BPOM-2018-Purwiyatno Hariyadi - TEK BARU PDF

Purwiyatno Hariyadi /dept itp, fateta, ipb /seafast center, ipb Email : phariyadi@apps.ipb.ac.id Blog : phariyadi.staff.ipb.ac.
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Purwiyatno Hariyadi /dept itp, fateta, ipb /seafast center, ipb Email : phariyadi@apps.ipb.ac.id Blog : phariyadi.staff.ipb.ac.id
Kuliah Umum:
Kajian Penggunaan Teknologi Baru di Industri Pangan dan Konsep
Pertahanan Pangan (food defense) di Indonesia
BPOM RI, 12 April 2018
__________________
BAG I:
KAJIAN PENGGUNAAN TEKNOLOGI
BARU DI INDUSTRI PANGAN DI
INDONESIA
Purwiyatno Hariyadi
phariyadi.staff.ipb.ac.id
phariyadi@apps.ipb.ac.id
Teknologi Baru ?
Acuan ttg “Baru” -- Seberapa “baru”?
• The Protein Advisory Group of the United

Nations University (PAG/UNU) – 1972/1983:
• Novel foods were defined as foods not
previously eaten by humans.
• Novel = “Baru”, belum dikenal sebelumnya
Teknologi Baru ?
• Novel foods are defined as foods or food

ingredients that do not have a significant history of
consumption within the EU prior to the 15 May
1997.
• All novel foods are subject to a pre-market safety
assessment in accordance with the Novel Food
Regulation (EC) 258/97.
Teknologi Baru ?
• “Baru”? Produk pangan yang :
1. Teknologi bahan baku baru
• Tek rekayasa genetika?
2. Teknologi baru pengoolahan/pengawetan
• Microwave4.
• Ohmic heating
• High Pressure Processing, dll
3. Ukuran baru ?????
• Teknologi Nano
4. Teknologi IT & lain-lain ?????
• Food Industri 4.0
Pangan Hasil Rekayasa Genetik
PP No 21/2005
Per KBPOM ( HK.03.1.23.03.12.1563/2012) )
Per KBPOM ( HK.03.1.23.03.12.1563/2012) )
Per KBPOM ( HK.03.1.23.03.12.1563/2012):

PEDOMAN PENGKAJIAN KEAMANAN PANGAN
PRODUK REKAYASA GENETIK:
1) Kesepadanan substansial (substantial
equivalence)
2) Perubahan Nilai Gizi ?
3) Perubahan alergenitas?
4) Toksisitas?
5) Pertimbangan Lain-lain?
TEKNOLOGI BARU ? –
.................. KEDEPAN ? ...............
Alternative-Emerging Food Processing
Technologies (FDA/IFT 2000)
http://www.fda.gov/Food/FoodScienceResearch/SafePracticesforFoodProcesses/ucm100158.htm
• Thermal Processing :
• Microwave and Radio Frequency
• Ohmic and Inductive Heating
• Non-Thermal Processing:
• High Pressure Processing
• Pulsed Electric Field
• High Voltage Arc Discharge
• Pulsed Light
• Ultraviolet Light
• Ultrasound
• X-Rays
.................. KEDEPAN ? ...............
http://www.ifst.org/science_technology_
• Non-Thermal Processing: resources/for_food_professionals/
• High Pressure Processing • Food Irradiation

• Pulsed Electric Field • Food Packaging
• High Voltage Arc Discharge • Biotechnology
• Pulsed Light • Omic-Technologies: Nutrigenomic
• Ultraviolet Light • Nano-Technology
• Ultrasound • ...
• X-Rays
.................. KEDEPAN ? ...............
• Ekivalen dengan pemanasan tradisional

