Overview of the EU rules on food information to consumers. General principles, mandatory and voluntary information on food labels. Nutrition & health claims made on foods. A clue on the draft EU Regulation, which is now under the exam of the European Parliament and the Council

1. Food information to
consumers:
EU rules and perspectives
©2008 Dario Dongo
Regulative Policies, Federalimentare, manager
dongo@federalimentare.it - GSM +39 335 7313 726
1

2. Index
Introduction
1) Labelling, presentation and advertising of
foodstuff (Dir. 2000/13/EC, 2008/5/EC)
2) Nutrition and health claims made on foods (EC
Reg. 1924/06)
3) food information to consumers, draft Regulation
(COM(2008) 40 final)
2

3. Introduction
Food legislation in all Member States derives
from EC Directives and Regulations
The main objective of these rules, traditionally,
is to guarantee the free movement of
goods (Art. 28-30 EC) in the Market
The common denominator of food law
worldwide is the Codex Alimentarius (FAO,
WHO)
3

4. Rules to be applied
General (horizontal) rules:
Dir. 2000/13/EC and further modifications,
Dir. 2008/5/EC (additional particulars to be included on
labels), Dir. 98/6/EC (indication of price), and others, shall
apply to all foods
Special (vertical) rules: hundreds of specific
rules, applied to single foods or food
categories, integrate and/or partially repeal
general rules
4

5. 1) Labelling, presentation and
advertising of foodstuff
Dir. 2000/13/EC (consolidated text)
+
Dir. 2008/5/EC
(additional particulars)
5

6. Scope
Foodstuff to be delivered as such to the final
consumer and mass caterers (ie. restaurants,
canteens,…)
-> Pre-packaged and food sold loose are both included
National rules actually provide some basic info to
be transferred even in B2B sales, ie.:
name under which the product is sold
list of ingredients
name and address of the producer/packager/retailer
lot/stock/delivery
6

7. The Golden Principle
Food labels have to be
readable and understandable
Their information must be
clear and substanciated
-> On this basis, information is divided into
mandatory and optional
7

8. Mandatory info (1)
In the same field of vision:
the name under which the product is sold,
physical condition
accompanied by particulars as to the
of the foodstuff or the specific treatment which it has
undergone (e.g. powdered, freeze-dried, deep-frozen,
concentrated, smoked) in all cases where omission of such
information could create confusion in the mind of the
purchaser
quantity (in case of prepackaged foods)
net
date of minimal durability [“best before”] or, in case of
foodstuffs highly perishable from the microbiological point of view,
“use by” date 8

9. Mandatory info (2)
list of ingredients, in descending order of
weight, as recorded at the time of their use in the
manufacture of the foodstuff
name or business name and address of the
manufacturer or packager, or of a seller
established within the Community
->Member States may retain national provisions which require
indication of the factory or packaging centre, in respect of
home production
batch code
9

10. Mandatory info (3)
Depending on the treatment or composition:
“Treated with ionising radiation” or “irradiated”
“Packaged in a protective atmosphere”
alcoholic strength by volume, for beverages
containing more than 1,2% by volume of alcohol (in
the same field of name, quantity, durability)
“with sweeteners” or “with sugar(s) and
sweetener(s)”
“contains a source of phenylalanine” (aspartame)
10

11. Mandatory info (4)
Depending on the treatment or composition:
caffeine and quinine, specific mention (excluding tea or
coffee-based drinks). “High in caffeine” (>150mg/litre)
“excessive consumption may produce laxative
effects” (added polyols >10%)
“contains liquorice” (unless the term is already included in
the name or in the ingredients list). “contains liquorice – people
suffering from hypertension should avoid excessive consumption”
(glycyrrhizinic acid or its ammonium salt, or the plant, at certain
concentrations)
GMO or GMO-derived (see EC Reg. 1829/03)
11

12. Mandatory info (5)
In particular cases:
nutrition labelling, when nutrition information
appears on labelling or advertising (with the exclusion of
generic advertising)
percentage of the characterising ingredient,
where:
- the ingredient or category of ingredients concerned appears
in the name under which the foodstuff is sold or is usually
associated
- where the ingredient or category of ingredients concerned is
emphasised on the labelling in words, pictures or graphics
- where the ingredient or category of ingredients concerned is
essential to characterise a foodstuff and to distinguish it from
products with which it might be confused because of its name
or appearance
12

13. Mandatory info (6)
Particular storage conditions and
conditions of use, when particular devices
(depending on the nature of the product) are required
Instructions for use, when it would be impossible
to make appropriate use of the foodstuff in the
absence of such instructions
Place of origin or provenance of the product,
where failure to give such particulars might mislead
the consumer to a material degree as to the true
origin or provenance (see EC Reg. 450/08, Art. 23-26)
13

