Transcript Risk Management Information System

EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Changes in labelling regime
Patrick DEBOYSER
Head of ‘Food Law & Biotechnology’
Health & Consumer Protection DG
EUROPEAN COMMISSION
P. Deboyser
Changes in labelling regime
Slide 1
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Changes in labelling regime : overview
 Changes already enacted:
 Labelling of food containing meat (Directive 2001/101/EC)
 Labelling of compound ingredients (Directive 2003/89/EC)
 Labelling of allergenic substances (Directive 2003/89/EC)
 Labelling of food containing quinine or caffeine (Directive … )
 Labelling of genetically modified (GM) food (Regulation 1829/2003)
 Changes being considered by Council and Parliament:
 Nutrition and health claims (Proposal COM(2003) …)
 Changes being considered by the Commission
 Nutrition labelling
 General review of food labelling
P. Deboyser
Changes in labelling regime
Slide 2
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
General labelling regime : Directive 2000/13/EC
 Consolidates previous legislation
 Objectives:
 To ensure the smooth functioning of the internal market
 To inform and protect consumers
 Has been adopted as a model for labelling legislation in many
countries around the world
 Applies to all foods placed on the market
but does not prevent rules applying to specific food
 Applies to the labelling of food,
and to certain aspects of presentation and advertising
 Applies to food sold pre-packaged
but not to food sold in bulk (not pre-packaged)
and not to food sold by mass caterers (restaurants, etc.)
P. Deboyser
Changes in labelling regime
Slide 3
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
General labelling requirements
 Labelling may not mislead the purchaser to a material degree:
 as to the characteristics of the food (e.g. in particular : nature, identity,
properties, composition, quantity, durability, origin or provenance,
method of manufacture or production);
 by attributing to the food effects or characteristics which it does not
possess;
 by suggesting that the food possess special characteristics when in fact
all similar food possess such characteristics.
 Labelling may not attribute to any food the property of preventing,
treating or curing human disease, or refer to such properties.
 A non-exhaustive list of claims, within the meaning of the two
requirements above, the use of which must at all events be
prohibited or restricted, shall be established by Council and
Parliament.
P. Deboyser
Changes in labelling regime
Slide 4
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Mandatory labelling: requirements
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The name of the food.
The list of ingredients.
The quantity of certain ingredients (QUID).
The net quantity of the food.
The date of durability or the ‘use by’ date.
Any special storage conditions or conditions of use.
The name and address of the manufacturer or packager, or of a
seller established in the European Union.
 The place of origin or provenance where failure to give it would
mislead the consumer to a material degree.
 Any instructions for usewhere they are needed.
P. Deboyser
Changes in labelling regime
Slide 5
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Mandatory labelling: derogations
 Provided by Directive 2000/13/EC itself (e.g. butter, cheese…).
 Provided in other EU legislation (e.g. fruit juices, fish…).
 Community provisions applicable to specified food and not to food
in general may provide for derogations in exceptional from the
requirements to provide the list of ingredients and/or the date of
minimum durability (not used so far).
 Community provisions applicable to specified food and not to food
in general may provide that other particulars must appear on the
labelling (e.g. indication of quinine and caffeine content).
 Where there are no Community provisions, Members States may,
subject to approval by the Community, provide that other particulars
must appear on the labelling.
P. Deboyser
Changes in labelling regime
Slide 6
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
List of ingredients: overview
 Very complex regime!
 Includes all the ingredients of the food, in descending order of
weight, as recorded at the time of their use in the manufacture of
the product.
 Many derogations: fresh fruits and vegetables, carbonated water,
fermentation vinegars, cheese, butter, fermented milk, alcoholic
beverages, compound ingredients…
 Important modification introduced in 2003 (Directive 2003/89/EC)
coming into force in 2005):
 Allergenic substances must always be labelled!
 Individual ingredients of compound ingredients must be labelled except
in very specific circumstances!
P. Deboyser
Changes in labelling regime
Slide 7
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
List of ingredients: allergenic substances (1)
 Substances which cause allergies, intolerances or hypersensitivity
must always be labelled.
 List of these substances is provided in Annex IIIa of Directive
2000/13/EC:
Cereals containing gluten
Milk
Crustaceans
Nuts
Eggs
Celery
Fish
Mustard
Peanuts
Sesame seeds
Soybeans
Sulphur dioxide
and all products thereof
P. Deboyser
Changes in labelling regime
Slide 8
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
List of ingredients: allergenic substances (2)
 Exemption may be granted (by the Commission) in respect of
ingredients for which it has been scientifically established that they
are not likely, under specific circumstances, to trigger allergenic
reactions.
