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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS Document No: 01 Revision No: 01 Page: 77 of 417 Effective Date: 1 March 2021 Annex 2 (a) SPECIFIC EXPORT REQUIREMENTS FOR EXPORT OF FISH AND FISHERY PRODUCTS TO PEOPLE’S REPUBLIC OF CHINA BACKGROUND Export establishments intend to export fish and fishery products to China shall comply with all China requirements on fish and fishery products. The export establishment and the category of the products to be exported shall be approved and listed by the General Administration of Customs China (GACC) prior to export. SPECIFIC REQUIREMENTS 1. Export establishments shall implement Hazard Analysis Critical Control Point (HACCP) as a food safety assurance programme. 2. The export establishment shall only process and export fish and fishery products to China once the export establishment is included in the List of Fishery Products Establishments Registered to P.R. China as published on the GACC website http://jckspj.customs.gov.cn/spj/zwgk75/2706880/2811812/2812040/index.html 3. Trader shall obtained fish and fishery products from the GACC approved establishments as listed on the GACC website http://jckspj.customs.gov.cn/spj/zwgk75/2706880/2811812/2812040/index.html 4. The listed export establishments shall participate in Monitoring Export Programme.

Annex 2 (a) SPECIFIC EXPORT REQUIREMENTS FOR EXPORT OF

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Page 1: Annex 2 (a) SPECIFIC EXPORT REQUIREMENTS FOR EXPORT OF

Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS

Document No: 01 Revision No: 01 Page: 77 of 417 Effective Date: 1 March 2021

Annex 2 (a)

SPECIFIC EXPORT REQUIREMENTS FOR EXPORT OF FISH AND FISHERY

PRODUCTS TO PEOPLE’S REPUBLIC OF CHINA

BACKGROUND

Export establishments intend to export fish and fishery products to China shall comply with

all China requirements on fish and fishery products. The export establishment and the

category of the products to be exported shall be approved and listed by the General

Administration of Customs China (GACC) prior to export.

SPECIFIC REQUIREMENTS

1. Export establishments shall implement Hazard Analysis Critical Control Point (HACCP) as a food safety assurance programme.

2. The export establishment shall only process and export fish and fishery products to

China once the export establishment is included in the List of Fishery Products

Establishments Registered to P.R. China as published on the GACC website

http://jckspj.customs.gov.cn/spj/zwgk75/2706880/2811812/2812040/index.html

3. Trader shall obtained fish and fishery products from the GACC approved

establishments as listed on the GACC website

http://jckspj.customs.gov.cn/spj/zwgk75/2706880/2811812/2812040/index.html

4. The listed export establishments shall participate in Monitoring Export Programme.

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS

Document No: 01 Revision No: 01 Page: 78 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 2 (b).

VERIFICATION AND LISTING PROCEDURE

Verification and listing procedure shall be carrying out as laid down in this protocol.

Verification checklist shall be as in Annex 2 (c).

ADDITIONAL INFORMATION

Export facilities shall ensure compliance to China requirements as laid down in the China

National Standard such as stated below. However, it is the responsibility of the export

facilities to check on the latest import requirements as imposed by the importing country as

it is subject to change from time to time

a) GB 2760-2014 Standard for Food Additive Use

b) GB 2761-2017 Maximum Limit of Mycotoxins in Foods

c) GB 2762-2017 Maximum Limit for Contaminant in Food

d) GB 2763-2019 Maximum Residue Limits for Pesticides in Food

e) GB 2733-2015 Fresh and Frozen Aquatic Product of Animal Origin

f) GB 5749-2006 Sanitary Standard for Drinking Water

g) GB 7718-2011 General Rules for the Labelling of Pre-packaged Foods

h) GB 10133-2014 Aquatic Seasoning Product

i) GB 10136-2015 Animal aquatic product

j) GB 14881-2013 General Hygiene Code for Food Production

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS

Document No: 01 Revision No: 01 Page: 79 of 417 Effective Date: 1 March 2021

k) GB 14882-1994 Limited Concentration Standard of Radioactive Substances in

Food

l) GB 14930.1-2015 Detergent

m) GB 14930.2-2012 Sanitizer

n) GB 19643-2016 Seaweed and its product

o) GB 20941-2016 Hygienic Code for the Production of Aquatic Products

p) GB 29921-2013 Maximum Limits for Pathogenic Microorganism in Food

q) GB 31602-2015 Dried Sea Cucumber

r) GB/T 27341-2009 HACCP System General Requirements for Food Processing

Plants

s) GB 28050-2011 General Rules for Nutrition Labelling of Pre-Packaged Foods

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS

Document No: 01 Revision No: 01 Page: 80 of 417 Effective Date: 1 March 2021

Annex 2 (b) (i)

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

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS

Document No: 01 Revision No: 01 Page: 81 of 417 Effective Date: 1 March 2021

3.0 Food Safety Assurance Program In-Place

HACCP Implementation Certification*

GMP Implementation Certification*

Others, please specify Implementation 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

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS

Document No: 01 Revision No: 01 Page: 82 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

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS

Document No: 01 Revision No: 01 Page: 83 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

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS

Document No: 01 Revision No: 01 Page: 84 of 417 Effective Date: 1 March 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, 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

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS

Document No: 01 Revision No: 01 Page: 85 of 417 Effective Date: 1 March 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

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS

Document No: 01 Revision No: 01 Page: 86 of 417 Effective Date: 1 March 2021

1.5 Registration number and type of transport vehicle to be used in the export supply chain:

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

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Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FOOD PRODUCTS

Document No: 01 Revision No: 01 Page: 87 of 417 Effective Date: 1 March 2021

Annex 2 b (ii)

