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Document No: 04 Revision No: 2 Page: 1 of 31 Effective Date: 27 May 2013 FOOD SAFETY AND QUALITY DIVISION MINISTRY OF HEALTH MALAYSIA COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S NEST TO CHINA

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Page 1: COMPLIANCE LISTING AND VERIFICATION PROTOCOL …fsq.moh.gov.my/v5/images/filepicker_users... · Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE

Document No: 04 Revision No: 2 Page: 1 of 31 Effective Date: 27 May 2013

FOOD SAFETY AND QUALITY DIVISION

MINISTRY OF HEALTH MALAYSIA

COMPLIANCE LISTING AND

VERIFICATION PROTOCOL FOR

EXPORT OF RAW CLEAN EDIBLE

BIRD’S NEST TO CHINA

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S

NEST TO CHINA

Document No: 04 Revision No: 2 Page: 2 of 31 Effective Date: 27 May 2013

Approved by:

Name: NORAINI BINTI DATO’ MOHD OTHMAN

Designation: Senior Director for Food Safety And Quality

Ministry Of Health Malaysia

Date: 27 May 2013

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S

NEST TO CHINA

Document No: 04 Revision No: 2 Page: 3 of 31 Effective Date: 27 May 2013

NO. DATE OF

AMENDMENT REVISION NO. AMENDMENT REFERENCE

1. May 2013 02 i. Statement “Exporter obtain raw clean

bird’s nest from processing establishment that has been listed with MOH and approved by CNCA” have been included in Part B : Middlemen / Exporter, Checklist on the Control of the Safety of Edible Bird’s Nest Along the Food Supply Chain”.

ii. Item 4 “Specific Requirements for Export of Raw Clean Edible Bird’s Nest to China” which include traceablitiy, Labelling of finished products, own check for water and control of detergent or disinfectant have been included in Part C : Processing Establishment, Checklist on the Control of the Safety of Edible Bird’s Nest Along the Food Supply Chain”.

iii. Item 7 “own check” have been included in Checklist on the Control of Nitrite Level in Edible Bird’s Nest

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S

NEST TO CHINA

Document No: 04 Revision No: 2 Page: 4 of 31 Effective Date: 27 May 2013

1. INTRODUCTION :

The safety of edible bird’s nest products has, and continues to attract international attention from both consumers and importing countries. This raises the need for food destined for export to be managed under systems that effectively control the hazards that can compromise food safety. This provides a sound basis for Food Safety and Quality Division (FSQD), Ministry of Health (MOH) as the Competent Authority to establish food safety control over the edible bird’s nest products supply chain in order for edible bird’s nest products produced will be safe for human consumption by complying to the Food Act 1983 and Food Regulations 1985, Food Hygiene Regulations 2009 as well as the importing countries’ requirements. Hence, the ultimate aim of MOH is to protect and boost Malaysia's reputation as a supplier of safe and good quality edible bird’s nest products to China. Compliance listing and verification are important steps to ensure that processing establishments and sources of raw material continuously meet importing countries’ requirements. It is the responsibility for the processing establishments to ensure compliance to the importing countries’ requirements. The processing establishments shall develop and implement a food safety assurance program as the minimum requirement to export the edible bird’s nest products to China. Such processing establishments shall obtain the edible bird’s nest raw materials from bird’s houses which have been complied with the requirements imposed by Department of Veterinary Services (DVS) and fulfill the requirement on food safety so as to ensure that the edible bird’s nest produced are safe for human consumption. Therefore, the processing establishments shall obtain raw materials from sources within the supply chain as listed and verified by Competent Authorities (CAs) i.e. FSQD and DVS. 2. SCOPE

This protocol establishes the mechanism for compliance listing and verification of the processing establishment for export of raw clean edible bird’s nest to China. 3. COMPLIANCE LISTING

3.1 Types of Compliance Listing

MOH maintains and manages list of processing establishment of raw clean edible bird’s nest to China whilst list of bird’s houses, middlemen and exporters shall be obtained from DVS. However, MOH as the Competent Authority on food safety shall conduct verification at random basis from time to

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S

NEST TO CHINA

Document No: 04 Revision No: 2 Page: 5 of 31 Effective Date: 27 May 2013

time to verify the compliance status of the listed bird’s houses, middlemen and exporters to China import requirements on food safety for raw clean edible bird’s nest.

3.2 Compliance Listing of Processing Establishments

The FSQD (HQ) shall maintain a compliance list of processing establishments. Only processing establishments in the Compliance List of Processing Establishment for Export of Raw Clean Edible Bird’s Nest to China are permitted to export raw clean edible bird’s nest to China. The processing establishment shall submit a completed Application Form to the FSQD (HQ) as shown in Appendix 1.

