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)
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:
in Article 5(2), point (c) shall be replaced by the following:
‘(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;
in Article 5(3), point (c) shall be replaced by the following:
‘(c) contain one or more flavourings as defined in Article 3(2)(a) of Regulation (EC) No 1334/2008;’;
in Annex I, point (9) shall be replaced by the following:
‘(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.’;
Annex II shall be amended as follows:
(a) paragraph 19(c) shall be replaced by the following: ‘(c) Other flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No 1334/2008 and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation, 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) paragraph 20(c) shall be replaced by the following: ‘(c) Only flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No 1334/2008 and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation shall be used for the production of gin so that the taste is predominantly that of juniper.’; (c) paragraph 21(a) (ii) shall be replaced by the following: ‘(ii) the mixture of the product of such distillation and ethyl alcohol of agricultural origin with the same composition, purity and alcoholic strength; flavouring substances and/or flavouring preparations as specified in category 20(c) may also be used to flavour distilled gin.’; (d) paragraph 23(c) shall be replaced by the following: ‘(c) Other flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No 1334/2008 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.’; (e) paragraph 24(c) shall be replaced by the following: ‘(c) Other natural flavouring substances as defined in Article 3(2)(c) of Regulation (EC) No 1334/2008 and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation may additionally be used, but the flavour of these drinks is largely attributable to distillates of caraway (Carum carvi L.) and/or dill (Anethum graveolens L.) seeds, the use of essential oils being prohibited.’; (f) paragraph 30(a) shall be replaced by the following: ‘(a) Bitter-tasting spirit drinks or bitter are 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 1334/2008 and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation.’; (g) in paragraph 32(c), the first subparagraph and the introductory part of the second subparagraph shall be replaced by the following: ‘(c) Flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No 1334/2008 and flavouring preparations as defined in Article 3(2)(d) of that Regulation may be used in the preparation of liqueur. However, only natural flavouring substances as defined in Article 3(2)(c) of Regulation (EC) No 1334/2008 and flavouring preparations as defined in Article 3(2)(d) of that Regulation shall be used in the preparation of the following liqueurs:’; (h) paragraph 41(c) shall be replaced by the following: ‘(c) Only flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No 1334/2008 and flavouring preparations as defined in Article 3(2)(d) of that Regulation may be used in the preparation of egg liqueur or advocaat or avocat or advokat.’; (i) paragraph 44(a) shall be replaced by the following: ‘(a) Väkevä glögi or spritglögg is a spirit drink produced by flavouring ethyl alcohol of agricultural origin with flavour 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 natural flavouring substances as defined in Article 3(2)(c) of Regulation (EC) No 1334/2008 of cloves or cinnamon or a combination of these methods.’; (j) paragraph 44(c) shall be replaced by the following: ‘(c) Other flavourings, flavouring substances and/or flavouring preparations as defined in Article 3(2)(b), (d) and (h) of Regulation (EC) No 1334/2008 may also be used, but the flavour of the specified spices must be predominant.’; (k) In point (c) of paragraphs 25, 26, 27, 28, 29, 33, 34, 35, 36, 37, 38, 39, 40, 42, 43, 45 and 46, the word ‘preparations’ shall be replaced by ‘flavouring preparations’.
Article 30
Entry into force
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 20 January 2011.
Article 10 shall apply from 18 months after the date of application of the Community list.
Articles 26 and 28 shall apply from the date of application of the Community list.