14. How to deliver information
Means:
- prepackaged foods -> labels
- non-prepackaged foods -> Member States shall
adopt detailed rules (and derogations)
- B2B sales -> commercial documents (that accompany
the food or to be sent before or at the same time as delivery)
Language: the Member State in which the product is
marketed may stipulate that information shall be given
in one or more official languages of the
Community
14

15. Optional information
Clear and accurate information. Must not:
a) mislead the purchaser as to the characteristics of
the foodstuff […]
b) attribute to the foodstuff effects or properties
which it does not possess
c) suggest that the product possesses special
characteristics, when in fact all similar products
possess the same characteristics
d) attribute to the foodstuff the property of preventing,
treating or curing diseases, or refer to such
properties (with the exceptions of mineral waters
and dietetic products)
-> see also EC Reg. No. 1924/06, regarding nutrition
& health claims 15

16. The “Allergens Directive” (1)
2003/89/EC Directive has modified the “Labelling
Directive” (2000/13/CE) with regard to the indication
of ingredients present in foodstuffs
The BASIC PRINCIPLE:
Each ingredient or substance, used in the
preparation of foodstuff and still present in the final
product, even if in an alterate form, must be
indicated in the label with its specific name, when
it belongs or is derived from an allergenic ingredient
This rule is applied to all foodstuffs, including
alcoholic beverages 16

17. The “Allergens Directive” (2)
List of allergens:
Cereals containing gluten (ie. wheat, rye, barley, oat, spelt,
and their hybrids)
Milk
Eggs
Fish, shellfish, molluscs
Fish
Soy
Dry fruit with shell (ie. almond, hazelnut, nut, peanut, cashew
nut, pecan nut, brazil nut, pistachio, macadamia nut)
Sesame
Mustard
Celery, Celeriac
Sulphurous anhydride (SO2), at concentration higher than 10
mg/kg or 10 mg/litre
Lupin
and products thereof 17

18. The “Allergens Directive” (3)
NB: compound ingredients, in the list of
ingredients, must be followed by the list of their
ingredients
-> ie. Biscuit - List of ingredients: flour, margarine (vegetable
oils, hydrogenated vegetable oils, water, emulsifier …, salt),
sugar, …
NB: substances derived from allergens but
excluded from the requirement of specific
mention of the allergenic ingredient: see Dir.
2007/68/EC (new Annex 3a Dir. 2000/13/EC)
18

19. The “Allergens Directive” (4)
Impact on process:
HACCP analysis must consider the risk of
(cross) contamination with allergens and/or
their derivatives, in all phases of
buying (suppliers’ warranties + random analysis) –
stocking – manufacturing – packaging –
deposit – transport – distribution
-> possible reformulation of the product
Impact on label:
-> “It may contain …” 19

20. The “Allergens Directive” (5)
Example 1: sandwich (UK)
20

21. The “Allergens Directive” (6)
Example 2: cake (UK)
21

22. 2) Nutrition & health claims
made on foods
(EC) Reg. No. 1924/06
22

23. Nutrition & health claims
EC Regulation No. 1924/06
Scope: nutrition and health claims made in
commercial communications, whether in the
labelling, presentation or advertising of foods to be delivered
as such to the final consumer -> TM, brand names, fancy
names included
Nutrition claim: “any claim which states, suggests or
implies that a food has particular beneficial nutritional
properties due to:
the energy (kcal) it provides; provides at a reduced or
increased rate; or does not provide; and/or
the nutrients or other substances it contains; contains in
reduced or increased proportions; or does not contain”
Health claim: “any claim that states, suggests or implies
that a relationship exists between a food category, a
food or one of its constituents and health” 23

24. General principles
The use of nutrition and health claims shall
not:
be false, ambiguous or misleading
give rise to doubt about the safety and/or the
nutritional adequacy of other foods
encourage or condone excess consumption of a
food
state, suggest or imply that a balanced and varied
diet cannot provide appropriate quantities of
nutrients in general
refer to changes in bodily functions which could
give rise to or exploit fear in the consumer, either
textually or through pictorial, graphic or symbolic
representations (Art. 3) 24

25. General conditions
the presence, absence or reduced content in a food or
category of food of a nutrient or other substance in respect
of which the claim is made has been shown to have a
beneficial nutritional or physiological effect, as
established by generally accepted scientific
evidence
the nutrient or other substance for which the claim is
made:
- is contained/reduced/not present in the final
product in a significant quantity - with reference to
the amount of product that can reasonably be
expected to be consumed – in order to produce the
nutritional or physiological effect claimed
- is available to be used by the body (where applicable)
the claim is understandable by the average
consumer (Art. 5) 25

