Required Report - public distribution

**Date:** 12/8/2005

**GAIN Report Number:** GM5030

GM5030

**Germany**

**Food and Agricultural Import Regulations and Standards**

**Annual**

**2005**

**Approved by:**

![](media/image1.wmf)Richard Petges

U.S. Embassy

**Prepared by:**

Dietmar Achilles

**Report Highlights:**

Mainly editorial changes to the FAIRS 2004 report in the appendix to the
report

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Berlin \[GM1\]

\[GM\]

Table of Contents

[Disclaimer 3](#disclaimer)

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

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

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

[B. Health / Medical Claims 6](#b.-health-medical-claims)

[Health Claims 6](#health-claims)

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

[A. Consumer Packaging Ordinance and Law on Weights and Measures
7](#a.-consumer-packaging-ordinance-and-law-on-weights-and-measures)

[B. Materials in Contact with Foodstuffs
8](#b.-materials-in-contact-with-foodstuffs)

[C. Packaging Disposal Regulations
9](#c.-packaging-disposal-regulations)

[Section IV. Food Additives Regulation
9](#section-iv.-food-additives-regulation)

[Section V. Pesticides and other Contaminants
11](#section-v.-pesticides-and-other-contaminants)

[Sections VI. Other Regulations and Requirements
11](#sections-vi.-other-regulations-and-requirements)

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

[B. Certification and Documentation Requirements - AGRIM Certificates
12](#b.-certification-and-documentation-requirements---agrim-certificates)

[Health Certificates 12](#health-certificates)

[Animal Products www.useu.be/agri/certification.html
12](#animal-products-www.useu.beagricertification.html)

[Processed Foods www.useu.be/agri/foodcertif.html
13](#processed-foods-www.useu.beagrifoodcertif.html)

[Sections VII. Other Specific Standards
13](#sections-vii.-other-specific-standards)

[A. Genetically Modified Foods and Feeds
13](#a.-genetically-modified-foods-and-feeds)

[B. Novel Foods 14](#b.-novel-foods)

[C. Functional Foods -- Food Supplements
14](#c.-functional-foods-food-supplements)

[D. Animal Products 14](#d.-animal-products)

[E. Seafood Products 16](#e.-seafood-products)

[F. Fruits and Vegetables 16](#f.-fruits-and-vegetables)

[G. Frozen Foodstuffs 16](#g.-frozen-foodstuffs)

[H. Irradiation of Foodstuffs for Sterilization
17](#h.-irradiation-of-foodstuffs-for-sterilization)

[I. Organic Foods 17](#i.-organic-foods)

[APPENDIX A. List of Major Regulatory Agencies
17](#appendix-a.-list-of-major-regulatory-agencies)

[APPENDIX B. List of German Food Laboratories
18](#appendix-b.-list-of-german-food-laboratories)

[APPENDIX C. World Trade Organization (WTO) Inquiry Post
20](#appendix-c.-world-trade-organization-wto-inquiry-post)

# Disclaimer

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

# Section I. Food Laws

Germany as a member of the European Union (EU) follows all EU
directives, regulations and obligations. It is therefore recommended
that this report is read in conjunction with the Food and Agricultural
Import Regulations and Standards (FAIRS) report produced by the US
Mission to the EU in Brussels, Belgium, available at
[www.useu.be/agri/usda.html]{.underline} as well as at
[www.fas.usda.gov/scriptsw/attacherep/default.asp.]{.underline}

The vast majority of food laws of the EU member countries have already
been fully harmonized into EU law. Areas such as vitamins, minerals and
other physiological substances as well as health claims are still
awaiting EU harmonization. The European Commission is in the process of
developing binding EU regulations, which are expected to be finalized by
the end of 2006. Maximum tolerance levels for pesticide residues in
foods and feeds are also not yet fully harmonized. For a number of
substances Germany applies national tolerance levels, see
[www.verbraucherministerium.de/verbraucher/verbraucherinfos.htm.]{.underline}

Maximum tolerances set for mycotoxins in grains, grain products and
coffee have been EU harmonized and will go into effect by July 2006.
National German maximum levels for DON, ZEA, fumosins and ochratoxin
will be replaced by the new EU levels. .

Based on the EU single market principle, all food products legally
imported and distributed in one member country of the EU can generally
also be distributed in all other member countries, except in those cases
when a country can prove health concerns about the product or an
ingredient of a product intended for import. However, a separate
application for approval of imports is still necessary for all those
products containing substances not yet harmonized (Art. 47a LMBG - Basic
German Food Law).

The German Food Law, hereafter referred to as the Food Law, consists of
about 230 different ordinances, including the Food Labeling Ordinance,
Packaging Ordinance, Dietetic Foods Ordinance, various hygienic and
veterinary requirements, as well as numerous other special product or
product group rules and regulations. The provisions on the Food Law are
voluminous, frequently quite complicated and often subject to
interpretation. Ultimately the German importer has final responsibility
for the marketability of any imported products into Germany. The German
law enforcement agencies hold the German importer solely responsible for
any violations of the Food Law since they cannot take action against
foreign products including those in other EU countries. Violations of
the Food Law by the importer constitute a punishable offence.

Basic regulations of the German food law are laid down in 61 articles of
the Lebensmittel- und Bedarfsgegenstaendegesetz (LMBG), last amended
September 1997. The act defines general food safety and health
protection rules, addresses labeling requirements, regulates inspection,
detention and seizure rules of suspect food. These rules apply to
domestically produced as well as to imported food products.

