Ir. Tetty Helfery Sihombing, MP. Director of Food Inspection and Certification

NADFC

FOOD RECALL AND TRACEABILITY

IN ORDER TO ENSURE FOOD SAFETY

• The primary responsibility for ensuring the right to adequate food and the fundamental right to freedom from hunger rests with national governments.

• Food quality and safety are important aspects of the right to food. Food safety implies the absence or safe levels of contaminants, bacteria, naturally occurring toxins or any other substance that may make food injurious to health.

“Everyone has the right to a standard of living adequate for the

health and well-being of himself and of his family, including food, clothing, housing and medical care ...” (Universal Declaration of

Human Right, article 25)

Source: http://www.fao.org/focus/e/rightfood/right2.htm

ISSUES RELATED TO FOOD SAFETY IN 21TH CENTURY

Various types of food products in the market

Food Product Development

Global Economical Crisis consumer needs cheaper foods

Lower consumer trust on food product

Increased demands for healthy, safe & environmentally friendly food

Trend changing on food expense

traceability - lack of food safety control from manufacturer and supplier, as well as coordination.

NEED EFECTIVE AND STRONG FOOD SAFETY CONTROL SYSTEM

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EFECTIVE AND STRONG FOOD

SAFETY CONTROL SYSTEM

Protect community health from potential risk of food hazards

Ensuring Food safety and quality both exported and imported food products (as trade competitiveness)

Effective national food control systems are essential to protect the health and safety of domestic consumers. They are also critical in enabling countries to assure the safety and quality of their

foods entering international trade and to ensure that imported foods conform to national requirements. The new global environment for food trade places considerable obligations on both importing and exporting countries to strengthen their food control systems and to implement and

enforce risk-based food control strategies.

Food Safety Control Challenges in Southeast Asia Region

Source: Othman NM. Food safety in Southeast Asia: challenges facing the region. Asian J. Agric. Dev. 2007;4(2):83–92 (accessed: http://ageconsearch.umn.edu/bitstream/166014/2/AJAD_2007_4_2_6Othman.pdf)

Establish and update food regulations, as well as regulation gapsidentification

Management of food safety control development of a risk-based control system by applying risk analysis principles

Quality of food inspection needs competent food inspector and preventive inspection procedures

Inadequate laboratory infrastructure

Effectively and sustainably information sharing among stakeholders

The framework of regional and international trade (TBT dan SPS agreements

Compliance of food industries on regulations and standards

Food safety Control

Challenges in ASEAN

Formal establishment of ASEAN Economic Challenges

(2015)

1ST pillar of AEC : Single market and production base (Free

flow of goods, services, investment, and skilled labour

whitin the region)

Asean Population : 3rd largest in the world in 2014 (622

million)

Total Trade 2007-2014 increase by nearly US 1 T intra-ASEAN trade comprises the largest share of ASEAN’s

total trade by partner

ATIGA : Food safety becomes an important issue in food

trading, including those are related to its regulation

“Food recall is a fundamental tool in the management of risks in response to food

safety events and emergencies”

Competent Authority responsible to develop guidance on the establishment,

implementation and maintenance of food recall plans and traceability

ASEAN Member States should establish national food recall

procedure

Principle 8 : Reliable Traceability System

REGULATIONS RELATED TO FOOD RECALL AND TRACIBILITY

Law No. 8/1999 on Consumer Protections

Law No. 36/ 2009 on Health

Law No. 18/2012 on Food

Government Regulation No.

69/1999 on Food Labelling and

Advertisement

Government Regulation No.

28/2004 on Food Safety, Quality and

Nutrition

Other technical regulations

Food recall is stated in all articles related to administrative sanctions against violations related to food safety and quality, as well as other provisions.

FOOD RECALL ON LAW NO. 18/2012 ON FOOD

RECALL AND/ OR DESTRUCTION

Government Regulation No. 28/2004 on Food Safety, Quality and Nutrition

Article 47(1) If, based on the results of the investigations as contemplated in Article

45 paragraph (3) and/or the results of the investigations as contemplated in Article 46, there are any violations, the Governor, Regent/Mayor of the Head of the Agency shall be authorized to take administrative measures.

(2) The administrative measures as contemplated in paragraph (1) shall include: a. written warning; b. prohibition from distribution temporarily and/or instruction to

withdraw the food products from distribution; c. food destruction, if it is proven to risk human health and lives; d. temporary production halt; e. imposition of penalty no greater than Rp.50,000,000 (fifty million

rupiahs); and/or f. revocation of production licenses, business licenses, registration

approvals or home industry food production certificates.

RECALL AND/ OR DESTRUCTIONGovernment Regulation No. 28/2004 on

Food Safety, Quality and Nutrition

Article 481) Withdrawal and/or destruction of the food as contemplated

in Article 47 shall be implemented by any person who produces or imports food into Indonesian territories and in accordance with the food withdrawal and destruction guidelines.

2) Any party involved in food distribution shall assist in the food withdrawal and/or destruction as contemplated in paragraph (1).

