CERTIFICATION PROGRAM TECHNICAL RULE SECTION 3 · PDF fileCER/NT3/January 2015 CERTIFICATION...

CER/NT3/January 2015

CERTIFICATION PROGRAM

TECHNICAL RULE

SECTION 3

Sanitary Requirements to Certify Fisheries Products Intended for

Export, in accordance with Destination Markets

FOREIGN TRADE SUBDIRECTION

CHILE


Page 1 of 80

INDEX

Pág.

I. Aim 4

II. Products for human consumption

Specific Requirements by destination

Market 4

1. Argentina 4

2. Australia 8

3. Brazil 9

4. Canada 12

5. China 13

6. Colombia 14

7. South Korea 15

8. Costa Rica 16

9. Cuba 18

10. El Salvador 20

11. United Arab Emirates 21

12. United States of America 22

13. Hong Kong 23


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14. India 25

15. Israel 25

16. Jamaica 27

17. Japan 27

18. Mexico 28

19. Norway 29

20. New Caledonia 29

21. New Zealand 30

22. Peru 31

23. Serbia 32

24. Singapore 32

25. Switzerland 33

26. Tahiti 33

27. Taiwan 34

28. Tunisia 34

29. Turkey 35

30. Customs Union 35

31. European Union 37

32. Uruguay 58


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33. Vietnam 59

III. Products not aimed for human consumption

Specific Requirements by destination market 60

1. Argentina 61

2. Australia 62

3. Brazil 63

4. Canada 65

5. China 65

6. Japan 68

7. Mexico 68

8. New Caledonia 69

9. Peru 70

10. Tahiti 70

11. Customs Union 71

12. European Union and Norway 72

13. Uruguay 80

14. Vietnam 80


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I. Aim

The aim of this Technical Rule is to set forth the specific requirements for

fisheries products aimed or not for human consumption required by

markets where the official health certification is mandatory.

This rule also provides specific restrictions for specific products and

markets.

For those markets not included in this rule, which require the voluntary

submission of health certification, the requirements set forth in Technical

Rule Nº 2 of the Certification Program shall be required.

II. Products intended for human consumption

Specific Requirements by destination market

1. Argentina

Fisheries products aimed for this market must be accompanied by the

Health Certificate for Argentina, Brazil and Uruguay, which can be found in a

PDF file and available in our web page at www.sernapesca.cl.*

The submission of the certificate is bound to the compliance of the

following requirements:

a) The facility must be authorized to export to such market, in

accordance with the requirements set forth in the Procedures Manual

HPB/MP1.

b) The facility must have a Quality Assurance Program (QAP) on the

basis of HACCP with product certification in accordance with the

* Regardless of the official controls realized by Sernapesca for the authorization of shipments or

sanitary certification, manufacturers and exporters shall be responsible of complying with the rules set

in established normative of such market, such as:

- Argentine Food Codex

- Mercosur Technical Rule

- National Plan of Residue Control and Food Hygiene (PLAN CREHA)

http://www.sernapesca.cl/


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QAP by means of a Health Certification Authorization of Origin

(AOCS).

c) The facility must request SENASA a process monograph for each

product aimed at this market, and could attach the corresponding

studies for conversion factors. Monographs must be processed in

accordance with Procedures Manual CER/MP1.

d) Living bivalve mollusks must be packaged only in facilities authorized

to export to Argentina.

e) Bivalve mollusks, echinoderms, tunicates and gastropods live or

chilled cooled, must comply with the health requirements set forth in

annex 7 of Procedures Manual CER/MP1.

f) Comply with the health standards set by Sernapesca in Technical Rule

CER/NT2, in accordance with the submission of the product.

g) Additionally, realize a microbiological analysis as follows:

Product Parameter Maximum Level

Fisheries products in

general

Listeria monocytogenes Absence in 25 g

Escherichia coli Less than the L.O.D

of the technique (i)

(ii)

(i)< 0,3 NMP/g for processed products < 0,2 NMP/g for live products (ii) NCh. 3056.Of2007

h) Perform the analysis of Cadmium, Mercury, Lead and Arsenic,

according to the following process:

Sampling Plan: n = 10 by manufacturing date

Analysis number: The sample units must be mixed to form a

composite, with which 1 determination shall be made.


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i) Species and certification standards

In accordance with the National Plan for Residue Control and

Hygiene in Foods (CREHA PLAN), dated 05.02.13, Version I, the

thresholds for heavy metals are as follows:

Cadmium

Product Maximum

Threshold

(mg/kg (ppm))

Fish

Fish in general

0,05

Bonito, mojarra, anguila, lisa, jack

mackerel, emperador, caballa, pilchard,

tuna, acedia, lenguadillo.

0,1

Melba (Auxis Rochei)

0,2

Little anchovy and swordfish

0,3

Crustaceans

0,5

Bivalve

mollusks

2,0

Cephalopods 2,0

Lead

Product Maximum

Threshold

(mg/kg (ppm))

Fish 0,3

Crustaceans 0,5


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Bivalve Mollusks 1,5

Cephalopods 1,0

Mercury

Product Maximum Threshold

(mg/kg (ppm))

Fish other than predators, crustaceans, bivalve

mollusks and cephalopods

0,5

Predator fish

1,0

The following species are considered predator fish:

Bonito (Sarda sarda)

Ray (Raja sp.)

Shark (all species)

Vitamin shark (Galeorhinus vitaminicus)

Gatuzo (Mustelus schmitti)

Swordfish (Xiphias gladius)

Tuna (Thunnus species, Ehuthynnus species, Katsuwonus pelamis)

Arsenic

Fish: 1,0 mg/kg (ppm).

j) For land transportation, the health certificate must display the seal

number and the truck identification, as per document CER/MP1

point 2.11, Chapter 2.

k) Signature of the Veterinarian.