• Lebih cepat  High Temperature Short Time
.................. KEDEPAN ? ...............
Pemanasan MICROWAVE (Gel MIKRO)
Questions
of Interest
+/-
Generator Food
Process Description? (Oscilator) Material
Mechanism of Activation? +/-
Critical Factors and
Quantification?
Process deviations?
O-
H H+ +
Organizms of concern? +
+ + +
Indicator organizms ? H H
Ionic
Main reseacrh need ?
-O displacement
“Change of Orientation
Polarization”
TEKNOLOGI BARU ? – Thermal Processing
Questions
of Interest
+/-
Generator Food
Process Description? (Oscilator) Material
Mechanism of Activation? +/-
Critical Factors and
Quantification?
Process deviations?
Organizms of concern?
Indicator organizms ?
Internal Heating
Main reseacrh need ? - keyword: Heating
Questions Technology
of Interest Microwave
Process Description? Well described
Mechanism of Activation? Well described
Critical Factors and Well described
Quantification? Hard to predict cold zone
Process deviations? As in conventional thermal
processing
Organizms of concern? As in conventional thermal
processing
Indicator organizms ? As in conventional thermal
processing
Main reseacrh need ? Prediction of cold zone
and Uniformity of heating
Pemanasan OHMIC
elektroda
BAHAN
Power
S Supply
P = I2R P : laju jumlah panas yang diproduksi

per satuan volume (W.m-3)
P = I2ke-1
E : kekuatan medan listrik (Volt cm-1)
I = keEL-1 ke : konduktivitas listrik (ohm-1/m, S/m)
I : densitas arus listrik (amps/m2)
R : tahanan listrik (ohm-1)
- kecepatan pemanasan tergantung pada nilai ke bahan pangan

- ke bahan pangan =f(kadar air, garam ionik dan asam)
- ke bahan pangan cair >> ke bahan padat
- minyak dan lemak mempunyai nilai ke sangat rendah
Pemanasan MICROWAVE (Gel MIKRO) & OHMIC
Questions Technology
of Interest Microwave Ohmic Heating
Process Description? Well described Well described
Mechanism of Activation? Well described Well described
Critical Factors and Well described Well described
Quantification? Hard to predict cold zone Hard to predict cold zone
Process deviations? As in conventional thermal As in conventional thermal
processing processing
Organizms of concern? As in conventional thermal As in conventional thermal
Indicator organizms ? As in conventional thermal As in conventional thermal
Main reseacrh need ? Prediction of cold zone Prediction of cold zone
and Uniformity of heating
.................. KEDEPAN ? ...............
http://www.ifst.org/science_technology_
• Non-Thermal Processing: resources/for_food_professionals/
• High Pressure Processing • Food Irradiation

• Pulsed Electric Field • Food Packaging
• High Voltage Arc Discharge • Biotechnology
• Pulsed Light • Omic-Technologies: Nutrigenomic
• Ultraviolet Light • Nano-Technology
• Ultrasound • ...
• X-Rays
TEKNOLOGI BARU ? – NonThermal Processing
High Hydrostatic Pressure Processing
(~36000 psi) (~87000 psi)
High Pressure (>600 Mpa) can kill microorganisms by interrupting with

their cellular function without the use of heat that can damage the taste,
texture, and nutritional value of the food.
(~36000 psi) (~87000 psi)
• The "mechanism" of high-pressure based bacteria kill is low energy and

does not promote the formation of new chemical compounds, "radiolytic"
by-products, or free-radicals.
• Vitamins, texture and flavor are basically unchanged.
• Eg. enzymes can remain active in high pressure produced orange juice.
• Pathogens such as salmonella and E.coli

0157:H7 can be effectively destroyed
without changing the fruit juice's fresh,
natural characteristics.
• A pressure exposure of 80,000 psi for 30
seconds can achieve a 3-5 log reduction of
all of the pathogens of concern in fresh juice
Pengolahan Oyster dengan HHP

• Destruction of Vibrio bacteria in raw oysters without destroying the raw
feel and taste of the oyster.
• A pressure of 200 to 300 MPa for 5 to 15 minutes at 25oC inactivate :
· Vibrio parahaemolyticus ATCC 17803,
· Vibrio vulnificus ATCC 27562,
· Vibrio choleare ATCC 14035,
· Vibrio choleare non-O:1 ATCC 14547,
· Vibrio hollisae ATCC 33564
· Vibrio mimicus ATCC 33653
("D. Berlin, D. Herson, D. Hicks, and D. Hoover; Applied and Environmental Microbiology, June 1999“)
Pengolahan Oyster dengan HHP
HHP memudahkan lepasnya

daging dari cangkang:
• Menghemat tenaga kerja
• Meningkatkan mutu daging
Contoh produk dari EU
ULTI / PAMPRYL (Groupe PERNOD-

