Food Safety in Indonesia and Opportunity to Increase

Food Safety in Indonesia and
Opportunity to Increase Trade
Between Indonesia and Australia
Roy Sparringa
National Agency for Drug and Food Control
Republic of Indonesia
(BPOM)
Presented at
Indonesia Australia Business Week
Jakarta, 18 November 2015
AGENDA
1 Introduction
2 BPOM’s profile
3
Regulation and procedure concerning
processed food and food supplement
4 Closing remarks
2
Indonesia Economy and Competitiveness
• The 16th largest economy (2014)
• GDP grew by 5.6% annually since 2004
• The world’s third fastest growing economy after China and
India over the last 10 years
• GDP contributes to 37% ASEAN GDP
• Home for 40% ASEAN people
Global Competitiveness Index 2014-2015:
• rank 34th out of 144 countries
• improvement in infrastructure and connectivity; the quality
of public and private governance; and government
efficiency
• Food industry contributes 30% of the country’s GDP from
the non-oil manufacturing industry
• 1 million food industries (1% large industry; 99% small
and medium industry)
3
9 Development Agenda in the National Medium
Development Plan 2015-2019
1. To renew the state obligation to protect all people and
provide security to all citizens
2. To affirm the presence of the government through a
clean, effective, democratic, and reliable governance
Vision: Indonesia
as a sovereign,
self-reliant, and
integrated
country based on
mutual
assistance
(‘gotong royong’)
3. To build Indonesia from its periphery by
strengthening the rural areas within the framework of
a unitary state of Indonesia
4. To strengthen the state by reforming the system
through corruption-free dignified, and reliable law
enforcement
5. To improve the Indonesian people and nation’s quality
of life
6. To improve people’s productivity and competitiveness
in the international market
7. To achieve economic self-reliance by triggering the
strategic sectors of the domestic economy
8. To revolutionize the nation character
9. To strengthen the Indonesian diversity and social
restoration
4
Policy Direction and Strategy for Health Development in the
National Medium Term Development Plan 2015-2019
To improve food and drug control by:
1. strengthening risk-based control
2. improving human resources
3. strengthening partnership among stakeholders
4. improving public and private sectors’ capability to
carry out risk-based control
5. improving capacity and innovation of business
operators to boost their products’ competitiveness
6. strengthening capacity and capability in laboratory
testing.
5
Government Regulation No 14/2015 concerning National industry
development masterplan (RIPIN) 2015-2035
Vision: Indonesia as a strong industrial country
Mainstay industry
food
Pharmacy, cosmetics
and medical devices
Textiles, leather,
footwear and
various
transportation
equipment
Information &
communication
technology
Power
plants
Supporting industry
capital goods, components and auxiliary materials, and industry service
Upstream industry
Agro-business Basic metal and non-metallic minerals
Basic chemicals
Basic capitals
Natural resources Human resources
Technology, innovation, creativity
Prerequisites
Infrastructure
Policy and regulation
Financing
6
Segmentation of Indonesian urban population
Urban population, in million people, 2013
Affluent consuming class
Mass consuming class
Aspiring class
Struggling class
Total urban
population
SOURCE: McKinsey Consumer Insights Indonesia 2013
• Urban population of 138 million
• The consuming class is growing by 5 million every year, thus will reach
86 million in 2020
• A subset of 20 million Affluent Consumers is breaking away from the
rest
7
Segmentation of Indonesian rural population
Millions
Millions
60
Consuming
110
Cluster rural
Aspiring
Rest
Struggling
Rural
Cluster rural
SOURCE: McKinsey Consumer Insights Indonesia 2013
• Rural city clusters are emerging around urban centers, and
include an attractive segment of 15 million consuming class
8
Product growth and penetration driven by the
consuming class (McKinsey, 2013)
• Increase in consuming class lead to rising demand for
more convenient, health and wellness food product
• Given the opportunity for industrial food technology
innovation development
9
AGENDA
1 Introduction
2 BPOM’s profile
3
Regulation and procedure concerning
