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

Meer informatie

1. Tekst

Delegations will find attached the text of the abovementioned proposal, following the discussion in

the Foodstuffs Working Party on 21 March 2007. Changes suggested by the Presidency with respect

to the Commission's proposal are highlighted in bold for additions, while deletions are indicated by

strikethrough. Positions of Delegations are noted in footnotes.

____________________

2006/0147 (COD)

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 Articles 37

and 95 thereof,

Having regard to the proposal from the Commission , 2

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 production needs to be updated in the light of technical and scientific developments. In the interests of clarity and efficiency Directive 88/388/EEC should be

replaced by the present Regulation.

(2) 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 provides for the establishment of that inventory within 24 months of its adoption. That Decision is now obsolete and should be repealed.

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).

OJ L 184, 15.7.1988, p. 67.

(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 production lays 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.

(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."

OJ L 42, 15.2.1991, p. 25.

(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 properties which, 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.

(9) Provisions should be established at Community level in order to prohibit or restrict the use of certain plant or animal 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 . 6

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

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).

(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 . (12) Flavouring substances are chemically defined substances with flavouring properties. 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 chemically defined substances obtained from materials of vegetable or animal or mineral 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 prior to approval.

(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 hitherto there is significant evidence of use for the production of flavourings, are

considered as food materials for this purpose, even though some of these source

materials, such as rose wood, oak wood chips and strawberry leaves, may not have been

used for food as such. They do not need to be evaluated.

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

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).

Some Delegations proposed to reformulate this recital.

(15) Likewise, thermal process flavourings produced from food under authorised 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 produced under non authorised conditions should be

evaluated prior to approval.

(16) Regulation (EC) No 2065/2003/EC of the European Parliament and of the Council of 10 11

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 impart flavour to food by chemical reactions occurring 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 prior to approval.

(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.

(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.

OJ L 309, 26.11.2003, p. 1.

(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 feed should be authorised according to that Regulation, prior to its approval under this Regulation. should 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 food additive should be granted

under 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. The source

of vanillin obtained from wood will, for example, have to be mentioned.

(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 name under which the product is sold 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.

OJ L 268, 18.10.2003, p. 1.

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).

(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.

(26) Annexes II to V to this Regulation should be adapted to scientific and technical progress. (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 rules and consequently the legal basis for the financing of the above measures will be Regulation (EC) No 882/2004.

OJ L 184, 17.7.1999, p. 23.

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

(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.

(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

subsidiarity 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 16

definition, description and presentation of spirit drinks and Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and

presentation of aromatised wines, aromatised wine based drinks and aromatised wine

product cocktails need 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 20

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 with the exception of smoke

flavourings falling within the scope of Regulation (EC) No 2065/2003;

(b) food ingredients with flavouring properties ; (c) food containing flavourings and/or food ingredients with flavouring properties; 18

DK, SI and UK entered a parliamentary scrutiny reservation.

AT, CZ and UK entered a scrutiny reservation on the reference to environment.

FI, proposed to replace "food ingredients with flavouring properties" by "herbs and spices". FR, IT and SE entered a reservation on this proposal.

NL and UK entered a scrutiny reservation with a view to exempt spices and herbs from the scope.

(d) source materials for flavourings and/or source materials for food ingredients 22

with flavouring properties . 2. This Regulation shall not apply to: (a) substances which have exclusively a sweet, sour or salty taste; 23 24 25

(b) raw or non compound foods . 3. Where necessary, it may be decided in accordance with the procedure referred to in Article 18(2) whether or not a given substance or mixture of substances, material or

type of food falls within the scope of this Regulation.

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 chemically defined substance with flavouring 28

properties ; 22

FI requested further clarification on the term "source materials".

FI suggested to separate b) "raw foods" and c) "non compound foods"

SE proposed to replace "raw food" by "unprocessed food".

EL suggested to add to this subparagraph "with flavouring properties that are not consumed as such". CION suggested to clarify this issue in recital 5.

FI proposed to rephrase certain paragraphs of this article as well as articles 7 and 8.

