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E-Siong Tee, PhD
Scientific Director, ILSI SEA Region
(nutrihealth.tes@myjaring.net)
1
n
2
Background ….
ÿ Health claims permitted in some countries in SEA region
v mostly arising from applications from food industry for
“other components”
v other function claims and disease reduction claims
ÿ Regulatory framework, in various forms, exist in SEA to
review applications
ÿ Authorities require substantiation of proposed health claims
ÿ Significant interest in the requirements for dossiers, review
process, why some applicants are not successful
ÿ Share experiences of the review process and key learnings
(especially from perspectives of Malaysia)
3
Outline ….
ÿ Summary of health claims status in SEA countries
v Other function claims
v Disease reduction claims
ÿ Regulatory framework for review of health claim
applications in SEA
v Expert committees
v Information required for review
ÿ Scientific substantiation of claims
v Sharing some lessons
v Common errors/omissions/weaknesses
3
Summary of regulatory status of
health claims in SEAsia
….. Brunei, Indonesia,
Lao PDR, Malaysia,
Philippines, Singapore,
Thailand, Vietnam
ÿ Survey of regulations in the SEAsian region
v input by regulators in 9 Southeast Asian countries
v responded to a structured format, including
– various aspects of nutrition labeling and FOP
– nutrition claims, nutrient function claims, other
function claims and disease risk reduction claims
– substantiation of health claims
– regulatory framework
– definition of claims as given in Codex Alimentarius
guidelines
ÿ Supplemented with information from website of regulatory
agencies
ÿ Only findings for other function claims and disease
reduction claims are presented here
St
ing
Br
Ind
La
Ma
My
Ph
Sin
Th
Vie
*T
y
Status of other function claims - other food components, functional
ingredients: permitted in 5 countries
Brunei Not permitted
Indonesia Yes, in new health claims regulations (dietary fibre, plant
sterol/stanols)
Lao PDR Not permitted
Malaysia Yes, 29 claims for variety of other food components; all
petitions from industry; positive list
Myanmar Not permitted
Philippines Yes, according to Codex; no positive list
Singapore 10 claims for collagen, probiotics, prebiotics, plant sterols;
positive list
Thailand Not permitted*
Vietnam Yes, according to Codex; no positive list
*Thailand has a positive list of permitted probiotic cultures
Status of disease risk-reduction claims : permitted only in 3
countries, for a limited number of nutrients/food components
Brunei Not permitted
Indonesia 7 types of components, positive list
Lao PDR Not permitted
Malaysia Not permitted
Myanmar Not permitted
Philippines Yes, according to Codex; no positive list
Singapore 5 nutrient/food specific claims, positive list
Thailand Not permitted
Vietnam Not permitted
Po
Bru
Ind
La
Ma
My
Ph
Sin
Th
Vie
Positive list of permitted health claims: yes in 3 countries
Brunei NA
Indonesia http://www.pom.go.id/search/query2.asp?qs_materi=t_hukum
Perundangan&qs_search=pengawasan+klaim&qs_TX=1
Lao PDR NA
Malaysia Yes, listed in Guide to Nutrition Labelling and Claims (as at
December 2010);
http://fsq.moh.gov.my/v4/index.php/component/k2/item/460
Myanmar NA
Philippines Only for probiotic as food supplement
Singapore Yes, listed on AVA website:
http://www.ava.gov.sg/FoodSector/FoodLabelingAdvertisemen
t/
Thailand Positive list of permitted probiotics
Vietnam NA
ÿ There are no harmonised health claims regulations in
SEAsian countries
ÿ There are significant differences
v other function claims permitted in 5 countries
– Indonesia, Malaysia, Philippines, Singapore, Vietnam
– relate to several bioactive components eg several
