EU Developments on nutrition and health claims

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EU Developments on nutrition and health
claims

Jacek Czarnecki Regulatory Affairs Manager
PepsiCo International Europe
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EC Nutrition and Health Claims Regulation

• Responding to the need to protect the consumer
  from misleading or inaccurate claims about diet
  and its impact on health and wellness (consumer
  safety, information and nutrition)
• Harmonizing EC criteria on claims
• Covers all commercial communications, including
  trade marks and website information
• Nutrient profiles will be developed. Compliance
  to the profile scheme will be a condition for
  using most claims
• Adopted in autumn 2006 after 4 years
  consultations between the European Commission,
  Parliament and the Council

• Regulation (EC) No 1924/2006 of the European
  Parliament and of the Council of 20 December 2006
  on Nutrition and Health Claims Made on Foods

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Content of Regulation

• Labelling and other commercial communication
• Incl. pictures, logos, brand names and trade
  marks
• Defined claims
• Nutrition claims
• Function health claims
• Reduction of disease risk claims

No added sugar
Rich in fibre
Calcium supports bone health
Plant sterols have shown to lower/reduce blood
cholesterol
Vitamin D is needed for normal growth and
development of bone in children
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Nutrition Claims
Nutrition claim means any claim that states,
suggests or implies that a food has particular
beneficial nutritional properties due to a/ the
energy (calorific value) it provides, provides at
a reduced or increased rate, or does not provide
and/or b/ the nutrients or other substances it
contains, contains in reduced or increased
proportions, or does not contain.

• The Regulation contains an annex of the nutrition
  claims allowed
• Comparative claims are allowed between food of
  the same food category

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New rules apply since 1 July 2007
Transition period till 31 July 2009
Requirements in force now
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Nutrition claims Positive list adopted

• Free, Low energy, fat, sats, sugar,
  sodium/salt, do not apply to ltno cholesterolgt
• very low sodium/salt
• No added sugar
• Reduced/Light/Lite 30 for nutrients, 25
  for Na/salt, 10 RDA for micro-nutrients
• Source of fibre, protein, vitamins minerals
  listed in 90/496/EEC
• High fibre, protein, vitamins minerals
  listed in 90/496/EEC (ltHigh energygt claims not
  likely to be accepted)
• Contains any nutrients or other substances
  where no specific rules
• Increased 30 for nutrients other than
  micronutrients
• Naturally/Natural permitted as a prefix
  where true e.g. naturally sugar free

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Old and New Nutrition Claims
The nutrition claims which are not included in
the Annex but which have been used in Member
State before 1 January 2006 in compliance with
national provisions
Will have to be removed after 19 January 2010
may continue to be used until 19 January 2010

• The list of authorised nutrition claims will be
  updated regularly and amended through the new
  comitology procedure with scrutiny of the
  European Parliament. First five claims referring
  to unsaturated fatty acids were adopted by the
  Commission Scientific Committee on Food Chain and
  Animal Health
• Source of Omega 3
• High Omega 3
• High mono unsaturated fat
• High poly unsaturated fat
• High unsaturated fat

Procedure for new nutrition claims (annex
amendments)
Commission endorses or rejects the claims
Publication in the Official Journal of EC
EP scrutiny
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Health Claims
Function Health claims
Reduction of disease risk claims
Claims referring to childrens development and
health

• any claim that states, suggests or implies
• a relationship between food constituents and
• health, i.e.
• development and the functions of the body,
• psychological and behavioural functions,
• slimming or weight control,
• a reduction in the sense of hunger
• an increase in the sense of satiety
• reduction of the available energy from the diet

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
a health claim that solely refer to the
development and health of children and where the
scientific substantiation is only valid for
children
DEFINITION

• a register prepared based by the Member
• States Submissions
• EFSA to review the claims and publish opinions
• EFSA has recently reviewed the first
• batch of 525 claims (more than 3000 still left)
• Commission to adopt a Regulation based on
• the EFSA opinions

• Individual submissions by Member States
• EFSA to review the claim and publish opinion
  (EFSA guidance on application
• and dossier content)
• Commission to adopt a positive or negative
  decision
• Some opinions have already been issued (see next
  slide)