The German Food Law is a federal law whose enforcement is the
responsibility of the federal states (German Laender). This implies that
on occasion, a minor infraction to the food law may be tolerated in one
state but not in another. However, major violations are persecuted in
all federal states. Domestic and foreign goods are equally being checked
by random sampling methods by government laboratories at the point of
sale or any other point in the trade chain or at the processing
location. German government laboratories, in addition to looking for
prohibited ingredients or proper labeling, evaluate the general nature
of a product in terms of honest trading practices and general consumer
expectations. Whenever, a product violates the Food Law and presents a
**risk to public health**, regardless of whether it is a domestic or
foreign product, this becomes known to the press, which will mention the
brand name, importer or producer when informing the consumer. A general
administration commandment regarding food safety requires German food
safety authorities to take five samples per thousand inhabitants
annually. This includes samples at any location of the production and
trade chain.

In 2003, the German government reformed and reorganized its consumer
protection and food safety supervising systems. Prior to that, in 2001,
the former Federal Ministry Food, Agriculture and Forestry had already
been reorganized and gained responsibility for consumer protection
issues and is now named Federal Ministry of Consumer Protection, Food
and Agriculture. Responsible for monitoring compliance with German food
law regulations under the supervision of the Federal Ministry of
Consumer Protection, Food and Agriculture is

Bundesamt fuer Verbraucherschutz und Lebensmittelsicherheit (BVL)

(Federal Office of Consumer Protection and Food Safety)

Rochusstrasse 65

53123 Bonn, Germany

Tel.: +49 228 6198 0

Fax: +49 228 6198 120

E-mail: [poststelle@bvl.bund.de]{.underline}

Homepage: [www.bvl.bund.de]{.underline}

The BVL has been established as an independent higher federal authority
and also meets tasks of risk management. BVL, inter alia, exercises
authority over substances and products that harbor potential risks and
that are directly or indirectly related to food safety (plant protection
products and veterinary drugs).

It is involved in formulating general administrative rules to implement
laws in the fields of consumer health protection and food safety, as
well as in the preparation and monitoring of surveillance schemes and
plans by the Laender. In addition, BVL acts as coordinator in the run-up
to inspections carried out by the European Food and Veterinary Office
(FVO) in Grange, Great Britain, and accompanies these inspections. It is
responsible for implementing the European rapid alert system in the
fields of consumer health protection and food safety in Germany. The
national reference laboratory for the detection of residues and the
Community reference laboratory for the detection of residues are also
part of BVL.

Product registration is not required for foods in Germany. An official
agency, which could answer questions on the interpretation of Germany's
extensive food law requirements for label registration, review, product
clearance and approval, does not exist in Germany. In some instances,
German inspection agencies at the point of entry may require the
importer to arrange for further inspection of an imported product to
satisfy the importers' legal duty to exercise due care and diligence. To
protect the consumer, the importer may be required to engage a private
food chemist to determine if the importers' product is free of illegal
substances and residues and labeled properly. German importers
frequently use the assistance of officially certified commercial food
chemists. Fees for these services vary greatly, depending on the
expertise and work required. (For a list of food laboratories see
Appendix B - German Laboratories.)

## Section II. Labeling Requirements

## 

## A. General Requirements

All imported food products must comply with the German Food Law. If any
indication required under the German Labeling Regulation is missing,
goods can be prevented from being sold. All foods must be labeled in
German. Multi-language labels are allowed. Labeling can also include
illustrations. It is forbidden to show ingredients on the label that are
not contained in the product, e.g. illustrations of fruits if only
artificial flavors are used or a multi-fruit juice may only show
pictures of those fruits contained in the product. There are numerous
other special labeling requirements pertaining to specific foods or food
groups. Since many other requirements are applicable, such as the actual
size of letters and placing of the various elements on the label and
picture shown, U.S. food manufacturers and exporters are urged to
contact their potential German importer before making changes in labels
on products labeled for distribution in Germany.

Some importers may agree to adhering computer generated, **adhesive
labels** in Germany for smaller quantities during a test-marketing
phase.

All food and beverage products imported into Germany for retail sale
must be labeled in German and provide the following information as laid
down in the Lebensmittel-Kennzeichnungs-Verordnung (LMKV - Food Labeling
Ordinance of Dec. 1999):

-   **Name of the product as commonly used in the trade**

> This may be the name prescribed by law or a name customary in the area
> where the food is sold or a precise name to be distinguished from
> products with which it could be confused. The name may be a name or a
> description. Trade, brand or fantasy names are permitted but may not
> be substituted for the name of the food.
>
> The product name, the statement of quantity and the indication of
> minimum shelf life (or a reference to it) must all appear in the same
> field of vision.

-   **List of ingredients** **and food additives**

> The list of ingredients should start with the word 'Zutaten'.
> Ingredients should be listed in descending order of weight as used at
> the time of preparation. Ingredients used in concentrated or
> dehydrated form and which reconstitute during preparation of the food
> may be listed as if reconstituted.
>
> Certain ingredients may be designated by the name of their category
> group rather than the specific name. These include refined vegetable
> oils excluding olive oil, refined fats, flour blends, starch, fish,
> cheese, spices, herbs, gum bases, crumbs, sugar, dextrose, glucose
> sirup, milk protein, cocoa butter, crystalized fruit, vegetables and
> wine.
>
> The sequence listing for coloring agents is free.

