Amended by:
| Official Journal | |||
| No | page | date | |
|
Regulation （EC） No 1882/2003 of the European Parliament and of the Council of 29 September 2003 |
L284 | 1 | 31.10.2003 |
| Commission Directive 2003/120/EC of 5 December 2003 | L333 | 51 | 20.12.2003 |
| Commission Directive 2008/100/EC of 28 October 2008 | L285 | 9 | 29.10.2008 |
|
Regulation （EC） No 1137/2008 of the European Parliament and of the Council of 22 October 2008 |
L311 | 1 | 21.11.2008 |
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission （1），
In cooperation with the European Parliament （2），
Having regard to the opinion of the Economic and Social Committee （3），
Whereas it is important that measures should be adopted with a view to the progressive establishment of the internal market by 31 December 1992; whereas the internal market is an area without internal frontiers in which freedom of movement is ensured for goods, persons, services and capital;
Whereas there is growing public interest in the relationship between diet and health and in the choice of an appropriate diet to suit inpidual needs;
Whereas the Council and the Representatives of the Governments of the Member States meeting within the Council, in their resolution of 7 July 1986 on the European programme against cancer, considered the improvement of nutrition to be a priority;
Whereas knowledge of the basic principles of nutrition and appropriate nutrition labelling of foodstuffs would contribute significantly towards enabling the consumer to make this choice;
Whereas the provision of nutrition labelling should assist action in the area of nutrition education for the public;
Whereas, for the benefit of the consumer on the one hand, and to avoid any possible technical barriers to trade on the other, nutrition labeling should be presented in a standardized form applying throughout the Community;
Whereas foodstuffs bearing nutrition labelling should conform to the rules laid down in this Directive;
Whereas all other forms of nutrition labelling should be prohibited but foodstuffs bearing no nutrition labelling should be able to circulate freely;
Whereas, to appeal to the average consumer and to serve the purpose for which it is introduced, and given the current low level of knowledge on the subject of nutrition, the information provided should be simple and easily understood;
Whereas application of this Directive for a certain length of time will enable valuable experience on the subject to be gained and consumer reaction to the way in which nutrition information is presented to be evaluated thus enabling the Commission to review the rules and propose any appropriate amendments;
Whereas in order to encourage interested parties, especially small and medium-sized undertakings, to provide nutrition labelling for as many products as possible, measures to make information more complete and more balanced should be introduced gradually;
Whereas the rules laid down in this Directive should also take into account the Codex Altimentarius guidelines on nutrition labelling;
Whereas general labelling provisions and definitions are contained in Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer （1）， as last amended by Directive 89/395/EEC （2）；
Whereas this Directive can therefore be confined to those provisions pertaining to nutrition labelling,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive concerns nutrition labelling of foodstuffs to be delivered as such to the ultimate consumer. It shall also apply to foodstuffs intended for supply to restaurants, hospitals, canteens and other similar mass caterers（hereinafter referred to as 'mass caterers'）。
2. This Directive shall not apply to:
- natural mineral waters or other waters intended for human consumption,
- diet integrators/food supplements.
3. This Directive shall apply without prejudice to the labeling provisions of Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses （3） and specific Directives as referred to in Article 4 of that Directive.
4. For the purposes of this Directive:
（a）'nutrition labelling' means any information appearing on labeling and relating to:
（i） energy value;
（ii） the following nutrients:
- protein,
- carbohydrate,
- fat,
- fibre,
- sodium,
- vitamins and minerals listed in the Annex and present in significant amounts as defined in that Annex.
Measures designed to amend non-essential elements of this Directive and changing the list of vitamins, minerals and their recommended daily allowances shall be adopted by the Commission
in accordance with the regulatory procedure with scrutiny referred to in Article 10（3）；
（b）'nutrition claim' means any representation and any advertising message which states, suggests or implies that a foodstuff has particular nutrition properties due to the energy （calorific value） it
-provides,
-
- provides at a reduced or increased rate or
- does not provide,
and/or due to the nutrients it
- contains,
- contains in reduced or increased proportions or
- does not contain.
A reference to qualities or quantities of a nutrient does not constitute a nutrition claim in so far as it is required by legislation.
