Common Position (EC) No 9/2008 of 10 March 2008 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to the adoption of a Regulation of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulations (EEC) No 1576/89 and (EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC (Text with EEA relevance)
Date: 2008-03-10
Institutions: Council of the European Union
Subjects: approximation of laws, consumer protection, flavouring, food safety, foodstuff, foodstuffs legislation, labelling, public health

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COMMON POSITION (EC) No 9/2008

adopted by the Council on 10 March 2008

with a view to adopting Regulation (EC) No …/2008 of the European Parliament and of the Council
of … on flavourings and certain food ingredients with flavouring properties for use in and on
foods and amending Council Regulations (EEC) No 1576/89 and (EEC) No 1601/91, Regulation (EC)
No 2232/96 and Directive 2000/13/EC

(Text with EEA relevance)

(2008/C 111 E/04)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European Com-
munity, 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
Article 251 of the Treaty (2),

laid down in

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 mate-
rials for their production (3) needs to be updated in the
light of
In the
technical and scientific developments.
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
inventory within 24 months of its adoption. That Deci-
sion is now obsolete and should be repealed.

Commission Directive 91/71/EEC of 16 January 1991
completing Council Directive 88/388/EEC on the approx-
imation of the laws of the Member States relating to
flavourings for use in foodstuffs and to source materials
for their production (5) lays down rules on the labelling
of flavourings. Those rules are replaced by this Regu-
lation 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 (not yet published
in the Official Journal), Council Common Position of 10 March 2008,
Position of the European Parliament of … (not yet published in the
Official Journal) and Council Decision of …

(3) OJ L 184, 15.7.1988, p. 61. Directive as last amended by Regulation
(EC) No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

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

(4)

(5)

(6)

(7)

(8)

The free movement of safe and wholesome food is an
essential aspect of the internal market and contributes
significantly 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
(hereinafter
‘food ingredients with
flavouring properties’), their source material and foods
containing them.

referred to as

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
mixtures 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 and food ingredients with flavouring proper-
ties 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. Their
use must not mislead the consumer and their presence in
food should, therefore, always be indicated by appropriate
labelling. Misleading the consumer includes, but is not
limited to, issues related to 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 including societal, economic,
traditional,
ethical and environmental factors and the feasibility of
controls.

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 Council of 28 January 2002 laying down the general
principles and requirements of food law, establishing the
European Food Safety Authority and laying down

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procedures in matters of food safety (1) have expressed
opinions on a number of substances occurring naturally
in source materials for flavourings and food ingredients
with flavouring properties which, according to the
Committee of Experts on Flavouring Substances of the
Council
concern.
raise
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.

toxicological

Europe,

of

(9)

Due to their natural occurrence in plants, undesirable
substances 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
these
which contribute most to the human intake of
substances, taking into account both the need to protect
human health and their unavoidable presence in tradi-
tional foods.

(10) Maximum levels for certain naturally occurring undesir-
able substances should focus on the food or food cate-
gories which contribute most
to dietary intake. This
would allow Member States to organise controls on a
risk basis in line with Regulation (EC) No 882/2004 of
the European Parliament and of the Council of 29 April
2004 on official controls performed to ensure the verifi-
cation of compliance with feed and food law, animal
health and animal welfare rules (2). Food producers are
however obliged to take into account the presence 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,
animal, microbiological or mineral materials which raise
concern for human health in the production of flavour-
ings and food ingredients with flavouring properties and
their applications in food production.

(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 …/2008 of … establishing a common authorisa-
tion procedure for food additives, food enzymes and food
flavourings (3).

flavouring

flavouring

substances obtained

flavouring substances

Flavouring substances are defined chemical substances,
by
which include
chemical synthesis or isolated using chemical processes,
substances. An evaluation
and natural
is ongoing in
programme of
accordance with Regulation (EC) No 2232/96 of
the
European Parliament and of the Council of 28 October
1996 laying
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 inclu-
sion in the list referred to in Article 2(1) of Regulation
(EC) No …/2008 (*).

down a Community procedure

flavourings other

Flavouring preparations
than
are
defined chemical substances obtained from materials of
vegetable, animal or microbiological origin, by appro-
priate physical, enzymatic or microbiological processes,
either in the raw state of the material or after processing
for
preparations
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
flavouring preparations produced from
non-food material should be evaluated and approved.

consumption.

Flavouring

human

Regulation (EC) No 178/2002 defines
food as any
substance or product, whether processed, partially
processed or unprocessed, intended to be, or reasonably
expected to be, ingested by humans. Materials of vege-
table, 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 materials 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.

(12)

Risk assessments should be carried out by the Authority.

(17)

thermal process flavourings produced from
Likewise,
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,

(1) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission

Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).

(2) OJ L 165, 30.4.2004, p. 1. Corrected version in OJ L 191, 28.5.2004,
p. 1. Regulation as amended by Council Regulation (EC) No 1791/2006
(OJ L 363, 20.12.2006, p. 1).

(3) See page 1 of this Official Journal.
(4) OJ L 299, 23.11.1996, p. 1. Regulation as amended by Regulation (EC)

No 1882/2003.

(*) See page 1 of this Official Journal.