-   **Quantitative ingredient declaration (QUID)**

> If in a label, special emphasis is placed on the presence of an
> ingredient, the minimum amount as a % must be declared either next to
> the name of the food or near the name of the ingredient in the
> ingredient list

-   **Alcohol content**

> Alcoholic beverages containing more than 1.2% alcohol measured at 20
> degree Celsius, need to be shown as 'Alkohol (or alc.) \...% vol'

-   **Uncoded minimum shelf-life date** (interpreted as the date until
    which the product maintains its maximum level of quality under
    proper storage conditions). The words to be used are 'Mindestens
    haltbar bis \...' Determination of the minimum shelf-life lies
    entirely in the hands of the manufacturer or importer.

```{=html}
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```
-   Declaration of minimum shelf-life is not necessary for fresh fruits
    and vegetables, alcoholic beverages of more than alc. 10%, portioned
    ice cream, table salt, crystal sugar, flavored and/or colored sugar
    candies, chewing gum, wine-like beverages.

-   If the product for microbiological reasons may cause a health threat
    after a certain storage period, it has to carry an uncoded latest
    consumption date using the words 'verbrauchen bis \...'

-   **Storage Conditions**

> Any special storage conditions or conditions of use should be stated.
> Instructions for use should be given as necessary.

-   **Metric units for all measurements**

> Net quantity of prepackaged foodstuffs expressed in metric units
> (liter, centiliter, milliliter, kilogram or gram)

-   **Name and address of manufacturer, packer or importer in
    Germany/EU**

-   **Coded lot identification**

A coded lot identification is needed for all products which do not show
a minimum shelf-life containing day and month identification. The
marking shall be preceded by the letter 'L' except in cases where it is
clearly distinguishable from other indications on the label.

-   **Bar codes**

> Germany uses the European Article Number (EAN) also refered to as
> International Article Number (IAN) system with 13 digits while the
> U.S. uses Universal Product Codes (UPC) with 12 digits. U.S. bar codes
> will work perfectly in Germany and other EU countries.

## B. Health / Medical Claims

# 

# Health Claims

Medical claims or images attributing to a foodstuff the property of
preventing, treating or curing human diseases are explicitly prohibited
in the German/EU labeling directive. This rule does not apply to
dietetic foods.

**Dietetic Foods Ordinance:**

The German Dietetic Food Law defines the properties foods must have in
order for the manufacturer to label them as dietetic. It requires that
foods and beverages labeled as dietetic must differ substantially from
other regular foods. A simple listing of the nutrient content, bread
units, and/or caloric value on the label is not sufficient to allow the
use of the term "dietetic." Health-related statements are strictly
limited. Examples for such statements are:

> Diaetetisches Lebensmittel geeignet zur Behandlung von \...
>
> (Dietetic food suited to cure \...)
>
> Diaetetisches Lebensmittel geeignet zur Behandlung von \... nur unter
> staendiger aerztlicher Kontrolle verwenden.
>
> (Dietetic food suited to cure \... only use if under continuous
> medical supervision)
>
> zur besonderen Ernaehrung bei \... im Rahmen eines Diaetplanes
>
> (special diet for \... if part of a diet plan)

It is strongly recommended that U.S. exporters consult with a German
food laboratory before making any dietary claims for products to be
marketed in Germany.

**Nutritional Value Labeling Ordinance:**

Nutritional value labeling is not mandatory in Germany and other EU
countries unless a nutrition claim is made on the label or in
advertising messages. The EU Nutritional Value Labeling Directive
90/496/EEC establishes rules for the separate labeling of the caloric
and nutritional values of foods. Though not mandatory for all foods, it
establishes certain conditions, which must be fulfilled if the industry
wishes to provide information that either emphasize a particularly low
caloric content or a particularly high nutritional value of a certain
food.

Where nutritional labeling is provided, the information to be given
should consist of either of the following orders:

-   the energy value, plus the amount of protein, carbohydrates and fat
    or

-   the energy value, plus the amount of protein, carbohydrates, sugar,
    fat, saturates, fibre and sodium.

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

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.

## 

# Section III. Packaging and Container Regulations

## 

## A. Consumer Packaging Ordinance and Law on Weights and Measures

The German Law on Weights and Measures provided the legislative basis
for the *Consumer Packaging Ordinance (CPO).* It contains certain
provisions establishing standard sizes for containers of pre-packaged
foods, as well as numerous labeling and gauging requirements for
consumer-ready containers. The quantity of fill must be indicated when
marketed.

  ----------------- -----------------------------------------------------
  By weight:        In grams or kilograms.

  By volume:        In milliliters, centiliters or liters.

  By length:        In centimeters or meters.

  By area:          In square centimeters or square meters.
  ----------------- -----------------------------------------------------

For solid food packed in "liquid," the drained weight must be shown in
addition to the total quantity of fill. The CPO provided for minimum
heights of numbers is used on the label designating the quantity of
fill. The Container Ordinance lays down specific container sizes (either
mandatory or recommended) for individual products. As the main purpose
of packaging material is to protect the contained product, the size of
packaging must not be misleading to the consumer and must not lead to
the expectation of a higher than actual fill.

