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REGULATION OF PROCESSED FOOD IN INDONESIA NATIONAL AGENCY FOR DRUG AND FOOD CONTROL REPUBLIC REGULATION OF PROCESSED FOOD IN INDONESIA NATIONAL AGENCY FOR DRUG AND FOOD CONTROL REPUBLIC OF INDONESIA Drs. Tepy Usia, Apt, M. Phil, Ph. D Director for Food Product Stabdardization Presented at Session on Standard Indonesia-European Business Dialogue Jakarta – November 28 th, 2017 1

The Republic of Indonesia Area : 1. 904. 569 km 2 (5 major islands The Republic of Indonesia Area : 1. 904. 569 km 2 (5 major islands and about 30 smaller groups ) Population : 237, 56 Million More than 400 ethnics as well as languages diversity. Archipelago of 18. 000 islands. Geography: P stretches from 6 08’ north latitude to 11 15’ south latitude and from 94 45’ to 141 05’ east longitude. P It lies between two oceans, the Pacific and the Indian and bridges two continents Asia and Australia 2

NATIONAL AGENCY OF DRUG AND FOOD CONTROL REPUBLIC OF INDONESIA (INDONESIAN FDA) 3 NATIONAL AGENCY OF DRUG AND FOOD CONTROL REPUBLIC OF INDONESIA (INDONESIAN FDA) 3

Vision • Safe Food and Medicine to Improve Public Health and National Competitiveness. Mission Vision • Safe Food and Medicine to Improve Public Health and National Competitiveness. Mission • Intensifying Risk-based Drug and Food Control System to protect public health • Encouraging Self Reliance of Food Business Operators in ensuring Drug and Food Safety and strengthening partnership with stakeholders • Enhancing NADFC institutional capacity. 4

ORGANISATION THE HEAD OF NADFC Permanent Secretary • • Deputy for Therapeutic Products and ORGANISATION THE HEAD OF NADFC Permanent Secretary • • Deputy for Therapeutic Products and Narcotics, Psychotropic and Addictive Substance Control Planning and Financing International Cooperation Legislation and Public Relation General Affairs Deputy for Food Safety and Hazardous Substance Control Deputy for Traditional Medicines, Cosmetics and Complementary Product Control 34 PROVINCIAL OFFICES

Deputy 3 Deputy for Food Safety and Hazardous Substance Control Directorate of Food Product Deputy 3 Deputy for Food Safety and Hazardous Substance Control Directorate of Food Product Standardization Directorate of Food Safety Evaluation Directorate of Food Inspection and Certification Directorate of Food Safety Surveillance and Extension Directorate of Product and Hazadous Substance Control

ORGANISATION ORGANIZATIONAL STRUCTURE DIRECTORATE OF FOOD PRODUCT STANDARDIZATION ORGANISATION ORGANIZATIONAL STRUCTURE DIRECTORATE OF FOOD PRODUCT STANDARDIZATION

THE CONTROL SYSTEM FRAMEWORK GOVERNMENT National Agency for Drug and Food Control Republic of THE CONTROL SYSTEM FRAMEWORK GOVERNMENT National Agency for Drug and Food Control Republic of Indonesia Drug and Food Industry Consumers The control system conducted by the government includes legislation and regulation, standardization, evaluation of safety, efficacy and quality of products before marketing, inspection and investigation, product sampling in the market and laboratory testing, public warning together with law enforcement Producer should have an internal control system for complying with the requirements of the Code of Good Manufacturing Practices to enable early detection of every product deviation of safety and quality standards The control system by consumers or community is through increased awareness and improved knowledge on product safety and quality for the intended purpose NADFC 8

Management Standardization System EVALUATION MONITORING DRAFTING IMPLEMENTATION ADOPTION DISSEMINATION/ SOCIALIZATION Management Standardization System EVALUATION MONITORING DRAFTING IMPLEMENTATION ADOPTION DISSEMINATION/ SOCIALIZATION

Process of developing standard apply Good Regulatory Practices Identify the need of the regulation Process of developing standard apply Good Regulatory Practices Identify the need of the regulation and policy objectives Do the risk assessment (collaboration with expert) Considering the international and regional standard Involve stakeholders (government, food industry, consumer, academia) Notification to WTO (TBT and SPS)

Food (Food Law No. 18/2012) Food shall mean anything originating from biological agriculture, plantation Food (Food Law No. 18/2012) Food shall mean anything originating from biological agriculture, plantation , forestry, fishery, farms and water sources, either processed or unprocessed, designated as food or beverage for human consumption, including food additives, food raw materials and other materials used in the process of preparing, processing and/or making food or beverage. 11

