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Successful Health
Claims: Challenges for
Natural (Whole Foods)
Nigel Baldwin, B.Sc., MIFST, CSci
Director, Scientific & Regulatory Consulting, Europe
Intertek
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“Natural”
“Botanical” – “Food Herbal”
•The situation is still not clear what will happen to these (800+) claims
related mainly to their background of traditional use
•Both EFSA and the Commission have to decide and
regulation is at member state level on case by case basis
“Natural”
•Generally refers to foods from primary production, i.e. whole foods
and their basic preparation
•Regulation (EC) No 1924/2006 applies to these products
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Key Points for a Successful Health Claims
Submission
Healthy Claim Application
1) Clarity in claim
Wording*
2) Food/ constituent is characterised*
3) Transparent, comprehensive
literature search*
4) High quality human
studies*
5) Study population relevant* 6) Valid
outcome measures*
7) Biologically relevant
magnitude of effect
8) Consistency
9) Statistical significance
10) Other causality criteria
* Especially
challenging for
natural/whole
foods
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1) Clarity in Claim Wording
versus
“An apple a day keeps the
doctor away”?
(not specific enough)
“Apple juice contains vitamin
C. Vitamin C contributes to
maintain the normal function
of the immune system.”
(Article 13)
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2) Food Constituent is Characterised
Characterising whole foods/botanical foods give rise to tremendous variation
• “Walnuts are seeds from the walnut tree (genus Juglans) of which about 20 different
species are known in different parts of the world. Walnuts are drupes, rather than nuts.
• One of the most popular varieties of walnut is the Persian or English walnut, which has
a large seed and a thinner shell, yielding more edible walnut meat by weight than
other species. Black walnuts are another commonly sold walnut species, as are white
walnuts, also called butternuts.
• The nut kernels contain about 57-65 % fat, of which about 3-6 % are saturated fatty
acids (SFAs), 9-15 % are monounsaturated fatty acids (MUFAs), and 35-47 % are
polyunsaturated fatty acids (PUFAs) (33-38 % linoleic acid (LA), and 2-9 % alpha-
linolenic acid (ALA)). The nut kernels also contain about 5-7 % fibre, of which about 25
% is soluble fibre, 15-29 % protein, and small amounts of plant sterols and other
phytochemicals.
• The Panel notes the variation in terms of macronutrient composition between different
types of walnuts.”
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Example: Cranberry Extract
Standardisation of bioactives is easier for extracts
Example of how cranberry extract is standardised: to PAC
content:
“The food that is the subject of the health claim is the cranberry extract
and D-mannose containing food supplement Uroval® According to a
conformity declaration for “Uroval® manosa”, one tablet, coated with a
polymer film agent, a hydroxyl-propylmethylcelullose, contains 300 mg
of D(+)-mannose and 100 mg of “cranberry extract” with 10%
proanthocyanidins, and the additives talc (5 mg), microcrystalline
cellulose (90 mg) and magnesium stearate (5 mg). According to a
certificate of analysis issued by the Chinese company Dalian Hongjiu
Biotech Co Ltd., the botanical source of the ethanol/water- extracted
cranberry powder is Vaccinum macrocarpon L.”
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3) Transparent, Comprehensive Literature Search
Literature search must be systematic, comprehensive,
transparent, reproducible, and properly documented.
For natural/whole foods, how do you conduct a meaningful
literature search on such wide criteria? Characterisation of the
food defines what you search for.
A search on “Milk and Bone” reveals 1000+ initial individual
publications.
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4) High Quality Human Studies
High quality double blind placebo-controlled studies are more
often focussed on single components and/or well
characterised/defined ones within more complex foods
Whilst there may be many studies for whole foods and
botanicals that are traditionally consumed there are usually
very few high quality studies
• What is an appropriate control for a whole food?
• What is the expectation for blinding in whole food studies? Although
single-blinding is achievable, many whole food studies are not blinded.
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4) High Quality Human Studies
Walnuts – endothelium-mediated vasodilation
“In weighing the evidence, the Panel took into account that one
intervention study in healthy subjects, adequately powered and
controlled, showed a sustained effect of the consumption of walnuts
on endothelium-dependent vasodilation, that the results of one
additional intervention study in type 2 diabetic subjects on blood
pressure-lowering, cholesterol-lowering, and/or oral antidiabetic
medication are consistent with these findings, and that an acute
intervention study also showed a positive effect of the consumption of
walnuts on endothelium-mediated vasodilation.”