Mandatory container sizes are established for following product groups

> Wine, incl. Fruit wine
>
> Beer
>
> Liqueur
>
> Milk
>
> Water
>
> Lemonade
>
> Fruit juice
>
> Sugar
>
> Chocolate
>
> Cocoa

In addition to the EU mandatory container sizes, Germany permits
additional national container sizes for the different product groups.

Underfilling tolerances are strictly regulated.

  ------------------------- ----------------------- ---------------------
  Container Size in g or ml Permitted Negative      
                            Tolerance               

                            in % of Quantity        in g or ml

  5 to 50                   9                       \-

  50 to 100                 \-                      4.5

  100 to 200                4.5                     \-

  200 to 300                \-                      9

  300 to 500                3                       \-

  500 to 1000               \-                      15

  1000 to 10000             1.5                     \-
  ------------------------- ----------------------- ---------------------

An over-filling or under-labeling of the actual container fill is not
generally prohibited. However, based on the regulations of the German
competition law a regular over-filling which is not technically
necessary may be judged as misleading and challenged by competitor
companies.

## 

## B. Materials in Contact with Foodstuffs

Regulations for materials in contact with food have been EU-harmonized,
see [www.useu.be/agri/packaging.html]{.underline} . EU directives have
been transferred into German law and are laid down in the
'Bedarfsgegenstaendeverordnung'. Materials in contact with foodstuffs
have to bear an indication 'fuer Lebensmittel' which can be replaced by
a specific symbol designated in Council Directive 80/590/EEC.

## C. Packaging Disposal Regulations

Germany is widely regarded as being in the forefront of European
environmental legislation, including that on packaging. There has been
longstanding public concern over the excessive use of packaging material
in Germany.

**The German Packaging and Waste Avoidance Law**

With the tremendous growth of waste and disposal problems, Germany has
established legislation to keep packaging separate from the municipal
waste stream and shift the responsibility for waste disposal over to the
retailers and distributors by forcing them to take back used packaging
materials and to handle disposal or recycling or institute a nation-wide
system to collect and recycle packaging waste. The "Duales System
Deutschland" (DSD) was established by the German industry to certify
product packaging materials which could be recycled, reused or otherwise
legally disposed of independent of the existing public waste disposal
system. Participating companies receive guaranteed pick up, on a regular
basis, of their materials against a license fee. DSD set up a
nation-wide collection system for packaging materials carrying the "Der
Gruene Punkt"-symbol. Under this law German consumers collect packaging
material other than paper and glass in a separate container system to be
picked up on a regular schedule by contract companies of the DSD. Paper
and glass are collected in public containers located at designed
locations spread all over the metropolitan areas.

**Green Dot System**

Because the German Packaging and Waste Avoidance Law established
specific rules for packaging material the "Green Dot" (Der Gruene Punkt)
system was developed. The "Green Dot" is a recycling symbol which is
found on the packaging material of virtually all products retailed in
Germany. While packaging material for products retailed in Germany is
not legally required to carry the "Green Dot," it is almost impossible
to market a product in Germany without it. Typically, [the producer or
the importer]{.underline} pays a licence fee to use the Green Dot,
dependent on the type and amount of packaging, and provides the exporter
with the information necessary.

For further information on the Green Dot packaging material disposal and
recycling program you may wish to make direct contact with your
potential German importer and/or with the following company:

Duales System Deutschland GmbH (DSD)

Frankfurter Strasse 720-726 Tel: (49-2203) 937-0

> D-51145 Koeln, Germany Fax: (49-2203) 937-190 or 495

Internet: [www.gruener-punkt.de]{.underline}

**Mandatory Refund for One-way Beverage Packages**

As of Jan 2003, a mandatory refund system was put in place for one-way
beverage packages. The refund is collected at the retail level and
applies to domestically produced or filled products as well as to
imported drinks. Excluded from this refund system are primarily
multi-layer carton packages since they are regarded to be the least
environmentally disturbing. Wine, spirits and milk are also excluded
from the refund system.

## 

## 

# Section IV. Food Additives Regulation

Food additives already have been fully harmonized within the EU, see
[www.useu.be/agri/additive.html]{.underline}. German and EU food law
prohibits all food additives or other substances, which are not
specifically approved for use. With the exception of a smaller number of
additives, which are approved for general use, most food additives are
only approved for specific purposes and foods.

The German definition of "food additive" is fairly broad. "Technical aid
substances" are substances required only during the processing of a food
product and tolerated if either totally removed or technically
unavoidable during the processing. Labeling of technical aid substances
is not required. The use of food additives, food coloring substances,
artificial sweeteners and preservatives is regulated by the Food
Additives Ordinance. Only certain food additives are approved for use
with foods, and only under conditions specified in this ordinance. Food
additives must appear clearly visible on the label, written in easily
legible print (minimum character height of 2mm) and in combination with
the product name or identification.