RICARD) - France freshly squeezed fruit juice
Fresh pressed
Spain –
sliced cooked ham
Contoh produk dari AS
Contoh produk dari AS
Equivalence of alternative technologies
Questions Technology of High Hydrostatic Pressure
of Interest
Process Description? Well described
Mechanism of Activation? Well described
Critical Factors and Well described
Quantification? Proposed Models
Process deviations? Well described
Organizms of concern? Identified
Suggested
Indicator organizms ?
Validation kinetics
Main reseacrh need ? Influence of synergistic processing conditions
Applications for High Pressure Processing are
found in the areas of...
Styrofoam cup subjected to

40,000 psi, fruit pack (with
juice) and sliced ham
subjected to 80,000 psi.
Commercial High-Pressure Processed products
marketed in Japan, Europe and the United States
Guacamole & Salsas

Avomex (Keller, TX)
Jams & Fruit

Toppings
(Japan)
TEKNOLOGI BARU ? – Non/Thermal Processing
Thermally-assisted High Hydrostatic Pressure Processing :
800-1000 MPa,
Prion Inactivation
121-137oC
Sterilization
Pressure
(Mpa)
Tempera- Pressure Products

ture
90°C 700 MPa Main meal entrees, meats, pasta dishes,

most vegetables, sauces, cheese, soups,
stews, flavored milk drinks
80°C 830 MPa Whole potatoes, most vegetables
70°C 1,000 MPa All potato products, all vegetables,

seafood
60°C 1,240 MPa Eggs, milk
Source: Richard S. Meyer, PhD, Washington Farms, Inc.
• TEKNOLOGI NANO. Apa itu?
• Formal Definition of Nanotechnology

(Source: National Nanotechnology Initiative)
Nanotechnology is the understanding and control of

matter at dimensions between approximately 1 and 100
nanometers, where unique phenomena enable novel
applications. Encompassing nanoscale science,
engineering, and technology, nanotechnology involves
imaging, measuring, modeling, and manipulating matter
at this length scale.
• NANO ?
Berasal dari Yunani; yang artinya “kerdil”  kecil
• NANO ?
• NANO ?
- 1 nm = 10-9 m
• NANO: Seberapa kecil ?
1Å= 1 um =
1 mikron 1 mm 1 cm
1 Angstrom
10-1 1 10 102 103 104 105 106 107 108
Nanometer
Skala Nano
10-1 1 10 102 103 104 105 106 107 108
Nanometer
Skala Nano
10-1 1 10 102 103 104 105 106 107 108
Nanometer
Sukrosa :
Skala Nano
10-1 1 10 102 103 104 105 106 107 108
Nanometer
~ 5000 nm
Skala Nano
~8*103 nm
10-1 1 10 102 103 104 105 106 107 108
Nanometer
~ 5000 nm
Skala Nano
~8*103 nm
10-1 1 10 102 103 104 105 106 107 108
Nanometer
Skala Nano
~8*103 nm
10-1 1 10 102 103 104 105 106 107 108
Nanometer
10 nm
10-1 1 10 102 103 104 105 106 107 108
Nanometer
 2 nm  diameter molekul DNA (helix)

 5 nm  diameter molekul insulin
 6 nm  diameter molekul hemoglobin
 10nm  ketebalan dinding sel bakteri gram negatif
 200nm  diameter bakteri terkecil
10 nm
10-1 1 10 102 103 104 105 106 107 108
Nanometer
• Teknologi Susu :
– Misel kasein  50-300 nm
– Protein whey  4-6 nm
– Laktosa  0.5 nm
– Gobula lemak  300 nm
10 nm
10-1 1 10 102 103 104 105 106 107 108
Nanometer
• Teknologi Nano tidak merupakan
teknologi yang sama sekali BARU
• Hanya..
• Perkembangan peralatan dan
instrumentasi telah memungkinkan
perkembangan yg BARU
10 nm
10-1 1 10 102 103 104 105 106 107 108
Nanometer
Microscopy:
• scanning electron,
• transmission electron, and
• atomic force microscopy
10 nm
• NOVELTY: Size matters !
Nano’ is best understood to mean fundamentally different
Skala Makro Skala Nano

Potensi perubahan salah satu (atau lebih)

sifat-sifat : Sifat-sifat baru
(“nano-ness”)
• Optis (warna, transparansi)? atau ini menciptakan
• Elektrik (konduktivitas)? atau partikel atau
bahan yang unik
• Fisik (kekerasan,titik leleh, difusifitas) atau (‘baru’)
• Kimia (reaktivitas, (konstant) laju reaksi)
Skala Makro Skala Nano

