FOOD ADDITIVES Trend and Safety Issues

FOOD ADDITIVES
Trend and Safety Issues
Dr. Ir. Sukarno, M. Sc.
Departemen Ilmu dan Teknologi Pangan
Fateta IPB
2015
UU PANGAN Nomor 18 Tahun 2012
PANGAN
Segala sesuatu yang berasal dari sumber hayati produk
pertanian, perkebunan, kehutanan, perikanan, peternakan,
perairan, dan air, baik yang diolah maupun tidak diolah
yang diperuntukkan sebagai makanan atau minuman
sebagai konsumsi manusia, termasuk bahan tambahan
pangan, bahan baku paangan, dan bahan lainnya yang
digunakan dalam proses penyiapan, pengolahan, dan/atau
pembuatan makanan atau minuman.
Asas Penyelenggaraan Pangan:
Kedaulat
an
Kemandi
rian
Keadilan
Berkelan
jutan
Azas
Pemerat
aan
Ketahan
an
Keaman
an
Manfaat
Keamanan Pangan:
Kondisi dan upaya yang diperlukan untuk mencegah
pangan dari kemungkinan cemaran biologis, kimia, dan
benda lain yang dapat mengganggu, merugikan, dan
membahayakan kesehatan manusia serta tidak
bertentangan dengan agama, keyakinan, dan budaya
masyarakat sehingga aman untuk dikonsumsi.
Bab VII. Keamanan Pangan
Bagian ke1.
2.
3.
4.
5.
6.
7.
8.
Umum
Sanitasi Pangan
Pengaturan Bahan Tambahan Pangan
Pengaturan Pangan Produk Rekayasa
Genetik
Pengaturan Iradiasi Pangan
Standar Kemasan Pangan
Jaminan Keamanan Pangan dan Mutu
Pangan
Jaminan Produk Halal Bagi yang
Dipersyaratkan
Bab XIV. Penyidikan
Menjelaskan penyidikan dalam tindak pidana di bidang Pangan sesuai
dengan ketentuan peraturan perundangundangan di bidang Hukum
Acara Pidana.
Bab XV
Ketentunan Pidana
Menjelaskan ketentuan pidana bagi pelanggar peraturan perundangan ini
Food Additive atau Bahan
Tambahan Pangan
Definisi FDA:
Zat yang secara sengaja ditambahkan ke
dalam makanan untuk menghasilkan sifat
fungsional tertentu pada makanan baik secara
langsung atau tidak langsung dan menjadi
bagian dari makanan tersebut (termasuk zat
yang digunakan selama produksi,
pengemasan, pengolahan, transportasi,
penyimpanan).
What is a Food Additive?
Sec. 201(s) FFDCA: Definition
IN SHORT


Any substance, that is reasonably expected to
become a component of food as a result of its
intended use,
If such use in not Generally Recognized As Safe
(GRAS)
Food and Drug Law

Sec. 409 Unsafe Food Additives: the use of a food

Sec. 402 Adulterated Food: a food is adulterated…if it

Sec. 301 Prohibited Acts: the introduction or delivery
additive is unsafe, unless that use conforms to a regulation,
notification, or exemption issued by FDA under Sec. 409.
is, or if it contains any food additive that is unsafe.
into interstate commerce of any food that is adulterated or
misbranded.
MOM’S
Apple Pies
Sweetner
Unapproved
Food
Additive
Adulterated Food
Maryland 
Virginia
Interstate Commerce
FDA
Enforcement
Food and Drug Law
[A]
Dave’s
Candy
New antioxidant Antioxidant
“Unapproved”
migrates
FDA
Interstate Commerce
Enforcement
Adulterated Food
Food and Drug Law
Why are food additives regulated?
Unsafe Food Additive = Adulterated Food
Unapproved Food Additive = Unsafe Food Additive
Unapproved Food Additive = Adulterated Food
NATURAL vs SYNTHETIC CHEMICALS




Are natural chemicals safer than synthetic
chemicals?
Which set pose a greater risk?
Which set is more amenable to control and
regulation?
Fundamental concept of toxicology: all
substances can be toxic; it is a matter of DOSE .



