Food Safety Hygene Monitoring

12/3/2010
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SAFETY ASSESSMENT OF CHEMICALS
(FOOD ADDITIVES AND
CONTAMINANTS) IN FOODCONTAMINANTS) IN FOOD
Jakarta, 9 Desember 2010
Jakarta, 9 Desember 2010
SAFETY ASSESSMENT OF CHEMICALS
(FOOD ADDITIVES AND
CONTAMINANTS) IN FOOD
Nuri Andarwulan
SEAFAST Center, IPB
Southeast Asian Food & Agr. Sci & Tech Center
Departemen Ilmu dan Teknologi Pangan, IPB
12/3/2010
nuri@seafast.org
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Agenda
• Chemicals in Food
• Risk Analysis
• Current Research on Risk Assessments of
Chemicals in Food
3
CHEMICALS IN FOOD
1.Food additives
2.Pesticides
3.Veterinary Drug Residue
4 Ct i t4.Contaminants
WHO, 2009
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FOOD ADDITIVESFOOD ADDITIVES
• A food additive may be a single
chemical substance achemical substance, a
manufactured chemical mixture
or a natural product.
• Those that are added directly to
a food to accomplish a technicala food to accomplish a technical
effect (e.g. a preservative or
colour).
PESTICIDES
• any substance or mixture of substances intended for
preventing, destroying or controlling any pest, including
vectors of human or animal disease, unwanted species of
plants or animals causing harm during or otherwise
interfering with the production, processing, storage,
transport or marketing of food, agricultural commodities,
wood and wood products or animal feedstuffs, or
substances which may be administered to animals for the
control of insects, arachnids or other pests in or on their
bodies.
• The term includes substances intended for use as a plant
h l dfli di fgrowth regulator, defoliant, desiccant or agent for
thinning fruit or preventing the premature fall of fruit.
• Also used as substances applied to crops either before or
after harvest to protect the commodity from deterioration
during storage and transport.
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VETERINARY DRUG RESIDUESVETERINARY DRUG RESIDUES
• Veterinary drugs cover a broad range of
chemical structures and usually undergo
metabolism after administration to an
animal.
• Modes of administration include injection,
implantation, dermal application by spray or
pour‐on, and inclusion in feed or water, all
of which may result in different rates ofof which may result in different rates of
absorption, with possible differences in the
tissue distribution and nature of the
residues.
CONTAMINANTS
• Contaminants in the diet may
include:
– environmental pollutants, such as
heavy metals and industrial chemicals,
– mycotoxins,
– migrants from packaging materials,
– other substances not authorized for
use in food.
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Risk Assessment Risk Management
Policy
based
Science
based
g
•Hazard Identification
•Hazard Characterisation
•Exposure Assessment
•Risk Characterisation
•Risk Evaluation
•Option Assessment
•Option Implementation
•Monitoring & Review
Risk Communication
Interactive exchange
of information and opinions
concerning risks
Hazard vs Risk (Codex, 2009)
●Hazard: A biological, chemical or physical
agent in, or condition of, food with the
potential to cause an adverse health effect.
●Risk: A function of the probability of an
adverse health effect and the severity of ff y f
that effect, consequential to a hazard(s) in
food.
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Chemicals in Food Risk Assessment
• Hazard Identification• Hazard Identification
• Hazard Characterisation
• Exposure Assessment
• combining consumption data and level of food additives
use to estimate the exposure
• Risk Characterisation
• Comparison of exposure with the ADI
The development step of ADI
• Comparison of exposure with the ADI
HAZARD IDENTIFICATION
INFORMASI YANG HARUS DIMILIKI
• Identitas dan sifat‐sifat senyawa ybs
• Rencana aplikasinya dan perkiraan konsumsinya
(intake)
• Stabilitas selama pengolahan dan penyimpanan
• Metode analisis dari:
• Senyawa ybs
• Hasil samping (impurities)
• Hasil degradasi
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IDENTITAS DAN SIFAT BTP/KONTAMINAN
• Nama kimia, nama trivial, IUPAC, CAS‐No.