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

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Document No: 01 Revision No: 01 Page: 88 of 417 Effective Date: 1 March 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

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Document No: 01 Revision No: 01 Page: 89 of 417 Effective Date: 1 March 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:

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

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Document No: 01 Revision No: 01 Page: 90 of 417 Effective Date: 1 March 2021

Annex 2 (b) (iii)

Name List of Fishery Establishments Applying to Register in China

Name Address City/

County

State/

Province/

District

Processing

Capacity

(Annual output)

Date:

Company

stamp:

Signature of Applicant:

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Document No: 01 Revision No: 01 Page: 91 of 417 Effective Date: 1 March 2021

Annex 2 (b) (iv)

Registration Conditions For Production

Enterprise of Imported Aquatic Product

And Key Points of Reference Check

Instructions for filling the form:

1. According to the Provisions on the Administration of Registration of

Overseas Production Enterprises of Imported Food (Order No. 243 of the

General Administration of Customs), the sanitary conditions of overseas

aquatic product production enterprises that apply for registration in China shall

comply with the relevant provisions of Chinese laws, regulations and

standards and the Protocol of Inspection and Quarantine Requirements For

The Aquatic Products Exported To China. This form is for the overseas

competent authority of the imported aquatic products to conduct official

inspection on aquatic product production enterprises by carrying out key point

reference audit based on the main conditions and basis listed in this form. At

the same time, overseas aquatic product production enterprises should fill in

and submit supporting materials based on the listed main conditions and

basis. Overseas aquatic product production enterprises may carry out self-

inspection according to the key points of the reference check as self-

assessment before applying for registration.

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Document No: 01 Revision No: 01 Page: 92 of 417 Effective Date: 1 March 2021

2. Overseas competent authority and overseas aquatic product production

enterprises should truthfully make compliance judgments based on the actual

situation of the comparison inspection/check.

3. The submitted materials should be filled out in Chinese or English, and the

content should be true and completed. The attachments should be numbered.

The number and content of the attachments should accurately correspond to

the item numbers and content in the "Filling Requirements and Evidentiary

Materials" column, and a list of the supporting materials shall be submitted at

the same time.

4. "Aquatic products" refers to aquatic animal and plant products and their

products for human consumption, including aquatic animal products and their

products such as jellyfish, mollusk, crustaceans, echinoderms,

cephalochordate, fish, amphibians, reptiles, aquatic mammals, etc. and

marine plants and their products such as algae, excluding live aquatic animals

and aquatic animal and plant propagation materials.

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Document No: 01 Revision No: 01 Page: 93 of 417 Effective Date: 1 March 2021

□New registration □Renovation and expansion

□Restore registration qualification

Part I Enterprise Basis Profile

1. Enterprise name

2. Address

3. Registration number

4. Registration Approval Agency

5. Enterprise Type

□ Aquatic product production enterprise

□ Freezer fishing vessel

□ Factory fishing vessel

□ Transport fishing vessel

□ Warehouse/ Cold Store

6.Type of registered product (list the specific product name and storage

conditions: for example, Atlantic salmon (chilled/frozen)

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Document No: 01 Revision No: 01 Page: 94 of 417 Effective Date: 1 March 2021

□ Fish:

□ Crustaceans:

□ Mollusca:

□ Echinoderms:

□ Jellyfish:

□ Aquatic plants:

□Others (cephalochordate, amphibians, reptiles, aquatic mammals,

etc.):

7. Production processing capacity (tons/year, For warehouse/storage,

please fill in the storage capacity)

8. Current importing country

9. Contact person name, phone number and email

10. Has the enterprise conducted self-inspection in accordance with the

"Registration Conditions For Production Enterprise of Imported

Aquatic Product And Key Points of Reference Check " and confirmed

that it can meet the corresponding requirements. (YES/NO)

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Document No: 01 Revision No: 01 Page: 95 of 417 Effective Date: 1 March 2021

Part II Enterprise Statement

1. This enterprise declares that the aquatic products exported to China

and their production process comply to the relevant provisions of Chinese

laws, regulations and standards.

2. The above information and additional materials submitted are true and

correct.

Name and position of legal representative

________________________________________

Signature of legal representative and company seal Date

________________________________________

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Document No: 01 Revision No: 01 Page: 96 of 417 Effective Date: 1 March 2021

Part III Confirmation by the Competent Authority

After verification and confirmation, it is hereby certified that the above-

mentioned materials provided by the enterprise are true and correct, and that

the enterprise's sanitary condition can meet the relevant provisions of Chinese

laws, regulations and standards.

Name and position of the person in charge

__________________________________________

Signature of person in charge and stamp of Competent Authority (Date)

__________________________________________

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Part IV Main Conditions of Registration for Overseas Production Enterprises of Imported Aquatic Products and Key Points of Reference Check

Items Conditions and Basis Filling Requirements And

Evidentiary Materials

Audit Key Points Compliance

Judgement

Remarks

1. Basic situation of the company

1.

Enterprise

Basis

Profile

1. Articles 6 and 7 of the

Provisions on the

Administration of Registration

of Foreign Production

Enterprises of Imported Food

2. "Administrative Measures for

Inspection, Quarantine and

Supervision of Import and

Export Aquatic Products"

3. Protocol on Inspection and

1.1 Fill in 1. Basic

Information Form of

Overseas Production

Enterprise of Imported

Aquatic Products

1. The enterprise shall

fill in the information

truthfully, and the basic

information should be

consistent with the

information submitted by

the competent authority

of the exporting country,

and shall be consistent

with the actual

production and

□ Compliant

□ Incompliant

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Document No: 01 Revision No: 01 Page: 98 of 417 Effective Date: 1 March 2021

Quarantine of Aquatic

Products Exported to China

signed by the competent

authority of the applicant

country and the General

Administration of Customs

processing situation.

