Commission Regulation (EC) No 41/2009 of 20 January 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten (Text with EEA relevance)
Date: 2009-01-20
Institutions: European Commission
Subjects: consumer information, food consumption, food poisoning, foodstuff, health risk, labelling, nutrition, nutritional disease, nutritional needs

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COMMISSION REGULATION (EC) No 41/2009

of 20 January 2009

concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

gluten-free food is difficult. Consequently, many food­
stuffs for this particular nutritional use on the market
may contain low residual amounts of gluten.

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 89/398/EEC of 3 May 1989
on the approximation of the laws of the Member States relating
to foodstuffs intended for particular nutritional uses (1), and in
particular Article 2(3) and Article 4a thereof,

Whereas:

(1)

(2)

Directive 89/398/EEC concerns foodstuffs intended for
particular nutritional uses which owing to their special
composition or manufacturing process are intended to
satisfy the particular nutritional requirements of specific
categories of the population. People with coeliac disease
are such a specific group of the population suffering
from a permanent intolerance to gluten.

The food industry has developed a range of products
presented as ‘gluten-free’ or similar equivalent
terms.
Differences between national provisions concerning the
conditions for the use of such product descriptions may
impede the free movement of the concerned products
and may fail to ensure the same high level of protection
for consumers. For the sake of clarity and in order to
types of
avoid confusing consumers with different
product descriptions at national
the conditions
level,
the terms related to the absence of
for the use of
gluten should be laid down at Community level.

(3) Wheat (i.e. all Triticum species, such as durum wheat,
spelt, and kamut), rye and barley, have been identified
as grains that are scientifically reported to contain gluten.
The gluten present in those grains can cause adverse
to gluten and
intolerant
health effects
therefore should be avoided by them.

to persons

(4)

The removal of gluten from gluten-containing grains
presents considerable technical difficulties and economic
totally
constraints and therefore the manufacture of

(1) OJ L 186, 30.6.1989, p. 27.

(5)

(6)

(7)

(8)

Most but not all people with intolerance to gluten can
include oats in their diet without adverse effect on their
health. This is an issue of ongoing study and investi­
gation by the scientific community. However, a major
concern is the contamination of oats with wheat, rye
can occur during grain harvesting,
or barley that
transport, storage and processing. Therefore, the risk of
gluten contamination in products containing oats should
be taken into consideration with regard to labelling of
those products.

foodstuffs appropriate for

Different people with intolerance to gluten may tolerate
variable small amounts of gluten within a restricted
In order to enable individuals to find on the
range.
market a variety of
their
needs and for their level of sensitivity, a choice of
products should be possible with different low levels of
It is important,
gluten within such a restricted range.
however, that the different products should be properly
labelled in order to ensure the correct use of
those
to gluten with the
products by people
fostered in the
support of
Member States.

information campaigns

intolerant

Foodstuffs for particular nutritional uses which have been
specially formulated, processed or prepared to meet the
dietary needs of people intolerant to gluten and marketed
as such should be labelled either as ‘very low gluten’ or
‘gluten-free’ in accordance with the provisions laid down
in this Regulation. These provisions can be achieved by
the use of foodstuffs which have been specially processed
to reduce the gluten content of one or more gluten
containing ingredients
the
and/or
gluten containing ingredients have been substituted by
other ingredients naturally free of gluten.

foodstuffs where

for

foodstuffs

for normal

Article 2(3) of Directive 89/398/EEC provides for the
possibility
consumption
which are suitable for a particular nutritional use to
indicate such suitability. Therefore, it should be possible
for a normal food which is suitable as part of a gluten-
free diet because it does not contain ingredients derived
from gluten containing grains or oats to bear terms indi­
cating the absence of gluten. Directive 2000/13/EC of the
European Parliament and of the Council of 20 March
2000 on the approximation of the laws of the Member

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States relating to the labelling, presentation and adver­
foodstuffs (1), requires that such a statement
tising of
does not mislead the consumer by suggesting that the
food possesses special characteristics when in fact all
similar foodstuffs possess such characteristics.

HAS ADOPTED THIS REGULATION:

Article 1

Scope

(9)

(10)

(11)

(12)

(13)

Commission Directive 2006/141/EC of 22 December
2006 on infant formulae and follow-on formulae and
amending Directive 1999/21/EC (2), prohibits the use of
ingredients containing gluten in the manufacture of such
the terms ‘very low
foodstuffs. Therefore,
the use of
gluten’ or ‘gluten-free’ on the labelling of such products
should be prohibited given that pursuant to the present
Regulation, this labelling is used for indicating respec­
tively a content of gluten not exceeding 100 mg/kg
and 20 mg/kg.