• Struktur kimia, rumus kimia, BM
• Komposisi, kemurnian, senyawa impurities
• Sifat fisik: titik leleh, BJ, rotasi optis, dll
• Prosedur sintesis:
™ Bahan baku
™ Pelarut, katalis
™ Kondisi sintesis
™ kemurnian
• Stabilitas: pengolahan & penyimpanan
Kemurnian
• o‐toluen sulfonamida (OTS)
• Impurity dari sakarin
• Terbentuk pada proses tertentu
• Diduga menginduksi tumor
• Limit dalam produk 0.0025%
• Penelitian terakhir mengeliminir dugaan tersebut
• 5‐bensil‐3,6‐diokso‐2‐piperazin asam asetat
• Produk siklisasi aspartam
• Limit dalam produk 1.5%
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• To date, JMPR (Joint FAO/WHO Meeting on
Ptiid Rid ) h ltd l th
Kemurnian
Pesticide Residues) has evaluated only the
active ingredients (pure and technical grade)
of pesticide formulations.
• The toxicity of other ingredients of the
formulations—such as solvents, emulsifiers ,
and preservatives— that may occur as
residues in food has not been considered.
• Sifat fisik dan kimia BTP/kontaminan
• Menentukan jumlahnya dalam pangan
METODE ANALISIS
• Menentukan jumlahnya dalam pangan
• Menentukan jumlah senyawa impurities
• Menentukan jumlah senyawa hasil degradasinya
• Bersifat mudah
• Dapat dilakukan di semua laboratorium
• Dapat dilakukan oleh teknisi (bukan ahli)
Bift ifik d kt• Bersifat spesifik dan akurat
• Penting untuk law enforcement
• Menentukan jumlahnya dalam pangan
• Menentukan konsumsinya oleh masyarakat
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Ak li tk
STUDI KEAMANAN
HAZARD CHARACTERIZATION
• Aspek yang paling menentukan
• Bagi produsen BTP yang paling lama dan membutuhkan biaya
• Aspek yang diteliti:
• Uji toksisitas
• Uji karsinogenisitas
• Uji genotoksisitas
• Uji mutagenisitas
• Uji teratogenisitas
• Uji farmakokinetik
• Menggunakan hewan percobaan
• Metodologi sangat menentukan
• Menentukan dosis konsumsi maksimal yang tidak
menyebabkan efek negatif terhadap hewan
percobaan
PENETAPAN NILAI ADI (Acceptable Daily Intake)
•NOAEL (no observable adverse effect level)
•NOEL (no observable effect level)
•Jumlahyang dikonsumsi dalam mg/kg berat badan/hari
•NOAEL dan NOEL
•Ditentukandariuji in vivo dengan hewan yang
memberikan respon paling sensitifmemberikan respon paling sensitif.
• Dosis NOEL: 0 – dosis terukur mg/kg berat badan/hari
• Dosis: 0 untuk antisipasi proses sesuai GMP tanpa
bahan kimia ybs
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•Angka/dosis NOEL digunakan untuk
menentukan ADI
PENETAPAN NILAI ADI (Acceptable Daily Intake)
•Jumlah bahan kimia (mg/kg) yang dapat dikonsumsi oleh
seseorang setiap hari, selama hidupnya, tanpa resiko
menimbulkan efek negatif terhadap kesehatan
•ADI = 1/100 x NOEL
•100 = faktor keamanan ekstrapolasi hewan percobaan ke•100 = faktor keamanan, ekstrapolasi hewan percobaan ke
manusia (uncertainty factor)
Exposure Assessment
Level of food additive use x Level of consumption
FFQFFQ
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• Jenis makanan, tergantung sifat fisik & kimia
• Aspartam
RENCANA APLIKASI DAN INTAKE
Aspartam
• Jumlah yang ditambahkan
• Jumlah impurities yang terkonsumsi
• BTP tetap dapat berfungsi selama shelf‐life produk tsb.