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the safety of thermal process flavourings produced from
non-food material or not complying with certain condi-
tions of production should be evaluated and approved.

to the authorisation procedure under that Regulation
with regard to the safety assessment of the genetic modi-
fication, while the final authorisation of the flavouring or
source material should be granted under this Regulation.

(18)

(19)

Regulation (EC) No 2065/2003 of
the European
Parliament 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 frac-
tions the use of which is authorised to the exclusion of
all others.

(24)

Flavour precursors such as carbohydrates, oligo-peptides
and amino acids impart flavour to food by chemical reac-
tions which occur during food processing. Flavour
precursors 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
material should be evaluated and approved.

in Directive 2000/13/EC of

Flavourings remain subject to the general labelling obliga-
tions provided for
the
European Parliament and of the Council of 20 March
2000 on the approximation of the laws of the Member
States relating to the labelling, presentation and adver-
tising of foodstuffs (4) and, as the case may be, in Regula-
tions
(EC)
(EC) No 1829/2003 and Regulation
No 1830/2003 of the European Parliament and of the
Council of 22 September 2003 concerning the trace-
ability and labelling of genetically modified organisms
and the traceability of food and feed products produced
from genetically modified organisms (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.

(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 flavour-
ings which are obtained by heating oil or fat to an extre-
mely high temperature for a very short period of time,
resulting in a grill-like flavour.

(25)

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

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

(26)

(22)

Flavourings can contain food additives as permitted by
Regulation (EC) No …/2008 of the European Parliament
and of the Council of … on food additives (2) and/or
other food ingredients for technological purposes such as
for their storage, standardisation, dilution 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 subject

Specific information requirements should ensure that
consumers are not misled concerning the source material
used for the production of natural flavourings. In particu-
lar, if the term natural is used to describe a flavour, the
flavouring 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. The other maximum 5 % can only
be used for standardisation 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. When a source
material is claimed in the description of natural flavour-
ings,
the flavouring component other
than that derived from this particular source should not
reproduce or imitate the flavour of the source referred to.

the fraction of

(1) OJ L 309, 26.11.2003, p. 1.
(2) See page 10 of this Official Journal.
(3) OJ L 268, 18.10.2003, p. 1. Regulation as amended by Commission

Regulation (EC) No 1981/2006 (OJ L 368, 23.12.2006, p. 99).

(4) OJ L 109, 6.5.2000, p. 29. Directive as last amended by Commission

Directive 2007/68/EC (OJ L 310, 28.11.2007, p. 11).

(5) OJ L 268, 18.10.2003, p. 24.

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(27)

(28)

(29)

(30)

Consumers should be informed if the smoky taste of a
particular food is due to the addition of smoke flavour-
ings. In accordance with Directive 2000/13/EC, the label-
ling should not confuse the consumer as to whether the
product 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 flavourings and the term ‘natural’ for the descrip-
tion of flavourings laid down in this Regulation.

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
flavouring substances added to food should therefore be
checked on a regular basis.

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 conferred on the Commission (1).

In particular the Commission should be empowered to
amend the Annexes to this Regulation and to adopt
appropriate transitional measures regarding the establish-
ment 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 accordance with the regulatory procedure with scru-
tiny provided 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)

In order to develop and update Community law on
flavourings in a proportionate and effective way,
it is
information and
necessary

to collect data,

share

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 appropriate 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
flavouring 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 …/2008 (*).
However, the time periods provided for in that Regu-
lation for the adoption by the Authority of its opinion
and for
the submission by the Commission to the
Standing Committee on the Food Chain and Animal
Health of a draft Regulation updating the Community list
should not apply, because priority should be given to the
ongoing evaluation programme.

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.

Council Regulation (EEC) No 1576/89 of 29 May 1989
laying down general rules on the definition, description
and presentation of spirit drinks (2) and Council Regu-
lation (EEC) No 1601/91 of 10 June 1991 laying down
general rules on the definition, description and presenta-
tion of aromatised wines, aromatised wine-based drinks
and aromatised wine-product cocktails (3) need to be
adapted to certain new definitions laid down in this
Regulation.

(34)

(35)

(36)

(37)

Regulations (EEC) No 1576/89, (EEC) No 1601/91 and
(EC) No 2232/96 and Directive 2000/13/EC should be
amended accordingly,

(*) See page 1 of this Official Journal.
(2) OJ L 160, 12.6.1989, p. 1. Regulation as last amended by the 2005 Act

of Accession.

(1) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision

(3) OJ L 149, 14.6.1991, p. 1. Regulation as last amended by the 2005 Act

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

of Accession.

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HAVE ADOPTED THIS REGULATION:

For the purposes of this Regulation, the following defini-

2.
tions shall also apply:

CHAPTER I

(a)

‘flavourings’ shall mean products:

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter

This Regulation lays down rules on flavourings and food ingre-
dients with flavouring properties for use in and on foods to
ensure the effective functioning of the internal market and a
high level of protection of human health and protection of
consumers'
including fair practices in food trade,
taking into account, where appropriate, the protection of the
environment.

interests,

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

This Regulation shall apply to:

1.

