2. Contents
Background of Food Supplement in Indonesia
Food Supplement Regulations
Company Profile
2
Food Supplement Product Registration
Requirements of Food Supplement Registration
3. What is Food Supplement in
Indonesia?
According to the BPOM (National
Agency of Drug and Food Control in
Indonesia), food supplement is
• products that are intended to
supply the nutritional needs,
• maintain, enhance and improve
health functioning,
• contain one or more ingredients
such as vitamins, minerals,
amino acids or other materials
(derived from plant or not plant)
that has nutritional value and /
or physiological effects,
• that are not intended as food.
3
4. Contents
Background of Food Supplement in Indonesia
Food Supplement Regulations
Company Profile
4
Food Supplement Product Registration
Requirements of Food Supplement Registration
5. 5
Food Supplement Regulations
Main regulations issued by the Head of BPOM regarding food
supplements:
• Number 27 Year 2013 : Control of Food and Drug Entry in
to Indonesia
• Number HK.03.1.23.06.10.5166 : Inclusion of Information
of Certain Materials of Origin, Content of Alcohol, and
Expiration Date on the Label of Drug, Food Supplement,
and Food
• Number HK.00.05.41.1381 : Procedures of Food
Supplement Registration
• Number HK.00.05.23.3644 : Provisions of Food
Supplement Control
6. 6
Import Regulations
• BPOM regulations Number 27 Year 2013 regarding The
Control of Food and Drug Entry in to Indonesia, stating
that for all food and drug, includes food supplement
entering Indonesia shall possess:
– Product license
– Fulfill prevailing import law
– Obtain approval from the Head of BPOM for Import
Notification Letter (SKI) that is valid for one-time of
importation.
• There is no formal import barrier on food supplement. The
import duty for food supplement is 10 % plus 10 % VAT.
The rates are lower for 0 - 5 % for products originating in
ASEAN FTA members.
.
7. 7
Halal Certification
• Halal certificate is issued by the Indonesian Council of
Ulama (MUI) based on assessment conducted by the
Assessment Institute for Foods, Drugs, and Cosmetics The
Indonesian Council of Ulama (LPPOM MUI).
• Government bodies responsible for food controlling:
– Ministry of Agriculture for meat and animal based
foods
– National Agency for food and drug control (BPOM) for
food packaged product
• According to the regulations, it is mandatory to have Halal
certification for food supplement, however it has not been
implemented yet until now and planning to be
implemented by the year of 2017 or 2018.
.
8. Contents
Background of Food Supplement in Indonesia
Food Supplement Regulations
Company Profile
8
Food Supplement Product Registration
Requirements of Food Supplement Registration
9. Food Supplement Registration
Overview
• The National Agency of Drug and Food Control (Indonesian
acronym BPOM) is responsible to regulate and control the
registration, distribution, and quality of food supplement.
• All food supplement products shall be registered at BPOM to
obtain registration number of food supplement product to be
able to be distributed legally in Indonesia.
• The food supplement products shall be registered under
Indonesian company, as distributor or agent in Indonesia (it is
not allowed to be registered by foreign company or
individual).
9
10. • The product license is valid for 5 years only under 1 company.
Meaning that after registration, this company will receive
some kind of exclusivity on the products, since this company
holds the product license and without their approval, the
principal or exporter is not able to change the company or
make any registration under the other distributor.
• Food supplement registration in Indonesia takes around 3 - 6
months. The registration lifetime of food supplement is valid
until 5 years as long as it is still meeting the prevailing
provisions and extendable through re-registration of food
supplement product.
