Developments in EU food legislation and initiatives that may have an impact on U.S. exports of food and agricultural products are highlighted on a blue background.
THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY
USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT
Required Report - public distribution
GAIN Report Number: E70048
Food and Agricultural Import Regulations and Standards -
FAIRS Country Report
This report updates each of the nine sections and provides an overview of food laws currently in force in
the EU-27. Developments in EU food legislation and initiatives that may have an impact on U.S.
exports of food and agricultural products are highlighted on a blue background. Information provided
in this report is also available on the new USEU/FAS website http://www.usda-eu.org.
WHAT IS NEW FOR 2012?
All sections of this report were updated. The main developments in EU food legislation and other key
updates are highlighted on a blue background.
SECTION I. FOOD LAWS
SECTION II. LABELING REQUIREMENTS
SECTION III. PACKAGING & CONTAINER REQUIREMENTS
SECTION IV. FOOD ADDITIVES
SECTION V. PESTICIDES & CONTAMINANTS
SECTION VI. OTHER REGULATIONS & REQUIREMENTS
SECTION VII. OTHER SPECIFIC STANDARDS
SECTION VIII. COPYRIGHTS AND/OR TRADEMARK LAWS
SECTION IX. IMPORT PROCEDURES
APPENDIX I. GOVERNMENT REGULATORY AGENCY CONTACTS
APPENDIX II. OTHER IMPORT SPECIALIST CONTACTS
APPENDIX III. EU INITIATIVES
APPENDIX IV. WEBSITE LINKS & GUIDANCE DOCUMENTS
DISCLAIMER: This report was prepared by the Office of Agricultural Affairs, U.S. Mission to the
European Union in Brussels, Belgium for U.S. exporters of domestically produced 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
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
The European Union (EU) has gradually expanded to become the world’s largest multi-nation trading
bloc. Since January 1, 2007, the European Union comprises 27 member states with approximately 500
million consumers. EU member states: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg,
Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.
Croatia will become the 28th EU Member State on July 1, 2013. Iceland, the Former Yugoslav Republic
of Macedonia and Turkey are candidates to join the EU.
All EU Member countries accept the “Community acquis”, i.e. the entire body of EU laws and
obligations associated with the treaties and international agreements to which the EU is a party. Since
the EU was originally created as a Customs Union, EU common rules extend to all aspects of trade
policy including preferential trade, health and environmental controls, and the common agricultural and
fisheries policies, and all MS must comply with them.
The process of harmonizing existing Member State legislation has been long and cumbersome and is
still ongoing. According to a European Commission memo published in December 2012, around 98%
of food legislation is harmonized at the EU level. 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. National measures still exist, for example, for certain food contact materials, the
addition of nutrients to food and food supplements, maximum levels for vitamins and minerals, and for
fees for official controls. 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. These
reports can be downloaded from the FAS website at http://gain.fas.usda.gov/Pages/Default.aspx.
The main principle of the single market concept is the “principle of mutual recognition” 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. There is one exception to this principle:
certain directives allow Member States to make exceptions e.g. in cases where a country can prove
public safety, health or environmental concerns about a product intended for import. Regulation
764/2008, adopted in July 2008, sets out the procedural requirements for denying mutual recognition
and defines the rights and obligations of national authorities on the one hand and enterprises on the
other. Free movement can only be guaranteed when all aspects are covered by harmonized legislation:
e.g. a foodstuff may comply with the general labeling directive but may carry a health claim for which
harmonized rules have not yet been finalized. Imported products must meet existing Member State
requirements in cases where EU regulatory harmonization is not yet complete.
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.). EU food legislation is characterized by a constant flow of new regulations and
directives, amendments to existing legislation and implementation rules. EU laws are translated into the
23 official languages in use in the EU-27 and published chronologically in the Official Journal.
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.
Consolidated texts, i.e. the consolidation of a basic legal act and subsequent amendments into one text,
are available on the European Commission’s website but come with a warning that they are not legally
binding. When legislation is referenced in this guide, it is implied that all further amendments also
apply. Where possible, this guide links directly to the consolidated versions of referenced EU
legislation. The Eurlex website (http://eur-lex.europa.eu/en/index.htm) provides free access to European
In the context of “Better Regulation” the EU is in the process of carrying out a “rolling simplification
program.” The main objectives of this program are the simplification of existing EU law and the
introduction of a new regulatory approach. One of the main simplification tools consists in substituting
directives with regulations. Under this new approach, the use of regulations instead of directives should
help eliminate the diverging interpretations by the different Member States and as regulations are
directly applicable, Member States no longer need to go through the lengthy process of transposing into
national laws. Another simplification tool is the codification and consolidation of legal acts and their
amendments into a single text which is legally binding once published in the Official Journal. More
information is available on the European Commission’s “Better Regulation” website
The EU has developed an integrated “Farm to Fork” approach covering all sectors of the food and feed
chain, based on the precautionary principle and including traceability as described in the Commission
Communication on the Precautionary Principle. Key elements of this approach include the
establishment of a framework regulation laying down the general principles and requirements of EU
food law (Regulation 178/2002); the establishment of the European Food Safety Authority (EFSA)
which is an independent body providing scientific advice to the legislators; the development of specific
food and feed safety legislation; and, the creation of a framework for harmonized food controls
(Regulation 882/2004). The regulations on general food law, food and feed controls, food and feed
hygiene make up the body of the EU’s food safety laws. Revisions of existing EU food regulations or
new regulations all apply the principles contained in the framework regulations. For more information
For ethical issues, the Commission has given a mandate to the “European Group” (EGE) to provide
advice on ethical questions relating to sciences and new technologies. The EGE delivers opinions on the
ethical implications of modern developments in agriculture technologies. Its mandate is renewed every
five years. For more information see http://ec.europa.eu/bepa/european-group-ethics/index_en.htm.
