Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (Text with EEA relevance)
Date: 2008-12-16
Institutions: Council of the European Union, European Parliament
Subjects: consumer protection, environmental protection, flavouring, food safety, foodstuff, labelling, public health

L 354/34

EN

Official Journal of the European Union

31.12.2008

REGULATION (EC) No 1334/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 16 December 2008

on flavourings and certain food ingredients with flavouring properties for use in and on foods and
amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008
and Directive 2000/13/EC

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

(4)

(5)

(6)

(7)

Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and
Social Committee (1),

Acting in accordance with the procedure laid down in Article 251
of the Treaty (2),

Whereas:

(1)

(2)

(3)

Council Directive 88/388/EEC of 22 June 1988 on the
approximation of the laws of the Member States relating to
flavourings for use in foodstuffs and to source materials for
their production (3) needs to be updated in the light of
technical and scientific developments. In the interests of
clarity and efficiency Directive 88/388/EEC should be
replaced by this Regulation.

Council Decision 88/389/EEC of 22 June 1988 on the
establishment, by the Commission, of an inventory of the
source materials and substances used in the preparation of
flavourings (4) provides for the establishment of that inven-
tory within 24 months of its adoption. That Decision is
now obsolete and should be repealed.

Commission Directive 91/71/EEC of 16 January 1991
completing Council Directive 88/388/EEC on the approxi-
mation of the laws of the Member States relating to fla-
vourings for use in foodstuffs and to source materials for
their production (5) lays down rules on the labelling of fla-
vourings. Those rules are replaced by this Regulation and
the Directive should now be repealed.

(1) OJ C 168, 20.7.2007, p. 34.
(2) Opinion of the European Parliament of 10 July 2007 (OJ C 175 E,
10.7.2008, p. 176), Council Common Position of 10 March 2008
(OJ C 111 E, 6.5.2008, p. 46). Position of the European Parliament of
8 July 2008 (not yet published) and Council Decision of 18 Novem-
ber 2008.

(3) OJ L 184, 15.7.1988, p. 61.
(4) OJ L 184, 15.7.1988, p. 67.
(5) OJ L 42, 15.2.1991, p. 25.

The free movement of safe and wholesome food is an
essential aspect of the internal market and contributes sig-
nificantly to the health and well-being of citizens, and to
their social and economic interests.

In order to protect human health, this Regulation should
cover flavourings, source materials for flavourings and
foods containing flavourings. It should also cover certain
food ingredients with flavouring properties which are
added to food for the main purpose of adding flavour and
which contribute significantly to the presence in food of
certain naturally occurring undesirable substances (herein-
after referred to as food ingredients with flavouring prop-
erties), their source material and foods containing them.

Raw foodstuffs which have not undergone any processing
treatment and non-compound foodstuffs such as spices,
herbs, teas and infusions (e.g. fruit or herbal tea) as well as
mixtures of spices and/or herbs, mixtures of tea and mix-
tures for infusion, as long as they are consumed as such
and/or not added to the food, do not fall within the scope
of this Regulation.

Flavourings are used to improve or modify the odour
and/or taste of foods for the benefit of the consumer. Fla-
vourings and food ingredients with flavouring properties
should only be used if they fulfil the criteria laid down in
this Regulation. They must be safe when used, and certain
flavourings should, therefore, undergo a risk assessment
before they can be permitted in food. Where possible,
attention should be focused on whether or not the use of
certain flavourings could have any negative consequences
on vulnerable groups. The use of flavourings must not mis-
lead the consumer and their presence in food should,
therefore, always be indicated by appropriate labelling. Fla-
vourings should, in particular, not be used in a way as to
mislead the consumer about issues related to, amongst
other things, the nature, freshness, quality of ingredients
used, the naturalness of a product or of the production
process, or the nutritional quality of the product. The
approval of flavourings should also take into account other
factors relevant to the matter under consideration includ-
ing societal, economic, traditional, ethical and environ-
the precautionary principle and the
mental
feasibility of controls.

factors,

31.12.2008

EN

Official Journal of the European Union

L 354/35

(8)

(9)

Since 1999, the Scientific Committee on Food and subse-
quently the European Food Safety Authority (hereinafter
referred to as the Authority) established by Regulation (EC)
No 178/2002 of the European Parliament and of the Coun-
cil of 28 January 2002 laying down the general principles
and requirements of food law, establishing the European
Food Safety Authority and laying down procedures in mat-
ters of food safety (1) have expressed opinions on a num-
ber of substances occurring naturally in source materials
for flavourings and food ingredients with flavouring prop-
erties which, according to the Committee of Experts on
Flavouring Substances of the Council of Europe, raise toxi-
cological concern. Substances for which the toxicological
concern was confirmed by the Scientific Committee on
Food should be regarded as undesirable substances which
should not be added as such to food.

Due to their natural occurrence in plants, undesirable sub-
stances might be present in flavouring preparations and
food ingredients with flavouring properties. The plants are
used traditionally as food or food ingredients. Appropriate
maximum levels should be established for the presence of
these undesirable substances in foods which contribute
most to the human intake of these substances, taking into
account both the need to protect human health and their
unavoidable presence in traditional foods.

(10) Maximum levels for certain naturally occurring undesirable
substances should focus on the food or food categories
which contribute most to dietary intake. Should additional
naturally occurring undesirable substances pose a risk to
the health of the consumer, maximum levels should be set
following the opinion of the Authority. Member States
should organise controls on a risk basis in line with Regu-
lation (EC) No 882/2004 of the European Parliament and
of the Council of 29 April 2004 on official controls per-
formed to ensure the verification of compliance with feed
and food law, animal health and animal welfare rules (2).
Food producers are obliged to take into account the pres-
ence of these substances when using food ingredients with
flavouring properties and/or flavourings for preparation of
all food to ensure that food which is not safe is not placed
on the market.

(11)

Provisions should be established at Community level in
order to prohibit, or restrict the use of, certain plant, ani-
mal, microbiological or mineral materials which raise con-
cern for human health in the production of flavourings
and food ingredients with flavouring properties and their
applications in food production.

(12)

Risk assessments should be carried out by the Authority.

(13)

(14)

(15)

(16)

In order to ensure harmonisation, the risk assessment and
approval of flavourings and source materials that need to
undergo an evaluation should be carried out in accordance
with the procedure laid down in Regulation (EC)
No 1331/2008 of the European Parliament and of the
Council of 16 December 2008 establishing a common
authorisation procedure for food additives, food enzymes
and food flavourings (3).

