Proposal for 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 Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC - State of play

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Proposal for 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 Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91, Regulation (EC) No 2232/96 and Directive 2000/13/EC

State of play

Introduction

1.On 28 July 2006 the Commission submitted to the Council and the European Parliament a package of four Draft Regulations designed to overhaul the Community's rules on food

improvement agents. The proposals aim at reviewing the current legislation on food additives and flavourings and introducing a simplified common Community approval procedure for

food additives, flavourings and enzymes, which would be based on scientific opinions from

the European Food Safety Authority (EFSA). Pending the European Parliament first reading

opinion, the Council reached on 31 May 2007 general approaches on three draft Regulations

concerning:

Documents 12179/06, 12180/06, 12181/06 and 12182/06.

the common authorisation procedure; food additives; food enzymes. 2

Concerning the proposal on food flavourings, the Council took note of the progress achieved

and the German and the Portuguese Presidencies continued the discussion at working party

level, taking into account the views of Member States.

Outstanding issues

2.The Working Party on Foodstuffs was able to find solutions for most of the open issues. However, the text is still subject to some reservations noted in footnotes 20 to 23.

In addition, there are three main outstanding issues, which the Presidency decided to put in

brackets subject to the future discussion with the European Parliament, which adopted its first

reading opinion on 10 July 2007.

These three main outstanding issues are as follows:

a)Article 5 proposal to exempt herbs and spices from the scope of the proposal when they are used in restaurants.

Some Delegations proposed for reasons of proportionality and practicability to exempt from

the scope of the proposal herbs and spices when used in places where food is prepared and

served on the same site, e.g. restaurants (see footnote 19).

b)

Article 14 and corresponding recital 22 minimum percentage of the flavouring

component from the source material referred to, when using the term `natural'.

Many Delegations entered a general reservation on the proposed percentage and the

Presidency suggests to address this question at a later stage.

doc. 9536/07 ADD 4.

c)

Annex III, part B setting of maximum limits for coumarin for certain food categories.

Some Delegations proposed to set maximum levels for coumarin for certain food categories.

The working party recognized the need to consider this issue further and, if necessary, to

establish maximum levels for coumarin in certain food categories for its inclusion in Annex

III of the current proposal on flavourings. Therefore, on the basis of the data provided by

Member States, the Commission will take as soon as possible the appropriate measures to

consider and, if necessary, to establish such levels in order to maintain a high level of

consumer protection.

COREPER is invited to examine the remaining reservations in footnotes 21 to 24 and to agree to the

text as a position of the Council for future discussions with the European Parliament.

Next steps

4.The Presidency will analyze the outcome of the European Parliament's plenary vote on all four proposals, which took place on 10 July 2007 and discuss it at the Working Party level in

September 2007. Afterwards, the Presidency intends to submit to Coreper a proposal for a

negotiation mandate on all four proposals with a view to have an agreement with the

European Parliament at the stage of the Council's common position.

_______________________

Following the discussion in the Counsellor/Attaché meeting on 12 July 2007, changes suggested by

the Presidency with respect to the previous document (11537/07) are highlighted in bold for

additions, while deletions are indicated by strikethrough. Revised positions of Delegations are noted

in footnotes.

________________________

ANNEX

Proposal for 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 Regulation (EEC) No 1576/89, Council Regulation (EEC) No 1601/91,

Regulation (EC) No 2232/96 and Directive 2000/13/EC

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95

thereof,

Having regard to the proposal from the Commission, 4

Having regard to the opinion of the European Economic and Social Committee, Acting in accordance with the procedure laid down in Article 251 of the Treaty,

Whereas:

(1)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

productionneeds 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 the present

Regulation.

OJ C , , p. .

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).

(2)Council Decision 88/389/EEC of 22 June 1988 on the establishment, by the Commission, of 6

an inventory of the source materials and substances used in the preparation of flavourings

provides for the establishment of that inventory within 24 months of its adoption. That

Decision is now obsolete and should be repealed.

(3)Commission Directive 91/71/EEC of 16 January 1991 completing Council Directive 88/388/EEC on the approximation of the laws of the Member States relating to flavourings for

use in foodstuffs and to source materials for their productionlays down rules on the labelling of flavourings. These rules are being replaced by the present Regulation and the Directive

should now be repealed.

(4)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.

(5)In order to protect human health the scope of 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 (`food ingredients with flavouring properties'), their source

material and foods containing them.

