Legal provisions of COM(2007)671 - 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 (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)

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dossier COM(2007)671 - Flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation ...
document COM(2007)671 EN
date October 24, 2007

Contents

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 a high level of human health protection and consumer protection and the effective functioning of the internal market and a high level of human health protection and consumer protection .

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, with out prejudice to more specific provisions laid down in 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;

(d) source materials for flavourings and 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.

(b) raw or non-compound foods.

3. Where necessary, it may be decided in accordance with the procedure referred to in Article 18 20 (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;

(iii) which may contain food including additives as permitted by Regulation (EC) No XXX/2007 of the European Parliament and of the Council of … on food additives;

(b) flavouring substance shall mean a chemically defined 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;

(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;

(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;

(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 , without prejudice to the listing of traditional food preparation processes in Annex II, and does not involve 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.

4. Where necessary, it may be decided in accordance with the procedure referred to in Article 18 20 (2) whether or not a given substance falls within a specific category listed in paragraph 2(b) to (j).

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;

(b) their use does not mislead the consumer.

Article 5 - Prohibition of non-compliant flavourings and/or non-compliant foodstuffs

No flavouring and/or any food in which such a flavouring has been used may be placed on the market, if the flavouring or its use does not comply with this Regulation and its implementing measures.

Article 5 - 6 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 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 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.

3. Detailed rules for the implementation of paragraph 2 may be adopted in accordance with the procedure referred to in Article 18 20 (2).

Article 6 - 7 Use of certain source materials

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

2. Flavourings and 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 - 8 Flavourings for which an evaluation and approval is not required

1. The following flavourings 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 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 20(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. On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 20(4).

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

Article 8 - 9 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) or for which the conditions for the production of thermal process flavourings and 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 - 10 Community list of flavourings and source materials

Of the flavourings and source materials referred to in Article 8 9 , only those included in the Community list may be placed on the market as such and used in or on foods.

Article 10 - 11 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 - 12 Flavourings or source materials falling within the scope of Regulation (EC) No 1829/2003

A flavouring or source material falling within the scope of 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. only after it has been authorised in accordance with the procedure referred to in Article 7 of Regulation (EC) No 1829/2003.

CHAPTER IV - LABELLING

SECTION 1 - LABELLING OF FLAVOURINGS NOT INTENDED FOR SALE TO THE FINAL CONSUMER


Article 12 - 13 Labelling of flavourings not intended for sale to the final consumer

1. Flavourings not intended for sale to the final consumer may be marketed only if they comply with the labelling if their packaging, containers or accompanying documents bear the information provided for in Articles 1 3 4 and 1 4 5 , which must be easily visible, clearly legible and indelible. The information provided for in Article 14 shall be in a language easily understandable to purchasers.

2. Within its own territory, the Member State in which the product is marketed may, in accordance with the rules of the Treaty, stipulate that this information shall be given in one or more 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 - 14 General information requirements for labelling of 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(2)(a)(iii), their packaging or containers of 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;

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

( f c ) if necessary, the special conditions for storage and use;

( h d ) a mark identifying the batch or lot;

( d 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 contained in the product or, where appropriate, their E-number and an indication a accordance with Regulation (EC) No 1829/2003;

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

( e 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 , including Regulation (EC) No 1829/2003 ;

( i h ) the net quantity.

( g i ) a date of minimum durability;

(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 ( c e ) to (g) and (j) 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.

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 - 15 Specific information requirements for the sales description of flavourings

1. The term ‘natural’ may only be used to describe a flavouring in the sales description referred to in Article 13 14 (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 category or a vegetable or animal flavouring source, if at least 90 95 % [by w/w] of the 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 flavourings” may only be used if the flavouring component is partially derived from the source material referred to and can easily be recognised.

The flavouring component may contain flavouring preparations and/or natural flavouring substances.

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 - 16 Labelling of flavourings intended for sale to the final consumer

1. Without prejudice to Directive 2000/13/EC, Directive 89/396/EEC and where appropriate, Regulation (EC) No 1829/2003 , flavourings sold singly or mixed with each other and/or to which other substances have been added 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 1 3 4 (1)(a) only as provided for in Article 1 4 5 .

Article 17 - Other labelling requirements

Articles 13 to 16 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 - 18 Reporting by the food business operators

1. A producer or user of a flavouring substance shall inform the Commission immediately of any new scientific or technical information which might affect the assessment of the safety of the flavouring substance.

1 2 . The food business operators or their representatives shall report to the Commission the annual amounts of flavouring substances added to foods in the Community and the use levels for each food category in the Community.

2 3 . Detailed rules for the implementation of paragraph 1 2 shall be adopted in accordance with the procedure referred to in Article 18 20 (2).

Article 17 - 19 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 and report their findings each year 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 be adopted in accordance with the procedure referred to in Article 18 20 (2).

Article 18 - 20 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.

5. The Committee shall adopt its Rules of Procedure.

Article 19 - 21 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 20(3 ). , shall be adopted in accordance with the procedure referred to in Article 18(2).

On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 20(4).

Article 20 - 22 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 - 23 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 - 24 Establishment of 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 nine 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 20(3). may be adopted in accordance with the procedure referred to in Article 18(2).

Article 23 - 25 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)( 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) 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 - 26 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 - 27 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 - 28 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 term ‘natural’ for the description of flavourings shall be used as laid down in Article 14 15 of Regulation (EC) No […] [Regulation on flavourings].”

* OJ L […], […], […]

Article 27 - 29 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 10 , 23 25 and 24 26 shall apply from the date of application of the Community list.

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.