2. The aquatic products

intended to be exported

to China shall comply

with the product scope

as stipulated in the

relevant agreements,

protocols,

memorandums, etc. for

the inspection and

quarantine of aquatic

products exported to

China.

2. Enterprise Location And Workshop Layout

2.1 Site

selection

and

1. Clause 3.1 and 3.2 of

"General Hygienic Code for

Food Production" (GB14881).

2.1.1 Provide layout plan

of the plant area,

indicating the names of

1. The plant layout

meets the needs of

production and

□ Compliant

□ Incompliant

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Document No: 01 Revision No: 01 Page: 99 of 417 Effective Date: 1 March 2021

surrounding

of the plant

2. Clause 3.1 and 3.2 of

"Hygienic Code for the

Production of Aquatic

Products" (GB 20941).

different operation areas.

2.1.2 Provide pictures of

surrounding area where

the plant is located. The

pictures shall indicate the

surrounding area

information (urban,

suburban, industrial,

agriculture and residential

areas).

processing.

2. There is no pollution

source around the plant.

2.2

Workshop

layout

1. Clause 4.1 of "General

Hygienic Code for Food

Production" (GB14881).

2. Clause 4.1 of "Hygienic

Code for the Production of

Aquatic Products" (GB 20941).

2.2 Provide workshop

layout plan , indicating the

worker flow, raw material

and finished goods flow,

water flow, processing

flow, and areas with

different cleanliness level.

1. The workshop layout

shall be reasonable to

meet the requirements

of production and

processing and avoid

cross contamination.

□ Compliant

□ Incompliant

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3. Facilities and Equipment

3.1

Production

and

processing

equipment

1. Clause 5.2.1 of "General

Hygienic Code for Food

Production" (GB14881).

2. Clause 5.2.1 of "Hygienic

Code for the Production of

Aquatic Products”

(GB 20941).

3.1 Provide a list of main

equipment and facilities,

and their processing

capabilities.

1. The enterprise shall

be equipped with

production equipment

which match its

production capacity.

□ Compliant

□ Incompliant

3.2 Storage

facilities

1. Part 10 of "General

Hygienic Code of Food

Production" (GB14881).

2. Clause 10.2 of " Hygienic

Code for the Production of

Aquatic Products " (GB

20941).

3.2 If there is a cold

storage, please describe

the temperature control

requirements and

monitoring methods.

(When applicable)

1. The storage facility

could meet the product

storage temperature

requirements.

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Document No: 01 Revision No: 01 Page: 101 of 417 Effective Date: 1 March 2021

4. Water/Ice/Steam

4.1

Production

and

processing

water/

steam/ ice

(if

applicable)

1. "Sanitary Standard for

Drinking Water" (GB 5749)

2. Clause 5.1.1 of "Hygienic

Code for the Production of

Aquatic Products " (GB

20941).

3. Clause 5.1.1 of " General

Hygienic Code for Food

Production " (GB14881).

4.1.1 Provide the photos

of self-provided water

sources or secondary

water supply facilities, and

explain whether there are

any food defense

measures such as

assigning specific person

in charge, locking and so

on. (If applicable)

4.1.2 Provide the

monitoring plan for

production and processing

water and ice/steam which

is direct contact with food

(when applicable),

including bacteriological

1. The production water

monitoring plan should

cover all water outlets in

the plant.

2. Whether the

parameters and

methods meet the

requirement of

"Standard of Drinking

Water" (GB5749).

3. The hygiene control procedures for secondary water supply facilities shall be designated and implemented with appropriate food

□ Compliant

□ Incompliant

□ Not applicable

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examination parameters,

methods, frequency,

records, test results and

the latest 2 test reports.

4.1.3 Provide the boiler

additives used in the

production of steam which

is direct contact with food,

and explain whether they

meet the requirements of

food production and

processing.

defense measures.

.

4. The boiler additives used to produce steam which is direct contact with food shall meet the requirements of food production and processing.

5. Raw Materials, Processing Aids and Packaging Materials

5.1

Receiving of

Raw

Material and

Processing

1. Part 7 of " General Hygienic

Code for Food Production "

(GB14881).

2. Part 7 of " Hygienic Code

5.1 Provide receiving

procedure for raw

materials and additives,

including acceptance

criteria and inspection

1. Acceptance criteria

for raw materials and

additives shall comply

with Chinese regulations

and standard

□ Compliant

□ Incompliant

□ Not applicable

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Aid for the Production of Aquatic

Products " (GB 20941).

methods. requirements.

5.2 Source

of raw

materials

1. Clause 7.2 of " Hygienic

Code for the Production of

Aquatic Products " (GB 20941)

2. The aquatic animal viscera,

egg, skin, fin, scale, bone,

shell and other non-muscle

tissue which are used as raw

materials for aquatic products

shall comply with "Fresh and

Frozen Aquatic Product of

Animal Origin" (GB 2733).

3. The raw materials of animal

aquatic products shall comply

with ""Fresh and Frozen

Aquatic Product of Animal

Origin " (GB 2733)

5.2.1 For the raw materials

of aquatic product with

natural biological toxins or

raw materials of raw

consumed aquatic

products, please provide

the most recent test

report. (When applicable)

5.2.2 If it is a fishing

vessel, provide the official

licensing documents of the

fishing vessel's operating

area, operating time, and

fishing species and

description of fishing

methods. (When

1. The raw materials of

aquatic products with

natural biological toxins

such as bivalves and

puffer fish shall be

tested for toxins, and

received and processed

in accordance with

relevant stipulate to

ensure the safety of raw

materials.