Flavouring substances are defined chemical substances,
which include flavouring substances obtained by chemical
synthesis or isolated using chemical processes, and natural
flavouring substances. An evaluation programme of fla-
vouring substances is ongoing in accordance with Regula-
tion (EC) No 2232/96 of the European Parliament and of
the Council of 28 October 1996 laying down a Commu-
nity procedure for flavouring substances used or intended
for use in or on foodstuffs (4). Under that Regulation a list
of flavouring substances is to be adopted within five years
of adoption of that programme. A new deadline should be
set for the adoption of that list. That list will be proposed
for inclusion in the list referred to in Article 2(1) of Regu-
lation (EC) No 1331/2008.

Flavouring preparations are flavourings other than defined
chemical substances obtained from materials of vegetable,
animal or microbiological origin, by appropriate physical,
enzymatic or microbiological processes, either in the raw
state of the material or after processing for human con-
sumption. Flavouring preparations produced from food do
not need to undergo an evaluation or an approval proce-
dure for use in and on foods unless there is doubt about
their safety. However, the safety of flavouring preparations
produced from non-food material should be evaluated and
approved.

Regulation (EC) No 178/2002 defines food as any sub-
stance or product, whether processed, partially processed
or unprocessed, intended to be, or reasonably expected to
be, ingested by humans. Materials of vegetable, animal or
microbiological origin, for which it can be sufficiently
demonstrated that they have hitherto been used for the
production of flavourings, are considered to be food mate-
rials for this purpose, even though some of these source
materials, such as rose wood and strawberry leaves, may
not have been used for food as such. They do not need to
be evaluated.

(1) OJ L 31, 1.2.2002, p. 1.
(2) OJ L 165, 30.4.2004, p. 1. Corrected version in OJ L 191, 28.5.2004,

p. 1.

(3) See page 1 of this Official Journal.
(4) OJ L 299, 23.11.1996, p. 1.

L 354/36

EN

Official Journal of the European Union

31.12.2008

(17)

(18)

(19)

Likewise, thermal process flavourings produced from food
under specified conditions need not undergo an evaluation
or an approval procedure for use in and on foods unless
there is doubt about their safety. However, the safety of
thermal process flavourings produced from non-food
material or not complying with certain conditions of pro-
duction should be evaluated and approved.

(24)

Regulation (EC) No 2065/2003 of the European Parlia-
ment and of the Council of 10 November 2003 on smoke
flavourings used or intended for use in or on foods (1) lays
down a procedure for the safety assessment and approval
of smoke flavourings and aims to establish a list of primary
smoke condensates and primary tar fractions the use of
which is authorised to the exclusion of all others.

Flavour precursors such as carbohydrates, oligo-peptides
and amino acids impart flavour to food by chemical reac-
tions which occur during food processing. Flavour precur-
sors produced from food do not need to undergo an
evaluation or an approval procedure for use in and on
foods unless there is doubt about their safety. However, the
safety of flavour precursors produced from non-food mate-
rial should be evaluated and approved.

(20) Other flavourings which do not fall under the definitions
of the previously mentioned flavourings may be used in
and on foods after they have undergone an evaluation and
approval procedure. An example could be flavourings
which are obtained by heating oil or fat to an extremely
high temperature for a very short period of time, resulting
in a grill-like flavour.

(26)

(21) Material of vegetable, animal, microbiological or mineral
origin other than food may only be authorised for the pro-
duction of flavourings after its safety has been evaluated
scientifically. It might be necessary to authorise the use of
only certain parts of the material or to set conditions of
use.

(22)

Flavourings can contain food additives as permitted by
Regulation (EC) No 1333/2008 of the European Parlia-
ment and of the Council of 16 December 2008 on food
additives (2) and/or other food ingredients for technologi-
cal purposes such as for their storage, standardisation, dilu-
tion or dissolution and stabilisation.

(23) A flavouring or a source material which falls within the
scope of Regulation (EC) No 1829/2003 of the European
Parliament and of the Council of 22 September 2003
on genetically modified food and feed (3) should be

authorised in accordance with that Regulation as well as
under this Regulation.

Flavourings remain subject to the general labelling obliga-
tions provided for in Directive 2000/13/EC of the Euro-
pean Parliament and of the Council of 20 March 2000 on
the approximation of the laws of the Member States relat-
ing to the labelling, presentation and advertising of food-
stuffs (4) and, as the case may be,
in Regulations (EC)
No 1829/2003 and Regulation (EC) No 1830/2003 of the
European Parliament and of the Council of 22 September
2003 concerning the traceability and labelling of geneti-
cally modified organisms and the traceability of food and
feed products produced from genetically modified organ-
isms (5). In addition, specific provisions on the labelling of
flavourings sold as such to the manufacturer or to the final
consumer should be contained in this Regulation.

(25)

Flavouring substances or flavouring preparations should
only be labelled as ‘natural’ if they comply with certain cri-
teria which ensure that consumers are not misled.

Specific information requirements should ensure that con-
sumers are not misled concerning the source material used
for the production of natural flavourings. In particular, if
the term natural is used to describe a flavour, the flavour-
ing components used should be entirely of natural origin.
In addition, the source of the flavourings should be
labelled, except when the source materials referred to
would not be recognised in the flavour or taste of the food.
If a source is mentioned, at least 95 % of the flavouring
component should be obtained from the material referred
to. As the use of flavourings should not mislead the con-
sumer, the other maximum 5 % can only be used for stan-
dardisation or to give a, for example, more fresh, pungent,
ripe or green note to the flavouring. When less than 95 %
of the flavouring component derived from the source
referred to has been used and the flavour of the source can
still be recognised, the source should be revealed together
with a statement that other natural flavourings have been
added, for example cacao extract in which other natural
flavourings have been added to impart a banana note.

(27)

Consumers should be informed if the smoky taste of a par-
ticular food is due to the addition of smoke flavourings. In
the labelling
accordance with Directive 2000/13/EC,
should not confuse the consumer as to whether the prod-
uct is smoked conventionally with fresh smoke or treated
with smoke flavourings. Directive 2000/13/EC needs to be
adapted to the definitions of flavourings, smoke flavour-
ings and the term ‘natural’ for the description of flavour-
ings laid down in this Regulation.

(1) OJ L 309, 26.11.2003, p. 1.
(2) See page 16 of this Official Journal.
(3) OJ L 268, 18.10.2003, p. 1.

(4) OJ L 109, 6.5.2000, p. 29.
(5) OJ L 268, 18.10.2003, p. 24.