3.3 Procedures for the Compliance Listing of Processing Establishments

3.3.1 Application for Compliance Listing

The processing establishment shall submit a completed Application Form as in Appendix 1 to FSQD (HQ).

3.3.2 Application Review

3.3.2.1 The FSQD HQ shall review the following documents:

a) Completed Application Form; b) Supporting documents e.g. license, registration of company, any food

safety assurance programme certification and others.

3.3.2.2 The FSQD HQ shall record all applications in a central registry.

3.3.3 Verification

Verification is carried out for the following purposes:

i. To assess the compliance status of processing establishments of raw clean edible bird’s nest products;

ii. To conduct surveillance verification on the maintenance of the compliance

status of processing establishments for purposes of export raw clean edible bird’s nest to China.

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S

NEST TO CHINA

Document No: 04 Revision No: 2 Page: 6 of 31 Effective Date: 27 May 2013

iii. To conduct random verification on food safety aspect of the listed bird’s houses, traders and middlemen by DVS.

3.3.3.1 Verification of processing establishment shall be carried out as follows:

i. The FSQD HQ shall assign auditors to carry out the compliance verification of the processing establishment once the application has been reviewed.

ii. Assigned auditors shall verify the compliance status of the processing establishments based on the following Standard Operating Procedures:

a) Standard Operating Procedure for the Control of the Safety of Edible

Bird’s Nest Along the Food Supply Chain; and b) Standard Operating Procedure on the Control of Nitrite Level in Edible

Bird’s Nest.

iii. Verification of processing establishments shall be carried out by assigned auditors by using the relevant checklist as in Appendix 2 and Appendix 3.

iv. The assigned auditors shall report the verification findings to the processing establishment including the non conformances to the processing establishment. The auditors will discuss the verification findings, and issue corrective action requests (CARs) using the CAR format in Appendix 4 for non-conformances together with the completed verification checklists to the management of the processing establishment at the closing meeting.

v. Corrective actions shall be undertaken on the non-conformances by the processing establishment within the agreed time frame by auditors and processing establishment. Follow-up visits shall be carried out when necessary.

vi. CARs shall be closed out not exceeding 6 months from the date of compliance verification or otherwise a new application shall be submitted by the processing establishment provided the corrective actions on the non conformances issued in the previous verification have been undertaken.

vii. The lead auditor will forward a preliminary report on the verification findings and the corrective action request form which has been completed with the corrective action that will be undertaken by the processing establishment and the completion target date to FSQD HQ within 5 working days from date of compliance verification using the specific format as in Appendix 5.

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S

NEST TO CHINA

Document No: 04 Revision No: 2 Page: 7 of 31 Effective Date: 27 May 2013

viii. The lead auditor shall submit a final report on the compliance status of the processing establishment based on the verification findings to FSQD HQ within 14 working days from the date of all CARs have been closed out.

ix. The FSQD (HQ) shall review the report and decide on the compliance status of the application. A copy of final report on the verification shall be given to the processing establishment and the successful applicant shall be listed in the Compliance List of Processing Establishment for Export of Raw Clean Edible Bird’s Nest to China.

x. The FSQD (HQ) shall notify the applicant in writing the outcome of the compliance status of the processing establishment.

3.4 Conduct of Surveillance Verification on the Listed Processing Establishment

for the Export of Raw Clean Edible Bird’s Nest to China

3.4.1 Surveillance verifications are conducted every six (6) months on the listed processing establishment by the assigned auditors.

3.4.2 The purpose of the surveillance verification is to verify the maintenance of the food safety assurance system in-place and the compliance to the importing countries’ requirements on raw clean edible bird’s nest.

3.4.3 Relevant verification checklists shall be used as a tool for verification.

3.4.4 The auditors will discuss the surveillance verification findings and issue corrective action requests (CARs) for non-conformances to the management of the processing establishment at the closing meeting.

3.4.5 The lead auditor will forward a preliminary report on the verification findings and the corrective action request form which has been completed with the corrective action that will be undertaken by the processing establishment and the completion target date to FSQD HQ within 5 working days from date of compliance verification using the format as in Appendix 5.

3.4.6 Follow-up audit will be carried out, if necessary.

3.4.7 CARs shall be closed within the agreed time frame of not exceeding 30 days.

3.4.8 The lead auditor shall forward a final report on the surveillance verification to FSQD (HQ) within 14 working days from the date of CARs have been closed out.