2. The raw materials

used shall meet the

requirements of relevant

agreements, protocols,

memorandums, etc. for

□ Compliant

□ Incompliant

□ Not applicable

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4. The raw materials of algae

products shall comply with

"Algae and its products" (GB

19643).

5. Table 1 of "Limits for

Pathogenic Bacteria in Food"

(GB29921)

6. Clause 3.6 and 3.7 of

"Animal Aquatic Product"

(GB10136).

applicable)

5.2.3 If it is a aquaculture

raw material, provide the

qualification certificate of

the aquaculture farm.

(When applicable)

the inspection and

quarantine of aquatic

products exported to

China。

5.3 Bivalve

Shellfish

Raw

Material

(when

applicable)

1. Clause 7.2 of " Hygienic

Code for the Production of

Aquatic Products " (GB

20941).

2. Table 1 of "Limits of

Pathogenic Bacteria in Foods"

(GB29921).

5.3.1 Provide the sea area

location description of the

source of the shellfish raw

materials and the official

license of the bivalve

catcher.

5.3.2 Provide the

depuration method of

1. Bivalve shellfish shall

come from officially

permitted aquaculture or

fishing water area and

be depurated if

necessary. Farmers or

catchers of shellfish raw

materials shall have a

□ Compliant

□ Incompliant

□ Not applicable

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3. Clause 3.6 and 3.7 of

"Animal Aquatic Product"

(GB10136-2015).

shellfish raw materials.

5.3.2 Provide shellfish

toxin monitoring measures

on raw material shellfish.

license from an official

authority.

2. Perform shellfish

toxin testing on shellfish

raw materials regularly

to verify the safety of

raw materials.

5.4 Food

Additive

(when

applicable)

1. Clause 7.3 of " General

Hygienic Code for Food

Production " (GB14881)

2. Clause 7.3 of " Hygienic

Code for the Production of

Aquatic Products " (GB 20941)

3. "National Food Safety

Standard - Standard for Food

Additive Use " (GB 2760)

5.4 List of food additives

used in production and

processing (including

name, function, addition

amount, etc.).

1. The food additives

used in the production

comply with China's

regulations on the use

of food additives.

□ Compliant

□ Incompliant

□ Not applicable

5.5 1. Clause 8.5 in " General 5.5.1 Provide the 1. The packaging □ Compliant

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Packaging

materials

Hygienic Code for Food

Production " (GB14881).

2. Clause 8.5 in " Hygienic

Code for the Production of

Aquatic Products " (GB

20941).

3. Relevant bilateral inspection

and quarantine agreements,

memoranda and protocols.

supporting materials

indicating that the internal

and external packaging

materials are suitable for

product packaging.

5.5.2 Provide label

sample of finished

products intended to be

exported to China.

material does not affect

the safety and product

characteristics of the

food product under

specific storage and use

conditions.

2. The packaging

labelling shall comply

with the requirements of

bilateral inspection and

quarantine agreements,

memoranda and

protocols.

□ Incompliant

6. Production and Processing Control

6.1

Establishme

nt and

1. Clause 8.1 of " Hygienic

Code for the Production of

Aquatic Products " (GB

6.1.1 Provide the process

flow chart, hazard analysis

worksheets and HACCP

1. The HACCP plan

shall analyze and

effectively control

□ Compliant

□ Incompliant

□ Not applicable

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operation of

HACCP

system

20941).

2. "Hazard Analysis and

Critical Control Point (HACCP)

System - General

Requirements for Food

Production Enterprise" (GB/T

27341).

plan summary of all

products intended to be

exported to China.

6.1.2 Provide CCP

monitoring records,

correction records, and

verification record sample

sheets.

biological, physical and

chemical hazards.

2. The process flow

shall be reasonable and

shall prevent cross

contamination.

3. The setting of CCP

points shall be scientific

and feasible, and the

corrective actions and

verification measures

shall be appropriate.

6.2

Temperatur

e control

1. Clause 8.2.2.1.4, 8.2.2.1.6

of "Hygienic Code for the

Production of Aquatic

Products" (GB 20941)

2. Clause 8.2.2.2.1 of

6.2.1 Provide the thawing

method of raw materials,

as well as the thawing

time and temperature

control requirements (if

1. Control the thawing

time and temperature of

raw materials.

□ Compliant

□ Incompliant

□ Not applicable

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"Hygienic Standards for the

Production of Aquatic

Products" (GB 20941).

(Applicable to refrigerated

aquatic products)

applicable).

6.2.2 Provide temperature

control requirements and

temperature monitoring

equipment for processing

workshop and storage.

(Applicable to refrigerated

aquatic products).

2. The refrigerated

aquatic product

processing workshop

shall have temperature

control measures, and

the processed aquatic

products should be

moved to the

refrigerated environment

as soon as possible,

and the refrigerated

room should be

equipped with

temperature indicators.

6.3 Frozen

aquatic

products

1. Clause 8.2.2.2.2 of "

Hygienic Code for the

Production of Aquatic

Products" (GB 20941)

6.3.1 Provide freezing

method, time and freezing

temperature control

requirements and the

1. Determine the

freezing time and

temperature according

to the thickness, shape

□ Compliant

□ Incompliant

□ Not applicable

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validation of frozen aquatic

products.

6.3.2 For raw consumed

aquatic products, provide

cold treatment

temperature and time.

and production volume

of aquatic products to

ensure that the products

pass the zone of

maximum ice crystal

formation as soon as

possible.

