Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (Text with EEA relevance)

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 with a view to ensuring the effective functioning of the internal market whilst ensuring a high level of protection of human health and a high level of consumer protection, including the protection of consumer interests and fair practices in food trade, taking into account, where appropriate, the protection of the environment.

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 (hereinafter referred to as the ‘Community list’);

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

(c) rules on the labelling of flavourings.

Article 2

Scope

This Regulation shall apply to:

(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.

This Regulation shall not apply to:

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

(b) raw foods;

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

Article 3

Definitions

For the purposes of this Regulation, 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 or modify 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 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, without prejudice to the listing of traditional food preparation processes in Annex II, and does not involve, inter alia, the use of singlet oxygen, ozone, inorganic catalysts, metal catalysts, organometallic reagents and/or UV radiation.

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 risk to the health of the consumer; and

(b) their use does not mislead the consumer.

Article 5

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

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

Article 6

Presence of certain substances

Article 7

Use of certain source materials

Article 8

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

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

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

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

CHAPTER III

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

Article 9

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

This Chapter shall apply 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 within Article 3(2)(e)(ii) and/or for which the conditions for the production of thermal process flavourings and/or the maximum levels for certain undesirable substances set out in Annex V are not met;

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

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

(f) source materials other than food referred to in Article 3(2)(j)(ii).

Article 10

Community list of flavourings and source materials

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

Article 11

Inclusion of flavourings and source materials in the Community list

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.

Article 12

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

Article 13

Interpretation decisions

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

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

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

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

CHAPTER IV

LABELLING

Article 14

Labelling of flavourings not intended for sale to the final consumer

Article 15

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

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

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

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

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

(d) a mark identifying the batch or lot;

(e) in descending order of weight, a list of: (i) the categories of flavourings present and (ii) the names of each of the other substances or materials in the product or, where appropriate, their E-number;

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

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

(h) the net quantity;

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

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

Article 16

Specific requirements for use of the term ‘natural’

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

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

Article 17

Labelling of flavourings intended for sale to the final consumer

Article 18

Other labelling requirements

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

CHAPTER V

PROCEDURAL PROVISIONS AND IMPLEMENTATION

Article 19

Reporting by the food business operators

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

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

Article 20

Monitoring and reporting by the Member States

Article 21

Committee

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.

Article 22

Amendments to Annexes II to V

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

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

Article 23

Community financing of harmonised policies

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

CHAPTER VI

TRANSITIONAL AND FINAL PROVISIONS

Article 24

Repeals

Article 25

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

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

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

Article 28

Amendments to Regulation (EC) No 110/2008

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

‘(c) contain flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods (^*1) and flavouring preparations as defined in Article 3(2)(d) of that Regulation;

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

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