31.12.2008

EN

Official Journal of the European Union

L 354/37

For the evaluation of the safety of flavouring substances for
human health, information on the consumption and use of
flavouring substances is crucial. The amounts of flavour-
ing substances added to food should therefore be checked
on a regular basis.

submission by the Commission to the Standing Commit-
tee on the Food Chain and Animal Health of a draft regu-
lation updating the Community list should not apply,
because priority should be given to the ongoing evaluation
programme.

The measures necessary for the implementation of this
Regulation should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down the
procedures for the exercise of implementing powers con-
ferred on the Commission (1).

(35)

(28)

(29)

(30)

In particular the Commission should be empowered to
amend the Annexes to this Regulation and to adopt appro-
priate transitional measures regarding the establishment of
the Community list. Since those measures are of general
scope and are designed to amend non-essential elements of
this Regulation, inter alia, by supplementing it with new
non-essential elements, they must be adopted in accor-
dance with the regulatory procedure with scrutiny pro-
vided for in Article 5a of Decision 1999/468/EC.

(31) When, on imperative grounds of urgency, the normal time-
limits for the regulatory procedure with scrutiny cannot be
complied with, the Commission should be able to apply
the urgency procedure provided for in Article 5a(6) of
Decision 1999/468/EC for the adoption of measures
described in Article 8(2) and amendments to Annexes II
to V to this Regulation.

(32) Annexes II to V to this Regulation should be adapted as
necessary to scientific and technical progress, taking into
account the information provided by producers and users
of flavourings and/or resulting from the monitoring and
controls by the Member States.

(33)

(34)

In order to develop and update Community law on fla-
vourings in a proportionate and effective way, it is neces-
sary to collect data, share information and coordinate work
between Member States. For that purpose, it may be useful
to undertake studies to address specific issues with a view
to facilitating the decision-making process. It is appropri-
ate that the Community finance such studies as part of its
budgetary procedure. The financing of such measures is
covered by Regulation (EC) No 882/2004.

Pending the establishment of the Community list, provi-
sion should be made for the evaluation and approval of fla-
vouring substances which are not covered by the
evaluation programme provided for in Regulation (EC)
No 2232/96. A transitional regime should therefore be laid
down. Under that regime such flavouring substances
should be evaluated and approved in accordance with the
procedure laid down in Regulation (EC) No 1331/2008.
However, the time periods provided for in that Regulation
for the adoption by the Authority of its opinion and for the

Since the objective of this Regulation, namely to lay down
Community rules on the use of flavourings and certain
food ingredients with flavouring properties in and on
foods, cannot be sufficiently achieved by the Member
States and can therefore, in the interests of market unity
and a high level of consumer protection, be better achieved
at Community level, the Community may adopt measures,
in accordance with the principle of subsidiary as set out in
Article 5 of the Treaty. In accordance with the principle of
proportionality, as set out in that Article, this Regulation
does not go beyond what is necessary in order to achieve
that objective.

(36)

Council Regulation (EEC) No 1601/91 of 10 June 1991
laying down general rules on the definition, description
and presentation of aromatised wines, aromatised wine-
based drinks and aromatised wine-product cocktails (2) and
Regulation (EC) No 110/2008 of the European Parliament
and of the Council of 15 January 2008 on the definition,
description, presentation, labelling and the protection of
geographical
indications of spirit drinks (3) need to be
adapted to certain new definitions laid down in this
Regulation.

(37)

Regulations (EEC) No 1601/91, (EC) No 2232/96 and (EC)
No 110/2008 and Directive 2000/13/EC should be
amended accordingly,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter

This Regulation lays down rules on flavourings and food ingredi-
ents with flavouring properties for use in and on foods with a
view to ensuring the effective functioning of the internal market
whilst ensuring a high level of protection of human health and a
high level of consumer protection, including the protection of
consumer interests and fair practices in food trade, taking into
account, where appropriate, the protection of the environment.

(1) OJ L 184, 17.7.1999, p. 23.

(2) OJ L 149, 14.6.1991, p. 1.
(3) OJ L 39, 13.2.2008, p. 16.

L 354/38

EN

Official Journal of the European Union

31.12.2008

For those purposes, this Regulation provides for:

(a) a Community list of

flavourings and source materials
approved for use in and on foods, set out in Annex I (here-
inafter referred to as the ‘Community list’);

(b) conditions of use of flavourings and food ingredients with

flavouring properties in and on foods;

(c)

rules on the labelling of flavourings.

Article 2

Scope

1.

This Regulation shall apply to:

(ii) made or consisting of the following categories: flavour-
ing substances, flavouring preparations, thermal process
flavourings, smoke flavourings, flavour precursors or
other flavourings or mixtures thereof;

(b)

‘flavouring substance’ shall mean a defined chemical sub-
stance with flavouring properties;

(c)

‘natural flavouring substance’ shall mean a flavouring sub-
stance obtained by appropriate physical, enzymatic or micro-
biological processes from material of vegetable, animal or
microbiological origin either in the raw state or after process-
ing for human consumption by one or more of the tradi-
tional food preparation processes listed in Annex II. Natural
flavouring substances correspond to substances that are natu-
rally present and have been identified in nature;

(a)

flavourings which are used or intended to be used in or on
foods, without prejudice to more specific provisions laid
down in Regulation (EC) No 2065/2003;

(d)

‘flavouring preparation’ shall mean a product, other than a
flavouring substance, obtained from:

(b)

food ingredients with flavouring properties;

(c)

food containing flavourings and/or food ingredients with fla-
vouring properties;

(i)

food by appropriate physical, enzymatic or microbio-
logical processes either in the raw state of the material or
after processing for human consumption by one or
more of the traditional food preparation processes listed
in Annex II;

(d)

source materials for flavourings and/or source materials for
food ingredients with flavouring properties.

and/or

2.

This Regulation shall not apply to:

(a)

substances which have exclusively a sweet, sour or salty taste;

(b)

raw foods;

(c) non-compound foods and mixtures such as, but not exclu-
sively, fresh, dried or frozen spices and/or herbs, mixtures of
tea and mixtures for infusion as such as long as they have not
been used as food ingredients.

(ii) material of vegetable, animal or microbiological origin,
other than food, by appropriate physical, enzymatic or
microbiological processes, the material being taken as
such or prepared by one or more of the traditional food
preparation processes listed in Annex II;

(e)

‘thermal process flavouring’ shall mean a product obtained
after heat treatment from a mixture of ingredients not nec-
essarily having flavouring properties themselves, of which at
least one contains nitrogen (amino) and another is a reduc-
ing sugar; the ingredients for the production of thermal pro-
cess flavourings may be:

Article 3

Definitions

1.
For the purposes of this Regulation, the definitions laid
down in Regulations (EC) No 178/2002 and (EC) No 1829/2003
shall apply.