(a)

(i) not intended to be consumed as such, which are added

to food in order to impart odour and/or taste;

(ii) made or

consisting of

categories:
flavouring substances, flavouring preparations, thermal
process flavourings, smoke flavourings, flavour precur-
sors or other flavourings or mixtures thereof;

following

the

(b)

(c)

‘flavouring substance’
substance with flavouring properties;

shall mean a defined chemical

flavouring substance’

‘natural
shall mean a flavouring
substance obtained by appropriate physical, enzymatic or
microbiological processes from material of vegetable, animal
or microbiological origin either in the raw state or after
processing for human consumption by one or more of the
traditional food preparation processes listed in Annex II.
Natural flavouring substances correspond to substances that
are naturally present and have been identified in nature;

(d)

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

(i)

food by appropriate physical, enzymatic or microbiolo-
gical 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;

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;

and/or

(b) food ingredients with flavouring properties;

(c)

food containing flavourings and/or food ingredients with
flavouring properties;

(d) source materials for flavourings and/or source materials for

food ingredients with flavouring properties.

2.

This Regulation shall not apply to:

(a) substances which have exclusively a sweet, sour or salty

taste;

(b) raw foods;

(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)

treatment

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

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

(i)

food;

and/or

Article 3

Definitions

1.
For the purposes of this Regulation, the definitions laid
down in Regulations (EC) Nos 178/2002 and 1829/2003 shall
apply.

(ii) source material other than food;

(f)

shall mean a product obtained by
‘smoke flavouring’
condensed smoke
fractionation and purification of a
yielding primary 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;

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(g)

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

(a)

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

(b) their use does not mislead the consumer.

(ii) source material other than food;

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

1.
as such to food.

(i)

(j)

(k)

(i)

food;

and/or

(ii) source material other than food;

(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);

‘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
modifying its flavour and which contributes significantly to
the presence in food of certain naturally occurring undesir-
able substances;

‘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:

(i)

food;

or

‘appropriate physical process’ shall mean a physical process
which does not intentionally modify the chemical nature of
the components of the flavouring and does not involve,
inter alia, the use of singlet oxygen, ozone, inorganic cata-
lysts, metal
and/or
UV radiation.

catalysts, organometallic

reagents

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

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

CHAPTER II

CONDITIONS FOR USE OF FLAVOURINGS, FOOD INGREDI-
ENTS WITH FLAVOURING PROPERTIES AND SOURCE
MATERIALS

Article 4

General conditions for use of flavourings or food ingredi-
ents with flavouring properties

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

(*) See page 10 of this Official Journal.

Article 5

Prohibition

of

non-compliant
non-compliant food

flavourings

and/or

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.

Article 6

Presence of certain substances

2. Without prejudice
to Regulation (EC) No 1576/89,
in
maximum levels of certain substances, naturally present
flavourings and/or food ingredients with flavouring properties,
in the compound foods listed in Part B of Annex III shall not be
exceeded as a result of the use of flavourings and/or food ingre-
dients with flavouring properties in and on those foods. The
maximum levels of the substances set out in Annex III shall
apply to foods as marketed, 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.

Article 7

Use of certain source materials

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.

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and/or

Flavourings

2.
food ingredients with flavouring
properties produced from source materials listed in Part B of
Annex IV may be used only under the conditions indicated in
that Annex.

Article 8

Flavourings and food ingredients with flavouring proper-
ties for which evaluation and approval are not required

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

(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
process flavourings and/or the maximum levels for certain
undesirable substances set out in Annex V are not met;

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

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

(f)

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

other

than

food

referred

to

in

Article 10

(a)

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

Community list of flavourings and source materials

(b) thermal process flavourings referred to in Article 3(2)(e)(i)
which comply with the conditions for the production of
thermal process flavourings and maximum levels for certain
substances
in
Annex V;

in thermal process

flavourings

set out

(c)

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

(d) food ingredients with flavouring properties.

if

Notwithstanding paragraph 1,

the Commission, a
2.
Member State or the Authority expresses doubts concerning the
safety of a flavouring or food ingredient with flavouring proper-
ties 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 to 6 of Regulation (EC)
No …/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
IV and/or V where appropriate. On imperative
Annexes III,
grounds of urgency,
the Commission may use the urgency
procedure referred to in Article 21(4).

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 condi-
tions of use specified therein, where applicable.

Article 11

Inclusion of

flavourings and source materials in the

Community list

A flavouring or source material may be included in the
1.
Community list, in accordance with the procedure laid down by
Regulation (EC) No …/2008 (*), only if it complies with the
conditions 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

CHAPTER III

may be used.

COMMUNITY LIST OF FLAVOURINGS AND SOURCE MATE-
RIALS APPROVED FOR USE IN OR ON FOODS

The Community list shall be amended in accordance with

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

Article 9

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

Article 12

This Chapter shall apply to:

(a)

flavouring substances;

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

(*) See page 1 of this Official Journal.

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

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

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Article 13

(c)

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

Interpretation decisions

(d) a mark identifying the batch or lot;

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);

(e)

in descending order of weight, a list of:

(i)

the categories of flavourings present; and

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

(b) to which specific category, defined in Article 3(2)(b) to (j), a

given substance belongs;

(f)

the name or business name and address of the manufac-
turer, packager or seller;

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

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 Arti-
cles 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, stipu-
late that the information provided for in Article 15 shall be
given in one or more of the official
languages of the Com-
munity, to be determined by that Member State. This shall not
preclude such information from being indicated in several
languages.