Safety is relative and there is no absolute
safety.
Thus there are toxic and non toxic doses
for any substance.
Frequency-response curve: a plot of the
% of individual with specific response as a
function of dose.
Cumulative response-curve
(compounds A and B)
Dose-response curve

TOXICOLOGICAL TERMS
Toxin /Toxicant:
A substance that has been shown to present
some significant degree of possible risk when
consumed in sufficient quantity by humans or
animals.
Natural/Inherent:
Toxicants occur in foods as a result of
biosynthetic origin.

Acute Toxicity

Chronic Toxicity

Sub-chronic feeding test

Maximum tolerated dose (MTD)

No observable adverse effect level (NOAEL)

Acceptable daily intake (ADI)

Lethal dose fifty (LD50)

Tumor dose fifty (TD50)

GRAS


Acute toxicity: toxic response ,often
immediate, induced by single exposure.
The acute toxicity of a substance is
defined by its LD50 / lethal dose that will
kill 50% of a group of exposed animals .

LD50 is also used to
determine the level
of toxicity
LD50 (/Kg
Substance
body weight
200mg
Caffeine
100ng
Botulinum
toxin
40g
Sodium
chloride
LD50
Toxicity Level
≤ 1mg
Extremely Toxic
1-50mg
Highly toxic
50-500mg
>500mg
Moderately toxic
Non Toxic


Chronic toxicity:
Toxic effect that requires some time to
develop, e.g. cancer.
Testing for chronic toxicity involve
continuous feeding of the test substance
to rodents for 20-24 months.

By analogy to LD50, the amount of a
carcinogen required to induce cancer in
50% of a group of exposed animal is
referred to as TD50
Toxicology and Risk
Analysis


Traditional high dose feeding of a few
rats/other rodents.
A safety margin of a 100-fold is usually
applied from the NOAEL (no observable
adverse effect level) to determine safe
dose for man, i.e. the ADI (acceptable
daily intake).
Food Shall be Deemed to be
Adulterated

If it bears or contains any poisonous or
deleterious substance which may render it
injurious to health, but if not an added
substance it will not be adulterated if the
quantity of substance does not ordinarily
render it injurious to health.
Food Shall be Deemed to be
Adulterated

If it bears or contains
any added poisonous or deleterious substance
that is unsafe within the meaning of section
406 FDCA (tolerances for poisonous
ingredients).
 Pesticide residue.
 Unsafe food additive or unsafe new animal
drug.

Food Shall be Deemed to be
Adulterated



Consists in whole or part of any
filthy, putrid, or decomposed
substances, or if it is otherwise unfit
for food.
Prepared, packed or held under
unsanitary conditions.
Others.
Generally Recognized as
Safe (GRAS)

Any substance that is intentionally added to food is a
food additive and is subject to premarket review and
approval by FDA, unless the substance is generally
recognized, among qualified experts, as having been
adequately shown to be safe under the conditions of its
intended use, or unless the use of the substance is
otherwise excluded from the definition of a food
additive.
Food Additive Petition





Chemical composition, substances used in preparation,
etc.
Amount & proposed.
Data that it will have intended effect.
Methods to determine amount of additive in food.
Safety reports.
Food Additive-Safety
Standard

General two-part food additives standard:
Legislative history- whether substance is
hazardous to the health of man or animal.
 Must be “reasonable certainty” that no harm
will result.

The Delaney Clause

Another FDA standard is called the
Delaney cause
This states that any food additive that is shown to
cause cancer in humans or animals may not be
added to food
 GRAS List = substances, such as spices, natural
seasoning, and flavorings, that are considered safe
for human consumption and not regulated as
additives.


The GRAS list currently numbers about 670 items
The Delaney Clause _ Cont.
The Food Additives Amendment –
Delaney Clause:

Asserts that “no additive shall be deemed
to be safe if it is found to induce cancer
when ingested by man or animal, or if it is
found after tests which are appropriate for
the evaluation of the safety of food
additives, to induce cancer in man or
animal …”
Food Additives
Toxicity Testing

NOEL: No-Observed-Effect Level

Highest exposure that does not produce an
adverse effect.
Safety Factor

Safety Factor: used to account for
differences between humans and animals.