3) The food withdrawal and/or destruction as contemplated in paragraph (1) shall, in respect of fresh food, be implemented at the instruction of the Governor, Regent/Mayor in accordance with their respective duties and authority.

4) The food withdrawal and/or destruction as contemplated in paragraph (1) shall, in respect of processed food, be implemented at the instruction of the Head of the Agency.

Good Manufacturing Practices Guideline (Ministry of Industry No. 75/M-IND/PER/7/2010)

Product recall is a process to withdraw products frommarket, in case the products suspected to have potentiallycause of food poisoning or other health issues.

Recall is taken if the product is suspected to have potentially cause of food poisoning or other health issues.

The process of recall should be paid attention

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DEFINITION OF FOOD RECALL

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• “The action to remove food from the market at any stage of the food chain, including that possessed by consumers”

WHO:

• ”Food recall is an action taken by a company to remove unsafe food products from the market”.

Canada:

• “A recall is an action taken to remove from distribution, sale and consumption, food which may pose a health and safety risk to consumers.”

ANZFA:

• a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.

Market withdrawal

• a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.

Recall

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Definisi Penarikan PanganDEFINITION OF FOOD RECALL BY FDA

THE SUBSTANDARD PRODUCT SHOULD BE RECALLED?

To protect people from substandard food that could be harm and / or endanger health, such as

food contaminated by microbiological contamination, chemical contamination, and / or

physical contamination; mislabeling related to unstated raw materials or food additives used;

other mislabeling issues, packaging damage; and other indications of nonconformity.

“Everyone who produce, import food products to Indonesia region”

FOOD CONTROL SYSTEM BY NADFC

• GMP, GDP evaluation• Evaluation of food safety and quality

as pre requisite to get registration number.

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• product imports control through publishing import recommendation letter

• Publishing export recommendation letter, (including certificate of health, GMP certificate, Hygiene and Sanitation Certificate, free sale recommendation, as required)

• Product specifications related to Food Safety and Quality

• Label monitoring• Routine manufactory Inspection• Mobile laboratory• Sampling and laboratory analysis• Intensification of food distribution control• Increasing Community Awareness

through IEC, GN-WOMI• Law Enforcement

PRE MARKET EVALUATION POST MARKET VIGILANCE

• Food recall from market is basically done on theorders of the Head of the POM RI (mandatory recall)

• However, manufacturer, importers, or distributorscan initiate food recall as their responsibility toprotect public health (voluntary recall).

• The manufacturer, importer, or distributor shall toreport voluntary food recall to the NADFC

MANDATORY VS VOLUNTARY

RECALL CLASSIFICATION

For food that potentially have seriously illness and death. I.e, contain hazardous material, pathogen microbiological, physical contamination (glass, metal, plastic, etc

Recall dateline : 24 h public warning and 14 days of recall process

Class 1 For food product

that has issues related to label, substandard food additives used, packaging damage, etc

Recall dateline : 30 days of recall process

Class 2

For food product that has other infringement beside Recall type 1 and 2

Recall dateline : 60 days of recall process

Class 3

TRACEABILITY SYSTEM AS PRE-REQUISITE OF EVECTIVE

RECALL PROCESS

• Manufacturers, importers and distributors are mandatory to have an effective and documented food recall system.

• As a pre-requisite for effective food recall, every food manufacturer, importer, and distributor, must have a food traceability system.

• Food traceability is the ability to track, identify a product unit or lot / batch at all food process stages, storage and distribution.

• The organization shall establish and apply a traceability system that enables the identification of product lots and their relation to batches of raw materials, processing and delivery records.

• The traceability system shall be able to identify incoming material from the immediate suppliers and the initial distribution route of the end product.

• Traceability records shall be maintained for a defined period for system assessment to enable the handling of potentially unsafe products and in the event of product withdrawal. Records shall be in accordance with statutory and regulatory requirements and customer requirements and may, for example, be based on the end product lot identification.

ISO 22000:2005 (clause 7.9)

TRACEABILITY SYSTEMINTERNAL vs EXTERNAL

Raw material Food processing Finish products

external externalinternal

• WHO are the raw material suppliers?

• HOW much each raw material from each supplier?

• IDENTITY of each raw material

• IDENTITY of raw material used? (including batch / lot / production code, received date, expire date)

• Production records (process temperature, process time, machine line, weighing, products amount)

• Records of food safety and quality control, including laboratory analysis

• Storage record, Storage conditions, product Stock

• WHO is the distributor?

• Distribution record (including product amount)?

• IDENTITY of finished product of each distributor?

Good Traceability System is useful to identify the origin of contamination that may occur during the food

production process

Source : Surono, I.S, Sudibyo, A, Waspodo, P (2016), Pengantar Keamanan Pangan untukIndustri Pangan. DeePublish, Yogyakarta.

CASE OF FOOD TRADE INFRINGEMENT CASE OF FOOD TRADE INFRINGEMENT

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TERIMA KASIH

Direktorat Inspeksi dan Sertifikasi PanganDeputi Bidang Pengawasan Keamanan Pangan

dan Bahan BerbahayaBadan POM RI