(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;

(h) the net quantity;

(i) a date of minimum durability or use-by-date;

(j) where relevant,

information on a flavouring or other
substances referred to in this Article and listed in Annex IIIa
to Directive 2000/13/EC as regards the indication of the
ingredients 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
indication ‘not for retail sale’ appears on an easily visible part of
the packaging or container of the product in question.

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

Article 15

Article 16

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

Specific requirements for use of the term ‘natural’

1. Where flavourings not
intended for sale to the final
consumer 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;

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 shall apply.

The term ‘natural’ for the description of a flavouring may
the flavouring component comprises only

2.
only be used if
flavouring preparations and/or natural flavouring substances.

The term ‘natural flavouring substance(s)’ may only be
in which the flavouring component

3.
used for
contains exclusively natural flavouring substances.

flavourings

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4.
The term ‘natural’ may only be used in combination with
a reference to a food, food category or a vegetable or animal
flavouring source if
the flavouring component has been
obtained exclusively or by at least 95 % by w/w from the source
material referred to. The maximum of 5 % (w/w) of
the
flavouring component derived from other source materials shall
not reproduce the flavour of the source material referred to.

CHAPTER V

PROCEDURAL PROVISIONS AND IMPLEMENTATION

Article 19

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

Reporting by the food business operators

‘Natural (food(s) or food category or source(s)) flavouring
5.
with other natural
the
flavouring component is partially derived from the source mate-
rial referred to, the flavour of which can easily be recognised.

flavourings’ may only be used if

6.
The term ‘natural flavouring’ may only be used if the
flavouring 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
Directive 89/396/EEC of 14 June 1989 on indications or marks
identifying the lot to which a foodstuff belongs (1) and Regu-
lation (EC) No 1829/2003, flavourings sold singly or mixed
with each other and/or with other food ingredients and/or to
which other substances are added and which are intended for
sale to the final consumer may be marketed only if their packa-
ging contains the statement either ‘for food’ or ‘restricted use in
food’ or a more specific reference to their intended food use,
which must be easily visible, clearly legible and indelible.

1.
A producer or user of a flavouring substance, or the repre-
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 as well as
the use levels for specific food categories in the Community.
Such information 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
necessary data to allow an evaluation of the flavouring to be
undertaken 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 might affect the assessment of
the safety of the flavouring and/or source materials.

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

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.

Article 20

Monitoring and reporting by the Member States

Article 18

Other labelling requirements

1. Member States shall establish systems to monitor the
consumption 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
appropriate frequency to the Commission and to the Authority.

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
such
applying to the
substances.

transport of

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 Com-
munity 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 … (*).

(1) OJ L 186, 30.6.1989, p. 21. Directive as last amended by Directive

92/11/EEC (OJ L 65, 11.3.1992, p. 32).

(*) Two years after the entry into force of this Regulation.

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Article 21

Committee

The Commission shall be assisted by the Standing

1.
Committee 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 provisions 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
scientific 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.

Article 25

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

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

Pending the establishment of the Community list, Regu-
2.
lation (EC) No …/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 periods of
six months and nine months referred to in Article 5(1) and
Article 7 of Regulation (EC) No …/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

Amendment to Regulation (EEC) No 1576/89

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

Regulation (EEC) No 1576/89 is hereby amended as follows:

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 … (*).

Regulation (EC) No 2232/96 shall be repealed from the
2.
date 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.

1. Article 1(4)(m) shall be amended as follows:

(a)

In point (1)(a), the second subparagraph shall be replaced
by the following:

‘Other flavouring substances as defined in Article 3(2)(b)
of Regulation (EC) No …/2008 of
the European
Parliament and of the Council of … on flavourings and
certain food ingredients with flavouring properties for
use in and on foods and amending Council Regulations
(EEC) No 1575/89 and (EEC) No 1601/91, Regulation
(EC) No 2232/96 and Directive 2000/13/EC (*), 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 sometimes attenu-
ated.

(*) OJ L …’.

(b) Point 2(a) shall be replaced by the following:

it

‘The drink may be called “gin” if
is produced by
flavouring organoleptically suitable ethyl alcohol of
agricultural origin with flavouring substances as defined
in Article 3(2)(b) of Regulation (EC) No …/2008 (***)
and/or
in
preparations
Article 3(2)(d) of that Regulation so that the taste is
predominantly that of juniper.’.

flavouring

defined

as

(*) Two years after the entry into force of this Regulation.

(**) See page 1 of this Official Journal.
(***) This Regulation.

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(c)

In point 2(b), the first subparagraph shall be replaced by
the following:

‘The drink may be called “distilled gin” if it is produced
solely by redistilling organoleptically suitable
ethyl
alcohol of agricultural origin of an appropriate quality
with an initial alcoholic strength of at least 96 % vol. in
stills traditionally used for gin, in the presence of juniper
berries and of other natural botanicals provided that the
juniper taste is predominant. The term “distilled gin” may
also apply to a mixture of the product of such distillation
and ethyl alcohol of agricultural origin with the same
composition, purity and alcoholic strength. Flavouring
substances and/or flavouring preparations, both of which
are specified in (a), may also be used to flavour distilled
gin. London gin is a type of distilled gin.’.