Meningkatnya luas
permukaan
64 kubus
1 kubus 8 kubus @ p=l=t=0.25cm
p=l=t=1cm @ p=l=t=0.5cm
A= 6*(0,25*0,25) cm2
A= 6*(0,5*0,5) cm2 A= 0,375 cm2
A= 1,5 cm2
A=6*1cm2
A=6 cm2 A= 8*8 * 0,375 cm2
A= 8 *1,5 cm2 A= 24 cm2
Purwiyatno Hariyadi A=itp, fateta,
/dept 12 ipb cm2 /seafast center, ipb Email : phariyadi@apps.ipb.ac.id Blog : phariyadi.staff.ipb.ac.id
Meningkatnya luas
permukaan
250
Luas Permukaan TOTAL (cm2)

1 kubus
p=l=t=1cm
200
150
100
50
0
A=6*1cm2 0 0.5 1 1.5
A=6 cm2
Sisi kubus (cm)
Meningkatnya luas Meningkatkan reaktivitas?

permukaan
Meningkatnya Meningkatkan Toksisitas?

bioavailabilitas
Dosis efektif lebih kecil Menurunkan dosis toksik?

(LD50 <<)?
Meningkatnya Mempengaruhi ekosistem
kemampuan penetrasi permukaan?
Mempercepat “onset of Toksisitas baru? Karena
action” rute/transport yg berbeda?
Potensi BARU Risiko BARU

Contoh  Nano-ness J. Nanosci. Nanotechnol. 2007, 7, 3048.
Particle number LD50

Copper Toxicity class
(per mg) (mg/kg)
Microscale
44 5610 Nontoxic Class 5
(17 mm)
Nanoscale 10 Moderately toxic
1. 7×10 413
(23.5 nm) Class 3
Ionic Moderately toxic
(0.072 nm) 9. 4×1015 110
Class 3
There is an indication that
nanoparticles interact with
biological systems like molecules. Risiko BARU
Contoh  Nano-ness
• Emas :
• Dalam skala makro (bulk gold)

berwarna kuning (emas)
• Dalam skala nano berwarna merah

Partikel emas (12 nm)
• Zink :
• Dalam skala makro (bulk zink) berwarna

putih dan opaque;
• Zinc nano : transparan
• Karbon :
• Carbon nanotubes : penghantar listrik
• Partikel ZnO ukuran makro:

• Menahan cahaya UV
• Menyebarkan cahaya tampa
• Berwarna putih
• Partikel ZnO ukuran nano

• Menahan cahaya UV
• Tidak menyebarkan cahaya tampak
• Transparan
• Application to sunscreen
• TiO2 : Application to sunscreen
• Silver
http://www.theecologist.org/green_green_living/behind_the_label/340403/behind_the_label_nanosilver.html
• Silver
http://www.sharperimagebest.com/zn021.html
Prinsip Evaluasi Keamanan Pangan:

• Kesepadanan substansial
• Kajian Risiko
KAJIAN RISIKO
Sience  Identifikasi Bahaya
-based  Karakterisasi Bahaya
 Kaijan paparan
 Karakterisasi Risiko
• APLIKASI di INDUSTRI PANGAN?
Contoh aplikasi
• APLIKASI di INDUSTRI PANGAN?
Contoh aplikasi
Akhirnya ….
Lagi-lagi
Apapun bahayanya …
Perlu kajian risiko ……….
KAJIAN RISIKO
Sience  Identifikasi Bahaya
-based  Karakterisasi Bahaya
 Kaijan paparan
 Karakterisasi Risiko
SMART INDUSTRY :
 At the Era of INDUSTRY 4.0 ??
 History of Industrial Revolution
Degree of Complexity
First
Mechanical Loom
1784
1st Revolution
 through introduction
of mechanical
Hunting production facilities
& powered by water and
Gathering steam
Society
 INDUSTRY 1.0
TIME
End of
18th Century
Adapted from www.siemens.com/press

SMART INDUSTRY :
First
Mechanical Loom
1784
2nd Revolution
 through introduction
of mass production
1st Revolution based on the division of
 through introduction labour powered by
of mechanical electrical energy
Hunting production facilities  INDUSTRY 2.0
Gathering steam
Society
 INDUSTRY 1.0
TIME
End of Start of
18th Century 20th Century

