Voluntary Report - public distribution

**Date:** 10/6/2005

**GAIN Report Number:** E35196

E35196

**EU-25**

**Food and Agricultural Import Regulations and Standards**

**Allergen Labeling - Implementation November 25, 2005**

**2005**

**Approved by:**

![](media/image1.wmf)Norval E. Francis, Jr.

U.S. Mission to the EU

**Prepared by:**

Hilde Brans

**Report Highlights:**

New food allergen labeling rules were introduced by Directive
2003/89/EC, an amendment to the general food labeling directive
2000/13/EC. The new rules will be fully implemented as from November 25,
2005. Products not complying with the new legislation will be prohibited
for sale in the EU.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Brussels USEU \[BE2\]

\[E3\]

# Allergen Labeling -- Implementation November 25, 2005

## Legislation

New food allergen labeling rules were introduced by Directive
2003/89/EC, an amendment to the general food labeling directive
2000/13/EC. This directive requires food manufacturers to indicate 12
groups of potential allergens by reference to the source allergen if
they are used as an ingredient at any level in pre-packed foods,
including alcoholic drinks. The new rules also abolish the "25 percent
rule" under which it was not mandatory to label components of compound
ingredients if they made up less than 25 percent of the final food
product. The new allergen labeling rules will be fully implemented as
from November 25, 2005. Products not complying with the new legislation
will be prohibited for sale in the EU.

### List of potential allergenic ingredients to be labeled (Annex IIIa to Directive 2003/89/EC):

-   Cereals containing gluten and products thereof

-   Crustaceans and products thereof

-   Eggs and products thereof

-   Fish and products thereof

-   Peanuts and products thereof

-   Soybeans and products thereof

-   Milk and dairy products (including lactose)

-   Nuts and nut products

-   Celery and products thereof

-   Mustard and products thereof

-   Sesame seeds and products thereof

-   Sulphur dioxide and sulphites at concentrations of more than 10
    mg/kg or 10 mg/l expressed as SO2

## Exemptions

As a general rule, labeling derogations will not be allowed for
allergenic ingredients. However, certain derivatives of the listed
allergens may not trigger an allergic reaction. Directive 2003/89/EC
establishes during a transitional period, a procedure that allows for a
temporary exemption while food manufacturers conduct studies to provide
the necessary scientific evidence. Directive 2005/26/EC establishes a
list of allergen derivatives that, based on the European Food Safety
Authority's risk assessments, are temporarily exempted - until November
25, 2007 - from mandatory labeling. Substances for which no final
studies will have been delivered before the November 25, 2007 deadline
will be re-included in the allergenic ingredients list.

### List of allergen derivatives that are temporarily exempted (Annex to Directive 2005/26/EC):

+---------------+------------------------------------------------------+
| **            | **Products thereof provisionally excluded**          |
| Ingredients** |                                                      |
+---------------+------------------------------------------------------+
| Cereals       | \- Wheat based glucose syrups including dextrose     |
| containing    |                                                      |
| gluten        | \- Wheat based maltodextrins                         |
|               |                                                      |
|               | \- Glucose syrups based on barley                    |
|               |                                                      |
|               | \- Cereals used in distillates for spirits           |
+---------------+------------------------------------------------------+
| Eggs          | \- Lysozym (produced from egg) used in wine          |
|               |                                                      |
|               | \- Albumin (produced from egg) used as fining agent  |
|               | in wine and cider                                    |
+---------------+------------------------------------------------------+
| Fish          | \- Fish gelatin used as carrier for vitamins or      |
|               | carotenoid preparations and flavors                  |
|               |                                                      |
|               | \- Fish gelatin or Isinglass used as fining agent in |
|               | beer, cider and wine                                 |
+---------------+------------------------------------------------------+
| Soybean       | \- Fully refined soybean oil and fat                 |
|               |                                                      |
|               | \- Natural mixed tocopherols (E306), natural D-alpha |
|               | tocopherol, natural D-alpha tocopherol acetate,      |
|               | natural D-alpha tocopherol succinate from soybean    |
|               | sources                                              |
|               |                                                      |
|               | \- Vegetable oils derived phytosterols and           |
|               | phytosterol esters from soybean sources              |
|               |                                                      |
|               | \- Plant stanol ester produced from vegetable oil    |
|               | sterols from soybean sources                         |
+---------------+------------------------------------------------------+
| Milk          | \- Whey used in distillates for spirits              |
|               |                                                      |
|               | \- Lactitol                                          |
|               |                                                      |
|               | \- Milk (casein) products used in fining agents in   |
|               | cider and wines                                      |
+---------------+------------------------------------------------------+
| Nuts          | \- Nuts used in distillates for spirits              |
|               |                                                      |
|               | \- Nuts (almonds, walnuts) used (as flavor) in       |
|               | spirits                                              |
+---------------+------------------------------------------------------+
| Celery        | \- Celery leaf and seed oil                          |
|               |                                                      |
|               | \- Celery seed oleoresin                             |
+---------------+------------------------------------------------------+
| Mustard       | \- Mustard oil                                       |
|               |                                                      |
|               | \- Mustard seed oil                                  |
|               |                                                      |
|               | \- Mustard seed oleoresin                            |
+---------------+------------------------------------------------------+

## Guidelines

General labeling directive 2000/13/EC sets out possible derogations for
labeling "normal" ingredients. Although derogations are not allowed for
allergenic ingredients, the Commission has published informal guidelines
explaining why in some cases, derogations can also be admitted for such
ingredients. The guidelines address questions relating to the indication
or repetition of an ingredient and/or the source of that ingredient, the
name under which the foodstuff is sold, the level of sulphur dioxide and
the definition of "products thereof".

Examples:

\- The label on a foodstuff sold under the name "cake flavored with
almonds" could include the category name "flavor" alone in the list of
ingredients, even where the flavor has been made using almond extracts
because the name of the product clearly refers to the allergen
ingredient concerned.

\- A product containing additives, carriers and processing aids derived
from wheat could be labeled as follows: "..., additive (1), carrier (1),
processing aid (1),...(1) from wheat". The reference to the allergen
ingredient from which the additives, carriers and processing aids
originate must not be repeated as many times as these substances are
present in the foodstuff.

The guidelines can be downloaded from the Commission's website at
<http://europa.eu.int/comm/food/food/labellingnutrition/foodlabelling/guidelines_6_10.pdf>

## References

European Parliament and Council Directive 2000/13/EC relating to the
labeling, presentation and advertising of foodstuffs.

<http://europa.eu.int/comm/food/fs/fl/fl01_en.pdf>

European Parliament and Council Directive 2003/89/EC, amending Directive
2000/13/EC as regards indication of the ingredients present in
foodstuffs.

<http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_308/l_30820031125en00150018.pdf>

Commission Directive 2005/86/EC establishing a list of food ingredients
provisionally excluded from Annex IIIa of Directive 2000/13/EC.

<http://europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2005/l_075/l_07520050322en00330034.pdf>

(corrected by Commission Directive 2005/63/EC -
<http://europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2005/l_258/l_25820051004en00030003.pdf>)

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

**Related reports from USEU Brussels:**

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

  E35060                                                       Allergen Labeling -- Temporary       March 2005
                                                               Exemptions                           

  E34093                                                       Allergen Labeling on Wine            November 2004

  E23186                                                       New Allergen Labeling                September 2003

  E35162                                                       Food & Agricultural Import           August 2005
                                                               Regulations & Standards              

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