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S

NEST TO CHINA

Document No: 04 Revision No: 2 Page: 8 of 31 Effective Date: 27 May 2013

3.4.9 In the case of CARs which are not closed out within 30 days e.g. upgrading of major

infrastructures, another agreed time frame shall be given not more than 6 months from the date of the surveillance audit. A Reminder Notice shall be issued by the auditor regarding the unclosed CARs after 4 months from the date of surveillance audit with a copy to FSQD (HQ).

3.4.10 A separate report on the remaining CARs shall be forwarded to FSQD (HQ) within 5 working days by auditor.

3.4.11 In case of CARs are not closed out, the assigned auditors may recommend to FSQD (HQ) to suspend the export of raw clean edible bird’s nest to China by the processing establishment.

3.4.12 The lead auditor shall immediately recommend to the FSQD (HQ) by submitting a written report with recommendation to suspend the compliance status of the processing establishment if it is found totally not in compliance.

3.5 Verification on Listed Bird’s Houses, Middlemen and Exporters Involved in the Export of Raw Clean Edible Bird’s Nest to China

3.5.1 Verification on listed bird’s houses, middlemen and exporters involved in the export

of raw clean edible bird’s nest to China shall be carry out at random from time to time by State Health Department.

3.5.2 Verification shall be done by using appropriate checklist as in Appendix 2.

3.5.3 Verification shall be carry out as stated in para 3.4 excluding para 3.4.1.

3.5.4 FSQD (HQ) will notify DVS in writing if any of the listed bird’s houses, middlemen and exporters is found to be not in compliance with the food safety requirements based on the verification findings done by MOH.

4.0 CHANGES TO COMPLIANCE LIST

The processing establishment that has been listed in the Compliance List shall

submit a written request to the FSQD (HQ) to change any details of the processing establishment. The FSQD (HQ) shall assess whether the requested changes merit

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S

NEST TO CHINA

Document No: 04 Revision No: 2 Page: 9 of 31 Effective Date: 27 May 2013

a verification activity / audit. If so the FSQD (HQ) shall assign auditors to undertake the verification.

5.0 VOLUNTARY DELISTING OF PROCESSING ESTABLISHMENT

5.1 Listed processing establishment intending to be delisted from the Compliance

List for Processing of Raw Clean Edible Bird’s Nest to China shall make a request in writing to the FSQD (HQ).

5.2 The processing establishment that requested the voluntary delisting shall not export raw clean edible bird’s nest from the date of request for delisting.

6.0 DELISTING OF PROCESSING ESTABLISHMENT BY THE FSQD (HQ)

A. Formal Delisting from the Compliance List

A listed processing establishment of raw clean edible bird’s nest shall be delisted from the Compliance List if:

i. The processing establishment of raw clean edible bird’s nest fails to rectify

non-conformances within an agreed timeframe; ii. The processing establishment of raw clean edible bird’s nest has stopped

operating for a time period more than 6 months;

iii. The processing establishment of raw clean edible bird’s nest did not export to China for a time period more than 18 months.

FSQD (HQ) shall notify the affected processing establishment in writing of its intention to delist the facility from the Compliance List. The processing establishment shall be given two (2) weeks from the date of notification to appeal against the proposed delisting. If there is no response from the processing establishment within the two (2) weeks time limit, the FSQD (HQ) shall delist the processing establishment from the Compliance List.

B. Suspension and Reinstatement of Issuance of Health Certificates

If the level of compliance in a complying processing establishment is unacceptable, the issuance of Health Certificates for the export of raw clean edible bird’s nest to China shall be suspended until a satisfactory level of compliance has been attained within an agreed timeframe.

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S

NEST TO CHINA

Document No: 04 Revision No: 2 Page: 10 of 31 Effective Date: 27 May 2013

Notification of suspension and reinstatement of issuance of Health Certificates shall be given in writing to the processing establishment with a copy sent to the Food Safety and Quality Division, State Health Department.

C. Communication of Changes

Any changes in the Compliance List shall be communicated in writing to all concerned parties by the FSQD (HQ).

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S

NEST TO CHINA

Document No: 04 Revision No: 2 Page: 11 of 31 Effective Date: 27 May 2013

Flow Chart: Assessment of Compliance Status of Processing Establishment for Export of Raw Clean Edible Bird’s Nest to China

Submission of application (form + supporting documents) by

Processing Establishment

Listing of processing establishment into the Compliance List for Export of Edible Bird’s Nest to China

Final report reviewed by the FSQD (HQ)

On-site verification performed by the assigned auditors

CARs

Comply

Closed

Not Closed within 6

months

Yes

No

Lead Auditor forwards a preliminary report to FSQD (HQ)

within 5 working days from date of audit

Follow-up audit shall be carried out, where necessary

Review of application

by FSQD (HQ) Not Complete

Complete

The lead auditor shall submit a written report with

recommendation for listing of the processing establishment to

FSQD (HQ)