26. Nutrition claims
Nutrition claims shall only be permitted if they
are listed in the Annex and are in conformity with
the conditions set out in the Regulation
Claims, as listed in the Annex, must be adapted
to usage conditions, and they shall apply from 1
July 2007
Nutrition claims which have been used in a
Member State before 1 January 2006, in
compliance with national provisions and which are
not included in the Annex, may continue to be used
until 19 January 2010 under the responsibility of
food business operators
26

27. Nutrition claims: Annex (1)
LOW ENERGY: <40kcal (170kJ)/100g for
solids, or <20kcal (80kJ)/100ml for liquids
ENERGY-REDUCED: energy value is
reduced by at least 30%, with an indication
of the characteristic(s) which make(s)
the food reduced in its total energy
value
ENERGY-FREE: <4kcal (17kJ)/100ml
27

28. Nutrition claims: Annex (2)
LOW FAT: <3g fat per 100g (solids), or <1,5g
fat per 100ml (liquids)
-> semi-skimmed milk: <1,8g fat per 100ml
FAT-FREE: <0,5g fat per 100g/ml
-> claims expressed as ‘X % fat-free’ are prohibited
LOW SATURATED FAT: <1,5g saturated
fatty acids and trans-fatty acids per 100g
(solids), or 0,75g per 100ml (liquids) and in
either case no more than 10% of energy
SATURATED FAT-FREE: <0,1g saturated
fat per 100g/ml 28

29. Nutrition claims: Annex (3)
LOW SUGAR: <5g sugar per 100g (solids), or
<2,5g sugar per 100ml (liquids)
SUGAR-FREE: <0,5g per 100g/ml
WITH NO ADDED SUGAR: where the product
does not contain any added mono- or
disaccharides or any other food used for its
sweetening properties
-> If sugar is naturally present in the food, the
following indication should also appear on the label:
‘CONTAINS NATURALLY OCCURRING
SUGAR’
29

30. Nutrition claims: Annex (4)
LOW SODIUM/SALT: <0,12g sodium (or
salt-equivalent) per 100g/ml
VERY LOW SODIUM/SALT: <0,04g sodium
(or salt-equivalent) per 100g/ml
SODIUM-FREE or SALT-FREE: <0,005g
sodium (or salt-equivalent) per 100g/ml
SOURCE OF FIBRE: >3g fibre per 100g, or
>1,5g fibre per 100 kcal
HIGH FIBRE: > 6g fibre per 100g, or >3g
fibre per 100 kcal 30

31. Nutrition claims: Annex (5)
SOURCE OF PROTEIN: at least 12% of the
energy value of the food is provided by protein
HIGH PROTEIN: at least 20% of the energy
value of the food is provided by protein
SOURCE OF [NAME OF VITAMIN/S AND/OR
MINERAL/S]: at least a significant amount
(15% RDA)
HIGH [NAME OF VITAMIN/S AND/OR
MINERAL/S]: at least twice the value of
‘source of [VITAMIN/S and/or MINERAL/S]’
(30%RDA) 31

32. Nutrition claims: Annex (6)
CONTAINS [NAME OF THE NUTRIENT OR
OTHER SUBSTANCE]: the product shall comply
with all the applicable provisions of the
Regulation (Article 5, in particular)
INCREASED [NAME OF THE NUTRIENT]: at
least 30 % increase in content, compared to a
similar product
REDUCED [NAME OF THE NUTRIENT]: at least
30% reduction in content compared to a
similar product, except for micronutrients (10
% difference) and for sodium, or the
equivalent value for salt (25% difference)
32

33. Nutrition claims: Annex (7)
LIGHT/LITE: a claim stating that a product is ‘light’
or ‘lite’, and any claim likely to have the same
meaning for the consumer, shall follow the same
conditions as those set for the term ‘reduced’
-> the claim shall also be accompanied by an
indication of the characteristic(s) which
make(s) the food ‘light’ or ‘lite’
NATURALLY/NATURAL: where a food naturally
meets the condition(s) laid down in the Annex for
the use of a nutritional claim, the term
‘naturally/natural’ may be used as a prefix
33

34. Health claims:
specific conditions (1)
Health claims shall be prohibited unless they
comply with the general requirements (..)
and the specific requirements (…), and are
included in the lists of authorised claims
provided for in Articles 13 and 14
34

