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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
Document No: 01 Revision No: 01 Page: 158 of 417 Effective Date: 1 March 2021
Annex 4 (a)
SPECIFIC REQUIREMENT FOR EXPORT OF FISH AND FISHERY PRODUCTS TO
SAUDI ARABIA
BACKGROUND
Export establishments intend to export fish and fishery products to Saudi Arabia shall
comply with all Saudi Arabia’s requirements on fish and fishery product. The export
establishment and the category of products to be exported shall be approved and listed by
the Saudi Food & Drug Authority (SFDA) prior to export.
SPECIFIC REQUIREMENTS
1. Processing establishment shall implement Hazard Analysis Critical Control Points (HACCP).
2. The FSQD (MOH) shall grant approval to the processing establishment if it is found to be in compliance with Saudi Arabia requirements.
3. The FSQD (MOH) shall notify Saudi Arabia on the addition of the new approved processing establishment.
4. Once the processing establishment is included in the updated List of Malaysia Approved Establishments for The Export of Fish and Aquatic Products to the Kingdom of Saudi Arabia, MOH shall notify the processing establishment of its Approval Number.
5. The FSQD (HQ) shall maintain a registration list of processing establishment. Only processing establishment in the List of Malaysia Approved Establishments for The Export of Fish and Aquatic Products are permitted to export fish and fishery products to Saudi Arabia
Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
Document No: 01 Revision No: 01 Page: 159 of 417 Effective Date: 1 March 2021
APPLICATION PROCESS
The application shall be submitted to FSQD (HQ) according to the application form as
stated in Annex 4 (b).
VERIFICATION AND LISTING PROCEDURE
1. Verification and listing procedure shall be carrying out as laid down in this protocol.
2. Export facilities shall complete the Self Audit of Foreign Establishment form as in
Annex 4 (c) and it shall be verified by MOH.
ADDITIONAL INFORMATION
The List of Malaysia Approved Establishments for The Export of Fish and Aquatic
Products as published on the SFDA website https://www.sfda.gov.sa/en/list_countries
Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
Document No: 01 Revision No: 01 Page: 160 of 417 Effective Date: 1 March 2021
Annex 4 (b)
APPLICATION FORM FOR EXPORT FISH AND FISHERY PRODUCTS TO SAUDI
ARABIA
1. Application Form for the Compliance Listing of Processing Establishment For
Export of Fish and Fishery Products - CLF-AF/2015 Rev. 1
2. Application Form For Compliance Listing Of Trader For Export Of Fish And Fishery
Products - CLF-AF/2015 (T)
3. Self- Audit of Foreign Establishment
4. Check of Implementation of HACCP
Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
Document No: 01 Revision No: 01 Page: 161 of 417 Effective Date: 1 March 2021
Annex 4 (b)
CLF-AF/2015 Rev. 1
Ministry of Health Malaysia
APPLICATION FORM FOR THE COMPLIANCE LISTING OF PROCESSING ESTABLISHMENT
FOR EXPORT OF FISH AND FISHERY PRODUCTS
1.0 Type of Application (1): New Re-apply
Others, please specify …………………………………………………………..
2.0 Particulars of Applicant 2.1 Name of Applicant: ………………………………………………………………………………………………….……… 2.2 NRIC Number: ………………………………………………………………………………………………………………… 2.3 Name and Address of Company: ……………………………………………………………………………………..... ............................................................................................................................................................. ............................................................................................................................................................. 2.4 Tel. No.: ………………………… 2.5 Fax No.: …………………………… 2.6 H/P No. ……………………...... 2.7 E-mail address: ……………………………………………………………………………………………………………….. 2.8Company Registration Number (ROC): ……………………………………………………………………………….. (Please attach copy of the certificate)
2.9Company Licence Number: .............................................................................................................. (Please attach copy of the licence)
2.10 Address / Location of processing Establishment: ……………………………………………………………………… ………………………………………………………………………………………………………………………………………….