(i)

food;

and/or

For the purposes of this Regulation, the following defini-

2.
tions shall also apply:

(ii)

source material other than food;

(a)

‘flavourings’ shall mean products:

(i) not intended to be consumed as such, which are added
to food in order to impart or modify odour and/or taste;

(f)

‘smoke flavouring’ shall mean a product obtained by fraction-
ation and purification of a condensed smoke yielding pri-
mary smoke condensates, primary tar fractions and/or
derived smoke flavourings as defined in points (1), (2) and (4)
of Article 3 of Regulation (EC) No 2065/2003;

31.12.2008

EN

Official Journal of the European Union

L 354/39

(g)

‘flavour precursor’ shall mean a product, not necessarily hav-
ing flavouring properties itself, intentionally added to food
for the sole purpose of producing flavour by breaking down
or reacting with other components during food processing;
it may be obtained from:

CHAPTER II

CONDITIONS FOR USE OF FLAVOURINGS, FOOD
INGREDIENTS WITH FLAVOURING PROPERTIES AND
SOURCE MATERIALS

(i)

food;

and/or

Article 4

General conditions for use of flavourings or food
ingredients with flavouring properties

(ii)

source material other than food;

Only flavourings or food ingredients with flavouring properties
which meet the following conditions may be used in or on foods:

(h)

‘other flavouring’ shall mean a flavouring added or intended
to be added to food in order to impart odour and/or taste and
which does not fall under definitions (b) to (g);

(a)

they do not, on the basis of the scientific evidence available,
pose a safety risk to the health of the consumer; and

(i)

(j)

‘food ingredient with flavouring properties’ shall mean a food
ingredient other than flavourings which may be added to
food for the main purpose of adding flavour to it or modify-
ing its flavour and which contributes significantly to the pres-
ence in food of certain naturally occurring undesirable
substances;

(b)

their use does not mislead the consumer.

Article 5

Prohibition of non-compliant flavourings and/or
non-compliant food

‘source material’ shall mean material of vegetable, animal,
microbiological or mineral origin from which flavourings or
food ingredients with flavouring properties are produced; it
may be:

No person shall place on the market a flavouring or any food in
which such a flavouring and/or food ingredients with flavouring
properties are present if their use does not comply with this
Regulation.

(i)

food;

or

Article 6

Presence of certain substances

(ii)

source material other than food;

Substances listed in Part A of Annex III shall not be added

1.
as such to food.

(k)

‘appropriate physical process’ shall mean a physical process
which does not intentionally modify the chemical nature of
the components of the flavouring, without prejudice to the
listing of traditional food preparation processes in Annex II,
and does not involve, inter alia, the use of singlet oxygen,
ozone, inorganic catalysts, metal catalysts, organometallic
reagents and/or UV radiation.

3.
For the purpose of the definitions listed in paragraph 2(d),
(e), (g) and (j), source materials for which hitherto there is signifi-
cant evidence of use for the production of flavourings shall be
considered as food for the purpose of this Regulation.

4.
Flavourings may contain food additives as permitted by
Regulation (EC) No 1333/2008 and/or other food ingredients
incorporated for technological purposes.

2. Without prejudice to Regulation (EC) No 110/2008, maxi-
mum levels of certain substances, naturally present in flavourings
and/or food ingredients with flavouring properties, in the com-
pound foods listed in Part B of Annex III shall not be exceeded as
a result of the use of flavourings and/or food ingredients with fla-
vouring properties in and on those foods. The maximum levels of
the substances set out in Annex III shall apply to foods as mar-
keted, unless otherwise stated. By way of derogation from this
principle, for dried and/or concentrated foods which need to be
reconstituted, the maximum levels shall apply to the food as
reconstituted according to the instructions on the label, taking
into account the minimum dilution factor.

3.
Detailed rules for the implementation of paragraph 2 may
be adopted in accordance with the regulatory procedure referred
to in Article 21(2), following the opinion of the European Food
Safety Authority (hereinafter referred to as the ‘Authority’), where
necessary.

L 354/40

EN

Official Journal of the European Union

31.12.2008

Article 7

Use of certain source materials

CHAPTER III

COMMUNITY LIST OF FLAVOURINGS AND SOURCE
MATERIALS APPROVED FOR USE IN OR ON FOODS

1.
Source materials listed in Part A of Annex IV shall not be
used for the production of flavourings and/or food ingredients
with flavouring properties.

Article 9

Flavourings and source materials for which an evaluation
and approval is required

2.
Flavourings and/or food ingredients with flavouring prop-
erties produced from source materials listed in Part B of Annex IV
may be used only under the conditions indicated in that Annex.

This Chapter shall apply to:

(a)

flavouring substances;

Article 8

Flavourings and food ingredients with flavouring
properties for which evaluation and approval are not
required

(b)

flavouring preparations referred to in Article 3(2)(d)(ii);

(c)

thermal process flavourings obtained by heating ingredients
which fall partially or totally within Article 3(2)(e)(ii) and/or
for which the conditions for the production of thermal pro-
cess flavourings and/or the maximum levels for certain unde-
sirable substances set out in Annex V are not met;

1.
The following flavourings and food ingredients with fla-
vouring properties may be used in or on foods without an evalu-
ation and approval under this Regulation, provided that they
comply with Article 4:

(d)

flavour precursors referred to in Article 3(2)(g)(ii);

(e) other flavourings referred to in Article 3(2)(h);

(a)

flavouring preparations referred to in Article 3(2)(d)(i);

(f)

source materials other
Article 3(2)(j)(ii).

than food

referred

to in

(b)

thermal process flavourings referred to in Article 3(2)(e)(i)
which comply with the conditions for the production of ther-
mal process flavourings and maximum levels for certain sub-
stances in thermal process flavourings set out in Annex V;

(c)

flavour precursors referred to in Article 3(2)(g)(i);

(d)

food ingredients with flavouring properties.

Article 10

Community list of flavourings and source materials

Of the flavourings and source materials referred to in Article 9,
only those included in the Community list may be placed on the
market as such and used in or on foods under the conditions of
use specified therein, where applicable.