There are three main institutions involved in developing policies and passing legislation that applies
throughout the EU: the European Commission, the Council of the European Union and the European
Parliament. In principle, the Commission proposes new laws and the Council and European Parliament
adopt them under the “Ordinary Legislative Procedure” (ex co-decision). The Member States then
implement them and the Commission ensures that EU laws are properly applied and implemented.
EFSA is responsible for providing scientific advice to the legislators on matters related to food safety.
EFSA’s “Applications Helpdesk” acts as a front office and support desk for applicants who have
questions regarding applications in the following scientific areas: animal by-products, decontamination
substances, feed additives, food contact materials, food ingredients, food processing, agricultural
biotechnology products, nutrition and pesticides. For more information see
Enforcement of EU food legislation is done by Member State officials. Auditing oversight of Member
State performance is done by European Commission officials. The European 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 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 may be variations 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.
VISIT OUR NEW WEBSITE HTTP://WWW.USDA-EU.ORG! An overview of EU food laws
currently in force can be found in the section “Trade with the EU.”
AS A REMINDER: Exports of red meat, meat products, farmed and wild game meat, ratites, milk and
milk products, seafood, bovine embryos an semen, porcine and equine semen, gelatin, animal casings
and animal by-products to the EU from the U.S. may originate only from EU approved U.S.
For more information see http://www.usda-eu.org/trade-with-the-eu/eu-import-
SECTION II. LABELING REQUIREMENTS
A. General Requirements
The standard U.S. label fails to comply with EU labeling requirements.
General provisions on the labeling, presentation and advertising of pre-packaged foodstuffs marketed in
the EU are laid down in European Parliament and Council Directive 2000/13/EC. It applies not only to
foodstuffs intended for sale to the ultimate consumer but also for supply to restaurants, hospitals and
other mass caterers.
Directive 2000/13/EC will be repealed by European Parliament and Council Regulation 1169/2011.
This new EU Regulation, adopted in November 2011, establishes new horizontal food labeling
requirements which will apply from December 13, 2014, except for the new mandatory nutrition
declaration requirement which will apply from December 13, 2016, and Part B of Annex VI (specific
requirements concerning the designation of minced meat) which will apply from January 1, 2014.
Detailed information on the EU’s new food labeling requirements is available in GAIN Report E70002
“New EU Food Labeling Rules Published”.
Section VII of this report covers labeling requirements for specific products, including genetically
modified and novel foods.
The compulsory information must appear on the pre-packaging or on a label attached to it. The
information must be marked in such a way that it is easily visible, clearly legible and indelible. The
following information is mandatory on labels:
1) The name under which the product is sold.
2) The list of ingredients, in descending order of weight. A) Important exceptions include added
water in foods reconstituted from concentrates, and cheese, which is covered by special rules. B)
The following ingredients require a specific statement on the label: GMO’s, packaging gases,
sweeteners, certain food colorings, aspartame and polyols, quinine and caffeine, phytosterols and
phyostanols and licorice.
3) Allergens: Annex IIIa to Directive 2000/13/EC lists the groups of potential allergenic ingredients
which must be indicated on food labels: cereals containing gluten, crustaceans, eggs, fish,
peanuts, soybeans, milk and dairy products (including lactose), nuts and nut products, sesame
seeds, lupin and products thereof, mollusks and products thereof and sulfite at concentrations of at
least 10 mg per kg or 10 mg/l, celery, and mustard. Allergen labeling also applies to alcoholic
beverages. A temporary derogation for wines fined with egg and milk derivatives expired on June
30, 2012. For more information see Section VII-G “Wine, Beer and Other Alcoholic Beverages”.
GAIN report E36066 lists the different languages that the EU member states will accept for the
purpose of allergen labeling of wine.
Guidelines for the implementation of the allergen labeling rules are available on the
Commission’s website at
guidelines also specify in which cases derogations may be accepted: for foodstuffs for which no
ingredients list is required, for sub ingredients of certain compound ingredients, for ingredients
which belong to well defined categories and for substances that are not regarded as ingredients.