Article 22 shall apply from 20 January 2009. Foods lawfully placed on the market or labelled prior to 20 January 2011 which do not comply with this Regulation may be marketed until their date of minimum durability or use-by-date.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
UNION LIST OF FLAVOURINGS AND SOURCE MATERIALS
PART A
Union list of flavouring substances
Table 1 contains the following information:
| Category number | Food Category |
|---|---|
| 0. | All categories of foods |
| 01. | Dairy products and analogues |
| 01.1 | Unflavoured pasteurised and sterilised (including UHT) milk |
| 01.2 | Unflavoured fermented milk products, including natural unflavoured buttermilk (excluding sterilised buttermilk) non-heat-treated after fermentation |
| 01.3 | Unflavoured fermented milk products, heat-treated after fermentation |
| 01.4 | Flavoured fermented milk products including heat-treated products |
| 01.5 | Dehydrated milk as defined by Directive 2001/114/EC |
| 01.6 | Cream and cream powder |
| 01.6.1 | Unflavoured pasteurised cream (excluding reduced fat creams) |
| 01.6.2 | Unflavoured live fermented cream products and substitute products with a fat content of less than 20 % |
| 01.6.3 | Other creams |
| 01.7 | Cheese and cheese products |
| 01.7.1 | Unripened cheese excluding products falling in category 16 |
| 01.7.2 | Ripened cheese |
| 01.7.3 | Edible cheese rind |
| 01.7.4 | Whey cheese |
| 01.7.5 | Processed cheese |
| 01.7.6 | Cheese products (excluding products falling in category 16) |
| 01.8 | Dairy analogues, including beverage whiteners |
| 01.9 | Edible caseinates |
| 02. | Fats and oils and fat and oil emulsions |
| 02.1 | Fats and oils essentially free from water (excluding anhydrous milkfat) |
| 02.2 | Fat and oil emulsions mainly of type water-in-oil |
| 02.2.1 | Butter and concentrated butter and butter oil and anhydrous milkfat |
| 02.2.2 | Other fat and oil emulsions including spreads as defined by Regulation (EC) No 1234/2007 and liquid emulsions |
| 02.3 | Vegetable oil pan spray |
| 03. | Edible ices |
| 04. | Fruit and vegetables |
| 04.1 | Unprocessed fruit and vegetables |
| 04.1.1 | Entire fresh fruit and vegetables |
| 04.1.2 | Peeled, cut and shredded fruit and vegetables |
| 04.1.3 | Frozen fruit and vegetables |
| 04.2 | Processed fruit and vegetables |
| 04.2.1 | Dried fruit and vegetables |
| 04.2.2 | Fruit and vegetables in vinegar, oil, or brine |
| 04.2.3 | Canned or bottled fruit and vegetables |
| 04.2.4 | Fruit and vegetable preparations, excluding products covered by 5.4 |
| 04.2.4.1 | Fruit and vegetable preparations excluding compote |
| 04.2.4.2 | Compote, excluding products covered by category 16 |
| 04.2.5 | Jam, jellies and marmalades and similar products |
| 04.2.5.1 | Extra jam and extra jelly as defined by Directive 2001/113/EC |
| 04.2.5.2 | Jam, jellies and marmalades and sweetened chestnut puree as defined by Directive 2001/113/EC |
| 04.2.5.3 | Other similar fruit or vegetable spreads |
| 04.2.5.4 | Nut butters and nut spreads |
| 04.2.6 | Processed potato products |
| 05. | Confectionery |
| 05.1 | Cocoa and chocolate products as covered by Directive 2000/36/EC |
| 05.2 | Other confectionery including breath refreshening microsweets |
| 05.3 | Chewing gum |
| 05.4 | Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4 |
| 06. | Cereals and cereal products |
| 06.1 | Whole, broken, or flaked grain |
| 06.2 | Flours and other milled products and starches |
| 06.2.1 | Flours |
| 06.2.2 | Starches |
| 06.3 | Breakfast cereals |
| 06.4 | Pasta |
| 06.4.1 | Fresh pasta |
| 06.4.2 | Dry pasta |
| 06.4.3 | Fresh pre-cooked pasta |
| 06.4.4 | Potato gnocchi |
| 06.4.5 | Fillings of stuffed pasta (ravioli and similar) |
| 06.5 | Noodles |
| 06.6 | Batters |
| 06.7 | Pre-cooked or processed cereals |
| 07. | Bakery wares |