The following zoosanitary statements must be indicated on the health


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certificate, as appropriate according to each product:

a) Os animais utilizados como matéria-prima para fabricação do produto não foram obtidos a partir de cultivo e não apresentaram lesões atribuíveis à doença/infecção no momento da recepção da matéria prima */los animales utilizados como materia prima en la fabricación del producto no fueron obtenidos de cultivo y no presentaron lesiones atribuibles a enfermedad/infección en el momento de la recepción de la materia prima;*/Animals used as raw material to manufacture this product were not obtained from farming and do not display injuries as a result of disease/infection upon reception of the raw material.*

b) Os produtos certificados não incluem espécies de camarão*/los productos certificados no incluyen las especies de camarones, langostinos o gambas;*/ The certified products do not include shrimp or prawns species.*

c) Os produtos certificados não incluem animais vivos, nem material de reprodução viável*/los productos certificados no incluyen animales vivos ni material de reproducción viable;*/The certified products do not include live animals nor viable breeding material.*

For live bivalve molluscs and gastropods aimed for export, the following statement must be included:

d) In accordance to the results of the Specific Health Program to Monitor Diseases

that affect Bivalve Molluscs, there is no evidence of the presence of the causative agents of the following diseases in (name of country):

Bonamia exitiosa

Bonamia ostrae

Marteillia refringens

Mikrocytos mackini

Perkinsus marinus

Perkinsus olseni

2. Australia

The issuance of a Sanitary Certification requires the compliance of the



Page 9 of 80

a) The manufacturing facility must be included in the List of Companies

under Sernapesca’s Health Control Program.

b) Comply with the requirements established in Technical Rule No. 2 of

the Certification Program (CER/NT2) Sanitary Requirements and

Sample Plans for Sanitary Certification of Fisheries Products intended

for export, in accordance to the presentation of the product.

c) Additionally, the following requirements must be met as described in

CER/NT2:

Product Parameter N C M M

Bivalve Molluscs

other than oysters

Eshcerichia

Coli

(NMP / g)

5 1 2.3 7

Restrictions

Exports of chilled-refrigerated or frozen salmon species are prohibited.

3. Brazil

Fisheries products aimed for this market must be accompanied by the

Health Certificate for Argentina, Brazil and Uruguay, which can be found in a

PDF file and available in our web page at www.sernapesca.cl.



a) The facility must be included in the DIPOA Registry in Brazil,

which shall be verified in the List of Companies under Sernapesca’s

Health Control Program.



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(AOCS).

c) For bivalve mollusks, the resources must originate from raw material

harvested in farms under the SPBM USA or UE.

d) The companies’ labels must be registered in DIPOA for each product

and packaging, in accordance with the agency’s Technical Regulation

for Labelling of Packaged Food.

The authorization procedure for facilities and labels is described in

document HPB/MP1.

e) Comply with Sernapesca’s sanitary requirements described in

Technical Rule CER/NT2, in accordance with the product’s

packaging.

f) Veterinarian’s signature

The following zoosanitary statements must be indicated on the health certificate, as appropriate according to each product:

a) Os animais utilizados como matéria-prima para fabricação do produto não foram obtidos a partir de cultivo e não apresentaram lesões atribuíveis à doença/infecção no momento da recepção da matéria prima */ los animales utilizados como materia prima en la fabricación del producto no fueron obtenidos de cultivo y no presentaron lesiones atribuibles a enfermedad/infección en el momento de la recepción de la materia prima;* Animals used as raw material to manufacture this product were not obtained from farming and do not display injuries as a result of disease/infection upon reception of the raw material.*

b) Os produtos certificados não incluem espécies de camarão*/ los productos

certificados no incluyen las especies de camarones, langostinos o gambas;* The certified products do not include shrimp or prawns species.*


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c) Os produtos certificados não incluem animais vivos, nem material de reprodução

viável*/los productos certificados no incluyen animales vivos ni material de reproducción viable;* The certified products do not include live animals nor viable breeding material.*

For living bivalve mollusks and gastropods aimed for export, the following statement must be included:

d) In accordance to the results of the Specific Health Program to Monitor Diseases

that affect Bivalve Molluscs, there is no evidence of the presence of the causative agents of the following diseases in (name of country):

Bonamia exitiosa

Bonamia ostrae


Mikrocytos mackini

Perkinsus marinus

Perkinsus olseni

Salmonidae roes

The product shall be subject to a minimum temperature of 70ºC for at least

2 hours.

Restrictions

Salmon consignments intended for this destination market may only include

products that comply with the definition for minor injuries set forth in rule

HPB-NT1 or absence of injuries, following visual inspection. (RIISPOA,

Industrial and Sanitary Inspection Regulation for Products of Animal

Origin, Art. 445).


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4. Canada

Eviscerated fish do not require certification.

Packaged and processed fish ready for consumption do not require

certification.

Farmed Scallops with raw gonads

Each shipment must be accompanied by a “Sanitary Certificate for farmed

scallops with raw gonads aimed for Canada”, which format is found in PDF file

and available at the webpage www.sernapesca.cl.



a) The harvesting areas and the facility must be included in the

Sanitary Program for Bivalve Molluscs USA (SPBM USA).

b) The facility must have a Quality Assurance Program (QAP) on

the basis of HACCP with product certification in accordance

with the QAP by means of a Health Certification

Authorization of Origin (AOCS).

c) Comply with Sernapesca’s sanitary requirements described in Technical

Rule CER/NT2.

Farmed Salmonidae

To obtain authorization for each shipment notification, the following

requirements must be complied:

a) The facility must be included in the List of Companies under

Sernapesca’s Health Control Program.


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b) Comply with Sernapesca’s sanitary requirements described in

Technical Rule CER/NT2.

Restrictions

Exports of raw bilvalve mollusks and gastropods are not authorized, except

for farmed oysters with gonads.

5. China

Fisheries products aimed at this market must be accompanied by a “Health

Certificate for export of fishery products to the P.R.of China”. The model certificate

is available in Word file at www.sernapesca.cl.

Live fisheries products aimed to this market must be accompanied by a

“Health Certificate for aquatic animals intended for export from Republic of Chile to the

People’s Republic of China”. The model certificate is available in Word file at

www.sernapesca.cl.




Sernapesca’s Health Control Program and be previously enrolled and

authorized to export to this market.




(AOCS).

c) Additionally to the described in Technical Rule No. 2 of the

Certification Program (CER/NT2), it shall comply with the following

requirements:


Fisheries products in general Salmonella Absence in 25 g


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(cooked and raw) Vibrio parahaemolyticus ≤100 NMP/g

Algae and by-products

thereof

Salmonella Absence in 25 g

Vibrio parahaemolyticus ≤100 NMP/g

Fish oil (*) Salmonella Absence in 25 g

S. aureus < 1 UFC/g

Sampling Plan:

(*)For microbiological analysis, n= 6, c=0, with 6 analysis, must be

considered.

Execution frequency: Fortnightly checks in facilities with Quality Assurance

Programs.

Polycyclic Aromatic Hydrocarbons (PAH) Benzopyrenes

Product Maximum allowed

(mg/kg)

Sampling Plan

Smoked Fish flesh 0,005 n=5 c=0

Restrictions

Only fresh by-products originating from facilities authorized to manufacture

fisheries products intended for human consumption its permitted to export.

Export of abalone, Japanese oysters, Chilean oysters and living salmon

species to China is restricted.

6. Colombia




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(AOCS).

Restrictions

Exports of whole farmed fish with viscera are prohibited.

7. South Korea

Fish by-products aimed for human consumption

Each shipment must be accompanied by a “Sanitary Certificate for Fisheries and

Aquaculture Products” the model certificate is available in PDF format at the

webpage www.sernapesca.cl.