(5a) 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 under the scope of this regulation.

OJ L 184, 15.7.1988, p. 67.

OJ L 42, 15.2.1991, p. 25.

(6)Flavourings and food ingredients with flavouring properties may 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. They

should 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 food

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.

(7)Since 1999, the Scientific Committee on Food and subsequently the European Food Safety Authority has expressed opinions on a number of substances occurring naturally in source

materials for flavourings and food ingredients with flavouring propertieswhich, according to the Committee of Experts on Flavouring Substances of the Council of Europe, raise

toxicological 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.

(8)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 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.

http://europa.eu.int/comm/food/food/chemicalsafety/flavouring/scientificadvice_en.htm.

(8a) Maximum levels for certain naturally occurring undesirable substances should focus on the

food or food categories 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 on

official feed and food controls. 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.

(8b) Flexibility as regards maximum limits of certain substances, naturally present in some

ingredients with flavouring properties, is also appropriate to enable the continued use of

local and/or traditional production and consumption of food, notably for restaurants

and similar food business premises. where food is prepared and served at the same site.

Flexibility should not compromise food hygiene objectives and food safety principles.

(9)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 flavourings and food ingredients with flavouring properties and

their applications in food production.

(10) Risk assessments should be carried out by 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

procedures in matters of food safety. (11) 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 [...] establishing a common approval procedure

for food additives, food enzymes and food flavourings. 9

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).

OJ L [...], [...], p [...].

(12) 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 flavouring substances is ongoing in accordance with

Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October

1996 laying down a Community procedure for flavouring substances used or intended for use

in or on foodstuffs. 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 Regulation (EC) No [...].

(13) 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 consumption. Flavouring 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.

(14) 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 vegetable, animal or microbiological origin, for which it can be

sufficiently demonstrated that hitherto they have been used for the production of flavourings,

are considered as 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.

(15) 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 production should be evaluated

and approved.

OJ L 299, 23.11.1996, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

(16) Regulation (EC) No 2065/2003/EC of the European Parliament and of the Council of 10

November 2003 on smoke flavourings used or intended for use in or on foods, 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.

(17) Flavour precursors such as carbohydrates, oligo peptides and amino acids impart flavour to

food by chemical reactions 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.

(18) 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. Examples could be flavourings obtained by heating oil or fat for a very

short period to an extremely high temperature, giving a grill like flavour.

(19) 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 evaluated scientifically. It

might be necessary to authorise the use of only certain parts of the material or to set

conditions of use.

(19a) Flavourings can contain food additives as permitted by [Regulation...on food additives]

and/or other food ingredients for technological purposes such as for their storage,

standardization, dilutions or dissolution and stabilization.

(20) A flavouring or a source material which falls under 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 feedshould be subject to the authorisation procedure under that Regulation with regard to the safety assessment of the genetic modification, while the

final authorisation of the flavouring or source material should be granted under this

Regulation.

OJ L 309, 26.11.2003, p. 1.

OJ L 268, 18.10.2003, p. 1.

(20a) Flavourings remain subject to the general labelling obligations as provided for in Directive

2000/13/EC and, as the case may be, in Regulations (EC) Nos 1829/2003 and 1830/2003. In

addition, specific provisions on labelling of flavourings sold as such to the manufacturer or to

the final consumer should be contained in this Regulation

(21) Flavouring substances or flavouring preparations should only be labelled as `natural' if they

comply with certain criteria which ensure that consumers are not misled.

(22) Specific information requirements should ensure that consumers 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 flavouring components used should entirely be from

natural origin. In addition, the source of the flavourings should be labelled, except when the

source materials referred to would not be recognized in the flavour or taste of the food. If a

source is mentioned, at least [90] % of the flavouring component should be obtained from the

material referred to. The other maximum [10] % can only be used for standardisation or to

give a more fresh, pungent, ripe, green etc. note to the flavouring. When less than [90] % 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 with the mentioning that

other natural flavourings have been added. E.g. cacao extract in which other natural

flavourings have been added to impart banana note. When a source material is claimed in the

description of natural flavourings, the fraction of the flavouring component other than that

derived from this particular source should not reproduce or imitate the flavour of the source

referred to.

(23) Consumers should be informed if the smoky taste of a particular food is due to the addition of

smoke flavourings. In accordance with Article 5 of 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 advertising of foodstuffs, the labelling should not confuse the consumer as to whether the product is smoked conventionally

with fresh smoke or treated with smoke flavourings. This Directive needs to be adapted to the

definitions of flavourings, smoke flavourings and the term `natural' for the description of

flavourings laid down in the present Regulation.

