Health claim dossier: opportunities for SMEs
and lessons learnt
Alfonso Siani, MD
Institute of Food Sciences, CNR
Chair, E...
2
Claims substantiated by
Reg. (EC) No 1924/2006
“Health claims should only be authorised for use in the Community
after a...
3
Reg. (EC) No 1924/2006
 “In order to ensure a harmonised scientific assessment of
these claims, EFSA should carry out s...
4
HEALTH CLAIMS
Regulation (EC) 1924/2006
Art.13.1
Generally
accepted
scientific
evidence
Art.13.5
Newly developed
scienti...
5
 subjects with a disease cannot be the target population for
health claims made on food
 function claims cannot refer ...
6
Human data are central
 Claim definition
1. Is the food/constituent defined and characterised?
2. Is the claimed effect...
7
 Selection/review of pertinent human studies:
central for substantiation
 Review of supportive studies on biological
p...
8
SCIENTIFIC ASSESSMENT
Possible conclusions
Main title
• a cause and effect has not
been established
• insufficient evide...
9
 Applications on Article 13.5 and Article 14
health claims: 460 received
 Art 13.1 list: finalised except botanicals
(...
10
Issues arising while reviewing scientific
evidence for health claims
Delays in evaluation process
Reasons for clock sto...
11
Main title
Characterisation
of the food
constituents
12%
Claimed effect &
target population
13%
Studies
submitted
for
s...
12
Main title
Study
participants
8%
Study products
vs. controls
9%
Outcomes
13%
Sample
size/power
calculation
5%
Randomisa...
13
MIS-REPORTING OF STUDIES
Main title
 Published papers may not accurately represent
what was done and what was the outc...
14
General
 Preparation and presentation of applications (revised 2011)
 General scientific guidance for stakeholders (p...
15
Main title
Thank you!
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Health claim dossier: opportunities for SMEs and lessons learnt by Alfonso Siani, EFSA

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TeRiFiQ Conference
Reducing salt, fat and sugar in everyday foods – Results from TeRiFiQ EU project and opportunities for food industry
27 October 2015 ♦ Milan EXPO, Italy

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Health claim dossier: opportunities for SMEs and lessons learnt by Alfonso Siani, EFSA

  1. 1. Health claim dossier: opportunities for SMEs and lessons learnt Alfonso Siani, MD Institute of Food Sciences, CNR Chair, EFSA Standing Working group on Claims
  2. 2. 2 Claims substantiated by Reg. (EC) No 1924/2006 “Health claims should only be authorised for use in the Community after a scientific assessment of the highest possible standard” MAIN CRITERIA FOR HEALTH CLAIMS Reg. (EC) No 1924/2006 “generally accepted scientific evidence” “totality of the available scientific data” “weighing the evidence”
  3. 3. 3 Reg. (EC) No 1924/2006  “In order to ensure a harmonised scientific assessment of these claims, EFSA should carry out such assessments”  NDA Panel applies a single standard of evidence for substantiation of all health claims  NDA Panel adopts scientific opinions  EFSA’S ROLE Reg. (EC) No 1924/2006 AUTHORISATION: by Commission/Member States, European Parliament scrutiny EU Register of Claims (http://ec.europa.eu/nuhclaims/)
  4. 4. 4 HEALTH CLAIMS Regulation (EC) 1924/2006 Art.13.1 Generally accepted scientific evidence Art.13.5 Newly developed scientific data / proprietary data Art.14 Reduction of disease Risk Children’s development & health List Claims Applications
  5. 5. 5  subjects with a disease cannot be the target population for health claims made on food  function claims cannot refer to a disease  disease risk reduction claims cannot refer to the reduction of the risk of a disease, but should refer to the reduction of a risk factor for disease  The NDA Panel considers that the target population for health claims made on food is the general population or subgroups thereof defined on the basis of age, gender, physiological conditions and/or lifestyle (e.g. children, men, post-menopausal women, adults performing endurance exercise) REGULATORY REQUIREMENTS Main title
  6. 6. 6 Human data are central  Claim definition 1. Is the food/constituent defined and characterised? 2. Is the claimed effect defined and is it a beneficial physiological effect, and can it be measured in vivo in human?  Substantiation 3. Is a cause and effect relationship established between the consumption of the food/constituent and the claimed effect?  for the target group and under the proposed conditions of use SCIENTIFIC ASSESSMENT 3 main questions Main title
  7. 7. 7  Selection/review of pertinent human studies: central for substantiation  Review of supportive studies on biological plausibility (e.g. mechanisms that explain the effect of the food)  Weighing the evidence - combining the relevant human studies + other studies to conclude on substantiation SCIENTIFIC ASSESSMENT Steps Main title
  8. 8. 8 SCIENTIFIC ASSESSMENT Possible conclusions Main title • a cause and effect has not been established • insufficient evidence for cause and effect …. • a cause and effect has been established
  9. 9. 9  Applications on Article 13.5 and Article 14 health claims: 460 received  Art 13.1 list: finalised except botanicals (1548 on hold) HEALTH CLAIMS (STATUS 22/09/2015)
  10. 10. 10 Issues arising while reviewing scientific evidence for health claims Delays in evaluation process Reasons for clock stops requesting supplementary information (from 109 clock stop letters to applicants) HEALTH CLAIM APPLICATIONS
  11. 11. 11 Main title Characterisation of the food constituents 12% Claimed effect & target population 13% Studies submitted for substantiation of claims 75% Reasons for clock stops
  12. 12. 12 Main title Study participants 8% Study products vs. controls 9% Outcomes 13% Sample size/power calculation 5% Randomisation 5% Blinding 3% Statistics 23% Result reporting 14% Others 20% Questions on studies submitted for substantiation of claims
  13. 13. 13 MIS-REPORTING OF STUDIES Main title  Published papers may not accurately represent what was done and what was the outcome  incomplete reporting, e.g. subject selection, enrolment, randomisation, retention and drop outs; statistical analyses  selective reporting of outcomes, subgroup analyses – mainly favourable outcomes reported  EFSA may request additional information from the applicant, including full study report for key studies
  14. 14. 14 General  Preparation and presentation of applications (revised 2011)  General scientific guidance for stakeholders (public consultation Jul-August; finalisation Dec 2015) Specific  Gut, immune (public consultations; finalisation Dec 2015)  Bone, joints, skin, oral  Appetite, body weight, blood glucose  Antioxidants, cardiovascular  Physical performance  Neurological, psychological function CLAIMS GUIDANCE
  15. 15. 15 Main title
  16. 16. Thank you!

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