In addition, under point 4 of item IV (Remarks/Observaciones) the

following sentence must be included: “The products are classified as HS Code 03

and are fit for human consumption.”



a) The manufacturing facility must be included in the List of Facilities

under Sernapesca’s Sanitary Control Program and classified at least in

category D.

b) The facility must be authorized by the Ministry for Food, Agriculture,

Forestry and Fishing of the Republic of Korea (MIFAFF) to export

*The by-products specified by MIFAFF with respect of which these requirements are applied are: 1) whole southern hake and tuna fish heads (refer to specific restrictions by market, detailed in chapter IV of this rule); 2) viscera by-products of any eatable species (i.e.: eggs, intestines, gonadas, among other viscera); and 3) eatable meat surrounding the head such as cocochas, cheeks, collars, among other by-products.


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fish sub-products to this market. The authorization request must be

submitted to the relevant regional office.

c) Comply with the requirements established in Technical Rule No. 2 of

Certification Program (CER/NT2) Sanitary Requirements and

Sampling Plans to obtain the Sanitary Certification for Fisheries

Products aimed for Export, in accordance with the product’s

packaging.

d) In addition to Technical Rule Nº 2 of the Certification Program

(CER/NT2), the following requirements must be met:

Product Parameter Maximum Threshold

Fish by-products aimed

to human consumption

E. coli < 0,3 NMP / g

Mercury ≤ 0,5 mg/kg (ppm)

Lead ≤ 0,5 mg/kg (ppm)

Restrictions

Exports of fish heads from species other than Southern Hake (Merluccius

australis), tuna and certain toothfish species (Gadus morhua, Gadus ogac, Gadus

macroephalus) are prohibited.

8. Costa Rica

Fisheries products aimed at this market must be accompanied by an “Official

Veterinarian Certificate” for fisheries products aimed at Costa Rica, available in

PDF file at www.sernapesca.cl.




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Bivalve Mollusks

a) The facility must have a Quality Assurance Program (QAP) on


with the QAP by means of a Health Certification Authorization

of Origin (AOCS).

b) Bivalve Mollusks must originate from raw material harvested in

farms under SPBM USA or UE.

c) Compliance with Sernapesca’s sanitary requirements described

in Technical Rule CER/NT2, Sanitary Requirements and


Products aimed for Export, in accordance with the product’s

packaging.

Other products

a) The facility must have a Quality Assurance Program (QAP) on


with the QAP by means of a Health Certification Authorization

of Origin (AOCS).

b) Compliance with Sernapesca’s sanitary requirements described

in Technical Rule CER/NT2.

c) As to fish from farms, farms and manufacturing facilities must

participate in the Program for the Control of Residues from

Pharmaceutical Products and Contaminants.

Restrictions

Exports of whole farmed fish with viscera are prohibited.


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9. Cuba

Fisheries products aimed at this market must be accompanied by a “Sanitary

Certificate for Fisheries and Aquaculture Products”, available in PDF file at

www.sernapesca.cl.



1) The facility must be included in the List of Companies under

Sernapesca’s Health Control Program and authorized for export to

this market, in accordance to the requirements described in

Procedures Manual HPB/MP1.

2) Comply with the following specific requirements:

Frozen Fish

a) Comply with the sanitary requirements described in Technical

Rule Nº 2 of Certification Program (CER/NT2).

b) The Sanitary Certificate must include the sentence: "This

product comes from an area free of Vibrio cholerae", in

accordance with the procedure detailed in point 5.5 of

document CER/MP1.

c) Include the following parameters in the sensorial physical

examination (after defreezing) (n=5; c=0):

Frozen whole fish

Gills: Red-pink characteristic colour and normal odour

Internal aspect: Differentiated viscera, firm parietal regions (free

from enzymatic attack) and characteristic odour.

Mechanical damage: under 5% of surface.

Muscular mass: Firm texture, elastic, characteristic of species,

firmly adhered to spine. Characteristic odour.


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Frozen sliced fish

Internal aspect: Firm parietal regions, no viscera.

Muscular mass: Elastic firm texture, characteristic of

species, firmly adhered to spine.

Characteristic odour.

Parasites: Absence of live or dead parasites.

Mechanical damage: Absent.

Canned fish

a) Comply with sanitary requirements described in Technical Rule

No. 2 of Certification Program (CER/NT2). The organoleptic

physical examination must apply the sampling plan n = 8; c =

1.

b) The following parameter must be included in the organoleptic

physical examination:

Appearance: Absence of honey-comb appearance

(enzymatic breakdown) in each part of the analyzed can.

c) Chemicals (n = 5; c = 0)

pH: 4,5 - 6,5

Sodium Chloride: Not exceeding 1,5 %

Other fisheries products

a) Comply with Sernapesca’s sanitary requirements described in

Technical Rule CER/NT2, Sanitary Requirements and

Sampling Plans to obtain the Sanitary Certification for

Fisheries Products aimed for Export, in accordance with the

product’s packaging.

Labelling requirements

Submit a sworn declaration in the Spanish language, stating that

the fisheries products intended for Cuba are compliant with the


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following labelling requirements:

- Product name,

- Name of manufacturing facility,

- Commercial brand name,

- Content (mass, volume, weight / volume, units, portions,

etc.),

- List of ingredients,

- Identification of lot, coded or written in a clear and easily

comprehensible language,

- Manufacturing date of packaging or freezing,

- Expiration date,

- Storage temperature,

- Instructions of use (if appropriate).

10. El Salvador



www.sernapesca.cl.





b) The manufacturing facility must be authorized by the Ministry

of Agriculture and Livestock of El Salvador. To this end, the

facility must coordinate an inspection visit on behalf of such

Ministry with Sernapesca. Such visit must be financed by the

requesting party.


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11. United Arab Emirates



www.sernapesca.cl.



a) The manufacturing facility must be included in the List of Facilities

under Sernapesca’s Sanitary Control Program and classified at least in

category D.


Technical Rule CER/NT2, Sanitary Requirements and Sampling

Plans to obtain the Sanitary Certification for Fisheries Products aimed

for Export, in accordance with the product’s packaging.

In addition, under point 4 of item IV (Remarks/Observaciones) the

following sentences must be included, depending on the product

intended for export:

- For fisheries products obtained with extractive fishing methods,

the sentence “Wild Catch/captura”.

- For farmed species other than salmon species: “Product not fed with

animal proteins / product no alimentado con proteína animal”.

- For salmon species: “In case of farmed fish, fish has only been fed on feed

materials free from pork protein and pork derivatives / En el caso de los peces

de cultivo, éstos sólo han sido alimentados con materia prima libre de proteína y

derivados de cerdo.”