**Vitamin - Enriched Foods**

The use of vitamins is still awaiting EU harmonization. The German Bill
on Food Vitaminization establishes rules for the use of vitamins in
foods. Vitamin-enriched foods must be clearly labeled in the list of
ingredients or immediately next to the trade name of the product. The
label must indicate the type of vitamin and the quantity based on 100
grams of food. The following vitamins may be freely added to any type of
food and must be shown in the list of ingredients, but need not be shown
as food additives.

> 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 and
>
> Vitamin-A-palmitate;
>
> Ergocalciferol,
>
> Cholecalciferol,
>
> Cholecalciferol-cholesteric.

Since vitamins are not yet harmonized importation of modern food
supplements such as vitamin concentrations may require a special import
permit for Germany if the product is already legally marketed in another
EU-country. As a rule of thumb, German authorities only tolerate a
vitamin concentration of three times of the daily recommended allowance
(RDA). However, upon specific request higher vitamin concentrations may
be tolerated if a risk assessment approves this approach.

# Section V. Pesticides and other Contaminants

To date, only about 30 percent of the tolerance levels for pesticide
residues have been harmonized within the EU. The German Pesticide
Residue Bill establishes maximum tolerances for a large number of
pesticides in foods derived from both animals and plants. It also
includes tolerances for a considerable number of pesticides which are
not approved for use in Germany, and thus allows the importation of
certain foods and food products which have been treated with certain
pesticides approved for use in the country of origin, as long as such
foods meet the established German maximum tolerances.

A list of the most recent approved maximum residue levels is available
on the homepage of the German Federal Ministry of Consumer Protection,

www.verbraucherministerium.de/verbraucher/verbraucherinfos.htm

click on Verbraucherschutz\'

click on Lebensmittelsicherheit\'

Rueckstands‑Hoechstmengenverordnung\'

For application of an import tolerance for a not yet regulated substance
contact the

Federal Ministry of Consumer Protection, Food and Agriculture

Referat 313 - Rueckstaende u. Kontaminanten in Lebensmitteln

Rochusstr. 1

53123 Bonn, Germany

Tel.: +49 228 529 3677

Fax: +49 228 529 4262

Internet: [www.verbraucherministerium.de]{.underline}

# Sections VI. 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 (see also Section 1 -- Food Law).

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.
Details about the conformity checks are laid down in EU regulation
1148/2001. These have been established 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, for miniature produce, walnuts
and hazelnuts. Marketing standards can be downloaded from
[www.useu.be/agri/Fruit-Veg.html]{.underline}

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). 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)
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) 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 licences (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 licence, an application form must be
submitted and security fee must be paid to the issuing Member State.
Licences vary in validity with most expiring three months after the
month of issuance. The licence is applied for by the importer.

### Health Certificates 

**Plant Products** [www.useu.be/agri/plantcertif.html]{.underline}

Phytosanitary certificates issued by APHIS have to accompany plant,
fruit, vegetables and nut shipments to the EU.

### Animal Products **[www.useu.be/agri/certification.html]{.underline}**

The European Community is 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.

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. 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. At present, the following products must come from an
EU-approved establishment:

  ----------------------- ----------------------- -----------------------
  red meat                Ratites                 equine semen

  meat products           bovine embryos          animal casings

  farmed game meat        bovine semen            fish and fishery
                                                  products

  wild game meat          porcine semen           milk & milk products

  Gelatin                                         
  ----------------------- ----------------------- -----------------------

Lists can be accessed through [www.useu.be/agri/estab.html]{.underline}

The third level is the requirement that all shipments be accompanied by
animal health and/or public health certificates signed by U.S. officials
to guarantee that individual lots or shipments of products meet
Community requirements.

For other 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
15 Member States maintaining different sets of lists of third countries,
lists of establishments, certificate requirements, and inspection
programs.

Contact information for the agencies issuing export certificates is
available from our website.

### Processed Foods **[www.useu.be/agri/foodcertif.html]{.underline}**

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 egg
products/dairy products, the Commission believes they should be
considered as such. More details are available from the above shown
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 to determine which
documentation is required.

# Sections VII. Other Specific Standards

## A. Genetically Modified Foods and Feeds

German/EU politicians claim that German/EU consumers oppose foods
derived from genetically modified plants. Whether or not such a
statement is true cannot be verified since there are very few
genetically modified labeled products on the market. From 1998 until May
2004, a de facto moratorium for further approvals of GMO events had been
in place in the EU, restricting the importation of bulk corn and other
GMO products. In April 2004, the new EU legislation for labeling GMO
