Malaysia Maximum Residue Limit Regulatory Enforcement

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2018/SCSC/WKSP8/009

Malaysia Maximum Residue Limit Regulatory Enforcement

Submitted by: Malaysia

Workshop on a Trade Facilitative Approach to Maximum Residue Limit

ComplianceBrisbane, Australia9-10 October 2018

MALAYSIA MRL REGULATORY ENFORCEMENT

1Food Safety and Quality Programme Ministry of Health Malaysia

APEC FSCF PTIN MRL Harmonization: A Trade Facilitative Approach to MRL Compliance9-10 October 2018, in Brisbane, Australia

RAFEAH SIBILSenior Principal Assistant Director

Food Safety & Quality DivisionWebsite : http://fsq.moh.gov.my

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MRL Domestic and Import

MRL in Regulations

MRL Domestic Monitoring

Clearance of MRL Import

OBJECTIVE FOOD SAFETY AND QUALITY

PROGRAMME

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General Objective

To protect the public against health hazards and fraud in the preparation, sale and storage of food.

To facilitate food trade

Food Safety and Quality Programme Ministry of Health Malaysia

COMPETENT AUTHORITY

The Food Safety and QualityDivision, Ministry of Health is theregulatory authority for food safetyin Malaysia


PROGRAMME STRUCTURE

Food Safety and Quality Programme Ministry of Health Malaysia 6

FSQD HEADQUARTERS

STATE HEALTH DEPARTMENT

DISTRICT HEALTH OFFICE

Planning and Policy Development

Supervision on Implementation of

Activities

Implementation of Activities

INFRASTRUCTURE

INFRASTRUCTURE NO.

STATES 15

DISTRICTS 136

ENTRY POINTS 56 (sea, land and air)

MOH LABORATORIES 15 (10 FSQLs and 5 PHLs)


FOOD LAWS

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FOOD ACT 1983

FOOD REGULATIONS

1985 FOOD HYGIENE REGULATIONS

2009

FOOD (ISSUANCE OF HEALTH CERTIFICATE

FOR EXPORT OF FISH & FISH PRODUCT TO THE

EUROPEAN UNION) REGULATIONS 2009FOOD

IRRADIATIONREGULATIONS

2011

FOOD (FOOD ANALYSIS FEES) REGULATIONS

2016

FOOD (COMPOUNDING OF

OFFENCES) REGULATIONS 2017


MRL Import activity are governed by 2 agencies asbelow:

Food Safety & Quality Division (FSQD),Ministry of Health, Malaysia (MOH)

Department of Agriculture (DOA),Ministry of Agriculture and Agro-Based Industry (MOA)

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2Food Safety and Quality Programme

Ministry of Health Malaysia

Roles and AuthoritiesMinistry of HealthFood safety Quality Food stuffs Disease identification

Testing materials include MRLInspections of Processors

Inspections of food establishmentsBorder inspectionsIssuance of certificates for export & import

Department of AgricultureInspectionsBorder ControlPhytosanitary CertificatesTestingQuarantine

Pesticide controlFarm Certification (SALM)

CompaniesSet standards quality & food safetySupplier ContractsManufacturingAdvertising

Importing CountriesInspectionsTestingQuarantineIn-economy inspectionsNotificationsDestruction of materialsImport Standards

Consumers UnionRegister complaintsAdvocacy for consumersTest samples for safetyWork with government to improve overall performance

Food Chain

Processor

ExporterRetailerRestaurantKiosksImporter

ConsumerFarm or

Fishing vessel

FeedWaterFertilizerPesticides Intermediate

Processing

Ministry of AgricultureDept. of Veterinary ServicesInspectionsBorder ControlSanitary CertificatesTestingVaccination, quarantine & disease free zonesAnimal Health Certificates

Ministry of AgricultureDepartment of FisheriesInspectionsHealth CertificatesAquaculture registrationTestingDisease-free zonesCertification (SALM)

FSQD

Approve MRL and enforcing MRL safety at the point of sale

DOA

Register new Pesticide and ensuring Good

Agriculture Practice (GAP) at Farms


• Applicable for Domestic and import food product

• MRL stated;a. Under regulation 41, 16

Schedule, The Food Regulations 1985; or

b. Codex Alimentarius; orc. 0.01 mg/kg

1. New MRL approval• Submit application to

FSQD• Up to 12 months process

to approve

2. Pesticide registration• Submit application to

DOA





Notify the proposal of new regulation or amendment of current regulation to Malaysia Productivity Corporation (MPC)

