safe use, or

\- to which a production process not currently used has been applied,
where that process changes the composition or structure of the food or
food ingredient significantly

The following non-GM novel foods are approved to be marketed in the EU:

> \- phospholipids from egg yolk\
> - yellow fat spreads / salad dressings / milk & yoghurt type products
> / milk based fruit drinks / soy drinks / cheese type products / spicy
> sauces with added phytosterol and phytostanol (esters)\
> - dextran produced by Leuconostoc mesenteroides\
> - pasteurized fruit preparations pasteurized by high-pressure
> treatment\
> - trehalose\
> - coagulated potato proteins\
> - noni juice\
> - oil rich in DHA from the micro-algae Schizochytrium sp

Two products were refused: the herbal product Stevia Rebaudiana and
Nangai nuts.

## C. Dietetic or Special Use Foods 

([www.useu.be/agri/partnutr.html](http://www.useu.be/agri/partnutr.html))

Council Directive 89/398/EEC is a framework directive laying down rules
for foodstuffs intended for particular nutritional uses. These are
foodstuffs, which due to their special composition or manufacturing
process, can clearly be distinguished from foodstuffs for normal
consumption. Commission Directive 2001/15/EC lists the chemical
substances in each category of nutritional substances (vitamins,
minerals and amino acids) that may be added for specific nutritional
purposes in foodstuffs for particular nutritional uses.

Provisions including compositional and hygiene requirements, provisions
regarding the quality of raw materials, a list of additives/substances,
specific labeling requirements, sampling procedures and analysis methods
have been laid down in specific directives for four product categories:

> \- Commission Directive 96/5/EC on processed cereal-based foods and
> baby foods for infants and young children.
>
> \- Commission Directive 96/8/EC on foods intended for use in
> energy-restricted diets for weight reduction.
>
> \- Commission Directive 91/321/EC on infant formula and follow-on
> formula.
>
> \- Commission Directive 1999/21/EC on dietary foods for special
> medical purposes.

To take advantage of technological developments, the Commission may
authorize the marketing of products, which do not comply with the
requirements of the specific directives for a two-year period.

Specific directives on foods and beverages for sports people or on foods
intended for diabetics are still subject to Member State legislation.
The introduction of foodstuffs intended for particular nutritional uses
for which no specific rules are set must be notified to the Member State
where the food is sold.

## D. Wine, Beer and Other Alcoholic Beverages 

([www.useu.be/agri/wine.html](http://www.useu.be/agri/wine.html))

The U.S. and the EU are currently negotiating a bilateral agreement on
wine. Exports of U.S. wine to the EU continue under derogations, which
permit certain U.S. oenological practices which would otherwise be
prohibited. The current derogation has been extended until December 2005
(Council Regulation 2324/2003) or until the conclusion of a US-EU wine
agreement.

Commission Regulation 883/2001 lays down detailed rules for implementing
Council Regulation 1493/1999 as regards trade with third countries in
wine, grape juice and grape must. All U.S. wine imports must be
accompanied by the certificate and analysis report or VI1-form (Annex
VII to 883/2001) that certifies its origin and compliance with EU
standards. Under the current regulation, the producers may issue the
certification themselves if they provide certain assurances. A list of
U.S. agencies / laboratories / wine producers authorized to draw up
VI1-forms was published in Official Journal C 322 of December 21, 2002
or can be obtained from the Bureau of Alcohol, Tobacco, Firearms and
Explosives ([www.atf.gov](http://www.atf.gov/)).

Commission Regulation 753/2002 lays down labeling rules for wine. This
regulation was amended by Regulation 316/2004 to respond to a number of
concerns raised by the U.S. and other non-EU wine producing countries.
In an effort to conform with its WTO commitments, the EU has adopted new
conditions for the use of traditional expressions on wine labels by
third countries. Regulation 753/2002 established a system of two
categories of traditional expressions to designate quality wines. The
first category contained expressions that could be used by third
countries under certain conditions while the second category included
expressions exclusively reserved for EU wines. The amendment simplifies
this system by merging the two categories into one single category and
third countries will be allowed to use them under very strict
conditions.