 Where studies are currently being undertaken for that purpose, the
Commission may grant exemption until completion of the said
studies or 25 November 2007 at the latest, provided a notification
has been made to the Commission prior to 25 November 2004.
P. Deboyser
Changes in labelling regime
Slide 9
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
List of ingredients: compound ingredients
 Abolition of the 25 % rule (whereby individual ingredients of
compound ingredients constituting less than 25 % of the final
product did not need to be indicated in the list of ingredients of the
final product).
 Ingredients of compound ingredients have to be listed except:
 where the composition of the compound ingredient is defined in current
Community legislation (e.g. jam) and the compound ingredient
constitutes less than 2 % of the finished product;
 where the compound ingredient consists of spices and/or herbs and the
the compound ingredient constitutes less than 2 % of the final product;
 where the compound ingredient is a food for which a list of ingredients
is not required in Community legislation (e.g. cheese, butter…).
P. Deboyser
Changes in labelling regime
Slide 10
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
List of ingredients: flexibility introduced
 Fruits, vegetables and mushrooms:
 when used in proprortions that may vary, and where none of them
predominates,
 may be grouped together in the list of ingredients under the designation
« fruit », « vegetables » or « mushrooms » followed by the phrase « in
varying proportions » and by a list of the fruit, vegetables or
mushrooms present.
 Ingredients constituting less than 2 % may be listed in a different
order, after the other ingredients.
 Where two ingredients are substitutable in the production of a
product, they may be referred to by means of the phrase « contains
… and/or … » provided that:
 they represent less than 2 % of the finished product;
 At least one of the two ingredients is present.
P. Deboyser
Changes in labelling regime
Slide 11
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
List of ingredients: categories of ingredients
 Annex I to Directive 2000/13/EC defines categories of ingredients
which may be designated by the specific name of the category
rather than by the specific name of the ingredient considered for
inclusion in the list of ingredients (e.g. vegetable oil, fish…).
 The category « … meat » was been recently added to that list
(Directive 2001/101/EC):
 the name(s) of the animal species must be included;
 the maximum amount of fat and connective tissues contained in the
ingredient designated by the category « … meat » is specified (e.g. for
poultry: 25 % fat and 25 % connective tissue).
 mechanically recovered meat is excluded, and must be labelled as
such.
 this only concerns meat which constitutes and ingredient of another
food!
P. Deboyser
Changes in labelling regime
Slide 12
EUROPEAN COMMISSION
Health and Consumer Protection DG
P. Deboyser
Changes in labelling regime
SANCO.D.4
Food Law &
Biotechnology
Slide 13
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Labelling of genetically modified (GM) food
 New provisions (Regulation 1829/2003) have recently
come into application (18 April 2004).
 They provide for the mandatory labelling of all GM food
and GM food ingredients which consist of, contain or are
derived from a GMO, irrespective of:
 any safety or nutritional consideration;
 the is sometimes referred to as « labelling the method of
production ».
P. Deboyser
Changes in labelling regime
Slide 14
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Labelling of GM food: examples
 In practice, following labelling is typically required:
 In the case of a food consisting of a GMO (e.g. Bt11 corn), the
label shall bear « genetically modified corn » as the name of the
product.
 In the case of a food containing a GMO (e.g. Bt11 corn), the list
of ingredient will include the terms « genetically modified corn ».
 In the case of a food produced from a GMO (e.g. oil from Bt
cotton seeds), the label shall bear « GM cotton seeds oil ».
 In the case of a food containing an ingredient (e.g. oil from Bt
cotton seeds), the list of ingredients will include the terms « GM
cotton seeds oil ».
P. Deboyser
Changes in labelling regime
Slide 15
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Labelling of GM food: additional labelling
 In addition, where a GM food (or ingredient) is different from its
conventional counterpart as regards:
 its composition
 its nutritional value or nutritional effects
 its intended use
 its implications for the health of certain sections of the population
this must be mentioned in the labelling provisions (Regulation
1829/2003) have recently come into application (18 April 2004).
 In addition, where a food may give rise to ethical or religious
concerns, this shall also be mentioned.
 Where a GM food does not have a conventional counterpart, the
labelling shall contain appropriate information about the nature and
characteristics of the food.
P. Deboyser
Changes in labelling regime
Slide 16
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Labelling of GM food: scope
 In contrast with the general labelling requirements (Directive
2000/13/EC) the provisions of Regulation 1829/2003 apply to all
food, whether sold pre-packaged or not.
 There are divergences as to the application of these provisions to
food provided by mass caterers (e.g. restaurants, canteens,
schools, prisons…).