Postcode :……………………….. District: …………………………………..........State :…………………………........ 2.11 Correspondence Address (if different from para 3.3): . …………………………………………………………. …………………………………………………………………………………………………………………………………………. (1) Tick () where appropriate
Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
Document No: 01 Revision No: 01 Page: 162 of 417 Effective Date: 1 March 2021
3.0 Food Safety Assurance Program in-place
HACCP Implementaion Certification*
GMP Implementaion Certification*
Others, please specify Implementaion Certification*
…………………………………………………………
4.0 Particulars of Food Handlers
4.1 Have all the food handlers been medically examined and vaccinated by a registered medical practitioner in accordance with the Food Hygiene Regulations 2009 ?(1)
Yes No 4.2 Have all the food handlers attended any food handlers training?(1) Yes No If yes, please attach the names of the workers, name and date of training, name of trainer and training institution. (1) Tick () where appropriate
* Please state certification body
Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
Document No: 01 Revision No: 01 Page: 163 of 417 Effective Date: 1 March 2021
5.0 Source of Raw Materials for Fishery Products (1)
5.1 Captured Fishery Product (FP)
No Common Name of FP
Type of Raw Material
(finfish, crustaceans or cephalopods)
Species Registration No. of Fishing
Vessel
Name, Address and Registration No. of Landing Site
Name and Address of Middleman
Please provide the information in a separate annex if the available space is inadequate
5.2 Aquaculture Fishery Product (FP)
No Common Name of FP
Type of Raw Material
(finfish or crustaceans)
Species Name, Address and Registration No. of Aquaculture Farm
Name and Address of Middleman
Please provide the information in a separate annex if the available space is inadequate
(1) To be completed where appropriate
Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
Document No: 01 Revision No: 01 Page: 164 of 417 Effective Date: 1 March 2021
5.3 Fishery Product (FP) Processed Using Imported Fishery Raw Material (Including Semi-Processed Fishery Raw Material)(2)
No Common Name of FP
Type of Imported
Fishery Raw
Material
Species Captured Fishery(3)
Aquaculture(3) Country of Origin Foreign Supplier
Name and Address of Processing Establishment
Please provide the information in a separate annex if the available space is inadequate
5.4 Fishery Product (FP) Processed Using Locally Produced Semi-Processed Fishery Raw Material
No Common Name of FP
Type of Semi-Processed Fishery Raw Material
Species Name and Address of Establishment Processing Semi-Processed Fishery Raw Material
Please provide the information in a separate annex if the available space is inadequate
(2) Application for compliance listing shall be made using “Application Form for the Compliance Listing of Sources of Imported Fishery Raw Materials in the Supply Chain”
(3) Tick () where appropriate
Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
Document No: 01 Revision No: 01 Page: 165 of 415 Effective Date: 1 January 2021
6.0 List of Importing Countries and Products Please specify product(s) to be exported :
No. Name of
Importing Country
Name and Type of Exported Products (finfish,
crustaceans or cephalopods)
Species Processing type /
activity (4) Name and Address
of Importers
Please provide the information in a separate annex if the available space is inadequate
(4) RW = raw ; L = filleting ; S = salted; K = smoked ; M = marinated; CN = canned; F = freezing; C = chilling; H = heading; G = gutting; W = wrapping; HT = heat treatment; O = other (please specify)
7.0 Applicant Declaration I , ………………………………………………………………………………. (Name of Applicant) Declare that:
the information supplied in this application is true ;
fully committed to comply with the Food Hygiene Regulations 2009 and
have undertaken necessary measures to comply with the importing countries’ requirements for fishery products.
……………………………….... …………………………… ……………………………….. (Signature of Applicant) (Company Stamp) (Date)
8.0 Please return completed application form to:
Senior Director for Food Safety and Quality Division Ministry of Health Malaysia Level 4, Menara Prisma No. 26, Jalan Persiaran Perdana, Precint 3 Federal Government Administrative Centre 62675 Federal Territory of Putrajaya, Malaysia Tel. No :03 – 8885 0797 Fax. No :03 – 8885 0790
Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
Document No: 01 Revision No: 01 Page: 166 of 415 Effective Date: 1 January 2021
1.0 Middlemen supply raw materials of fish and fishery products to processing establishment
To be filled up by processing establishment or middlemen contracted by processing establishment
A separate form is to be filled for each middleman.
Please provide the information in a separate if the available space is inadequate.
i) Particulars of Middleman
Supply to : ………………………………………………..(1) Company Name : ……………………………………………….. Company Registration Number (ROC) : ……………………………………………….. Address : ……………………………………………….. Owner Name : ……………………………………………….. Owner I.C. No. : ……………………………………………….. Tel. No. : ……………………………………………….. Fax No. : ……………………………………………….. Email : ………………………………………………..
1.1 Number of worker(s) : ………………………………………
1.2 Name and NRIC Number of worker(s) :
No. Name NRIC No.
Please provide the information in a separate annex if the available space is inadequate
1.3 Name and address of supplier(s) and type of raw material (s) sourced:
No. Name of Aquaculture Farm / Importer
Address of Aquaculture Farm / Importer
Type of raw material (s)
Please provide the information in a separate annex if the available space is inadequate
1.4 Address of Fish Collection Centre (s) (if applicable) :
No. Fish Collection Centre Address
Please provide the information in a separate annex if the available space is inadequate
(1) Name of export facilities
1.5 Registration number and type of transport vehicle to be used in the export supply chain:
Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
Document No: 01 Revision No: 01 Page: 167 of 415 Effective Date: 1 January 2021
No. Registration No. of Transport Vehicle Type of Vehicle (2)
Please provide the information in a separate annex if the available space is inadequate
(1) Refrigerated truck / covered lorry / others, please specify
2.0 Applicant shall submit documents as follows:
HACCP / GMP Certificate (if the establishment is HACCP / GMP certified); Any other appropriate supporting documents. List of supporting documents: …………………………………………………………..