No …/2008 (*) may be used in the preparation of the spirit
drinks defined in Article 1(4), except in the case of those
defined in Article 1(4)(m), (n) and (p). However, flavouring
substances as defined in Article 3(2)(b) of Regulation (EC)
No …/2008 (*) shall be authorised in liqueurs except those
mentioned below.’.

Article 27

Amendment to Regulation (EEC) No 1601/91

Article 2(1) is hereby amended as follows:

2. In Article 1(4)(n)(1),

the second subparagraph shall be

replaced by the following:

1. In point (a), the first sub-indent of the third indent shall be

replaced by the following:

‘Other flavouring substances as defined in Article 3(2)(b) of
Regulation (EC) No …/2008 (*) and/or flavouring prepara-
tions as defined in Article 3(2)(d) of that Regulation may
additionally be used but there must be a predominant taste
of caraway.’.

the European Parliament and of

‘— flavouring substances and/or flavouring preparations as
defined in Article 3(2)(b) and (d) of Regulation (EC)
No …/2008 of
the
Council of … on flavourings and certain food ingredi-
ents with flavouring properties for use in and on foods
and amending Council regulations (EEC) No 1576/89
and (EEC) No 1601/91, Regulation (EC) No 2232/96
and Directive 2000/13/EC (**), and/or

3. In Article 1(4)(p), the first subparagraph shall be replaced by

the following:

(**) OJ L …’.

‘Spirit drinks with a predominantly bitter taste produced by
flavouring ethyl alcohol of agricultural origin with flavouring
substances as defined in Article 3(2)(b) of Regulation (EC)
No …/2008 (*) and/or flavouring preparations as defined in
Article 3(2)(d) of that Regulation.’.

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 …/2008 (*), and/or’.

4. In Article 1(4)(u), the first subparagraph shall be replaced by

the following:

3. In point (c), the first sub-indent of the second indent shall be

replaced by the following:

‘A spirit drink produced by flavouring ethyl alcohol of agri-
cultural origin with flavouring of cloves and/or cinnamon
the following processes: maceration and/or
using one of
distillation, redistillation of the alcohol
in the presence of
parts of the plants specified above, addition of flavouring
substances as defined in Article 3(2)(b) of Regulation (EC)
No …/2008 (*) of cloves or cinnamon or a combination of
these methods.’.

5. In Article 4(5), the first and second paragraphs, excluding
the lists in points (a) and (b), shall be replaced by the
following:

‘Only natural flavouring substances and flavouring prepara-
tions as defined in Article 3(2)(c) and (d) of Regulation (EC)

(*) This Regulation.

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

Article 28

Amendment to Regulation (EC) No 2232/96

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

The list of

flavouring substances

referred to in
‘1.
Article 2(2) shall be adopted in accordance with the proce-
dure referred to in Article 7 by 31 December 2008 at the
latest.’.

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Article 29

Amendment to Directive 2000/13/EC

2. The term “natural” for the description of

flavourings
shall be used in accordance with Article 16 of Regulation
(EC) No …/2008 (*).

In Directive 2000/13/EC, Annex III shall be replaced by the
following:

(*) OJ L …’.

‘ANNEX III

DESIGNATION OF
INGREDIENTS

FLAVOURINGS IN THE LIST OF

1. Without prejudice to paragraph 2, flavourings shall be

designated by the terms

Article 30

Entry into force

if

the flavouring,

— “flavourings” or a more specific name or description
of
the flavouring component
contains flavourings as defined in Article 3(2)(b), (c),
(d), (e), (f), (g) and (h) of Regulation (EC) No …/2008
of the European Parliament and of the Council of …
on flavourings and certain food ingredients with
flavouring properties for use in and on foods and
amending Council Regulations (EEC) No 1576/89
and (EEC) No 1601/91, Regulation (EC) No 2232/96
and Directive 2000/13/EC (*),

— “smoke flavouring(s)” if the flavouring component
contains flavourings as defined in Article 3(2)(f) of
Regulation (EC) No …/2008 (*) and imparts a smoky
flavour to the food.

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

It shall apply from … (*).

Articles 10, 26 and 27 shall apply from the date of application
of the Community list.

Article 22 shall apply from the date of the entry into force of
this Regulation. Foods lawfully placed on the market or labelled
prior to … (*) 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 Brussels,

For the European Parliament

The President

For the Council

The President

(*) Two years after the entry into force of this Regulation.

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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

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

These maximum levels shall not apply to compound foods which are prepared and consumed on the same site, contain
no added flavourings and contain only herbs and spices as food ingredients with flavouring properties.