Council Regulation 1576/89, as amended, lays down the general rules on
the definition, description and presentation of spirit drinks. There is
no Community legislation for beer, although some member states have
adopted national provisions to make the list of ingredients compulsory.

## E. Organic Foods 

([www.useu.be/agri/organic.html](http://www.useu.be/agri/organic.html))

Council Regulation 2092/91, as amended, on organic products covers the
following requirements and definitions: production and processing
methods, labeling and marketing, inspection and imports from third
countries. It was supplemented by Regulation 1804/99 to include
livestock production. The term "organic" on the label may only be used
for product conforming these regulations.

While organic standards have been set at the EU level, implementation
and enforcement of the regulation is the responsibility of the
individual member states. This member state responsibility also extends
to imports of organic products. In order to import U.S. organic
products, EU importers must work through their designated member state
authority to obtain an import authorization. These authorizations are
granted on a case-by-case basis, subject to the member state's review of
two main elements: the organic standards and inspection measures applied
by the certifier of the product and the certifier's compliance with EN
45011 or ISO Guide 65.

The importer must demonstrate that the product was produced according to
standards equivalent to the EU standards. In addition, the importer must
provide evidence that the certifier of the product has been accredited
to EN 45011/ISO 65 by an authority recognized by the member state.
Individual member states may have different criteria for judging
compliance with these requirements. In the U.S., USDA' Agriculture
Marketing Service (AMS) has been designated as the competent authority
to accredit U.S. organic certifiers for compliance with ISO 65. To date,
Austria, Netherlands, Denmark, Spain, Sweden, United Kingdom and certain
German states have officially recognized AMS' ISO 65 accreditation.

Commission Regulation 1788/2001 lays down detailed rules for a
certificate of inspection for imports from third countries. Certifiers
of U.S. organic products must use the EU certificate format for products
to be exported to the EU. An original certificate must accompany the
good and is verified at the border by the member state authorities.
Goods are not released until the authorities have verified that a valid
import authorization has been granted for the consignment. Member states
have several options for implementing the regulation, which means that
procedures may differ from member state to member state.

## F. Vertical Legislation (Breakfast Directives) 

([www.useu.be/agri/vertic.html](http://www.useu.be/agri/vertic.html))

Vertical legislation on the manufacture and marketing of specific
products has been developed for sugars, cocoa and chocolate products,
honey, fruit juices and similar products, preserved milk, coffee
extracts and chicory extracts and fruit jams and similar products.

## 

## G. Animal Products

**Beef Labeling**
([www.useu.be/agri/label](http://www.useu.be/agri/label))

A compulsory beef labeling scheme has been in place since September
2000. Full implementation of the beef labeling scheme went into effect
on January 1, 2002. (Regulations 1760/2000 and 1825/2000). Under this
scheme, labels for all bovine meat must indicate the following
information:

  -----------------------------------------------------------------------
  "Born in: name of third country"

  "Reared in: name of third country or third countries"

  For beef derived from animals born, raised and slaughtered in the same
  third country, the above indications may be combined as "Origin: name
  of third country"

  A reference number ensuring the link between the meat and the animal or
  animals

  "Slaughtered in: third country / approval number of slaughterhouse"

  "Cutting in: third country / approval number of cutting plant"

  A traceability code linking the meat to the animal or a group of
  animals representing the production of maximum one day
  -----------------------------------------------------------------------

**Egg Labeling**
([www.useu.be/agri/label.html](http://www.useu.be/agri/label.html))

The mandatory marking of grade A eggs (fresh eggs for human consumption)
by a code designating the producer and farming method entered into force
on January 1, 2004, as part of an amendment to Council Regulation
1907/90 establishing marketing standards for eggs. Each egg produced in
the EU has to be stamped individually with one of the following codes
indicating the farming method:  O = organic, 1 = free range, 2 = barn, 3
= cage. For eggs imported from the U.S., the new rules are not totally
clear yet.  The European Commission must first evaluate the U.S.
labeling rules in force to determine whether they are equivalent to the
EU\'s technical rules and standards.  Pending the outcome of this
evaluation, imported grade A eggs may be stamped individually with
either a code corresponding to the mentioned methods of production or
with a code identifying the unspecified nature of the farming method.

