Summary

Some milestones of the development of the European legislation on food labelling are briefly outlined. The presentation starts with the first comprehensive and harmonized directive 79/112/EEC on labelling and goes on over the regulation of nutrition labelling, the declaration of genetically modified organisms as well as allergenic ingredients to the decisions of the European parliament of May 25/26, 2005 on nutrition and health claims that were taken on May 25/26 in the year 2005. During these sessions the parliament had to decide over a proposal on a regulation on nutrition and health claims and another proposal on the addition of vitamins and minerals and certain other substances to foods.

The regulations on nutrition claims as well as fortification was hardly controversial and passed easily. It is remarkable that the parliament replaced the definition of "certain other substances" into “biologically active substances obtained either by extraction or synthesis which have a proven physiological effect..” instead of “nutritional and physiological effect”.“Thereby it is insured hat such substances as caffeine are also covered”was the justification for this amendment.

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Summary (2)

• Deleting of article 4 which contained restrictions of claims for food products that comply with certain nutrition profiles (no high contents of energy, fat, sugar and salt).

• Moderation of article 10, not allowing implied health claims such as claiming non-specific benefits of a nutrient or claims which make reference to slimming. Such claims may now be allowed if they are scientifically substantiated.

• Replacement of an authorisation procedure for claims with a much easier notification procedure.

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Health claims however, were very controversial and the European parliament has made some significant amendments. These amendments were all targeted towards more liberal and flexible and less bureaucratic solutions.

The most important amendments are:

Politicians however, are already working on ways to reverse those decisions of the parliament that are too liberal for many persons.

Zusammenfassung

Im Vortrag werden einige Meilensteine in der Entwicklung des Europäischen Rechts zur Kennzeichnung von Lebensmitteln kurz aufgezeigt. Die Präsentation beginnt mit der ersten, umfassenden und harmonisierten Richtlinie 79/112/EWG zur Kennzeichnung und führt über Regelungen der Nährwertangaben, der Kennzeichnung genetisch modifizierter Organismen sowie allergieauslösenden Substanzen zu den Entscheidungen des Europäischen Parlaments vom 25/26. Mai 2005. In diesen Sessionen hatte das Parlament über einen Vorschlag für eine Verordnung über nährwert- und gesundheitsbezogene Angaben sowie einen solchen zur Anreicherung von Lebensmitteln Beschluss zu fassen.

Die Bestimmungen zu den Nährwertangaben und zur Anreicherung waren wenig umstritten und wurden schnell verabschiedet. Bemerkenswert ist, dass das Parlament im Verordnungsvorschlag zur Anreicherung die Definition der „bestimmten anderen Stoffe“ geändert hat indem sie nun lautet „biologisch aktive Stoffe, die ... eine erwiesene physiologische Wirkung haben...“ anstelle von „ernährungsphysiologischer Wirkung“. „Dadurch wird erreicht, dass z.B. auch Stoffe wie Koffein erfasst sind“, lautet die Erklärung dazu. Eine Positivliste von erlaubten nährwertbezogenen Angaben mit den zugehörigen Bedingungen und Einschränkungen findet sich im Anhang zur Verordnung über nährwert- und gesundheitsbezogene Angaben in Lebensmitteln.

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Zusammenfassung (2)

• Ersatzlose Streichung des Artikels 4. Dieser beinhaltete die Einschränkung von nährwert- und gesundheitsbezogenen Angaben auf Lebensmittel, die bestimmten Nährwertprofilen entsprechen (nicht zu hohe Gehalte an Energie, Fett, Zucker oder Salz).

• Milderung des Verbots von gewissen „impliziten gesundheits-bezogenen Angaben“, wie nichtspezifische Vorteile eines Nährstoffs oder der Hinweis auf schlankmachende Eigenschaften. Diese können verwendet werden, wenn sie wissenschaftlich untermauert sind.

• Die Ersetzung eines Bewilligungsverfahrens für nährwert- und gesundheitsbezogene Angaben durch ein wesentlich einfacheres Anzeigeverfahren.

