Ir. Tetty Helfery Sihombing, MP Director of Food Product Standardization National Agency of Drug and Food Control Indonesia Cambodia, 20 February

Transcription

1 Ir. Tetty Helfery Sihombing, MP Director of Food Product Standardization National Agency of Drug and Food Control Indonesia Cambodia, 20 February 2014

2 OUTLINE 2

3 1. Introduction The availability of standards/regulation is important for the consumer protections and support fair trade. Consequently the quality of standards/regulation is also important. 3

4 1. Introduction (cont.) The benefits of standards/regulation will be test during the implementation stage. Effective implementation of Regulation should starts from the preparation and development steps. 4 Good preparation and development is a strong base for effective implementation of regulations.

5 2. The Importance of Regulation Is there a need for the availability of standards/regulation? Awareness of the importance of regulations need to be built and harmonized among all: Government institutions Food industries Consumers

6 2. The Importance of Regulation (cont.) 1. For Government - Regulations used as tools to carry out consumer protections. 2. For Food industries Regulations used as guidance in producing and marketing innovative and competitive food products. 3. For Consumers Regulations placed as references for the assurance of the safety and quality of food products that will be consumed.

7 2. The Importance of Regulation (cont.) 1. Government Could be in the formed of Food Act, Food law, Government Regulations, Technical regulations, Standards and technical documents.. Tools for inspection, certification, supervision Directing the preparation and strengthened certification body and laboratories, Underline the scope of concern: downstream or manufacturing, national products or import products, or limited to certain commodities. Parties involved.

8 2. The Importance of Regulation (cont.) 2. Food Industry Responsible for safety and quality of the products through out the food chain. Regulations used as benchmark in preparing and implementing of internal control. Also used as guidelines in contributing to the national food safety systems

9 2. The Importance of Regulation (cont.) 3. Consumer The availability of regulations assure consumers of the effort in assuring consumer s protection. NADFC Indonesia, Cambodia 2014

10 People will find the importance of regulations when: Meets the needs (government, industry and consumer) Prepared in time Implemented There are evaluations and monitoring of implementation.

11 3. GOOD REGULATORY PRACTICES ASEAN GOOD REGULATORY PRACTICE (GRP) GUIDE (2009)

12 When deciding to regulate, the regulator needs to consider how regulation is prepared, adopted and reviewed so that it will be effective over time.

13 Principle of Good Regulatory Practices 1. serve clearly identified policy objectives, and be effective in achieving those objectives; 2. have a sound legal and empirical basis; 3. produce benefits that justify costs, considering the distribution of effects across society and taking economic, environmental and social effects into account; 4. minimise costs and market distortions; 5. be clear, simple, and practical for users; 6. be consistent with other regulations and policies; 7. be transparent to both regulators and those affected by regulation;

14 Principle of Good Regulatory Practices 8. be based on international or national standards that are harmonized to international standards, except where legitimate reasons for deviations exist; 9. be based on international or national standards that are harmonized to international standards, except where legitimate reasons for deviations exist; 10.reference only those parts of a standard that represent minimum requirements to fulfil the desired objectives; 11.be least trade restrictive to achieve the desired objectives; 12.be performance based rather than prescriptive; 13.accord equal treatment to products of national origin and like products imported from Member States; and 14.be subject to review to maintain flexibility and adaptability to changes.

15 Important analysis. Background Availability of update information, references and good process will produce good regulations. Food borne incidence report Retention of export Food inspection data Result of study or survey New international standards: Codex National interest

16 Process Important analysis. Participation of all related stakeholder Experts involvement Scientific assessment of all available data including national data Sounding and notification Source and availability of Funds

17 Important analysis. Take into consideration Capability of food industry including SMEs Implementation/grace periode Laboratory capacity Inspection capability Implementation of penalties Grace period Role and responsibility of every related institution.. coordination

18 Preparation Compliance Review Regulatory Impact Assessment (RIA) Post market surveillance system Regulatory Impact Assessment (RIA)

19 - Indonesia experience-

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

21 Process of developing standard apply Good Regulatory Practices Identifying the need of the regulation and policy objectives Do the risk assessment (collaboration with expert) Considering the international and regional standard involving stakeholder (government, food industry, consumer, academia) Notification to WTO

22 SCHEME FOR PROCESS OF DEVELOPING STANDARD Pengumpulan Mate ri preparation Reference Kajian Pustaka Pemetaan dan Kaji Banding Assessment Nasion al National Regional Internasional Draft Awal Pengaturan draft Prod uk Pangan Draft Pertama Pengaturan First Prod draft uk Pangan Pembahasan Pertama Disscussion I (Prakonsensus) Narasumber (expert, & Stakeholder stakeholder) Adoption Disscussion II (expert, stakeholder) Pembahasan Kedua Narasumber & Stakeholder Draft Akhir Pengaturan Final Prod draft uk Pangan ADFC Indonesia, Cambodia 2014 Draft Kedua Pengaturan Second Proddraft uk Pangan Disscussion III Pembahasan Akhir (Konsensus) Narasumber (expert, & Stakeholder stakeholder)

23 Reference National (national data, research, expert recommendation, etc) Regional (ASEAN, EU) Internasional (Codex) Bilateral (FSANZ, Malaysia, US-FDA)

24 Involvement Of Related Sectors Representatives from Ministry of Health, Industry, Trade, Agriculture, Fisheries, based on the issued Expert Team, from different Universities and Professional Association Representatives of Consumer

25 Monitoring of Regulation To assess the conformity/implementation of regulation Economic data (premarket, postmarket, trading, etc.) Food safety evaluation data (JECFA, etc) Cases data (complaint from industry, consumer, etc) Compliance (reasons of non complience, reasons not being tested)

26 Case Study 1 - Developing Nutrition and Health Claim Regulation Adoption regulation of functional food 2011 Revised : regulation of nutrition and health claim Adopted on 1 Dec Under revision Prolonged grace periode until Dec 2014

27 Case Study 2 - Developing Food additives Regulation - MoH Regulation on food additives /2014 Regulate 11 functional classess and maximum limit for each food category MoH Regulation on food additives Regulate 27 functional classess 27 Head of NADFC regulations on food additives Regulate maximum limit fro 27 functional classess on each food category development of international regulation, science and technology

28 * Shared responsibilities stated in the Government Regulation. Several Technical Regulation guide the coordination among institutions. Integrated Food Safety System regulated in a Regulation (Menkokesra 23 tahun 2011 ). National Food Safety Network covers Food Intelligence WG, Food Safety Control WG, Food Safety Promotion WG, coordinate in a regular meeting. Coordination with the local government need to enhance. 28

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