1. Raw consumed

aquatic products should

have adequate cold

treatment methods to

ensure that parasites

harmful to the human

body are killed. Frozen

storage for 7 days at

ambient temperature

below -20℃;

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Frozen to solid at -35°C

or below ambient

temperature, and store

at -35°C or below

ambient temperature for

15 hours;

Frozen to solid at -35°C

or below ambient

temperature, and store

at -20°C or below

ambient temperature for

24 hours.

6.4 Dried

aquatic

products

(when

applicable)

1. Clause 8.2.2.2.3 of

"Hygienic Code for the

Production of Aquatic

Products" (GB 20941)

6.4 Provide the drying

time, drying temperature,

environmental humidity

and water activity of the

final dried aquatic product

1. Ensure that the water

activity of the dried

product is within a safe

range.

□ Compliant

□ Incompliant

□ Not applicable

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and packaging, storage

method.

6.5 Pickled

aquatic

products

(when

applicable)

1. Clause 8.2.2.2.4 of

"Hygienic Code for the

Production of Aquatic Products

" (GB 20941).

6.5 Provide the

sugar/salinity of pickled

aquatic products.

1. Adequate salinity

shall be applied in the

production of pickled

products to prevent the

reproduction of non-

halophilic bacteria.

□ Compliant

□ Incompliant

□ Not applicable

6.6 Canned

aquatic

products

(when

applicable)

1. Clause 8.2.2.2.5 of

"Hygienic Code for the

Production of Aquatic Products

" (GB 20941).

6.6.1 Provide the

sterilization temperature

and time requirements of

canned aquatic products

with different

specifications, and the

latest

sterilization/temperature

record.

1. Canned aquatic

products shall ensure

sufficient sterilization

temperature and time.

□ Compliant

□ Incompliant

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6.6.2 Provide heat

penetration and heat

distribution reports of

sterilization containers

with different

specifications for the

canned aquatic products.

7. Cleaning and Sanitization

7.1

Cleaning

and

sanitization

1. Clause 8.2.1 of "General

Hygienic Code for Food

Production " (GB14881).

2. Clause 8.2.1 of "Hygienic

Code for the Production of

Aquatic Products " (GB

7.1 Provide cleaning

and sanitization measures,

including cleaning and

sanitization methods and

frequency, and verification

for cleaning and

1. Cleaning and

sanitization measures

shall be able to

eliminate cross-

contamination and meet

sanitary requirements.

□ Compliant

□ Incompliant

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20941). sanitization effectiveness.

7.2

Environmen

tal

microbiologi

cal

monitoring

1. Clause 8.2.2.1.2 and

8.2.2.1.3 of "Hygienic Code for

the Production of Aquatic

Products " (GB 20941).

7.2 Provide the

product microbiological

monitoring plan for the

environment and during

processing, including

monitoring parameters,

frequency, judgment

standards, and corrective

measures for positive

results.

1. The focus of

monitoring shall cover

area where

microorganisms are

easy to hide and

reproduce.

2. Sampling point

setting. For example,

when there is major

maintenance,

construction activities,

or sanitary conditions

deteriorate, necessary

sampling points shall be

added to the monitoring

plan.

3. Whether to

□ Compliant

□ Incompliant

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adjust the frequency of

environmental

monitoring plan

implementation

according to the test

results and the risk and

severity of

contamination.

4. Corrective

measures for positive

results.

8. Chemicals, Waste, Pest Control

8.1

Chemical

control

1. Clause 8.3 of "General

Hygienic Code for Food

Production " (GB14881-2013).

2. Clause 8.3 of "Hygienic

Code for the Production of

Aquatic Products " (GB

8.1 Briefly describe the

chemical use and storage

requirements.

1. Prevent

contamination of

products by the

chemicals used.

□ Compliant

□ Incompliant

□ Not applicable

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20941).

8.2 Waste

manageme

nt

1. Clause 8.1.4 of "Hygienic

Code for the Production of

Aquatic Products " (GB

20941).

8.2.1 Provide the pictures

for identification and

separation of the edible

product containers and

waste storage containers

in the workshop.

8.2.2 Briefly describe the

requirements for waste

management procedures.

1. Edible product

containers and waste

storage containers in

the workshop shall be

clearly marked and

separated.

2. Waste shall be stored

separately and disposed

in time to avoid

contamination to the

production.

□ Compliant

□ Incompliant

8.3 Pest

control

1. Clause 6.4 of "General

Hygienic Code for Food

Production " (GB14881)

8.3 Provide the pest

control method and layout

plan, and provide third-

party qualification if

1. Pests and rodents

shall be prevented from

affecting the safety and

hygiene of production

□ Compliant

□ Incompliant

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undertaken by a third

party.

9. Product Traceability

9

Traceability

and recall

1. Part 11 of "General Hygienic

Code for Food Production "

(GB14881).

2. Part 11 of "Hygienic Code

for the Production of Aquatic

Products " (GB 20941).

9. Briefly describe the

product traceability

procedures, taking the

batch number of a batch of

finished product as an

example, explain how to

trace to the corresponding

raw material from the

finished product.

1. Traceability

procedures shall be

established to achieve

the two-way traceability

of the entire chain of

raw materials and

finished products.

□ Compliant

□ Incompliant

10. Personnel Management and Training

10.1

Personnel

health and

hygiene

1. Clause 6.3 of "General

Hygienic Code for Food

Production " (GB14881).

2. Clause 6.3 of "Hygienic

10.1 Provide requirements

of the employees pre-

employment health

management and

1. Before employment,

physical examination

shall be done and prove

to be suitable working in

□ Compliant

□ Incompliant

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manageme

nt

Code for the Production of

Aquatic Products " (GB20941).

employee physical

examination

food processing

enterprise.