Some Delegations suggested to change into "defined chemical substance".

FR supported by some Delegations proposed to reformulate this subparagraph as follows: .... obtained either by appropriate `natural' processes or by chemical synthesis or isolated by chemical processes"

(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 ; (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 appropriate physical processes ; and/or

(ii) material of vegetable, animal or microbiological origin, other than food, obtained by one or more of the traditional food preparation processes listed

in Annex II and/or appropriate physical, enzymatic or microbiological

processes;

FR proposed the following wording for this subparagraph: natural flavouring substances correspond to substances that are naturally present and identified in natural material of vegetable or animal origin, either in the raw state or after processing for human consumption by traditional food preparation processes.

FR proposed to reformulate this subparagraph as follows:

"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 appropriate physical processes; and/or

ii)

material of vegetable, animal or microbiological origin, other than food, obtained by one or more of the traditional food preparation processes l i st ed i n An nex II and/ or ap prop ri at e p h ysi cal , e nz ym at i c o r microbiological processes by appropriate physical, enzymatic or microbiological processes, the material being taken as is or transformed 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;

IE proposed to give some examples in the corresponding recital (17) CION suggested that amino acid meat extracts could be mentioned in recital 17.

(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 34

materials for which hitherto there is significant evidence of use for the production of 35

flavourings, are considered as food for the purpose of this Regulation . 4. Where necessary, it may be decided in accordance with the procedure referred to in Article 18(2) whether or not a given substance falls within a specific category listed in

paragraph 2(b) to (j).

4a (new) Flavourings may contain food additives and/or other food ingredients.

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

IT and FR entered a reservation as regards source materials of mineral origin.

IT proposed to introduce a reference to Annex II.

FR proposed to add the word "safe" before "use". On contrary, CZ opposed this.

FI, FR and SE entered a scrutiny reservation on this subparagraph.

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

Prohibition of non-compliant food flavourings

No person shall place on the market a food flavouring, or food ingredients with flavouring

properties or any food in which such a food flavouring or food ingredients with flavouring

properties are present if the use of the food flavouring 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. 2. 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 shall apply to the compound foods as offered ready for

consumption or as prepared according to the instructions of the manufacturer.

The maximum levels of food additives set out in Annex II 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.

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 EFSA, where

necessary.

FR proposed to add to the title "of toxicological concern".

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;

FR proposed to introduce a reference to the EC contaminant regulation (1881/2006).

2.

Notwithstanding paragraph 1, if the Commission, a Member State or the European Food Safety Authority (`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) in accordance with the procedure referred to in

Article 18 (2). Such measures shall be laid down in Annexes III, IV and/or V as

appropriate.

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: 38

(a) the identification of the flavouring or the source material approved ; 39

(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 only after it has been authorised in accordance with the

procedure referred to in Article 7 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.

FR and IT proposed to introduce a number system in order to identify the flavouring or the source material.

FR proposed to add the words "...and/or the source material."

Article 11a (new)

Interpretation decisions

Where necessary, it may be decided in accordance with the procedure referred to in

Article 18(2) as to whether or not:

a)

a given substance or mixture of substances, material or type of food falls within the scope of this Regulation.
b)

a given substance falls within a specific category listed in paragraph 2(b) to (j). CHAPTER IV

LABELLING

SECTION 1

LABELLING OF FLAVOURINGS NOT INTENDED FOR SALE TO THE FINAL

CONSUMER

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 if their packaging,

containers or accompanying documents bear the information 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. The first and

second subparagraph of This paragraph shall not preclude such information from being indicated

in several languages.

Article 13

General information requirements for labelling of flavourings

Where food flavourings not intended for sale to the final consumer, are sold singly or

mixed with each other and/or other food ingredients and/or to which other substances

are added, their The packaging or containers of food flavourings not intended for sale to

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

(c) the statement either `for use in food' or the statement `restricted use in food' or a more specific reference to its intended food use;

(d) 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 contained in the product or, where appropriate, their E number;

(e) 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;

(f) if necessary, the special conditions for storage and/or use; 40

(g) a date of minimum durability ; (h) a mark identifying the batch or lot; (i) the net quantity. 2. By way of derogation from paragraph 1, the information required in points (d) to (f) 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 'intended for

the manufacture of food and not for retail sale' appears on an easily visible part of the

packaging or container of the product in question.