• Perkiraan intake (konsumsi)
• Average consumer vs high consumer
• Digunakan untuk menghitung EDI (estimated daily intake)
Stepwise approach to obtaining realistic dietary
exposure assessments
Stepwise approach to obtaining realistic dietary
exposure assessments
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• EDI (estimated daily intake)
(t f fd d dil) (tti f dditi i fd)
RISK CHARACTERIZATION
• (amount of food consumed daily) x (concentration of additive in food)
• EDI = concentration (C) x intake (I)
• Sum of all sources of additive/contaminant in food and non food
• Unique number for each direct additive/contaminant
• The sum of EDIs for an additive from all sources cannot
exceed the RfD/ADI
• Reference Dose (RfD)( )
• An estimate (with uncertainty spanning perhaps an order of magnitude) of
a daily oral exposure to the human population (including sensitive
subgroups) that is likely to be without an appreciable risk of deleterious
effects during lifetime)
• Can be derived from NOAEL or benchmark dose
CURRENT RESEARCH ON RISK
ASSESSMENT OF CHEMICALS IN FOOD
• Food additives:Food additives:
– Tartrazine
– Glutamic Acid (MSG)
– Cyclamate
– Benzoate
• Pesticide residue in vegetables
• Contaminant: heavy metals
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Priority of Food Additive Exposure
Assessment (CAC, 1989)
1. Level of usage is quite high
2. present in food products which are consumed
by most population
3. ADI value is low  
Not priority:py
– ADI: not specified
– Maximum level of usage: GMP
Asam sitrat
9.97%
i
The use of food additives in food products
(BPOM 2001‐2006)
Na karbonat
5.29%
MSG
5.46%
Tartrazin
9.15%
n=36921
Le s it in
4.54%
Karamel
2.95%
A mm ka rb o n a t
2.53%
Ponceau 4R
2.97%
Biru berlian
4.21%
Kuning FCF
4.86%
Na benzoat
5.22%
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Tartrazine
• E number E102, C.I.19140, or FD&C Yellow 5
• Trisodium (4E)‐5‐oxo‐1‐(4‐sulfonatophenyl)‐4‐
[(4‐sulfonatophenyl)hydrazono]‐3‐
pyrazolecarboxylate
• ADI : 0 – 7.5 mg/kg BW
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Food Products containing tartrazine
(BPOM, 2001‐2006)
mi instan
Susu fermentasi
1.35%
Pangan khusus
2 01%
N = 2887
mi instan
19.50%
Kembang gula
2.01%
Minuman beralkohol
3.57%
Makanan ringan
Buah Olahan
6.37%
es krim
3.98%
19.15%
Minuman ringan
14.96%
Produk bakeri
12.71%
8.42%
300
350
400
m/capita/day)
Level of Food Consumption
370
360
50
100
150
200
250
Chidren
Adolescence
Adult
od consumption (gram
185
0
Type of food
Foo
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Biskuit
types of food containing tartrazine which had
the highest value of mean consumption
Mi in stan
49%Minuman
nonkarbonasi
10%
Minuman
berkarbo nasi
6%
6% Lain -lain
12%
Minuman
serbuk
17%
10%
No. Food product Tartrazine level in food
product (mg/kg)
Maximum limit of tartrazine in food product
according to regulation (mg/kg)
Mean Min ‐ Max Indonesia Codex Europe
1Instant noodle:
‐Before processed
22.50 1 ‐ 100 300 300 ‐
‐After processed 16.77 8.28 ‐ 27.25
Tartrazine Level in Food Products
2 Candies 90.53 5 ‐ 300 300 300 300
3 Carbonated drink 13 10 ‐ 15 70 mg/l (ready‐to‐eat product) 300 100
4Non carbonated
drink
22 10 ‐ 40 70 mg/l (ready‐to‐eat product) 300 100
5Powdered drink 13.30 0.16 ‐ 40 70 mg/l ((ready‐to‐eat product) 300
6Fruity drink, squash 10 4 ‐ 20 70 mg/l ((ready‐to‐eat product) 300 100
7 Syrup 18 4.2 ‐ 33.33 70 mg/l (ready‐to‐eat product) 300 100
8Layer cake 200 200 ‐ 200 300 300 200