Commission Directive 2007/68/EC established a list of ingredients and substances which are
permanently exempted from the mandatory allergen labeling requirement.
4) 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, wine and meat preceded by the name(s) of the animal
species from which it comes.
5) The quantity of certain ingredients or categories of ingredients (QUID) – see below.
6) The net quantity of prepackaged foodstuffs expressed in metric units (liter, centiliter, milliliter,
kilogram or gram).
7) 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 minimum durability date is replaced by
the “use by” date consisting of the day, the month and possibly the year (articles 9-10 of Directive
2000/13/EC). Detailed information can be found in the “Guidance on the application of date
labels to food” published by the U.K.’s Department for Environment, Food and Rural Affairs
8) Any special storage conditions or conditions of use.
9) The name or business name and address of the manufacturer or packager, or of the seller
established within the Community.
10) Particulars of the place of origin or provenance in case absence of such information might mislead
11) Instructions for use.
12) The actual alcoholic strength for beverages containing more than 1.2 percent alcohol by volume.
13) 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. Foods
marked with a “Best Before” or “Use By” date that consists of at least the Day and Month – in
that order - are exempt from the lot marking requirement. Detailed information on indications or
marks identifying the lot to which a foodstuff belongs is provided in Directive 2011/91/EU.
14) Treatments undergone, with specific indications for irradiated foods and deep-frozen foods (see
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 to fulfill the traceability requirement,
which became mandatory on January 1, 2005.
- 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. Specific requirements for the use of the term “natural” to describe a flavoring are set out in
Article 16 of European Parliament and Council Regulation 1334/2008. For more information see
Section IV “Food Additive Regulations”.
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.
This Directive will be repealed on December 13, 2014, when the EU’s new labeling Regulation
1169/2011 becomes applicable.
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”.
This Directive will be repealed on December 13, 2014, when the EU’s new labeling Regulation
1169/2011 becomes applicable.
Quantitative Ingredients Declaration (QUID)
Quantitative ingredients declaration (QUID) is compulsory in the following cases (Article 7 of Directive
- 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 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
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 can be downloaded from the European Commission’s
website at http://ec.europa.eu/food/food/labellingnutrition/resources/fl02_en.pdf.
This Directive will be repealed on December 13, 2014, when the EU’s new labeling Regulation
1169/2011 becomes applicable.
Warnings on Labels
Commission Directive 2008/5/EC establishes a list of foodstuffs that require a warning on the label:
- foodstuffs whose durability has been extended by means of packaging gases
- foodstuffs containing (a) sweetener(s)
- foodstuffs containing added sugar(s) and sweetener(s)
- foodstuffs containing aspartame
- foodstuffs containing more than 10% added polyols
- confectionery or beverages containing liquorice
This Directive will be repealed on December 13, 2014, when the EU’s new labeling Regulation
1169/2011 becomes applicable.
Regulation 1333/2008 requires foodstuffs containing the food colors sunset yellow (E110), quinoline
yellow (E104), carmoisine (E122), allura red (E129) and ponceau 4R (E124) to be labeled “may have an
adverse effect on activity and attention in children”. For more information see Section IV “Food
Any non-edible parts of a packaging system that consumers could mistake for food must be labeled with
the words “DO NOT EAT” and where technically possible carry the following warning symbol:
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
Belgium French AND Dutch, German also recommended
Czech Republic Czech
Ireland British English
Luxembourg French or German
Malta Maltese or English or Italian
United Kingdom British English
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.
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 http://www.usda-eu.org/trade-with-the-eu/eu-import-rules/fairs-reports/.
Labeling of Genetically Modified Foods
Section VII 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. All foods and ingredients that are produced in whole
or in part from genetically modified organisms should indicate this on their labels. The same rules apply
to flavors and additives. For detailed information see Section VII-A.
B. Medical / Health / Nutrition Claims
European Parliament and Council Regulation 1924/2006 sets EU-wide conditions for the use of nutrition
claims such as “low fat” or “high in vitamin C” and health claims such as “helps lower cholesterol.”
The regulation applies to any food or drink product produced for human consumption that is marketed
on the EU market. In order to carry a claim, foods must fit a certain “nutrient profile” (below certain
salt, sugar and/or fat levels).
The development of nutrient profiles, originally scheduled for January 2009, has not been finalized yet.
The European Commission is still working on a proposal but a timeline is not yet available. Once the
nutrient profiles, based on scientific evaluations by the European Food Safety Authority (EFSA), have
been set, there will be another two-year period before the nutrient profiles begin to apply to allow food
operators time to comply with the new rules. Nutrition claims can fail one criterion, i.e. if only one
nutrient (salt, sugar or fat) exceeds the limit of the profile, a claim can still be made provided the high
level of that particular nutrient is clearly marked on the label. For example, a yogurt can make a low-fat
claim even with a high sugar content but only if the label clearly states “high sugar content”. Health
claims cannot fail any criteria.
