Download NL-Draft proposal (15-11-2006) Generic list health claims: criteria

NL-Draft proposal (15-11-2006)
Generic list health claims: criteria
This document is based on a the explanatory notes made by …??. It has been developed to
assist companies and other interested parties to compile a list of health claims, based on
generally accepted scientific data/knowledge, well understood by the average consumer,
describing or referring to
(a) The role of a nutrient or other substance in growth, development and the functions of
the body, or
(b) Psychological and behavioural functions, or
(c) Without prejudice to Directive 96/8/EC, slimming or weight-control or a reduction in
the sense of hunger or an increase in the sense of satiety or to the reduction of the
available energy from the diet,
and the necessary conditions applying to them, as laid down in Article 13 of the proposed
Nutrition and Health Claims Regulation.
This document describes the template to be used when submitting claims and it includes
further details about which claims are within the scope of this list and therefore eligible and
guidance on scientific evidence.
1. Format of the list (Art. 13)
The nutrition and health claims regulation does not provide for a format of the list under
Article 13. It only specifies that the list should contain the claims, the conditions applying to
them and the references to the relevant scientific justification.
Based on this and in order to be able to collate the scientific information relating to the
claims, the following format is proposed by the CIAA:
Food Category,
Food or
Health
Conditions of Nature of
Food
Relationship use (if any) evidence
Component
References
Example of
wording
Entry 1: Food Category, Food or Food Component
Background
Article 2.5 defines a health claim as “any claim that states, suggests or implies that a
relationship exists between a food category, a food or one of its constituents and health”.
Article 13 refers to ‘the role of nutrients’ and ‘other substances’ in growth, development and
the functions of the body. However, health claims are often linked to more complex entities,
e.g. a combination of nutrients or substances, a food as a whole or even a combination of
foods in a specific diet. In all cases, the effect will be linked to the nutrients or other
substances contained in such entities. Therefore, for the purposes of assembling the list of
claims, the broadest interpretation of food category, food or food component will be used.
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The diet, food category, food, nutrient, food component, botanical, other substance that is
the subject of the health relationship mentioned in the claim should be sufficiently
characterised and described (see Table 1).
Filling in instructions
Table 1: Entry 1
Requirements
regarding the provided
data
A diet
A food category
A food(product)
A constituent:
Nutrient
A component
/ a substance
A botanical
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the Latin (botanical) and
English name, the origin,
the plant part used,
characteristics of the
isolate or extract,
including where relevant
minimal or maximal limits
of active components
and specifications on the
amount to be used in
relation to the
relationship and claims
listed, etc.
Example
a diet low in saturated fat or
high in fruit and vegetables,
high in fibre, low in salt etc
fruit and vegetables, whole
grain cereals, nuts, oily fish
whole oats, salmon, almonds,
cranberry juice, tomatoes,
fermented dairy products
macronutrient such as a
protein sources, a
carbohydrate source;
micronutrients such as a
vitamin or mineral
whey protein, soy protein,
inulin, other fibre materials
like oat bran, beta-glucan
soluble fibre, omega-3 fatty
acid, L-lysine, sterols and
stanols, lycopene, lutein,
glucosamine, probiotics,
prebiotics like fructooligosaccharide (FOS),
conjugated linoleic acid
(CLA) etc
garlic, ginseng, bilberry,
ginger, etc
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Entry 2: Health Relationship
Background
Article 13 refers to:
 The role of a nutrient or other substance in growth, development and the functions of the
body, or
 Psychological and behavioural functions, or
 Without prejudice to Directive 96/8/EC, slimming or weight control or a reduction in the
sense of hunger or an increase in the sense of satiety or to the reduction of the available
energy from the diet.
For example, nutrients and other substances can be necessary for and/or contribute to the
structure and functions of particular organs and several physiological states, e.g.
reproduction, conception, growth and development, body maintenance. The well-established
functions of nutrients and other substances are documented extensively in the scientific
literature.