(24) 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.

(25) 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. (25a) In particular power should be conferred on the Commission to amend the Annexes to this

Regulation and to adopt appropriate 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, and/or to supplement it by the addition of new non

essential elements, they must be adopted in accordance with the regulatory procedure with

scrutiny provided for in Article 5a of Decision 1999/468/EC.

(25b) 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 use the urgency

procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of measures

described in Article 7 paragraph 2 and amendments to Annexes II to V.

OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, p. 15).

OJ L 184, 17.7.1999, p. 23.

(26) 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.

(27) In order to develop and update Community legislation on flavourings in a proportionate and

effective way, it is necessary 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 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 of the European Parliament and of the

Council of 29 April 2004 on official controls performed to ensure the verification of

compliance with feed and food law, animal health and animal welfare rulesand consequently the legal basis for the financing of the above measures will be Regulation (EC)

No 882/2004.

(28) Pending the establishment of the Community list, provision 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 [procedural Regulation].

However the time periods provided for in that Regulation for the Authority to adopt its

opinion and for the Commission to submit a draft Regulation updating the Community list to

the Standing Committee on the Food Chain and Animal Health should not apply, because

priority should be given to the ongoing evaluation programme.

OJ L 165, 30.4.2004, p. 1. Corrected version (OJ L 191, 28.5.2004, p. 1).

(29) Since the objective of the action to be taken, 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, by reason of market unity

and 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 those

objectives.

(30) Council Regulation (EEC) No 1576/89 of 29 May 1989 laying down general rules on the

definition, description and presentation of spirit drinksand 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

cocktailsneed to be adapted to certain new definitions laid down in the present Regulation. (31) Regulations (EEC) No 1576/89, (EEC) No 1601/91 and (EC) No 2232/96 and Directive

2000/13/EC should be amended accordingly,

OJ L 160, 12.6.1989, p. 1. Regulation as last amended by the 2003 Act of Accession.

OJ L 149, 14.6.1991, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003.

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter

This Regulation lays down rules on flavourings and food ingredients 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' interests, including fair practices in food

trade, taking account of, where appropriate, the protection of the environment.

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 (`the Community list');

(b)conditions of use of flavourings and food ingredients with flavouring properties in and on foods;

(c)rules on labelling of flavourings. Article 2

Scope

1.This Regulation shall apply to: (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;

(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; (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.

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.

2.The following definitions shall also apply: (a)'flavourings' shall mean products: (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 the following categories: flavouring substances, flavouring preparations, thermal process flavourings, smoke flavourings, flavour precursors

or other flavourings or mixtures thereof;

(b)'flavouring substance' shall mean a defined chemical substance with flavouring properties;

(c)'natural flavouring substance' 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 microbiological 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;

and/or

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 necessarily having flavouring properties themselves, of

which at least one contains nitrogen (amino) and another is a reducing sugar; the

ingredients for the production of thermal process flavourings may be:

(i)food; and/or

(ii)source material other than food; (f)`smoke flavouring' shall mean a product obtained by fractionation and purification of a condensed smoke 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;

(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

down or reacting with other components during food processing; it may be obtained

from:

(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 the definitions (b) to

(g);

(i)`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 undesirable substances;

(j)`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

(ii)source material other than food; (k)`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 among others 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 significant evidence of use for the production of flavourings, are

considered as food for the purpose of this Regulation.

4a.Flavourings may contain food additives as permitted by [Regulation... on food additives] and/or other food ingredients incorporated for technological purposes.

CHAPTER II

CONDITIONS FOR USE OF FLAVOURINGS, FOOD INGREDIENTS WITH

FLAVOURING PROPERTIES AND SOURCE MATERIALS

Article 4

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

Only flavourings or food ingredients with flavouring properties which meet the following

conditions may be used in or on foods:

(a)they do not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer and

(b)their use does not mislead the consumer Article 4a

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

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 5

Presence of certain substances 1.Substances listed in Part A of Annex III shall not be added as such to food. 19

DELETED proposed to exempt from the scope of the proposal the herbs and spices when

used for food which is prepared and served on the same site e.g. restaurants from the scope of the proposal.

2.Without prejudice to Council Regulation No 1576/89 maximum levels of certain substances, naturally present in 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 ingredients with flavouring properties in and on those foods.