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Gesundheitsbezogene Angaben waren im Gegensatz dazu sehr um-stritten. Das Parlament hat hier einige sehr bedeutende Änderungen eingebracht, die alle in Richtung von liberaleren, flexibleren und unbürokratischen Lösungen hinzielen. Die 3 wichtigsten Änderungen sind:

Die Politiker sind jedoch bereits wieder damit beschäftigt, einige der Beschlüsse des Parlaments wieder rückgängig zu machen, die gewissen Leuten als all zu liberal erscheinen.

What‘s New in Food Labelling?

Presentation, held at the

6th European Forum for DietitiansGeneva, 2nd – 5th June 2005

by

Rudolf Buri, PhD

Basel, Switzerland

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Milestones in Food Labelling

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22 Sep 2003• Regulation (EC) No 1829/2003Genetically Modified Food and Feedstuff

28 Jan 2002• Regulation (EC) No 178/2002 Establishing the European Food Safety AuthorityTraceability of food and feedstuff

20 Mar 2000• Council Directive 2000/13/EECQuantitative Ingredient Declaration (QUID)

24 Sep 1990• Council Directive 90/496/EEC

on nutrition labelling for foodstuffs

18 Dec 1978• Council Directive 79/112/EEC

labelling, presentation and advertising offoodstuffs for sale to the ultimate consumer

(Milestones in Food Labelling 2)

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10 Nov 2003

25/26 May 2005

• Proposal for a Regulation on the addition of vitamins and minerals and of certain other substances to foods (COM(2003)671

16 Jul 2003

25/26 May 2005

• Proposal for a Regulation on Nutrition and Health Claims COM(2003)0424

• Decisions of Plenary Session

21 Mar 2005• Commission Directive 2005/26/ECAmendment to Council Directive 2003/89/EC Exclusion of certain food ingredientsfrom allergenic list (wheat based glucose sirup, refined soy oil etc.)

10 Nov 2003• Council Directive 2003/89/EC

Allergenic ingredients in foodstuffs12 Groups of Substances must be declared if present, even in the smallest amount (wheat, soy etc.)

Nutrition Labelling, QUID

Council Directive 79/112/EEC labelling, presentation and advertising of

foodstuffs for sale to the ultimate consumer

a) The name of the food

b) A list of ingredients

c) The appropriate durability indication

d) Any special storage conditions or conditions of use

e) The name or business name and an address of the manufacturer or packer, or of a seller

f) Particulars of the place of origin of the food, if failure to give such particulars might mislead and

g) Instructions for use if it would be difficult to make appropriate use of the food in the absence of such instructions

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Council Directive 90/496/EECon nutrition labelling for foodstuffs

• Nutrition labelling Group 1: - the energy value, and - the amount of protein, carbohydrate and fat,

• or Group 2: - the energy value, and - the amount of protein, carbohydrate, sugar, fat, saturated fatty acids, dietary fibre and sodium.

• The information shall be expressed per 100g or per 100ml or per package.

• Information on vitamins and minerals must also be expressed as a percentage of the recommended daily allowance (RDA) (RDA’s listed in the Appendix)

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Council Directive 2000/13/EECQuantitative Ingredient Declaration (QUID)

• Declaration of the quantity of an ingredient shall be stated if the ingredient either…

– Appears in the name of the product

– Is emphasised in words, by pictures or graphics

– Is essential to characterise a foodstuff

• The net quantity shall be expressed

– In units of volume in the case of liquids

– In units of mass in the case of other products

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Regulation (EC) No 178/2002 Establishing the European Food Safety Authority.

Traceability of food and feedstuff

1. The traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution.

2. Food and feed Business operators shall be able to identify any person from whom they have been supplied with a food, a feed, or a food-producing animal ...to be, incorporated into a food or feed.

3. Food and feed business operators shall have in place Systems andprocedures to identify the other businesses to which their products have been supplied. This information shall be made available to the competent authorities on demand.

4. ....

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Regulation (EC) No 1829/2003Genetically Modified Food and Feedstuff

1. Applies to foods which

– Contain or consist of GMOs; or

– Are produced from or contain ingredients produced from GMOs,without making any distinction between those containing DNA or genetic modifications in the chromosomes

2. Shall not apply to foods containing material which contains GMOs in a Proportion no higher than 0,9 per cent of the food or individual ingredient, provided that this presence is adventitious or technicallv unavoidable.