PROCEDURE
Commission Decision up to 5 months
Individual submission by a Member State
EFSA opinion up to 5 months
Function claims based on new science same
procedure applies as DRRC and Childrens Claims
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Disease Risk Reduction and Childrens Claims
evaluated by EFSA
? Positive opinions Plant sterols Unilever
Calcium and vitamin D claims Yoplait Dairy
Crest Calcium vitamin D claims French milk group
ATLA (Association de la Transformation Laitiere
Francaise.) Reduced risk of caries LEAF Int, Leaf
Holland and Leaf Suomi Bone growth French dairy
producers (Transformation Laitiere
Francaise) Water-soluble tomato concentrate (WSTC
I and II) and platelet aggregation Provexis
Natural Products Limited Visual development of
infants Mead Johnson Nutritionals
? Negative opinions Linoleic acid and growth and
development of children Unilever Plant stanols
McNeil Nutritonals Black tea claim (active
ingredients caffeine and theanine) Unilever
Anxiety reduction drink ELVIR SAS
(France) Hunger claims ELVIR SAS Cranberry juice
and sweetened dried berries reduce disease
Cranberry Cooperative Ocean Spray Mineral water
claim Unicer Bebidas (Portugal) Infant formula
gut health claim Heinz owned Plada Industriale
(Italy) Child growth Ferrero
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Health Claims
Timelines
Commission to adopt a Regulation after each batch
Transition period for claims that will get
negative opinions (6 months after each Regulation
Functional health claims submitted to EFSA by 31
December 2008
EFSA to issue opinions in batches
Claims being brand names or trade marks are
exempt from the Regulation until 19 January 2022

• Conclusions
• Both industry and authorities in the EU made huge
  job to collect and consolidate the health claims
  lists
• The EU experiences can be used by other food
  legislation systems that follow the EU directions
• The system of independent scientific assessment
  has been implemented and is running

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Nutrient Profiles, as required by the Claims
Regulation

• Profiles will be established to prevent products
  high in sugar, salt and saturated fats from
  making claims
• There will be profiles for some selected food
  categories and generic thresholds for other foods
• Some foods will be exempt from profiling thanks
  to their importance in a healthy diet or as
  dietetic foods covered by other legislation .
• Derogations
• A nutrition claim can still be made, where a
  single nutrient exceeds the profile provided that
  a statement about the specific nutrient appears
  close to the nutrient claim at stake e.g. Rich
  in vitamin C. High sugars content
• Claims on reduction of fat, saturates, TFA,
  sugars and salt/sodium will be allowed without
  reference to the nutrient profile

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Commission Proposal on Profiles

• Last draft from March 2009. Work suspended due to
  the appointment of new Commissioners. To be
  continued this autumn
• Foods proposed to be exempt from profiling
• Specific categories
• Fruit, vegetables (including fruit juices and
  nuts)
• Meat
• Fish and other seafood
• Bread containing at least 3 fibre or 1.5 g/100
  kcal
• Honey
• Food supplements
• Table top sweeteners
• Cough drops, chewing gum and dextrose tablets
• Dietetic foods
• Cereal based foods for young children
• Foods for energy restricted diets
• Infant and follow-on formulae
• Foods for special medical purposes

DRAFT
Covered with relevant vertical legislation
Covered with relevant vertical legislation
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Profile proposal for specific categories

• Following categories to be covered by individual
  profiles fats, fruit and vegetable products,
  meat products, fishery products, dairy products,
  cereal products, ready meals, soy based products,
  non-alcoholic beverages

DRAFT
Examples of profiles proposed by the Commission
Sodium mg/100g or 100 ml
Saturates g/100g or 100ml
Sugars g/100g or 100ml
Products of fruit and vegetables, except oils,
min. 50 fv nectars
400
5
15
Seeds and nuts products, except oils, min 50 of
seeds and nuts
15
400
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Cheeses, min 50 of dairy constituents
900
20
15
Breakfast cereals, min 50 of cereals
500
5
25
OTHER FOODS, as they do not qualify for one of
the above mentioned categories
300
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Summary

• EU framework regulation on health and nutrition
  claims is adopted and in force
• The implementation of the regulation is in
  progress, different transitional periods apply
• Developments in the area of health claims are
  based on independent scientific opinions from
  EFSA and some opinions have already been issued
• There are some delays on generic function claims
  community register and nutrient profiles
  development but there is a clear direction and
  calendar of the next steps

Thank you Jacek Czarnecki Regulatory Affairs
Manager PepsiCo International Europe