Article 13 list includes:
 Specific diets. These may also have specific effects on health in general. These may be
listed in so far as the effect of such diets can be attributed to the foods, food
components, nutrients or other substances that characterise the specific diet (e.g. high in
fibre, low in fat, etc)
 relate to the maintenance of healthy body functions, organs of the body or health in
general, and refer only to maintenance of the healthy state of those body functions or
processes (body metabolism, cholesterol, metabolism, digestion etc).
Article 13 list excludes:
Refer to any food category, food or food component (including a nutrient) that has the
property of treating, preventing or curing human disease or make any reference to
such a property, i.e. medicinal claims.
Nor must a reduction of a disease risk relationship or claim be listed
Diets, food categories, foods, nutrients, other substances and botanicals can have specific
beneficial effects on physiological, psychological, cognitive functions or biological activities.
Ingredients and a whole range of substances can be included as long as they have wellestablished physiological or biological functions in the body. For example, a function of a
food category, food or food component can apply to constituents that have cholesterollowering effects, calcium-absorption effects, prebiotic or probiotic effects. Specific physical or
chemical properties of a food category, food or food component may influence a particular
function, e.g. a low glycaemic index due to specific structural or starch properties.
Filling in instructions
Table 2: Entry 2
Requirements regarding the provided data
listed as precisely as possible, in line with the scientific
supportive evidence.
In case the benefit is meant for a specific group, this
should be mentioned.
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Example
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Entry 3: Conditions for the Claim to be Valid
Background
The general ‘principles’, ‘conditions’ and ‘specific conditions’ of the Regulation on nutrition
and health claims, which apply to all health claims, are laid down in Articles 3, 5 and 10,
respectively.
Article 13 states that claims should be accompanied by the conditions applying to them and
by references to the relevant scientific justification, wherever appropriate.
Filling in instructions
Table 3: Entry 3
Requirements regarding the
provided data
The quantity of the food
category, food or food
component that will produce the
nutritional or physiological effect
claimed.
Where relevant, an indication
should be given on the
specificity of the substance
(origin, form etc) and the validity
of the claim for a specific food or
substance, e.g. by indication of
specific analytical methods
Where relevant, an indication
should be given on the influence
of other foods on the availability
of the substance/nutrient for
use.
Example
the conditions could relate to an indication of the
amount of a food category, food or food component
that should be consumed per quantified serving or per
day, and whether the health relationship applies only
to certain groups of the population. Such as:
Soy protein
25g/day
Oat beta-glucan
3 g/day
Fish oil fatty acids
2 portions/week
Fruits and vegetables At least 5 servings/day
Vitamins/minerals
At least 5 servings/day
Botanicals
Indication of the amount of the
botanical and/or active
components
in the case of botanicals
Example: the effect of fytosterol in fatty foods is higher
compare with less fatty/light foods
Entry 4: Nature of Evidence
Background
It is clear from all the existing international laws, codes of practice and guidelines that the
claimed effect must be supported by scientifically valid evidence that demonstrates the effect
of the nutrient, other substances, food category, food or food component in humans and
under conditions that reflect the actual conditions of use and exposure. The relationship
between a nutrient, other substances, food category, food or food component and health can
be demonstrated by a number of different types of studies and designs. Methodological
soundness is critical, given that the validity of the study type depends on the quality of
design, execution and analysis. In brief, studies on humans are accorded greater weight
than animal and in vitro studies, and human intervention studies have greater weight than
observational or epidemiological studies.
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Article 13 claims must be based on generally accepted scientific data/knowledge. Hence, it
is necessary to evaluate the totality of the available evidence and weigh up the evidence on
a case-by-case basis. In many cases this process of evaluation has already been carried out
by expert panels and organisations. This is e.g. the case with the knowledge usually found in
recognised textbooks, monographs, scientific opinions by officials scientific bodies (e.g.
SCF, EFSA, NAS, etc) and claims already approved by national authorities (e.g. USA FDA,
etc).
The terminology to be used in completing the template is:
 Authoritative body
 Textbook
 Monographs
 Critical Reviews
 Meta-analysis
 Single Large Human studies
 Multiple Small Studies
The scientific data and knowledge to justify the health claims may come from one or more of
these sources. It is only when the food category, food or food component is supported by
lower grades of evidence that the individual papers will need to be scrutinised (see table 5,
5c and see H2 Classification of scientific data).