dietary fibres and non-digestible oligosaccharides,
plant sterols, PUFAs
v Disease risk reduction claims are considered higher level
claims and are permitted only in 3 countries
– Indonesia, Philippines and Singapore
– and only for a few nutrients or bioactive compounds
or food
am
vel
s
Regulatory framework for review
of health claims in SEAsia
….. Indonesia,
Malaysia, Singapore,
ÿ Regulatory system related to claims differ considerably
v 3 countries adopt a positive-list approach
v claims not on the listed are not permitted, but industry
may apply on a case-by –case basis
v approval based on scientific substantiation of proposed
claim
ÿ Each claim has to be accompanied by scientific
substantiation which will be reviewed by a panel of experts
appointed by the regulatory agency
v Experts from various agencies and expertise
d
s
ÿ Examples of expert committees
v National Agency for Drug and Food Control, Indonesia
v Expert Group on Nutrition, Health Claims and
Advertisement – Food Safety & Quality Division, MOH
Malaysia; meet every month to review applications and
other regulatory matters
v Advisory Committee for Evaluation of Health Claims –
Agri-Food and Veterinary Authority, Singapore
v and a variety of approaches by Philippines Food and
Drug Administration, Thailand Food and Drug
Administration, Vietnam National Institute for Food
Control
ÿ Similar requirements in the application forms from the 3
countries – Indonesia, Malaysia, Singapore
http://www.pom.go.id/pom/hukum_perundangan/pdf/18_klaimlbelpn_8.pdf
Use application form in
Guide Book to assist
industry and enforcement
officers understand
nutritionl labeling and
claims regulations
Revised December 2010
http://fsq.moh.gov.my/v3/images/filepicker_users/5ec35272cb-
78/Perundangan/Garispanduan/Pelabelan/GuideNutritionLabel.pdf
Health Claims and Scientific Substantiation in SEA_2015
http://www.ava.gov.sg/AVA/Templates/AVA-
GenericContentTemplate.aspx?NRMODE=Published&NRNODEGUID=%7bB96B0EC2-1D1E-4448-9C25-
ABD8470D2BF4%7d&NRORIGINALURL=%2fFoodSector%2fFoodLabelingAdvertisement%2f&NRCACHEHINT=Guest#F
oodForSale
Malaysia -
Applying for new health claims –
other function claims (Regulation
18E)
general principles are same for
other countries
ÿ For a compound to make a health claim, it must be a
permitted “added nutrient”
ÿ Regulation 26 of Food Regulations 1985 regulates the use
of added nutrients to foods
v added nutrients includes any mineral, vitamin, amino
acid, fatty acid, nucleotide or other food components
which, when added singly or in combination to food,
improves the nutritional value of the food
v other food components include various non-nutrients or
functional ingredients with proven physiological effects
beneficial to health
ÿ If is not in this list, an application has to be submitted for
approval for use prior to application for health claim
Health Claims and Scientific Substantiation in SEA_2015
Health Claims and Scientific Substantiation in SEA_2015
ÿ Basic information eg
v chemical structure and properties and physical
properties of the nutrient
v stability in the foods serving as vehicles
v bioavailability
v analytical method
v physiological role
ÿ Safety evaluation important as it is a novel ingredient
ÿ Benefits of adding the nutrient to the food
v Provide clear scientific evidence
Main information required for new “added nutrient”
application
ÿ Name the food (s) to which the nutrient is to be added
v Preferably, provide a table of the list the foods and
indicate the approximate amount that will be added to
each of the foods listed
ÿ Provide an estimate of the daily intake of the nutrient, eg
from various food sources containing the nutrient.