The compliance of requirements for farmed fish shall be responsibility

of the manufacturing facility, nevertheless they shall be verified by

Sernapesca as follows:


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- Those facilities under a Quality Assurance

Program (PAC, its abbreviation in Spanish) must include Dubai as

destination market in such Program, and demonstrate by means of

a simple sworn declaration issued by the farm or the manufacturing

company, that the food used to feed the fish introduced for

processing, is free from pork protein or pork derivatives. This

statement shall be regularly verified by Sernapesca, during the PAC

supervisions carried out in the facility.

Consequently, the compliance of the prior condition shall allow the

facility to obtain the Authorization at Origin for Sanitary Certification

(AOCS) intended for Dubai.

- Those facilities that intend to export to Dubai

and do not have PAC, or have not included the market in their

Program, shall submit a simple sworn declaration upon processing

the consignment notification (NEPPEX) issued by the farm or

manufacturing company indicating that the manufactured product

was not fed with pork protein or pork derivatives.

12. United States of America

Raw bivalve mollusks and scallops with coral

Shipments of raw bivalve mollusks and scallops with coral, must be

accompanied by a “Sanitary Certificate for Fisheries and Aquaculture Products”,

which is available in PDF file at www.sernapesca.cl.



a) The facility must have a Quality Assurance Program (QAP) on the basis

of HACCP with product certification in accordance with the QAP by means

of a Health Certification Authorization of Origin (AOCS).


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b) Raw bivalve mollusks and scallops with coral must be included in and

comply with the requirements of the US Bivalve Mollusk Sanitary Program,

described in documents SMB/MP1 “Sanitary Conditions Applicable to

Facilities under the US Bivalve Mollusc Sanitary Program” and SMB/NT1

“Classification and Monitoring of Harvesting Areas for Bivalve Mollusks

intended for the US, and Technical Rule HPB/NT4 “Sanitary Conditions

Applicable to Facilities under the US Bivalve Mollusk Sanitary Program”.

c) Comply with Sernapesca’s sanitary requirements described in Technical

Rule CER/NT2 ‘’Sanitary Requirements and Sampling Plans to obtain the

Sanitary Certification for Fisheries Products aimed for Export’’.

13. Hong Kong

Oysters

Shipments of raw oysters (Live, Chilled and Frozen) must be accompanied

by a “Sanitary Certificate for Fisheries and Aquaculture Products”, available in PDF

file at www.sernapesca.cl.





b) Oysters must come from harvesting areas included in the SPBM USA

or UE, classified as Type A or Approved and under a monitoring

program for Norovirus

c) An analysis to detect Norovirus must be performed, with n = 1 (12

units of oysters) by manufacturing date and origin, so if a

manufacturing date has more than one origin, n = 1 for each origin,

shall be considered.

d) The technique to be applied is described in Rule LAB /NT7


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Raw aquaculture products

Aquaculture products intended for this market as raw products must be


which is available in PDF file at www.sernapesca.cl, and in which must also

include the following statement under the ‘’observations’’ field:

The aquatic products have been handled, prepared or processed, identified, stored and transported under a competent sanitary programme consistently implemented and in accordance with the requirements laid down in Codex Code of Practice for Fish and Fishery Products.






Technical Rule CER/NT2, ‘’Sanitary Requirements and


Products aimed for Export’’.

Living aquaculture animals

Aquaculture products intended for this market must be accompanied by a

“Sanitary Certificate for Fisheries and Aquaculture Products”, available in PDF file

at www.sernapesca.cl, which must also include the following statement

under the “observations” field:

The aquatic animals have been produced, packed, stored and transported under sanitary condition, which were under the supervision of competent authority and in accordance with the requirements laid down in Codex Code of Practice for Fish and Fishery Products.




Page 25 of 80


a) The facility must be included in the List of Companies


b) Comply with Sernapesca’s sanitary requirements described

in Technical Rule CER/NT2, “Sanitary Requirements and


Fisheries Products aimed for Export”.

14. India

Frozen salmon intended for this market must be accompanied by a “Sanitary

Certificate for Fisheries and Aquaculture Products”, available in PDF file at the

web page www.sernapesca.cl. which must also include the following

statement under the “observations” field:

Total Bacterial Count (TPC) at 37°C <500,000 CFU/g (5x105 CFU/g) (max); E. coli <20 MPN/g (maximum); Coagulase positive Staphylococci <100 CFU/g (maximum); Salmonella Absent/25g; Vibrio parahaemolyticus Absent/25g

The product comes from a Vibrio cholerae free zone

The sanitary certificate must contain a description of the specific product in

this field, and must set forth that the lot intended for export is frozen

salmon.

The submission of the certificate is bound to the inclusion of the facility in

the List of Companies under Sernapesca’s Health Control Program.

15. Israel

Fisheries products aimed to this market must be accompanied by a

“Veterinary certificate for export of fish and fishery products to Israel”, available in

Word file at www.sernapesca.cl.




Page 26 of 80

Requirements for sanitary certification



a) The facility and the products manufactured therein must be authorized to

export to the European Union, in accordance with the List of Companies


b) The facility must have a Quality Assurance Program (QAP) on the basis

of HACCP with product certification in accordance with the QAP by

means of a Health Certification Authorization of Origin (AOCS).

c) The extraction area, either a natural bank or farm, must be included in the

List of Harvesting Areas under the Sanitary Program for Bivalve Mollusks

intended for the European Union (PSMB-UE).

d) Israeli legislation sets forth the lifespan of raw fish, in accordance with

the following table, which must be indicated on the label in Hebrew, but

can still remain the original label of the product as an additional. The

manufacturing company shall be responsible for complying with this

requirement, which shall be controlled by the authority at the point of

destination.

Lifespan of raw fish

Manufacturing

Line Species Lifespan of the

product Comments

Chill refrigerated raw fish

Dicentrarchus labrax Salmo salar Sparus aurata

7 days Starting the day of extraction or harvesting Other fish 5 days

Frozen raw fish All fish 12 months


Page 27 of 80

16. Jamaica

Products intended for this market must be accompanied by a “Sanitary

Certificate for Fisheries and Aquaculture Products”, which is available in PDF file

at the web page www.sernapesca.cl.





b) Compliance with Sernapesca’s sanitary requirements described

in Technical Rule CER/NT2, in accordance with the product’s

packaging.

17. Japan

1. Specific sanitary requirements to obtain Shipping notification

authorizations (NEPPEX) for aquaculture products*

Shipment authorizations for any product originating from farmed fish

intended for human consumption in this market shall, in addition of

following the Procedures Manual CER/MP1, comply with Procedures

Manual No. 1 of the Residue Control Program (FAR/MP1) and the

complying of the MRL specified for Japan in Annex 1 of such Manual.

