POSITION PAPER ON EVALUATION OF
PROBIOTIC CLAIMS
GAP SECRETARIAT
C/O BURSON-MARSTELLER SQUARE DE MEEÛS 37 1000 BRUSSELS BELGIUM
EMAIL: GapSecretariat@bm.com
SUMMARY
The current evaluation and authorisation of health claims for individual probiotic strains has been
problematic. Despite the fact that the benefits of probiotics have been recognised by health
authorities in EU member states and around the world and are supported by a solid base of scientific
evidence, more than 300 probiotic applications submitted under the EU Nutrition and Health Claims
Regulation have received negative assessment by EFSA.
GAP seeks to work constructively with EFSA, the European Commission, member states and all
relevant parties to find a viable solution. GAP calls for an open dialogue with EFSA to clarify the
outstanding questions and to agree on an approach to defining the health benefits of probiotics. In
line with EFSA’s case-by-case evaluation of probiotics claims submissions, a system should be
established whereby a claim applicant can discuss transparently with EFSA specific scientific and
procedural questions, both before the official submission of a dossier and during the evaluation
process. Under certain conditions, there should be a possibility for prospective applicants to request a
formal pre-submission meeting with EFSA, so that applicants can fully understand all criteria that will
be applied to evaluate a claim.
Probiotics are at the cutting edge of food sector innovation and the sector is a European success story.
The sector needs certainty regarding scientific assessment and the regulatory environment in order to
maintain its growth and to be able to communicate the health benefits of probiotics to consumers.
THE CURRENT
FRAMEWORK FOR
THE ASSESSMENT
OF PROBIOTICS
HEALTH CLAIMS IN
THE EU HAS BEEN
PROBLEMATIC
It is clear that the evaluation and authorisation of health claims on individual probiotic strains has been
problematic. More than 300 probiotic applications submitted under the EU Nutrition and Health Claims
Regulation have received negative assessment by the European Food Safety Authority (EFSA) and
thereby no approvals from the European Commission. This makes probiotics one of the types of foods
that have been most negatively affected by the Regulation. One generic claim on live yoghurt has
received a positive opinion
1
. By strict definition this could be regarded as a probiotic claim, though in
reality it is a more general yoghurt claim, with the enzyme lactase as the common factor for the whole
category.
Nonetheless, the benefits of probiotics have been recognised by health authorities in individual
member states of the EU and around the world, with a solid base of peer reviewed scientific
publications on probiotics (in the last 10 years, more than 9, 000 papers were published and listed on
PubMed). Moreover, the European Commission has itself contributed more than €70 million of
research funding to related topics. Clearly there is a problem that needs resolution, and GAP seeks to
work constructively with EFSA, the European Commission, member states and all relevant parties to
find a solution.
One of the reasons that applications for probiotic claims have not been accepted by EFSA is that
companies involved had insufficient information about what EFSA would require when they were
designing research studies. Companies submitting claim applications did so in good faith based on
what they felt was a responsible approach taking into account established scientific standards and the
best information available at the time. The industry welcomes the publication of EFSA’s first guidance
note on gut and immunity claims, but notes that it was only provided in April 2011, more than two
years after the deadline for submission of Article 13.1 claims-dossiers, and also after several claims
applications had already been negatively assessed by EFSA. Moreover, the guidance leaves several
important issues unaddressed, making it difficult to prepare a dossier meeting the standards required
by EFSA. An open dialogue with EFSA would help to clarify these and other points.
1
Scientific Opinion on the substantiation of health claims related to live yoghurt cultures and improved lactose digestion (ID 1143, 2976) pursuant to Article 13(1) of
Regulation (EC) No 1924/2006
A MORE OPEN
DIALOGUE IS
NEEDED
GAP and its members call for a more open dialogue with EFSA to clarify outstanding questions and to
agree on an approach to defining the health benefits of probiotics. In line with EFSA’s case-by-case
evaluation of probiotic claims submissions, claim applicants should be able to transparently discuss
with EFSA specific scientific and procedural questions, both before the official submission of a dossier
and during the evaluation process. Some key questions are raised at the research stage, e.g. the study
design, study protocol, recognition of biomarkers. In order to invest in the most promising research
with a chance to obtain a positive EFSA opinion, potential applicants should have the opportunity to
address specific questions to EFSA at the early research stage. Such an approach would save time and
resources for applicants and for EFSA.