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,
estragol

Dairy products

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

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

Micro breath freshening confectionery

Chewing gum

Mint/peppermint containing alcoholic beverages

Dairy products

Meat preparations and meat products,
game

including poultry and

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

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Name of the substance

Compound food in which the presence of the substance is restricted

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

Maximum level
mg/kg

250

2 000

350

20

100

Quassin

Non-alcoholic beverages

Bakery wares

Alcoholic beverages

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

dioxy

Meat preparations and meat products,
game

including poultry and

Fish preparations and fish products

Soups and sauces

Non-alcoholic beverages

Teucrin A

Bitter-tasting spirit drinks or bitter (1)

Thujone (alpha and beta)

Liqueurs (2) with a bitter taste

Other alcoholic beverages

Alcoholic beverages, except
species

those produced from Artemisia

Alcoholic beverages produced from Artemisia species

Non-alcoholic beverages produced from Artemisia species

Coumarin

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
seasonal bakery ware containing a reference to cinnamon in the
labelling

Desserts

(1) As defined in Article 1(4)(p) of Council Regulation (EEC) No 1576/89.
(2) As defined in Article 1(4)(r) of Council Regulation (EEC) No 1576/89.

0,5

1

1,5

15

15

25

1

5

5

2

10

35

0,5

50

20

15

5

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ANNEX IV

LIST OF SOURCE MATERIALS TO WHICH RESTRICTIONS APPLY FOR THEIR USE IN THE PRODUCTION
OF FLAVOURINGS AND FOOD INGREDIENTS WITH FLAVOURING PROPERTIES

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

properties

Source material

Latin name

Common name

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

Conditions of use

Quassia amara L. and Picrasma excelsa (Sw) Quassia

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

White agaric mushroom

Hypericum perforatum L.

Teucrium chamaedrys L.

St John's wort

Wall germander

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

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ANNEX V

CONDITIONS FOR THE PRODUCTION OF THERMAL PROCESS FLAVOURINGS AND MAXIMUM LEVELS
FOR CERTAIN SUBSTANCES IN THERMAL PROCESS FLAVOURINGS

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

Substance

2-amino-3,4,8-trimethylimidazo [4,5-f] quinoxaline (4,8-DiMeIQx)

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

Maximum levels
µg/kg

50

50

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STATEMENT OF THE COUNCIL'S REASONS

I.

INTRODUCTION

On 28 July 2006, the Commission adopted its proposal on flavourings and certain food ingredients
with flavouring properties for use in foods (1). The proposal is based on Article 95 of the Treaty estab-
lishing the European Community.

The European Parliament adopted its Opinion in first reading on 10 July 2007 (2).

Following the European Parliament's first reading opinion, the Commission submitted an amended
proposal on 24 October 2007 (3).

On 10 March 2008, the Council adopted its Common Position in accordance with Article 251(2) of the
Treaty.

In carrying out its work, the Council also took account of the opinion of the European Economic and
Social Committee adopted on 25 April 2007 (4).

II. OBJECTIVE OF THE PROPOSED REGULATION

The aim of the proposed Regulation, as part of four proposals designed to overhaul the Community's
rules on food improvement agents, is to update the Community rules on flavourings and certain food
ingredients with flavouring properties, taking into account the technological and scientific developments
in this area (5) as well as the developments in food legislation in the European Community, in particular,
the new legislation on food safety (6).

The proposed Regulation provides for the establishment of a Community list of flavourings and of
source materials approved for use, as well as for rules on labelling the flavourings.

The objective of the proposed Regulation is to ensure the proper functioning of the internal market,
including fair practices in food trade, and a high level of protection of human health, of consumer inter-
ests and of the environment.

III. ANALYSIS OF THE COMMON POSITION (7)

1. Introductory remarks

The Common Position reflects the result of the examination of the Commission's proposal by the
Council. The Council introduced a number of modifications in the text, some of them inspired by
the amendments proposed by the European Parliament. On its own initiative, the Council introduced
some of the European Parliament amendments in each of the three sectoral proposals, with a view to
harmonising their provisions. The modifications introduced by the Council may be summed up as
follows:

(1) COM(2006) 427 final.
(2) Doc. 11639/07 CODEC 775.
(3) COM(2007) 671 final.
(4) OJ C 168, 20.7.2007, p. 29.
(5) Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavour-
ings for use in foods and to source materials for their production (OJ L 184, 15.7.1988, p. 61. Directive as last amended by
Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1)) will be
replaced.

(6) Approved by Regulation (EC) No 178/2002 of the European Parliament and of the Council 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 matters of food safety (OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Regulation (EC)
No 1642/2003 (OJ L 245, 29.9.2003, p. 4)).

(7) In addition to changes already introduced by the Council, Article 26 will require update due to entry into force on
20 February 2008 of the Regulation (EC) No 110/2008 of the European Parliament and of the Council on the definition,
description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council
Regulation (EEC) No 1576/89 (OJ L 39, 13.2.2008).

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— Preference for a single legal basis: Article 95 of the Treaty

According to established case-law (1), the legal basis for an act must be determined having regard
to its own aim and content. If the examination of a Community measure reveals that it serves a
two-fold purpose or that it has a two-fold component and if one of those is identifiable as the
main or predominant purpose or component, whereas the other is merely incidental, the act
must be based on a single legal basis, namely that required by the main or predominant purpose
or component (2). In this case, the Council considered that the agricultural aspects of the proposal
are merely incidental while the internal market objective is the main or predominant purpose or
component and as such, in line with the case law of the ECJ, it decided to retain Article 95 as the
sole legal basis.

— ‘Misleading the consumer’ (in line with amendment 1, second part)

The Council included, in recital 7, elements integrating the notion of misleading the consumer.