2. Specific sanitary requirements to obtain sanitary certification

for fisheries and aquaculture products.

In case of requiring sanitary certification for this market, products must be


which is available in PDF file at www.sernapesca.cl and must comply with

the following:

a. The certificates set forth in Technical Rule No. 2 of the Certification




Page 28 of 80

Program (CER/NT2), in accordance with the product’s packaging.

b. The certificates must not display the words “to Order” in the

consignee field, nor additional statements in the Observations field.

c. For by-products of farmed fish these requirements are additional to

those set forth in item 1.

_________________________________ *Without prejudice of the official controls carried out by Sernapesca related to

shipment authorizations or sanitary certificates, the manufacturers and

exporters shall be responsible for complying with the Japanese Rule

“Specifications and Standards for Foods Additives, Under the Food Sanitation

Law”.

18. Mexico

Crustaceans

a) Shipments of raw crustaceans must be accompanied by a “Sanitary


www.sernapesca.cl, to which in the Observations field must include

the following statement:

Products are free of Yellow Head Disease (YHV), White Spot Disease

(WSSV), Infection by Penaeus vannamei Nodavirus (PvNV) and Infectious

Mionecrosis (IMNV).

b) Shipments of cooked crustaceans must be accompanied by a “Sanitary

Certificate for Fisheries and Aquaculture Products”, which in the

Observations field must include the following statement:

The resource at its thermal center, has undergone a heat treatment at a

temperature of 70ºC for a minimum time of 5 minutes.



Page 29 of 80

19. Norway

Fisheries products intended for this market must be accompanied by a

“Health Certificate for imports of fishery products intended for human consumption”,

available in PDF file at www.sernapesca.cl.

The submission of the certificate is bound to the following requirements:

a)The facility must be included in the List of Companies under


b)Compliance with Sernapesca’s sanitary requirements described

in item 1 of the above Rule, required for exports intended for the

European Union.

20. New Caledonia

Fisheries products intended for this market must be accompanied by the

“Veterinarian Certificate for products intended for human consumption destined to New

Caledonia”, available in PDF file at www.sernapesca.cl.




b) Compliance with Sernapesca’s sanitary requirements described in


packaging.

c) In case of crustaceans it shall also be proved that they were subjected

to the following heat treatments:

A procedure that is at least equivalent to core treatment at 50ºC

for at least 60 min, or

A procedure that is at least equivalent to furnace drying at 50ºC

for at least 90 min, or

A procedure that is at least equivalent to a complete drying at

30ºC for at least 1 hour, or




Page 30 of 80

Core heat treatment at 90ºC for 20 min, or

Core heat treatment at 80ºC for 30 min.

Restrictions

Exports of whole aquaculture fish with viscera are prohibited.

Exports of live mollusks are prohibited.

21. New Zealand

Frozen or processed bivalve mollusks intended for this market must be

accompanied by a “Sanitary Certificate for Bivalve Mollusks intended New

Zealand”, printed in special format.

In the case of pectinidae, it may also be exported as chilled eviscerated

product.


a)The facility and the manufactured products must be authorized

for export to the European Union, as set forth in the List of

Companies under Sernapesca’s Health Control Program.

b)The facility must have a Quality Assurance Program (QAP) on

the basis of HACCP with product certification in accordance with

the QAP by means of an Health Certification Authorization of

Origin (AOCS).

c)The harvesting area, whether is a natural bank or farm, must be

included in the List of Harvesting Areas under the Sanitary

Program for Bivalve Mollusks intended for the European Union

(SPBM US-UE).

d)In the case of natural banks, the manufacturing facility must

participate in the Sanitary Program for Bivalve Mollusks intended

for the European Union, which may be verified on the List of


Page 31 of 80

Companies under Sernapesca’s Health Control Program.

Scallops without coral are excluded from this requirement, and may be

exported without the use of the above certificate.

Restrictions

Exports of chilled-refrigerated or frozen salmon are prohibited.

Exports of living and/or refrigerated bivalve mollusks are prohibited.

Re-exports of bivalve mollusks that have been imported to Chilean

territory are prohibited.

22. Peru



www.sernapesca.cl.



Sernapesca’s Health Control Program. Whole chilled cooled fish

from extractive fishing, not subject to processing, shall be

excluded from this requirement.


in Technical Rule CER/NT2, in accordance with the product’s

packaging.

c)Products intended to reprocessing and/or re-exportation to the

European Union, must come from facilities authorized by

Sernapesca to export to the EU. In this case, the sanitary

certificate must include the following sentence in the

“Observations” field: “The facility described in Item II complies with

Regulations 852/2004, 853/2004 and 854/2004 of the European

Union”.

d)Bivalve mollusks intended for re-export to the EU, apart from


Page 32 of 80

complying with the above, must come from harvesting areas

authorized for the EU.

23. Serbia

From December 1st, 2011, any fisheries product intended for human

consumption to this market, must be accompanied by a “Sanitary Certificate

for importations of fisheries products intended for human consumption”, in the Serbian-

English language, printed in a special format.

The submission of the certificate is bound to the compliance of all technical,

administrative and sanitary requirements applicable to facilities and

products, set forth in the section related to the European Union of this rule.

24. Singapore



www.sernapesca.cl.






in Technical Rule CER/NT2. The Sanitary Certificate must set

forth the following sentence in the Observations field: “THE

PRODUCT WAS HARVESTED FROM AN AREA FREE OF

MARINE BIOTOXINES“.

c)Bivalve mollusks, gastropods, tunicates and echinoderms in any

presentation, must originate from harvest areas included in the

SPBM, or otherwise comply with the requirements set forth with

relation to sampling and analysis of biotoxins in rule CER/NT2


Page 33 of 80

(Annex VII “Sampling plans for the analysis of biotoxins for the

sanitary certification of bivalve molluscs, echinoderms, tunicates

and gastropods”).

Restrictions

Exports of chilled-refrigerated oysters are prohibited.

25. Switzerland


“Sanitary Certificate for Importations of Fisheries Products intended for human

consumption”, available in PDF file at www.sernapesca.cl.




b) Compliant with the sanitary requirements described in item II

of this rule, required for exports intended for the European

Union.

26. Tahiti (French Polinesia)


“Sanitary Certificate for Importations of Fisheries Products intended for Tahiti”,







Technical Rule CER/NT2, Sanitary Requirements and



Page 34 of 80

Fisheries Products aimed for Export, in accordance to the

product’s presentation.

c) Comply with the sanitary and zoosanitary declarations included

in the sanitary certificate:

Shrimp and decapod crustaceans have been:

i. Totally pealed (without shell or head), de-vained, frozen, manufactured

and packaged for direct retail and the packaging includes a label

indicating: “Ne pas utiliser comme appat pour la peche”.

ii. Cooked or pasteurized in accordance with heat treatment set forth in the

OIE’s sanitary code for aquatic animals according to pathogen agent,

species and sanitary status of the country, zone or area or origin;

iii. Frozen at temperatures under or equal to -20° during at least 72 hours in

case of by-products of river crabs.