The FSQD (HQ) shall review the report

Notify applicant

Terminate

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Flow Chart: Surveillance Verification on the Listed Processing Establishment for the Export of Raw Clean Edible Bird’s Nest to China

Surveillance verification performed by assigned auditors

(every 6 months)

CARs (within agreed

time frame of not exceeding 30

days)

Lead auditor forwards a preliminary report FSQD (HQ) within

5 working days from the date of surveillance audit

Follow-up audit shall be carried out where necessary

Closed

Not Closed Agreed time frame not more than

6 months from the date of surveillance audit

(e.g. major upgrading)

Maintained in the Compliance List for Export of Edible Bird’s Nest to China

Final report reviewed by the FSQD (HQ)

Delisted from the Compliance List

Suspension / Reinstatement of issuance Health Certificate (if HC is required)

Reminder notice for unclosed CARs after 4 months from the date of surveillance audit with a copy to

FSQD (HQ)

Report on the remaining closed CARs to FSQD (HQ) within 5

working days

Lead auditor forwards a final report to FSQD (HQ) within 14 working days from

the date of CARs be closed

CARs Closed

Yes

No

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S NEST

TO CHINA

Document No: 04 Revision No: 2 Page: 13 of 31 Effective Date: 27 May 2013

Appendix 1 Form EBN/E/1-2013

Ministry of Health

APPLICATION FORM FOR LISTING OF PROCESSING ESTABLISHMENT FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S NEST TO CHINA

1.0 Type of Application(1): New Re-apply

Others, please specify …………………………………………………………

2.0 Product (1): Raw clean Others, please specify……………………………………..

3.0 Particulars of Applicant 3.1 Name of Applicant: ………………………………………………………………………………………………….…… 3.2 NRIC Number: …………………………………………………………………………………………………………….. 3.3 Name and Address of Company: …………………………………………………………………………………….. ........................................................................................................................................................... ........................................................................................................................................................... 3.4 Tel. No.: ………………………………3.5 Fax No.: …………………………..3.6 H/P No. ……………………….. 3.7 E-mail address: …………………………………………………………………………………………………………… 3.8 Company Registration Number (ROC): …………………………………………………………………………… (Please attach copy of the certificate)

3.9 Correspondence Address (if different from para 2.3): . ……………………………………………………… ……………………………………………………………………………………………………………………………………… ...........................................................................................................................................................

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S NEST

TO CHINA

Document No: 04 Revision No: 2 Page: 14 of 31 Effective Date: 27 May 2013

3.10 Supporting Documents (please attach e.g. license, any certification etc.):……………………………………… ---------------------------------------------------------------------------------------------------------------------------------- (1) Tick () where appropriate

4.0 Information on Sources of Raw Material:

(a) Bird House

No Name of bird house Address of bird house Registration no.with

Department of

Veterinary Services

(b) Middlemen

No Name of middlemen Address

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S NEST

TO CHINA

Document No: 04 Revision No: 2 Page: 15 of 31 Effective Date: 27 May 2013

(c) Processing establishment

No Name of Processing establishment Addresss

I hereby, based on my knowledge and the information gathered to this date, certify that the above

statements are all correct without prejudice.

Signature: ______________________________

Name: ______________________________

Date: ______________________________

Company stamp :_________________________

Please return complete application form to:

Senior Director Food Safety and Quality Division Ministry of Health Level 3, Block E7, Complex E, 62590 Putrajaya. Tel. No:03-88833558/3557 Fax No:03-88893815 Email: [email protected]

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S NEST

TO CHINA

Document No: 04 Revision No: 2 Page: 16 of 31 Effective Date: 27 May 2013

Appendix 2

Ministry of Health

FOOD SAFETY AND QUALITY DIVISION MINISTRY OF HEALTH MALAYSIA

CHECKLIST ON THE CONTROL OF THE SAFETY OF EDIBLE BIRD’S NEST

ALONG THE FOOD SUPPLY CHAIN

ESTABLISHMENT NAME AND ADDRESS:

DATE INSPECTED: PRODUCT(S):

NAME AND TITLE OF RESPONSIBLE PLANT OFFICIAL:

TEL. NO.:

INSTRUCTIONS:

Answer the following questions by checking the appropriate box.

