Professional Documents
Culture Documents
2.The so-called 'Risk Reduction Claims' on reducing a risk factor in the development of a disease.
For example: "Plant stanol esters have been shown to reduce blood cholesterol. Blood cholesterol
is a risk factor in the development of coronary heart disease"
3.Health 'Claims referring to children's development' For example: "Vitamin D is needed for the
normal growth and development of bone in children”
EXAMPLE – VITAMIN D
Food supplement Medicine
Vitamin D contributes to: To supplement vitamin D
normal absorption/use of calcium and In intensive growing stages
phosphate,
During pregnancy
to maintain optimal blood calcium levels,
to maintain healthy bone structure, In some diseases
to maintain healthy muscle function, To prevent Vitamin D insufficiency
to maintain healthy teeth, To the complementary treatment of age-
related osteomalacia and osteoporosis
normal functioning of the immune system.
POSSIBLE
INGREDIENTS
Vitamins
Minerals
Amino acids
Enzymes
Probiotics
Essential fatty acids
Fibre
Plant and herbal extracts
VITAMINS AND
MINERALS
MARKET OF FOOD
SUPPLEMENTS
https://ec.europa.eu/food/sites/food/files/safety/docs/labelling_nutrition-supplements-2008_2976_f_wd1_en.pdf
LIMIT OF VITAMINS AND
MINERALS
The levels of intake have been cause of concerns both for being potentially on the low
side but also because of the adverse effects that excessive intakes of certain vitamins and
minerals may cause.
Vitamins and minerals used in food supplements or The setting of maximum levels for vitamins and
added to foods should result in a minimum amount minerals is becoming increasingly a pressing need
being present. Otherwise, the presence of too small for the responsible authorities to ensure that the
amount would not offer any benefit to potential sum of intakes from all sources on the
consumers, namely to supplement the normal diet market should not threaten to undermine
in the case of food supplements, and would be human health
misleading
HOW MUCH IS
TOO MUCH?
We should know:
UL: Tolerable upper intake - The upper safe levels of each vitamin and mineral established by
scientific risk assessment based on generally accepted scientific data, taking into account, as
appropriate, the varying degrees of sensitivity of different consumer groups
For adults, the UL from all sources is established by scientific risk assessment when available. The children’s ULs are
derived from extrapolated values based on reference bodyweights for 4–6-year-old children
MHI: Mean habitual Intake - The intake of vitamins and minerals from all dietary sources (how to
measure this?)
The Mean Highest Intake (MHI) is the 97.5 percentile (P97.5) intake data from food sources (including fortified foods but
excluding food supplements) from male adults or 4–10-year-old male children
RDA: Recommended Daily Allowance - Reference intakes of vitamins and minerals for the
population
https://www.efsa.europa.eu/sites/default/files/assets/UL_Summary_tables.pdf
NATURAL INTAKE
The estimates of intakes are essentially derived through dietary surveys data
and relevant food composition data.
Household surveys record the food purchases of a household for a certain
period of time with estimates of individual intake.
In some cases there may also be information on the extremes of intakes both
the lower and higher levels and on intakes of specific population groups (e.g.
infants, adolescents, elderly).
The Recommended Daily Allowances (RDAs), are based on the principle that
individuals of a population (or a specific population group) should obtain an
adequate nutrient intake to satisfy their requirements. Such recommended
values are generally based on the principle of the average requirement.
These values were mainly determined on the basis of the concept of optimal
nutrition which implied that these values were determined to prevent
deficiencies, to optimise body stores and to reduce the risk of diseases.
INTAKES
Group 2: the “low risk of exceeding the UL”, is a PSI greater than 1.5 for both adults
and children,
Group 3: the “potential risk of excessive intakes”, is a PSI of 1.5 or less.
GROUP 1: NO UPPER LIMIT
https://foodsupplementseurope.org/wp-content/themes/fse-theme/documents/publications-and-guidelines/fseriskmanagement.pdf
CALCULATING MAXIMUM
LEVELS
For vitamins:
For minerals:
https://foodsupplementseurope.org/wp-content/themes/fse-theme/documents/publications-and-guidelines/fseriskmanagement.pdf
GROUP 2: LOW RISK
https://foodsupplementseurope.org/wp-content/themes/fse-theme/documents/publications-and-guidelines/fseriskmanagement.pdf
GROUP 3: POTENTIAL RISK
https://foodsupplementseurope.org/wp-content/themes/fse-theme/documents/publications-and-guidelines/fseriskmanagement.pdf
MINIMUM AMOUNT
Vitamins or minerals may be declared in nutrition labelling, they have to be present
in a significant amount, which, as a rule, is the amount in 100 g or 100 ml of the
food representing 15% of the recommended daily allowance.