Some Delegations suggested to use the term "use by date".

Article 14

Specific information requirements for the sales description of flavourings use of the term

"natural"

1.

The term `natural' may only be used to describe a flavouring in the sales description referred to in Article 13(1)(a) as provided for in paragraphs 2 to 6.
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 43 44

category or a vegetable or animal flavouring source, if at least 90% [by w/w] of the 45 46

flavouring component has been obtained from the source material referred to.

The flavouring component may contain flavouring preparations and/or natural

flavouring substances.

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 47

flavourings" may only be used if the flavouring component is partially derived from the source material referred to the flavour of which and can easily be recognised.

The flavouring component may contain flavouring preparations and/or natural

flavouring substances.

Several Delegations entered a scrutiny reservation on this article.

Some Delegations suggested to replace "may" by "shall".

SI proposed to add another subparagraph dealing with flavourings derived from only one source material.

Several Delegations entered a reservation on the percentage.

Several Delegations entered a reservation on the obligation to mention the source in paragraphs 4 and 5 of this article.

FR proposed to following wording for this subparagraph: The maximum of 10% (w/w) of flavouring component derived from source materials other than the source material referred to shall not reproduce the flavour of the source material referred to and shall not contain added natural flavouring substances characteristic of the source referred to, except in trace amounts

FR supported by several Delegations proposed to use the term "mainly". CION opposed this.

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.

The flavouring component may contain flavouring preparations and/or natural

flavouring substances.

SECTION 2

LABELLING OF FLAVOURINGS INTENDED FOR SALE TO THE FINAL

CONSUMER

Article 15

Labelling of flavourings intended for sale to the final consumer

1.

Without prejudice to Directive 2000/13/EC, flavourings sold singly or mixed with each other and/or other food ingredients intended for sale to the final consumer may

be marketed only if their packaging contains the statement either `for use in 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.

The term `natural' shall be used to describe a flavouring in the sales description referred to in Article 13(1)(a) only as provided for in Article 14.

CHAPTER V

PROCEDURAL PROVISIONS AND IMPLEMENTATION

Article 16

Reporting by the food business operators

1.

The food business operators or their representatives producers and users of flavouring substances shall report to the Commission the annual amounts of flavouring substances

added to foods in the Community per year and the use levels for each specific food

categoryies in the Community.

1a. For a food 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 submit to

the Commission the necessary data to allow an evaluation of the food flavouring

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

by the Authority.

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 part B on a risk based approach and report their findings each year 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 may shall be adopted in

accordance with the procedure referred to in Article 18(2) . 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.

Several Delegations proposed to put subparagraph 2 before subparagraph 1.

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 The Committee shall adopt its Rules of Procedure.

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, inter alia by

supplementing it 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. shall be adopted in accordance with the procedure referred to in Article 18 (2)

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. 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.

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

Article 22

Establishment 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 placing 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). may be adopted in accordance with the procedure referred to in Article 18 (2)

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."

IE proposed to make a reference to "source materials".

CZ entered a reservation. FR entered a scrutiny reservation.

(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) (b) (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) (c) of Regulation (EC)

No [...] and flavouring preparations as defined in Article 3(2)(d) of that Regulation

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) 51

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."

FR proposed the following wording: "natural flavouring substances and/or flavouring preparations as defined in Article 3(2)(b) (c)

and (d) of Regulation (EC) No [ ... ], and/or""

FR proposed to put Article 25 before Article 21.

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 used as laid down in in accordance with Article 14 of Regulation (EC) No [...] [Regulation on

flavourings]."

*

OJ L [...], [...], [...] Article 27

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

Official Journal of the European Union.