 According to the Commission, the provisions do not apply to food
which is processed or prepared by mass caterers, but they do apply to
food which are supplied to mass caterers and delivered as such to the
final consumer.
 Some Member States (e.g. Germany, France) consider that the
provisions of Regulation 1829/2003 apply also to all food served by
mass caterers to final consumers.
 In practice, this divergence is of little practical importance as, under the
Commission interpretation, Member States are allowed to extend the
provisions of the Regulation to food sold by mass caterers to final
consumers on their territory.
P. Deboyser
Changes in labelling regime
Slide 17
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Labelling of GM food: exemption
 The provisions of Regulation 1829/2003 do not apply to the
unintentional presence of GM material in conventional food
provided that:
 this presence is no higher than 0,9 % of any ingredient or of the food
itself;
 the operator is in a position to establish that this presence is
adventitious or technically unavoidable (i.e. appropriate steps have
been taken to avoid this presence.
 The 0,9 % threshold may be lowered by the Commission through
the comitology procedure.
 The 0,9 % labelling threshold operates independently from the
0,5 % tolerance threshold for the adventitious presence of
unauthorized GM material. However, as the case may be, any
unauthorised GM material present will be counted against the 0,9 %
labelling threshold.
P. Deboyser
Changes in labelling regime
Slide 18
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Labelling of GM food: controls
 The control of the respect of the new labelling provisions has been
greatly improved in three respects:
 the precise labelling requirements applicable to any GM food will
henceforth be specified in the authorization of the food;
 a validated method of detection will be available for all GM food
authorised in the EU, as validation of the detection method is now a
prerequisite for the authorisation;
 in addition to detection as well as in cases where no transgenic DNA or
protein is detectable, controls will be based on the paper track
(traceability).
 Regulation 1830/2003 requires the mandatory traceability of GMOs
and food derived from GMOs. The exemptions provided by this
Regulation are based on and therefore similar to those laid down in
respect of labelling by Regulation 829/2003.
P. Deboyser
Changes in labelling regime
Slide 19
EUROPEAN COMMISSION
Health and Consumer Protection DG
P. Deboyser
Changes in labelling regime
SANCO.D.4
Food Law &
Biotechnology
Slide 20
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Nutrition and health claims
 As consumers have become increasingly concerned about what
they eat and how this affects their health, the food industry has
responded by providing more detailed nutrition labelling and often
making claims about the beneficial effects of certain foods.
 The existing EU rules on labelling and nutrition labelling do not
define conditions for the use of nutrition claims and do not allow
health claims to be made.
 Consumers can therefore be misled by claims that have not been
properly substantiated.
 The Commission submitted a proposal for a Parliament and Council
Regulation on nutrition and health claims in July 2003.
 The proposed Regulation will give legal security and address these
issues by specifying the conditions for the use of nutrition and
health claims, prohibiting certain claims and scientifically evaluating
the use of claims in relation to the nutritional profile of foods.
P. Deboyser
Changes in labelling regime
Slide 21
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Nutrition claims
 Nutrition claims, such as “low fat” or “high fibre”, refer to what is or is
not contained in the product.
 There are currently no legally binding conditions regulating the use of
these claims.
 The proposed Regulation aims to harmonise the use of such claims
so that products claiming to be for example “high fibre” have a defined
minimum amount of fibre per a defined unit (e.g. 6 g / 100g).
 Furthermore, some claims may be misleading. For example a product
claiming to be “90% fat free” may be stating correct facts but it is still
misleading since it implies that it has a low fat content while in reality
10% fat represents a fairly high fat content.
 The proposal includes an Annex listing the only nutrition claims that
will be allowed and the conditions for using them.
P. Deboyser
Changes in labelling regime
Slide 22
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Health claims: general
 Health claims refer to the potential health benefits that a food or a
food component may bring to consumers.
 It is currently prohibited to make any claims that are misleading to
consumers, as well as any claim which refers to a human disease.
 The proposal distinguishes between two types of health claims:
 health claims regarding the role of a nutrient in normal body functions,
which are uncontroversial and well established.
Example: “Calcium plays an important role in strengthening thebones”.
 health claims which are more novel
Example: “Whole grain may keep your heart healthy”
and claims referring to the reduction of a risk factor of a disease
Example: “Regular consumption of whole grain may reduce the risk of
heart disease”
P. Deboyser
Changes in labelling regime
Slide 23
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Health claims: authorisation
 Well established health claims:
 Within three years of the Regulation entering into force, the Commission
will, on the basis of notifications by the Member States, make a positive
list of such well established claims that will be permitted.