Generally, a safety factor of 100 is used to
apply animal test data to man.

May be modified based on subpopulation (e.g.
children where it might be increased).
Apakah Bahan Tambahan Pangan?
Definisi PerMenkes No.722/Menkes/Per/IX/88:
Bahan yang biasanya tidak digunakan sebagai
makanan dan biasanya bukan merupakan ingredien
khas makanan, mempunyai atau tidak mempunyai nilai
gizi, yang dengan sengaja ditambahkan ke dalam
makanan untuk maksud teknologi pada pembuatan,
pengolahan, penyiapan, perlakuan, pengepakan,
pengemasan, penyimpanan atau pengangkutan
makanan untuk menghasilkan suatu komponen atau
mempengaruhi sifat khas makanan tersebut.
Beberapa peraturan pemerintah yang menyangkut
penggunaan BTP pada makanan yaitu:







Peraturan Menteri Kesehatan RI No.329/Menkes/Per/XII/76 tentang
Produksi dan Peredaran Makanan
Peraturan Menteri Kesehatan RI No.79/Menkes/Per/III/78 tentang
Label dan Periklanan Makanan
Keputusan Menteri Kesehatan RI No.23/Menkes/SK/I/78 tentang
Pedoman Cara Produksi Yang Baik Untuk Makanan
Peraturan Menteri Kesehatan RI No.453/Menkes/Per/XI/83 tentang
Bahan-Bahan Berbahaya
Peraturan Menteri Kesehatan Rl No.208/Menkes/Per/IV/85 tentang
Pemanis Buatan
Peraturan Menteri Kesehatan RI No.239/Menkes/Per/V/85 tentang
Zat Warna Tertentu yang dinyatakan Sebagai Bahan Berbahaya
Peraturan Menteri Kesehatan No.722/Menkes/Per/XI/88 tentang
Bahan Tambahan Makanan
Beberapa peraturan pemerintah yang menyangkut
penggunaan BTP pada makanan yaitu:





Keputusan Direktur Jenderal Pengawasan Obat dan Makanan
No.02987/B/SK/XII/90 tentang Pendaftaran Bahan Tambahan
Makanan Tertentu
Keputusan Direktur Jenderal Pengawasan Obat dan Makanan
No.01415/B/SK/IV/91 tentang Tanda Khusus Pewama Makanan
Keputusan Direktur Jenderal Pengawasan Obat dan Makanan
No.02240/B/SK/V1I/91 tentang Pedoman Persyaratan Mutu Serta
Label dan Periklanan Makanan
Keputusan Direktur Jenderal Pengawasan Obat dan Makanan
No.02592/B/SK/V1I1/91 tentang Penggunaan Bahan Tambahan
Makanan
Keputusan Direktur Jenderal Pengawasan Obat dan Makanan
No.02593/B/SK7VI1I/91 tentang Tata Cara Pendaftaran Produsen
dan Produk Bahan Tambahan Makanan
Why Additives

Formulated Foods
>5000 foods in the Grocery Stores that
combine multiple components to give desired
characteristics to the product
 Each component is there for a specific
purpose
 Least cost functionality
 Synergistic effects

Food Ingredients
1. Main ingredients
2. Functional Ingredients:
•
•
Micronutrient ingredients (Vitamins and
minerals)
Non-nutrient ingredients (prebiotics,
polyphenol etc)
3. Food Additives
How are ingredients listed on
the label?

Manufacturers are required
to list all ingredients on the
package label

Product order


Greatest amount to the least
amount
How Ingredients are listed


Description
Use
Bahan Tambahan Pangan (BTP)
 Senyawa (campuran
senyawa) kimia
 Sengaja ditambahkan ke
dalam makanan
 Berperan dalam pengolahan,
pengemasan, penyimpanan
 Bukan bahan (ingredient)
utama
 Bukan kontaminan
Bahan Tambahan Pangan (BTP)
 Menyediakan makanan bagi kelompok khusus
(diabetes, pasca operasi, dll)
 Bukan untuk menyembunyikan penggunaan bahan
yang salah atau tidak memenuhi persyaratan
 Bukan untuk menyembunyikan cara kerja yang
salah
 Bukan untuk menutupi kerusakan makanan
How Additives Are Used

The purpose of additives fall into four
categories
1.
2.
3.
4.
5.
Improve storage properties
Increase healthfulness
Make food more appealing
Improve processing and preparation
Cost-benefit
Improving Processing and
Preparation

Stabilizer, substance that keeps a
compound, mixture, or solution from
changing its form or chemical nature.