NC= No Conformity PC= Partial Conformity C= Conformity

PART A : BIRD HOUSE NC PC C COMMENTS 1 Bird houses shall be designed to facilitate

regular cleaning

2 Bird houses shall have adequate ventilation to prevent the build up of ammonia and dust

3 The surfaces of batten area shall be made with material which is impervious and solid. Joints and corners shall be properly sealed

4 Birds house, its surroundings and equipment used shall be kept clean to prevent cross contamination to the EBN

i. Guano shall be removed regularly and shall not be allowed to accumulate to a level which may cause food safety hazard

ii. Cleaning equipment shall be cleaned before and after each use and stored at an appropriate place

iii. Tools used to collect EBN shall be kept clean before and after each use and stored at an appropriate place

iv. Containers used to hold EBN shall be made from non-toxic materials and easy to clean. Containers used shall be kept clean before and after each use and stored at an appropriate place

v. Chemical shall not be stored in the bird house. Chemicals shall be kept separately

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S NEST

TO CHINA

Document No: 04 Revision No: 2 Page: 17 of 31 Effective Date: 27 May 2013

and under lock and key

vi. Cleaning schedule and records shall be made available

5 Pest control: i. Pesticide may be used to control pests.

However, the use of pesticides shall be controlled to prevent contamination to EBN. Prohibited pesticides shall not be used. Records on pest control shall be made available

6 EBN handlers shall maintain personal hygiene and shall: i. wear clean, suitable and proper clothing

including shoes

ii. maintain personal iii. wash hands before entering the bird

house and after using the toilet. Hand washing facilities with liquid soap shall be provided

iv. only use potable water or clean water, whenever necessary

7 EBN handlers who suffers from, or is a carrier of food-borne diseases or suspected to be suffering from, or to be a carrier of food-borne diseases shall: i. not be allowed to enter bird’s house or

handle EBN

ii. immediately report to the management of bird’s house pertaining to his health condition

iii. be suspended from working in the bird’s house until he is certified cured from the disease and medically fit to work by a registered medical practitioner before he is allowed to enter the bird’s house or handle EBN

8 Employers are responsible for ensuring that EBN handlers are adequately trained and knowledgeable in food safety requirement

9 All records on the above requirements shall be maintained and made available

GENERAL COMMENTS

EVALUATION OF COMPLIANCE

VERIFIERS NAME AND SIGNATURE

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S NEST

TO CHINA

Document No: 04 Revision No: 2 Page: 18 of 31 Effective Date: 27 May 2013

Ministry of Health

FOOD SAFETY AND QUALITY DIVISION MINISTRY OF HEALTH MALAYSIA CHECKLIST ON THE CONTROL OF THE SAFETY OF EDIBLE BIRD’S NEST

ALONG THE FOOD SUPPLY CHAIN ESTABLISHMENT NAME AND ADDRESS:

DATE INSPECTED: PRODUCT(S):

NAME AND TITLE OF RESPONSIBLE PLANT OFFICIAL:

TEL. NO.:

INSTRUCTIONS:

Answer the following questions by checking the appropriate box.

NC= No Conformity PC= Partial Conformity C= Conformity

NC PC C COMMENTS

GENERAL COMMENTS

EVALUATION OF COMPLIANCE

VERIFIERS NAME AND SIGNATURE

PART B : MIDDLEMEN / EXPORTER

1 All middlemen / exporter involved in edible bird’s nest supply chain shall: iv. Registered with DVS

v. Implement one step up and one step

down food traceability system with written procedure and record in place

vi. Obtain raw unclean edible bird’s nest from bird house that has been registered with DVS

vii. Exporter obtain raw clean bird’s nest from

processing establishment that has been listed with MOH and approved by CNCA

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S NEST

TO CHINA

Document No: 04 Revision No: 2 Page: 19 of 31 Effective Date: 27 May 2013

Ministry of Health

FOOD SAFETY AND QUALITY DIVISION MINISTRY OF HEALTH MALAYSIA CHECKLIST ON THE CONTROL OF THE SAFETY OF EDIBLE BIRD’S NEST

ALONG THE FOOD SUPPLY CHAIN

ESTABLISHMENT NAME AND ADDRESS:

DATE INSPECTED: PRODUCT(S):

NAME AND TITLE OF RESPONSIBLE PLANT OFFICIAL:

TEL. NO.:

INSTRUCTIONS:

Answer the following questions by checking the appropriate box.