3 days

RIA IS NOT REQUIRED (PROCESS A) RIA IS REQUIRED

1 monthSTEP I

Proposed amendment/ issue will be discuss in Expert Working Group

Conduct Regulatory Impact Analysis (RIA) andconsultation

2-6 month

1 monthSTEP II

Food Regulation 1985 Advisory Committee deliberate the proposal from expert working group

Submit Regulatory Impact Statement (RIS) to MPC. Assesment and review of RIS by MPC

3 weeks

1-2 monthSTEP III

Public Consultation (Online/ Dialog with stakeholdes / WTO notification)

Submission of RIS to NDPC 1 week

1 monthSTEP IV

Draft amendment will revised accordingly and translation prepared

NDPC examines RIS for adequacy 3 weeks

1 monthSTEP V

Draft amendment forwarded to Legal Advisor of Ministry of Health for review

Provide RIS to decision maker. RIS is forwarded to the Cabinet, Minister or other authority responsible.

2 monthSTEP VI

Draft amendment forwarded to Attorney General Chamber (AGC) for approval

Publication of RIS. MPC to consult regulator on publication of RIS

PROCESS A2 weeks STEP VII

Application of Minister of Health signature

STEP VIII1 month New Regulation or amendment forwarded to AGC to be

AMENDMENT PROCESSNew MRL approval

12 Expert Working Group under the Advisory Committee on Food

Regulations 1985

Expert Committee on

Nutrition/ Claims and

AdvertisementExpert

Committee on Food Additive

Expert Committee on

Food Contaminants

Expert Committee on Microbiology

Task Force on Pesticide

Residues in Food

Expert Committee

on Drug Residues in

Food

Ad-Hoc Expert

Committee on Water Standard

Ad-hoc Expert Committee on

Genetically Modified Food

Expert Committee

on Food Labelling

Expert Committee on Food Standard

Commodity

Expert Committee

on Food Packaging

Expert Committee

on Food Irradiation

Public ConsultationIn line with the government's commitment to ensure that the

amendments are made in a transparent manner and takes into account the views of relevant stakeholders

Online Public Engagement

1 month

Dialogue with related stakeholders, agencies and

consumer association

WTO Notification60 days


• Domestic samples are taken from retail outlets in domestic markets such as wet market, supermarkets, hypermarkets, etc. while import samples are taken at the entry points and send to laboratory for analysis

• Pesticide residue screening and analysis in food items is being conducted by accredited laboratory under ISO 17025

• conviction, to a fine not exceeding one hundred thousand ringgit (RM 100, 000.00) or to imprisonment for a term not exceeding ten years or both


PHL Kota Kinabalu

FSQ LAB Miri

FSQ LAB Sandakan

FSQ LAB Sarawak

FSQ LAB Pahang

FSQ LAB Terengganu

FSQ LAB Kelantan

PHL Johor Bharu

NPHL Sg Buloh

PHL Ipoh

FSQ LAB Penang

FSQ LAB Perlis

FSQ LAB Alor Setar

MOH Laboratories Throughout Malaysia

FSQ LAB Selangor

PHL Kelantan

Transaction Database

MasterDatabase

KnowledgeDatabase

LEVEL 1AUTO

CLEARANCE

LEVEL 2DOCUMENT

EXAMINATION

LEVEL 3MONITORINGEXAMINATION

LEVEL 4SURVEILLANCEEXAMINATION

LEVEL 5HOLD TEST &

RELEASE

LEVEL 6AUTO

REJECTION

3. Import Declaration (K1)

IMPORTERS / FORWARDING AGENTS

FOOD SAFETY INFORMATION SYSTEM OF MALAYSIA – FOOD IMPORTATION PROCESS

8. Sample for Analysis

1. Registration

ENTRY POINT

INSPECTION / SAMPLING

LABORATORYCUSTOMS INFORMATION SYSTEM (SMK)

Food Safety Information System of Malaysia

RecommendsExamination Level

Automated Examination Level

Inspection Action

Ministry of Health


• Enforcement approach for MRL are coordinated effort between multiple government agencies


Rafeah SibilFood Safety and Quality Division

Ministry of Health Malaysia([email protected])

Malaysia Maximum Residue Limit Regulatory Enforcement

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