Example without stabilizer, the fat in peanut butter
separates from the protein, creating an oil pool
over a stiff paste.

Ice cream is creamy, in part because thickeners prevent
crystals from forming as it freezes and stabilizes.
 Many stabilizers are natural and starch-based.
 Some are made from pectin, casein, sodium
caseinate, and gelatin.
Increasing Healthfulness

Increasing additives is also included in boosting a food’s
nutritional profile.
 Fortification = is adding nutrients that are not normally



found in a food (ex. Milk is fortified with vit. D)
Restoration = nutrients that are lost in processing are
returned to the food with the process called restoration
(reestablishes the product’s original nutritive value ex. Vit.
C is put back into canned oranges)
Enrichment = adding nutrients lost in processing
(contain more nutrients than existed in the food before
processing (ex. Vitamins are increased)
Nitrification = process that adds nutrients to a food with
a low nutrient/kcalorie ratio so the food can replace a
nutritionally balanced meal (nutrition bars and shakes are
examples)
Concerns About Food Additives

Some people believe that some additives
cause “more trouble than they’re worth.”

One concern is not enough is known about
the long-term effects

Example is nitrites which react with amines
(preservative in meat) is suspected of causing
cancer


Nitrites prevent botulism, which the FDA believe will out
way the risks of using them, however the FDA required
them to be used in lower quantities.
DO YOU THINK THERE ARE ANY RISKS IN EATING SO
MANY PROCESSED FOODS?
The Value of Food Additives

Preservatives extend the shelf life of many
foods


Ex. mold inhibitor calcium propionate and BHT are
used in bread to prevent mold (keeping the fat
fresh)
Supporters of food additives say additives
prevent disease caused by malnutrition

Goiter = an enlargement of the thyroid glad
caused by a lack of iodine


This was then added to table salt in 1924
Vit. D was added to milk in the 1930’s to help with
rickets (bone-deforming disease)
Mengapa Produsen Pangan Perlu
Mengetahui BTP?

Penyimpangan atau pelanggaran mengenai
penggunaan BTP yang sering dilakukan oleh
produsen pangan, yaitu:


Menggunakan bahan tambahan yang dilarang
penggunaannya untuk pangan

Menggunakan BTP melebihi dosis yang diizinkan

Adulteration
Produsen pangan perlu mengetahui mengenai sifatsifat dan keamanan penggunaan BTP, serta
mengetahui peraturan-peraturan yang telah
dikeluarkan oleh pemerintah mengenai penggunaan
BTP.
Mengapa Konsumen Pangan Perlu
Mengetahui BTP?

BTP umum digunakan/ditemui oleh masyarakat,
termasuk dalam pangan jajanan.

Pelanggaran penggunaan BTP oleh produsen:




Penyebab pelanggaran:





Menggunakan BT yang terlarang & berbahaya
Menggunakan BTP melebihi dosis yang diizinkan
Adulteration
Faktor
Faktor
Faktor
Faktor
ketidaktahuan
biaya produksi  lebih murah
daya tarik bahan/produk pangan
daya simpan bahan/produk pangan
PENTING! Pengaruh BTP terhadap
keamanan pangan/kesehatan.
Common Additives
Ingredient Type
Purpose
Seen on the Label As
Preservatives
Prevent food spoilage and
slow changes in color,
texture, and flavor
Sodium benzoate, calcium
propionate, sodium
nitrite, potassium sorbate,
BHA, BHT
Flavors and Spices
Add natural and synthetic
flavors
Natural flavoring, artificial
flavor, spices,
Monosodium glutamate
(MSG)
Fat Replacers
Provide mouthfeel, flavor,
and texture to replace the
fat in low-fat or fat-free
foods
Olestra, cellulose gel,
carrageenan. modified
food starch, guar gum,
xanthan gum, whey
protein concentrate
Stabilizers, thickeners,
texturizers
Provide texture and
mouthfeel
Gelatin, pectin, guar gum,
carrageenan, xanthan
gum, whey
Commonly Researched
Additives