For example:
„This is a rich source of vitamin C”. (It is the same for foodstuff, too)
RDA of vitamin C is 80 mg.
80 mg x 15% = 12 mg
There should be at least 12 mg vitamin C in every 100 g/ml.
Here should go some examples of products, but there is so much
difference in the markets of countries, that I can not see the point
of showing some random Hungarian products.
EXAMPLES
AMINO ACIDS
AMINO ACIDS
IN FOOD
SUPPLEMENTS
Essential type – it needs to be included
in our diet
Branched-chain amino acids (BCAA):
leucine, isoleucine, valine
Non-essential type – our body can
synthesize them
Arginine
Proteins
ARGININE
ARGININE
They try to distribute for:
erectile dysfunction (it can be found in many combination
products, too)
contribution to normal spermatogenesis
vasodilating for training and feel „pumped”
However:
These are not scientifically proven! so can not be health
claims
Actually, there are no valid health claims other than
preventing arginine insufficiency
PROTEINS
Main indication: to muscle weight gain, for athletes, vegans, vegetarians
Based on: proteins can help increasing and maintaining healthy muscle weight
Contain: only proteins or mixtures with vitamins and minerals, amino acids etc.
Sources:
milk protein (whey)
egg white
beef
vegetable based
ENZYMES
LACTASE
Use: breaking down lactose may be beneficial to the
health of individuals with symptomatic lactose
maldigestion
Origin: fungi
Kluyveromyces fragilis
Kluyveromyces lactis
Aspergillus niger
Aspergillus oryzae
Can be added directly to foods – see lactose free milk
PROBIOTICS
PRO- AND PREBIOTICS
The terms ‘probiotic’ and ‘ prebiotic’ are health claims themselves.
Stating ‘contains probiotic’ (or similar) on a product is not the same as saying ‘contains ingredient X’.
It is more than just mentioning the product contains bacteria. It implies that the product contains a
substance that may be beneficial for health.
But! Medicines with probiotics have many beneficial effects, and they are effective for
the treatment of acute GIT infections
and to restore bacterial flora after antimicrobial therapy.
Many clinical trials to treat autoimmune diseases.
PRO- AND PREBIOTICS
Can contain:
bacterial strains of Lactobacillus and Bifidobacterium
yeasts such as Saccharomyces boulardii
prebiotics like fructooligosaccharides (FOS) or inulin
Quantitative comparability:
CFU= colony forming units = number of live cells
ESSENTIAL FATTY
ACIDS
LINOLEIC ACID (LA)
AND ALPHA-
LINOLENIC ACID
(ALA)
Structure: Ω-6 and Ω-3 fatty acids
Origin: LA in vegetable oils, nuts, ALA in linseed oil, chia seeds
Authorised health claims:
Essential fatty acids are needed for normal growth and development of children.
BUT: beneficial effect is obtained with a daily intake of 2 g of α-linolenic acid (ALA) and a daily
intake of 10 g of linoleic acid (LA)
POLY UNSATURATED FATTY
ACIDS (PUFAS)
Structure: Ω-3 fatty acids
Origin: seafood, like predatory fish or krill
Problem: predatory fish not only accumulate oil, but other
environmental toxins, too
For instance:
mercury,
dioxins, and
polychlorinated biphenyls
DHA maternal intake contributes to the normal development of the eye of the foetus and
breastfed infants.
with a daily intake of 200 mg of DHA in addition to the recommended daily intake for
omega-3 fatty acids for adults, i.e.: 250 mg DHA and EPA. The claim can be used only for
food which provides a daily intake of at least 200 mg DHA.
FIBRE
FIBRES
Structure: is the portion of plant-derived food (usually
carbohydrates or lignin) that cannot be completely broken down
by human digestive enzymes
Soluble fibres: can swell in water forming viscous mucus
delays gastric emptying which can result in an extended feeling
of fullness
generally fermented in the colon by gut bacteria, and thus have
prebiotic effect
e.g.: beta-glucans (in oats, barley, and mushrooms), psyllium
(nonfermented fibre), pectin
Insoluble fibre:
Coarsely ground insoluble fibre triggers the secretion of mucus
in the large intestine, providing bulking
Finely ground insoluble fibre does not have this effect and can
actually have a constipating effect.
e.g.: wheat bran, cellulose, and lignin
FIBRES – REDUCING BLOOD
CHOLESTEROL
Beta-glucans
contribute to the maintenance of normal blood cholesterol levels
at least 1 g of beta-glucans from oats, oat bran, barley, barley bran, or from mixtures of
these sources per quantified portion
a daily intake of 3 g of beta-glucans from oats, oat bran, barley, barley bran, or from
mixtures of these beta-glucans.
