EHPM Consultation Submission
Generic Comments
Line 157: Only 18 of 130 applications for article 13.5 health claims received since Regulation (EC)
No 1924/2006 came into force have been successful. Given the expense involved in preparing a
submission it is obvious that companies submit applications with a view to approval not rejection.
The 14% success rate clearly show that the pre-submission guidance is not allowing applicants to
fully appreciate the requirements. Pre-submission meetings are required to enable open dialogue
take place and address uncertainties. Such a process exists with the European Medicines Agency
without the integrity of those assessing dossiers being compromised. Companies do not spend
hundreds of thousands of euros on trials and prepare dossiers frivolously. Investment in innovation
will continue to decline in the sector until companies feel confident enough in the fairness of the
assessment process to fund the type of research being sought be EFSA. This is particularly the case
with SMEs who cannot afford to spend huge amounts on trials. The fact that the success rate has
dipped to 13.2% on applications submitted since 2012 clearly illustrates that pre-submission
guidance documents on their own do not suffice.
Line 166: It is not clear what use this guidance will be if it is not intended to “cover potential
future health claims which have not be evaluated by the panel”.
Line 174: A definition for what constitutes “generally accepted scientific evidence” should be
included in this section of the document. In the assessment of Article 13.1 general function claims
there appeared to be a clear disparity between what constituted general accepted scientific
evidence for vitamins and minerals (textbook references) and other substances (rejection in most
cases in the absence of clinical trials).
Line 181: For consistency the definition of other substances should be that used in Regulation (EC)
No 1924/2006.
Line 184: The definition of a “pertinent study” is clearly problematic in general in relation to
health claims given the arbitrary manner that many studies have been dismissed despite applicants
being confident that based on the guidance provided, they had designed an appropriate study. It is
clear that the pertinence of studies can only be guaranteed through thorough pre-submission
meetings. In addition, EFSA should provide precise indications regarding the number of clinical
trials required, the statistical output required and the methodology to be followed.
Line 269: There is no provision in the health claims regulation that indicates that only healthy
persons are concerned by health claims. In addition, an article 13.1 health claim granted to Vitamin
C, collagen and normal teeth (EFSA Journal 2009;7(9): 1226) is based on scurvy, which is clearly a
pathology. EFSA should take into consideration the benefit of food and food supplement in a nonhealthy population as far as it is considered as a complementary intervention, not a treatment and
should clarify population sub-groups taken into account (menopausal and pregnant women, elderly
with enlarged prostate).
7. What are the main issues addressed by the NDA Panel for the evaluation of health claims?
7.1. Characterisation of the food/constituent
Line 373: For clarity it would be useful if reference is made here to sources approved for use in
food supplements (Directive 2002/46/EC and Regulation 1170/2009).
7.2 Characterisation of the claimed effect
Line 433: Reference is made to “beneficial physiological effect” but not to “beneficial nutritional
or physiological effect” as specified in Article 5(1)(a) of the regulation. This is indicative of the
tendency in EFSA’s approach to health claims assessment of ignoring the general nutritional benefit
of substances and requiring demonstration of a medical level improvement to justify a health
benefit for a food. The same error occurs in lines 436, 444, 458,464, 468 and 470.
7.3. What is the evidence required for the scientific substantiation of health claims?
Line 531: This line refers to the possibility of a positive opinion where there is no evidence of a
mechanism. This contradicts other sections of the guidance.
7.4. How does the NDA Panel identify pertinent human studies?
Line 538: As indicated previously in this submission what constitutes a “pertinent study” is clearly
problematic in general in relation to health claims given the arbitrary manner that many studies
have been dismissed despite applicants being confident that based on the guidance provided, they
had designed an appropriate study. It is clear that the pertinence of studies can only be guaranteed
through thorough pre-submission meetings. In addition, EFSA should provide precise indications
regarding the number of clinical trials required, the statistical output required and the
methodology to be followed.
7.5. How meta-analyses can be used to inform decisions on substantiation?
Line 561: This section should be more extensive to better enable applicants to judge when and
where to use meta-analyses in applications.
7.8. On what basis does the NDA Panel propose conditions of use for health claims evaluated
with a favourable outcome?
Line 652: Much of the problems surrounding the implementation of the health claim regulation
could be resolved through the NDA panel proposing conditional wordings for claims. Food interacts
differently with different subjects as is also the case with medicines. An approved medicine might
work well for one subject but not for another. For substances such as glucosamine where there is
clearly evidence to suggest a beneficial effect, the simple insertion of the “may” before “support
joint flexibility” would provide a claim that is accurate, understandable to the average consumer
and in no way misleading.
7.9. On what basis does the NDA Panel propose wordings for health claims evaluated with a
favourable outcome?
Line 654: The NDA panel should take consumer understanding into account when proposing the
wording for a claim. It is totally unreasonable that applicants take consumer understanding into
account when proposing a wording for a claim but the panel can then approve a wording that will
clearly be incomprehensible to the average consumer. The suggested ‘negotiation’ with the risk
managers on wordings should not be necessary.
8. What are the key scientific aspects to consider for preparing a health claim application?
Line 693: It needs to be made clearer to applicants what information is needed to support a
mechanism or potential mechanism. How much will in-vitro or animal studies be taken into account
or is data from human an absolute requirement?
Annex A – Administrative and procedural aspects governing the life cycle 759 of a claim
application from claim formulation to authorisation
Line 869: EHPM has been made aware of examples where applicants have indicated to EFSA that
they would rather withdraw an application if it were to be rejected. The response received is that
the applicant will only be informed of the final opinion once the panel has adopted its opinion. This
is entirely unnecessary. The last line of recital 23 of the health claims regulation states that “Upon
request the applicant should be able to have access to his file to check the status of the
procedure”. EFSA can easily use this provision to justify informing an applicant of the likelihood of
a negative decision. The rejection of a particular claim for a new product can have knock on
commercial effects for existing products associated with a particular brand even if the other
products in the brand range have approved claims. As a claim will only every be used if approved
there is clearly no public interest in publishing a negative opinion on a claim that has never even
been placed on the market.