2. Employees shall be

physical examined

regularly and the

records shall be kept.

10.2

Personnel

training

1. Part 12 of " General

Hygienic Code for Food

Production " (GB14881).

2. Part 12 of " Hygienic Code

for the Production of Aquatic

Products " (GB20941).

10.2 Provide employee

annual training plan,

content, assessment and

records

1. The training content

shall cover the

memorandum of

inspection and

quarantine of aquatic

products exported to

China, agreements and

protocols, Chinese

regulations and

standards, etc.

□ Compliant

□ Incompliant

11. Self-inspection and self-control

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11. Finished

product

inspection

1. Part 9 of " General Hygienic

Code for Food Production "

(GB14881)

2. Part 9 of " Hygienic Code for

the Production of Aquatic

Products " (GB20941)

3. "National Food Safety

Standard - Fresh and Frozen

Aquatic Products of Animal

Origin" (GB 2733)

4. "National Food Safety

Standard-Animal Aquatic

Products" (GB 10136)

5. "National Food Safety

Standard-Aquatic Seasoning"

(GB 10133)

6. "National Food Safety

Standard-Algae and Its

11.1 Provide finished

product testing

parameters, indicators,

testing methods and

frequency.

11.2 Enterprise with own

laboratory, submits the

enterprise’s laboratory

capability and qualification

certificate; Enterprise

entrusts a third-party

laboratory, provide the

entrusted laboratory

qualification

1. Finished product

testing parameters meet

the requirement of

Chinese standards.

□ Compliant

□ Incompliant

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Products" (GB 19643)

7. " National Food Safety

Standard - Standard for Food

Additive Use " (GB 2760)

8. "National Food Safety

Standard - Limits for

Mycotoxins in Food" (GB 2761)

9. "National Food Safety

Standard - Limits for

Contaminants in Food" (GB

2762)

10. National Food Safety

Standard - Maximum Residue

Limits for Pesticides in Food

(GB 2763)

"Limited Concentrations of

Radioactive Materials in

Foods" (GB 14882)

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"National Food Safety

Standard-Dried Sea

Cucumber" (GB 31602)

12. Statement

11.1

Enterprise

Statement

1. Articles 6 and 7 of the

Provisions on the

Administration of Registration

of Overseas Production

Enterprises of Imported Food

Shall have the signature

of the legal person and

the company stamp.

□ Compliant

□ Incompliant

11.2

Confirmatio

n by the

competent

authority

1. Articles 6 and 7 of the

Provisions on the

Administration of Registration

of Overseas Production

Enterprises of Imported Food

Shall have the

competent authority

personnel signature

and the competent

authority stamp

□ Compliant

□ Incompliant

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Annex 2 (c) AUDIT -9/2014

FOOD SAFETY AND QUALITY DIVISION

MINISTRY OF HEALTH MALAYSIA

GMP IMPLEMENTATION CHECKLIST

PREMISE NAME AND ADDRESS:

AUDIT DATE:

INSTRUCTIONS:

Answer the following questions by checking the appropriate box.

C= Compliance NC= Non-Compliance

1.0 LAYOUT & INFRASTRUCTURE C NC COMMENTS

1.1 Does premise located near to any contamination source? If yes, are the preventive action has been taken to minimize the contamination risk?

1.2 Are premises free of harborages and/or breeding places for rodents, insects and other pests

1.3 Is adequate drainage provided to avoid contamination of facilities and products

1.4 Is sufficient space provided for placement of equipment, storage of materials and for production operations

1.5 Are floors, walls and ceilings constructed of easily cleanable materials and kept clean and in good repair

1.6 Are food and food contact surfaces protected from contamination from pipes, etc., over working areas

1.7 Are food processing areas effectively separated from other operations which may cause contamination of food being processed

1.8 Are food products and processing areas have adequate lighting and protected against contamination from breakage of light bulbs and other glass fixtures

1.9 Is air quality and ventilation adequate to prevent contamination by dust and/or other airborne substances

1.10 Are doors, windows and other openings protected to eliminate entry by insects, rodents and other pests

1.11 Changing Room/Area C NC COMMENTS

Does the changing room/area provided

Does the room/area adequate and appropriate

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1.12 Water Supply C NC COMMENTS

Are the water supply came from the source that comply with regulations and analyzed.

Are the water supply facility designed to prevent the contamination/cross contamination

1.13 Is the sewage disposal system adequate

1.14 Is the plumbing adequately sized, designed, installed and maintained in a manner to prevent contamination

1.15 Storage C NC COMMENTS

Does all the raw material, packaging material and finished product have been stored in separate storage rooms or have a clear separation and arranged properly

Does the storage area clean and properly maintained

1.16 Does the sanitation facility adequate and proper

1.17 Storage of food chemical (ingredient)

2.0 EQUIPMENT AND UTENSILS C NC COMMENTS

2.1 Are all utensils and equipment constructed of adequately cleanable materials and suitable for their intended uses

2.2 Is the equipment designed and used in a manner that precludes contamination with lubricants, contaminated water, metal fragments, etc.

2.3 Is the equipment installed and maintained so as to facilitate the cleaning of equipment and adjacent areas

2.4 Food-contact surfaces shall be corrosion-resistant when in contact with food.

2.5 Each freezer and cold storage compartment used to store and hold food capable of prevent the growth of microorganisms shall be monitored with calibrated thermometer, temperature measuring device, or temperature-recording device.

2.6 Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment shall be treated in such a way that food is not contaminated with unlawful indirect food additives.

2.7 Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food.