derived food and feed products, and for implementing a tracing system
identifying what kind of GMO events have been used in the production of
the food/feed product, became effective. Under the EU labeling
regulations, processed products produced from GMO crops, such as soybean
oil, must have a GMO label even though no GMOs are present in the final
processed product. The new regulations require that an adventitious
presence of more than 0.9 percent GMO in one single ingredient has to be
labeled on the final product, see also
[www.useu.be/agri/GMOs.html]{.underline}

The relevant authority for the approval of new GMO events and for
monitoring the trade of products derived from GMOs is the Federal
Ministry of Consumer Protection, Food and Agriculture, see Section I

## B. Novel Foods

Novel foods and feeds are not only products derived from GMOs. This term
also applies to food and feed products actually new to the EU. These can
be exotic fruits and juices which have not to a significant extent been
marketed in Europe. The EU novel food regulation requires an evaluation
process for these novelties including a risk assessment process. Just
recently, noni-juice, a DHA rich oil extracted from the algae
schizochytrium sp., isomaltolose and several phytosterines received EU
approval.

## C. Functional Foods -- Food Supplements

The problem of functional foods in many cases is its definition and
demarcation from pharmaceutical products, which require special product
approval, foods don't. A recent German Federal Court ruling determines
that products may be classified as foods if a pharmaceutical effect is
not evident to the consumer and consumers do not expect pharmaceutical
effects if they consume the product according to the producers dosage
advice. In particular, the improvement of physical fitness and
muscle-building with the assistance of foods and/or food supplements is
increasingly regarded as a positive effect of food intake.

## D. Animal Products

Meat and poultry (including game and fowl) products can only be imported
from U.S. plants approved by the European Union (EU). All meat products
(beef, pork, veal, lamb, etc.) in any form (including canned, frozen,
soups, stews, etc.) must also be accompanied by the following
certificates issued at the slaughtering or processing plant by a U.S.
Department of Agriculture meat and poultry inspector.

+----------------------+-----------------------------------------------+
| FSIS Form 9060-5     | Meat and Poultry Export Certificate of        |
|                      | Wholesomeness                                 |
+----------------------+-----------------------------------------------+
| MP 150               | Animal Health Certificate                     |
+----------------------+-----------------------------------------------+
| MP 157               | Public Health Certificate                     |
+----------------------+-----------------------------------------------+
| MP 410-10            | Beef and Other Meats                          |
+----------------------+-----------------------------------------------+
| MP 410-11            | For Processed Meats Only                      |
+----------------------+-----------------------------------------------+
| MP 410-12            | For Pork Products Only                        |
+----------------------+-----------------------------------------------+
| MP 410-13            | Domestic Ruminants                            |
|                      |                                               |
|                      | \*Hormone-Free Certification                  |
+----------------------+-----------------------------------------------+

All poultry products (chicken, turkey, duck, quail, etc.) must be
accompanied by the following products:

  ----------------------- -----------------------------------------------
  FSIS Form 9060-5        Meat and Poultry Export Certificate of
                          Wholesomeness

  MP 70                   Sanitary Certificate

  MP 58                   Fresh Poultry

  MP 59                   Processed Poultry Products
  ----------------------- -----------------------------------------------

**Beef labeling**

In the EU, 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. Under this scheme, labels for all bovine
meat must indicate the following information:

-   \"geboren in: name of third country\" - born in

-   \"gemaestet in: name of third country or third countries\" - reared
    in.

-   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

-   \"geschlachtet in: third country / approval number of
    slaughterhouse\"

-   \"zerlegt 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.

In addition to the compulsory labeling program, the German food industry
initiated a 'Quality and Safety' program (QS) which shall assure the
consumer that the production of such labeled products is fully
controlled and recorded based on legal requirements and additional
industry-determined production process criteria. The quality and safety
program is certified by an approved certification organization. The
objective of the QS system is to render foodstuff production processes
transparent to consumers from the field and stable to the sales counter,
thus increasing consumer confidence in the production, processing and
marketing of foodstuffs. The system is open for domestic and imported
products.

QS Qualitaet und Sicherheit

Margarethenstr 1

53175 Bonn (Friesdorf)

Phone +49 228 350680

Fax +49 228 3506 810

Dr. Hermann-Josef Nienhoff

[nienhoff@q-s.de]{.underline}

[www.q-s.info]{.underline}

**Meat and Poultry - Import Derogation for Product Samples:**

Sample shipments of food products containing meat, poultry or cheese
from plants not approved for export to the EU require a derogation
(special import permit) from the (state) veterinary authority at the
first port of entry into the European Union. For shipments to Germany,
this is often Frankfurt airport. Frankfurt airport is located in the