| 07.1 | Bread and rolls |
| 07.1.1 | Bread prepared solely with the following ingredients: wheat flour, water, yeast or leaven, salt |
| 07.1.2 | Pain courant français; Friss búzakenyér, fehér és félbarna kenyerek |
| 07.2 | Fine bakery wares |
| 08. | Meat |
| 08.1 | Fresh meat, excluding meat preparations as defined by Regulation (EC) No 853/2004 |
| 08.2 | Meat preparations as defined by Regulation (EC) No 853/2004 |
| 08.3 | Meat products |
| 08.3.1 | Non-heat-treated meat products |
| 08.3.2 | Heat-treated meat products |
| 08.3.3 | Casings and coatings and decorations for meat |
| 08.3.4 | Traditional and traditionally cured meat products with specific provisions concerning nitrites and nitrates |
| 08.3.4.1 | Traditional immersion cured products (Meat products cured by immersion in a curing solution containing nitrites and/or nitrates, salt and other components) |
| 08.3.4.2 | Traditional dry cured products. (Dry curing process involves dry application of curing mixture containing nitrites and/or nitrates, salt and other components to the surface of the meat followed by a period of stabilisation/maturation) |
| 08.3.4.3 | Other traditional and traditionally cured products (including immersion and dry cured processes used in combination or where nitrite and/or nitrate is included in a compound product or where the curing solution is injected into the product prior to cooking) |
| 09. | Fish and fisheries products |
| 09.1 | Unprocessed fish and fisheries products |
| 09.1.1 | Unprocessed fish |
| 09.1.2 | Unprocessed molluscs and crustaceans |
| 09.2 | Processed fish and fishery products including mollusks and crustaceans |
| 09.3 | Fish roe |
| 10. | Eggs and egg products |
| 10.1 | Unprocessed eggs |
| 10.2 | Processed eggs and egg products |
| 11. | Sugars, syrups, honey and table-top sweeteners |
| 11.1 | Sugars and syrups as defined by Directive 2001/111/EC |
| 11.2 | Other sugars and syrups |
| 11.3 | Honey as defined in Directive 2001/110/EC |
| 11.4 | Table-top sweeteners |
| 11.4.1 | Table-top sweeteners in liquid form |
| 11.4.2 | Table-top sweeteners in powder form |
| 11.4.3 | Table-top sweeteners in tablets |
| 12. | Salts, spices, soups, sauces, salads and protein products |
| 12.1 | Salt and salt substitutes |
| 12.1.1 | Salt |
| 12.1.2 | Salt substitutes |
| 12.2 | Herbs, spices, seasonings |
| 12.2.1 | Herbs and spices |
| 12.2.2 | Seasonings and condiments |
| 12.3 | Vinegars and diluted acetic acid (diluted with water to 4–30 % by volume) |
| 12.4 | Mustard |
| 12.5 | Soups and broths |
| 12.6 | Sauces |
| 12.7 | Salads and savoury based sandwich spreads |
| 12.8 | Yeast and yeast products |
| 12.9 | Protein products, excluding products covered in category 1.8 |
| 13. | Foods intended for particular nutritional uses as defined by Directive 2009/39/EC |
| 13.1 | Foods for infants and young children |
| 13.1.1 | Infant formulae as defined by Commission Directive 2006/141/EC (1) |
| 13.1.2 | Follow-on formulae as defined by Directive 2006/141/EC |
| 13.1.3 | Processed cereal-based foods and baby foods for infants and young children as defined by Commission Directive 2006/125/EC (2) |
| 13.1.4 | Other foods for young children |
| 13.1.5 | Dietary foods for infants and young children for special medical purposes as defined by Commission Directive 1999/21/EC (3) and special formulae for infants |
| 13.1.5.1 | Dietary foods for infants for special medical purposes and special formulae for infants |
| 13.1.5.2 | Dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC |
| 13.2 | Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5) |
| 13.3 | Dietary foods for weight control diets intended to replace total daily food intake or an individual meal (the whole or part of the total daily diet) |
| 13.4 | Foods suitable for people intolerant to gluten as defined by Commission Regulation (EC) No 41/2009 (4) |