In December 2011, the European Commission proposed a list of 222 functional health claims for
substances other than botanicals. More than two years after the due date set by Regulation 1924/2006,
the list of EU-approved functional health claims and their conditions of use was finally adopted on May
25, 2012. Regulation 432/2012 establishing the EU positive list becomes applicable on December 14,
2012. Anyone will be able to use the permitted health claims provided the conditions set out in
Regulation 432/2012 are met. The EU’s online “Register of Nutrition and Health Claims” has been
updated not only with the 222 authorized health claims but also with the more than 1600 rejected claims
and the reasons for their non-authorization. Health claims referring to botanical substances have been
put on hold because the Commission and the Member States are discussing the potential conflict of the
Health Claims Regulation with the Traditional Herbal Medicinal Products Directive. All claims that are
not authorized and not on hold or under consideration are prohibited as of December 14, 2012. Food
products carrying claims must comply with the provisions of nutritional labeling directive 90/496/EC.
The list of permitted health claims is different from the individual applications for health claims relating
to disease risk reduction and claims referring to the health and development of children which require an
authorization on a case-by-case basis, following the submission of a scientific dossier to EFSA. A
simplified authorization procedure has been established for health claims based on new scientific data.
Regulation 353/2008 sets out implementing rules for applications for the authorization of health claims
as provided for in Article 15 of Regulation 1924/2006. GAIN Report E48055 describes how application
dossiers for authorization of health claims should be prepared and presented. A guidance document on
how companies can apply for health claim authorizations can be downloaded from EFSA’s website at
Trademarks and brand names that suggest health and/or nutritional benefits but do not comply with the
new rules must be entirely removed from the EU market by January 19, 2022.
The Annex to Regulation 1924/2006 lists the EU authorized nutrition claims and their conditions of use.
Commission Regulation 1047/2012 published in November 2012 adds a new “No Added Sodium/Salt”
claim to the EU positive list and amends the conditions of use of the “Reduced [Name of the Nutrient]”
Requirements Specific to Nutrition Labeling
Under the current rules, nutrition labeling is not mandatory in the EU unless a nutrition claim is made on
the label or in advertising messages. Nutrition labeling rules are laid down in Council Directive
90/496/EEC. "Nutrition labeling" means any information on the label that relates to energy value and to
the following nutrients: protein, carbohydrate, fat, fiber, sodium, vitamins and minerals present in
significant amounts as defined in the Annex to Directive 90/496/EC. The nutrition labeling rules do not
apply to food supplements and natural mineral waters.
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, carbohydrate - the amount of protein, carbohydrate, sugar, fat, saturates,
and fat fiber and sodium
When a nutrition claim is made for sugars, saturates, fiber and sodium, the information under Group 2
must be given.
The energy value and the proportion of nutrients must be declared in specific units per 100 grams or per
100 milliliters. Nutritional information may also include the amounts of starch, polyols, mono-
unsaturates, poly-unsaturates, cholesterol and any of the vitamins listed in the Annex to Directive
90/496/EC. Information on vitamins and minerals must be expressed in units specified in the Annex and
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. Examples of the
nutrition information panel can be found in a leaflet published by the EU’s Food & Drink Industry
In October 2008, Council Directive 90/496/EEC was amended by Commission Directive 2008/100/EC.
Commission Directive 2008/100/EC updates the list of vitamins and minerals and their Recommended
Daily Allowances (RDAs) and provides an EU definition of “fiber”. The conditions for the use of
nutrition claims such as “source of fiber” or “high fiber” are laid down in Regulation 1924/2006 (see
nutrition and health claims).
The EU’s new labeling regulation 1169/2011 which will apply from December 13, 2014, introduces the
mandatory declaration of the energy value and the amounts of fat, saturates, carbohydrates, sugars,
protein and salt expressed per 100 grams or per 100 milliliters in the same field of vision on food labels.
The salt content must be expressed as “salt” not “sodium” but where appropriate, a statement indicating
that the salt content is exclusively due to the presence of naturally occurring sodium may appear in close
proximity to the nutrition declaration. The nutrition declaration may additionally be given on a per
portion basis and expressed as a percentage of daily reference intakes set out in Part B of Annex XIII.
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
- Fortified foods
- Foodstuffs for particular nutritional uses including dietetic and baby/infant foods
- Spirit drinks
- Olive oil
- 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, poultry, eggs, dairy products, spreadable fats
- Pet food
More details on above products can be found in Section VII.
D. Country of Origin Labeling
In the EU, country of origin labeling is mandatory for beef and veal, fruit and vegetables, eggs, poultry
meat, wine, honey, olive oil, aquaculture products and for organic products carrying the EU logo. For
other products, the indication of the place of origin or provenance is mandatory only if the omission of
such information might mislead the consumer.