Amaranth

Tartrazine

Butylated Hydroxyanisole (BHA)

Sodium Nitrate and Sodium Nitrite
Amaranth

Amaranth is a general term that refers to a whole family
of herbs

The “Hopi Red Dye” was originally used by the Native
American tribe , the Hopi for a deep red dye

Today we know it better as FD&C Red No. 2

Uses

The “Red Scare”
Amaranth

A study was conducted to determine the
possible carcinogenic effects of the color
additive Amaranth
Done with mice
 Mice were given a dose of 200 or 1000 mg/kg
body weight
 Examined the mice gut and feces after given the
dose of amaranth

Study Results
Is Amaranth Safe?

Study Conclusions…


Supported amaranth as a safe additive
Amaranth is considered a non
mutagenic substance
Amaranth


Amaranth is still used in Canada and Europe today.
Despite research studies that support Amaranth as a
safe additive the FDA banned its use in the United
States based on the concept that the additive could
possibly not be safe!
Tartrazine



Also known as FD & C Yellow No. 5, C.I.
No. 19140, and Food Yellow No. 4
Orange/yellow powder that will dissolve
in water
Uses
Tartrazine Study



“Effects of tartrazine on exploratory
behavior in a three-generation toxicity
study in mice”
Study done with mice
Study Results

The levels of tartrazine that where used in
this study did produce a few side-effects on
neurobehavior through the generations of
mice.
Butylated Hydroxyanisole
(BHA)

Uses

Carcinogen or Anti-Carcinogen?
BHA as a Carcinogen

BHA as a carcinogen research…
Study done to determine the relationship
between BHA and bladder cancer and cancer
of the forestomach in mice
 Study to determine BHA carcinogenic effects
in Japanese House Shrews


Study Results
Increased cell growth and cancer in the
forestomach of mice
 Increased cell growth in the lungs

Anti-Carcinogenic Effects of
BHA



When given in large doses BHA may be a
possible anticarcinogen
Still needs more research to confirm the
claim
No definite answer!
BHA


Carcinogen vs. anti-carcinogen
We do not fully understand how BHA
works in both situations!


Still need more research
What can we believe about BHA?
No specific answer
 Currently it is an approved additive that
has been found to be safe by the FDA

Sodium Nitrite & Sodium
Nitrate

Uses


Food safety?


Found in meat and fish
Used as a tool to prevent food spoilage
that causes food born illness
Is sodium nitrite a cause of cancer or
other diseases?
Outcome of the re-evaluation of colours:
Example of Azo dyes
Azo dyes recently re-evaluated by EFSA
Tartrazine (E102)
 Azorubine/Carmoisine (E122)
 Allura Red AC (E129)
Conclusions:
1. The Panel concluded that there was no need to change the previously
established Acceptable Daily Intakes (ADIs)
2. Some children who consume large amounts of food and drink containing
Azorubine/Carmoisine or Allura Red AC could exceed the ADIs for these colours

Quinoline Yellow (E104)
 Sunset Yellow FCF (E110)
 Ponceau 4R (E124)
Conclusions:
1. The ANS Panel has lowered the ADIs (e.g. from 4 mg to 0.7 mg/kg bw/day for
Ponceau 4R)
2. The Panel concluded that exposure to these colours could exceed the new ADIs
for both adults and children

What Does the Research
Say?

There is research available that support
certain additives as a carcinogenic agent
and there are also studies that show some
additives are completely safe and could
also have anti-cancer affects.
Risk Assessment

Hazard identification

Linkage to specific health effects





Illness
Birth or developmental defects
Reproductive abnormalities
Cancer
Dose response assessment



Short term
Life time
No threshold for cancer
Risk Assessment (cont.)