Filling in instructions
Table 4: Entry 4
Requirements regarding the provided data
Example
Define whether the evidence is a
 Authoritative body
 Textbook
 Monographs
 Critical Reviews
 Meta-analysis
 Single Large Human studies
 Multiple Small Studies
Entry 5: References
Background
The references should be complete and allow an expert committee to find the information
quickly and efficiently. It is recommended that, for claims that are not underwritten by
recognised text books and monographs or groups of independent experts, the key hard copy
or electronic version of the individual scientific paper(s) is identified and assessed as set out
below. This is essential to enable companies and other interested parties to grade the
evidence. It also indicates that the company or other interested party is ready to provide the
supporting data if required by the European Commission, the Member States or EFSA.
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Handbook of Nutrition and Food. Edited by Carolyn D Berdanier...[et al.].
Boca Raton, Fla.: CRC Press, 2002.
Requirements regarding the
provided data
a. Evidence accepted by
independent expert bodies
and national and international
committees can include the
following sources (nonexhaustive list)
b. Evidence from recognised
text books and monographs
c. Evidence from individual
references
The relevant data should be
extracted objectively from
peer-reviewed publications in
the scientific literature and
presented in a clear, concise
manner.
[? which data is obligatory,
which additional?]
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Example
ANZFA: Permitted health claims by Food Standards
Australia and New Zealand
CEDAP: Commission d’étude des denrées alimentaires
destinées à une alimentation particulière (Fr).
FDA:
Food and Drug Administration (USA)
FNFC:
Ministry of Health and Welfare (Foshu, Japan)
FSB:
Federal Scientific Bodies (USA)
JHCI:
Joint Health Claims Initiative (UK)
NFA:
National Food Agency (Fin)
SNF:
Swedish Nutrition Foundation
VC:
Voedingscentrum (Nl)
WCRF: World Cancer Research Fund
WHO:
World Health Organisation
Encyclopedia of Human Nutrition 2E. Editor-in-chief,
Michele J. Sadler,
editors, J.J. Strain, Benjamin Caballero. San Diego :
Academic Press, c1999.
Handbook of Nutrition and Food. Edited by Carolyn D
Berdanier...[et al.].
Boca Raton, Fla.: CRC Press, 2002.
Introduction to Human Nutrition. Edited on behalf of The
Nutrition Society by
Michael J. Gibney, Hester H. Vorster and Frans J. Kok.
Blackwell Science,
September 2002.
 Title of the study
 Authors (and their affiliation)
 Journal or book reference
 Objective of the study
 Study type/design
 If the study type/design is a pooled analysis
(systematic review or meta-analysis) of many studies,
then include
 inclusion/exclusion criteria for the studies, and
 data extraction from the studies
 Study population (inclusion/exclusion criteria)
 Baseline characteristics of study subjects and controls
 Duration of the study
 Location of the study
 Methodology (including quality of the active
component)
 Dietary assessment technique
 Outcome measurement and other relevant
measurements
 Statistics
 Results
 Conclusion
 Points to note/further comments
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Entry 6: Examples of Claims Wording
Background
Examples of wording of health claims that are or could be made on product labels and in
advertising and other promotions should be included in the list.
The examples should respect the general principles and conditions of the proposed
regulation as set out in Articles 3, 5 and 10.
The wording explains the nature of the health effect, it gives a proper expectation of the
health effect. [?phraseology?]