The EU’s new labeling regulation 1169/2011 which will apply from December 13, 2014, extends the
mandatory country of origin labeling to meat listed in Annex XI (swine, sheep and goat, poultry) and
when the country of origin of a food is not the same as its primary ingredient. The European
Commission has until December 13, 2013, to carry out a feasibility study on the possible extension of
mandatory country of origin labeling to meat used as an ingredient. It has until December 13, 2014, to
assess the impact of country of origin labeling of other types of meat, milk, milk used as an ingredient in
dairy products, unprocessed foods, single-ingredient products, and ingredients that represent more than
50% of a food.
SECTION III. PACKAGING AND CONTAINER REQUIREMENTS
A. Size & Content
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.
Directive 2007/45/EC abolishes regulations on mandatory pack sizes at both EU and national levels.
The Directive frees sizes for all prepackaged products except wine and spirits, coffee and white sugar.
Member States in which mandatory nominal quantities are prescribed for white sugar may maintain
these rules until October 2013. Mandatory nominal quantities for wines and spirits are set out in the
Annex to Directive 2007/45/EC.
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. More information can be found on the Packaging
Recovery Organization Europe website which provides easy access to all Green Dot systems in Europe
C. Materials in Contact with Foodstuffs
European Parliament and Council Regulation 1935/2004 specifies the main requirements for materials
that come into contact with foodstuffs. It also sets out labeling and traceability requirements and the
procedure for the authorization of substances through the European Food Safety Authority. Additional
requirements will be proposed in specific measures and will include positive lists of authorized
substances and materials. Annex I to regulation 1935/2004 lists the group of materials for which
specific measures may be adopted. To date, specific directives have been developed for plastic materials
(Commission Regulation 10/2011), recycled plastic materials (Commission Regulation 282/2008),
regenerated cellulose film (Commission Directive 2007/42/EC) and ceramics (Council Directive
84/500/EC). In the case of ceramics, migration limits have been established for lead and cadmium.
Materials must bear an indication "for food contact" or the symbol reproduced in Annex II to Regulation
1935/2004. Commission Implementing Regulation 321/2011 restricts the use of Bisphenol A in plastic
infant feeding bottles.
Commission Regulation 450/2009 sets out definitions and authorization procedures for the use of active
and intelligent materials and articles intended to come into contact with food. An EU guidance
document on active and intelligent food contact materials is available on DG Sanco’s website.
Commission Regulation 2023/2006 lays down rules on good manufacturing practice (GMP) for the
groups of materials and articles intended to come into contact with food listed in annex I to Regulation
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. They
may also restrict or temporarily prohibit the use of certain materials authorized by the specific directives
for reasons of public health. A summary of EU and national legislation as well as guidance documents
and contact information with regard to the submission of applications for authorization can be
downloaded from the European Commission website at
For more information on specific substances, check out the European Commission’s Food contact
SECTION IV. FOOD ADDITIVE REGULATIONS
The “Package on Food Improvement Agents” includes four Regulations: Regulation 1331/2008
establishing a common authorization procedure for food additives, food enzymes and food flavorings,
Regulation 1332/2008 on food enzymes, Regulation 1333/2008 on food additives and Regulation
1334/2008 on flavorings.
The common authorization procedure for food additives, food enzymes and food flavorings, established
by Regulation 1331/2008 is introducing a single common procedure for the approval of food additives,
flavorings and enzymes. The benefits of this common approach include simplified legislation and more
consistency in the procedures used to approve additives, flavorings and enzymes with an emphasis on
the safety evaluations by EFSA on which the approval procedure is based.
The implementing rules are laid down in Commission Regulation 234/2011, Commission implementing
Regulation 562/2012, explaining the content of an application and all the data both administrative and
technical that have to be submitted to the Commission. The Commission will then request EFSA to
verify the suitability of the data. An application consists of a letter, a technical dossier and a summary of
Additives (including colors and sweeteners)
European Parliament and Council Regulation 1333/2008 setting out the rules for the use of food
additives, applies since January 20, 2010. This regulation provided for a revision of the food additives
approved under the old directives in order to establish an EU positive list of food additives including
colors and sweeteners. Annex I to this Regulation contains definitions of 26 different categories of food
Commission Regulation 1129/2011 establishes a list of all authorized food additives in foodstuffs as
well as the conditions of use and amends Annex II to Regulation 1333/2008. Only additives placed in
Annex II will be authorized for use in food products sold on the EU market. Regulation 1129/2011 will
apply as of June 2013 in order to allow the Union's food industry to adapt to the new rules.
Commission Regulation 1130/2011 establishes a second list of food additives and amends Annex III to
Regulation 1333/2008. This list concerns additives approved for the use in food ingredients such as
other food additives, food enzymes, food flavorings and nutrients. Regulation 1130/2011 applies since
December 2, 2011 but a transitional period of 24 months applies to preparations not complying with
Parts 2, 3 and/or Section A of Part 5 of Annex III and until May 31, 2013 for preparations not complying
with Parts 1 and 4 of Annex III. Until Annexes II and III become fully applicable, food additives
approved under the old directives will continue to be permitted. The authorized uses of additives are
from now on listed according to the category of food to which they may be added. The new legislation
also provides for clear conditions under which additives may be added to food.