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5) Study Population Relevant
Target populations can be extremely wide in some cases
(e.g., apple) or geographically narrow in others (e.g.,
baobab, monkfruit), in particular for traditional use claims.
Estimations of population exposure for risk reduction claims
based on epidemiological data will vary considerably.
Populations studied must be relevant to target populations.
Caution should be exercised in relying on studies in subjects
with disease. EFSA reviews these on a case-by-case basis.
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6) Valid Outcome Measures
There may be several valid outcome measures depending on
the nutritional complexity of the product and claimed effect:
Versus
Applicants should consult EFSA’s guidance documents to gain
perspective on the outcome measures and methods used to
assess the outcome measures that are considered acceptable
by EFSA.
“Keeps the doctor away”
(traditional use)
“Results in a significant decrease in risk of incidence of the
common cold”
(scientifically validated)
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Other Causality Criteria
• Magnitude of effect – statistically and clinically significant
• Consistency
• Dose response
• Biological plausibility/mechanism
• Specificity
• Temporality
These causality criteria can be difficult to establish
given the complexity of test article as a natural/whole
food.
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Examples of Authorised “Natural” Claims
Whole Foods (n=8):
• Dried plums/prunes
• Walnuts
• Meat or fish
• Olive oil polyphenols (recommended intake in terms of olive oil)
• Foods low in saturated fat
• Foods low in sodium
• Meal replacements for weight control (n=2)
Dietary Fibre (n=6):
• Sugar beet fibre
• Barley grain fibre
• Oat grain fibre
• Rye fibre
• Wheat bran fibre (n=2)
Macronutrients (n=5):
• Carbohydrates
• Protein (n=4)
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Authorised Claims for Whole Foods
Article Food Claimed Effect Conditions for Use
13(3) Dried
plums/prunes
Contribute to normal
bowel function
•Only for food which provides a daily intake of 100 g
of dried plums (prunes)
•Information shall be given to the consumer that the
beneficial effect is obtained with a daily intake of
100 g of dried plums (prunes)
13(3) Meat or fish Meat or fish
contributes to the
improvement of iron
absorption when
eaten with other
foods containing iron
The claim may be used only for food which contains
at least 50 g of meat or fish in a single quantified
portion. In order to bear the claim information shall
be given to the consumer that the beneficial effect is
obtained by consuming 50 g of meat or fish together
with food(s) containing non-haem iron.
13(3) Olive oil
polyphenols
Olive oil polyphenols
contribute to the
protection of blood
lipids from oxidative
stress
The claim may be used only for olive oil which
contains at least 5 mg of hydroxytyrosol and its
derivatives (e.g. oleuropein complex and tyrosol) per
20 g of olive oil. In order to bear the claim
information shall be given to the consumer that the
beneficial effect is obtained with a daily intake of 20
g of olive oil.