Some examples of wording of claims:
Food category, Food or
Health relationship
food component
Calcium
Necessary for normal
structure of bones and teeth
Glucosamine
Joint health
Ginseng
Wholegrain cereals
Enhancement of mental and
physical capacities in cases
of weakness, exhaustion,
tiredness and loss of
concentration
Maintenance of a healthy
heart
Oats (whole oats, flour,
oat bran and rolled oats as
sources of soluble fibre,
beta-glucan)
Reduces total and LDL
cholesterol
Oily fish (omega-3 PUFA)
Maintenance and promotion
of a healthy heart
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Example of wording
Maintains strong and healthy
bones and teeth
May help to maintain healthy
joints; helps keep joints
supple and flexible
Helps maintain optimal
stamina, feelings of energy
and vitality, physical and
mental well-being
A diet rich in wholegrain
foods, as part of a healthy
lifestyle, can help maintaining
a healthy heart
Oats can, as part of a healthy
lifestyle, can help reduce
cholesterol levels, which in
turn helps to maintain a
healthy heart
Two portions of omega-3
PUFA’s a week helps heart
health
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2. Classification of scientific data
The strength and consistency of the scientific evidence will underpin the “generally
acceptance” of the relationship in such a way that the balance of probabilities for the
scientific link between a nutrient or substance and a health relationship is justified.
As a framework for objective judgement the categorisation scheme from the US Food and
Drug Administration Centre for Food Safety and Applied Nutrition will be used as published
in the PASSCLAIM report.
Established or proposed health effects or nutrient functions were classified as ‘convincing’ in
case of consensus or acceptance by official independent scientific bodies, or ‘probable’ if the
scientific evidence in support of the effect outweighs the evidence against. In case of
contradictory or inconsistent results, or data based upon small studies, or in vitro studies,
effects were classified as ‘questionable’.
Scheme of scientific substantiation of generic health claims.
Single large
human study
In vitro or animal
(laboratory) data
only
+ supportive epidemiological data
+ contradictory epidemiological data
Single small human
study
Reported
Body of consistent, relevant evidence
from well designed human study, and/or
Epidemiological and laboratory studies.
Weight of evidence supportive
+ supportive laboratory data
+ contradictory laboratory data
+ supportive laboratory data
Multiple small
human studies
+ consistent results with
Small uncontrolled
human studies
Evidence accepted
flawed designs
+ consistent results with
Epidemiological data:
consistent results
by scientific bodies
good designs
or independent
+ contradictory results
expert bodies as
with good designs
+ difficulty measuring substance
basis for public
+ biological plausibility and
+ contradictory laboratory data
Reviews by
independent expert(s)
Epidemiological data:
contradictory results
1
emerging evidence
health messages
Critical reviews
by experts
consistent laboratory data
Meta analyses
2
3
4
5
significant scientific agreement
consensus
Explanation:
Cat. 1 & 2 : insufficient substantiation for generic list, more needed.
Cat. 3:
“positive outweighs the negative”, one publication of meta-analysis on peer
reviewed article  category “probable”.
Cat. 4 :
meta-analysis, peer reviewed publications  category “convincing” .
Cat. 5:
text-handbooks, monographs, judgement by government related
organisations,
scientific groups or expert organisations (like WHO, SCF etc.)  category
“convincing”.
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Categories 4 and 5 are translated as “convincing” and can be put on the generic list.
Category 3 in this respect is translated as “probable”. These food categories, foods or food
components in category 3 will be discussed within the NL working group case by case. Each
food category, food or food component in category 3 will be covered by a separate sheet
which includes detailed additional information (for the format of this separate sheet see
Annex 1). This additional information will be used to determine case by case if the data are
convincing enough to put the food category, food or food component on the generic list.
For the exact definition of all categories and especially the exact classification of borderline
cases, specialist(s) will be asked for advise to help the NL-working group.
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Annex 1
Title of the proposed claim
Claim forwarded by
For further information contact
: …………………….
: …………………….
1. Nutrient/other substance/food/diet
Short description of the nutrient /other substance/food/diet
2. Generally accepted role(s)
Describe the role of nutrient /other substance/food/diet w.r.t. its health related function in the sense of
article 13.
3. Essential elements of the claim associated with this/these role/roles
The proposed wording of the claim(s) is (are):
1.
2.
3.
Summary of the grade of evidence underlying the claim(s) : category ….
4. Scientific substantiation (max. of 10 literature references)
Nature of evidence
- Generally accepted role(s)
-
Proposed claim(s)(rank according to type of studies (e.g. meta-analysis, expert reviews, human
intervention or observational studies, other supporting studies)
5. Summary of the scientific substantiation
6. Indication of the conditions of use, incl. the relevance for the population or target group(s) or
individual consumer
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