SMART INDUSTRY :
First
Mechanical Loom
1784
3rd Revolution
 through Introduction of
electronics and IT for a
further automization of
2nd Revolution production
 through introduction  INDUSTRY 3.0
of mass production
Gathering steam
Society
 INDUSTRY 1.0
TIME
End of Start of Start of
18th Century 20th Century 70ies

SMART INDUSTRY :
4th Revolution
First  Through Cyber-
Mechanical Loom Physical Production
1784 Systems
3rd Revolution  INDUSTRY 4.0
 through Introduction of
electronics and IT for a
further automization of
2nd Revolution production
 through introduction  INDUSTRY 3.0
of mass production
Gathering steam
Society
 INDUSTRY 1.0
TIME
End of Start of Start of Today
18th Century 20th Century 70ies

SMART INDUSTRY :
TIME
End of
18th Century Start of Start of Today
20th Century 70ies
https://en.wikipedia.org/wiki/Industry_4.0
FOOD SAFETY ISSUES
 At Era of Smart Industry?
•MAIN TREND
“MAKE”: Efficiency.
• Batch  continuous processing
• Improving process reliability
• Reducing waste products, and
• MAKE • Effective energy utilization
SAFETY
•1970 •~1980 •~1990 •~2000 •~2010
FOOD SAFETY ISSUES
“SERVICE” :
• 24/7
•MAIN TREND
• Convinience, food
• SERVICE
service
• MAKE • MAKE
SAFETY
•1970 •~1980 •~1990 •~2000 •~2010
FOOD SAFETY ISSUES
“CARE” :
• CARE
•Care
for
•MAIN TREND
• SERVICE
• SERVICE
health
• MAKE • MAKE • MAKE
•Care
for
enviro
SAFETY
•1970 •~1980 •~1990 •~2000 •~2010
nment
Purwiyatno Hariyadi /dept itp, fateta, ipb /seafast center, ipb
•Care
Email : phariyadi@apps.ipb.ac.id Blog : phariyadi.staff.ipb.ac.id
FOOD SAFETY ISSUES • SMART
 At Era of Smart Industry? (personalized,
prescribed)
• CARE • CARE
•MAIN TREND
• SERVICE • SERVICE • SERVICE
• MAKE • MAKE • MAKE • MAKE
SAFETY
•1970 •~1980 •~1990 •~2000 •~2010
prescribed)
1. Product ID
Product has unique ID
(with all necessary
food safety & quality
•MAIN TREND
attribute)
Adapted from evrythng.com
SAFETY
•1970 •~1980 •~1990 •~2000 •~2010
prescribed)
2. Personal ID
1. Product ID
Consumer connect
using smart device
(with all necessary
and social network
•MAIN TREND
login, mobile number

attribute)
or any other ID
SAFETY
•1970 •~1980 •~1990 •~2000 •~2010
prescribed)
2. Personal ID 3. Personalization
1. Product ID
Consumer connect Our smart product profile
using smart device deliver contextual &
(with all necessary
and social network relationship-based web
•MAIN TREND
login, mobile number experiences and capture

attribute)
or any other ID analytics
SAFETY
•1970 •~1980 •~1990 •~2000 •~2010
FOOD SAFETY ISSUES
FOOD SAFETY ISSUES
 for the Millennials ?
FOOD SAFETY ISSUES
FOOD SAFETY ISSUES
How to make information of

“FOOD VALUE” readily :
• Available?
• Readable?
• Retrievable?
• Transferable?
• Communicable?
• SMART?
 able to apply a scientific logic
FOOD SAFETY ISSUES
How to make information of

“FOOD VALUE” readily :
• Available?
• Readable?
• Retrievable?
• Transferable? • Consumer Engagement
• Communicable?
• SMART?
• Tracking & Analytics
 able to apply a scientific logic
FOOD SAFETY ISSUES
evrythng.com
FOOD SAFETY ISSUES
In-Store product engagement (Millennials)