3.0 Applicant Declaration
I , ………………………………………………………………………………. (Name of Applicant)
Declare that:
the information supplied in this application is true ;
fully committed to comply with the Food Hygiene Regulations 2009 and
have undertaken necessary measures to comply with the importing countries’ requirements for fishery products.
……………………………….... …………………………… ……………………………….. (Signature of Applicant) (Company Stamp) (Date)
1.0 Please return completed application form to:
Senior Director for Food Safety and Quality Division Ministry of Health Malaysia Level 4, Prisma Tower No. 26, Jalan Persiaran Perdana, Precint 3 Federal Government Administrative Centre 62675 Federal Territory of Putrajaya, Malaysia Tel. No :03 – 8885 0797 Fax. No :03 – 8885 0790
Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
Document No: 01 Revision No: 01 Page: 168 of 415 Effective Date: 1 January 2021
Annex 4 (b)
CLF-AF/2015 (T)
Ministry of Health Malaysia
APPLICATION FORM FOR COMPLIANCE LISTING OF TRADER FOR EXPORT OF FISH AND FISHERY PRODUCTS
1.0 Type of Application(1): New Re-apply
Others, please specify …………………………………………………………
2.0 Particulars of Applicant 2.1 Name of Applicant:………………………………………………………………………………………………….…………. 2.2 NRIC Number:…………………………………………………………………………………………………………………… 2.3 Name and Address of Company:…………………………………………………………………………………………… ................................................................................................................................................................. ................................................................................................................................................................. 2.4 Tel. No.: ………………………………2.5 Fax No.: ………………………….. 2.6 H/P No.………………………........ 2.7 E-mail address: ………………………………………………………………………………………………………………….. 2.8 Company Registration Number (ROC):………………………………………………………………………………….. (Please attach copy of the certificate)
2.9 Correspondence Address (if different from para 2.3): . ……………………………………………………………. …………………………………………………………………………………………………………………………………………..... (1) Tick () where appropriate
Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
Document No: 01 Revision No: 01 Page: 169 of 415 Effective Date: 1 January 2021
3.0 Particulars of products to be exported 3.1 Name and address of supplier(s) and name of product (s) sourced:
No. Name of Processing Establishment
Address of Processing Establishment
Name of product (s)
Please provide the information in a separate annex if the available space is inadequate
3.2 Registration number and type of transport vehicle to be used in the export supply chain:
No. Registration No. of Transport Vehicle Type of Vehicle (1)
Please provide the information in a separate annex if the available space is inadequate
3.3 Address of Finished Products Storage (s) (if applicable) :
No. Name of Finished Products Storage
Address of Finished Products Storage
Type of Finished Products Storage (2)
Please provide the information in a separate annex if the available space is inadequate
(1) Refrigerated truck / covered lorry / others, please specify (2) Cold Room / Warehouse
4.0 Particulars of Food Handlers (Including Drivers)
4.1 Have all the food handlers been medically examined and vaccinated by a registered medical practitioner in accordance with the Food Hygiene Regulations 2009 ?(1)
Yes No
Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
Document No: 01 Revision No: 01 Page: 170 of 415 Effective Date: 1 January 2021
4.2 Have all the food handlers attended any food handlers training?(1) Yes No
If yes, please attach the names of the workers, name and date of training, name of trainer and training institution.
5.0 Applicant Declaration I , ………………………………………………………………………………. (Name of Applicant) Declare that:
the information supplied in this application is true ;
fully committed to comply with the Food Hygiene Regulations 2009 and
have undertaken necessary measures to comply with the importing countries’ requirements for fishery products.
……………………………….... …………………………… ……………………………….. (Signature of Applicant) (Company Stamp) (Date)
6.0 Please return completed application form to:
Senior Director for Food Safety and Quality Division Ministry of Health Malaysia Level 4, Prisma Tower No. 26, Jalan Persiaran Perdana, Precint 3 Federal Government Administrative Centre 62675 Federal Territory of Putrajaya, Malaysia Tel. No :03 – 8885 0797 Fax. No :03 – 8885 0790
Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
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Annex 4 (c)
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FOOD SAFETY AND QUALITY DIVISION MINISTRY OF HEALTH MALAYSIA
HACCP IMPLEMENTATION AND VERIFICATION CHECKLIST
PREMISE NAME AND ADDRESS:
AUDIT DATE:
INSTRUCTIONS:
Answer the following questions by checking the appropriate box.