Barley beta-glucans
lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of
coronary heart disease.
daily intake of 3 g of barley beta-glucan. The claim can be used for foods which provide at
least 1 g of barley beta-glucan per quantified portion.
FIBRES – REDUCING BLOOD
SUGAR
Arabinoxylan produced from wheat endosperm
contributes to a reduction of the blood glucose rise after that meals
at least 8 g of arabinoxylan (AX)-rich fibre produced from wheat endosperm (at least 60 %
AX by weight) per 100 g of available carbohydrates in a quantified portion as part of the
meal.
Beta-glucans
Consumption of beta-glucans from oats or barley as part of a meal contributes to the
reduction of the blood glucose rise after that meal
at least 4 g of beta-glucans from oats or barley for each 30 g of available carbohydrates in a
quantified portion as part of the meal.
FIBRES - DIGESTION
Barley, Oat, Sugar beet grain fibre
contribute to an increase in faecal bulk
at least 6 g of fibre per 100 g or at least 3 g of fibre per 100 kcal
Rye:
Rye fibre contributes to normal bowel function
Wheat bran:
Wheat bran fibre contributes to an acceleration of intestinal transit
contributes to an increase in faecal bulk
a daily intake of at least 10 g of wheat bran fibre.
PECTIN
Pectin
Consumption of pectins with a meal contributes to the reduction of the blood glucose rise after that
meal
Pectins contribute to the maintenance of normal blood cholesterol levels
10 g of pectins per quantified portion
Plants in
dietary All plants
Novel
supplement
foods
Negative
list
PROTECTED PLANTS
Over 38,700 species – including roughly 5,950 species of animals and 32,800
species of plants – are protected by CITES against over-exploitation through
international trade. They are listed in the three CITES Appendices.
NOVEL
FOODS
See next lectures!
Novel Food is defined as food
that had not been consumed to
a significant degree by humans
in the EU before 15 May 1997,
when the first Regulation on
novel food came into force.
NEGATIVE LIST
EFSA’s Compendium of Botanicals
Database of botanicals that are reported to contain naturally occurring substances of
possible concern for human health when present in food
The presence of a substance of concern in a botanical does not necessarily mean that the substance will
also be present in a botanical preparation and, if so, at a dosage that could cause a health concern.
This would depend largely on the plant part used, the preparation method and the conditions of
use. Eg. Poppy seeds are free from alkaloids
The absence of a botanical species from the compendium does not mean the species is devoid of
compounds hazardous to human health.
NEGATIVE LIST
type 1: generally toxic
type 2: can be used in medicines under stricter regulations, controlled dose
etc.
has toxic side effects in the case of overdose or inproper use
needs medical supervision when used
has interactions with other medications
type 3: the indication can not be the maintenance of a healthy condition,
only the treatment of diseases
type 4: limited information about the safety
type 5: psychogenic, hallucinogenic
GENERALLY
TOXIC PLANTS
Just a few examples:
Aconitum sp. – toxic alkaloids
Acorus sp. – toxic essential oil
components
Adonis sp. – toxic cardiac glycosides
Aristolochia sp- toxic aristolochic acid
PLANTS ALLOWED TO
USE IN MEDICINES BUT
NOT IN SUPPLEMENTS
St. John’s Worth
indication: treatment of mild depression – not health
maintenance!
interactions: induce CYP enzymes, can decrease the blood
level of other medications
Bearberry
hepatotoxicity if used chronically
Motherwort
indication: treatment of heart failure
Ivy
indication: treatment of productive cough
Comfrey
side effects: internally carcinogenic, can be used only
externally
PSYCHOACTI
VE PLANTS
Betel palm – piperidin alkaloids
Atropa sp, Datura sp – tropane alkaloids
(toxic anyway)
Ayahuasca – indol alkaloids
Cannabis sp – the oil of the seeds can be
used (THC content 10 mg/kg at
maximum)
Ephedra sp – ephedrine
Erythroxylon coca - cocaine
PLANTS IN FOOD
SUPPLEMENTS AND
MEDICINES
Plants that can be only used in medicines
Plants that can be distributed as both
Vitamins, minerals, enzymes, etc.