The maximum levels of the substances set out in Annex III 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 apply to the food as reconstituted

according to the instructions on the label, taking into account the minimum dilution factor.

[This article shall not apply for herbs and spices when used in food, which is prepared

and served on the same site.]

3.Detailed rules for the implementation of paragraph 2 may be adopted in accordance with the procedure referred to in Article 18(2), following the opinion of the European Food Safety

Authority ('the Authority'), where necessary.

Article 6

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.

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

Annex.

Article 7

Flavourings and food ingredients with flavouring properties for which an evaluation and approval

is not required

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

(a)flavouring preparations referred to in Article 3(2)(d)(i); (b)thermal process flavourings referred to in Article 3(2)(e)(i) and which comply with the conditions for the production of thermal process flavourings and maximum levels for

certain substances 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.

2.Notwithstanding paragraph 1, if the Commission, a Member 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 to 6 of Regulation (EC)

No [procedural Regulation] 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 18(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 18 (4).

CHAPTER III

COMMUNITY LIST OF FLAVOURINGS AND SOURCE MATERIALS APPROVED FOR

USE IN OR ON FOODS

Article 8

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

The present Chapter applies to:

(a)flavouring substances; (b)flavouring preparations referred to in Article 3(2)(d)(ii); (c)thermal process flavourings obtained by heating ingredients which fall partially or totally under 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 other than food referred to in Article 3(2)(j)(ii). Article 9

Community list of flavourings and source materials

Of the flavourings and source materials referred to in Article 8, 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 10

Inclusion of flavourings and source materials in the Community list

1.A flavouring or source material may be included in the Community list, in accordance with the procedure laid down by Regulation (EC) No [common procedure], only if it complies with

the conditions set out in Article 4.

2.The entry for a flavouring or source material in the Community 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. 3.The Community list shall be amended in accordance with the procedure referred to in Regulation (EC) No [...] establishing a common authorisation procedure for food additives,

food enzymes and food flavourings.

Article 11

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 Community list in Annex I in accordance with the present Regulation only when it

is covered by an authorisation in accordance with Regulation (EC) No 1829/2003.

Article 11a (new)

Interpretation decisions

Where necessary, it may be decided in accordance with the procedure referred to in Article 18(2) as

to:

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

b)which specific category listed in Article 3 paragraph 2 (b) to (j) a given substance belongs. c)whether or not a particular product belongs to a food category or is a food referred to in Annex I or Annex III B.

CHAPTER IV

LABELLING

Article 12

Labelling of flavourings not intended for sale to the final consumer

Flavourings not intended for sale to the final consumer may be marketed only with the labelling

provided for in Articles 13 and 14, which must be easily visible, clearly legible and indelible. The

information shall be in a language easily understandable to purchasers.

Within its own territory, the Member State in which the product is marketed may, in accordance

with the rules of the Treaty, stipulate that this information 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.

Article 13

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

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 to which other substances are added in

accordance with Article 3 (4a), 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 and on 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)a list in descending order of weight 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;

(f)the name or business name and address of the manufacturer or packager, or of a seller;

(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 legislation;

(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.

3.

By way of derogation from paragraph 1 of this article, 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.

Article 14

Specific requirements for use of the term "natural"

1.If the term `natural' is used to describe a flavouring in the sales description referred to in Article 13(1)(a) the provisions in paragraphs 2 to 6 shall apply.

2.The term `natural' for the description of a flavouring may only be used if the flavouring component comprises only flavouring 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 flavouring source, if the flavouring component has been obtained

exclusively or by at least [90%] [by w/w] from the source material referred to. The maximum

of [10%] (w/w) of the flavouring component derived from other source materials shall not

reproduce the flavour of the source material referred to.

The description shall read "natural <<food(s) or food category or source(s)>> flavouring".

5."Natural <<food(s) or food category or source(s)>> flavouring with other natural flavourings" may only be used if the flavouring component is partially derived from the source material

referred to, the flavour of which can easily be recognised.

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 15

Labelling of flavourings intended for sale to the final consumer

1.Without prejudice to Directive 2000/13/EC, Directive 89/396/EEC and to Regulation (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 intended for sale to the final consumer

may be marketed only if their packaging contains the statement either `for food' or the

statement `restricted use in food' or a more specific reference to its 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 13(1)(a), Article 14 shall apply.

Article 15a

Other labelling requirements

Articles 12 to 15 shall apply 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.

