Carlson, S.

Carvajal, R.

Coutrelis, N.

Dael, P., van

Desjeux, J.F.

Meulen, B.M.J., van der

Morelli, L.

Weir, C.

English

Wageningen Yield 

50 www . f d l i . o r gUpdate      September/October 2010
Recent developments in the European Union’s regulation on health claims used in food label-
ing could have the effect of suppressing 
publication of scientific research on the 
health benefits of food substances. Given 
that scientific research and collabora-
tion is an international phenomenon, the 
negative effect of the European Commis-
sion’s (the Commission) current direction 
might well be felt in the United States.
The seeds of this controversy were 
sown in December 2006, when the 
European Parliament issued Regulation 
(EC) No 1924/2006, which stipulates 
the circumstances under which health 
claims may be made for foods marketed 
in the European Union.2 At the outset, 
it’s important to note that the definition 
of “health claim” as that term is used in 
EU regulations is considerably broader 
than the definition of “health claim” in 
the Federal Food, Drug, and Cosmetic 
Act and its implementing regulations. 
The EU health claims regulation defines 
“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.”
This EU definition of “health claim” 
(hereinafter “EU health claim”) is suffi-
ciently broad as to encompass several dif-
ferent types of claims that can be made 
for foods marketed in the United States, 
including: (1) “health claims,” defined 
as claims that expressly or impliedly 
characterize the relationship of a nutri-
ent required to be included in nutrition 
labeling to a disease or a health-related 
condition; and (2) “structure/function 
claims,” defined as claims that describe 
“the role of a nutrient or dietary ingredi-
ent intended to affect normal structure or 
function in humans,” or that characterize 
“the documented mechanism by which 
a nutrient or dietary ingredient acts to 
maintain such structure or function.”3 
Thus, developments in the regulation of 
EU health claims have the potential to 
alter the landscape in the United States 
for both health claims and structure/
function claims.
The EU health claims regulation 
requires that new health claims (i.e., 
those not already on a list of approved 
claims) be the subject of a premarket ap-
proval application that includes relevant 
scientific studies and other information, 
Publish and Perish: A Disturbing 
Trend in the European Union’s Regulation of  
Nutrition Health Claims Made on Foods
by Susan Carlson, Ricardo Carvajal, Nicole Coutrelis, Jehan-Francois Desjeux, Lorenzo Morelli,  
Peter Van Dael, Bernd van der Meulen, Annemieke Tops, Cathy Weir1
From left, Jehan-Francois Desjeux, Nicole Coutrelis, Peter Van Dael, Cathy Weir, Annemieke Tops, 
Susan Carlson, Lorenzo Morelli, Ricardo Carvajal, Bernd van der Meulen.
FDLIseptoct.indd  50 10/18/10  11:11:04 AM
September/October 2010      Update 51FDLI
“including, where available, peer-re-
viewed studies.” However, an applicant 
has the option of designating data and 
other information in the application as 
“proprietary,” so long as the designation 
is accompanied by “verifiable justifica-
tion.” If the applicant has “exclusive 
right of reference” to the information 
designated as proprietary, and if the 
proprietary information is deemed es-
sential to the authorization of the health 
claim, then that information cannot be 
relied upon by subsequent applicants for 
a period of five years. In other words, the 
EU health claims regulation grants five-
year exclusivity with respect to use of the 
information designated as proprietary 
if the applicant meets the conditions 
described above.
Late last year, the Commission issued 
the first authorization of a health claim 
that granted protection of proprietary 
information pursuant to the EU health 
claims regulation.4 The applicant desig-
nated nine studies in the application as 
proprietary. The European Food Safety 
Authority (EFSA) agreed with the appli-
cant that the claim could not have been 
granted without relying on the studies 
designated as proprietary.5 However, 
the Commission concluded that only 
information in those studies which were 
unpublished was entitled to protection. 
With respect to studies that had been 
published, the Commission concluded 
that protection of those studies was “not 
justified” in light of the regulation’s 
objectives, among which is “to protect 
the investment made by innovators in 
gathering the information and data sup-
porting an application.” In summary, the 
Commission concluded that if a study is 
published, then nobody (including those 
who funded and conducted the study) 
can assert that the study represents an 
“investment” that is cognizable under the 