Source: Interactions, Retail Perception Report, Sept. 2014 (evrythng.com)
34% 29% 27%
Make mobile shopping Scan products to get info, Communicate via

lists deals or experiences mobile about products
evrythng.com
FOOD SAFETY ISSUES
AS CLEVER AS AS EASY AS AS IMMEDIATE AS AS INFORMATIVE AS
AS ENTERTAINING
AS SOCIAL AS AS VISUAL AS AS PERSONAL AS
AS
evrythng.com
FOOD SAFETY ISSUES
 Era of SMART “everythings”
So SMART . . .
FOOD SAFETY ISSUES
So SMART . . .
FOOD SAFETY ISSUES
So SMART . . .
FOOD SAFETY ISSUES
Example :
FOOD SAFETY ISSUES
Example :
FOOD SAFETY ISSUES
Example :
RipeSense®
FOOD SAFETY ISSUES
Example :
FOOD SAFETY ISSUES
Example :
FOOD SAFETY ISSUES
Example :
FOOD SAFETY ISSUES
Example :
Keamanan Hasil Tek Baru ??
... Konsep Dasar Peraturan Keamanan Pangan
FSO Food Safety Objectives
Food Safety Objectives (FSO)
FSO
The maximum frequency and/or concentration of a
hazard in a food at the time of consumption that
provides or contributes to the appropriate level of
protection (ALOP).
TUJUAN KEAMANAN PANGAN

Maksimum frekuensi dan/atau maksimum
FSO konsentrasi suatu “bahaya” pada produk pangan
pada saat konsumsi yang akan
memberikan/berkontribusi pada tercapainya
“Tingkat Perlindungan yang tepat” (Appropriate
level of protection, ALOP).
Dalam hal ini FSOs seharusnya ditentukan oleh

pemerintah (Otoritas Keamanan Pangan)
berdasarkan pada pertimbangan ilmiah dan
FSO kepentingan publik (societal considerations);
seperti keamanan, biaya, ketersediaan, dan
toleransi kesesuaian dengan populasi.
 FSO is a measure of safety that a country is

willing to tolerate.
Ho - ΣR + ΣI  FSO
• Dikembangkan/ diusulkan oleh Ditentukan

International Commission on Oleh Pemerintah
Microbiological Specifications for (Otoritas Keamanan
Foods (ICMSF) Pangan) untuk keperluan
memastikan tercapainya
• Diadopsi sebagai model untuk tingkat perlindungan thd
“science-based food safety kesehatan publik
regulation” ~ ALOP
Ho - ΣR + ΣI  FSO
Jumlah/ Food Safety
Tingkat Objective
Awal Tingkat
(starting Reduksi bahaya
Level) pada saat
Penambahan konsumsi
(Increase;
Recontamination
or growth)
Ho - ΣR + ΣI  FSO or PO
Jumlah/ Food Safety
Tingkat Objective Performance
Awal Tingkat Objective
(starting Reduksi bahaya Tingkat
Level) pada saat Bahaya
Penambahan konsumsi pada setiap
(Increase; mata
Recontamination rantai
or growth) pangan
Ho - ΣR + ΣI  FSO or PO
Performance
Objective
Tingkat
Karena rantai pangan bisa berbeda; dari satu negara Bahaya
ke negara lain; juga kondisi sanitasi, kebersihan, dll, pada setiap
maka tingak Ho, ΣR, atau ΣI, pada setiap mata rantai mata
bisa mempunyai PO yang berbeda; tetapi tetap hrs rantai
mencapai PO akhir yang “ekivalen” pangan
 Acuan:
 Acuan: Novel Food Regulation (EC) 258/97.
Categories:
• Foods with a new/modified primary molecular structure
(e.g. Phosphated distarch phosphate)
• Foods from micro-organisms/fungi/algae (e.g. lycopene)
• Foods from plants/animals obtained by traditional
practices but without a history of safe food use (e.g. Noni)
 Acuan: Novel Food Regulation (EC) 258/97.
Categories:
• Foods with a new/modified primary molecular structure
(e.g. Phosphated distarch phosphate)
• Foods from micro-organisms/fungi/algae (e.g. lycopene)
• Foods from plants/animals obtained by traditional
practices but without a history of safe food use (e.g. Noni)
• Foods produced using new food processing
methods (e.g. high pressure processing of
fruit preparations)
Re: Novel Food Regulation (EC) 258/97.
Evaluasi Keamanan Pangan : Kajian Risiko

• Proses untuk menetapkan (i) peluang/kemungkinan dan (ii)
tingkat keparahan terhadap kesehatan yang ditimbulkan oleh
terpaparnya seseorang terhadap suatu jenis bahaya “baru”
tertentu.
• Identifikasi bahaya
• Karakterisasi bahaya
• Kajian paparan
• Karakterisasi Risiko

