ir. tetty helfery sihombing, mp director of food product...

Ir. Tetty Helfery Sihombing, MP

Director of Food Product Standardization

National Agency of Drug and Food Control –

Indonesia

Cambodia, 20 February 2014

NADFC Indonesia, Cambodia 2014 2

OUTLINE

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.

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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.

Good preparation and

development is a strong

base for effective

implementation of

regulations.

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2. The Importance of Regulation

Awareness of the importance of regulations

need to be built and harmonized among all:

• Government institutions

• Food industries

• Consumers

NADFC Indonesia, Cambodia 2014

Is there a need for the availability of

standards/regulation?

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.

NADFC Indonesia, Cambodia 2014

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. NADFC Indonesia, Cambodia 2014

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

NADFC Indonesia, Cambodia 2014

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

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.

3.

GOOD REGULATORY PRACTICES

ASEAN GOOD REGULATORY PRACTICE

(GRP) GUIDE (2009)

When deciding to regulate, the

regulator needs to consider how

regulation is prepared, adopted and

reviewed so that it will be effective

over time.

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;

NADFC Indonesia, Cambodia 2014

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.

Important analysis ….

Background

Food borne incidence report

Retention of export

Food inspection data

Result of study or survey

New international standards: Codex

National interest

Availability of update information, references and

good process will produce good regulations.

NADFC Indonesia, Cambodia 2014

Important analysis ….

Process

Participation of all related stakeholder

Experts involvement

Scientific assessment of all available data

including national data

Sounding and notification

Source and availability of Funds

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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

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Preparation

Compliance

Review

Regulatory Impact

Assessment (RIA)

Post market

surveillance

system

Regulatory

Impact

Assessment (RIA)

NADFC Indonesia, Cambodia 2014

- Indonesia experience-

EVALUATION

IMPLEMENTATION

MONITORING DRAFTING

ADOPTION

DISSEMINATION/

SOCIALIZATION

Management Standardization System

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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

NADFC Indonesia, Cambodia 2014

SCHEME FOR PROCESS OF DEVELOPING STANDARD

Draft AwalPengaturan Produk Pangan

Draft KeduaPengaturan Produk Pangan

Pembahasan Pertama (Prakonsensus)

Narasumber & Stakeholder

Pembahasan Akhir(Konsensus)

Narasumber & Stakeholder

Kajian Pustaka

Internasional

Draft PertamaPengaturan Produk Pangan

Draft AkhirPengaturan Produk Pangan

Pembahasan KeduaNarasumber & Stakeholder

PengumpulanMateri

Pemetaan dan

Kaji Banding

RegionalNasional

preparation Reference

Assessment

draft

Disscussion I

(expert,

stakeholder)

First draft

Disscussion II

(expert,

stakeholder)

Second draft

Disscussion III

(expert,

stakeholder)

Final draft Adoption

National

NADFC Indonesia, Cambodia 2014

Internasional

(Codex)

National (national data, research,

expert recommendation, etc)

Regional (ASEAN, EU)

Bilateral

(FSANZ, Malaysia, US-FDA)

Reference

NADFC Indonesia, Cambodia 2014

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

NADFC Indonesia, Cambodia 2014

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)

NADFC Indonesia, Cambodia 2014

Case Study 1

- Developing Nutrition and Health Claim Regulation

-

2005

2011

2014

Adoption regulation

of functional food

Revised : regulation of

nutrition and health

claim

Under revision

Adopted on 1 Dec

2011

Prolonged grace

periode until Dec 2014

NADFC Indonesia, Cambodia 2014

Case Study 2

- Developing Food additives Regulation -

1988 2012 2013/2014

Regulate 11 functional

classess and maximum

limit for each food

category

Regulate 27

functional

classess

development of international regulation, science and technology

MoH Regulation on food

additives

MoH Regulation on food

additives

27 Head of NADFC

regulations on food

additives

Regulate

maximum limit

fro 27 functional

classess on each

food category

NADFC Indonesia, Cambodia 2014

*

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.

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