Article 11

Inclusion of flavourings and source materials in the
Community list

2.
Notwithstanding paragraph 1, if the Commission, a Mem-
ber State or the Authority expresses doubts concerning the safety
of a flavouring or food ingredient with flavouring properties
referred to in paragraph 1, a risk assessment of such flavouring or
food ingredient with flavouring properties shall be carried out by
the Authority. Articles 4, 5 and 6 of Regulation (EC)
No 1331/2008 shall then apply mutatis mutandis. If necessary, the
Commission shall adopt measures, following the opinion of the
Authority, which are designed to amend non-essential elements of
this Regulation, inter alia, by supplementing it, in accordance with
the regulatory procedure with scrutiny referred to in Article 21(3).
Such measures shall be laid down in Annexes III, IV and/or V
where appropriate. On imperative grounds of urgency, the
Commission may use the urgency procedure referred to in
Article 21(4).

1.
A flavouring or source material may be included in the
Community list, in accordance with the procedure laid down by
Regulation (EC) No 1331/2008, only if it complies with the con-
ditions set out in Article 4 of this Regulation.

The entry for a flavouring or source material in the Com-

2.
munity list shall specify:

(a)

the identification of the flavouring or the source material
approved;

(b) where necessary, the conditions under which the flavouring

may be used.

31.12.2008

EN

Official Journal of the European Union

L 354/41

The Community list shall be amended in accordance with

3.
the procedure referred to in Regulation (EC) No 1331/2008.

Article 15

General labelling requirements for flavourings not
intended for sale to the final consumer

Article 12

Flavourings or source materials falling within the scope of
Regulation (EC) No 1829/2003

A flavouring or source material falling within the scope of
1.
Regulation (EC) No 1829/2003 may be included in the Commu-
nity list in Annex I in accordance with this Regulation only when
it is covered by an authorisation in accordance with Regulation
(EC) No 1829/2003.

2. When a flavouring already included in the Community list
is produced from a different source falling within the scope of
Regulation (EC) No 1829/2003, it will not require a new autho-
risation under this Regulation, as long as the new source is cov-
ered by an authorisation in accordance with Regulation (EC)
No 1829/2003 and the flavouring complies with the specifica-
tions established under this Regulation.

Article 13

Interpretation decisions

1. Where flavourings not intended for sale to the final con-
sumer are sold singly or mixed with each other and/or with other
food ingredients and/or with other substances added to them in
accordance with Article 3(4), their packaging or containers shall
bear the following information:

(a)

the sales description: either the word ‘flavouring’ or a more
specific name or description of the flavouring;

(b)

the statement either ‘for food’ or the statement ‘restricted use
in food’ or a more specific reference to its intended food use;

(c)

if necessary, the special conditions for storage and/or use;

(d) a mark identifying the batch or lot;

(e)

in descending order of weight, a list of:

(i)

the categories of flavourings present and

Where necessary, it may be decided in accordance with the regu-
latory procedure referred to in Article 21(2):

(a) whether or not a given substance or mixture of substances,
material or type of food falls within the categories listed in
Article 2(1);

(ii)

the names of each of the other substances or materials
in the product or, where appropriate, their E-number;

(f)

the name or business name and address of the manufacturer,
packager or seller;

(b)

to which specific category, defined in Article 3(2)(b) to (j), a
given substance belongs;

(c) whether or not a particular product belongs to a food cat-
egory or is a food referred to in Annex I or Annex III, Part B.

(g) an indication of the maximum quantity of each component
or group of components subject to quantitative limitation in
food and/or appropriate information in clear and easily
understandable terms enabling the purchaser to comply with
this Regulation or other relevant Community law;

CHAPTER IV

LABELLING

Article 14

Labelling of flavourings not intended for sale to the final
consumer

1.
Flavourings not intended for sale to the final consumer may
only be marketed with the labelling provided for in Articles 15
and 16, which must be easily visible, clearly legible and indelible.
The information provided for in Article 15 shall be in a language
easily understandable to purchasers.

2. Within its own territory, the Member State in which the
product is marketed may, in accordance with the Treaty, stipulate
that the information provided for in Article 15 shall be given in
one or more of the official languages of the Community, to be
determined by that Member State. This shall not preclude such
information from being indicated in several languages.

(h)

the net quantity;

(i)

a date of minimum durability or use-by-date;

(j) where relevant, information on a flavouring or other sub-
stances referred to in this Article and listed in Annex IIIa to
Directive 2000/13/EC as regards the indication of the ingre-
dients present in foodstuffs.

2.
By way of derogation from paragraph 1, the information
required in points (e) and (g) of that paragraph may appear merely
on the documents relating to the consignment which are to be
supplied with or prior to the delivery, provided that the indica-
tion ‘not for retail sale’ appears on an easily visible part of the
packaging or container of the product in question.

3.
By way of derogation from paragraph 1, where flavourings
are supplied in tankers, all of the information may appear merely
on the accompanying documents relating to the consignment
which are to be supplied with the delivery.

L 354/42

EN

Official Journal of the European Union

31.12.2008

Article 16

Article 18

Specific requirements for use of the term ‘natural’

Other labelling requirements

If the term ‘natural’ is used to describe a flavouring in the
1.
sales description referred to in Article 15(1)(a) the provisions of
paragraphs 2 to 6 of this Article shall apply.

The term ‘natural’ for the description of a flavouring may
2.
only be used if the flavouring component comprises only flavour-
ing preparations and/or natural flavouring substances.

3.
The term ‘natural flavouring substance(s)’ may only be used
for flavourings in which the flavouring component contains
exclusively natural flavouring substances.

4.
The term ‘natural’ may only be used in combination with a
reference to a food, food category or a vegetable or animal fla-
vouring source if the flavouring component has been obtained
exclusively or by at least 95 % by w/w from the source material
referred to.

The description shall read ‘natural “food(s) or food category or
source(s)” flavouring’.

5.
The term ‘natural “food(s) or food category or source(s)” fla-
vouring with other natural flavourings’ may only be used if the
flavouring component is partially derived from the source mate-
rial referred to, the flavour of which can easily be recognised.

The term ‘natural flavouring’ may only be used if the fla-
6.
vouring component is derived from different source materials and
where a reference to the source materials would not reflect their
flavour or taste.

Article 17

Labelling of flavourings intended for sale to the final
consumer

1. Without prejudice to Directive 2000/13/EC, Council Direc-
tive 89/396/EEC of 14 June 1989 on indications or marks iden-
tifying the lot to which a foodstuff belongs (1) and Regulation (EC)
No 1829/2003, flavourings sold singly or mixed with each other
and/or with other food ingredients and/or to which other sub-
stances are added and which are intended for sale to the final con-
sumer may be marketed only if their packaging contains the
statement either ‘for food’ or ‘restricted use in food’ or a more spe-
cific reference to their intended food use, which must be easily
visible, clearly legible and indelible.

2.
If the term ‘natural’ is used to describe a flavouring in the
sales description referred to in Article 15(1)(a), Article 16 shall
apply.