 The list will be regularly updated to reflect progress in scientific
knowledge and food technology.
 Novel and disease risk related claims
 Only claims that can be substantiated will be permitted on the EU level.
 Operators wanting to make such claims will have to submit an application
to the European Food Safety Authority (EFSA).
 A decision on the acceptability of the claim will be taken by the
Commission.
 In some cases, the right to use the claim will be reserved for the applicant
who has put the file together (reward of innovation).
P. Deboyser
Changes in labelling regime
Slide 24
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Prohibited nutrition and health claims
 Some health claims will be prohibited irrespective of whether or not
they could be substantiated:
 vague claims referring to general wellbeing (e.g. "helps your body to
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resist stress", "preserves youth")
claims making reference to psychological and behavioural functions (e.g.
“improves your memory” or “reduces stress and adds optimism”)
slimming or weight control claims (e.g. "halves/reduces your calories
intake")
reference to and endorsement by doctors or health professionals
any claim suggesting that not eating the specified food might lead to
health problems.
 In addition, both nutrition and health claims will be prohibited in
respect of alcoholic beverages above 1.2 %. Only claims referring to a
reduction in alcohol or energy content, will be allowed.
P. Deboyser
Changes in labelling regime
Slide 25
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Nutritional profiles
 The basic principle in nutrition is that there are no “good foods” and
“bad foods” but rather “good diets” and “bad diets”. In a long-term
varied diet all foods can be included.
 However, foods bearing a nutrition or health claim will automatically
be perceived as "good" foods by consumers.
 The proposal therefore provides for the possibility of restricting the
use of claims on some foods based on their nutritional profile.
 The amount of total fat, saturates, sugar or salt are criteria for the
nutritional profile of products, since scientific evidence shows a link
between over-consumption of such nutrients and some chronic diseases
(see WHA Resolution of last week).
 Within 18 months of adoption of the Regulation, the Commission will
evaluate nutritional profiles in close consultation with stakeholders and
based on the opinion of the European Food Safety Authority (EFSA).
Exemptions may be necessary for certain claims on foods depending on
their role and importance in the diet of the population.
P. Deboyser
Changes in labelling regime
Slide 26
EUROPEAN COMMISSION
Health and Consumer Protection DG
P. Deboyser
Changes in labelling regime
SANCO.D.4
Food Law &
Biotechnology
Slide 27
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Nutrition labelling
 In the EU, nutrition labelling is currently only required where a
nutrition claim is being made. In such case it must conform to the
requirements laid down in Directive 90/496/EEC.
 Where nutrition labelling is offered voluntarily, it must also conform
to these requirements.
 The European Commission is considering a proposal to make
nutrition labelling compulsory on all pre-packaged food in the EU.
 A wide consultation of stakeholder and Member States has been
carried in 2003.
 There appears to be support for requiring the mandatory disclosure of
maximum 5-6 nutrition facts: total energy, total fats, saturated fats, total
carbohydrates, sugars, and sodium/salt.
 The Commission has now carrying an evaluation of the likely impact of
such a measure, in particular small and medium companies.
 A proposal to Parliament and Council may still be put forward before
the end of 2004.
P. Deboyser
Changes in labelling regime
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EUROPEAN COMMISSION
Health and Consumer Protection DG
P. Deboyser
Changes in labelling regime
SANCO.D.4
Food Law &
Biotechnology
Slide 29
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
General review of food labelling provisions
 The Commission has engaged in a major review of the
current food labelling provisions, with a view to:
 updating, modernizing and simplifying them;
 making labels clearer, more readable and better
understandable to consumers;
 reflecting changes in consumer expectations;
 taking into account progress in communication means and
technologies.
 A preleminary evaluation has been undertaken.
 This will constitute a major project for the new
Commission.
P. Deboyser
Changes in labelling regime
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EUROPEAN COMMISSION
Health and Consumer Protection DG
P. Deboyser
Changes in labelling regime
SANCO.D.4
Food Law &
Biotechnology
Slide 31
EUROPEAN COMMISSION
Health and Consumer Protection DG
SANCO.D.4
Food Law &
Biotechnology
Issues of common interest
 Improving consumer awareness of the presence of
allergens in food
 Addressing obesity:
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prominence of energy-related (calorie) information in labelling
packaging/serving size information
importance of education (reading labels and acting upon them)
satiety claims assessment
 How to improve consumer information – including nutrition
information – on food which are not sold pre-packaged
and those supplied by mass-caterers (restaurants,
canteens…)
P. Deboyser
Changes in labelling regime
Slide 32