**Other**

\- Council Regulation 1906/90 of 26 June 1990 on certain marketing
standards for poultry

\- Council Regulation 1898/97 limits the use of the word "milk" or other
dairy products to actual dairy products

\- Council Regulation 2991/94 establishes standards for spreadable fats

\- Council Regulation 2406/96 of 26 November 1996 laying down common
marketing standards for certain fishery products

Product briefs on seafood and pet food can be found on our website at
[www.useu.be/agri/seafood2.html]{.underline} and
[www.useu.be/agri/petfood.html.]{.underline}

### 

## H. Frozen Foodstuffs 

([www.useu.be/agri/frozen.html](http://www.useu.be/agri/frozen.html))

### 

Council Directive 89/108/EEC sets rules for quick-frozen foodstuffs and
for their packaging and labeling. Quick-frozen foodstuffs sold to the
final consumer should carry the following additional labeling
indications: the product name with the indication "quick-frozen", the
date of minimum shelf life, the period during which the purchaser may
store the product, the storage temperature and/or type of storage
equipment required, batch identification and a clear indication of the
type "do not re-freeze after defrosting".

## I. Irradiated Foodstuffs 

([www.useu.be/agri/irradiation.html](http://www.useu.be/agri/irradiation.html))

Harmonization of EU rules on food irradiation has been slow and only a
few products have so far received EU- wide approval.

Framework Directive 1999/2/EC outlines the marketing, labeling, import
and control procedures and technical aspects of food irradiation.
Irradiated foods must be labeled \"irradiated\" or \"treated with
ionizing radiation\" even if the irradiated ingredients used in compound
ingredients constitute less than 25% of the finished product.

Implementing Directive 1999/3/EC establishes a Community list of foods
and food ingredients authorized for irradiation treatment. The list
contains only one food category: \"dried aromatic herbs, spices and
vegetable seasonings\". Until the positive list is expanded, the
national authorizations listed on our website continue to apply.

## J. Fruits and Vegetables 

([www.useu.be/agri/Fruit-Veg.html](http://www.useu.be/agri/Fruit-Veg.html))

Fresh fruits, vegetables and nuts are subject to phytosanitary controls
(see section 6.B) and are checked for compliance with EU marketing
standards for quality and labeling. A conformity certificate or a
certificate of industrial use, to be obtained by the importer at the
point of entry, is required for all shipments of fresh produce.
Marketing standards for fruits and vegetables are available on our
website. Standards exist for apples and pears, apricots, artichokes,
asparagus, aubergines (eggplant), avocados, beans, Brussels sprouts,
cabbage, carrots, cauliflowers, celery, cherries, citrus fruit,
courgettes (zucchini), cucumbers, garlic, kiwis, leeks, lettuce, curly
and escarole chicory, melons, onions, peaches and nectarines, peas for
shelling, plums, spinach, strawberries, sweet peppers, table grapes,
tomatoes, watermelons, witloof chicory, miniature produce, mixes of
fruit and vegetables, walnuts and hazelnuts.

## K. Seafood 

([www.useu.be/agri/seafood2.html](http://www.useu.be/agri/seafood2.html))

Fishery and aquaculture products offered for retail sale in the EU must
be properly labeled providing the following information:

-   Commercial name of the species (each member state has established a
    list of commercial designations).

-   Product method: "caught in...", "caught in freshwater", "farmed" or
    "cultivated".

-   Catch area: for products caught at sea, a reference to one of the
    areas listed in the annex.