CHAPTER V

PROCEDURAL PROVISIONS AND IMPLEMENTATION

Article 16

Reporting by the food business operators

1.A producer or user of a flavouring substance, or their representative, 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.

1a.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, before marketing the flavouring a producer or user shall

submit to the Commission the necessary data to allow an evaluation of the flavouring with

regard to the modified production method or characteristics to be undertaken by the

Authority.

1b.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.

2.Detailed rules for the implementation of paragraph 1 shall be adopted in accordance with the procedure referred to in Article 18(2).

Article 17

Monitoring and reporting by the Member States

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 report their findings with appropriate frequency to the Commission and to

the Authority.

2.After the Authority has been consulted, a common methodology for the gathering of information by the Member States on the consumption and use of flavourings set out in the

Community list and of the substances listed in Annex III shall be adopted in accordance with

the procedure referred to in Article 18(2) within two years after entry into force of this

Regulation.

Article 18

Committee

1.The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health (hereinafter referred to as `the Committee').

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 19

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 18(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 18 (4).

Article 20

Community financing of harmonised policies

The legal basis for the financing of measures resulting from this Regulation is Article 66(1)(c) of

Regulation (EC) No 882/2004.

CHAPTER VI

TRANSITIONAL AND FINAL PROVISIONS

Article 21

Repeals

1.Directive 88/388/EEC, Decision 88/389/EEC and Directive 91/71/EEC are repealed from the date of the application referred to in Article 27, paragraph 2.

Regulation (EC) No 2232/96 is repealed from the date of application of the list referred to in

Article 2(2) of that Regulation.

2 3. References to the repealed acts shall be construed as references to this Regulation.

Article 22

Introduction of the list of flavouring substances in 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 in Annex I to this Regulation at the

time of its adoption.

2.Until the establishment of the Community list, Regulation (EC) No [...] [the common procedure] 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 time periods of six months and nine months

referred to in Article 5(1) and Article 7 of Regulation (EC) No [...] [the common procedure]

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

regulatory procedure with scrutiny referred to in Article 18(3).

Article 23

Amendment to Regulation (EEC) No 1576/89

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

1.Article 1(4)(m) is 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 [...],

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

attenuated."

(b)Point 2(a) shall be replaced by the following: "The drink may be called `gin' if it 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 [...] and/or flavouring preparations as defined in Article

3(2)(d) of that Regulation so that the taste is predominantly that of juniper."

(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 as defined in Article

3(2)(b) of Regulation (EC) No [...] and/or flavouring preparations as specified at (a)

may also be used to flavour distilled gin. London gin is a type of distilled gin."

2.In Article 1(4)(n)(1), the second subparagraph shall be replaced by the following: "Other flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No [...] 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."

3.In Article 1(4)(p), the first subparagraph shall be replaced by the following: "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 [...] and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation."

4.In Article 1(4)(u), the first subparagraph shall be replaced by the following: "A spirit drink produced by flavouring ethyl alcohol of agricultural origin with flavouring of

cloves and/or cinnamon using one of the following processes: maceration and/ or 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 [...] 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 preparations as defined in Article 3(2) (c)

and (d) of Regulation (EC) No [...] 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 [...]

shall be authorized in liqueurs except those mentioned below:"

Article 24

Amendment 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 [...], and/or"

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 [...], 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 [...], and/or"

Article 25

Amendment to Regulation (EC) No 2232/96

In Article 5 of Regulation (EC) No 2232/96, paragraph 1 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 2008 at the latest."

Article 26

Amendment to Directive 2000/13/EC

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

"Annex III

DESIGNATION OF FLAVOURINGS IN THE LIST OF INGREDIENTS

1.Without prejudice to paragraph 2, flavourings shall be designated by the terms "flavourings" or a more specific name or description of the flavouring, if the flavouring

component contains flavourings as defined in Article 3(2)(b), (c), (d), (e), (f), (g) and

(h) of Regulation (EC) No [...] of the European Parliament and of the Council*

[Regulation on flavourings];

"smoke flavouring(s)" if the flavouring component contains flavourings as defined in Article

3 (2) (f) of Regulation EC No [...] [Regulation on flavourings] and imparts a smoky

flavour to the food.

2.The use of the term `natural' for the description of flavourings shall be in accordance with Article 14 of Regulation (EC) No [...] [Regulation on flavourings]."

*OJ L [...], [...], [...]