(1) OJ L 186, 30.6.1989, p. 21.

Articles 14 to 17 shall be without prejudice to more detailed or
more extensive laws, regulations or administrative provisions
regarding weights and measures or applying to the presentation,
classification, packaging and labelling of dangerous substances
and preparations or applying to the transport of such substances
and preparations.

CHAPTER V

PROCEDURAL PROVISIONS AND IMPLEMENTATION

Article 19

Reporting by the food business operators

A producer or user of a flavouring substance, or the repre-
1.
sentative of such producer or user, shall, at the request of the
Commission, inform it of the amount of the substance added to
foods in the Community in a period of 12 months. The informa-
tion provided in this context shall be treated as confidential inso-
far as this information is not required for the safety assessment.

Information on the use levels for specific food categories in the
Community shall be made available to Member States by the
Commission.

2. Where applicable, for a flavouring already approved under
this Regulation which is prepared by production methods or
starting materials significantly different from those included in the
risk assessment of the Authority, a producer or user shall, before
marketing the flavouring, submit to the Commission the neces-
sary data to allow an evaluation of the flavouring to be under-
taken by the Authority with regard to the modified production
method or characteristics.

3.
A producer or user of flavourings and/or source materials
shall inform the Commission immediately of any new scientific or
technical information which is known and accessible to him and
which might affect the assessment of the safety of the flavouring
substance.

4.
Detailed rules for the implementation of paragraph 1 shall
be adopted in accordance with the regulatory procedure referred
to in Article 21(2).

Article 20

Monitoring and reporting by the Member States

1. Member States shall establish systems to monitor the con-
sumption and use of flavourings set out in the Community list
and the consumption of the substances listed in Annex III on a
risk-based approach, and shall report their findings with appro-
priate frequency to the Commission and to the Authority.

31.12.2008

EN

Official Journal of the European Union

L 354/43

After the Authority has been consulted, a common meth-
2.
odology for the gathering by Member States of information on
the consumption and use of flavourings set out in the Commu-
nity list and of the substances listed in Annex III shall be adopted
in accordance with the regulatory procedure referred to in
Article 21(2) by 20 January 2011.

Regulation (EC) No 2232/96 shall be repealed from the date
2.
of application of the list referred to in Article 2(2) of that
Regulation.

References to the repealed acts shall be construed as refer-

3.
ences to this Regulation.

Article 21

Committee

The Commission shall be assisted by the Standing Commit-

1.
tee on the Food Chain and Animal Health.

2. Where reference is made to this paragraph, Articles 5 and 7
of Decision 1999/468/EC shall apply, having regard to the pro-
visions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1)
to (4) and Article 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

4. Where reference is made to this paragraph, Article 5a(1), (2),
(4) and (6) and Article 7 of Decision 1999/468/EC shall apply,
having regard to the provisions of Article 8 thereof.

Article 22

Amendments to Annexes II to V

Amendments to Annexes II to V to this Regulation to reflect sci-
entific and technical progress which are designed to amend non-
essential elements of
this Regulation shall be adopted in
accordance with the regulatory procedure with scrutiny referred
to in Article 21(3), following the opinion of the Authority, where
necessary.

On imperative grounds of urgency, the Commission may use the
urgency procedure referred to in Article 21(4).

Article 23

Community financing of harmonised policies

The legal basis for the financing of measures resulting from this
Regulation shall be Article 66(1)(c) of Regulation (EC)
No 882/2004.

CHAPTER VI

TRANSITIONAL AND FINAL PROVISIONS

Article 24

Repeals

Directive 88/388/EEC, Decision 88/389/EEC and Directive

1.
91/71/EEC shall be repealed from 20 January 2011.

Article 25

Introduction of the list of flavouring substances into the
Community list of flavourings and source materials and
transitional regime

The Community list shall be established by introducing the
1.
list of flavouring substances referred to in Article 2(2) of Regula-
tion (EC) No 2232/96 into Annex I to this Regulation at the time
of its adoption.

Pending the establishment of the Community list, Regula-
2.
tion (EC) No 1331/2008 shall apply for the evaluation and
approval of flavouring substances which are not covered by the
evaluation programme provided for in Article 4 of Regulation
(EC) No 2232/96.

By way of derogation from that procedure, the period of nine
months referred to in Article 5(1) and Article 7 of Regulation (EC)
No 1331/2008 shall not apply to such evaluation and approval.

3.
Any appropriate transitional measures which are designed
to amend non-essential elements of this Regulation, inter alia, by
supplementing it, shall be adopted in accordance with the regu-
latory procedure with scrutiny referred to in Article 21(3).

Article 26

Amendments to Regulation (EEC) No 1601/91

Article 2(1) is hereby amended as follows:

1.

in point (a), the first sub-indent of the third indent shall be
replaced by the following:

‘— flavouring substances and/or flavouring preparations as
defined in Article 3(2)(b) and (d) of Regulation (EC)
No 1334/2008 of the European Parliament and of the
Council of 16 December 2008 on flavourings and cer-
tain food ingredients with flavouring properties for use
in and on foods (*), and/or

(*) OJ L 354, 31.12.2008, p. 34.’

2.

in point (b), the first sub-indent of the second indent shall be
replaced by the following:

‘— flavouring substances and/or flavouring preparations as
defined in Article 3(2)(b) and (d) of Regulation (EC)
No 1334/2008, and/or’;

3.

in point (c), the first sub-indent of the second indent shall be
replaced by the following:

‘— flavouring substances and/or flavouring preparations as
defined in Article 3(2)(b) and (d) of Regulation (EC)
No 1334/2008, and/or’.

L 354/44

EN

Official Journal of the European Union

31.12.2008

Article 27

Amendment to Regulation (EC) No 2232/96

Article 3(2)(d) of that Regulation shall be used for
the production of gin so that the taste is predomi-
nantly that of juniper.’;

Article 5(1) of Regulation (EC) No 2232/96 shall be replaced by
the following:

(c) paragraph 21(a) (ii) shall be replaced by the following:

‘1. The list of flavouring substances referred to in Article 2(2)
shall be adopted in accordance with the procedure referred to
in Article 7 by 31 December 2010 at the latest.’.

Article 28

Amendments to Regulation (EC) No 110/2008

Regulation (EC) No 110/2008 is hereby amended as follows:

1.

in Article 5(2), point (c) shall be replaced by the following:

‘(c) contain

as

defined

flavouring

substances

in
Article 3(2)(b) of Regulation (EC) No 1334/2008 of the
European Parliament and of the Council of 16 Decem-
ber 2008 on flavourings and certain food ingredients
with flavouring properties for use in and on foods (*) and
flavouring preparations as defined in Article 3(2)(d) of
that Regulation;

(*) OJ L 354, 31.12.2008, p. 34.’