Herbal Food
medicines supplements
DIFFERENCE BETWEEN
MEDICINES AND FOOD
SUPPLEMENTS
Herbal medicines Food supplements
Indications: keeping healthy state AND Only can state health claims
treating symptoms, diseases
E.g. „Ginkgo Naturally Supports Brain,
E.g. Ginkgo leaf medicines containing Nervous System and Memory”
the dry extract can be used to improve
the age-related cognitive impairment
(worsening of mental abilities) and
quality of life of adults with mild
dementia
DIFFERENCE BETWEEN
MEDICINES AND FOOD
SUPPLEMENTS
Herbal medicines Food supplements
Must be proven: Health claims are checked, but
safety marketing labels are not
effectiveness Safety and quality are not checked
quality No regulations for herbal preparations.
CASE STUDIES ON THE
QUALITY OF FOOD
SUPPLEMENTS
https://bmcmedicine.biomedcentral.com/articles/10.1186/1741-7015-11-222
45 preparations of 31 different manufacturers have been tested,
containing nominally extracts of one of the following species:
https://www.ncbi.nlm.nih.gov/pubmed/27625778
Formulations:
• Powder
• Capsule
• Tablet
• Liquid extract
• Dried fruit
Preparation of an
aqueous extract
Analysis of anthocyanin
profile by HPLC-DAD
+
Measurement of
anthocyanin content
(mg/100g)
https://www.ncbi.nlm.nih.gov/pubmed/27625778
ANTHOCYANIN PROFILE OF
PREPARATIONS CONTAINING
NOMINALLY CRANBERRIES
Original cranberry
cyanidin
Supplements
peonidin
https://www.ncbi.nlm.nih.gov/pubmed/27625778
RESULTS:
14 preparations (30%) did not contain the labeled Vaccinium extract
The anthocyanin content ranged from 0 (n = 6) to 10704.7 mg / 100g
None of the liquid formulations contained anthocyanins
https://www.ncbi.nlm.nih.gov/pubmed/27625778
„Safe dietary supplement against
hypertension”
Side effects:
collapses, loss of
consciousness
Crataegus monogyna Olea europea
62
https://www.ncbi.nlm.nih.gov/pubmed/24013031
Compounds that are not constituents of any of the indicated plants were also
detected
Fractionation, isolation
reserpine
2. 3. 4.
1.
5. 6. 7.
Donor
Lipid membrane
Acceptor
Judit Müller: Gyógyszerhatóanyagok felszívódásának és szöveti megoszlásának modellezése in vitro nem sejtes módszerekkel (PhD dissertation)
65
Donor side
Absorbance (mAu)
EGb 761
83 compounds
Acceptor side
Absorbance (mAu)
EGb 761
19 compounds
Absorbance (mAu)
12 compounds
Acceptor side
Absorbance (mAu)
Dietary supplement
0 compounds
Hosszú Levente: Gyógynövény kivonatok komponenseinek szövetspecifikus permeabilitás vizsgálata PAMPA módszerekkel
ADULTERATION
1995 WHO: every salt should be iodised (except for kosher salt)
RDA of iodine:
150 ug/day for adult, 220 ug/day for pregnant women, 290 ug/day in lactation
https://ods.od.nih.gov/factsheets/Iodine-HealthProfessional/
FOLIC ACID
Problems to prevent:
neural tube defects during pregnancy
e.g. spina bifida, anencephaly
supplementing pregnant women decreased the incidence by 72%
1998, the U.S. Food and Drug Administration (FDA) began requiring
manufacturers adding 140 ug folic acid/100 g to enriched breads,
cereals, flours, cornmeals, pastas, rice, and other grain products to
reduce the risk of neural tube defects
https://ods.od.nih.gov/search.aspx?zoom_query=folic%20acid
NIACIN
Problems to prevent:
pellagra (amongst the poor eating mainly corn based diet)
RDA of iodine:
14-16 mg/day for adult, 18 mg/day for pregnant women, 17
mg/day during lactation
https://ods.od.nih.gov/factsheets/Niacin-HealthProfessional/#h4
VITAMIN D
Problems to prevent:
rickets
osteoporosis
Vitamin D is fat soluble, thus can be only added to vegetable oils, margarins, milk.
RDA of vitamin D:
highly depends on the country and organization!!!
from 400 IU to 2000 IU for adults
https://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/#h2
PHYTOSTEROLS
Problems to prevent:
high cholesterol level