C= Compliance NC= Non-Compliance
1.0 FACILITIES AND PROCESS DESCRIPTION C NC COMMENTS
1.1 Company/section general description providing sufficient information?
1.2 Compromise: Commitment for HACCP clearly expressed
1.3 HACCP team: Responsibilities documented and updated
1.4 HACCP team: Adequate qualification and experience available
1.5 HACCP team: Documented references and resources utilized
1.6 Personnel: Informed about the objectives of HACCP
2.0 PRODUCT DESCRIPTION C NC COMMENTS
2.1 Products description clear and complete?
2.2 Include origin and specifications of raw material
2.3 Include composition, packaging, distribution, validity, storage condition
2.4 Include additives and/or ingredients in the final product.
3.0 USERS/ CONSUMERS C NC COMMENTS
3.1 Sensitive consumers identified?
3.2 Instructions given for the distribution, storage and utilisation
4.0 PROCESSING SPECIFICATION C NC COMMENTS
4.1 Flow diagram includes each stage of processing chain
4.2 Flow diagram confirmed
Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
Document No: 01 Revision No: 01 Page: 184 of 415 Effective Date: 1 January 2021
5.0 HAZARD IDENTIFICATION AND ANALYSIS C NC COMMENTS
5.1 Includes Ph, Ch and Bi1 hazards associated to raw materials
5.2 Includes Ph, Ch and Bi hazards associated to each step of processing
5.3 Hazards evaluated in terms of likelihood and severity
5.4 Includes references, bibliography or external advice used on the analysis
5.5 Identifies potential process and staff variations
5.6 Preventive measures identified to control each relevant risk.
5.7 Critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after harvest;
6.0 DETERMINATION OF CCP C NC COMMENTS
6 1 The Identification is consistent with the identified hazards
6.2 It includes references to methodologies and resources used
6.3 Control measures were identified for each CCP
7.0 ADOPTION OF CRITICAL LIMITS C NC COMMENTS
7.1 Established for each CCP determined before
7.2 Are the CLs able to be determined simple and routinely during production
7.3 Are limits validated taking into account published/experimental evidence
8.0 MONITORING OF CCP C NC COMMENTS
8.1 Responsibilities and activities documented for each CCP.
8.2 Includes what, who, when, where and how each CCP is monitored
8.3 Includes verifiable records and identification of the responsibilities
9.0 CORRECTIVE ACTIONS C NC COMMENTS
9.1 Responsibilities and activities documented for each CCP.
9.2 Includes what, who, when, where and how corrective actions are taken on the system and non-conformance products
9.3 Are CA realistic and cover destination of non suitable products
9.4 Includes measures or action to avoid re-occurrence?
10.0 VERIFICATION PROCEDURES C NC COMMENTS
Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
Document No: 01 Revision No: 01 Page: 185 of 415 Effective Date: 1 January 2021
10.1 Responsibilities and activities documented for each CCP.
10.2 Includes what, who, when, where and how verification activities take place
10.3 Includes final product testing and calibration of equipment
10.4 Includes action in case that verification shows non compliances
10.5 Reassessment of the HACCP plan (follow agenda MS1480:2007)
11.0 DOCUMENTATION AND RECORDS C NC COMMENTS
11.1 Records are documented for each component of the HACCP plan.
11.2 Includes what, who, when, where and how records are taken and stored
11.3 Procedure for the annual plan review adopted and documented
12.0 VERIFICATION OF HACCP PLAN C NC COMMENTS
12.1 Changes and Modifications
12.1.1 Changes or modification in process -raw materials included in the plan
12.1.2 Modifications non communicated or approved if affecting product.
12.1.3 The responsible (as documented) are in control of operations
12.2 Documentation and Records
12.2.1 Records are available in their respective areas and updated
12.2.2 Records can be traced and reviewed as far as the last regulatory verification
12.3 Management of the Plan
12.3.1 Preventive measures followed and verifiable?
12.3.2 Monitoring procedures followed and verifiable?
12.3.3 Corrective actions followed and verifiable?
12.3.4 Verifications activities followed and verifiable?
EVALUATION OF COMPLIANCE:
Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS
Document No: 01 Revision No: 01 Page: 186 of 415 Effective Date: 1 January 2021
LEAD AUDITOR SIGNATURE AND OFFICIAL STAMP
…………………………………………………
AUDITOR(S) SIGNATURE AND OFFICIAL STAMP :
…………………………………………………