NC= No Conformity PC= Partial Conformity C= Conformity

PART C : PROCESSING ESTABLISHMENT NC PC C COMMENTS 1 All processing establishments shall:

i. Registration of food premises (Reg. 3, FHR) Premise shall be registered with Ministry of Health Malaysia

ii. Food safety assurance programme (Reg. 9, FHR) Implement food safety assurance programme in the food premises

iii. Food traceability system (Reg. 10, FHR) a) Implement one step up and one step

down food traceability system at any specified stage of a food chain from production to distribution with written procedure and records in place

iv. Food handlers training (Reg. 11 & 30, FHR) a) All workers has undergone food

handlers training prior to work

b) All food handlers shall obtain valid SLPM training certificate

v. Medical examination and health condition of food handler (Reg. 11 & 31, FHR) a. All workers has been medically

examined and vaccinated by a registered medical practitioner prior to work

b. Any food handler who carrier or suspected or suffering from food-borne diseases shall—

1. not allow to enter processing area or handle food until being certified

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S NEST

TO CHINA

Document No: 04 Revision No: 2 Page: 20 of 31 Effective Date: 27 May 2013

medically fit by a registered medical practitioner

2. immediately report to the management pertaining to his health condition

vi. Clothing of food handler (Reg. 32, FHR) A food handler shall wear :

a. Clean, suitable and light coloured outer overall or

b. Light coloured apron, head cover and footwear

b. The protective clothing shall not be worn other than in food premises and shall be kept in suitable place when not in use

vii. Personal hygiene of food handler (Reg. 33, FHR) A food handler during processing shall maintain good personal hygiene practices

viii. Duty to keep food premises clean (Reg. 34, FHR) A food handler shall ensure that food premises where the food is handled are kept clean and free from rubbish, pest, dirt or soot, sweepings, ashes, wastes and cobwebs at all time

ix. Handling of food, appliances, etc. (Reg. 35, FHR) Food appliances and containers shall be handled in accordance with the following requirements:

1. Prevent food contamination 2. All appliances and containers used in

food premises are to be maintained in a good condition, easily cleaned and, where necessary disinfected at all times

3. All appliances and containers made from safe material and easy to clean

4. All appliances and containers are installed in such manner as to allow adequate cleaning

5. Separate food contact surface shall be used for raw clean and raw unclean edible bird’s nest

6. Cleaning activity shall not be carried out while food is being handled

x. Preparing, Packing and Serving of Food (Reg. 36, FHR) 1. Food packaging material and packaging

operation provide adequate protection for food products to minimize contamination and prevent damage to the food products from any contamination

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S NEST

TO CHINA

Document No: 04 Revision No: 2 Page: 21 of 31 Effective Date: 27 May 2013

2. Food packaging materials are non-toxic and of sufficient strength to resist tearing and puncturing

3. Food packaging materials do not affect safety and suitability of food under the specified conditions of storage and use

4. Adequate and suitable facilities to store packaging material

5. Not use his bare hands to handle any unwrapped food

6. Not use any raw material or ingredient that may be contaminated with parasites, pathogenic microorganisms, toxic, or decomposed or foreign substances which may cause the finished food product unfit for human consumption

xi. Storage of food (Reg. 25 & 38, FHR) Food shall be stored store food in accordance with the following requirements:

1. Food is not stored in a same storage facility with cleaning agent and disinfectant

2. Different store room for the storage of raw food materials and ingredients and for the storage of processed food materials in all food premises

3. All fittings or equipment used or to be used for the storage of food shall be made from suitable material, permit adequate cleaning and disinfection and adequate space for storage of food.

4. Clean, free from contamination, odours, protected from damp, dust or pests and prevented from being in contact with raw material or any other article which may contribute to any contamination of food

5. Food is placed or stacked with a minimum space of:

i. 15 centimeters between the wall of a storage facility and the food stored; and

ii. 20 centimeters above the floor

6. Raw materials is labelled and stored properly

7. Stock is rotated regularly on a “first in first out” basis

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S NEST

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Document No: 04 Revision No: 2 Page: 22 of 31 Effective Date: 27 May 2013

iv. Location (Reg. 12, FHR) Food premises shall be located away from sources of contamination including aeration ponds, septic tanks and waste disposal sites

v. General design (Reg. 13, FHR) Food premises shall be designed and constructed as such to facilitate cleaning and disinfection

vi. Water supply (Reg. 14, FHR) a. Adequate supply of potable water and

facilities for storage

b. The water supply shall be adequately protected against any contamination

vii. Cleanliness of food premises (Reg. 15, FHR) a. Food premises shall be maintained at

all times in a good, clean and tidy condition and free from harbourage of pest.

b. The cleaning of food premises shall be carried out at least once daily.

c. Adequate facilities for the cleaning, disinfecting and storing of appliances used in food premises. Facilities shall be constructed from corrosion resistant materials and easily cleaned.

d. Shall be provided an adequate supply of suitable cleaning agents, disinfectant and tools to enable regular and proper cleaning of a food premises and appliances used.

e. Every cleaning agent and disinfectant used in the food premises shall be adequately labelled.

viii. Pest control in food premises (Reg. 16, FHR) a. Food premises shall, free from pest at

all time.