Commission Regulation 1131/2011 approves the sweetener steviol glycosides, commonly known as
stevia, which is extracted from the leaves of the Stevia Rebaudiana Bertoni plant. Stevia’s approval for
its use in several food categories will allow industry to innovate and to develop new products. Annex II
to Regulation 1333/2008 is amended accordingly.
Specifications for food additives listed in Annexes II and III are laid down in Commission Regulation
231/2012. Additionally, Regulation 1333/2008 also provides for an evaluation program, set up by
Commission Regulation 257/2010, for food additives permitted before January 2009. Those food
additives shall be subject to a new risk assessment carried out by EFSA and the re-evaluation of
approved food additives shall be completed by the end of:
- 2015 for food colors (currently listed in Directive 94/36/EC)
- 2018 for all additives other than colors and sweeteners (currently in Directive 95/2/EC)
- 2020 for all sweeteners (currently listed in Directive 94/35/EC)
Annex I of Regulation 257/2010 lists the approved food additives for which the re-evaluation by EFSA
was already completed at the time of adoption of Regulation 257/2010.
Foods containing any of the six food colors Quinoline Yellow (E104), Sunset Yellow (E110), Ponceau
4R (E124), Tartrazine (E102), Azorubine/Carmoisine (E122) and Allura Red AC (E129), will have to be
labeled with the phrase, ‘may have an adverse effect on activity and attention in children’ (Annex V to
Regulation 1333/2008). The limits for these food colors have recently been lowered by Commission
For an overview of the rules in force until the new regulation becomes fully applicable see the 2008
FAIRS report (GAIN report E48078). An important difference from U.S. legislation is the use of flour
bleaching agents: chlorine, bromates and peroxides are not allowed in the EU.
See also the Commission’s food additives database which contains all necessary information on the
different food additives allowed in the EU.
Commission Directive 2009/163/EU sets conditions for the use of neotame as a sweetener.
Detailed information on the use of food additives can be obtained from the European Commission’s
website at http://ec.europa.eu/food/food/chemicalsafety/additives/new_regul_en.htm.
Regulation 1334/2008 on flavorings and certain food ingredients with flavoring properties sets specific
rules for the use of the term “natural”. The new rules apply since January 20, 2011.
The new union list on flavoring substances, which was finally published in the Official Journal on
October 2, 2012, will be introduced in Annex I of Regulation 1334/2008 on flavorings and certain food
ingredients with flavoring properties. It contains more than 2500 substances that are authorized for use
in the EU. The two new pieces of legislation clarify and harmonize the use of flavoring substances
within the single market list and will be introduced in Annex I of framework Regulation 1334/2008 on
Commission Implementing Regulation (EU) No 872/2012 provides for a new EU wide list of flavoring
substances which can be used in food and will apply from April 22, 2013, giving time for the EU food
industry to adapt to the new rules. All flavoring substances not in the list will be prohibited after a
phasing out period of 18 months. The current Regulation 2232/96 is repealed by this new legislation and
will no longer be in force as of April 21, 2013.
Commission Regulation (EU) No 873/2012 concerns transitional measures for other flavorings such as
flavorings made from non-food sources and apply since October 22, 2012.
The authorized uses of flavoring substances are listed according to the category of food to which they
may be added and are also available in an on-line database allowing consumers, food businesses and
food control authorities to easily identify which flavoring substances are authorized in food.
A Community procedure for the safety assessment and the authorization of smoke flavorings intended
for use in or on foods is established in Regulation 2065/2003.
Regulation 1332/2008 on food enzymes introduces harmonized rules for their scientific evaluation and
authorization in the EU and establishes labeling requirements. Food enzymes have not been regulated
before or are regulated similar to processing aids under the legislation of the Member States. Regulation
234/2011, last amended by Commission Implementing Regulation 562/2012, regarding the
implementation of the common authorization procedure, sets out a deadline of two years starting from
September 11, 2011 to submit applications on existing and new enzymes and for industry to provide the
information for the risk assessment. Until the adoption of an EU positive list of authorized enzymes, the
existing national provisions on the marketing of food enzymes will continue to apply.
Processing aids are subject to Member States national legislation. EU harmonized rules exist only for
certain categories of 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
2009/32/EC (last amended by Directive 2010/59/EC).
SECTION V. PESTICIDES AND CONTAMINANTS
Regulation 1107/2009 sets out new rules for the authorization of plant protection products (PPPs) and
replaces Directive 91/414/EEC and fully applies since June 14, 2011. Rules cover pesticides currently or
formerly used in agriculture in or outside the EU (around 1100).