3. Operators are to supply evidence that they have taken appropriate steps to avoid the presence of such material.

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Regulation (EC) No 1829/2003 ffGenetically Modified Food and Feedstuff

Labelling Requirements

• Where the food consists of more than one ingredient, the words

„genetically modified“ or „produced from genetically modified X“ shall appear in the list of ingredients parentheses immediately following the ingredient concerned;

• In case of a category the words „contains genetically modified X“ or „contains X or produced from genetically modified X shall appear in the list of ingredients;

• Where there is no list of ingredients, the words „geneticallymodified“ or „produced from genetically modified (name of

organism)“ shall appear clearly on the labelling;

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Council Directive 2003/89/EC Allergenic ingredients in foodstuffs

Ingredients of the following 12 Groups of Substances (ANNEX IIIa) must be declared, even if present in smallest amount only :

• Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains) and products thereof

• Crustaceans and products thereof

• Eggs and products thereof

• Fish and products thereof

• Peanuts and products thereof

• Soybeans and products thereof

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Council Directive 2003/89/EC Allergenic ingredients in foodstuffs ff

• Milk and products thereof (including lactose)

• Nuts i. e. Almond, Hazelnut Walnut, Cashew, Pecan nut, Brazil nut, Pistachio nut, Macadamia nut and Queenslandnut and products thereof

• Celery and products thereof

• Mustard and products thereof

• Sesame seeds and products thereof

• Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or l

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Commission Directive 2005/26/ECAmendment to Council Directive 2003/89/EC

List of food Ingredients and Substances provisionally excluded from Annex IIIa

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- Whey used in distillates for spirits- Lactitol

- Milk (casein) products used as fining agents in cider and wines

Milk

- Mustard oil, seed oil, seed oleoresinMustard

- Celery leaf and seed oil, seed oleoresin Celery

- Nuts used in distillates for spiritsNuts

- Fully refined soybean oil and hat- Natural mixed tocopherols (E306), from soybean sources- Vegetable oils derived phytosterols and phytosterol esters

Soybeen

- Fish gelatine used as carrier for Vitamins and flavours- Fish gelatine or Isinglass used as fining agent in beer and wine

Fish

- Lysozym (produced from egg) used in wine - Albumin used as fining agent in wine and cider

Eggs

- Glucose syrups, dextrose, maltodextrins, based on wheat or barley- Cereals used in distillates for spirits

Cereals containing gluten

Products thereof provisionally excluded Ingredients

Proposal for a Regulation on Nutrition and Health Claims

Definitions

• „Claim“ means any message, including pictorial, graphic or symbolic representation, which states, suggests or implies that a food has particular characteristics

• Types of Claims of this Proposal:

– „Nutrition Claims“ suggest that a food has particular nutrition

properties due to its content (normal, reduced or increased)

– „Health Claims“, suggest or imply a relationship between a

food category, a food or one of its constituents and health

– Reduction of Disease Risk Claims“ suggest that a food or one of its constituents significantly reduces a risk factor in the

development of a human disease

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Main Objectives

• Establish a new regulatory framework for nutrition and health Claims, authorising:

– The use of nutrition Claims

– The use of health Claims that are subject to a notification procedure.

• Insure consumer protection and food safety

• Insure the free movement of food products

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Nutrition Claims

• Content Claims

– Free of...

– Very low in...

– Low in...

– Source of... , natural source of..., contains ...

– High in...

– Very high in..