# SECTION 8. COPYRIGHT AND/OR TRADEMARK LAWS

### Trademarks

Community trademark policy was created by Council Regulation 40/94 and
implemented by Commission Regulation 2868/95. This regulation creates a
single, unitary registration system covering the whole Community
territory.

In practice, a Community trademark must meet two conditions: it must be
a sign which can be represented in graphic form, and it must make it
possible to distinguish goods and services from those of another
company. It is valid for a period of 10 years. Applications for
registering Community trademarks under these regulations may be filed
with the Alicante, Spain, based Office of Harmonization for the Internal
Market, subject to the fees set out in Commission Regulation 2869/95, or
at a national industrial property office in a Member State of the
European Union.

On completion of the registration procedure, the trademark is registered
in the Register of Community trademarks.

The Community Trademark did not replace the existing trademark laws of
the member states, for which a need will continue to exist, but
co-exists alongside national trademarks. [Council Directive
89/104/EEC](http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&numdoc=31989L0104&model=guicheti)
approximates national trademark rules as regards what can and cannot be
registered, the exclusivity of rights and conditions under which
trademark rights can be forfeited.

### Protected Geographical Indications

Geographical indications (GIs) are "indications which identify a good
where a given quality, reputation or characteristic of the good is
essentially attributable to its geographic origin". Regulation 2081/92
sets out the rules on the protection of geographical
indications/designations of origin for listed European agricultural
products and foodstuffs. The EU does not allow for the registration of
foreign GIs in its own system. It furthermore does not fully guarantee
protection of trademarks that are similar or identical to a GI.

# SECTION 9. IMPORT PROCEDURES

Council Regulation 2913/92 establishes the Community Customs Code. The
Code lists all the customs procedures applicable to the trade in goods
with third countries. Import duties are determined by the tariff
classification of goods and by the customs value. With the
implementation of the Code, the member states of the European Union form
a customs union which means that all the member states apply the same
tariff on goods imported from outside the EU. Once an imported good is
cleared in one member state, it can move freely throughout the EU.

The EU uses the Combined Nomenclature (CN) for the customs
classification of goods. The CN eight digit code numbers are based on
the Harmonized System (HS) nomenclature: the first six digits refer to
the HS headings, the two following digits represent the CN subheadings.
The EU's on-line customs database can be consulted to look up commodity
codes and relevant import duties:
<http://europa.eu.int/comm/taxation_customs/dds/en/tarhome.htm>[.]{.underline}
It is also possible to obtain Binding Tariff Information (BTI) from a
member state's customs authority to get the proper product
classification. Through this system, traders know in advance the tariff
classification of the goods they intend to import. BTI is legally
binding in all the member states. A list of customs authorities can be
found on the Internet at
<http://europa.eu.int/comm/taxation_customs/databases/bti_en.htm>. The
customs value of a good is the CIF price at the European border derived
from the product price found on the invoice and the transportation costs
reflected in the airway bill or the bill of lading.

Goods are only released after payment of the import duty and other taxes
that may be due. Duties payable on goods imported into the EU may
include:

\- import duty (expressed as ad valorem tariffs or specific tariffs per
unit weight/volume/number of pieces)

\- additional duties on flour and sugar (processed products)

\- entry price (fruit and vegetables)

\- environmental taxes - not harmonized

\- inspection fees - not harmonized

\- Value Added Tax (VAT) - not harmonized

\- excise duties (alcohol and tobacco) - not harmonized

A list of VAT rates applicable in the different member states can be
found on the Internet at
<http://europa.eu.int/comm/taxation_customs/taxation/vatindex_en.htm>.

A list of excise duties applicable on alcoholic beverages and tobacco
can be found at
<http://europa.eu.int/comm/taxation_customs/publications/info_doc/info_doc.htm#duty-rates>[.]{.underline}

Other customs procedures described in detail in the Code include entry
into free zones, situations where no import duty is payable: e.g. the
inward processing regime, under which goods can be imported for
processing but the finished product must be exported from the Community
market. The Code also provides for a two-stage right of appeal lodged in
the Member State where a decision has been taken or applied for: in the
first instance to the customs authority, then to the national courts.