State of Hesse; consequently, the veterinary office in Wiesbaden, the
capital of Hesse, is responsible for issuing the import permit:

Hessisches Ministerium fuer Umwelt, laendlichen Raum und
Verbraucherschutz

(Ministry of Environment, Rural Regions and Consumer Protection of the
State of

> Hesse)

Hoelderlinstr. 1-3

65187 Wiesbaden, Germany

Tel.: +49 611 817 3723

Fax: +49 611 44789 770

E-Mail: veteinfuhr@hmulv.hessen.de

The request for derogation can be made informally by letter, fax, or
email stating the quantity, origin, and composition (e.g. raw or cooked
meat) of the product as well as the intended purpose (machinery testing,
trade show display, product competition, etc.) and place of destination.
Based on this information the veterinary office will issue the import
permit, specifying the veterinary certificates they require in that
particular case.

The import permit is in German and the veterinary office charges a small
fee. Because of language, time difference, and distance (the permit will
be sent by commercial mail), it is recommended that the German recipient
of the product handle the application for the import permit, wherever
feasible. If the point of entry is different from Frankfurt, please
contact AgBerlin for information on the applicable veterinary office.

## E. Seafood Products

Seafood products can only be imported from U.S. firms approved by the
Food and Drug Administration. All seafood must be accompanied by
certificates issued by the U.S. Food and Drug Administration, Division
of Seafood district office or the National Marine Fisheries Service,
U.S. Department of Commerce district office. For information on
certification requirements for *seafood products to the EU* contact the
FDA Office of Seafood Programs on Tel: (202)418-3150; Fax:
(202)418-3196. The address is 200 C Street SW, Washington, DC 20204.

On retail level fishery products have to be labeled with origin
indication and production method:

> \"gefangen in \...\" (caught in \... catch region) or
>
> \"aus Binnenfischerei in \...\" (caught in freshwater in \... country)
> or
>
> \"aus Aquakultur in \... \" (farmed in \... country) or
>
> \"gezuechtet in \... \" (cultivated in \... country).

## F. Fruits and Vegetables

Fresh fruits and vegetables and unprocessed/raw nuts must be accompanied
by a U.S. Department of Agriculture phytosanitary certificate or PPQ577.
The certificate is issued upon inspection of the commodity being
exported to determine that it is free of insects, plant diseases, and
other organisms considered harmful by the receiving country. The
phytosanitary certificate must be issued by an official USDA Animal,
Plant Health Inspection Service (APHIS) inspector. To arrange for an
inspection you must make a written application to your nearest APHIS
office. For more information on the phytosanitary certificate contact
USDA/APHIS PPQ (Plant Protection and Quarantine), 4700 River Road, Unit
140, Riverdale, MD 20737, Tel: (301) 734-8537, Fax: (301) 734-5786.

## G. Frozen Foodstuffs

Fresh fruits and vegetables and unprocessed/raw nuts must be accompanied
by a U.S. Department of Agriculture phytosanitary certificate or PPQ577.
The certificate is issued upon inspection of the commodity being
exported to determine that it is free of insects, plant diseases, and
other organisms considered harmful by the receiving country. The
phytosanitary certificate must be issued by an official USDA Animal,
Plant Health Inspection Service (APHIS) inspector. To arrange for an
inspection you must make a written application to your nearest APHIS
office. For more information on the phytosanitary certificate contact
USDA/APHIS PPQ (Plant Protection and Quarantine), 4700 River Road, Unit
140, Riverdale, MD 20737, Tel: (301) 734-8537, Fax: (301) 734-5786.

## H. Irradiation of Foodstuffs for Sterilization

Harmonization of EU rules on food irradiation has been slow and only a
few products have so far received EU-wide approval, see
[www.useu.be/agri/irradiation.html]{.underline} . In Germany, treatment
with ionizing rays is only permitted for dried aromatic herbs and spices
and for monitoring purposes. Ultraviolet rays may be used to sterilize
drinking water, fruit surfaces and hard cheese during storage. Treated
products have to be labeled as 'bestrahlt' or 'mit ionisierenden
Strahlen behandelt'.

Treated herbs and spices or products containing treated herbs and spices
imported from a non-EU country have to be accompanied by a certificate
providing the name and address of the treatment installation, type of
treatment, company name ordering the treatment, recipient of the treated
products, date of treatment, type of packing material during treatment,
parameters describing the supervision of the treatment process and
validated test results.

## I. Organic Foods

Foodstuffs which shall be marketed as organic products have to meet
requirements laid down in EU Council Directive 2092/91 amended by
Regulation 1804/99 to include livestock products. Responsible for the
implementation of these regulations are the EU member countries, see
also [www.useu/be/agri/organic.html]{.underline} . Applications for
import authorizations of organic products into Germany should be
directed to

> Bundesanstalt fuer Landwirtschaft und Ernaehrung (BLE)
>
> Deichmannsaue 29
>
> 53179 Bonn, Germany
>
> Tel.: +49 228 6845 3332
>
> Fax: +49 228 6845 3787
>
> Internet: [www.ble.de]{.underline}
>
> Contact: Klaus Budde

Mail: <klaus.budde@ble.de>

# APPENDIX A. List of Major Regulatory Agencies

**Bundesministerium fuer Verbraucherschutz, Ernaehrung und**

**Landwirtschaft, BMVEL**

[(Federal Ministry of Consumer Protection, Food and
Agriculture]{.underline}

Rochusstr. 1

53123 Bonn, Germany

Tel: (49-228) 529-0

Fax: (49-228) 529-4262

Homepage: [http://www.verbraucherministerium.de]{.underline}

**Bundesamt fuer Verbraucherschutz und Lebensmittelsicherheit, BVL**

[(Federal Office of Consumer Protection and Food Safety)]{.underline}

Rochusstr. 65

53123 Bonn, Germany

Tel: (49-228) 6198 0

Fax: (49-228) 6198 120

E-mail: [poststelle@bvl.bund.de]{.underline}