10
Food Supplement Registration
Timeframe
11. Products Registered at BPOM
by end of July 2016
11
7 days ago From 201630 days ago
Food & Beverage
Food Supplement
Cosmetics
Traditional Drug Food Supplement
Drug
12. 12
Food Supplement Registration
Process –
Legal Entity Registration
Fill out legal entity
online registration
form
1
Verification process2
Facility inspection to
the office and
warehouse
3
4 5Submit legal entity
documents and
inspection report to
BPOM
Data verification by
BPOM
Returned to be
corrected or
completed
6bUser ID and
password
provided by
email
IncompleteComplete
6a
13. 13
Food Supplement Registration
Process –
Product Registration
Fill out product
online registration
form
1
Submit product
documents to
BPOM
2
Pre-registration
payment to BPOM
3
Verification of
pre-registration
payment
4
Pre-registration
process
Request for
additional data
6bRegistration
payment to
BPOM
6a
5
IncompleteComplete
Verification of
registration
payment
7
Evaluation of
registration
process
8
Product
registration
number issued
Letter
requesting
additional data
Rejection letter
9b
9c
9a
Rejected
Incomplete
Approved
14. Contents
Background of Food Supplement in Indonesia
Food Supplement Regulations
Company Profile
14
Food Supplement Product Registration
Requirements of Food Supplement Registration
15. 15
Registration Requirements –
Company documents
• Article of Association and its’ amendments
• Deed of Establishment and its’ amendments
• Domicile letter
• Tax ID
• Business License – stating food supplement trading
• Company Registration Certificate
• Import License – which covers food supplement product
16. 16
Registration Requirements –
Product Documents
• Letter of Authorization (LoA) – from Principal to Distributor or
Agent, shall be legalized by Indonesian Embassy in the origin
country
• Certificate of Free Sales (CFS) from origin country – legalized by
Indonesian Embassy in the origin country
• Good Manufacturing Procedure (GMP)
• Relationship Letter – if the Principal is different with the
Manufacturer
• Certificate of Analysis of finished product – with detail % of
each ingredients
• Certificate of Analysis of each raw materials
• Safety test certificate from authorized laboratory in Indonesia
• Toxicity test, if the product safety is unknown
17. 17
Registration Requirements –
Labelling
The label should includes points in the following:
• Word : Food Supplement (in Indonesian is “Suplemen Makanan”)
• Product name
• Net weight or net volume
• Name and address of manufacturer or importer
• Indication, direction of use and serving size / dosage
• Composition / ingredients in qualitative and quantitative
• Energy value per serving (in calorie) for energy drink product
• Alcohol content for oral solution, if any
• Expiry date, production code, and registration number
• Contraindication, side effect, and warning, if any
• Other information related to safety or quality or source of material
according to the provisions
• Label shall be mentioned in Bahasa Indonesia language.
18. Contents
Background of Food Supplement in Indonesia
Food Supplement Regulations
Company Profile
18
Food Supplement Product Registration
Requirements of Food Supplement Registration
19. 19
Our Vision
To be leading consulting firm of business services
to clients expanding and operating in Indonesia.
Our Mission
To provide full-range of market-entry and
corporate services to enable our clients to focus
on their core business and activities in Indonesia
and beyond.
PT. Cekindo Bisnis Grup is a
leading consulting firm of
Market-Entry and Corporate
secretarial services to clients
expanding and operating in
Indonesia and further to
Southeast Asia.
Our Values
Client-focused
Excellence performance
Knowledgable locally
Integrity moral
Normative operations standards
Delivered on-time
One stop services provider
Company Profile
20. 20
Our main services:
Business Set
Up
Business
Process
Outsourcing
Local
Representation
Company
Registration
License & Product
Registration
Market Research
& Analysis
Local Partner
Selection
Trade Mission
Land & Property
Ownership
Recruitment & HR
Establishment
Payroll
Management
Accounting & Tax
Reporting
Visa & Work
Permit
Mystery Shopping
Local Distributor
& Partner
Buying Agent
Office Space
Cekindo Services
21. 21
Senior Advisor
Prof. Dr. Rahardi Ramelan
Relevant Experience
Mr. Ramelan is currently Senior Advisor at PT Cekindo Bisnis Grup. Hi is a Research Professor at the Agency for the
Assessment and Application of Technology. The honorary degree of Doctor Honoris Causa from Monash
University, Australia and Northeastern University Boston.
Minister of State for Research and Technology of the Republic of
Indonesia and Chairman of the Agency for Assessment and Application of
Technology (BPPT) in the Seventh Development Cabinet of the Republic
of Indonesia.
Minister of Industry and Trade in the Development Reforms Cabinet of
the Republic of Indonesia and Chairman of National Logistic Agency.