 Ada bahaya bawaan pangan?,
seberapa besar/konsentrasinya,
penyakit apa yang ditimbulkan
dsb?
 Bagaimana sifat bahaya tersebut dipengaruhi
oleh proses penyajian/pengolahan pangan,
• Identifikasi bahaya ketahanannya terhadap kondisi penyimpanan
• Karakterisasi bahaya tertentu, kemudahan/kesulitan
inaktivasinya/penghilangannya?
• Kajian paparan  Seberapa banyak orang terpapar (dimakan terus
menerus dalam jumlah besar atau jarang sekali
• Karakterisasi Risiko dlm jumlah sedikit)
 Hasil karakterisasi/Risk Estimate: ranking, jumlah
penyakit yang ditimbulkan/100,000 orang, per
100,000 porsi, titik kritis dalam pengolahan
pangan dsb?

 Ada bahaya bawaan pangan?, seberapa
besar/konsentrasinya, penyakit apa yang
ditimbulkan dsb?
 Bagaimana sifat bahaya tersebut
dipengaruhi oleh proses
penyajian/pengolahan pangan,
• Identifikasi bahaya ketahanannya terhadap kondisi
• Karakterisasi bahaya penyimpanan tertentu,
• Kajian paparan kemudahan/kesulitan
• Karakterisasi Risiko inaktivasinya/penghilangannya?
 Seberapa banyak orang terpapar (dimakan terus
menerus dalam jumlah besar atau jarang sekali
dlm jumlah sedikit)

ditimbulkan dsb?
ketahanannya terhadap kondisi penyimpanan
tertentu, kemudahan/kesulitan
• Identifikasi bahaya inaktivasinya/penghilangannya?
• Karakterisasi bahaya  Seberapa banyak orang terpapar

(dimakan terus menerus dalam
• Kajian paparan
jumlah besar atau jarang sekali
• Karakterisasi Risiko dlm jumlah sedikit)?
pangan dsb?

ditimbulkan dsb?
ketahanannya terhadap kondisi penyimpanan
tertentu, kemudahan/kesulitan
• Identifikasi bahaya inaktivasinya/penghilangannya?
 Seberapa banyak orang terpapar (dimakan terus
• Karakterisasi bahaya menerus dalam jumlah besar atau jarang sekali
• Kajian paparan dlm jumlah sedikit)
• Karakterisasi Risiko  Hasil karakterisasi/Risk Estimate:

ranking, jumlah penyakit yang
ditimbulkan/100,000 orang, per
100,000 porsi, titik kritis dalam
pengolahan pangan dsb?
Karakterisasi Risiko/Risk estimatation:

 Karakterisasi risiko atau estimasi risiko tidak
menghasilkan informasi apakah suatu risiko bisa

diterima atau tidak
 Keputusan mengenai akan menerima atau tidak
menerima hasil hasil kajian risiko adalah keputusan
masyarakat (stakeholders: pemerintah (politisi),
konsumen, industri)
 dalam bentuk manajemen risiko
Teknologi Baru
--- ekuivalensi
Teknologi Baru
--- ekuivalensi
Teknologi Baru
--- ekuivalensi
Teknologi Baru
--- ekuivalensi
NACMCF definition of ‘pasteurization’ :.
Any process, treatment, or combination thereof, that is

applied to food to reduce the most resistant
microorganism(s) of public health significance to a level
that is not likely to present a public health risk under
normal conditions of distribution and storage.
NACMCF recommends that regulatory agencies establish a Food Safety

Objective (FSO) and/or a performance standard for food/pathogen
combinations that can be used as the basis for judging equivalency when a
proposed process is evaluated as an alternative to traditional
pasteurization.
Teknologi Baru --- ekuivalensi
NACMCF guidelines to developing a proposed pasteurization
process:
• Conduct a hazard analysis to identify the microorganism(s) of public
health concern for the food.
• Determine the most resistant pathogen of public health concern that is
likely to survive the process.
• Assess the level of inactivation needed. Ideally, this would involve
determining the initial cell numbers and normal variation in concentration
that occurs before pasteurization.
• Consider the impact of the food matrix on pathogen survival.
• Validate the efficacy of the pasteurization process.
• Define the critical limits that need to be met during processing so that the
food will meet the performance standard.
• Define the specific equipment and operating parameters for the proposed
pasteurization process  This may include developing specific Good
Manufacturing Practices (GMPs) in addition to the HACCP system.
Scientific criteria to determine if a process is equivalent to
pasteurization?
= f (food-pathogen combinations).
• Milk  6-log10 reduction of Coxiella burnetii