— Protection of the environment

The Council considered that, apart from scientific evidence, the authorisation of the flavourings
should also take into account other relevant factors, such as the protection of the environment.
The Council also included a reference to the protection of the environment among the objectives
of the proposed Regulation.

— Clarification of the scope and definitions (in line with amendment 8)

The Council clarified that smoke flavourings are not completely excluded from the scope of the
proposed Regulation. It opted for complementary application of two Regulations, i.e. this Regu-
lation would apply in the absence of more specific rules in the Regulation (EC) 2065/2003 on
smoke flavourings (3).

Furthermore, it was made clear that the Regulation would also not apply to mixtures of herbs
and/or spices, mixtures of tea and mixtures for infusions, as long as they are not used as food
ingredients (in line with amendment 45).

The clarification of Article 2(2) can be found in recital 6.

The Council paid particular attention to the accuracy of definitions and their consistency
with other Community legislation. Clarifications were made in line with amendments 12 and 14.
The term ‘flavourings not elsewhere specified’
in amendment 13 has the same meaning as
the Commission formulation ‘other flavouring’, meaning flavouring not defined under points (b)
to (g) of Article 3. The Council favours the latter, which is more clear in the context of Article 3.

— Introduction of the regulatory comitology procedure with scrutiny (in line with amendments 24, 33, 34,

35)

The Council adapted the proposal to the new comitology procedure rules, requiring the regula-
tory procedure with scrutiny to be applied for the adoption of measures supplementing the Regu-
lation.

The Council also introduced the urgency procedure to enable the Commission to modify, on the
imperative ground of urgency, restrictions for the use of flavourings and food ingredients with
is not required and if appropriate to amend
flavouring properties for which an approval
Annexes II to V.

(1) See Case 45/86, Commission v Council [1987] ECR 1493, paragraph 11; Case C-300/89, Commission v Council (Titanium
Dioxide) [1991] ECR I-2867, paragraph 10; Case C-268/94, Portugal v Council [1996] ECR I-6177, paragraph 22; and Case
C-176/03, Commission v Council [2005] ECR I-0000, paragraph 45.

(2) See Case C-36/98, Spain v Council [2001] ECR I-779, paragraph 59; Case C-211/01, Commission v Council [2003]

ECR I-8913, paragraph 39; and Case C-338/01, Commission v Council [2004] ECR I-4829, paragraph 55.

(3) OJ L 309, 26.11.2003, p. 1.

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— Interpretation decisions

The Council regrouped all the provisions on interpretation decisions into a new single Article
and, as they would not supplement the Regulation, made them subject to the regulatory comi-
tology procedure without scrutiny.

— Provision prohibiting the placing on the market of non compliant flavourings or food containing such

flavourings

For reasons of clarity, legal certainty and proper functioning of the market, the Council inserted
an Article on the prohibition on placing non-compliant flavourings and/or food ingredients with
flavouring properties on the market. This is consistent with proposals on food additives and on
food enzymes.

— Use of the term ‘natural’ flavouring

To safeguard consumer interests, the Council agreed that the term ‘natural’ may only be used with
a reference to a food, food category or a vegetable or animal flavouring source if at least 95 % by
w/w has been obtained from the source material referred to (in line with amendment 29).

The Council has however added that the 5 % of the flavouring component derived from other
source materials shall not reproduce the flavour of the source material referred to.

— Authorisation of flavourings falling within the scope of Regulation (EC) 1829/2003 of the European
Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1)
(in line with amendments 41 and 42)

The Council agrees that, for any substance, the two authorisation procedures (one for its use as a
flavouring and the other with respect to its genetic modifications) can be carried out simulta-
neously, which is in line with the above amendments. The Council subjected that principle to
some drafting changes in order to make the provision more compatible with Regulation (EC)
No 1829/2003.

— Labelling

The Council streamlined labelling provisions, respecting the distinction between ‘business to busi-
ness’ labelling and labelling requirements for products intended for the sale to the final consumer.
Although the Council organised the labelling chapter in a way different from that proposed by
the European Parliament, the principles underlying its content are the same and are in line with
amendments 5, 29 and 30.

— Transitional measures for products already on the market (in line with amendment 39)

The Council provided for a 2 years transition period from the date of entry into force of the
proposed Regulation. Foods lawfully placed on the market or labeled during this 2 years may be
marketed until their date of minimum durability or use-by-date.

The Commission has accepted the Common Position agreed by the Council.

2. The amendments of the European Parliament

In its Plenary vote on 10 July 2007, the European Parliament adopted 43 amendments to the
proposal. In its Common Position, the Council incorporated, in full or in principle, 27 amendments.

(1) OJ L 268, 18.10.2003, p. 1.

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Amendments incorporated in the Common Position

In addition to amendments mentioned in part 1 above, the Common Position incorporates, in full or
in principle, other European Parliament's first reading amendments, aimed at improving or clarifying
the text, in particular amendments 4, 6, 7, 9, 12, 14, 31, 36, 41, 42.