13(3) Walnuts Contribute to the
improvement of the
elasticity of blood
vessels
•Only for food which provides a daily intake of 30 g
of walnuts
•Information shall be given to the consumer that the
beneficial effect is obtained with a daily intake of 30
g of walnuts
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Authorised Claims for Foods Low in Saturated
Fat or Sodium
Article Food Claimed Effect Conditions for Use
13(3) Foods with a
low or
reduced
content of
saturated
fatty acids
Reducing
consumption of
saturated fat
contributes to the
maintenance of
normal blood
cholesterol levels
Only for food which is at least low in
saturated fatty acids, as referred to in the
claim LOW SATURATED FAT or reduced
in saturated fatty acids as referred to in
the claim REDUCED [NAME OF
NUTRIENT] as per Reg (EC) No
1924/2006
13(3) Foods with a
low or
reduced
content of
sodium
Reducing
consumption of
sodium
contributes to the
maintenance of
normal blood
pressure
Only for food which is at least low in
sodium/salt as referred to in the claim
LOW SODIUM/SALT or reduced in
sodium/salt as referred to in the claim
REDUCED [NAME OF NUTRIENT] as per
Reg (EC) No 1924/2006
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Authorised Claims for Dietary Fibres
Article Food Claimed
Effect
Conditions for Use
13(5) Sugar
beet fibre
Increases
faecal bulk
Only for food which is high in that fibre as referred to in the
claim HIGH FIBRE as per Reg (EC) No 1924/2006
13(3) Barley
grain fibre
Contributes to
an increase in
faecal bulk
Only for food which is high in that fibre as referred to in the
claim HIGH FIBRE as per Reg (EC) No 1924/2006
13(3) Oat grain
fibre
Contributes to
an increase in
faecal bulk
Only for food which is high in that fibre as referred to in the
claim HIGH FIBRE as per Reg (EC) No 1924/2006
13(3) Rye fibre Rye fibre
contributes to
normal bowel
function
Only for food which is high in that fibre as referred to in the
claim HIGH FIBRE as per Reg (EC) No 1924/2006
13(3) Wheat
bran fibre
Contributes to
an acceleration
of intestinal
transit
•Only for food which is high in that fibre as referred to in
the claim HIGH FIBRE as per Reg (EC) No 1924/2006
•Information shall be given to the consumer that the
claimed effect is obtained with a daily intake of at least 10
g of wheat bran fibre
13(3) Wheat
bran fibre
Contributes to
an increase in
faecal bulk
Only for food which is high in that fibre as referred to in the
claim HIGH FIBRE as per Reg (EC) No 1924/2006
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Authorised Claims for Macronutrients
Article Food Claimed Effect Conditions for Use
13(3) Carbohydrates Contributes to the
maintenance of
normal brain function
•Information shall be given to the consumer that the
beneficial effect is obtained with a daily intake of 130 g
of carbohydrates from all sources.
•May be used for food which contains at least 20 g
carbohydrates which are metabolised by humans,
excluding polyols, per quantified portion and complies
with the nutrition claim LOW SUGARS or WITH NO
ADDED SUGARS as per Annex to Regulation (EC) No
1924/2006.
•Shall not be used on food which is 100% sugars.
13(3) Protein Contributes to a
growth in muscle
mass
Only for food which is at least a source of protein as
referred to in the claim SOURCE OF PROTEIN as per
the Annex to Regulation (EC) No 1924/2006.
13(3) Protein Contributes to the
maintenance of
muscle mass
Only for food which is at least a source of protein as
referred to in the claim SOURCE OF PROTEIN as per
the Annex to Regulation (EC) No 1924/2006.
13(3) Protein Contributes to the
maintenance of
normal bones
Only for food which is at least a source of protein as
referred to in the claim SOURCE OF PROTEIN as per
the Annex to Regulation (EC) No 1924/2006.
14(1)(b) Protein Needed for normal
growth and
development of
bone in children
The claim can be used only for food which is at least a
source of protein as referred to in the claim SOURCE
OF PROTEIN as listed in the Annex to Regulation
1924/2006.
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Disease Risk Reduction (Article 14)
To date there are no approved disease risk (factor)
reduction claims for whole or natural foods themselves
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Do we Need Claims on These Foods?
Is there a need to make specific health claims for all whole,
natural or “super" foods themselves?
Whole foods can in a number of cases make more indirect
nutrient claims based on their composition than would be shown
for the whole food in many expensive placebo-controlled studies
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Claims Related to Nutrients NATURALLY
Present TOGETHER in Walnuts
Poon T, Baldwin N (2014). Authorised EU health claim for walnuts (chapter 16). In: Sadler MJ, editor. Foods, Nutrients and Food Ingredients with Authorised
EU Health Claims: Volume 1. (Woodhead Publishing Series in Food Science, Technology and Nutrition, number 263). Amsterdam, The Netherlands: Elsevier /
Cambridge, UK: Woodhead Publishing Limited, pp. 329-348.
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Example: Walnuts are a “Natural Superfood”?
92 Article 13(3) claims related to nutrients NATURALLY
present TOGETHER in walnuts
• 4 related to MUFAs/PUFAs
• 34 related to vitamins
• 54 related to minerals
Versus 1 Article 13(3) claim for walnuts and the
improvement of the elasticity of blood vessels
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Thank you!
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