processed food and food supplement
4 Closing remarks
10
CHAIRMAN OF BPOM
Inspectorate
PERMANENT SECRETARY
Organization
chart of BPOM
•
•
•
•
National
Laboratory
of Drug &
Food
Control
DEPUTY FOR THERAPEUTIC
PRODUCTS AND NARCOTICS,
PSYCHOTROPIC AND ADDICTIVE
SUBSTANCES CONTROL
DEPUTY FOR TRADITIONAL
MEDICINES, COSMETIC
AND COMPLEMENTARY
PRODUCT CONTROL
Directorate for:
• Drug and Biological Products
Evaluation
• Therapeutic Products Standardization
• Therapeutic Product and Consumer
Goods Production Control
• Therapeutic Product and Consumer
Goods Distribution Control
• Narcotics, Psychotropic and Addictive
Substance Control
Directorate for:
• Traditional Medicines, Food
Supplemen and Cosmetic Evaluation
• Traditional Medicines, Cosmetic and
Complementary Product Inspection
and Certification
• Traditional Medicines, Cosmetic and
Complementary Product
Standardization
• Indonesia Indigenous Medicines
33 Regional Offices& 8 Pos POM
Bureau of Planning and Financing
Bureau of International Cooperation
Bureau of Legislation & Public Relation
Bureau of General Affairs
Centre of
Drug & Food
Investigation
Centre of
Drug &
Food
Research
Centre of
Drug &
Food
Information
DEPUTY FOR FOOD
SAFETY AND HAZARDOUS
SUBSTANCES CONTROL
Directorate for:
• Food Safety Evaluation
• Food Products Standardization
• Food Products Inspection and
Certification
• Surveilance and Food Safety
Extension
• Product and Hazardous
Substances Control
11
VISION, MISSIONS, and GOALS OF BPOM
2015-2019
Vision
Safe food and drug to
improve public health
and nation
competitiveness
Missions
1. Protecting public health by
strengthening risk-based food and
drug control system
2. Ensuring the resilience of business
operator to provide medicine and
food safety assurance, strengthening
partnerships with stakeholders
3. Improving institutional capacity of
Badan POM
Goals
1. Ensuring safety, efficacy,
and quality of food and
drug to increase public
health
2. Improving food and
medicine competitiveness
nationally and globally
through quality assurance
and innovation.
12
BPOM Policy direction 2015-2019
1
2
3
4
Strengthening risk-based
control system
Improving supervision
and assistance for
business operator
Improving partnership with
other government institutions,
business, and consumer
Strengthening institutional
capacity
Risk management and
partnership approach
Government
Manage risk by considering riskbenefit for the people
Business
Manage risk in the production and
distribution process for public
protection
Public/ consumer
Manage risk to protect themselves,
their family, and the environment
13
Food Control System
Producer control sub
system (e.g. GMP,
HACCP, halal
assurance system)
Government control subsystem (e.g. establish
standard, pre market
evaluation, post market
control)
FOOD
CONTROL
SYSTEM
Consumer control subsystem (e.g. consumer
empowerment, social
punishment)
14
Resources and facilities
• Quality Management System’s certification ISO
9001:2008 (55 units in head office and regional
offices)
• KNAPPP 02:2007 for Research Body
• 3604 permanent employees (2014):
3 Doctor, 316 master, 1333 pharmacist, 744
bachelor, and the rest is diploma or senior high
school graduate
• Accredited laboratories in each office (ISO/IEC
17025: 2005)
• Biomolecular laboratories in 6 provinces
(Banda Aceh, Pontianak, Yogyakarta,
Surabaya, Makassar, and Mataram)
• ASEAN food reference laboratory for food
additives
15
AGENDA
1 Introduction
2 BPOM’s profile
3
Regulation and procedure concerning
processed food and food supplement
4 Closing remarks
16
Ministries/Agencies involved in control and supervision of food
safety from farm to table in Indonesia (GR No 28/2004)
Ministry of Agriculture (MoA),
Ministry of Marine Affairs and Fisheries (MoMAF),
(Art. 4-5, 24, 51)
AGRICULTURE
POSTHARVEST
HANDLING
•
•
•
•
Ministry of Industry (MoI)
Ministry of Trade (MoT)
Ministry of Marine Affairs and Fisheries (MoMAF), and
National Agency for Drug and Food Control (BPOM)
(Art. 6, 14-19, 24, 42, 51)
FRESH FOODS
MANUFACTURING
PROCESSED
FOODS
DIRECT
RAW
CONSUMPTION MATERIALS
Pre market
BPOM (Art. 8 & 45)
Post Market
CONSUMERS
Supervision of local
government and
community by BPOM
(Art. 51)
FRESH FOODS,
PROCESSED
FOODS,
READY TO EAT
FOODS
BPOM, MoI, MoMAF, MoA,
Prov or District Govt.