| 14. | Beverages |
| 14.1 | Non-alcoholic beverages |
| 14.1.1 | Water, including natural mineral water as defined in Directive 2009/54/EC and spring water and all other bottled or packed waters |
| 14.1.2 | Fruit juices as defined by Directive 2001/112/EC and vegetable juices |
| 14.1.3 | Fruit nectars as defined by Directive 2001/112/EC and vegetable nectars and similar products |
| 14.1.4 | Flavoured drinks |
| 14.1.5 | Coffee, tea, herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products |
| 14.1.5.1 | Coffee, coffee extracts |
| 14.1.5.2 | Other |
| 14.2 | Alcoholic beverages, including alcohol-free and low-alcohol counterparts |
| 14.2.1 | Beer and malt beverages |
| 14.2.2 | Wine and other products defined in Part II of Annex VII to Regulation (EU) No 1308/2013 |
| 14.2.3 | Cider and perry |
| 14.2.4 | Fruit wine and made wine |
| 14.2.5 | Mead |
| 14.2.6 | Spirit drinks as defined in Regulation (EU) 2019/787 |
| 14.2.7 | Aromatised wine products as defined by Regulation (EU) No 251/2014 |
| 14.2.7.1 | Aromatised wines |
| 14.2.7.2 | Aromatised wine-based drinks |
| 14.2.7.3 | Aromatised wine-product cocktails |
| 14.2.8 | Other alcoholic beverages including mixtures of alcoholic beverages with non-alcoholic beverages and other alcoholic beverages based on distilled alcohol with alcoholic strength by volume less than 15 % |
| 15. | Ready-to-eat savouries and snacks |
| 15.1 | Potato-, cereal-, flour- or starch-based snacks |
| 15.2 | Processed nuts |
| 16. | Desserts excluding products covered in categories 1, 3 and 4 |
| 17. | Food supplements as defined in Directive 2002/46/EC |
| 17.1 | Food supplements supplied in a solid form, excluding food supplements for infants and young children |
| 17.2 | Food supplements supplied in a liquid form, excluding food supplements for infants and young children |
| 18. | Processed foods not covered by categories 1 to 17, excluding foods for infants and young children |
| (1) OJ L 401, 30.12.2006, p. 1. (2) OJ L 339, 6.12.2006, p. 16. (3) OJ L 91, 7.4.1999, p. 29. (4) OJ L 16, 21.1.2009, p. 3. |
(1) evaluation to be completed by the Authority
(2) additional scientific data shall be submitted by 31 December 2012
(3) additional scientific data shall be submitted by 30 June 2013
(4) additional scientific data shall be submitted by 31 December 2013
(5) additional scientific data shall be submitted in a timeframe agreed with the Commission Services, for the evaluation to be completed by the Authority.
Note 1: Ammonium, sodium, potassium and calcium salts as well as chlorides, carbonates and sulphates are covered by the generic substances, providing that they have flavouring properties.
Note 2: If the authorised flavouring substance is a racemate (an equal mixture of optical isomers), both the R- and S- form shall also be authorised for use. If only the R-form has been authorised then the S-form is not covered by this authorisation and vice versa.
Note 3: Maximum levels refer to levels in or on food as marketed. By way of derogation from that principle, for dried and/or concentrated foods which need to be reconstituted the maximum levels shall apply to the food as reconstituted according to the instructions in the labelling taking into account the minimum dilution factor.
Note 4: The presence of a flavouring substance shall be permitted:
(a) in a compound food other than as referred to in the Annex, where the flavouring substance is permitted in one of the ingredients of the compound food;
(b) in a food which is to be used solely in the preparation of a compound food and provided that the compound food complies with this Regulation.
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.
This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence.
EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.