Food Control Infrastructure and Regulatory Framework (FAO/WHO, 2003) 1. Food Legislation 2. Food Control Food Control Infrastructure and Regulatory Framework (FAO/WHO, 2003) 1. Food Legislation 2. Food Control Management (Single Agency System, Multi Agency System, Integrated System) 3. Inspection Activities 4. Laboratory Services 5. Information, Education, Communication and Training • Food Law (Law No. 18/ 2012) • Health (Law No 36/2009) • Consumer Protection Law (Law No. 8/1999) • Government Regulations: No. 69/1999 on Food Labeling and Advertisement • No. 28/2004 on Food Safety, Quality, and Nutrition Integrated Food Safety System in Indonesia Inspection of Food Establishment, Distributor/Retailer, Export/Import Food Testing Laboratories at Related Government Institutions (Including 33 NADFC Provincial Laboratories) Training (i. e. District Food Inspectors), Extension Service for Household Food Industry, Food Star Award and Food Safety Campaign 12

PRE MARKET CONTROL Head of NADFC (MD dan ML) Pre-Market Assessment for Processed Food PRE MARKET CONTROL Head of NADFC (MD dan ML) Pre-Market Assessment for Processed Food (as preventive control) Country Border AGRICULTURE PRODUCTION CORNBEEF POSTHARVEST PRODUCTION FRESH FOOD DIRECT CONSUMPTION RAW MATERIALS PROCESSING Regent/Mayor (P-IRT) PROCESSED FOOD Processed food for trade in retail packaging shall obtain the registration approval letter from NADFC, prior to distribution (based on the processed food safety, quality, and nutrition assessment results) Exempted processed food produced by home industries. Processed food made by home industries shall possess a home industry food production certificate issued by the Local Government.

Food Law No. 18/2012 q Regulate: Ø Food Security Ø Nutrition Ø Food Safety Food Law No. 18/2012 q Regulate: Ø Food Security Ø Nutrition Ø Food Safety Ø Labelling and Advertisement Ø Trade NADFC/BPOM : Processed Foods § Food Sanitation § Food Additives § Genetically Modified Food § Food Irradiation § Food Packaging § Food Quality and Safety Assurance § Halal Assurance for The Required Law

Food Law No. 18/2012 As further application of Food Law No. 8/2012, in 2016 Food Law No. 18/2012 As further application of Food Law No. 8/2012, in 2016 -2017 NADFC is developing 2 (two) Government Regulation drafts : - Government Regulation Draft on Food Safety (Revision of Government Regulation No. 28, 2004) - Government Regulation Draft on Food Labelling and Advertising (Revision of Government Regulation No. 69, 1999)

FOOD LAWS AND REGULATIONS IN INDONESIA - Law No. 8, 1999 on Consumer Protection FOOD LAWS AND REGULATIONS IN INDONESIA - Law No. 8, 1999 on Consumer Protection Law No. 18, 2012 on Foods Law No. 36, 2009 on Health Government Regulation No. 69, 1999 on Food Labeling and Advertisement - Government Regulation No. 28, 2004 on Food Safety, Food Quality and Nutrition - Ministry of Health Regulation No. 033 on Food Additive

Head of NADFC Regulation Related to Foods § § § Head of NADFC Regulation Head of NADFC Regulation Related to Foods § § § Head of NADFC Regulation Year 2013 -2016: Maximum Level of Food Additives (27 Decrees) Head of NADFC Regulation No. 2 Year 2016 on Technical Guideline for Monitoring of Processed Food Advertising Head of NADFC Regulation No. 8 Year 2016 on Food Additive Preparation Requirements Head of NADFC Regulation No. 9 Year 2016 on Reference Nutrition Labelling Head of NADFC Regulation No. 10 Year 2016 on The Use of Enzyme and Enzyme Immobilization Agent as Processing Aids in Food Processing Head of NADFC Regulation No. 13 Year 2016 on Claim and Advertisement Labelling Monitoring in Food Products ed at pd u

Head of NADFC Regulation Related to Foods § § § § Head of NADFC Head of NADFC Regulation Related to Foods § § § § Head of NADFC Regulation No. 14 Year 2016 on Safety and Quality Standards for Alcoholic Beverages Head of NADFC Regulation No. 16 Year 2016 on Microbiological Criteria for Processed Food Head of NADFC Regulation No. 21 Year 2016 on Food Category Head of NADFC Regulation No. 22 Year 2016 on Flavoring Agent Requirements Head of NADFC Regulation No. 23 Year 2016 on No Food Additives Claim in Food Labeling and Advertisement Head of NADFC Regulation No. 24 Year 2016 on Sterilized Commercial Food Product Requirements Head of NADFC Regulation No. 1 Year 2017 on Organic Processed Food Product Control ed at pd u

Direktorat Standardisasi Produk Pangan Gedung F Lantai 3, Jl. Percetakan Negara No. 23, Jakarta Direktorat Standardisasi Produk Pangan Gedung F Lantai 3, Jl. Percetakan Negara No. 23, Jakarta Telp. 021 -42875584, Fax. 021 -42875780 www. standarpangan. pom. go. id