2.

in Article 5(3), point (c) shall be replaced by the following:

‘(c) contain one or more flavourings as defined in
Article 3(2)(a) of Regulation (EC) No 1334/2008;’;

3.

in Annex I, point (9) shall be replaced by the following:

‘(ii)

the mixture of the product of such distillation and
ethyl alcohol of agricultural origin with the same
composition, purity and alcoholic strength; flavour-
ing substances and/or flavouring preparations as
specified in category 20(c) may also be used to fla-
vour distilled gin.’;

(d) paragraph 23(c) shall be replaced by the following:

‘(c) Other

as

defined

flavouring

in
substances
Article 3(2)(b) of Regulation (EC) No 1334/2008
and/or
flavouring preparations as defined in
Article 3(2)(d) of that Regulation may additionally
be used but there must be a predominant taste of
caraway.’;

(e) paragraph 24(c) shall be replaced by the following:

‘(c) Other natural flavouring substances as defined in
Article 3(2)(c) of Regulation (EC) No 1334/2008
flavouring preparations as defined in
and/or
Article 3(2)(d) of that Regulation may additionally
be used, but the flavour of these drinks is largely
attributable to distillates of caraway (Carum carvi L.)
and/or dill (Anethum graveolens L.) seeds, the use of
essential oils being prohibited.’;

‘(9) Flavouring

(f) paragraph 30(a) shall be replaced by the following:

Flavouring means using in the preparation of a spirit
drink one or more of
the flavourings defined in
Article 3(2)(a) of Regulation (EC) No 1334/2008.’;

4. Annex II shall be amended as follows:

(a) paragraph 19(c) shall be replaced by the following:

‘(c) Other

as

defined

flavouring

in
substances
Article 3(2)(b) of Regulation (EC) No 1334/2008
and/or
flavouring preparations as defined in
Article 3(2)(d) of that Regulation, and/or aromatic
plants or parts of aromatic plants may be used in
addition, but the organoleptic characteristics of
juniper must be discernible, even if they are some-
times attenuated.’;

(b) paragraph 20(c) shall be replaced by the following:

‘(c) Only

flavouring

in
substances
Article 3(2)(b) of Regulation (EC) No 1334/2008
flavouring preparations as defined in
and/or

defined

as

‘(a) Bitter-tasting spirit drinks or bitter are spirit drinks
with a predominantly bitter taste produced by fla-
vouring ethyl alcohol of agricultural origin with fla-
vouring substances as defined in Article 3(2)(b) of
Regulation (EC) No 1334/2008 and/or flavouring
preparations as defined in Article 3(2)(d) of that
Regulation.’;

(g)

in paragraph 32(c), the first subparagraph and the intro-
ductory part of
the second subparagraph shall be
replaced by the following:

‘(c) Flavouring substances as defined in Article 3(2)(b)
of Regulation (EC) No 1334/2008 and flavouring
preparations as defined in Article 3(2)(d) of that
Regulation may be used in the preparation of
liqueur. However, only natural
flavouring sub-
stances as defined in Article 3(2)(c) of Regulation
(EC) No 1334/2008 and flavouring preparations as
defined in Article 3(2)(d) of that Regulation shall be
used in the preparation of the following liqueurs:’;

31.12.2008

EN

Official Journal of the European Union

L 354/45

(h) paragraph 41(c) shall be replaced by the following:

‘ANNEX III

‘(c) Only

as

defined

flavouring

flavouring preparations

in
substances
Article 3(2)(b) of Regulation (EC) No 1334/2008
in
and
Article 3(2)(d) of that Regulation may be used in the
preparation of egg liqueur or advocaat or avocat or
advokat.’;

defined

as

(i) paragraph 44(a) shall be replaced by the following:

‘(a) Väkevä glögi or spritglögg is a spirit drink produced
by flavouring ethyl alcohol of agricultural origin
with flavour of cloves and/or cinnamon using one
of the following processes: maceration and/or dis-
tillation, redistillation of the alcohol in the presence
of parts of the plants specified above, addition of
as defined in
natural
Article 3(2)(c) of Regulation (EC) No 1334/2008 of
cloves or cinnamon or a combination of these
methods.’;

flavouring substances

(j) paragraph 44(c) shall be replaced by the following:

‘(c) Other flavourings, flavouring substances and/or fla-
vouring preparations as defined in Article 3(2)(b),
(d) and (h) of Regulation (EC) No 1334/2008 may
also be used, but the flavour of the specified spices
must be predominant.’;

(k)

In point (c) of paragraphs 25, 26, 27, 28, 29, 33, 34, 35,
36, 37, 38, 39, 40, 42, 43, 45 and 46, the word ‘prepa-
rations’ shall be replaced by ‘flavouring preparations’.

Article 29

Amendment to Directive 2000/13/EC

In Directive 2000/13/EC, Annex III shall be replaced by the fol-
lowing:

DESIGNATION OF
INGREDIENTS

FLAVOURINGS

IN THE

LIST OF

1. Without prejudice to paragraph 2, flavourings shall be des-

ignated by the terms

— “flavourings” or a more specific name or description of
the flavouring, if the flavouring component contains fla-
vourings as defined in Article 3(2)(b), (c), (d), (e), (f), (g)
and (h) of Regulation (EC) No 1334/2008 of the Euro-
pean Parliament and of the Council of 16 December
2008 on flavourings and certain food ingredients with
flavouring properties for use in and on foods (*);

— “smoke flavouring(s)”, or “smoke flavouring(s) produced
from “food(s) or food category or source(s)”” (e.g. smoke
flavouring produced from beech), if the flavouring com-
ponent contains flavourings as defined in Article 3(2)(f)
of Regulation (EC) No 1334/2008 and imparts a smoky
flavour to the food.

2. The term “natural” for the description of flavourings shall be
used in accordance with Article 16 of Regulation (EC)
No 1334/2008.

(*) OJ L 354, 31.12.2008, p. 34.’

Article 30

Entry into force

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

It shall apply from 20 January 2011.

Article 10 shall apply from 18 months after the date of applica-
tion of the Community list.

Articles 26 and 28 shall apply from the date of application of the
Community list.

Article 22 shall apply from 20 January 2009. Foods lawfully
placed on the market or labelled prior to 20 January 2011 which
do not comply with this Regulation may be marketed until their
date of minimum durability or use-by-date.

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

Done at Strasbourg, 16 December 2008.