# APPENDIX I. GOVERNMENT REGULATORY AGENCY CONTACTS

**Commission of the European Communities**

Rue de la Loi 200

1049 Brussels

Belgium

Tel: (32-2) 299 11 11

**Office for Harmonization in the Internal Market**

Avenida de Aguilera, 20

03080 Alicante

Spain

Tel. (34‑96) 513 92 43

Fax. (34‑96) 513 91 73

**United States Mission to the European Union**

Office of Agricultural Affairs

Mailing address:

27 Boulevard du Regent

1000 Brussels

Belgium

Tel: (32‑2)508‑2760

Fax: (32) (2) 511‑0918

e-mail: [AgUSEUBrussels@usda.gov](../AgUSEUBrussels@usda.gov)

**Other FAS Offices in the European Union**
<http://www.useu.be/agri/FAS-inEU-25.html>

**USDA/FDA contacts for certification of Animal Products**
<http://www.useu.be/agri/certification.html>

# APPENDIX II. HOW TO OBTAIN LEGISLATION

[www.useu.be/agri/legis.html](http://www.useu.be/agri/legis.html)

**The Official Journal**
[http://europa.eu.int/eur‑lex/en/oj/index.html]{.underline}

The Official Journal is the EU equivalent to the U.S. Government\'s
\"Federal Register\". The L (Legislation) and C (Information and
Notices) series of the Official Journal are published daily in all the
official languages of the EU. Legislation referenced in this report can
be looked up on the Eur-Lex website by using the search engine
(<http://europa.eu.int/eur-lex/en/search/index.html>).

**Sales Offices**

Subscriptions and paper editions of the Official Journal can also be
obtained from one of the sales offices in the U.S.:

+-----------------------------------+-----------------------------------+
| **Bernan Associates**             | **European Document Research**    |
|                                   |                                   |
| 4611-F Assembly Drive             | 1100 Seventeenth Str., N.W. Suite |
|                                   | 301                               |
| Lanham, MD 20706-4391             |                                   |
|                                   | Washington, D.C. 20036            |
| phone 800-274-4477                |                                   |
|                                   | phone 202-785-8594                |
| fax 301-459-0056                  |                                   |
|                                   | fax 202-785-8589                  |
| e-mail:                           |                                   |
| [query@bernan.com]{.underline}    | e-mail:                           |
|                                   | [edrwash@erols.com]{.underline}   |
| URL: [www.bernan.com]{.underline} |                                   |
|                                   | URL:                              |
|                                   | [www.e                            |
|                                   | uropeandocuments.com]{.underline} |
+-----------------------------------+-----------------------------------+
| **Advanced Information Databases, | **PSI-USA**                       |
| Inc.**                            |                                   |
|                                   | 5720 Jackrabbit Jct               |
| 23205 Gratiot Avenue              |                                   |
|                                   | Farmington, NM 87402              |
| Eastpointe, MI 48021              |                                   |
|                                   | phone 505-330-7374                |
| phone 800-890-1692                |                                   |
|                                   | fax 505-327-2323                  |
| fax 519-539-3176                  |                                   |
|                                   | e-mail:                           |
| e-mail:                           | [                                 |
| [adinfo@adinfo.com]{.underline}   | connelly@psi-usa.com]{.underline} |
|                                   |                                   |
| URL: [www.adinfo.com]{.underline} | URL: [psi-usa.com]{.underline}    |
+-----------------------------------+-----------------------------------+

Note: this is not an endorsement of any of the services offered by these
companies. The U.S. Government is not responsible for performance, or
lack thereof, of these companies.

