SPECIAL SECTION: Proceedings of the 2009 Cereals & Europe

Meeting: Whole Grain Global Summit

Regulatory Aspects for Whole Grain and Whole Grain Food

An EU Perspective

Nino M. Binns1

ABSTRACT Cereal Chem. 87(2):162–166

Whole grain and whole grain foods enjoy recommendation as part of
many national and international dietary guidelines. However, if the food
industry makes claims for the health benefits of whole grain foods, then a
raft of regulatory requirements must be met in the European Union (EU).
Under the relatively recent EU Regulation on nutrition and health claims
made on foods, any nutrition claims about the energy, nutrients, fiber, or
other beneficial substances the food contains need to comply with the
Annex of that Regulation. As far as health claims are concerned, until the
Community list of approved so-called Article 13 claims is published, food
businesses may use any health claims that can be validated by scientific
evidence, providing that they meet any specific requirements of the Regu-
lation that are applicable prior to that date and providing they are not 1)
prohibited claims or 2) claims referring to a reduction in the risk of dis-
ease or a disease risk factor or 3) referring to children’s development and
health or 4) claims that have been rejected by the EU regulatory proce-
dure. Claims under 2) or 3) require submission of a dossier. Once the
Community list of health Article 13 claims is published, then only those
claims included in the list or those claims approved following submission
of a dossier to the European Food Safety Authority may be used. Whole
grain foods making nutrition and health claims will also ultimately have
to respect the nutrient profiles that will be established under Article 4 of
the Regulation. Various definitions of what counts as a whole grain food
have been proposed but none has regulatory standing in EU. The condi-
tions of use that will be documented as part of the EU-approved list of
health claims may in essence establish a definition.

Whole grain and whole grain foods enjoy recommendation as
part of many dietary guidelines. For example, one of the U.K.
Food Standard’s Agency’s eight “eatwell” guidelines recommends
consumers base their meals on starchy foods and additionally
states “Try to choose whole grain varieties of starchy foods when-
ever you can.” (FSA 2009). The United States Department of Ag-
riculture consumer guidance (USDA 2005) also emphasises
whole grains based on a joint policy document from the U.S. De-
partment of Health and Human Services and USDA (HSS/USDA
2005) and, from a worldwide perspective, the World Health Or-
ganization expert report (WHO 2004) finds “probable” evidence
that whole grain cereals reduce the risk of cardiovascular dis-
eases. However, in spite of this impressive science base, if the
food industry makes claims in the European Union for the health
benefits of whole grain foods, then a raft of regulatory require-
ments must be met (or at least will have to be met in the coming
years). This report (written in mid 2009) describes the current EU
regulations on nutrition and health claims and how they affect
whole grain foods now and how they will affect them in coming
years.
of approved health claims under Articles 13 and 14 (Fig. 1). The
legal framework under which claims can be made is overlaid by a
requirement for consumer understanding which is not itself de-
fined in the Regulation; nor is there any procedure described for
its assessment. There are also specific additional labelling re-
quirements when nutrition and health claims are used and fur-
thermore, a proposed requirement for nutrient profiles. Nutrition
claims, health claims, and nutrient profiles are discussed here but
a more complete discussion of the regulation and its development
is reported by Binns (2009). There is also much information avail-
able on various websites. Rather than provide a link to individual
web pages (which may change over time), readers are advised to
search for links to the main institutions mentioned and search for
the appropriate pages.

EU Regulation of Claims
The Regulation on nutrition and health claims made on foods
(EC 2006) came into force in early 2007 but will be gradually
implemented up to 2010 and beyond. The Regulation applies to
any commercial communication about any food whether sold in a
supermarket or at a restaurant. Commercial communications in-
clude the label, advertising, point of sale information, leaflets,
websites, and so on. The Regulation limits nutrition claims to
those listed in the Annex to the Regulation and health claims to
those that will appear in one of the (European) Community lists

1 Corresponding author. Nino Binns Consulting, Grange Rath, Drogheda, Ireland.

E-mail: nino.binns@nbconsulting.eu

doi:10.1094 / CCHEM-87-2-0162 Fig. 1. Schematic summary of Regulation EC No 1924/2006 on nutrition

© 2010 AACC International, Inc. and health claims made on foods (EC 2006).