Commission Directive 2006/125/EC of 5 December
2006 on processed cereal-based foods and baby foods
for infants and young children (3) requires the indication
the presence or the absence of gluten when the
of
product
is intended for infants below six months of
age. The absence of gluten in those products should be
indicated in accordance with the requirements laid down
in this Regulation.

The Codex Standard for Foods for Special Dietary Use for
Persons Intolerant to Gluten was adopted by the 31st
session of the Codex Alimentarius Commission in July
2008 (4), with a view to enabling those persons to find
on the market a variety of food suitable to their needs
and to their level of sensitivity to gluten. That standard
should be taken appropriately into consideration for the
purposes of this Regulation.

In order to allow the economic operators to adapt their
production process, the date of application of the present
Regulation should allow the necessary transitional period.
However products which at the date of entry into force
this Regulation already comply with it can be
of
marketed in the Community as from the date of entry
into force of the present Regulation.

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

(1) OJ L 109, 6.5.2000, p. 29.
(2) OJ L 401, 30.12.2006, p. 1.
(3) OJ L 339, 6.12.2006, p. 16.
(4) http://www.codexalimentarius.net/download/standards/291/

cxs_118e.pdf

This Regulation shall apply to foodstuffs other than the infant
formulae
covered by Directive
2006/141/EC.

and follow-on formulae

Article 2

Definitions

For the purposes of this Regulation, the following definitions
shall apply:

(a)

‘foodstuffs for people intolerant to gluten’ means foodstuffs
for particular nutritional uses which are specially produced,
prepared and/or processed to meet the special dietary needs
of people intolerant to gluten;

(b) ‘gluten’ means a protein fraction from wheat, rye, barley,
oats or their crossbred varieties and derivatives thereof, to
which some persons are intolerant and which is insoluble in
water and 0,5 M sodium chloride solution;

(c)

‘wheat’ means any Triticum species.

Article 3

Composition and labelling of foodstuffs for people
intolerant to gluten

1.
Foodstuffs for people intolerant to gluten, consisting of or
containing one or more ingredients made from wheat, rye,
barley, oats or their crossbred varieties which have been espe­
cially processed to reduce gluten, shall not contain a level of
gluten exceeding 100 mg/kg in the food as sold to the final
consumer.

The labelling, advertising and presentation of the products
2.
referred to in paragraph 1 shall bear the term ‘very low gluten’.
They may bear the term ‘gluten-free’ if the gluten content does
not exceed 20 mg/kg in the food as sold to the final consumer.

3.
to
Oats contained in foodstuffs for people intolerant
gluten must have been specially produced, prepared and/or
processed in a way to avoid contamination by wheat, rye,
barley, or their crossbred varieties and the gluten content of
such oats must not exceed 20 mg/kg.

Foodstuffs for people intolerant to gluten, consisting of or
4.
containing one or more ingredients which substitute wheat, rye,
barley, oats or their crossbred varieties shall not contain a level
of gluten exceeding 20 mg/kg in the food as sold to the final
consumer. The labelling, presentation and advertising of those
products shall bear the term ‘gluten-free’.

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5. Where foodstuffs for people intolerant to gluten contain
both ingredients which substitute wheat, rye, barley, oats or
their crossbred varieties and ingredients made from wheat,
rye, barley, oats or their crossbred varieties which have been
especially processed to reduce gluten, paragraphs 1, 2, and 3
shall apply and paragraph 4 shall not apply.

(b) foodstuffs for particular nutritional uses which are specially
formulated, processed or prepared to meet special dietary
needs other than those of people intolerant to gluten but
which are nevertheless suitable, by virtue of their compo­
sition, to meet the special dietary needs of people intolerant
to gluten.

The terms ‘very low gluten’ or ‘gluten-free’ referred to in
6.
paragraphs 2 and 4 shall appear in proximity to the name
under which the food is sold.

2.
The labelling, advertising and presentation of foodstuffs
referred to in paragraph 1 shall not bear the term ‘very low
gluten’.

Article 4

Composition and labelling of other foodstuffs suitable for
people intolerant to gluten

1. Without prejudice
to Article 2(1)(a)(iii) of Directive
2000/13/EC, the labelling, advertising and presentation of the
following foodstuffs may bear the term ‘gluten-free’ provided
that the gluten content does not exceed 20 mg/kg in the food
as sold to the final consumer:

(a)

foodstuffs for normal consumption;

Article 5

Entry into force and application

This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

It shall apply as from 1 January 2012.

However, foodstuffs which at the date of entry into force of the
present Regulation already comply with the provisions of the
Regulation may be placed on the market in the Community.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 January 2009.

For the Commission

Androulla VASSILIOU
Member of the Commission