• Egg (liquid)  8.75-log10 reduction of Salmonella
• Egg (in-shell)  5-log reduction of Salmonella
• Beef (e.g., cooked beef, roast beef, cooked corn beef, and cooked poultry
products)  6.5-log10 reduction of Salmonella
• Pultry  7-log10 reduction of Salmonella.
• Fishery products  6-log10 reduction of L. monocytogenes
• Crabmeat  based on shelf life extension and significantly exceeds a 12-
log10 reduction of type E non-proteolytic C. botulinum
• Juice  5-log10 reduction of the most resistant microorganism of public
health significance
Effect of pressure is very

similar to the effect of
temperature in thermal
processes
Figure. Change in inactivation of Zygosaccharomyces bailii with pressure. Note

that 345 MPa = 50,000 psi. (Enrique Palou, GRA, BSysE Dept., WSU)
• Teknologi Nano (Nanotechnology) :
• Mencakup disain, karakterisasi, produksi dan

aplikasi suatu stuktur (bahan), alat atau sistem
pada skala nano.
• Mencakup kegiatan yang sangat luas lebih

tepat disebut sebagai teknologi-teknologi nano
('nanotechnologies‘).
Terimakasih
...
Purwiyatno Hariyadi:
phariyadi@apps.ipb.ac.id

BPOM-2018-Purwiyatno Hariyadi - TEK BARU PDF

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Purwiyatno Hariyadi /dept itp, fateta, ipb /seafast center, ipb Email : phariyadi@apps.ipb.ac.id Blog : phariyadi.staff.ipb.ac.

• The Protein Advisory Group of the United

• Novel = “Baru”, belum dikenal sebelumnya

• Novel foods are defined as foods or food

Per KBPOM ( HK.03.1.23.03.12.1563/2012) )

Per KBPOM ( HK.03.1.23.03.12.1563/2012) )

Per KBPOM ( HK.03.1.23.03.12.1563/2012):

• High Pressure Processing • Food Irradiation

• Ekivalen dengan pemanasan tradisional

P = I2R P : laju jumlah panas yang diproduksi

- kecepatan pemanasan tergantung pada nilai ke bahan pangan

• High Pressure Processing • Food Irradiation

(~36000 psi) (~87000 psi)

High Pressure (>600 Mpa) can kill microorganisms by interrupting with

(~36000 psi) (~87000 psi)

• The "mechanism" of high-pressure based bacteria kill is low energy and

• Pathogens such as salmonella and E.coli

Pengolahan Oyster dengan HHP

Pengolahan Oyster dengan HHP

HHP memudahkan lepasnya

Contoh produk dari EU

ULTI / PAMPRYL (Groupe PERNOD-

Contoh produk dari AS

Contoh produk dari AS

Organizms of concern? Identified

Styrofoam cup subjected to

Guacamole & Salsas

Jams & Fruit

Tempera- Pressure Products

90°C 700 MPa Main meal entrees, meats, pasta dishes,

70°C 1,000 MPa All potato products, all vegetables,

60°C 1,240 MPa Eggs, milk

Source: Richard S. Meyer, PhD, Washington Farms, Inc.

• Formal Definition of Nanotechnology

Nanotechnology is the understanding and control of

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 2 nm  diameter molekul DNA (helix)

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Skala Makro Skala Nano

Potensi perubahan salah satu (atau lebih)

Skala Makro Skala Nano

Luas Permukaan TOTAL (cm2)

Meningkatnya luas Meningkatkan reaktivitas?

Meningkatnya Meningkatkan Toksisitas?

Dosis efektif lebih kecil Menurunkan dosis toksik?

Potensi BARU Risiko BARU

Contoh  Nano-ness J. Nanosci. Nanotechnol. 2007, 7, 3048.

Particle number LD50

• Dalam skala makro (bulk gold)

• Dalam skala nano berwarna merah

• Dalam skala makro (bulk zink) berwarna

• Partikel ZnO ukuran makro:

• Partikel ZnO ukuran nano

Prinsip Evaluasi Keamanan Pangan: