standard operating procedure for issuance of...

FOOD SAFETY AND QUALITY DIVISION

MINISTRY OF HEALTH MALAYSIA

STANDARD OPERATING

PROCEDURE FOR ISSUANCE OF

HEALTH CERTIFICATE FOR EXPORT

OF AQUATIC ANIMALS AND THEIR

PRODUCTS INTENDED FOR RETAIL

USE/FOOD SERVICE TO CANADA

Document No: Revision No: 1 Page: 1 of 47 Effective Date: April 2013

Title: STANDARD OPERATING PROCEDURE FOR ISSUANCE OF HEALTH CERTIFICATE FOR EXPORT OF

AQUATIC ANIMALS AND THEIR PRODUCTS INTENDED FOR RETAIL USE/FOOD SERVICE TO CANADA


Approved by:

Name:

SHAMSINAR ABDUL TALIB

Designation:

Director of Planning, Policy Development and Codex Standard Food Safety and Quality Division Ministry of Health Malaysia

Date:




1. Introduction

It is the responsibility of the exporter to apply for Health Certificate for export of

aquatic animals and their products intended for retail use/food service based on

the requirements of the importing countries. The exporter shall ensure that aquatic

animals and their products intended for retail use/food service to be exported

comply with the requirements of the importing countries.

The Designated Officer of the Health Office in the district where the product to be

exported is manufactured or stored shall be responsible for the issuance of Health

Certificates to facilitate the export of aquatic animals and their products intended

for retail use/food service.

2. Procedure

i. Application for Health Certificate

i. The processing establishment that wish to apply for Health Certificate

for the purpose of export of aquatic animals and their products

intended for retail use/food service shall comply with the Canada

Export Requirement of Aquatic Animals for Food Service/ Retail Use.

The requirements for export of aquatic animals and their products

intended for retail use/food service to Canada are as in Appendix 1.

ii. A separate application shall be submitted by the exporter to the

Designated Officer for each consignment of aquatic animals and their

products intended for retail use/food service to be exported.

iii. The application for Health Certificate shall be made to the

Designated Officer of the Health Office in the district where product

to be exported is manufactured or stored.

iv. Exporter shall ensure that the requirements for issuance of Health

Certificate for export of aquatic animals and their products intended

for retail use/food service to Canada are being fulfilled before

applying the Health Certificate. The requirements for export of

aquatic animals and their products intended for retail use/food

service to Canada are as in Appendix 1.




v. The following documents shall be attached with the application for

Health Certificate:

a. Application Form For Issuance of Health Certificate For Export of

Aquatic Animals And Their Products Intended For Retail Use/Food

Service to Canada, HC/FCAN-2013 as in Appendix 2;

vi. The exporter is responsible to ensure that all the information

provided in the application form is accurate before it is submitted to

the Designated Officer. Any inaccurate information may result in the

shipment of the consignment being delayed or the affected

consignment may be recalled.

vii. Random verification on the information provided by export

establishment for the application of Health Certificate shall be carry

out by State Health Department regularly.

viii. Fees for the issuance of Health Certificates are as prescribed by the

Ministry of Health as in Appendix 3.

2.2 Preparation and Issuance of Health Certificates

i. Sampling shall be carried out by the officer at the District Health

Office where the product is stored prior to the issuance of Health

Certificate and sent to the laboratories which are recognized by

Ministry of Health. The updated list of laboratories can be

downloaded via website www.fsq.moh.gov.my/v3.

ii. The list of parameters of analysis is as in Appendix 4.

iii. The inspection of processing establishment shall be conducted by

the officer at the District Health Office where the processing

establishment is located. However at the discretion of the officer the

previous inspection report may be used if the inspection of the

processing establishment has been carried out not longer than six (6)

months from the date of application of Health Certificate.

iv. If the processing establishment is located not within the area of the

officer at the District Health Office, the officer at the District Health

http://www.fsq.moh.gov.my/v3




Office shall request for the inspection report of the processing

establishment conducted by the relevant District Health Office in

which the processing establishment is located.

v. The issuance of Health Certificate is subjected to the compliance

status of the processing establishment including the sampling result

and the requirements for export of fish and fishery products to

Canada as stated in Appendix 1.

vi. Processing establishments with valid HACCP Certification from MOH

may be exempted from sampling and premise inspection. However,

the officer at the District Health Office may conduct premise

inspection and sampling as part of verification.

vii. Completed Health Certificates shall be signed by the Designated

Officer.

viii. The format of the Health Certificate for Export of Aquatic Animals

And Their Products Intended For Retail Use/Food Service to Canada

shall be as in Appendix 5.

ix. The Health Certificate shall only be issued for consignments to which

it relates before it leaves the control of the District Health Office.

x. The Health Certificate, once issued shall not be modified in any way.

The Designated Officer shall keep file copies of all issued Health

Certificates for 2 years.

xi. Health Certificates shall be completed according to the Instructions

for Completion of Health Certificate for Export of Aquatic Animals


as in Appendix 6.

2.3 Amendment / Replacement of Health Certificate

i. Any request for an amendment or replacement of a Health Certificate

shall be made to the District Health Office. The Designated Officer

may approve the request for an amendment or replacement of a

Health Certificate on a case-by-case basis.




ii. In cases of a lost Health Certificate, the exporter shall make a written

request for a new certificate to the District Health Office providing

explanation for the loss of the Health Certificate. A copy of a police

report shall be provided once request for a replacement of the Health

Certificate is being made.

iii. If satisfied with the given explanation, the Designated Officer shall

issue a replacement Health Certificate with the following declaration

included in the new Certificate at the top of the front page:

“Replacement of Certificate No. …… Dated …… that has been lost.”

iv. Replacement Health Certificates shall be issued with a new

identification number.

v. The Designated Officer shall record on the file copy of the original

Health Certificate that it has been cancelled and the reference

number and date of the replacement Health Certificate added. A file

copy of the original amended Health Certificate shall be kept.

vi. Fee shall be imposed for replacement / amendment of Health

Certificates.

3. List of Appendices

i. Appendix 1 - Export Certification Requirements for Aquatic Animals for

Food Service/Retail Use

ii. Appendix 2 - Application Form for Issuance of Health Certificate for Export

of Aquatic Animals and Their Products Intended for Retail Use/Food

Service to Canada

iii. Appendix 3 - Fees for the Issuance of Health Certificates for Export Of

Aquatic Animals And Their Products Intended For Retail Use/Food Service

to Canada

iv. Appendix 4 - List of Parameters of Analysis for Export of Aquatic Animals

and Their Products Intended for Retail Use/Food Service to Canada

v. Appendix 5 – Format of Health Certificate for Export Of Aquatic Animals


vi. Appendix 6 - Instructions For Completion Of Health Certificate for Export

Of Aquatic Animals And Their Products Intended For Retail Use/Food

Service to Canada




vii. Appendix 7 – Susceptible Species of Aquatic Animals listed in Schedule III

of Canada’s Health of Animals Regulations

viii. Appendix 8 - Checklist For Application of Issuance Of Health Certificate for

Export of Aquatic Animals and Their Products Intended for Retail

Use/Food Service to Canada




Appendix 1

EXPORT CERTIFICATION REQUIREMENTS FOR AQUATIC ANIMALS FOR FOOD

SERVICE/RETAIL USE

Packaging and Shipping Requirements

1. The international aquatic animal health certificate pertaining to the shipment must

either be issued by an official veterinary inspector of the competent authority for

aquatic animal health services of the country of origin or by a designate of the

competent authority for aquatic animal health of the country of origin. This

certificate must be endorsed by an official veterinary inspector of the competent

authority for aquatic animal health of the country of origin.

2. The accompanying export documentation must be issued in either English or

French, as well as the official language of the exporting country (unless that is

already English or French).

3. The international aquatic animal health certificate must clearly describe the

shipment and the Country(ies)/Zone(s)/Region(s)/Compartment(s)/Premise(s) of

origin. The certificate must clearly identify the aquatic animal(s) by taxonomic

name and quote the Canadian import permit number under which the commodity

is being imported. The certificate must includeinformation in accordance with Part

XVI, Section 194 of the Health of Animals Regulations,and consistent with the

OIE’s Aquatic Animal Health Code, and certify compliance with the conditions

listed on the permit.

4. The aquatic animals must be packaged in shipping containers, holding units

and/or conveyances that are either new or cleaned and disinfected. The shipping

containers and/or holding units must prevent release of the shipping contents

(eg. water or animals) while en route.

5. The finfish must be packaged in shipping containers, holding units and/or

conveyances that are either new or cleaned and disinfected. The shipping

containers and/or holding units must prevent release of the shipping contents

(eg. water or animals) while en route.

6. For molluscs and crustaceans, the aquatic animals must be packaged in shipping

containers, holding units and/or conveyances that are either new or cleaned and




disinfected. The shipping containers and/or holding units must prevent release of

the shipping contents (eg. animals) while en route

7. A visible, legible label must be present on the containers used to transport the

aquatic animals. The label must contain information that clearly identifies the

origin and destination of the consignment and its detailed contents, including the

location in which the aquatic animal(s) was born, the taxonomic name of the

aquatic animal(s), whether the aquatic animal(s) was(were) wild or farmed, and

the number or biomass of the aquatic animal(s) in the shipment. Please refer to

the CFIA website for a list of current taxonomic names.

Zoosanitary Requirements for Wild or Farmed or Cultivated Aquatic Animals:

1. The disease(s) of concern to Canada listed below is/are compulsorily notifiable to

the competent authority in the exporting country.

2. For cultured aquatic animals, the aquatic animal(s) and their broodstock are not

under any restriction by the exporting country’s competent authority or intended

for destruction or slaughter for disease control purposes.

3. For wild aquatic animals, the aquatic animal(s) or their broodstock are not under

any restriction by the exporting country’s competent authority or intended for

destruction or slaughter for disease control purposes.

4. The transport water, and ice if included, as well as any other susceptible aquatic

animals which contact the animals to be exported during transport, must be

EITHER free of the disease(s) of concern, OR treated in a manner that will

destroy these pathogens prior to contact with the aquatic animals.

*The condition stated above is subject to change from time to time. Please refer to

the website http://fsq.moh.gov.my for the latest information.

http://fsq.moh.gov.my/




Appendix 2

Form HC/FCAN-2013

MINISTRY OF HEALTH

APPLICATION FORM FOR ISSUANCE OF HEALTH CERTIFICATE FOR EXPORT

OF AQUATIC ANIMALS AND THEIR PRODUCTS INTENDED FOR RETAIL

USE/FOOD SERVICE TO CANADA

Instruction:

These form shall be submitted for each application of Health Certificate

1.0 Particulars of Applicant 1.1 Name of Applicant: ………………………………………………………………………….. 1.2 NRIC Number: .……………………………………………………………………………… 1.3 Name and Address of Company: …………………………........................................... ........................................................................................................................................... 1.4 Tel. No.: ……………...1.5 Fax No.: ………………..1.6 H/P No. ……………………….. 1.7 E-mail address: …………………………………………………………………….............. 1.8 Registration number of food premises with Ministry of Health: :………………………..

(as required under the Regulation 3, Food Hygiene Regulations 2009)

1.9 Company Registration Number (ROC): ………………………………………………….. (Please attach copy of the certificate) 1.10 Correspondence Address (if different from para 1.3):………………………………….. ............................................................................................................................................ ............................................................................................................................................




2.0 Description of Consignment

2.1 Name of product :.....................................................................................

2.2 Quantity & Total weight : ....................................................................................

of product (in Kg)

2.3 Consignment number :.....................................................................................

2.4 Code and Serial Number :.....................................................................................

2.5 Name of packer/processing establishment that produced the above products :

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

2.6 Address of the above mentioned packer/processing establishment:

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

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

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

2.7 Canada Import Permit Number:

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

2.8 Name of Exporter :.....................................................................................

2.9 Address of Exporter :.....................................................................................

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

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

2.10 Name of Importer :.....................................................................................

2.11 Address of Importer :.....................................................................................

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

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

2.12 Date of Departure :.....................................................................................

2.13 Port of Shipment :.....................................................................................

2.14 Destination :.....................................................................................

2.15 Means of transport : Flight Vessel Other

please specify ...............

2.15.1 Name of Vessel :.....................................................................................

2.15.2 Flight number :.....................................................................................

2.16 Location of the products to be exported :.................................................................

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

3.0 Information on Sources of Raw Material:

3.1 Aquaculture

No. Name of aquaculture

farm

Address of

aquaculture farm

Type of Product

& Common

Name

Name of species Disease of

concern

Country of origin Foreign Supplier (for

imported raw material)

Name and address of

processing establishment

(if any)

3.2 Wild catch

No. Name of catch area Address of catch

area (if any)

Type of product

& Common

Name


concern

Country of origin Foreign Supplier (for

imported raw material)

Name and address of

processing

establishment (if any)

3.3 Middleman

No Name of middleman Address of middleman Type of product &

Common Name


concern

Country of origin

*Please fill in related table and use separate sheet if required

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

4.0 Declaration

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 : ______________________________




Appendix 3

FEES FOR THE ISSUANCE OF HEALTH CERTIFICATES FOR EXPORT OF

AQUATIC ANIMALS AND THEIR PRODUCTS INTENDED FOR RETAIL USE/FOOD

SERVICE TO CANADA

Schedule A – Fees for Health Certificate for Export Purpose for each consignment

Schedule B – Fees for Health Certificate for Exhibition Purpose

Type of Exhibition Fee / certificate

Encouraged by Govenment

Agency

RM 30

Individual RM50

No. of Health Certificate

applied Fee / certificate

1 – 3 RM80.00

4 – 6 RM60.00

7 – 9 RM40.00

10 RM30.00




Appendix 4

LIST OF PARAMETERS OF ANALYSIS FOR EXPORT OF AQUATIC ANIMALS AND

THEIR PRODUCTS INTENDED FOR RETAIL USE/FOOD SERVICE TO CANADA

1. Chemical contaminants

CONTAMINANTS PRODUCT TYPE ACTION LEVEL 1

Mercury

All fish products (except swordfish,

shark, fresh and frozen tuna,

escolar, orange roughy and

marlin)

0.5 ppm

Swordfish, shark, fresh and frozen

tuna, escolar, orange roughy and

marlin

1.0 ppm

DDT and

Metabolites (DDD

and DDE)

All fish products

5.0 ppm

1. Microbiological

Test Organism1 Product Type No. of

sample

units

Acceptance

number (c)2

m/g2 M/g2 Criteria for action

Escherichia coli Cooked or ready- to-eat

products

5 1 4 40 Reject if 2 or more units

exceed m, or if any unit

exceeds M

Escherichia coli Raw molluscan

shellfish

5 1 230/100

g

330/100

g

Reject if 2 or more units


exceeds M

Escherichia coli All other types 5 2 4 40 Reject if 3 or more units


exceeds M

Coagulase-Positive

Staphylococci

All types 5 1 1000 10000 Reject if 2 or more units


exceeds M

Salmonella spp All types 5 Absent in each

25 g sample or in

pooled samples

of 125 g.

Reject if Salmonella spp

is detected

Vibrio cholerae Cooked or ready- to-eat

products

5 Absent in each

25 g sample or in

pooled samples

of 125 g

Reject if Vibrio cholerae

is detected.

1 The analysis of all aquatic animals products shall be conducted in accordance with approved methods;

2 m - number of bacteria per gram separating acceptable from marginally acceptable samples, c - number of samples that may exceed this number of bacteria per

gram, M - no sample can exceed this number of bacteria per gram




Listeria monocytogenes

Product Type Laboratory method to be applied

Unsatisfactory if:

Lower risk RTE fish product :

refrigerated with a shelf-life 10 days, OR

frozen, OR

pH < 5, OR

Aw 0.92, OR

pH < 5.5 AND an Aw < 0.95

Enumeration

(MFLP-74* or equivalent) on 5 sample

units

> 100 cfu/g*

All other RTE fish products

Presence/absence in 25 g

(MFHPB-30 or equivalent) on 5

sample units

Detected in 25 g

*as per method reporting limit

2. Additives

ADDITIVE PRODUCT TYPE BACKGROUND LEVEL 1

Nitrites

All fish and fish products

(except marine mammal meat

6)

15 ppm (see note 1)

Nitrates

All fish and fish products 15 ppm (see note 1)

Sulphites 2

Clams (raw and canned) 10 ppm

Phosphates 3

Shrimp (raw, cooked and

canned)

1.60 %

Scallops (raw)

1.47 %

Fish fillets

1.37 %

Crab (raw and cooked)

1.70 %

Lobster (raw and cooked) 1.47 %

Surf clams (raw and cooked)

1.00 %

1

When the additive is not permitted, then the action level is the background level or detection limit; when the additive is permitted, then the action level is the background level or detection limit plus the permitted amount. 2 Calculated as sulphur dioxide.

3 Calculated as sodium phosphate, dibasic.

Note: 1. Some herbs, including parsley, contain high levels of naturally occurring nitrates. This has to be

considered when nitrates are detected in fish products containing herbs as an ingredient.

3. Ice

Parameter Parametric value

Microbiology: Escherichia coli Coliform Bacteria

Nil

<10 MPN/g




4. Veterinary drugs/ Therapeutants

Class Name Substance Species Action Level

Amphenicols Florfenicola

Chloremphenicol

Thiamphenicol

Salmonids

All

All

0.8ppm

Not Detected

Not Detected

Fluoroquinolones Ciprofloxacin

Danofloxacin

Enrofloxacin

Sarafloxacin

All 0.001ppmb

Macrolides Eryhtromycin Fish, Crustaceans 0.03 ppmc

Nitorfurans All Not Detected

Dyes

Gentian Violet

(Leucogentian

Violet)

Malachite Green

(Leucomalachite

Green)

All Not Detected (see notes d,e,f, g)

NOTES:

a - A lot of fish will be considered to be rejected when the sum of florfenicol (parent drug) and

florfenicol amine (metabolite) detected in the sample exceeds the florfenicol MRL.