3.0 SANITARY FACILITIES AND CONTROLS C NC COMMENTS

3.1 Toilet

Provided, equipped and maintained clean and in good repair.

Maintaining the facilities in a sanitary condition.

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Keeping the facilities in good repair at all times.

Providing self-closing doors.

Providing doors that do not open into processing area areas where food is exposed to airborne contamination

3.2 Are adequate hand washing and/or sanitizing facilities provided where appropriate

3.3 Is all refuse properly stored and protected where necessary from insects, rodents and other pests and disposed of in an adequate manner

4.0 MAINTENANCE AND SANITATION C NC COMMENTS

4.1 Is responsibility for overall plant sanitation specifically assigned to competent individual

4.2 Testing procedures shall be used where necessary to identify sanitation failures or possible food contamination

4.3 Are the building, facility, utensil and equipment kept clean and in good condition

4.4 Cleaning and sanitation program C NC COMMENTS

Does the premise have written procedure and training on cleaning and sanitation for all equipments

Does the cleaning and sanitation procedure appropriate and conducted according to schedule

Does the cleaning chemical used according to the procedure

Does the Cleaning and sanitation program have been followed accordingly

Is cleaning of facilities and equipment conducted in such a manner as to avoid contamination of food products

Does the company conducted any testing to monitored the effectiveness of the cleaning program

Are detergents, sanitizers, hazardous materials and other supplies used in a safe and effective manner

Are cleaning compounds and hazardous materials kept in original containers, stored separate from raw materials and locked in designated area.

4.5 Cleaning / Maintenance tools C NC COMMENTS

Tools are suitable with the intended use and maintained

Stored properly at the designated area

Made from the materials that is easy to cleaned

4.6 Equipment- Maintenance and Calibration C NC COMMENTS

Does the premise have the maintenance program and schedule as

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well as calibration program and schedule

Does the preventive maintenance has been followed

Are there any written protocols including the method and calibration frequency for the equipment

Calibration and maintenance conducted by the trained workers

Are there any sign where the maintenance and calibration program has been postponed without valid justification

4.7 Pest Control Program C NC COMMENTS

Pest Control program conducted internally or externally or both?

Do the treatment, trap location and monitoring frequency are adequate and suitable at the premise

Does the pest control program has been followed

Does the Pest Control layout accurate

Does the Pest control program effectively implemented

Are the processing areas maintained free of insects, rodents and other pests

Are insecticides and rodenticides used and stored so as to prevent contamination of food

4.8 Waste Management C NC COMMENTS

Does the waste management is suitable and implemented effectively

Does the grease trap and garbage trap adequate and suitable?

Refuse bin are adequate and appropriate

Does the refuse bin are cleaned and sanitize at regular frequency to minimize the contamination risk

There are facility to clean the refuse bin near the waste area (e.g. water pipe)

4.9 Sewage management C NC COMMENTS

Does the sewage system designed and built in a way that prevent the connection to the others waste system

The sewage system doesn’t enter directly into the processing area unless it has been control to prevent the contamination.

4.10 Utensils and equipment C NC COMMENTS

Cleaned and sanitized at intervals frequent enough to avoid contamination of food products

Food-contact surfaces used for manufacturing shall be in a sanitary condition.

Non-food-contact surfaces of equipment used in the operation of food plants should be cleaned as frequently as necessary to

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protect against contamination of food.

4.11 Are utensils and portable equipment stored so as to protect them from splash, dust and other contamination

5.0 PROCESSES AND CONTROLS C NC COMMENTS

5.1 Raw materials and ingredient

Raw materials unload from the transport in a way that prevents the contamination to the raw materials and packaging material.

Raw Material and packaging materials received at the proper area

Adequately inspected, processed as necessary and stored to assure that only clean, wholesome materials are used

Raw materials and other ingredients shall comply with company specification

Are there any safety and quality procedure control implemented to the received raw material?

Supplier’s guarantee or certification.

Control of thawing process

5.2 Storage of raw material and finished good C NC COMMENTS

Raw materials and finished good stored in appropriate temperature

Raw materials and finished good has been handled and stored in a way that can prevent the damage and contamination

There are stock control procedure to monitor the incoming and outgoing of raw material and finished goods

Raw material and finished goods were stored 20 cm from floor and 15cm from the wall and label

5.3 Are any important food safety parameter measured and recorded (temperature/time/pressure etc.)

5.4 Is ice, water and steam (where used) manufactured from potable water and stored and handled in a sanitary manner

5.5 Food processing C NC COMMENTS

Conducted in a manner to prevent contamination and minimize harmful microbiological growth.

Cross-contamination on raw materials or others ingredients from personnel and environment

5.6 Are the preventive action adequate to prevent the risk of physical, chemical and microbiological contamination

5.7 Effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food.

5.8 Control of non-conformance product, finish product food.

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5.9 Are packaging processes and materials adequate to prevent contamination

5.10 Type of packaging materials doesn’t have any reaction to the finished products, suitable and in good condition

5.11 Are only approved additives used

5.12 Are products coded to enable positive lot identification, and are records maintained in excess of expected shelf-life

5.13 Are weighing and measuring practices adequate to ensure the declared quantity of contents

5.14 Are labels of products covered during inspection in compliance (submit violated labels as exhibits)

5.15 Water C NC COMMENTS

If the water and ice used as a raw material, does the water used undergo filtration process

Are the suitable filter used

If the water and ice used as raw material doesn’t undergo filtered system, is there other treatment used to ensure the quality and safety of the water

Are the treated water used to clean the packaging materials that have direct contact with food

Is the water supply adequate in quantity and quality for its intended uses

5.16 Steam C NC COMMENTS

Water used in the boiler is inspected regularly and chemical treatment is controlled to avoid contamination

Steam produced from treated water and adequate for operation requirement

5.17 Ice C NC COMMENTS

Comply with MOH ice licensed requirement

5.18 Verification of finished product C NC COMMENTS

Sampling and analysis procedure are adequate

Are the analysis conducted in by competent personnel (internal) and certified lab (external)

If the screening device used, what is the sensitivity and is the sensitivity adequate, calibrated and maintain properly?