b. A pest control treatment shall only be carried out by using a suitable chemical agent and without posing a threat to the safety of food.

ix. Disposal of refuse (Reg. 17, FHR) a. All food waste, non edible by-products and other refuse shall be—

1. removed from where food is present as soon as possible

2. deposited in closable containers and kept in a good condition, easily cleaned and where necessary,

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S NEST

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Document No: 04 Revision No: 2 Page: 23 of 31 Effective Date: 27 May 2013

disinfected b. Adequate provision for storage and

disposal of food waste or non edible by-products and other refuse.

x. Floor surfaces (Reg. 18, FHR) All floors in food premises shall be made from impervious, non-absorbent, non-toxic materials, maintained in a good condition, easily cleaned and adequately drained, where necessary disinfected

xi. Wall surfaces (Reg. 19, FHR) All walls in food premises shall be made from impervious, non-absorbent, non-toxic materials, maintained in a good condition, easily cleaned, require a smooth surface up to a height appropriate for a food process, where necessary disinfected

All angles between a wall and a floor in a food premises shall be sealed and coved to facilitate cleaning, where necessary

xii. Lighting (Reg. 20, FHR) Provided with adequate lighting and does not lead, or cause any contamination of food

xiii. Ventilation (Reg. 21, FHR) a. A ventilation system in food premises shall be:

1. provided with adequate ventilation and does not lead, or cause any contamination

2. enable filters and other parts readily accessible for cleaning or replacement

b. In place to avoid air flow from contaminated area to clean area

xiv. Ceiling (Reg. 22, FHR) All ceilings made from suitable material and able to prevent accumulation of dirt and dust

xv. Door (Reg. 23, FHR) All doors in food premises shall be made from smooth, non absorbent surface, and easily cleaned; self closing system, where necessary disinfected

xvi. Furniture fitting and food contact surfaces (Reg. 24, FHR) All furniture, fittings and food contact surfaces used or to be used for the preparation, serving, storage, conveyance or distribution of food in any food premises shall be well maintained and kept

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S NEST

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Document No: 04 Revision No: 2 Page: 24 of 31 Effective Date: 27 May 2013

clean at all times and shall be of impervious material and easily cleaned. xvii. Changing room (Reg. 26, FHR) Changing room shall be made available. xviii. Wash-basin (Reg. 27, FHR)

a. Adequate number of non-hand operated (tap) wash-basin suitably provided.

b. The wash-basin shall, at all times, be: 1. supplied with potable running

water;

2. supplied with detergent and hand drying facilities i.e. paper towel or automatic hand dryer

3. kept clean and maintained in a good condition;

c. Separate wash-basin for washing hand and washing food

xix. Toilet room (Reg. 28, FHR) a. Adequate number of toilets shall be

provided.

b. Toilet shall— 1. be provided running water,

detergent and hand drying facility or clean roller towels or paper towels at all times

2. be kept clean and properly ventilated

3. not directly open to any room used for storage, production and serving of food

xx. Drainage facility (Reg. 29, FHR) a. Adequate, made from suitable material,

easily cleaned and well maintained.

b. Avoid flow of waste water from dirty to clean area

2. Receiving Of Raw Material a. Raw material obtained from DVS listed

birdhouse or middlemen.

b. Container to carry raw material shall be made from suitable and safe material, easily cleaned and prevent contamination.

3. Carriage Of Food (Reg. 56, FHR) 1. A person who carries food shall ensure

that a vehicle used in the course of carriage of food-

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Document No: 04 Revision No: 2 Page: 25 of 31 Effective Date: 27 May 2013

a. is clean and in a good working condition

b. where necessary, effectively permit the separation of food from non-food items during carriage to prevent any risk of contamination

c. is not used for carrying hazardous, toxic or poisonous item

2. A person who intends to use any vehicle to carry food shall ensure that the vehicle is cleaned after being used to carry different foods or non-food items

2. A person who uses any vehicle to carry food of swine origin (sus scrofa) shall not use the same vehicle to carry any food of non-swine origin

4 Specific Requirements for Export of Raw Clean Edible Bird’s Nest to China

a) Traceability The traceability system should able to identify the bird’s house supplying the raw materials.

b) Labelling of finished products

1. The outer and inner packaging shall indicate :

a) name and weight of product b) registration number of swiflet premises c) name, address and registration

number of processing establishment

d) storage requirements e) manufacturing date f) other relevant information 2. All information shall be written in both

Chinese and English

c) Own check for water a) Scheduled for own check shall be

available (at least twice per year)

b) Minimum parameter tested according to MOH requirement

c) Report of analysis shall be available and comply with the standard

d) Investigation has been carried out for contravening sample. Report shall be

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S NEST

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Document No: 04 Revision No: 2 Page: 26 of 31 Effective Date: 27 May 2013