For the European Parliament
The President
H.-G. PÖTTERING

For the Council
The President
B. LE MAIRE

L 354/46

EN

Official Journal of the European Union

31.12.2008

Community list of flavourings and source materials approved for use in and on foods

ANNEX I

ANNEX II

List of traditional food preparation processes

Chopping

Heating,
frying (up to 240 °C at
atmospheric pressure) and pressure cooking (up to 120 °C)

cooking, baking,

Cutting

Drying

Evaporation

Fermentation

Grinding

Infusion

Microbiological processes

Peeling

Pressing

Roasting/Grilling

Steeping

Coating

Cooling

Distillation/rectification

Emulsification

Extraction,
Directive 88/344/EEC

incl. solvent extraction in accordance with

Filtration

Maceration

Mixing

Percolation

Refrigeration/Freezing

Squeezing

31.12.2008

EN

Official Journal of the European Union

L 354/47

ANNEX III

Presence of certain substances

Part A:

Substances which shall not be added as such to food

Agaric acid

Aloin

Capsaicin

1,2-Benzopyrone, coumarin

Hypericine

Beta-asarone

1-Allyl-4-methoxybenzene, estragole

Hydrocyanic acid

Menthofuran

4-Allyl-1,2-dimethoxybenzene, methyleugenol

Pulegone

Quassin

1-Allyl-3,4-methylene dioxy benzene, safrole

Teucrin A

Thujone (alpha and beta)

Part B: Maximum levels of certain substances, naturally present in flavourings and food ingredients with flavouring properties, in cer-

tain compound food as consumed to which flavourings and/or food ingredients with flavouring properties have been added

Name of the substance

Compound food in which the presence of the substance is restricted

Maximum level mg/kg

Beta-asarone

Alcoholic beverages

1-Allyl-4-methoxybenzene,

Dairy products

Estragol (*)

Processed fruits, vegetables (incl. mushrooms, fungi, roots,
tubers, pulses and legumes), nuts and seeds

Fish products

Non-alcoholic beverages

Hydrocyanic acid

Nougat, marzipan or its substitutes or similar products

Canned stone fruits

Alcoholic beverages

Menthofuran

Mint/peppermint containing confectionery, except micro
breath freshening confectionery

Micro breath freshening confectionery

Chewing gum

Mint/peppermint containing alcoholic beverages

4-Allyl-1,2-dimethoxy-benzene,

Dairy products

Methyleugenol (*)

Meat preparations and meat products, including poultry and
game

Fish preparations and fish products

Soups and sauces

Ready-to-eat savouries

Non-alcoholic beverages

1,0

50

50

50

10

50

5

35

500

3 000

1 000

200

20

15

10

60

20

1

L 354/48

EN

Official Journal of the European Union

31.12.2008

Name of the substance

Compound food in which the presence of the substance is restricted

Maximum level mg/kg

Pulegone

Mint/peppermint containing confectionery, except micro
breath freshening confectionery

Micro breath freshening confectionery

Chewing gum

Mint/peppermint containing non-alcoholic beverages

Mint/peppermint containing alcoholic beverages

Quassin

Non-alcoholic beverages

Bakery wares

Alcoholic beverages

1-Allyl-3,4-methylene dioxy
benzene, safrole (*)

Meat preparations and meat products, including poultry and
game

Fish preparations and fish products

Soups and sauces

Non-alcoholic beverages

Teucrin A

Bitter-tasting spirit drinks or bitter (1)

Liqueurs (2) with a bitter taste

Other alcoholic beverages

Thujone (alpha and beta)

Alcoholic beverages, except those produced from Artemisia
species

Coumarin

Alcoholic beverages produced from Artemisia species

Non-alcoholic beverages produced from Artemisia species

Traditional and/or seasonal bakery ware containing a reference
to cinnamon in the labelling

Breakfast cereals including muesli

Fine bakery ware, with the exception of traditional and/or sea-
sonal bakery ware containing a reference to cinnamon in the
labelling

Desserts

250

2 000

350

20

100

0,5

1

1,5

15

15

25

1

5

5

2

10

35

0,5

50

20

15

5

(*) The maximum levels shall not apply where a compound food contains no added flavourings and the only food ingredients with flavour-
ing properties which have been added are fresh, dried or frozen herbs and spices. After consultation with the Member States and the
Authority, based on data made available by the Member States and on the newest scientific information, and taking into account the use
of herbs and spices and natural flavouring preparations, the Commission, if appropriate, proposes amendments to this derogation.

(1) As defined in Annex II, paragraph 30 of Regulation (EC) No 110/2008.
(2) As defined in Annex II, paragraph 32 of Regulation (EC) No 110/2008.

31.12.2008

EN

Official Journal of the European Union

L 354/49

List of source materials to which restrictions apply for their use in the production of flavourings and food
ingredients with flavouring properties

ANNEX IV

Part A:

Source materials which shall not be used for the production of flavourings and food ingredients with flavouring properties

Latin name

Common name

Source material

Tetraploid form of Acorus calamus L.

Tetraploid form of Calamus

Part B:

Conditions of use for flavourings and food ingredients with flavouring properties produced from certain source materials

Source material

Latin name

Common name

Quassia amara L. and
Picrasma excelsa (Sw)

Quassia

Laricifomes officinales
(Vill.: Fr) Kotl. et Pouz
or
Fomes officinalis

White agaric mushroom

Hypericum perforatum L.

St John’s wort

Teucrium chamaedrys L.

Wall germander

Conditions of use

Flavourings and food ingredients with flavouring properties
produced from the source material may only be used for the
production of beverages and bakery wares

Flavourings and food ingredients with flavouring properties
produced from the source material may only be used for the
production of alcoholic beverages

L 354/50

EN

Official Journal of the European Union

31.12.2008

Conditions for the production of thermal process flavourings and maximum levels for certain substances
in thermal process flavourings

ANNEX V

Part A:

Conditions for the production

(a)

The temperature of the products during processing shall not exceed 180 °C.

(b)

The duration of the thermal processing shall not exceed 15 minutes at 180 °C with correspondingly longer times at
lower temperatures, i.e. a doubling of the heating time for each decrease of temperature by 10 °C, up to a maximum
of 12 hours.

(c)

The pH during processing should not exceed the value of 8,0.

Part B: Maximum levels for certain substances

2-amino-3.4,8-trimethylimidazo [4,5-f] quinoxaline (4,8-DiMeIQx)

2-amino-1-methyl-6-phenylimidazol [4,5-b]pyridine (PhIP)

50

50

Substance

Maximum levels µg/kg