5.19 Product recall system C NC COMMENTS

Is there any product has been recalled

If Yes, is the system effectively implemented? Provide the record to prove the effectiveness of the recall system

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If not, are there mock recall has been conducted.

6.0 PERSONNEL C NC COMMENTS

6.1 Are personnel with sores, infections, etc., restricted from handling food products

6.2 Do personnel wear clean outer garments, use adequate hair restraints and remove excess jewellery when handling food

6.3 Do personnel thoroughly wash and sanitize hands as necessary

6.4 Do personnel refrain from eating, drinking and smoking and observe good food handling techniques in processing areas

6.5 Do the officer in charge supervise the personnel’s cleanliness

6.6 Does the personnel undergo health screening and vaccinated

6.7 Worker’s Flow:

Does the worker’s flow follows the procedure and doesn’t permit cross contamination to the product.

6.8 Visitor C NC COMMENTS

Does the proper protective cloth provided to the visitor when entering the process area

Does the visitor required to fill in the visitor log book / form

Does the visitor required to fill in the visitor health declaration form before enter the production area

7.0 TRANSPORTATION AND DISTRIBUTION C NC COMMENTS

7.1 Does the transport suitable and can prevent the contamination to the product

7.2 Does the arrangement in the transport is suitable

7.3 If the transport is used for many different products, does the transport have a clear separation area or have a control to prevent contamination

7.4 Does the cleanliness of the transport is monitored and satisfactory

7.5 If using cold truck/ freezer truck, does the temperature adequate

7.6 Are there any temperature recorded during transportation of the product (for related product only)

8.0 TRACEABILITY C NC COMMENTS

8.1 Does the finished product have a identification code at the packaging

8.2 Does the identification code follow the procedure

8.3 If the finished product contain active ingredient and its percentage is not identified, does the company have classification letter from MOH to prove that finished product is a food.

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9.0 INTERNAL AUDIT C NC COMMENTS

9.1 Does the internal audit has been conducted

9.2 Does the checklist and internal audit report are adequate and cover all the element

9.3 Does the corrective action taken for all CAR issued? If not, does the written justification are provided

9.4 If necessary, do the audit has been conducted upon the main raw material supplier and additive supplier to ensure the safety and quality of the product. If no, state why.

9.5 Does the frequency of the internal audit adequate

10.0 TRAINING C NC COMMENTS

10.1 Does all the food handlers have been to the food handler’s training provide by the MOH certified SLPM

10.2 Training schedule provided

10.3 Do the food safety training (HACCP & GMP) training has been given to the top management and the workers

10.4 Are there any other training related to the food safety provided to the workers

10.5 Does the effectiveness of the training has been conducted and recorded.

10.6 Does the frequency training given adequate

10.7 Does the training given by competent individual/agency

10.8 Does the worker has been given the training that suit with their job

10.9 Does the training given based on the Training Schedule. If not, explain why.

EVALUATION OF COMPLIANCE:

LEAD AUDITOR SIGNATURE AND OFFICIAL STAMP

…………………………………………………

AUDITOR(S) SIGNATURE AND OFFICIAL STAMP :

…………………………………………………

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AUDIT-8/2014

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

5.0 HAZARD IDENTIFICATION AND ANALYSIS C NC COMMENTS

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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

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

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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:

LEAD AUDITOR SIGNATURE AND OFFICIAL STAMP

…………………………………………………

AUDITOR(S) SIGNATURE AND OFFICIAL STAMP :

…………………………………………………

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CLF-CL-CH/2015

Ministry of Health

FOOD SAFETY AND QUALITY DIVISION

MINISTRY OF HEALTH MALAYSIA

SPECIAL REQUIREMENTS

FOR EXPORT OF FISH AND FISHERY PRODUCTS TO CHINA

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 C= Conformity

C NC COMMENTS

1.0 BASIC PRINCIPLES

1.1 Quality management system based on HACCP principles should be established, and implemented with necessary food defense;

2.0 RAW MATERIALS AND INGREDIENTS

2.1 Fish and fishery products should be imported with health certificates or hygiene certificates and certificates of origin issued by the competent authorities of the export country, and should be under the inspection of the competent authorities.

3.0 WORKSHOPS

3.1 Production water directly discharging onto the floors should be avoided; and the waste water from the production should not be discharged from low clean area to high clean area

4.0 TEMPERATURE AND TIME CONTROL

4.1 For histamine formation species group, should control the temperature and time from raw materials to finish according to the characteristics of the product, when necessary, it should test the histamine level.

5.0 STORAGE

5.1 Cooling storage/quick-frozen storage and cold storage should be equipped with automatic temperature recording device, and have a periodic calibration. The temperature in cooling storage shall be controlled between 0’C-4’C; The temperature in cold storage shall be controlled below -18’C; The temperature in quick-frozen storage shall be controlled below -28’C.

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C NC COMMENTS

6.0 PERSONNEL HYGIENE

6.1 It shall distinguish the work clothes/hat using different color or marking for clean area and non-clean area/cooked area and uncooked area. Personnel in different processing areas should not go to other non-related areas.

GENERAL COMMENTS

EVALUATION OF COMPLIANCE

VERIFIERS NAME AND SIGNATURE