– No added sugar

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Nutrition Claims

• Comparative Claims

– Reduced, light (lite): at least 30% less (-10% for vitamins)

– Increased: at least 30% more

compared to a similar product

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Energy

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< 4kcal (17 kJ)/100mlENERGY FREE

30% lessENERGY REDUCED

Indication by which measure

<40 kcal (170 kJ)/100g

<20 kcal ( 80 kJ)/100ml

LOW ENERGY

Fat

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<0.1g saturates/100g or mlSATURATED FAT FREE

<1.5g saturates/100g<0.75g /100ml

LOW SATURATED FATfor either cases: saturated fat

provides < 10% of Energy

< 0.5g fat/100g or 100mlFAT FREE

< 3g fat/100g

< 1.5g fat/100ml< 1.8g fat/100ml

LOW FAT

skimmed milk

Sugars

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No added mono-or disaccharides

WITH NO ADDED SUGAR

< 0.5g sugars/100g

or 100 ml

SUGARS-FREE

< 5g sugars/100g

or 100ml

LOW SUGARS

Protein

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<20% of the energy is

provided by protein

HIGH PROTEIN

>12% of the energy is

provided by protein

SOURCE OF PROTEIN

Vitamins and Minerals

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>30% of RDA per

100g or 100 ml

HIGH VITAMINS AND/OR MINERALSNATURAL OR ENRICHED

>15% of RDA per

100g or 100 ml

ENRICHED OR FORTIFIED IN VITAMINS AND/OR MINERALS

>15% of RDA per

100g or 100 ml

NATURAL SOURCE OF VITAMINS AND/OR MINERALS

Sodium / Salt

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< 0.005g sodium or

the equivalent for saltper 100g or 100 ml

SODIUM-FREESALT-FREE

< 0.04g sodium or the

equivalent for salt per 100g or 100 ml

VERY LOW SODIUM/SALT

< 0.12g sodium or the

equivalent for salt per 100g or 100 ml

LOW SODIUM/SALT

Health ClaimsExample of a General Health Claim (USA)

Disease Risk Claim

• Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber….may lower the risk of coronary heart disease.

(E Federal Regulations], [Title 21, Volume 2] , [CITE: 21CFR101.77 )

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Health ClaimsSpecific Conditions

• Health Claims shall be permitted if they comply with the

general and specific requirements and have been notifiedin accordance with the procedure in Article 14, and if the Commission has raised no

– objections within 6 Months

– In case of serious concerns with regard to the scientific substantiation of health claim that a favourable opinion by the

Authority cannot be expected, the Commission may prohibit the continued use of a health claim.

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Health ClaimsGeneral requirements

• A positive physiological effect has to be substantiated by accepted scientific knowledge

• The substance is contained in sufficient amount and is bioavailable

• The claim must be understood by the average consumer

• There are no requirements in regard to nutrition profiles (Article 4 has been deleted by the parliament)

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Health ClaimsLabelling requirements

• Health Claims shall only be permitted if the following information is included on the label:

– A Statement indicating the importance of a balanced diet and a healthy lifestyle;

– The quantity of the food and pattern of consumption required to obtain the claimed beneficial effect;

– Where appropriate, a Statement addressed to persons who should avoid using the food;

– Where appropriate, a warning not to exceed quantities of the product that may represent a risk to health.

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Health Claims

• The proposed wording of the health claim is to be substantiated scientifically

• The Authority will monitor advertising campaigns for foods including nutrition and health claims to ensure that, in line with Directive 2000/13/EC, the consumer is not misled by the information provided.

• Enter into force by the 20th day following that of its publication in the Official Journal of the European Union.

• It shall apply from the first day of the 18th month following publication

• This Regulation shall be binding in its entirety and directly applicable in all Member States.

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Proposal for a Regulation on the addition of Vitamins and minerals and of

certain other substances to foods1

Purposes:

a) Restoration

b) Nutritional equivalence of substitute foods

c) Fortification or enrichment

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1 „Certain other substances“ means biologically active substances which have a proven physiological effect

Restrictions

Vitamins and minerals may not be added to:

a) Fresh non-processed produce, including, but not limited to, fruits, vegetables, meat, poultry and fish;

b) Beverages containing more than 1.2% by volume of alcohol.

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Labelling, presentation and advertisingof foods to which vitamins, minerals and certain other

substances have been added

• The labelling, presentation and advertising shall not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients.

• Nutrition labelling is compulsory (Group 2).

• Information on vitamins und minerals 34should be given per serving size (amount per serving) and g/100g or ml in absolute numbers and as a percentage of the RDA

• The manufacturer‘s recommended daily intake of the product

• A warning not to exceed the stated RDA

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The End

Thank you very much for your attention

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Disclaimer

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