It shall apply from [please insert date] [24 months after entry into force]. However, Articles 9, 23

and 24 shall apply from the date of application of the Community list.

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 53

Some Delegations proposed to introduce the possibility to further characterize smoke flavourings.

FR and PL proposed to establish transitional measures for flavourings and food ingredients with flavouring properties which are already on the market.

ANNEX I

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

SE and FR proposed to structure this Annex into different groups of flavourings and source materials.

ANNEX II

List of traditional food preparation processes by which natural flavouring substances and

natural flavouring preparations are obtained

Chopping Coating 57

Cooking, baking, frying (up to 240°C) Cooling Cutting Distillation / rectification Drying Emulsification 58

Evaporation Extraction, incl. solvent extraction 59

Fermentation Filtration Grinding Heating Infusion Maceration Microbiological processes Mixing Peeling Percolation Pressing Refrigeration/Freezing Roasting / Grilling Squeezing Steeping

FR and PL suggested to delete "natural" in "natural flavouring preparation".

FR suggested to add the following wording: Heating, cooking, frying (up to 240°C at atmospheric pressure)

FR proposed to make a reference to the Directive on extraction solvents( 88/344/EEC).

FR suggested to delete "fermentation".

ANNEX III

Presence of certain substances

Part A: Substances which may shall not be added as such to food

Agaric acid

Capsaicin

Hypericine

Beta asarone

1 Allyl 4 methoxybenzene

Hydrocyanic acid

Menthofuran

4 Allyl 1,2 dimethoxybenzene

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

Name of the Compound food in which the presence of Maximum level 63

substance the substance is restricted [mg/kg] Beta asarone Alcoholic beverages 1.0 1 Allyl 4 Dairy products 50 methoxybenzene Processed fruits, vegetables (incl. 50 mushrooms, fungi, roots, tubers, pulses and

legumes), nuts and seeds

Fish products 50 Non alcoholic beverages 10 60

FR suggested to add to the chemical name of the substances listed in this Annex, also their trivial name.

Several Delegations stated the need to add further substances to part A of this Annex, e.g. Aloin and Coumarin.

Several Delegations suggested to add Coumarin to part B of this Annex.

Some Delegations proposed to introduce a general maximum level for certain substances for all foods.

Hydrocyanic acid Nougat, marzipan or its substitutes or 50 similar products

Canned stone fruits 5 Alcoholic beverages 35 Menthofuran Mint/peppermint containing confectionery, 500 except micro breath freshening

confectionery

Micro breath freshening confectionery 3000 Chewing gum 1000 Mint/peppermint containing alcoholic 200 beverages

4 Allyl 1,2 Dairy products 20 dimethoxybenzene, Meat and meat products, including poultry 15 and game

Fish and fish products 10 Soups and sauces 60 Ready to eat savouries 20 Non alcoholic beverages 1 Pulegone Mint/peppermint containing confectionery, 250 except micro breath freshening

confectionery

Micro breath freshening confectionery 2000 Chewing gum 350 Mint/peppermint containing non alcoholic 20 beverages

Mint/peppermint containing alcoholic 100 beverages

Candies with intensive taste; weight per candy not more than 1 g.

Quassin Non alcoholic beverages 0,5 Bakery wares 1 Alcoholic beverages 1.5 1 Allyl 3,4 Meat and meat products, including poultry 15 methylene dioxy and game benzene, safrole Fish and fish products 15 Soups and sauces 25 Non alcoholic beverages 1 Teucrin A Alcoholic beverages 2 Thujone (alpha and Alcoholic beverages, except those produced 10 beta) from Artemisia species Alcoholic beverages produced from 35 Artemisia species

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 Tetraploid 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 name Common name Quassia amara L. Quassia Flavourings and food ingredients with and flavouring 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

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

Maximum levels

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 ________________________

FR entered a scrutiny reservation on this Annex.

DK proposed to reduce the maximum levels to 5 g / kg.

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publicatiedatum	27-04-2007
kenmerk	8776/07