9 Biscuit 72.86 10 ‐ 200 300 300 200
10 Bread 11 11 ‐ 11 300 300 200
11 Snacks 88.57 10 ‐ 200 300 300 200
12 Jelly 25.95 5.4 ‐ 84.35 200 500 ‐
13 Jam and jelly 213 200 ‐ 226 200 500 ‐
14 Ice cream 76 10 ‐ 200 100 ‐‐
15 Fermented milk 50.50 1 ‐ 100 18 (come from aroma used) 300 ‐
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Total Exposure of Tartrazine for all respondents
2.5
3
3.5 3.08% (0,23 mg/kg BW/day)
0
0.5
1
1.5
2
%ADI
Type of food
Total Exposure of Tartrazine for each group
5
6
5.90
1
2
3
4
Children
Adolescence
Adult
% ADI
2.33
1.00
0
Type of Foods
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No. Food product Tartrazine level in food
product (mg/kg)
Maximum limit of tartrazine in food product
according to regulation (mg/kg)
Mean Min ‐ Max Indonesia Codex Europe
1Instant noodle:
‐Before processed
22.50 1 ‐ 100 300 300 ‐
‐After processed 16.77 8.28 ‐ 27.25
Tartrazine Level in Food Products
2 Candies 90.53 5 ‐ 300 300 300 300
3 Carbonated drink 13 10 ‐ 15 70 mg/l (ready‐to‐eat product) 300 100
4Non carbonated
drink
22 10 ‐ 40 70 mg/l (ready‐to‐eat product) 300 100
5Powdered drink 13.30 0.16 ‐ 40 70 mg/l ((ready‐to‐eat product) 300
6Fruity drink, squash 10 4 ‐ 20 70 mg/l ((ready‐to‐eat product) 300 100
7 Syrup 18 4.2 ‐ 33.33 70 mg/l (ready‐to‐eat product) 300 100
8Layer cake 200 200 ‐ 200 300 300 200
9 Biscuit 72.86 10 ‐ 200 300 300 200
10 Bread 11 11 ‐ 11 300 300 200
11 Snacks 88.57 10 ‐ 200 300 300 200
12 Jelly 25.95 5.4 ‐ 84.35 200 500 ‐
13 Jam and jelly 213 200 ‐ 226 200 500 ‐
14 Ice cream 76 10 ‐ 200 100 ‐‐
15 Fermented milk 50.50 1 ‐ 100 18 (come from aroma used) 300 ‐
What is glutamate?What is glutamate?
C C
O H
C C
O
L Gl t i AidGl t i Aid C
H2
C
H2HO
C
NH3
C
O
C C
O H
C C
O
L‐Glutamic AcidGlutamic Acid
MW 147
MSG
MW 188
(lt t 147C
H2
C
H2HO
C
NH2
C
O Na
(glutamate= 147,
Na=23,
Water=18)
Na content in MSG= 12.2%
Na content in Salt = 39.3%
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LU  
35
 FLD1 A , Ex=328, Em=530 (BERCA \MSG00003.D)
 1.407
5 .2 4 5
What is glutamate?What is glutamate?
min0 2.5 5 7.5 10 12.5
0
5
10
15
20
25
30
 4.399
  5
 9.346
• MSG determination: as free glutamic acidfree glutamic acid
• Williams ATR and Winfield SA. 1982. Determination of
Monosodium Glutamate in Food using High‐performance Liquid
Chromatography and Fluorescence Detection. Analyst; 107: 1092‐
1094
SAFETY OF MSG
/ ()• ADI = 0 – 120 mg/Kg BW (JECFA)
• Maximum Daily Intake (BW 60 Kg)=
7.2 g/cap/day
• Maximum permitted level = GMP• Maximum permitted level = GMP
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Source of Dietary Free Glutamate
Food Frequency Survey
(Every free GLU containing
food item)
Household Survey
(MSG + Condiments)
*Food cooked
at home
Free Glu Analysis
Total free Glutamate
Itk f  F d
** free Glutamate Analysis
Free Glutamate Intake
from Seasoning
Free GLU from
Raw materials +
Cooking Process
Eat out
(Food services)
Processed
Foods
Intake from Foods
MSG + Condiments
Difficult to know
Glutamate intake in rural:
Glutamate Intake
0.78, 43%
0.71, 39%
0.32,
18%
Glutamate intake in rural:
1.81 g/cap/day
Dish menu cooked at  home
Dish menu prepared out side
Processed foods
SEAFAST Center, 2007
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0,4; 18%
Glutamate intake in urban:
224 g/cap/day
Glutamate Intake
0,95; 42%
,;
Dish menu cooked at home
Di h d t id
2.24 g/cap/day
0,89; 40%
Dish menu prepared out side
Processed foods
SEAFAST Center, 2007
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