35. Health claims:
specific conditions (2)
Health claims shall only be permitted if the
following information is included in the
labelling, or if no such labelling exists, in the
presentation and advertising:
a) a statement indicating the importance of a varied
and balanced diet and a healthy lifestyle
b) the quantity of the food and pattern of
consumption required to obtain the claimed
beneficial effect
c) where appropriate, a statement addressed to
persons who should avoid using the food; and
d) an appropriate warning for products that are likely
to present a health risk if consumed to excess 35

36. Health claims:
general references
Reference to general, non-specific
benefits of the nutrient or food for overall
good health or health-related well-being
may only be made if accompanied by a
specific health claim included in the lists
provided for in Article 13 or 14
NB: the reference should not apply to the
general organoleptic characteristics as far as
the product specification regards its own value
36

37. Health claims:
functional claims (1)
A Community Register will be established of
health claims, substantiated by scientific
evidence, describing or referring to:
a) role of a nutrient or other substance in growth,
development and the functions of the body
b) psychological and behavioural functions
c) slimming or weight-control or a reduction in
hunger or an increase in the sense of satiety or
reduction of the available energy from the diet,
without prejudice to Directive 96/8/EC (Art. 13) 37

38. Health claims:
functional claims (2)
Member States have provided the Commission with
lists of claims, with all necessary conditions for the
use of these claims -> the Commission, after the
opinion of EFSA, will publish the Community
Register by 31 Jan. 2010
Claims may be made under the conditions
mentioned in the Community Register, complying
with the nutrient profiles rules
NB: The reduction of disease risk claims and claims
referring to childrens’ development and health are
excluded from this regime
38

39. Health claims:
other claims
The
reduction of disease risk claims* and
claims referring to childrens’
development and health
-> can only be made where they have been
authorised in accordance with the Commission
and EFSA (Art. 14)
(*)”any health claim that states, suggests or implies
that the consumption of a food category, a
food or one of its constituents significantly
reduces a risk factor in the development of a
human disease 39

40. Nutrition profiles, criteria
By 19 January 2009, the Standing Committee for the
Food Chain and Animal Health will establish the
Nutrient Profiles, for food and/or certain categories
of food, taking into account in particular:
1) the quantities of certain nutrients and other
substances contained in the food, such as
- fat, saturated fatty acids, trans-fatty acids,
- sugars,
- salt/sodium
2) the role and importance of the food (or of
categories of food) and the contribution to the diet
of the population in general or, as appropriate, of certain
risk groups including children,
3) the overall nutritional composition of the food
and the presence of nutrients that have been scientifically
recognized as having an effect on health 40

41. Nutritional profiles, effects
In 24 months from the adoption, foods not
complying with the nutrient profiles will not be
allowed to bear health claims. These products
might use nutrition claims in two different
cases:
1) where the reduction of fat, saturated fatty acids,
trans-fatty acids, sugars and salt/sodium is
referred to (Art. 4.2.a)
2) where a single nutrient exceeds the nutrient
profile. In this case, a statement about the specific
nutrient must appear in close proximity to the
nutrition table on the label: ‘High […] content’ (Art.
4.2.b) 41

42. 3)Commission proposal for a
Regulation on the provision of
food information to consumers
(COM(2008) 40 final)
42

43. Objectives
Simplification:
- recast horizontal Directives in a Regulation
- technical specifications in the Annex (easier
amendment procedures)
-> vertical rules database? Uniform compliance dates?
Consumers’ health protection (Art. 153 CE, White
Paper on Nutrition, overweight, obesity)
Making labels more efficient:
- legibility (3mm font size)
- allergens (information from mass caterers to consumers)
- origin
- alcoholic beverages (composition, energy value) 43

44. Nutrition labelling (1)
Mandatory information, on Front of Pack:
energy (kcal)
fat
saturated fat
carbohydrates
(of which) sugars
sodium (expressed as salt-equivalent)
-> per 100g/100ml/portion
-> where appropriate (?), indication of the percentage of the
reference intake value provided by the food (see GDAs,
under CIAA guidelines on nutrition labelling) 44

45. Nutrition labelling (2)
Additional information:
- trans fats
- mono-unsaturates
- polyunsaturates
- polyols
- starch
- fibre
- protein
- certain minerals and vitamins
-> are voluntary, unless a claim is made upon them
-> can be provided either on Front or Back of Pack
45

46. Nutrition labelling (3)
Exemptions
from mandatory nutrition labelling:
single ingredients products (ie. raw meat, flour)
wine, beer, spirits (review 5 years after entry into force)
tea, coffee, spices, salt
flavourings, food additives, enzymes, processing aids,
gelatine, yeast
small packages (largest surface <25 cm2)
small quantities of foods directly supplied by
manufacturer to the final consumer
food sold occasionally by private persons 46