Patrick DEBOYSER

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Changes in labelling regime

• Patrick DEBOYSER
• Head of Food Law Biotechnology
• Health Consumer Protection DG
• EUROPEAN COMMISSION

2
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

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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.)

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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.

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Mandatory labelling requirements

• 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.

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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.

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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!

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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

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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.

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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).

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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.

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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!

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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 .

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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 .

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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.

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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.

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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.

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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.

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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.

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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.

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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

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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).

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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 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.

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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.

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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.

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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.

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Changes in labelling regime

• Patrick DEBOYSER
• Head of Food Law Biotechnology
• Health Consumer Protection DG
• EUROPEAN COMMISSION