Pearl oysters have been subject to a sterilization treatment.

27. Taiwan

Restrictions

Exports of whole farmed fish with viscera are prohibited. Exports of eggs

or products manufactured from internal organs are also prohibited.

28. Tunisia


“Sanitary Certificate for Fisheries and Aquaculture Products intended for Tunisia”,

available in PDF format at www.sernapesca.cl.



a) The facility and its manufactured products must be authorized

to export, as indicated in the List of Companies under


Page 35 of 80


b) The facility must have a Quality Assurance Program (QAP) on




c) In the case of farmed fish, the farm and the manufacturing

facilities must participate in the Program for the Control of

Residues from Pharmaceutical Products and Pollutants, which

may be verified in the List of Companies under Sernapesca’s


29. Turkey


“Veterinary Health Certificate for Exports of Fishery Products Intended for Human

Consumption to the Republic of Turkey”, available in Word file at

www.sernapesca.cl.


a) The facility and its manufactured products must be authorized

to export, as indicated in the List of Companies under


b) Comply with the sanitary requirements described in point II of

this rule, required for exports intended for the European

Union.

30. Customs Union (Russian Federation, Kazakhstan, Belarus)

Fisheries products intended for this market must accompany a “Veterinary

certificate for fish and seafood (fishery products) and their processing intended for human

consumption, exported from the Republic of Chile into the Russian Federation”,




Page 36 of 80


a) The facility must be authorized to export to this market, in

accordance with the requirements set forth in the Procedures

Manual N°1 of the Program for Authorization of Plants,

Factory Vessels and Vessel (HPB/MP1).

c) The facility must have a Quality Assurance Program (QAP) on




c) Comply with Sernapesca’s sanitary requirements described in


packaging.

In addition to Technical Rule N°2 above, the following microbiological

requirements must be complied:

†

Product

Maximum Limit

RAM(1) (UFC/g)

Total coliforms(2) Listeria

monocytogenes Raw, frozen, chilled-refrigerated fish, crabs and other invertebrates (cephalopods, echinoderms, gastropods).

≤1x105 Absence in 0,001 g

Absence in 25 g

Smoked fish in hot frozen ≤1x104 Absence in 1 g

Whole smoked fish in cold ≤1x104 Absence in 0,1 g

† Regardless of the official controls realized by Sernapesca for the authorization of shipments or



- Decision No. 299, May 28th

2010 of the Customs Union commission, in its modified version

by the Decisions No. 341 from August 17th

2010, No. 383 from September 20th

2010, No. 432

from October 14th

2010 and No. 456 from November 18th

2010.

- Decision No. 317, June 18th


by Decision No. 342 from August 17th

2010, No. 455 from November 18th

2010, No. 569 and

No. 570 from March 2nd

2011, No. 623 from April 7th

2011, No. 724 from June 2011 and No.

726 from July 15th

2011.


Page 37 of 80

frozen

Smoked Fish filets, portions and slices in cold frozen


Cut fish vacuum packaged ≤5x104 Absence in 0,1 g

Frozen and chilled-refrigerated raw bivalve mollusks


Cooked frozen bivalve mollusks, crustaceans, crabs and similar and other invertebrates (cephalopods, echinoderms, gastropods).


Frozen raw fish eggs ≤5x104 Absence in 1 g

Dry algae ≤5x104 Absence in 1 g

(1) Count of mesophile and optional anaerobic microorganisms (Government Rule GOST 10444.15-94)

(2) Government rule GOST 52816-2007

d) Products exported to this market must display the label

attached to the container, in such a manner that it may not be

opened without violating its integrity, in order to avoid its

reuse (Decision N°317 of the Customs Union).

e) Veterinarian signature.

Restrictions

Salmonidae consignments intended for this market may only include

products that do not show visible signs of injury as a result of infectious

diseases.

31. European Union

The following requirements shall be applied to the countries that form part

of the community market:


Page 38 of 80

Germany Denmark France Latvia United

Kingdom

Austria Slovakia Greece Lithuania Czech

Republic

Belgium Slovenia Holland Luxemburg Romania

Bulgaria Spain Hungary Malta Sweden

Cyprus Estonia Ireland Poland

Croatia

Finland Italy Portugal


“Sanitary Certificate for Importations of Fisheries Products intended for human

consumption”. This model form is available in the relevant languages in PDF


For exports of live bivalve mollusks, gastropods, tunicates or echinoderms,

the “Sanitary Certificate for Imports of Live Marine Bivalve Mollusks, Echinoderms,

Tunicates and Gastropods intended for Human Consumption”, is available in the

relevant languages in PDF file at www.sernapesca.cl.

Certificates must be drafted in at least one of the official languages of the

member state of the EU in which the inspection takes place at the border

point and the destination member state.

1. Requirements for sanitary certification


1.1. Technical Administrative Requirements:

a)The facility and its manufactured products must be authorized

to export to the EU, as indicated in the List of Companies under


b)The facility must have a Quality Assurance Program (QAP) on

the basis of HACCP with product certification in accordance with


Page 39 of 80

the QAP by means of a Health Certification Authorization of

Origin (AOCS). The above shall be comply also by

establishments that export crustaceans, bivalve mollusks,

gastropods, tunicates and echinoderms.

c)Facilities that export live bivalve mollusks, echinoderms,

tunicates and gastropods, the harvesting area, be it a natural bank

or a farm, must be included in the List of Harvesting Areas for

Bivalve Mollusks under the Sanitary Program for Bivalve

Mollusks intended for the European Union (SPBM EU).

d)In the case of natural banks, the manufacturing facility must

participate in Sernapesca’s Sanitary Program for Bivalve Mollusks

(SPBM), which must be verified in the List of Companies under

Sernapesca’s Sanitary Control Program.

e)Where live gastropods do not come from a harvesting area

included under a SPBM, they must comply with the sanitary

requirements set forth in the following item 1.2.1.

f)In the case of farmed fish, the farm and the manufacturing

facilities must participate in the Program for the Control of

Residues from Pharmaceutical Products and Pollutants, which

may be verified in the List of Companies under Sernapesca’s


g)Marine gastropods and pectinidae from natural banks must

comply with the requirements set forth in point 1.5, Chapter III,

of Technical Rule PAC/NT2.