As in the case of other European agencies, under certain conditions prospective applicants should have
the possibility to request a formal pre-submission meeting with EFSA. Such a meeting would provide a
vital opportunity for applicants to obtain procedural advice, and would enable them to perform
research and submit applications that are in conformity with the scientific and regulatory requirements,
which could be validated more efficiently. Without such consultations, probiotics applicants cannot
reasonably be expected to understand all the criteria that will be applied to evaluate a claim.
Once the evaluation process has begun, under the ‘stop the clock’ procedure EFSA poses additional
questions to applicants. Applicants should have the opportunity to use that procedure to enter into a
real dialogue with EFSA, with an opportunity to ask questions and to comment on EFSA’s remarks
before providing a final response. The current system, under which applicants are simply given a
deadline to provide a definitive response, limits the ability to respond to EFSA in the best possible way.
Such measures are of crucial importance for GAP as we currently consider how to define the
fundamental benefits of probiotics based on independent systematic reviews of existing science on our
well-characterised strains, with the final goal of submitting new dossiers to EFSA for evaluation. We
believe a rigorous collective review of the science may more clearly demonstrate common
characteristics and benefits of probiotics and may, consequently, meet the assessment of the highest
possible standard (Recital 23 of NHCR) that EFSA requires.
Clearly, for such an approach to work, it will be essential for applicants to enter into a constructive
scientific dialogue with EFSA to clarify the outstanding questions and agree on an approach to defining
the health benefits of probiotics – so that when applications for probiotic claims are made in the
future, applicants can be aware of expectations in advance.
AN INNOVATIVE
AND SPECIFIC
FOOD SECTOR
PROVIDING
HEALTH BENEFITS
TO CONSUMERS
The benefits of probiotics have been recognised by health authorities around the world for decades. In
2001, the World Health Organisation and the Food and Agriculture Organisation acknowledged the
work done by renowned scientists on the health benefits of probiotics. The category has also been
recognised (or claims have been approved) in many countries around the world, including Canada,
Japan, South Korea, Russia, China and Turkey. In the past, national authorities in the EU, including
France and Sweden, have authorised health claims on probiotics. The EU has invested in research into
the science of the human gut microbiota (the group of microorganisms that reside in the human
gastrointestinal tract) and probiotics, with more than €70 million of funding from the EU’s research
framework programmes provided for projects in these areas.
Probiotics science is constantly developing, building on a solid basis of evidence that has grown since
probiotics were first developed in the early 20
th
century. In the last 10 years, there have been more than
9,000 papers published on probiotics, including over 900 human trials, and listed on PubMed. These
papers outline the health benefits of probiotics, including reduction in the risk of gastroenteritis,
improved bowel function and improved gut comfort, demonstrating the key role that probiotics can
play in maintaining health – bringing much-needed savings to stretched national healthcare budgets.
Probiotics are at the cutting edge of food sector innovation, and the sector is a European success story:
In 2012 European sales of probiotic foods and supplements accounted for €5.13 billion. The sector has
been growing at a rate of around 6% each year, until recently when a retraction has been observed,
which could be due to the impact of both the regulatory situation and the economic environment.
It is clear that the probiotic sector needs certainty regarding scientific assessment and the regulatory
environment in order to maintain its commitment to innovation and growth and in order to be able to
communicate the health benefits of probiotics to consumers, when they meet the appropriate
requirements. For this, dialogue with EFSA is essential, and, in the medium term, a consultation for a
dossier prior to submission would help to achieve alignment between EFSA and the applicant.
Last updated February 2013