Amendments not introduced (1)

The Council was not able to accept all amendments, sometimes because it did not consider that they
would bring drafting clarity (see amendments 13 and 37) or for the specific reasons outlined below:

— Precautionary principle (amendments 2, 17 — recital 13 and Article 4(a))

The precautionary principle is one of the general principles underlying the general food law (2).
Consequently, it applies to the proposed Regulation with no need for a specific reference to it.
Moreover, in the risk analyses framework, the precautionary principle can only be taken into
account in the context risk management, never in the risk assessment phase as suggested by the
European Parliament.

— Definition of ‘appropriate physical process’ (amendment 15 — Article 3(2)(k))

The traditional food preparation processes listed in Annex II should not be confused with the
‘appropriate physical process’ defined in Article (3)(2)(k).

— Definition of ‘flavouring substance’ (amendment 49 — Article 3(2)(b))

The Council indicated, in recital 14, through which processes the flavouring substance can be
produced. The amendment would restrict the methods that can be used.

— Decisions submitted to the regulatory comitology procedure without scrutiny (amendments 11, 16, 23,

32 — Article 13(a), 13(b), 6(3), 20(2))

Decisions on whether or not a given substance falls within the scope of
the Regulation
(amendment 11); rules implementing methods on how to monitor Annex IIIB (amendment 23)
and the common methodology for monitoring of the consumption and use of flavourings
(amendment 32) are of an interpretative nature and would not supplement the Regulation. There-
fore, they do not fall within the scope of the regulatory comitology procedure with scrutiny.

— Labelling of genetically modified organisms (GMOs) (amendments 27, 28, 38 — Article 15(1)(e)(ii)

and (g), Article 29 (2a new))

As mentioned in recital 24, flavourings remain subject to the labelling provisions defined in
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 States relating to the labelling, presentation and adver-
tising of foodstuffs (3) and in Regulation (EC) No 1829/2003 on genetically modified food and
feed and their labelling (Articles 12 and 13 of the later). The Council insisted on retaining the
consistency between ‘GMOs’ Regulation, Directive 2000/13/EC (‘Labelling Directive’) and this
Regulation. Therefore, the Council did not accept amendments 27 and 38 as they are already
covered by Regulation (EC) No 1829/2003. Amendment 28 is not necessary as the term ‘other
relevant Community legislation’ in Article 15(1)(g) in the Common Position also includes the
above-mentioned Regulation.

(1) Numbering of Articles in this part refers to the text of the Common Position.
(2) Regulation (EC) No 178/2002 of the European Parliament and of the Council 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
matters of food safety (OJ L 31, 1.2.2002, p. 1). Regulation as last amended by Regulation (EC) No 575/2006 (OJ L 100,
8.4.2006, p. 34).

(3) OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2007/68/EC (OJ L 310, 28.11.2007, p. 11).

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A definition of general scope, such as the one proposed in amendment 52 would have to be part
of Regulation (EC) No 1829/2003 and not of the proposed Regulation.

— Conditions for use (amendments 19 and 20 — Article 4(ba new) and Article 4(bb new))

The Council did not include a reference to the benefit of the consumer and to the technological
need as general conditions for the use of flavourings because their implementation would have
been not possible owing to possible subjective interpretations. These two aspects are already
covered in the definition of flavourings, which states that they are added to food to impart odour
and/or taste.

— Labelling

Although the Council organised the labelling chapter in a way different from that proposed by
the European Parliament, the principles underlying its content are in line with some of the
amendments related to Articles 14 to 18. However, the Council was not able to accept the
suggestions relating to labelling of GMOs as explained above (amendments 27, 28, 38) and
amendment 26, which is not consistent with other specific Community legislation and may
create barriers to trade. Amendment 43 is not in line with the spirit of the provisions of
Article 16, which aims at providing adequate information to the consumers and protecting
consumer interests.

— Entry into force of Articles 10, 26, 27 (amendment 44 — Article 30(2)

Amendment 44 was not accepted as Articles 10, 26 and 27 can only apply after the Community
list of authorized flavourings and source materials has become applicable. In addition, the date of
application of that Community list can only be determined after it has been adopted through the
comitology procedure with scrutiny pending the outcome of the evaluation by EFSA as referred
to in Article 4 of Regulation (EC) 2232/96.

— Presence of toxic substances (amendments 21, 40, 46 — Article 6(2), Annex IIIB, Article 6(2a new))

Substances in Annex III B of the proposed Regulation pose a toxicological problem, confirmed
by the Scientific Committee on Food (SCF) or EFSA. Knowing that these substances are a toxico-
logical problem, they must be regulated based on the most recent scientific advice available. The
Council attached great importance to using a risk-based approach to set maximum limits in this
Regulation. For the Council, amendments 21 and 40 go against the need to provide a high level
of protection of human health. The Council considered that a general exclusion, as suggested by
amendment 46, in respect of the application of Annex III B to compound food to which only
herbs and spices have been added is too broad and would not provide sufficient protection the
consumers. The Council considers, in line with the principle of proportionality, that the exclusion
from maximum levels set in Annex III B is justified for the use of herbs and spices under the
condition that they are used in compound foods which are prepared and consumed on the same
site and thus will not affect cross-boarder trade.

IV. Conclusions

The Council believes that the Common Position represents a balance of concerns and interests that
would respect the objectives of the Regulation. It looks forward to constructive discussions with the
European Parliament with a view to the early adoption of the Regulation ensuring a high level of human
health and consumer protection.