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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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There is hope!

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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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Claims Related to Nutrients NATURALLY Present

TOGETHER in Walnuts

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Claims Related to Nutrients NATURALLY Present

TOGETHER in Walnuts

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Claims Related to Nutrients NATURALLY Present

TOGETHER in Walnuts

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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!

Email: nigel.baldwin@intertek.com

Website: www.intertek.com/food/consulting

NOTE: "Intertek Cantox" is now

"Intertek Scientific & Regulatory Consultancy".

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