Dose Response (cont)




Exposure Assessment


LOEL – lowest observed level effect
NOAEL –no observed level effect
ADI – acceptable daily level (NOAEL/100 if based on animal studies &
NOAEL/10 of based on human studies
Difficult to assess because of differences in consumer food habits
Risk characterization


Qualitative
Quantitative
Risks Associated with Food Supply (ranked
in order of importance)
Foodborne hazards of microbial origin
Nutritional hazards
Environmental contaminant hazzards
Foodborne hazards of natural origin
Food and color additives
1.
2.
3.
4.
5.

Often perceived by consumers as #1. One reason for this perception
is that they must be proven safe and absolute safety can not be
proven
Allergens _ Hypersensitive Reactions

Hypersensitivity


Allergy


Immunologic mechanisms involved in the pathogenesis
Atopic allergy


A small amount produces systems, can be fatal
Mediated by immunoglobulin E
Intollerance

A small amount of material causes reactions similar to that of an allergen, but
immunologic mechanisms not involved
Allergic Reactions

Anaphylactic (atopic)


Cytotoxic


Rarely caused by food additives; destruction of platelets, causing purpura
Immunocomplex disease


Symptoms appear within minustes and disappear within hours. Urticaria,, allergic
rhinitis, conjunctivitis, darrhea, sever itch)
Immunoglobuline G and M form complexes with the allergen, resulting in
purpura, articaria, arthritis and other symptons
Delayed allergy
-A rash similar to that caused by virus exanthema; granulomatosis
Intollerance

Non-specific histamine liberation


Intestinal diseases


Gluten intolerance causing skin and intestinal disorders
Enzyme deficiency


Fruits, citrus, strawberry, cocoa, etc.
Diarrhea and colic in lactose deficiency
Psychological causes may underlie various
kinds of skin and other reactions
Reactions to Food Additives

Nitrosamine


Histamine and tyramine


Urticaria, headaches, intestinal disorders
Phenylethylamine


Migraines, intestinal symptom
Sodium nitrite


Carcinogenic
Headaches
Sulfur dioxide & sulfites

Asthmatic symptoms; may relate to sulfite oxidase deficiency
Reactions to Food Additives
(cont.)
Azo dyes – BHT, BHA, parabens
Monosodium glutamate
Wine






Delayed sensitivity, manifested as eczema
Histamine releasing action of acetaldehyde
Richness of histamine in certain red and white wines
Benzoate intolerance
Quinine intolerance
Sulfur dioxide intolerance
Benefits

Health benefits



Supply benefits



Prevent spoilage
Provide new sources for desired functions
Hedonic (sensory satisfaction)


Prevent or reduce specific disease
Enhance nutrition
Improve color, flavor and/or texture
Convenience

Time saving during preparation
Faktor yang Mempengaruhi
Kerusakan Pangan
Air (Aw, RH, Kadar Air)
Suhu
Oksigen
pH
Cahaya
Waktu
Gesekan
MUTU
- Mutu Gizi,
- Warna,
- Tekstur,
- Mikroorganisme,
- Dll
Tekanan
Benturan/
stres fisik
Interaksi
eksternal
Katalis
Inhibitor
Interaksi internal
Peranan Aktivitas Air Terhadap Reaksi Kimia
dan Pertumbuhan Mikroba; Contoh
0.0
Zone II
Oksidasi lipid
Zone III
Reaksi
hidrolisis
Reaksi
kecoklatan
non-enzimatis
Moisture
Sorpsi Air
0.1
0.2
0.3
0.4
0.5
0.6
Aktivitas Air
0.7
Kadar Air
Laju Kecepatan Reaksi
Zone I
Kerusakan
0.8Mikrobiologis
0.9 1.0
Teknik Pengawetan Pangan

Pemanasan:











Sterilisasi (low acid foods)
Pasteurisasi (acid/acidified foods)
Hot-filling
Pengeringan (Aw<0.7)
Pengasaman (penurunan pH)
Penggaraman (>6%)
Penambahan gula (>40%)
Pembekuan
Pendinginan
Kombinasi teknik pengawetan
Penambahan pengawet pangan
Penggunaan
Pengawet
dapat
dibatasi
Hindarkan Tubuh Dari Bahaya!!!
(1)
BAHAYA BIOLOGIS
BAHAYA KIMIA
(2)
(3)
Pangan Aman
BAHAYA FISIK
BEBAS BAHAYA
Thank You