EU health claims regulation.
As written, the decision provides little 
insight into the Commission’s rationale. 
According to the decision, the Com-
mission sought clarification from the 
applicant with regard to whether the 
criterion of “exclusive right of refer-
ence” was satisfied, but the commission 
made no explicit finding on this point. 
Rather, the basis for the decision was 
cast in terms of the perceived need to 
protect investment made by innovators. 
Although this is a worthy objective, it is 
not clear why the Commission concluded 
that this objective is incompatible with 
scientific publication. One can readily 
envision arrangements through which 
an innovator that sponsors or conducts 
a study could document its investment 
and assert exclusive right of reference to 
data yielded by that study for purposes 
of an EU health claim application – even 
if the results of the study are published 
prior to submission of the application. 
Furthermore, if the main objective of the 
regulation is to foster innovation, then 
the Commission’s approach could be 
counterproductive in the long run. By 
creating a disincentive to publication, the 
Commission’s approach slows the flow 
of scientific information to the scientific 
community, where that information can 
be most thoroughly vetted and used to 
spur additional innovation.
Also problematic is the fact that the 
objective of fostering innovation is 
not the regulation’s sole objective. The 
regulation has other important objec-
tives, namely to “ensure a high level of 
protection for consumers,” and to “give 
the consumer the necessary information 
to make choices in full knowledge of the 
facts.” These objectives would seem to be 
ill-served by an approach that discourag-
es peer review and lacks transparency. As 
noted previously, the regulation specifi-
cally calls for EU health claim applicants 
to submit peer-reviewed studies where 
available – a tacit acknowledgment that 
peer-review generally provides assuranc-
es of superior quality and integrity. The 
value of peer review is recognized by the 
EFSA, which states in a guidance docu-
ment that “[d]ata provided to substanti-
ate a health claim should be of the quality 
expected from a peer-reviewed journal.”6 
Further, as noted in the EU health claims 
regulation, “[h]ealth claims should only 
be authorized for use in the Commu-
nity after a scientific assessment of the 
highest possible standard.” Although the 
regulation assigns the task of perform-
ing that assessment to EFSA, that body’s 
assessment is not a substitute for peer 
review. The value of transparency is also 
recognized by the EFSA, which states in a 
guidance document that “EFSA applies a 
high level of transparency when process-
ing information unless a clear regulatory 
requirement exists for a defined level of 
confidentiality. Transparency is the rule 
and confidentiality the exception.”7
Although the Commission’s decision is 
becoming the subject of heated debate in 
the EU, scant attention has been paid in 
the U.S. And yet, the Commission’s deci-
sion ought to be of more than academic 
interest to a U.S. audience. In the U.S., 
health claims must be based on publicly 
available evidence, much of which is gen-
erated abroad. Thus, any incentive in an 
influential jurisdiction that discourages 
the publication of scientific information 
that could be used in support of a health 
claim petition could have significant 
adverse effects.
With respect to structure/function 
claims, there is no requirement in the 
United States that information used 
to substantiate a structure/function 
claim be publicly available, nor is there 
a requirement that companies seek 
approval of a structure/function claim 
prior to using it in the marketplace. As 
a result, many companies compile their 
FDLIseptoct.indd  51 10/18/10  11:11:04 AM
52 www . f d l i . o r gUpdate      September/October 2010
substantiation information in a confiden-
tial file that is held in reserve in case of a 
challenge by a regulator. In case of such a 
challenge, a company will make its sub-
stantiation information available for the 
regulator’s review. However, the informa-
tion is regarded as confidential com-
mercial information that is not subject to 
public disclosure under the Freedom of 
Information Act.
Many companies in the United States 
choose to keep their substantiation 
information confidential precisely so that 
they can achieve or maintain a com-
petitive advantage by making structure/
function claims that their competitors 
cannot make without developing their 
own substantiation. The importance 
of the potential competitive advantage 
gained through this strategy should not 
be minimized. However, the EU health 