(Art. 45-47)
RETAIL
FOOD
SERVICE
DISTRIBUTION
MoI, MoMAF, MoA, (Art. 7),
BPOM (Art.45)
Ministry of Health (Art. 9),
District Government (Art. 51)
17
Export and import of food and beverages between
Indonesia and Australia in 2012-2014
1200
1005
USD million
1000
763
800
600
466
400
200
132
176
151
0
2012
2013
Export
2014
year
Import
Source: Ministry of Industry (2015)
18
Technical regulations on registration and
importation *
Chairman of BPOM Regulation on
processed food registration
Chairman of BPOM Regulation on
import
• Num. 3/2013 concerning E-registration
for processed food
• Num. 12/2015 concerning Control
of Drug and Food Importation
• Num. 42/2013 concerning Amendment
of Regulation No 09955 of 2011 on
Processed Food Registration
• Num. 13/2015 concerning Control
of Material Importation for Drug and
Food
• Num. 43/2013 concerning Amendment
of Regulation No 09956 of 2011 on
Procedure for Processed Food
Registration
• Num. 09955/ 2011 concerning
Processed Food Registration
Other technical regulation
• Chairman of BPOM Regulation
Num. 39/2013 concerning Standard
of Public Service
*available in http://jdih.pom.go.id/
• Num. 09956/2011 concerning
Procedure for Processed Food
Registration
19
Processed Food Control by BPOM
Pre market evaluation
Post market control
Administrative and technical
requirements
• Inspection of production
and distribution facilities
• Food sampling and
laboratory testing
• Monitoring on label and
advertisement
(Pre) assessment/
evaluation
Facility audit
Final evaluation
Approval (MD/ ML number,
halal logo)
Law enforcement
• Suspension
• Public warning
• Product recall, removal
• Banned license
• Penalty (imprisonment)/
fine
20
Procedure of electronic registration
for processed food (http://e-reg.pom.go.id/)
Issuance of
Approval
Letter
• Notification of
Approval Letter
Issuance
• Submit hardcopy
of label design &
proof of payment
•Product Data Application
Entry
Submit
•Raw Material
documents
Data Entry
•CoA Entry
•Submit
•Nutrition
hardcopy of
Information
CoA
Data Entry
•Product Claim
Data Entry
•File Upload
Evaluation &
Verification
•Validation
Process
Validation
•Evaluation
of Product
Data &
Label
•Verification
of Product
Data &
Label
• Verification
of Product
Category
Verification
•Issuance of
Instruction-to-Pay
Letter and Billing
ID
•Payment according
to Instruction-toPay Letter
•Application data
automatically sent
for evaluation
Payment
21
Registered Processed Food Imported
from Australia in 2010-August 2015
589
Number of registered product
600
477
500
400
331
311
255
300
236
200
100
0
2010
2011
2012
2013
2014
2015
year
22
Contact for Information and Complaint Access
Regarding Processed Food Registration
Address
Directorate for Food Safety Evaluation
Jl Percetakan Negara 23, B Building 3rd Floor
Jakarta
Phone
+62 21 42800221
Facsimile
+62 21 4245267
Cell phone +62 813 99133 050
Email
[email protected]
[email protected]
23
Procedure for
Registration of
Food Supplement
Pra Registration
Categories
Time Line
Registration Fee
Registration
(Pre Market Evaluation)
•
•
•
•
Document Administration
Data Safety and Efficacy
Document Quality
Labeling
Evaluation)
Rejected
Additional Data
(As Needed)
Approval
Note:
Clinical trial to be conducted in Indonesia shall follow Indonesia regulation (Chairman of
BPOM Regulation No 9/2014 and 13/2014)
24
Contact for Information Regarding Food
Supplement Registration
Address
Phone
Directorate for Traditional Medicines, Food
Supplement and Cosmetic Evaluation
Jl Percetakan Negara 23, B Building 2nd Floor
Jakarta
+62 21 4244691 (ext. 1053)
Email
[email protected]
25
Imported processed food control
Document evaluation
• Physical document evaluation for common
importer in order to obtain recommendation for
importation (Surat Keterangan Impor/ SKI)
• The system for food is implemented by BPOM
head office and 21 BPOM regional offices
Paperless evaluation
• Document evaluation through the online system at
http://e-bpom.pom.go.id/ linked to
http://www.insw.go.id/ in one day service
• For most reliable importer in order to obtain SKI
• SKI online for food is applied at BPOM head office