In accordance with the procedure laid down in Article 10（2）， it may be decided in certain cases whether the conditions described in this point are satisfied;
（c） 'protein' means the protein content calculated using the formula: protein = total Kjeldahl nitrogen × 6,25;
（d） 'carbohydrate' means any carbohydrate which is metabolized in man, and includes polyols;
（e） 'sugars' means all monosaccharides and disaccharides present in food, but excludes polyols;
（f） 'fat' means total lipids, and includes phospholipids;
（g） 'saturates' means fatty acids without double bond;
（h） 'mono-unsaturates' means fatty acids with one cis double bond;
（i） 'polyunsaturates' means fatty acids with cis, cis-methylene interrupted double bonds;
（j） 'fibre' means a material to be defined by the Commission and measured by a method of analysis to be determined by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10（3）；
（k） 'average value' means the value which best represents the amount of the nutrient which a given food contains, and reflects allowances for seasonal variability, patterns of consumption and other factors which may cause the actual value to vary.
Article 2
1. Subject to paragraph 2, nutrition labelling shall be optional.
2. Where a nutrition claim appears on labelling, in presentation or in advertising, with the exclusion of generic advertising, nutrition labeling shall be compulsory.
Article 3
The only nutrition claims permitted shall be those relating to energy, to the nutrients listed in Article 1（4）（a）（ii） and to substances which belong to, or which are components of, a category of those nutrients. Provisions restricting or prohibiting nutrition claims within the meaning of this
Article may be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10（3）。
Article 4
1. Where nutrition labelling is provided, the information to be given shall consist of either group 1 or group 2 in the following order:
Group 1
（a） energy value;
（b） the amounts of protein, carbohydrate and fat.
Group 2
（a） energy value;
（b） the amounts of protein, carbohydrate, sugars, fat, saturates, fibre and sodium.
2. Where a nutrition claim is made for sugars, saturates, fibre or sodium, the information to be given shall consist of group 2.
3. Nutrition labelling may also include the amounts of one or more of the following:
- starch,
- polyols,
- mono-unsaturates,
- polyunsaturates,
- cholesterol,
- any of the minerals or vitamins listed in the Annex and present in significant amounts as defined in that Annex.
4. The declaration of substances which belong to or are components of one of the categories of nutrients referred to in paragraphs 1 and 3 shall be compulsory where a nutrition claim is made.
In addition, where the amount of polyunsaturates and/or mono-unsaturates and/or the cholesterol rate is given, the amount of saturates shall also be given, the declaration of the latter not constituting - in this case - a nutrition claim within the meaning of paragraph 2.
Article 5
1. The energy value to be declared shall be calculated using the following conversion factors:
- carbohydrate （except polyols） 4 kcal/g -17 kJ/g
- polyols 2,4 kcal/g -10 kJ/g
- protein 4 kcal/g -17 kJ/g
- fat 9 kcal/g -37 kJ/g
- alcohol （ethanol） 7 kcal/g -29 kJ/g
- organic acid 3 kcal/g - 13 kJ/g
- salatrims 6 kcal/g - 25kJ/g
- fibre 2 kcal/g - 8 kJ/g
- erythritol 0 kcal/g - 0 kJ/g
2. Amendments to the conversion factors referred to in paragraph 1 and the addition to the list in that paragraph of substances which belong to, or are components of, one of the categories of nutrients referred to therein and their conversion factors, shall be adopted by the Commission in order to calculate more precisely the energy value of foodstuffs. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 10（3）。
Article 6
1. The declaration of the energy value and of the proportion of nutrients or their components shall be numerical. The units to be used are the following:
- energy - kJ and kcal grams （g）
- protein grams （g）
- carbohydrate grams （g）
- fat grams （g）
- fibre grams （g）
- sodium grams （g）
- cholesterol milligrams （mg）
- vitamins and minerals the units specified in the Annex
2. Information shall be expressed per 100 g or per 100 ml. In addition, this information may be given per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated.
3. In accordance with the procedure laid down in Article 10（2）。 it may be decided that the information in paragraphs 1 and 2 may also be given in graphical form according to formats to be determined.
4. The amounts mentioned shall be those of the food as sold. Where appropriate, this information may relate to the foodstuff after preparation, provided that sufficiently detailed preparation instructions are given and the information relates to the food as prepared for
consumption.
5. （a） Information on vitamins and minerals must also be expressed as a percentage of the recommended daily allowance （RDA）given in the Annex for the amounts as specified in
paragraph 2.