Article 27

Entry into force

1.

This Regulation shall enter into force on the twentieth day following that of its publication in

the Official Journal of the European Union.

2.

It shall apply from [please insert date] [24 months after entry into force].
3.

However, Articles 9, 23 and 24 shall apply from the date of application of the Community list.

and

4.

Article 19 shall apply from the date of the entry into force of this Regulation.

Foods lawfully placed on the market or labelled prior to [24 months after the entry into force of this

Regulation] which do not comply with this Regulation may be marketed until their date of

minimum durability.

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

Done at Brussels,

For the European Parliament For the Council The President The President

ANNEX I

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

ANNEX II

List of traditional food preparation processes

ChoppingCoating Heating, cooking, baking, frying (up toCooling 240°C at atmospheric pressure) and pressure

cooking (up to 120 °C)

CuttingDistillation / rectification DryingEmulsification EvaporationExtraction,incl.solventextractionin accordance with Directive 88/344/EEC

FermentationFiltration Grinding

InfusionMaceration Microbiological processesMixing PeelingPercolation PressingRefrigeration/Freezing Roasting / GrillingSqueezing Steeping

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.

DELETED suggested to add Berberin, Santonin and Isosafrol to Annex III part A. The CION

opposed this.

NameoftheCompound food in which the presence ofMaximumlevel substancethe substance is restricted[mg/kg] Beta asaroneAlcoholic beverages 1.0 1 Allyl 4Dairy products50 methoxybenzene,Processed fruits, vegetables (incl.50 estragolmushrooms, fungi, roots, tubers, pulses and legumes), nuts and seeds

Fish products50 Non alcoholic beverages10 Hydrocyanic acidNougat, marzipan or its substitutes or50 similar products

Canned stone fruits5 Alcoholic beverages35 21

MenthofuranMint/peppermint containing confectionery,500 except micro breath freshening

confectionery

Micro breath freshening confectionery*3000 Chewing gum1000 Mint/peppermint containing alcoholic200 beverages

DELETED entered a scrutiny reserve.

4 Allyl 1,2Dairy products20 dimethoxyMeatpreparationsandmeatproducts,15 benzene,including poultry and game methyleugenolFish preparations and fish products10 Soups and sauces60 Ready to eat savouries20 Non alcoholic beverages1 22

PulegoneMint/peppermint containing confectionery,250 exceptmicrobreathfreshening confectionery

Micro breath freshening confectionery*2000 Chewing gum350 Mint/peppermint containing non alcoholic20 beverages

Mint/peppermintcontainingalcoholic100 beverages

QuassinNon alcoholic beverages0,5 Bakery wares1 Alcoholic beverages 1.5 1 Allyl 3,4Meatpreparationsandmeatproducts,15 methylenedioxyincluding poultry and game benzene, safroleFish preparations and fish products15 Soups and sauces25 Non alcoholic beverages1 23

Teucrin AAlcoholic beverages2 22

DELETED entered a scrutiny reserve.

DELETED entered a scrutiny reservation.

Thujone (alpha andAlcoholic beverages, except those produced10 beta)from Artemisia species Alcoholic beverages produced from35 Artemisia species

Non alcoholic beverages produced from0,5 Artemisia species

[...][...] [Coumarin]

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 nameCommon name Tetraploid form of Acorus calamusTetraploid form of Calamus Part B: Conditions of use for flavourings and food ingredients with flavouring properties

produced from certain source materials

Source material

Conditions of use

Latin nameCommon name Quassia amara L.QuassiaFlavourings and food ingredients with andflavouring properties produced from the Picrasma excelsa source material may only be used for the (Sw) production of beverages and bakery wares. Laricifomes White agaric mushroom Flavourings and food ingredients with officinales (Vill.: Fr) flavouring properties produced from the Kotl. et Pouz source material may only be used for the or production of alcoholic beverages Fomes officinalis

Hypericum St Johns wort perforatum

Teucrium Wall germander chamaedrys

ANNEX V

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

substances in thermal process flavourings

Thermal process flavourings which do not comply with the conditions of Part A and the maximum

levels of Part B may not be used in or on foods without approval.

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

Maximumlevels Substance

g / kg

2 amino 3,4,8 trimethylimidazo [4,5 f] quinoxaline (4,8 DiMeIQx)50 2 amino 1 methyl 6 phenylimidazol [4,5 b]pyridine (PhIP)50 ___________________