Homepage: [http://www.bvl.bund.de](http://www.bvl.bund.de/)

The biotech division and the novel foods/feeds division of BVL are
responsible for registration and approval of GMOs and novel foods.

**Biologische Bundesanstalt fuer Land- und Forstwirtschaft, BBA**

[(Federal Biological Research Institute - approval of plant protection
chemicals)]{.underline}

Messeweg 11/12

38104 Braunschweig, Germany

Tel: (49-531) 2995

Fax: (49-531) 299-3000

E-mail: [Pressestelle@bba.de]{.underline}

Homepage: [http://www.bba.de]{.underline}

The plant chemicals approval and maximum residue limits (mrl) setting
division has been assigned to the BVL but still can be reached under the
BBA address.

# APPENDIX B. List of German Food Laboratories

**Bundesverband der Lebensmittelkontrolleure Deutschlands (BVLK)**

(Federal Association of Food Chemists in Germany)

Herderstr. 1a

38350 Helmstedt, Germany

Tel.: (49-5351) 595301

Fax: (49-5351) 595302

E-mail: [lebensmittelkontrolleure@t-online.de]{.underline}

Homepage: [http://www.lebensmittelkontrolle.de]{.underline}

**Analytec Labor fuer Lebensmitteluntersuchung**

Laufener Str. 83

83395 Freilassing, Germany

Tel: (49-8654) 62322 (German line)

Fax: (43-662) 438102 (Austrian line)

E-mail: [office@analytec.de]{.underline}

Homepage: [http://www.analytec.de]{.underline}

**Analytisches Institut Wulf Bostel**

Florianstr. 13

70188 Stuttgart, Germany

Tel: (49-711) 285280

Fax: (49-711) 2852855

e-Mail: [institut@bostel.de]{.underline}

Homepage: [http://www.bostel.de]{.underline}

**Arotop Food Creation GmbH & Co. KG**

Dekan-Laist-Str. 9

55129 Mainz, Germany

Tel: (49-6131) 583800

Fax: (49-6131) 5838080

E-mail: [arotop@arotop.de]{.underline}

Homepage: [http://www.arotop.de]{.underline}

**Chemisches Laboratorium Luebeck GmbH**

Hochofenstr. 23-25

23569 Luebeck, Germany

Tel: (49-451) 307840

Fax: (49-451) 307-8449

E-mail: [info@cll-gmbh.de]{.underline}

Homepage: [http://www.cll-gmbh.de]{.underline}

**Dr. Fintelmann und Dr. Meyer**

**Handels- und Umweltschutzlaboratorien GmbH**

Mendelssohnstrasse 15D

22761 Hamburg, Germany

Tel: (49-40) 899 664 0

Fax: (49-40) 899 664 50

E-mail: [info@inlabco.com]{.underline}

Homepage: [http://www.inlabco.de]{.underline}

**GeneScan Europe AG**

Engesserstr. 4

79108 Freiburg, Germany

Tel.: (49-761) 5038 0

Fax: (49-761) 5038 111

E-mail: [info@genescan.com]{.underline}

Homepage: [http://www.hanse-analytik.de]{.underline}

**ICCS International Commodity**

**Control Services GmbH**

Brook 1

20457 Hamburg, Germany

Tel: (49-40) 3698290

Fax: (49-40) 36982920

E-mail: [germany@controlunion.com]{.underline}

Homepage: [http://www.iccshamburg.com]{.underline}

**Institut Fresenius**

Im Maisel 14

65232 Taunusstein, Germany

Tel: (49-6128) 744-0

Fax: (49-6128) 744-890

E-mail: [info@fresenius.com]{.underline}

Homepage: [http://www.institut-fresenius.de]{.underline}

**Dr. Kaiser & Dr. Woldmann GmbH**

Stresemannstrasse 313 a

22761 Hamburg, Germany

Tel: (49-40) 8530-40

Fax: (49-40) 8530-4222

E-mail: [gomolzig@novalytik.de]{.underline}

Homepage: [http://www.alge.de]{.underline}

**Dr. Mielke & Streck**

Kleine Johannisstr. 20

20457 Hamburg, Germany

Tel: (49-40) 3741210

Fax: (49-40) 366835

E-mail: [MSA-lawyer@t-online.de]{.underline}

**SGS Controll-Co. mbH**

Raboisen 28

20095 Hamburg, Germany

Tel: (49-40) 301010

Fax: (49-40) 326331

E-mail: [sgscontroll_germany@sgs.com]{.underline}

Homepage: [http://www.sgs.com]{.underline}

**Dr. Helmut Weiss Handelslabor**

Spaldingstr. 130

20097 Hamburg, Germany

Tel: (49-40) 233429

Fax: (49-40) 230912

**Dr. Wessling Laboratorien GmbH**

Oststrasse 7

48341 Altenberge, Germany

Tel.: (49-2505) 896 25

Fax.: (49-2505) 896 20

E-mail: [Im-labor@wessling-gruppe.de]{.underline}

Homepage: [http://www.wessling-gruppe.de]{.underline}

**Eurofins Analytik GmbH**

**Dr. Specht Laboratorien**

St. Anscharplatz 10

20354 Hamburg, Germany

Tel: (49-40) 300 86 0

Fax: (49-40) 300 86 101

E-mail: [info@labor-specht.de]{.underline}

Homepage:[http://www.labor‑specht.de]{.underline}

**Eurofins Analytik GmbH**

**Wiertz-Eggert-Joerissen**

Stenzelring 14b

21107 Hamburg, Germany

Tel: (49-40) 7527090

Fax: (49-40) 75270935

E-mail: [info@wej.de]{.underline}

Homepage: [http://www.wej.de]{.underline}

# APPENDIX C. World Trade Organization (WTO) Inquiry Post

Each member government is responsible for the notification procedures
associated with the agreement under the World Trade Organization (WTO).
Examples here relate to the Sanitary and PhytoSanitary (SPS) and
Technical Barriers to Trade (TBT) Agreements. WTO obligations include
notifying any trade significant proposals which are not substantially
the same as international standards to the WTO, providing copies of the
proposed regulation upon request, allowing time for comments, and also
providing upon request copies of other relevant documents on existing
regulations related to food and agriculture. Information on the
country's regulations, standards and certification procedures can also
be obtained through the Enquiry Point(s) listed below:

Deutsches Informationszentrum fuer technische Regeln (DITR)

(German Information Centre for Technical Rules)

Burggrafenstr. 4-10

10772 Berlin, Germany

Tel: (49-30) 2601-600

Fax: (49-30) 2601-1231

E-mail: [postmaster@din.de]{.underline}

Homepage: [http://www.ditr.din.de]{.underline}

The DITR is being established by DIN, the German Standards Institute, in
co-operation with the Federal Government. This body is the central point
to which to address all questions concerning technical rules in the
Federal Republic of Germany.

The Centre provides information on all technical rules (including
standard, technical regulations and certification systems) valid in the
Federal Republic of Germany, irrespective of whether the technical rules
have been issued by federal or local authorities or by non-governmental
bodies. At present the computer-aided DITR databank has information on
36,000 technical rules either in force or in the draft stage.