（b） The percentage of the recommended daily allowance （RDA） for vitamins and minerals may also be given in graphical form.Rules for implementing this subparagraph may be adopted in
accordance with the procedure laid down in Article 10（2）
6. Where sugars and/or polyols and/or starch are declared, this declaration shall immediately follow the declaration of the carbohydrate content in the following manner:
- carbohydrate g
of which:
- sugars g
- polyols g
- starch g
7. Where the amount and/or type of fatty acid and/or the cholesterol rate is declared, this declaration shall immediately follow the declaration of total fats in the following manner:
- fat g
of which:
- saturates g
- mono-unsaturates g
- polyunsaturates g
- cholesterol mg
8. The declared values shall, according to the inpidual case, be average values based on:
（a） the manufacturer's analysis of the food;
（b） a calculation from the known or actual average values of the ingredients used;
（c） a calculation from generally established and accepted data.
The rules for implementing the first paragraph with regard in particular to the differences between the declared values and those established in the course of official checks shall be decided upon in accordance with the procedure laid down in Article 10（2）
Article 7
1. The information covered by this Directive must be presented together in one place in tabular form, with the numbers aligned if space permits. Where space does not permit, the information shall be presented in linear form.
It shall be printed in legible and indelible characters in a conspicuousplace.
2. Member States shall ensure that the information covered by this Directive appears in a language easily understood by purchasers, unless other measures have been taken to ensure that the purchaser is informed. This provision shall not prevent such information from being indicated
in more than one language.
3. Member States shall refrain from laying down requirements more detailed than those already contained in this Directive concerning nutrition labelling.
Article 8
In the case of non-pre-packaged foodstuffs put up for sale to the final consumer or to mass caterers and foodstuffs packed at the point of sale at the request of the purchaser or pre-packaged with a view to immediate sale, the extent of the information referred to in Article 4
and the manner of its communication may be determined by national law until the eventual adoption of measures by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 10（3）。
Article 9
Any measures likely to have an effect on public health shall be adopted after consultation of the Scientific Committee for Food set up by Decision 74/234/EEC （1）。
Article 10
1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, set up by Article 58 of Regulation（EC） No 178/2002 （2）， hereinafter referred to as 'the Committee'。
2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC （3） 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.
Article 11
1. Member States shall take the measures necessary to comply with this Directive and shall forthwith inform the Commission thereof. Those measures shall be applied in such a way as to:
- permit trade in products complying with this Directive by 1 April 1992,
- prohibit trade in products which do not comply with this Directive with effect from 1 October 1993.
2. Until… （five years following notification of this Directive）， the declaration in nutrition labelling, either on a voluntary basis or following a nutrition claim, of one or more of the following nutrients; sugars, saturates, fibre, sodium, shall not trigger the obligation set out in
Article 4 （1） and （2） to declare all these nutrients.
3. The Commission shall, by… （eight years after notification of this Directive）， submit to the European Parliament and the Council a report on the application of this Directive. At the same time, it shall submit to the Council any appropriate proposals for amendment.
Article 12
This Directive is addressed to the Member States.
ANNEX I
Vitamins and minerals which may be declared and their recommended daily
allowances （RDAs）
Vitamin A （μg） 800
Vitamin D （μg） 5
Vitamin E （mg） 12
Vitamin K （μg） 75
Vitamin C （mg） 80
Thiamin （mg） 1,1
Riboflavin （mg） 1,4
Niacin （mg） 16
Vitamin B6 （mg） 1,4
Folic acid （μg） 200
Vitamin B12 （μg） 2,5
Biotin （μg） 50
Pantothenic acid （mg） 6
Potassium （mg） 2 000
Chloride （mg） 800
Calcium （mg） 800
Phosphorus （mg） 700
Magnesium （mg） 375
Iron （mg） 14
Zinc （mg） 10
Copper （mg） 1
Manganese （mg） 2
Fluoride （mg） 3,5
Selenium （μg） 55
Chromium （μg） 40
Molybdenum （μg） 50
Iodine （μg） 150
As a rule, 15 % of the recommended allowance specified in this Annex supplied by 100 g or 100 ml or per package if the package contains only a single portion should be taken into consideration in deciding what constitutes a significant amount.
ANNEX II
Definition of the material constituting fibre and methods of analysis as referred to in Article 1（4）（j）
Definition of the material constituting fibre
For the purposes of this Directive 'fibre' means carbohydrate polymers with three or more monomeric units, which are neither digested nor absorbed in the human small intestine and belong to the following categories:
- edible carbohydrate polymers naturally occurring in the food as consumed;
- edible carbohydrate polymers which have been obtained from food raw material by physical, enzymatic or chemical means and which have a beneficial physiological effect demonstrated by generally accepted scientificevidence;
- edible synthetic carbohydrate polymers which have a beneficial physiological effect demonstrated by generally accepted scientific evidence.
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