162 CEREAL CHEMISTRY

 The EU Regulation on health claims is very complicated; in
particular the transition arrangements, which will be in place until
the Community lists of claims are available, are potentially con-
fusing and so those wishing to market products with claims
should seek expert advice.
Nutrition Claims
Nutrition claims include those about the nutrients or other
physiologically active substances the food contains. For example
contains calcium, a source of protein, high in fiber, rich in vita-
mins and minerals, or contains carotenoids or polyphenols. Also
those about nutrients that have been removed or reduced. For
example reduced fat or sugar-free. Finally, those comparing the
content or absence of energy or a nutrient with another food from
the same category
The list of permitted nutrition claims and the conditions that
have to be met for each claim are listed in the Annex to the Regu-
lation. If a nutrition claim that is in the Annex is used, the condi-
tions of use specified in the Annex must be respected. For
example, if a claim “rich in fiber” is used, then the food must
contain at least 6 g of fiber/100 g or 3 g/100 kcal of the food.
Note that the definition of fiber is documented in a separate Regu-
lation (EC 2008) that recently amended the primary rules on nu-
trition labeling (EC 1990). Claims about nutrients not listed in the
Annex or about substances such as phytochemicals, polyphenols,
or ferulic acid may be made under the provision “contains [name
of the nutrient or other substance]” but such claims are limited to
“contains” claims; “rich in” claims would not be allowed since
there are no established Dietary Reference Values (DRV) for these
substances. Furthermore, content claims can only be made for
substances that are beneficial (see Article 5 of the Regulation
1924/2006).
If a claim is in use that is not in the Annex and is not possible
under the claim “contains [name of the nutrient or other sub-
stance]”, for example “cholesterol free” “high energy”, then that
claim will be no longer permitted after January 19, 2010. How-
ever, a number of amendments may be made to the Annex prior to
January 2010 and some claims in common usage (especially in
the U.K.) may be included.
The statement “contains whole grain” or “rich in whole grain”
is essentially an indication of ingredients, not a nutrition claim, so
should not covered by the Regulation. However, there is a risk
that in future the mention of whole grain is considered an implied
TABLE I
Summary of Some Guidelines on the Compositional Requirements for Whole Grain and Whole-Grain Foods
a The Joint Health Claims Initiative was a UK initiative agreed between industry, consumers, and enforcement authorities for the voluntary approval and use of
health claims.
health claim because of the benefit it might imply to the con-
sumer. In my view, this takes the Regulation well beyond its in-
tended scope, especially since public health messages include
recommendations for whole grain foods, and so industry should
be encouraged to flag whole grain foods. There have been several
approaches to the definition of whole grain foods (Table I; also
Jones 2010), but so far in Europe, none have been enshrined in
law. An agreed definition at the European level would be helpful
to ensure a minimum standard for statements such as “contains
whole grain” or “whole grain food”. The conditions of use that
will be documented as part of the EU-approved list of health
claims may in essence establish a definition.
Health Claims
A number of health claims for whole grain have been approved
in various countries (Table II). The first was the health claim al-
lowed in 1999 by the U.S. Food and Drug Administration (FDA
1999) under the provisions of the Food and Drug Administration
Modernization Act of 1997 that allows claims based on state-
ments by authoritative bodies, in this case the National Academy
of Sciences. In the U.K. (JHCI 2002) and in Sweden (SNF 2003),
health claims for whole grain and heart health were also approved
under their voluntary codes, while the Australian and New Zea-
land regulatory authorities decided to reject a health claim for
whole grain (ANZFA 2006).
In the EU, “health claim” is defined 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. However,
the subdivision of the claims in the legal text is somewhat com-
plicated (Fig. 1). Article 13 claims are those about the effects of
foods or ingredients or nutrients on growth, development, and
functions of the body (including weight control and psychological
or cognitive effects). For example, calcium is good for bones;
high fiber diets help weight control; caffeine keeps you alert. Ar-
ticle 14 claims are those referring to a reduction in the risk of a
disease risk factor (for example: product “X” lowers blood cho-
lesterol to reduce the risk of heart disease) or claims referring to
child development and health (for example, calcium builds strong
bones).
Note that the legal definition of “reduction of disease risk
claim” requires the involvement of a “risk factor” and it is not
possible currently to make a direct claim for a reduction in dis-
ease risk, even if you can demonstrate a direct reduction in risk.
Vol. 87, No. 2, 2010 163
 TABLE II
Examples of Whole Grain Health Claims Allowed
and Rejected Around the World
However, implementation of the regulation is likely to be an on-
going process for a number of years, so this interpretation may