1.2 Specific Sanitary Requirements

1.2.1 Facilities that export live crustaceans, bivalve mollusks,

gastropods, tunicates and echinoderms

Facilities that export live crustaceans, bivalve mollusks, gastropods, tunicates

and echinoderms must comply with the following sanitary requirements:


Page 40 of 80

Live Crustaceans:


Live crustaceans

Lead 0,5 mg/ kg

Cadmium 0,5 mg/ kg

Mercury 0,5 mg/ kg

Sampling plan: n = 3 by manufacturing date

Analysis number: Sample units must be mixed to create a composite, from

which 1 determination must be made.

Samples to determine the presence of these substances must be made by

means of a Sampling and Analysis for Export Request (SMAE) with a

frequency of 1 for each 15 shipments made to the EU.

Live bivalve mollusks, gastropods, tunicates and echinoderms:

The following requirements apply to gastropods that do not originate from

a harvest area under a Sanitary Program for Bivalve Mollusks, and bivalve

mollusks, gastropods, tunicates and echinoderms when the dispatch center

or processing facility that performs the preparation and packaging, does not

have a Quality Assurance Program for these resources, in other processing

lines (frozen, canned, etc.)

Product Assessment

Parameter

Maximum Level

Living Bivalve

Mollusks,

gastropods,

tunicates and

echinoderms

Paralyzing Shellfish

Poison

800 g/kg STX

equiv.

Amnesic Shellfish

Poison

20 mg/kg

Lipophylic Toxins Absence

Escherichia coli 230 NMP/100 gr

Salmonella Absence in 25 gr

Sampling Plan: n = 1 for each raw material reception


Page 41 of 80

Samples to determine the presence of these compounds must be performed

by means of a Sampling and Analysis for Export Request (SMAE) prior to

the shipment of each product.

Product Parameter

Maximum Level

(mg/kg (ppm))

Living Bivalve Mollusks,

gastropods, tunicates and

echinoderms

Lead 1,5

Cadmium 1,0

Mercury 0,5

Benzoapyrene 0,005

Sum of benzopyrenes,

benzoanthracene,

benzofluranthine, and

chrysene

0,03

Sampling plan: n = 3 by manufacturing date

Analysis number: Sample units must be mixed to create a composite, from

which 1 determination must be made.

Samples to determine the presence of these substances must be made by

means of a Sampling and Analysis for Export Request (SMAE) with a

frequency of 1 for each 15 shipments made to the UE.

1.2.2 Fisheries products manufacturing facilities

Manufacturing companies, through the Quality Assurance Programs shall

ensure compliance of the following sanitary requirements.

a) Food Additives: All processed products must only contain

authorized additives, which must be used in accordance to

standing community regulations: Guideline 95/2/CE related to

food additives other than colours and sweeteners.

b) Organoleptic examinations: Organoleptic examinations must

be performed in order to verify the compliance of freshness

criteria


Page 42 of 80

1. Sampling plans: n = 5; c = 0

(n = Number of units that comprise the sample; c = number of

sampling units with values above standard values may be

accepted)

2. Analysis number: Analysis number must be equal to n.

3. Analysis methodology: Sensorial assessment shall include the

determination of such parameters described in Technical Rule

Nº 2 of the Certification Program (CER/NT2) Sanitary

Requirements and Sampling Plans to obtain the Sanitary

Certification for Fisheries Products aimed for Export, in

accordance to the product’s packaging.

4. The results shall be considered satisfactory if they comply with

the standards described in the above rule.

c) Freshness indicators: Determine Volatile Basic Nitrogen

(TVBN) and Trimethylamine Nitrogen (TMA –N).

Determination of Total Volatile Basic Nitrogen (TVBN).

(Regulations (EC) Nº 854/2004 and 2074/2005) Only in refrigerated

or frozen products, without additional treatment)


2. Analysis Number: The analysis number shall be equal to n.

3. Analysis methodology: The methodology established by

Sernapesca shall be applied, as described in Technical Rule No.

2 of the Lab Control Program (LAB/NT2).

4. Threshold values for specific categories: Un-processed

fisheries products included in the following categories are

considered unfit for human consumption when the

organoleptic exam is unfavourable or the chemical analysis


Page 43 of 80

shows that the following NBVT limits have been surpassed:

- 25 mg of nitrogen/100 g of flesh in the case of the following

species: Sebastes spp., Helicolenus dactylopterus y Sebastichthys

capensis.(cabrilla)

- 30 mg nitrogen/100 g flesh in the case of the Pleuronectidae

family species (except the halibut species: Hippoglossus spp.).

- 35 mg nitrogen/100 g of flesh in the case of Salmo salar,

species of the Merlucciidae family and species of the Gadidae

family.

The following table provides the details of the Merlucciidae and

Gadidae family species manufactured and exported by Chile:

Common Name Scientific Name Family

Common Hake Merluccius gayi gayi Merlucciidae

Hoki Macruronus magellanicus Merlucciidae

Southern Hake Merluccius australis Merlucciidae

Southern blue whiting Micromesistius australis Gadidae

Trimethylamine Nitrogen Determination (TMAN)

Only raw and dry salted products of marine origin:


(n = Number of units that comprise the sample; c = number

of sample units with values above the standard may be

accepted).

2. Number of analysis: The number of analysis to be performed


Page 44 of 80

shall be equal to n.

3. Analysis Methodology: The methodology established by

Sernapesca and described in Technical Rule No. 2 of the Lab

Control Program (LAB/NT2) shall be applied.

4. The results shall be considered satisfactory if there is

compliance of the following limits:

Product Maximum Level

(mg/100 g)

Fish 15

Crustaceans and mollusks except

cattlefish and squid

5

Cattlefish and squid 15

Salted and dried products 50

d) Histamine Determination ((EC) Rule Nº 2073/2005):

Determinations of histamine shall be made to all fisheries

products from fish species associated to high levels of histadine,

particularly fish species of the following families: Scombridae,

Clupeidae, Engraulidae, Coryfenidae, Pomatomidae and Scombresosidae. To

this end, the following shall apply:

1. Sampling plans n = 9; c = 2

(n = Number of units that comprise the sample; c = number

of sample units with values above the standard may be

accepted).

2. Number of analysis: The number of analysis to be performed

shall be equal to n.

3. Analysis Methodology: The methodology established by

Sernapesca and described in Technical Rule No. 2 of the Lab

Control Program (LAB/NT2) shall be applied.


Page 45 of 80

4. The result shall be considered satisfactory if the following is

complied:

- The average observed value is under 100 mg/Kg.

- A maximum of 2 of the units that comprise the sample

have a value over 100 mg/Kg and under 200 mg/Kg.

- None of the units that comprise the sample have a value

over 200 mg/Kg

Fish from such families that have undergone an enzyme ripening treatment

in brine may have higher histamine levels, but no more than twice the above

values.