Indicate if there is safety concern if this nutrient is added
to the foods proposed
… new added nutrient application
ÿ The basic information required for “added nutrient”
application
ÿ Propose a minimum level that the nutrient must be
present before the function claim can be made
v Provide scientific justification why this level is
proposed
v Usually this is the level at which the nutrient is
effective in bringing about the proposed function
claim (eg lowering blood cholesterol)
Main information required for new health claim
application
ÿ Provide sound scientific evidences for the claim
v All available literature including both positive and
negative findings on the proposed claim must be
provided
v Randomised, placebo-controlled, double-blind human
trials
v Epidemiological and experimental studies and reviewed
papers may be included as supportive evidences
v Studies should include those conducted by other
organizations or institutions
v Result of all these studies should be published in
refereed journals
v Submit a copy of all the scientific publications cited in this
section
Codex
Alimentarius
Guidelines
ILSI SEA Region
Guidelines
Examples of some errors/weaknesses in
submissions – lessons to be learnt
actual examples of dossiers submitted, but products
and compounds have been generalised
personal opinion & views
General errors
ÿ Inadequately prepared dossier
v too brief description of all required items in form
v skimpy information/ data presented
ÿ Poorly explained section on substantiation of claims eg
v mere listing of publications
v summaries of studies should be provided to facilitate
expert committee members reviewing the dossier
v point out how findings substantiate the claims
ÿ Insufficient scientific data to substantiate
v Proper literature search to be done
v Totality of evidence presented
Specific errors/weaknesses
ÿ Wordings of the proposed claim do not match the findings
of the studies
ÿ Publications provided are not relevant to the study
ÿ Extrapolated beyond the findings, eg
v findings are for a specific aspect of immune function, eg
gut immune function
v but the proposed claim is: “compound x helps to improve
immune function”
ÿ Gut immune function is only a specific aspect of immune
function
v and may not be extrapolated to bring about beneficial
effect to overall immune function
ÿ The compound used in the study does not match the
compound that is the subject of the claim, eg
v the claim refers to a specific compound x extracted from
a particular plant
v but the substance used in the study is an entire
aqueous extract of the plant
ÿ The plant extract contains compound x as well as many
other compounds
v beneficial effects cannot be attributed only to compound
x
m
d
ÿ The food vehicle for the compound does not match the
intended claim, eg
v the claim is for a compound x in milk and dairy products
v but the studies submitted had used different food matrix,
eg soya milk
ÿ The claim is only applicable for the food vehicle used in the
study
v It cannot be ascertained that the compound x is still
effective in other matrices
ÿ If the claim is intended for different foods, studies should be
done using the compound contained in of different
matrices, eg beverage, cereals, milk products, etc
ÿ Several applications received using studies carried out
using “pure” compounds
ÿ More like a supplement, consumed with water or a
beverage
v it cannot be ascertained that the compound is still
bioavailable and effective when combined in a food
matrix
ÿ Studies should be carried out using the compound of
interest added to food
v The regulation deals with food, not supplements
ÿ If the claim is intended for different foods, studies should be
done using the compound contained in different matrices
ÿ Several novel ingredients have started off as supplements
and not yet used in many food products
be
s
ÿ Study compounds include compound x plus other
biologically active components
v eg to study the prebiotic effect of compound x, other
undigestible carbs are also given
v eg to study effect of one PUFA, a mixture of PUFAs are
given
ÿ Findings confounded by other compounds present;
beneficial effects obtained cannot be attributed solely to
compound x
ÿ Study compound characteristics not presented
v could be for proprietary reasons
v diffcult to be approved because no distinguishing
feature(s), not unique to the compound in the claim
ÿ A few applications for whole foods
v eg nutrient fortified formulations
v Similarly, no clear unique characteristics
ÿ Study findings extrapolated to general population
v eg subjects in the studies were infants
v but the claim extrapolated to include older children and
teenagers
v It cannot be ascertained that the beneficial effect seen
in the study subjects will be similarly observed in other
age/physiological groups
ÿ Inappropriate scientific data cited
v eg publications were mostly citing usage of compound x
in treatment of subjects
v but the application is for improving specific physiological
condition in apparently healthy population
x
al
ÿ Wordings for claims bordering on disease reduction
v eg lowering blood pressure, prevent constipation,
diarrhoea
v diseases risk reduction claims not permitted
v Claims linked to diseases not permitted
Concluding thoughts
ÿ Health claims in place in SEA for a decade
v In Malaysia, system started in 2005
v applications still being reviewed by MOH regularly
ÿ Concerns with difficulty in preparation and submission of
dossiers
v Especially smaller companies
ÿ Concerns that the requirements for substantiation is too
stringent
v is there a need for such stringent requirements “for
other function claims”?
v in view that these are food claims, not drugs
ÿ Many Asian functional foods have been used for many
years as part of local cultures
v no proper documentation of health benefits
v what is the best approach to permitting some claims and
yet not misleading?
v how much evidence is enough?
v need to identify all beneficial components?