claims regulation (as interpreted by the 
Commission) goes beyond recogniz-
ing the potential value of this strategy 
to encouraging its pursuit by all parties 
with an interest in making an EU health 
claim. In doing so, the Commission fails 
to recognize that maintaining the confi-
dentiality of scientific information that 
substantiates a claim potentially imposes 
costs on both individual companies and 
the broader society. The potential cost to 
a company is that an increasingly skepti-
cal public, weary of being bombarded 
with claims that range from the plausible 
to the incredible, could shy away from 
products that make claims based on 
information that has never seen the light 
of day. The cost to society is that impor-
tant scientific information is unavailable 
to the public longer than it otherwise 
would be.
There is no ready solution to this 
dilemma in the United States, where 
the current regulatory scheme does not 
provide for the premarket approval of 
structure/function claims or the ac-
companying recognition of any type of 
exclusivity. Further, any proposal for 
premarket approval would be met with 
strong resistance grounded in the right to 
free speech provided by the First Amend-
ment to the U.S. Constitution. For the 
European Union, where a premarket 
approval scheme is already in place, the 
solution to the dilemma appears obvious: 
provide an incentive for the development 
of scientific data and other information 
to substantiate a claim, and structure that 
incentive so that it is not contingent on 
the maintenance of confidentiality. The 
EU health claims regulation (if properly 
interpreted) could offer precisely that 
solution. One can only hope that the 
Commission will not squander the op-
portunity by adhering to an unnecessar-
ily cramped interpretation of the regula-
tion. If the Commission reverses course, 
the result could be an enviable balancing 
of private and public interest that could 
serve as a model for other jurisdictions 
with similar regulatory schemes – and 
could lift the cloud that now hangs over 
those contemplating publication of any 
scientific research that might be used in 
support of an EU health claim. 
FDLI
1 Susan Carlson, PhD, Professor of Nutrition at Kansas 
University; Ricardo Carvajal, J.D., Of Counsel with 
Hyman, Phelps & McNamara, P.C., Washington 
D.C.; Nicole Coutrelis, Attorney at the Paris Bar, 
Partner of the Law Firm Coutrelis & Associés, Paris-
Brussels; Jehan-François Desjeux, Professor Emeritus 
at the Consevatoire des Arts et Metiers, Paris; 
Lorenzo Morelli, Professor and Chair of Food Micro-
biology and Biotechnology, Istituto di Microbiologia 
Università Cattolica S.C., Piacenza, Italy; Annemieke 
Tops, MSc, Manager Regulatory Innovation Europe 
at Mead Johnson Nutrition, Nijmegen, Netherlands; 
Peter Van Dael, Ph.D. Vice President Global Regula-
tory and Nutrition Science at Mead Johnson Nutri-
tion, Evansville, Indiana; B.M.J. van der Meulen, 
Professor of Law and Governance at Wageningen 
University, the Netherlands; Cathy Weir, PhD, RD., 
Global Regulatory and Nutrition Science at Mead 
Johnson Nutrition, Evansville, Indiana.
2 Regulation (EC) No 1924/2006 of the European Parlia-
ment and of the Council of 20 December 2006 on nutri-
tion and health claims made on foods, Official Journal 
of the European Union L 12/3, January 2007.
3 Claims That Can Be Made for Conventional Foods 
and Dietary Supplements, September 2003, available 
at http://www.fda.gov/Food/LabelingNutrition/La-
belClaims/ucm111447.htm.
4 Commission Decision of 17 December 2009 authoris-
ing a health claim on the effect of water-soluble 
tomato concentrate on platelet aggregation and 
granting the protection of proprietary data under 
Regulation (EC) No 1924/2006 of the European 
Parliament and of the Council, Official Journal of the 
European Union L 336/55, December 2009.
5 EFSA provides scientific advice and opinions but is 
not part of the Commission, which is responsible for 
initiating legislation and implementing policies. See 
Regulation (EC) No 178/2002 of the European Parlia-
ment and of the Council of 28 January 2002 laying 
down the general principles and requirements of food 
law, establishing the European Food Safety Authority 
and laying down procedures in matters of food safety, 
Official Journal of the European Communities L 31/1, 
January 2002.
6 Scientific and Technical Guidance for the Prepara-
tion and Presentation of the Application for Autho-
risation of a Health Claim, The EFSA Journal (2007) 
530, 1-44.
7 Transparency in Risk Assessment Carried Out by 
EFSA: Guidance Document on Procedural Aspects, 
The EFSA Journal (2006) 353, 1-16.
FDLIseptoct.indd  52 10/18/10  11:11:04 AM


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