GENERAL COMMENTS

EVALUATION OF COMPLIANCE

VERIFIERS NAME AND SIGNATURE

available d) Control of detergent or disinfectant

a) The expiry date of the cleaning agent

and disinfectant used in the food premises shall be stated in the label

b) The cleaning agent and disinfectant used is not expired

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF RAW CLEAN EDIBLE BIRD’S NEST

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Document No: 04 Revision No: 2 Page: 27 of 31 Effective Date: 27 May 2013

Appendix 3

Ministry of Health

STANDARD OPERATING PROCEDURE ON THE CONTROL OF NITRITE LEVEL IN EDIBLE BIRD’S NEST

ESTABLISHMENT NAME AND ADDRESS: NAME AND TITLE OF RESPONSIBLE PLANT OFFICIAL:

DATE INSPECTED:

INSTRUCTIONS:

Answer the following questions by checking the appropriate box.

NC= No Conformity PC= Partial Conformity C= Conformity NC PC C COMMENTS

1. *Standard Operating Procedure on the Control of Nitrite Level in Edible Bird’s Nest (EBN) shall be available.

2. Standard procedure for softening and cleaning of EBN shall be available and implemented. Records shall be available.

3. Standard procedure for softening and cleaning of EBN shall take into account criteria as stated in the SOP.*

4. Procedure for verification which includes laboratory testing shall be available.

5. Records on verification shall be available. 6. Laboratory shall use ion chromatography

method with limit of detection (LOD) 2 mg/kg or below for testing of nitrite in raw clean EBN.

7 Own check: a) Scheduled for own check shall be

available (at least twice per year)

b) Report of analysis shall be available and comply with the standard.

c) Investigation has been carried out for contravening sample. Report shall be available

GENERAL COMMENTS

EVALUATION OF COMPLIANCE

VERIFIERS NAME AND SIGNATURE

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Document No: 04 Revision No: 2 Page: 28 of 31 Effective Date: 27 May 2013

Appendix 4

Form CAR-EBN-Rev 00

VERIFICATION : CORRECTIVE ACTION REQUEST (CAR)

Audit No: CAR No.: Date: Processing Establishment/ Transport Vehicle/Trader/ Middlemen/Bird House

Address/Tel. No.:

Company representative(s):

Auditors:

Non-Conformance Report :

Partial Compliance (PC) Non-Compliance (NC)

Objective evidence & Location

Potential effect of non- Conformance

Root cause that needs to be addressed (if any)

Signature: Name: Company Representative

Signature: Name: Auditors

Corrective Action required to fix and prevent recurrence: (To be completed by the Company)

Completion target date: ……………………..

Signature:…………………. Name:…………………… Company Representative

Signature: …………………. Name: …………………….. CA Auditor

Follow-up audit comments Date Car Closed Out: ……………………………

Signature: ………………………. Name: …………………………… CA Auditor

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Document No: 04 Revision No: 2 Page: 29 of 31 Effective Date: 27 May 2013

Appendix 5

VERIFICATION REPORT

1. Name of Processing Establishment:

2. Address :

3. Date of Audit :

4. Audit No. :

5. Product(s) :

6. Scope of Audit :

7. Company Representative(s) :

8. Auditors :

9. Results and Observations1 :

1 Fill up the table below

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Document No: 04 Revision No: 2 Page: 30 of 31 Effective Date: 27 May 2013

NO. NON-CONFORMANCE CATEGORY

PC / NC

CORRECTIVE ACTION

TAKEN

COMPLETION

TARGET DATE

CLOSED-OUT

10. (a) Status of Overall Compliance of Establishment (please tick where relevant):

Compliance (C)i :

Partial Compliance (PC)2 :

Non-Compliance (NC)3 : :

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Document No: 04 Revision No: 2 Page: 31 of 31 Effective Date: 27 May 2013

(b) Reasons for Status of Overall Compliance :

------------------------------------------------------------------------------------------------------------------------------- ----

----------------------------------------------------------------------------------------------------------------------------- ------

General Comments/Recommendation:

Signature

Name of Auditor

Position

Date

:

:

:

:

.........................................................................................

.........................................................................................

.........................................................................................

.........................................................................................

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1 C (Compliance) : Probability of occurrence of food safety hazard is low

1 PC (Partial Compliance) : Situation where the probability of occurrence of food safety hazard is high if

control measures are not taken. Recurrence of partial compliance

can result in non compliance.

1 NC (Non-Compliance) : The non compliance subjects the product to an unacceptable level

of exposure to any food hazard that jeopardizes the fitness for

purpose food