b - As a minimum performance level of the laboratories testing for fluoroquinolones, the

laboratory must have a limit of quantification (LOQ) of at least 1.0 ng/g for fluoroquinolones.

c - Interim action level set by Health Canada.

d - As a minimum performance level of the laboratories testing for Malachite Green (MG) or

Leucomalachite Green (LMG), the laboratory must have a limit of quantification (LOQ) of at least

0.5 ng/g for MG or LMG.

e - Malachite green is not permitted in Canada for use during any part of the aquaculture fish

production life-cycle.

f - As a minimum performance level of the laboratories testing for Gentian Violet (GV) or

Leucogentian Violet (LGV), the laboratory must have a limit of quantification (LOQ) of

at least 0.5 ng/g for GV or LGV.

g - Gentian violet is not permitted in Canada for use during any part of the aquaculture fish

production life- cycle.




Appendix 5

FORMAT OF HEALTH CERTIFICATE FOR EXPORT OF AQUATIC ANIMALS AND

THEIR PRODUCTS INTENDED FOR RETAIL USE/FOOD SERVICE TO CANADA

Front Page




Back page




Appendix 6

INSTRUCTIONS FOR COMPLETION OF HEALTH CERTIFICATE FOR AQUATIC ANIMALS

AND THEIR PRODUCTS INTENDED FOR RETAIL USE/FOOD SERVICE TO CANADA

1. Health Certificate for Export of Aquatic Animals and Their Products Intended for Retail

Use/Food Service to Canada as attached in Appendix 5 is to be used.

2. The Certificate is to be completed as follows:

Name and address of exporter : Name and address (street, town and post code) of the exporter.

Name and address of importer : Name and address (street, town and post code) of the importer.

Name and address of packer : Name and address (street, town and post code) of the packer.

Canada Import Permit Number : Import permit number for export of fish and fishery products to Canada. This information is to be filled by applicants.

Name of Product : Name of the product intended to be exported.

Species : Taxonomic / Scientific name of the aquatic animal intended for export (Please refer APPENDIX 7 )

Common Name : Common name of the aquatic animal intended for export.

Type of product (cultured/wild) : Where the aquatic animal was caught i.e. either from aquaculture farm or sea/river catch.

Disease related to the species : Diseases related to the species of aquatic animal intended for export (Please refer APPENDIX 7). This information is to be filled in by Official Inspector.

Quantity and total weight : Total gross and net weights in Kg.

Country of Origin : The country of origin for each species to be exported




Consignment No. : This information is optional. If applicable, please indicate all the identification numbers of the container.

Code and serial number : The identification numbers of the seals / or if using courier service shall indicate the tracking number etc.

Sampling point : Place / location of sampling conducted by Ministry of Health

Port of Shipment

: Name of the port of shipment

Country of Destination : Province/city (point of entry) and country of destination

Name of vessel : Flight number (aircraft) or name (ship). Separate information is to be provided in the event of unloading and reloading

Every health certificate must have:

Bear a unique reference number

The signature of the certifying officer

The certifying officer’s official stamp (Name and designation)

The date of issue

Official stamp of Food Safety and Quality Division, Ministry of Health

Each page of a certificate must be numbered at bottom right so as to indicate that it is a particular page in a finite sequence




APPENDIX 7

SUSCEPTIBLE SPECIES OF AQUATIC ANIMALS LISTED IN SCHEDULE III OF CANADA’S HEALTH OF ANIMALS REGULATIONS




APPENDIX 8

CHECKLIST FOR APPLICATION OF ISSUANCE OF HEALTH CERTIFICATE FOR

EXPORT OF AQUATIC ANIMALS AND THEIR PRODUCTS INTENDED FOR

RETAIL USE/FOOD SERVICE TO CANADA

Name of Exporter : Date of Application :

No Type of Documents Yes (√) or No (x)

For official use Remarks

1 Application form for issuance of Health Certificate For Export Of Aquatic Animals And Their Products Intended For Retail Use/Food Service To Canada : HC/FCAN-2013

Complete Not Complete

2 Exporter provides Canada Import Permit Number

Provided Not provided

3 Processing establishments have been registered with Ministry of Health (MOH)

Registered Not Registered

4 Certificate of analysis (COA) from laboratory recognized by MOH

Date of COA :.................................. COA ref. No:..................................... Result : Comply Not comply

5 Inspection of processing establishment

Date of inspection:......................... Compliance status : Comply Not comply

6 Payment of certificate (mode of payment) e.g cheque/money order/postal order

Cheque /money order no :................................

Prepared by Verify by

Name : Name :

Designation : Designation :

Date : Date :