**Legislation in force**
([http://europa.eu.int/eur-lex/en/lif/index.html)]{.underline}

The texts are arranged under twenty main chapter headings. Legislation
relating to agriculture, biotechnology, organic farming, foodstuffs,
etc. can be found under heading 03 \"Agriculture\" and heading 15
\"Environment, Consumers and Health Protection\". An alphabetical index
using keywords is also available. On this site you can find the initial
legislation and all the amendments as published in the Official Journal.

**Consolidated texts**
([http://europa.eu.int/eur‑lex/en/consleg/index1.html](http://europa.eu.int/eur%1Elex/en/consleg/index1.html)[)]{.underline}

\"Consolidated\" means that the texts of all the amendments have been
incorporated into the text of the basic act. The consolidated texts are
for information purposes only and therefore not legally binding. Under
\"analytical structure\" you will find the same 20 thematic chapters. A
chronological index arranged by year of adoption is also available.
Please note that not all EU legislation is available through this
service.

# APPENDIX III. EU INITIATIVES

This report gives an overview of EU food laws currently in force.
However, below follows a list of EU proposals / initiatives that may
possibly affect U.S. food exports to the EU:

\- Additives

\- Alcoholic beverages

\- Enzymes

\- Flavorings

\- Food contact materials

\- Food hygiene

\- Foods for sport people

\- Foods for diabetics

\- Fortified foods

\- Frozen foodstuffs

\- Irradiation

\- Novel foods

\- Nutrition, functional and health claims

\- Organic food

\- Pesticide residues

\- Sweeteners

\- Zoonoses

\- Consumer Protection (the unfair commercial practices directive)

Please check our website ([www.useu.be/agri/usda.html)]{.underline} for
updates on legislative developments. You can also subscribe to our
bi-weekly e-newsletter "What's new on the USEU Agric Website" by sending
an e-mail to <Hilde.Brans@usda.gov>.

**Visit our website:** our website
**[www.useu.be/agri/usda.html]{.underline}** provides a broad range of
useful information on EU import rules and food laws and allows easy
access to USEU reports, trade information and other practical
information. FAIRS reports covering the EU AND the individual member
states can be found at
[www.useu.be/agri/fairs.html](http://www.useu.be/agri/fairs.html).
E-mail: AgUSEUBrussels@usda.gov

**Related reports from USEU Brussels:**

  ------------------------------------------------------------ ------------------------------------------- -------------
  **Report Number**                                            **Title**                                   **Date
                                                                                                           Released**

  E34035                                                       European Standards Set Tone in Food Safety  7/16/04
                                                               Area                                        

  E34027                                                       Addition of new border inspection posts     6/17/04

  E34025                                                       European Action Plan for Organic Food &     6/21/04
                                                               Farming                                     

  E34023                                                       Food and Feed Controls                      6/18/04

  E34015                                                       General Requirements for Veterinary         5/24/04
                                                               Certificates                                

  E34013                                                       Labeling and Presentation of Fresh Fruits   5/14/04
                                                               and Vegetables                              

  E34012                                                       New EU-25 Veterinary Certificates for       5/14/04
                                                               Transshipments                              

  E34009                                                       Update on EU's Biotech Approval Process     5/6/04

  E34003                                                       New Border Inspection Posts in Accession    4/27/04
                                                               Countries                                   

  E24064                                                       Stricter Organic Labeling Rules             4/6/04

  E24058                                                       Approval of Border Inspection Posts in      3/25/04
                                                               Accession Countries                         

  E24043                                                       EU Wine Labeling -- Amended Rules           3/2/04

  E24031                                                       EU Health and Consumer Protection Work Plan 2/17/04

  E23189                                                       EU Food & Drink Industry in Figures         10/8/03

  E23186                                                       New Allergen Labeling                       9/30/03

  These reports can be accessed through our website                                                        
  [www.useu.be/agri](http://www.useu.be/agri) or through the                                               
  FAS website                                                                                              
  <http://www.fas.usda.gov/scriptsw/attacherep/default.asp>.                                               
  ------------------------------------------------------------ ------------------------------------------- -------------