hopefully change in future. Also, it should be remembered that
reduction of disease risk claims are distinct from medicinal claims
about the prevention, treatment, or cure of disease. Medicinal
claims cannot be used on foods unless the food is also approved
as a medicine.
The Community list of approved health claims will also include
conditions of use and this is where we may see a definition of
whole grain as well as a required level of intake.
The European Food Safety Authority (EFSA) is currently re-
viewing a list of thousands of health claims that will form the
basis of the Community list of claims under Article 13 (EFSA
2009). The first EFSA scientific opinions were supposed to be
ready in July 2009 with the final list adopted in January 2010.
However, there have been some delays and EFSA may not publish
the first opinions until September 2009, unless the whole process
is delayed (preferred option by Commission, Member States and
industry) such that a list might not be available until 2011. It is
essential for the reader to get up-to-date information if there are
plans to use health claims!
From a regulatory point of view, it is generally accepted that
Article 13 claims can be made legally until the list is actually
published (see Article 28 of the Regulation). However, purveyors
of claims should also be aware that if a decision is published to
reject a claim (or a very similar claim) following a submission of
a dossier under Article 13.5 (that covers “new” claims) or under
Article 14, then it would be wise not to use that claim once the six
month transition period for the relevant decision is over. Note
that, in theory, Article 14 claims require prior approval, but in
practice there may be claims on the market that unwittingly turn
into Article 14 claims; for example, “whole grain for heart
health”. Although this claim is about a healthy heart, the epidemi-
ological evidence on which it is based is actually a reduction in
the risk of cardiovascular mortality or events. However, as there is
no specific risk factor reduced (other than death), the claim also
does not meet the Article 14 definition.
For whole grain, there are 11 claims included in the draft list
but these include duplicates and can be reduced to four areas (Ta-
ble III). The claims on weight control and blood sugar levels are
under review, but at the time of this writing, EFSA were awaiting
clarity on the claims for gut health and heart health as they want
to know what endpoints (or biomarkers) are being changed to
confer the benefit. Clarifying this may prove challenging for the
heart health claim because, as mentioned above, this is based on
observational evidence of a reduced risk of heart disease and not
on a change in an intermediate endpoint.
Note that a general claim that “whole grain is good for health”
would not be allowed unless it is accompanied by a more specific
164 CEREAL CHEMISTRY
TABLE III
Summary of Whole Grain Claims Submitted for Inclusion
in the Community List of Health Claims Under Article 13
of the EU Regulation (see European Food Safety Authority website
www.efsa.europa.eu for details)
approved health claim (see Article 10 of Regulation 1924/2006).
At the moment, it looks as if even the heart health claim is too
vague because EFSA is asking for clarification of the endpoints.
Thus, it remains to be seen what if anything will actually be per-
mitted.
EFSA is also reviewing dossiers that have been submitted under
Article 13.5 and 14 and some claims have received positive opin-
ions while many others have been negatively received. The regu-
latory decision on whether or not to permit the claim actually lies
with the member states in the Standing Committee on the Food
Chain and Animal Health, General Food Law under the scrutiny
of the European Parliament (the so-called Comitology procedure).
Once a claim is approved, a Commission Decision is published in
the Official Journal. At the time of this writing, no dossiers on
whole grain had been submitted.
Assessment of the Science
As noted above, all claims must be based on generally accepted
scientific evidence. It is the task of the EFSA NDA panel (panel
on dietetic products, nutrition, and allergies) to assess the evi-
dence. EFSA has drawn on past work by other regulatory agen-
cies on the substantiation of claims as well as work by Inter
national Life Sciences Institute (ILSI) Europe (Richardson 2003;
Aggett 2005) and by scientists working with national voluntary
codes such as the Joint Health Claims Initiative (JHCI) in the
U.K.
EFSA has set what is considered to be a very high standard for
the level of science required for premarket approval of health
claims (EFSA 2007) and this is evident from the requirements
described below and from a review of the opinions on the dossiers
already submitted under Article 13.5 and 14 and mostly rejected
and published on the EFSA website. In short, to grant approval,
EFSA expects to see evidence from a randomized controlled trial
(RCT) on the exact food or ingredient making the claim. The
same high standard is likely to be applied to claims on the long
list of draft Article 13, with the only exceptions being for “text
book” claims such as basic functional claims for the essential
nutrients where RCT are generally not available. Where the line is
drawn on what is accepted as text book science is not known.
In evaluating a dossier, EFSA considers five key areas: 1) char-
acterization of the food or ingredient; 2) relevance (benefit) to