ÿ Framework for health claims only in 3 countries in SEA
ÿ Health claims may be permitted in a few other countries,
but no clear review system in place
v Need for clear transparent framework in all countries
v Relevant experts, reviewing applications regularly
nd
ÿ The series of ILSI SEA Region seminars and workshops
will continue to be organised
v to facilitate continued sharing of progress, of experience
in area of nutrition labeling and claims
v including sharing of process for substantiation of claims
v Workshop in the afternoon can discuss some of the
concerns and issues raised and learnings from this
seminar
Health Claims and Scientific Substantiation in SEA_2015
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Health Claims and Scientific Substantiation in SEA_2015

  • 1. 1 E-Siong Tee, PhD Scientific Director, ILSI SEA Region (nutrihealth.tes@myjaring.net)
  • 2. 1 n 2 Background …. ÿ Health claims permitted in some countries in SEA region v mostly arising from applications from food industry for “other components” v other function claims and disease reduction claims ÿ Regulatory framework, in various forms, exist in SEA to review applications ÿ Authorities require substantiation of proposed health claims ÿ Significant interest in the requirements for dossiers, review process, why some applicants are not successful ÿ Share experiences of the review process and key learnings (especially from perspectives of Malaysia)
  • 3. 3 Outline …. ÿ Summary of health claims status in SEA countries v Other function claims v Disease reduction claims ÿ Regulatory framework for review of health claim applications in SEA v Expert committees v Information required for review ÿ Scientific substantiation of claims v Sharing some lessons v Common errors/omissions/weaknesses
  • 4. 3 Summary of regulatory status of health claims in SEAsia ….. Brunei, Indonesia, Lao PDR, Malaysia, Philippines, Singapore, Thailand, Vietnam
  • 5. ÿ Survey of regulations in the SEAsian region v input by regulators in 9 Southeast Asian countries v responded to a structured format, including – various aspects of nutrition labeling and FOP – nutrition claims, nutrient function claims, other function claims and disease risk reduction claims – substantiation of health claims – regulatory framework – definition of claims as given in Codex Alimentarius guidelines ÿ Supplemented with information from website of regulatory agencies ÿ Only findings for other function claims and disease reduction claims are presented here St ing Br Ind La Ma My Ph Sin Th Vie *T
  • 6. y Status of other function claims - other food components, functional ingredients: permitted in 5 countries Brunei Not permitted Indonesia Yes, in new health claims regulations (dietary fibre, plant sterol/stanols) Lao PDR Not permitted Malaysia Yes, 29 claims for variety of other food components; all petitions from industry; positive list Myanmar Not permitted Philippines Yes, according to Codex; no positive list Singapore 10 claims for collagen, probiotics, prebiotics, plant sterols; positive list Thailand Not permitted* Vietnam Yes, according to Codex; no positive list *Thailand has a positive list of permitted probiotic cultures
  • 7. Status of disease risk-reduction claims : permitted only in 3 countries, for a limited number of nutrients/food components Brunei Not permitted Indonesia 7 types of components, positive list Lao PDR Not permitted Malaysia Not permitted Myanmar Not permitted Philippines Yes, according to Codex; no positive list Singapore 5 nutrient/food specific claims, positive list Thailand Not permitted Vietnam Not permitted Po Bru Ind La Ma My Ph Sin Th Vie
  • 8. Positive list of permitted health claims: yes in 3 countries Brunei NA Indonesia http://www.pom.go.id/search/query2.asp?qs_materi=t_hukum Perundangan&qs_search=pengawasan+klaim&qs_TX=1 Lao PDR NA Malaysia Yes, listed in Guide to Nutrition Labelling and Claims (as at December 2010); http://fsq.moh.gov.my/v4/index.php/component/k2/item/460 Myanmar NA Philippines Only for probiotic as food supplement Singapore Yes, listed on AVA website: http://www.ava.gov.sg/FoodSector/FoodLabelingAdvertisemen t/ Thailand Positive list of permitted probiotics Vietnam NA
  • 9. ÿ There are no harmonised health claims regulations in SEAsian countries ÿ There are significant differences v other function claims permitted in 5 countries – Indonesia, Malaysia, Philippines, Singapore, Vietnam – relate to several bioactive components eg several dietary fibres and non-digestible oligosaccharides, plant sterols, PUFAs v Disease risk reduction claims are considered higher level claims and are permitted only in 3 countries – Indonesia, Philippines and Singapore – and only for a few nutrients or bioactive compounds or food
  • 10. am vel s Regulatory framework for review of health claims in SEAsia ….. Indonesia, Malaysia, Singapore,