Commission implementing Regulation 540/2011, establishes a list of approved active substances. Only
PPPs containing active substances included in the list may be authorized for use in the EU. Member
States can approve PPPs containing the active substances. According to the new Regulation, the EU is
divided in three different zones. Once a Member State approves the PPP it can be mutually recognized
and thus authorized within the same EU zone as set out in Annex I of the Regulation. The Maximum
Residue Levels (MRLs) for substances not on the list will be set at default level of 0.01 mg/kg. The
legislation allows exporters to request an "import tolerance" for active substances not yet evaluated or in
use in the EU.
Besides the framework Regulation above, the so called pesticide package also contains a Directive for
the sustainable use of pesticides.
Maximum Residue Limits (MRLs): Regulation 396/2005
Since September 2008 all MRLs in the EU have been harmonized by Regulation 396/2005 on food or
feed of plant and animal origin. Pesticide MRLs for processed or composite products are based on the
MRLs of the raw agricultural ingredients. MRLs apply to 315 fresh products and to the same products
after processing. See DG SANCO’s webpage for the latest updates.
Annex I lists the commodities to which MRLs apply.
Annex II contains existing MRLs that were already harmonized at EU level and replaces the EU’s old
Annex III lists EU “temporary” MRLs or pesticides for which, before September 1, 2008, MRLs were
only set at national level.
Annex IV lists the substances for which no MRLs are required and so are exempt from tolerance
Annex V will contain the list of pesticides for which a default limit other than 0.01 mg/kg will apply.
This Annex has not been published yet. Pesticide MRLs for processed or composite products are based
on the MRLs for the raw agricultural ingredients.
Annex VI will contain the list of conversion factors of MRLs for processed commodities. This Annex
has not been published yet.
Annex VII contains a list of pesticides used as fumigants for which the Member States are allowed to
apply special derogations before the products are placed on the market.
Annex VII contains active substance and product combinations for which Member States may authorize
residue levels that exceed the limits set in Annex II and III.
For a list of authorized active substances or pesticide-MRL combinations, see: DG Sanco’s pesticides-
If there is no EU legislation in place in the importing Member State, then the exporter can seek to obtain
an "import tolerance" for active substances that have not been evaluated or used in Europe before.
Applications for import tolerances must be submitted to the “Rapporteur Member State” (RMS). The
Commission assigns a Member State, if no RMS exists. The RMS reviewed dossiers are evaluated by
the European Food Safety Authority before being forwarded to the Commission. Information on import
tolerances can be obtained from http://www.pesticides.gov.uk/applicant_guide.asp?id=1239. Since
September 2, 2008 all MRLs, including import tolerances, apply EU wide.
Harmonized sampling methods are established for the official control of residues in and on products of
plant and animal origin by Commission Directive 2002/63/EC. Commission Regulation 788/2012
requires Member States to take and analyze samples for product and pesticide residue combinations in
food of plant and animal origin. Annex I to the Regulation sets out the pesticide and product
combinations to be monitored. Annex II sets out the number of samples that need to be taken for each
combination. The Member States must submit results of the sample tests to the EU by 31 August 2014,
2015 and 2016 for samples tested in 2013, 2014 and 2015 respectively.
EU wide harmonized maximum levels for contaminants are set in the Annex of Commission Regulation
1881/2006. The Annex to Regulation 1881/2006 includes maximum levels for:
- Nitrates in lettuce, spinach and infant food (section 1)
- Mycotoxins (section 2):
aflatoxins in nuts, dried fruit, cereals, maize, spices, milk and infant food
ochratoxin A in cereals, cereal products, dried vine fruit, roasted coffee, soluble coffee,
wine, grape juice, spices, infant food and licorice
patulin in fruit juices, spirit drinks, solid apple products, apple juice and infant food
deoxynivalenol in cereals, cereal products, maize, pasta and infant food
zearelenone en cereals, cereal products, maize, refined maize oil, bread and small bakery
wares and infant food
fumonisins in maize and maize based products
T-2 and HT-2 toxin in cereals and cereal products
- Heavy metals (section 3):
lead in milk, infant food, meat, offal, seafood, vegetables, fruit, wine and food
cadmium in meat, seafood, cereals, soybeans, vegetables, fruit, fungi and food
mercury in seafood and food supplements
tin in canned foods, canned beverages and canned baby foods
- 3-MCPD in vegetable protein and soy sauce (section 4)
- Dioxin and PCBs in meat, liver, fishery products, milk, eggs and oils & fats (section 5)
- Polycyclic aromatic hydrocarbons (PAH) in oils & fats, infant foods, (smoked) meat, fish and infant
food (section 6)
- Melamine in infant food (section 7)
Official Controls of Maximum Levels in Foodstuffs
The following regulations concern the sampling methods and methods of analysis for the official
controls of the levels of the different contaminants. Annex I describes the methods of sampling; Annex
II concerns the sample preparation and the performance criteria for the methods of analysis:
Nitrates: Commission Regulation 1882/2006
Mycotoxins: Commission Regulation 401/2006
Dioxins: Commission Regulation 252/2012
Heavy metals, Tin, 3-MCPD and benzo(a)pyrene: Commission Regulation 333/2007 as
amended by Commission Regulation 836/2011
Import Conditions for U.S. Almonds
In September 2007, the EU implemented special import conditions which called for mandatory testing
of U.S. almonds imported into the EU. USDA and The California almond industry have developed a
“Voluntary Aflatoxin Sampling Plan” (VASP) comparable to the EU sampling procedures so that
almonds can be uniformly tested before they are shipped to the EU. Per Commission Regulation
1152/2009, these procedures are considered to provide sufficient assurances which means that almonds
shipped under VASP are subject to random controls. The Regulation covers almonds in shell or shelled,
roasted almonds and mixtures of nuts or dried fruits containing almonds, and foodstuffs containing a
significant amount of almonds (at least 20%). While almonds shipped without a VASP certificate used
to be subject to 100 pct border controls in the original Commission Regulation 1152/2009, the regulation
has been amended in March 2012 to no longer authorize imports without a VASP (Commission
Regulation 1152/2009 also introduced the use of a Common Entry Document (CED). Importers have to
provide prior notification to the competent authorities at the designated port of entry for the goods
covered by the regulation at least 1 working day prior to the arrival of the goods, using the CED. The
CED was published as Annex II to Regulation 669/2009. Provisions for methods of sampling and
analysis for the official control of mycotoxins including aflatoxins are laid down in Commission
More information is available in the European Commission’s Guidance Document and on the Almond
Board of California’s website.