human health; 3) scientific substantiation (data); 4) wording that
reflects the scientific evidence; and 5) conditions of use (includ-
ing amount to be consumed). EFSA classifies data in accordance
with a hierarchy based on study design (see EFSA 2007).
 Note that although EFSA reviews the totality of the evidence
and weighs the evidence, the randomized, placebo-controlled,
double-blind intervention study is definitely assumed to provide
the strongest evidence and epidemiological and observational data
are generally accorded a lower weighting. Animal data are only
considered as supportive data and would never be sufficient alone
to substantiate a claim. So far, only Article 13.5 and 14 dossiers
based on human intervention studies have been approved, but
EFSA has not yet considered submissions based solely on epide-
miological data such as that used to support the heart health
claims on whole grain. However, it is expected most claims will
require human intervention studies. In addition, it should be noted
that each health benefit requires an individual dossier and that
EFSA requires that negative and neutral studies be evaluated as
well as positive studies.
EFSA does not grade the evidence but rather adopts a “yes” and
“no” approach, making a judgment about whether a cause and
effect relationship exists between the food and the heath benefit
claimed. As the evidence for whole grain is mainly observational,
cause and effect might not be considered as demonstrated. How-
ever, if the evidence is good enough for public health advice then
it should be good enough to allow industry to claim the benefits
on appropriate foods.
Nutrient Profiles
The use of nutrient profiles in the regulation of nutrition and
health claims aims to “avoid a situation where claims could mis-
lead consumers as to the overall nutritional quality of a food
product when they are trying to make healthy choices in the con-
text of a balanced diet”. EFSA stated in their opinion (2008) that
“The nutrient profile of the overall (habitual) diet is an important
determinant of health and the nutrient profile of a ‘balanced’ diet
is defined by science based recommendations for intakes of en-
ergy and nutrients. Because diets are composed of multiple foods,
overall dietary balance may be achieved through complementa-
tion of foods with different nutrient profiles so that it is not neces-
sary for individual foods to match the nutrient profile of a
‘balanced’ diet. Nevertheless, individual foods might influence
the nutrient profile of the overall diet, depending on the nutrient
profile of the particular food and its intake.”
EFSA advised that where there was a need for nutrient profiles,
they should be based on nutrients of public health concern for the
EU population, namely saturated fat and sodium and dietary fiber
and unsaturated fats as well as sugar for some products. In the
event, profiles are being established only for saturates, sodium,
and sugars. Although a profile was to be set “across the board”
the latest drafts have proposed many exceptions per category of
food (a category for cereal products is included) and in general
the profiles are more lenient than was expected (Table IV).
Profiles were due to be set by January 2009 but again there are
delays (Table IV). All food products that make nutrition and
health claims will have to comply two years after the profiles are
adopted so there is at least time to adapt.
To make a health claim, a food will have to comply fully with
whatever nutrient profile applies. For a nutrition claim, the food
may fail on one nutrient. However, in that case, the “high” level
of the failed nutrient must be stated on the label close to the main
claim. Take a hypothetical example. A whole grain bread could
make a high fiber nutrition claim if it contains 6 g/100 g of fiber,
even if it fails the profile for sodium although the claim would be
“rich in fiber” with the words “high sodium content” mentioned
nearby and with equal prominence. If the bread is used in a sand-
wich that fails the profile on sodium and saturates then it would
not be possible to make any fiber (nutrition) claim. Neither the
bread nor the sandwich could make a health claim about the
bowel health benefits of fiber as to make a health claim, all pro-
files will need to be met. Claims for reductions in either saturates
or sodium or sugars will be permitted, even if the resulting level
TABLE IV
Extract from An Unoffficial Draft Proposal for Nutrient Profiles
(March 17, 2009) Under Article 4 of Regulation EC No. 1924/2006
(EC 2006) for Foods Containing Cereal Products
(not all of the proposed food categories are included below)
exceeds the applicable profile (but only if the claim also meets the
requirements in the Annex, which are currently for a reduction in
30% for saturates and sugar and 25% for sodium).
Conclusions
It is clear that the EU Regulation on nutrition and health claims
made on foods (EC 2006) is very detailed, complex and prescrip-
tive and is also in a phase of evolution and transition. It is likely
that the regulation will have a significant effect on the marketing
of whole grain foods over the coming years and those companies
seeking to use nutrition and health claims are advised to take ex-
pert advice before embarking on marketing programs. It remains
to be seen if the Regulation will stifle the innovation it was sup-
posed to stimulate.
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