  • 11. ÿ Regulatory system related to claims differ considerably v 3 countries adopt a positive-list approach v claims not on the listed are not permitted, but industry may apply on a case-by –case basis v approval based on scientific substantiation of proposed claim ÿ Each claim has to be accompanied by scientific substantiation which will be reviewed by a panel of experts appointed by the regulatory agency v Experts from various agencies and expertise
  • 12. d s ÿ Examples of expert committees v National Agency for Drug and Food Control, Indonesia v Expert Group on Nutrition, Health Claims and Advertisement – Food Safety & Quality Division, MOH Malaysia; meet every month to review applications and other regulatory matters v Advisory Committee for Evaluation of Health Claims – Agri-Food and Veterinary Authority, Singapore v and a variety of approaches by Philippines Food and Drug Administration, Thailand Food and Drug Administration, Vietnam National Institute for Food Control ÿ Similar requirements in the application forms from the 3 countries – Indonesia, Malaysia, Singapore
  • 14. Use application form in Guide Book to assist industry and enforcement officers understand nutritionl labeling and claims regulations Revised December 2010 http://fsq.moh.gov.my/v3/images/filepicker_users/5ec35272cb- 78/Perundangan/Garispanduan/Pelabelan/GuideNutritionLabel.pdf
  • 17. Malaysia - Applying for new health claims – other function claims (Regulation 18E) general principles are same for other countries
  • 18. ÿ For a compound to make a health claim, it must be a permitted “added nutrient” ÿ Regulation 26 of Food Regulations 1985 regulates the use of added nutrients to foods v added nutrients includes any mineral, vitamin, amino acid, fatty acid, nucleotide or other food components which, when added singly or in combination to food, improves the nutritional value of the food v other food components include various non-nutrients or functional ingredients with proven physiological effects beneficial to health ÿ If is not in this list, an application has to be submitted for approval for use prior to application for health claim
  • 21. ÿ Basic information eg v chemical structure and properties and physical properties of the nutrient v stability in the foods serving as vehicles v bioavailability v analytical method v physiological role ÿ Safety evaluation important as it is a novel ingredient ÿ Benefits of adding the nutrient to the food v Provide clear scientific evidence Main information required for new “added nutrient” application
  • 22. ÿ Name the food (s) to which the nutrient is to be added v Preferably, provide a table of the list the foods and indicate the approximate amount that will be added to each of the foods listed ÿ Provide an estimate of the daily intake of the nutrient, eg from various food sources containing the nutrient. Indicate if there is safety concern if this nutrient is added to the foods proposed … new added nutrient application
  • 23. ÿ The basic information required for “added nutrient” application ÿ Propose a minimum level that the nutrient must be present before the function claim can be made v Provide scientific justification why this level is proposed v Usually this is the level at which the nutrient is effective in bringing about the proposed function claim (eg lowering blood cholesterol) Main information required for new health claim application
  • 24. ÿ Provide sound scientific evidences for the claim v All available literature including both positive and negative findings on the proposed claim must be provided v Randomised, placebo-controlled, double-blind human trials v Epidemiological and experimental studies and reviewed papers may be included as supportive evidences v Studies should include those conducted by other organizations or institutions v Result of all these studies should be published in refereed journals v Submit a copy of all the scientific publications cited in this section
  • 26. Examples of some errors/weaknesses in submissions – lessons to be learnt actual examples of dossiers submitted, but products and compounds have been generalised personal opinion & views
  • 27. General errors ÿ Inadequately prepared dossier v too brief description of all required items in form v skimpy information/ data presented ÿ Poorly explained section on substantiation of claims eg v mere listing of publications v summaries of studies should be provided to facilitate expert committee members reviewing the dossier v point out how findings substantiate the claims ÿ Insufficient scientific data to substantiate v Proper literature search to be done v Totality of evidence presented
  • 28. Specific errors/weaknesses ÿ Wordings of the proposed claim do not match the findings of the studies ÿ Publications provided are not relevant to the study ÿ Extrapolated beyond the findings, eg v findings are for a specific aspect of immune function, eg gut immune function v but the proposed claim is: “compound x helps to improve immune function” ÿ Gut immune function is only a specific aspect of immune function v and may not be extrapolated to bring about beneficial effect to overall immune function