and 13 BPOM regional offices
Physical check and
sampling at the border/
point of entry
For certain food products based on risk analysis,
importer track record, emergency condition, import
alert , suspected for violation
custom clearance for cargo release
26
Online Procedure for Obtaining
SKI via http://e-bpom.pom.go.id/
online
1. Valid for each shipment
2. Online system and single sign on (SSO)
3. Real time evaluation and
recommendation within 24 hours
4. Paperless
Account Registration
e-bpom.pom.go.id
Verification
Notification
email
User
Account
Further information for SKI for food:
Sub directorate for Food Certification
Jl Percetakan Negara 23, B Building 6th Floor
Jakarta 10560
Not Valid/ Not
Complete
Data Completion
Input and upload
importation data /
documents
E-payment
Phone: +62 21 4244691 (ext. 1325)
Email: [email protected]
Further information for SKI for food
supplement:
Directorate for Traditional Medicines,
Cosmetic and Complementary Product
Inspection and Certification
Jl Percetakan Negara 23, B Building 2nd Floor
Jakarta 10560
Phone: +62 21 4244691 (ext. 1044)
Facsimile: +62 21 4207683
Email: [email protected]
[email protected]
Print out
Billing
Payment
billing ID
Payment
Evaluation on Requirements
Payment
Validation
Follow Up
Custom
and
Excise
Recommendation
Not complete / Not
Valid
Evaluation
27
Service of The Issuance of SKI
(Before Deregulation VI)
Pay PNBP
manually &
upload online
[email protected]
Entry data
(online)
Evaluatio
n
Process
Follow Up
Process
SKI/ SKK
(Paperless)
Portal
of
INSW
Recommendati
on
Process
28
Priority Service of The Issuance of SKI
(After Deregulation VI)
Online
PNBP
Pay PNBP
manually &
upload online
[email protected]
Entry data
(online)
Evaluatio
n
Process
Follow Up
Process
Paperless
SKI
Portal
INSW
Recommendati
on
Process
29
Priority Service in the Issuance of
Recommendation for Importation
Service on the issuance of
SKI for food material and food
additive importation through
automatic recommendation
system
Good Importer Record
on Smart Company
Profiling
Risk Based and Fasten
Service for Import Control
Decree of Deputy Chairman for Food Safety and
Hazardous Substance Control No 3832 of 2015
concerning Food Industries to Have Priority
Service in the Issuance of Recommendation for
Importation of Food Material and Food Additives
Food Material Importers :
110 companies
Food Additives Importers :
59 companies
30
Importation Requirements for Food Supplement
1. Shall have
registration
number
2. Shall comply with all regulations
regarding importation (MoT
Regulation No 70/2015 concerning
Importer Identification Number and
MoT Regulation No 87/2015
concerning Importation
Requirements of Certain Products)
3. Shall be
completed with
SKI
31
Processed food import and export between
Indonesia and Australia
SKI issued by BPOM for importation
of processed food from Australia in
2014 (blue bar)-Sep 2015 (red bar)
Volume of processed food Exportation
to Australia (in USD) in 2013 (blue bar),
2014 (red bar) and 2015 (grey bar)
COCOA PRODUCTS
CHEESE
FLAVOURING AGENT
MILK PRODUCTS
PASTA
WINE
SOFT DRINKS
ALCOHOLIC BEVEREGES
CEREAL
BEEF PRODUCTS
FLOUR
WHEY POWDER
ADDITIVES
MARGARINE
SOY OIL
NUTS PRODUCTS
ICE CREAM
SHORTENING
BEVERAGES
INSTANT NOODLE
FLAVOUR ENHANCER
COOKIES
BOTTLED DRINKING WATER
TEA
SWEETENER
SNACKS
FROZEN FRUIT
COFFEE
CANDY
0
500
1000
1500
Number of SKI issued
0
5000000 10000000 15000000
Volume (USD)
32
AGENDA
1 Introduction
2 BPOM’s profile
3
Regulation and procedure concerning
processed food and food supplement
4 Closing remarks
33
Closing remarks
• Indonesia is always a lucrative and attractive market
for food. The food trade is challenged by ASEANAustralia-New Zealand Free Trade Area as well as
the shortcoming ASEAN Economic Community
(AEC).
• BPOM work is focused on the highest public health
protection and support a fair trade of the consumer
products, including processed food and food
supplement.
• In conducting its functions, BPOM emphasizes strong
partnership with stakeholders (government, private
sector, academia, and consumer)
34
Thank you
Terima kasih
35
36