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 pesticide residues as well as 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. Directive 96/23/EC states that any third country exporting to the EU must submit
a plan setting out the guarantees it offers as regards the monitoring of the groups of residues and
substances referred to in Annex I to Council Directive 96/23/EC. Furthermore, a split system has to be
in place guaranteeing that animals have not been treated with growth promotants if their products will be
exported to the EU.
SECTION VI. OTHER REGULATIONS AND REQUIREMENTS
A. Product Inspection and Registration
Member State authorities 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. Infringements of EU food and feed legislation are reported through the Rapid Alert System
on Food and Feeds (RASFF). The rapid alert system is a network of Member State authorities managed
by the European Commission. The weekly reports of the notifications under the rapid alert are available
on the European Commission’s website (http://ec.europa.eu/food/food/rapidalert/index_en.htm). The
information published on the website is limited to the notifying country, the reason for notifying and the
country of origin. Repeated non-compliance may lead to suspension of imports or special import
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.
Specific detailed inspection requirements exist for animal products (Directive 97/78/EC). Products of
animal origin must be presented at a Community border inspection post and submitted to an import
control following prior notification of the shipment. Commission Decision 2009/821/EC establishes a
list of EU border inspection posts approved to carry out veterinary checks on animals and animal
products from third countries. Commission Decision 2007/275/EC establishes a list of animals and
products that are subject to controls at border inspection posts, including certain composite products as
well as a list of composite products that are not subject to veterinary checks.
European Parliament and Council Regulation 854/2004 lays down specific rules for the organization of
official controls on products of animal origin. European Parliament and Council Regulation 882/2004
lays down general rules for the performance of official controls to ensure the verification of compliance
with feed and food law, animal health and animal welfare rules. Commission Regulation 669/2009
implements Regulation 882/2004 as regards the increased level of official controls on imports of certain
feed and food of non-animal origin.
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 on
Inspection fees for non-animal origin products 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
Generally, there is no EU requirement to register imported foods except for the introduction of novel
foods. 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. The introduction of foodstuffs with
particular nutritional uses 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. See Section VII for detailed
B. Certification and Documentation Requirements
An overview of legally required certificates in the EU and references to the U.S. authority issuing these
certificates is available on our website at http://www.usda-eu.org/trade-with-the-eu/eu-import-
SECTION VII. OTHER SPECIFIC STANDARDS
A. Genetically Modified Foods
Labeling regulations for genetically modified (GM) food products are established by Regulation
1829/2003 (articles 12-13). These rules apply to products that have undergone varying degrees of
processing. The regulation does not require labeling of food products that are not food ingredients, such
as processing aids. Meat, milk or eggs obtained from animals fed with GM feed or treated with GM
medicinal products do not require GM labeling.
The traceability rules require all business operators to transmit and retain information on GM products
in order to identify both the supplier and the buyer of the GM product.
Each individual genetically modified organism (GMO) must be approved before it can be used in food
and feed. 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 labeling requirement does not apply to foods containing GMOs in a proportion equal to or
less than 0.9 percent of the food ingredients considered individually, provided their presence is
adventitious or technically unavoidable. Above this level, all products must be labeled using the
- 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]”.
Example: a biscuit containing soy flour derived from GM-soy must be labeled “contains soy flour from
genetically modified soy”.
- 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.
Example: for vegetable oils containing rapeseed oil produced from genetically modified rapeseed, the
reference “contains rapeseed oil from genetically modified rapeseed” must appear in the list of
The designations may appear in a footnote to the in