Deputy Chairman for Industrial Analysis and Vice Chairman of the
National Development Planning Agency of the Republic of Indonesia
Several management positions and responsibilities related to Indonesian
Aviation industry, the Weapon industry.
Prof. Dr. Rahardi Ramelan
Profile Overview
22. 22
Principal Consultant
Michal Wasserbauer
Michal is currently Principal Consultant at PT Cekindo Bisnis Grup. He has more than 5 year‘s experience in the
Corporate Market research, Strategy and Evaluation Expansions, Business Consultancy, and Preparation of
Business Feasibility Studies. He has worked for various industries, namely Grocery and Marchandise Retail,
Energy, Medical Device, Heavy and Automation Industries.
+6281282300584 | michal.wasserbauer@cekindo.com
Michal Wasserbauer
Market opportunities valuation
Investment analysis
Performance management
Feasibility studies
Strategy planning
Stakeholder management
Marketing consultancy
Profile Overview
Relevant Experience
Relevant Skills
Multinational grocery and general merchandise retailer: Capital
Investment Appraisals
World‘s largest student and recent graduates-run organisation:
Financial Controller
International consultation company: Market Expansion Consultant
23. 23
Principal Consultant
Nurmia Agustina
Nurmia is currently Principal Consultant at PT Cekindo Bisnis Grup. She has wide experience in the areas of Business
Development, Legal Corporate Restrictions, Business Consulting, Project Management, Market Development &
Entry Strategy, Sales & Distribution, Management Strategy, Recruitment, Visa & Work Permit, and Change
Management. She has worked for various industries, namely Energy & Resources, Telecommunication, Retail,
Pharmaceutical & Medical, Financing, Non-Profit, IT and Heavy Industries.
+628119691987 | nurmia.agustina@cekindo.com
International Management company: Management & Legal
consultant
Chamber of Commercial: Head of Business Processing Section
Nurmia Dwi Agustina
Corporate law
Outsourcing processes
Company formation
Acquisitions
Project Management
Competitive Analysis
Business Planning
Risk Management
Talent Management Strategy
Recruitment
Visa & Work Permit
Change Management
Relevant Experience
Relevant Skills
Profile Overview
25. PT. Cekindo Bisnis Grup
Menara BCA Grand Indonesia 50th floor
Jl. MH. Thamrin No. 1
Jakarta Pusat - 10310
Indonesia
info@cekindo.com
+6221 80660999
Hinweis der Redaktion
Multinational grocery and general merchandise retailer: Capital Investment Appraisals
Performed a position of Senior Capital Investment Specialist for Czech & Slovak with key responsibilities for Capex, appraisals of new store openings, reconstructions, market opportunities valuation, long-term planning, financial performace strategy and performance evaluation, and financial reporting to Financial Director for Czech Republic & Slovak Republic.
World‘s largest student and recent graduates-run organisation: Financial Controller
As Vice President for Finance and member of Executive Board, responsible for managing the financial team. Ensuring financial stability and financial legality of all local entities in the Czech Republic, includes budgeting, controlling, financial education, coaching and mentoring. Implementing measurable performance indicators such as competencies and KPIs.
International consultation company: Market Expansion Consultant
Provided marketing consultancy and advisory for foreign companies with goal to expand to Indonesia. Delivered feasibility studies for energy, medical device, retail, heavy and automation industries. Assisted in establishment of the local and international company related to legal and bureaucracy requirements as well as outsourcing of supporting processes for foreign companies.
International Management company: Management & Legal consultant
Responsible in designing, developing, and implementing of strategies for market expansions, Project management, Develop communication and legal plan and program, support the organization alignment from current to new leagl and business process, conduct value chain mapping of prioritized businesses and alalyze.
Chamber of Commercial: Head of Business Processing Section
Responsible for business processing section, assisting European companies in their expansion legal process in Indonesia, holds position of the honorary Vice-President for the Asian market in the Portuguese Association Expandia.
She has worked for various industries, namely Energy & Resources, Telecommunication, Retail, Pharmaceutical & Medical, Financial Services, Non-Profit, IT and Heavy Industries.