  • 29. ÿ The compound used in the study does not match the compound that is the subject of the claim, eg v the claim refers to a specific compound x extracted from a particular plant v but the substance used in the study is an entire aqueous extract of the plant ÿ The plant extract contains compound x as well as many other compounds v beneficial effects cannot be attributed only to compound x
  • 30. m d ÿ The food vehicle for the compound does not match the intended claim, eg v the claim is for a compound x in milk and dairy products v but the studies submitted had used different food matrix, eg soya milk ÿ The claim is only applicable for the food vehicle used in the study v It cannot be ascertained that the compound x is still effective in other matrices ÿ If the claim is intended for different foods, studies should be done using the compound contained in of different matrices, eg beverage, cereals, milk products, etc
  • 31. ÿ Several applications received using studies carried out using “pure” compounds ÿ More like a supplement, consumed with water or a beverage v it cannot be ascertained that the compound is still bioavailable and effective when combined in a food matrix ÿ Studies should be carried out using the compound of interest added to food v The regulation deals with food, not supplements ÿ If the claim is intended for different foods, studies should be done using the compound contained in different matrices ÿ Several novel ingredients have started off as supplements and not yet used in many food products
  • 32. be s ÿ Study compounds include compound x plus other biologically active components v eg to study the prebiotic effect of compound x, other undigestible carbs are also given v eg to study effect of one PUFA, a mixture of PUFAs are given ÿ Findings confounded by other compounds present; beneficial effects obtained cannot be attributed solely to compound x ÿ Study compound characteristics not presented v could be for proprietary reasons v diffcult to be approved because no distinguishing feature(s), not unique to the compound in the claim ÿ A few applications for whole foods v eg nutrient fortified formulations v Similarly, no clear unique characteristics
  • 33. ÿ Study findings extrapolated to general population v eg subjects in the studies were infants v but the claim extrapolated to include older children and teenagers v It cannot be ascertained that the beneficial effect seen in the study subjects will be similarly observed in other age/physiological groups ÿ Inappropriate scientific data cited v eg publications were mostly citing usage of compound x in treatment of subjects v but the application is for improving specific physiological condition in apparently healthy population
  • 34. x al ÿ Wordings for claims bordering on disease reduction v eg lowering blood pressure, prevent constipation, diarrhoea v diseases risk reduction claims not permitted v Claims linked to diseases not permitted
  • 36. ÿ Health claims in place in SEA for a decade v In Malaysia, system started in 2005 v applications still being reviewed by MOH regularly ÿ Concerns with difficulty in preparation and submission of dossiers v Especially smaller companies ÿ Concerns that the requirements for substantiation is too stringent v is there a need for such stringent requirements “for other function claims”? v in view that these are food claims, not drugs
  • 37. ÿ Many Asian functional foods have been used for many years as part of local cultures v no proper documentation of health benefits v what is the best approach to permitting some claims and yet not misleading? v how much evidence is enough? v need to identify all beneficial components? ÿ Framework for health claims only in 3 countries in SEA ÿ Health claims may be permitted in a few other countries, but no clear review system in place v Need for clear transparent framework in all countries v Relevant experts, reviewing applications regularly
  • 38. nd ÿ The series of ILSI SEA Region seminars and workshops will continue to be organised v to facilitate continued sharing of progress, of experience in area of nutrition labeling and claims v including sharing of process for substantiation of claims v Workshop in the afternoon can discuss some of the concerns and issues raised and learnings from this seminar
  • 40. Asian Food Regulation Information Service is the largest database of Asian food regulations in the world – and it’s FREE to use. We publish AFRIS Communiqués, our breaking news service, which keeps our subscribers up-to-date on all the latest regulatory changes across Asia. Are you a global exporter requiring services more international? Check out our AFRIS International Exporter Edition, a magazine style publication covering Australia / New Zealand, Canada, EU and USA. www.asianfoodreg.com admin@asianfoodreg.com