The following table shows the species manufactured and exported by Chile

from the following families: Scombridae, Clupeidae, Engraulidae, Coryfenidae,

Pomatomidae y Scombresosidae

Common Name Scientific Name Family

Yellow Fin Tuna

Long Finned Tuna

Big Eyed Tuna

Black Skipjack

Bonito

Caballa

Stripe-bellied Bonito

Thunnus albacares

Thunnus alalunga

Thunnus obesus

Auxis spp.

Sarda chiliensis

Scomber japonicus

Katsuwonus pelamis

Scombridae

Pacific Sardine

Southern Sardine

Sardine

Common Sardine

Ethmidium maculatum

Sprattus fuegensis

Sardinops sagax

Strangomera bentincki

Clupeidae

Anchovy Engraulis ringens Engraulidae

Billfish Coryphaena hippurus Corphaenidae

Pomatomidae*

Agujilla Scomberesox saurus

scombroides

Scombresosidae

* This family does not have catch, processing or export statistical records in

Chile.


Page 46 of 80

e) Residues of pharmaceutical products and prohibited

substances: All fisheries products from farmed fishes must comply

with the corresponding procedures and requirements established in the

Procedures Manual No. 1 from the Residues Control Program

(FAR/MP1), providing assurance regarding the following Maximum

Residue Limits: (Directive 96/23/CE April 1996; Measures to monitor

certain substances and residues; Directive 96/22/CE concerning the

prohibition on the use of certain substances having a hormonal or

thyrostatic action and of ß – agonists; Regulation (CE) N° 470/2009 in

which Community procedures for the establishment of residue limits of

pharmacologically active substances in foodstuffs of animal origin are

established.)

Pharmaceutical products

Product Pharmaceutical

products

Maximum Residue

Limit

(g/ Kg (ppb))

Fisheries products from farmed fish

Oxytetracycline 100

Oxolinic acid 100

Flumequine 600

Sulfa (sulfadoxine) 100

Trimethoprim 50

Florfenicol 1000

Erythromycin 200

Enrofloxacin 100

Amoxicillin 50

Spiramycin Absence

Ivermectin Absence

Emamectin Benzoate 100

Diflubenzuron 1000

Deltamethrin 10

Unauthorized Substances

Product Unauthorized Maximum Limit


Page 47 of 80

substance (g/ Kg (ppb)) Fisheries products from farmed fish

Malachite green, crystal

violet, brilliant green

and metabolites thereof

Absence

Prohibited Substances

Product Prohibited Substance Maximum Limit

(g/ Kg (ppb)) Fisheries products from farmed fish

Chloramphenicol Absence

Nitroimidazoles Absence

Nitrofurans Absence

Stilbenes

(Diethylstilbestrol)

Absence

17 ß estradiol Absence

Note: Absence should be understood as results obtained below the method

detection limit.

f) Contaminants: Analysis should be carried out for Heavy Metals

(Lead, Cadmium and Mercury) and Polycyclic Aromatic

Hydrocarbon (PAH) -(benzpyrenes) to ensure compliance with the

criteria required in Regulation (EC) No. 1881/2006 and its

modifications, setting maximum levels for certain contaminants in

foodstuffs. In order to efficiently protect public health and in

accordance with the above Rule, products that contain

contaminants at levels exceeding the maximum limits, in this case

marine origin oils, may not be mixed so as to dilute the detected

contaminant at acceptable levels.

To this end, the following shall be complied with:

1. Sampling plan: n = 10 by manufacturing date.

2. Number of analysis: Sampling units shall be mixed creating

compost, from which 1 determination shall be carried out, and

which shall comply with the established limits for each case.


Page 48 of 80

3. Analysis methodology: Methodologies established by this Service

and described in Technical Standard No. 2 of the Laboratories

Control Program LAB/NT2 shall be applied.

4. Maximum contents allowed:

Lead

Product Max. Content Lead

mg/kg (ppm) weight fresh (vii)

a. Fish meat (i) (ii) 0,3

b. Crustaceans (iii). 0,5

c. Bivalve mollusks (iv) (v) 1,5

d. Cephalopods without viscera (vi) 1,0

e. Fish oil 0,1 (i) If the fish is intended to be eaten whole, the maximum content shall apply to whole

fish. (ii) It includes the following categories:

a. living fish b.fresh or refrigerated fish, except fillets and other fish meat detailed in d. c.Frozen fish, except fillets and other fish meat detailed in d. d. Fillets and other fresh, refrigerated or frozen fish meat (including diced)

(iii) Crustaceans, including pealed, living, fresh, refrigerated, frozen, dry, salted or in brine; unpealed crustaceans, cooked with water or vapor, including, refrigerated, frozen, dry, salted or in brine; flour, dust and aggregates (pellets) of crustacean fit for human consumption. Prepared or canned crustaceans.

(iv) Includes: a. Bivalve mollucs, including those separated from their valves, living, fresh refrigerated, frozen, dry, salted or in brine. b. Prepared Bivalve molluscs or in brine

(v) In the case of echinoderms, gasteropods and tunicates, and considering the absence of standard regulations, the levels applied to bivalve molluscs shall be applied.

(vi) Includes prepared or canned. (vii) Fresh weight not applicable to fish oil.


Page 49 of 80

Cadmium

Product Maximum

Cadmium

mg/kg weight

fresh

a. Muscle meat of fish, excluding species listed in

letter b, c and d.

0,05

b. Muscle meat of the following fish: mackerel

(Scomber spp.), tuna (Thunnus species, Euthynnus species,

Katsuwonus pelamis) and bichique (Sicyopteurs lagocephalus)

0,1

c. Muscle meat of bullet tuna (i)(ii)(Auxis spp.) 0,15

d. Muscle meat of: anchovy (Engraulis spp.),

swordfish (Xiphias gladius) and pilchard (Sardina pilchardus)

0,25

e. Crustaceans (iii) (meat from appendix and

abdomen). In case of crabs and similar (Brachyura and

Anomura), meat from appendix.

0,5

f. Bivalve mollusks (iv) (v) 1,0

g. Cephalopods (without visceras)(vi) 1,0 (i)If the fish is intended to be eaten whole, the maximum content shall apply to

whole fish. (ii)It includes the following categories:

a. living fish b.fresh or refrigerated fish, except fillets and other fish meat detailed in d. c.Frozen fish, except fillets and other fish meat detailed in d. d. Fillets and other fresh, refrigerated or frozen fish meat (including diced)

i. Crustaceans, including pealed, living, fresh, refrigerated, frozen, dry, salted or in brine; unpealed crustaceans, cooked with water or vapor, including, refrigerated, frozen, dry, salted or in brine; flour, dust and aggregates (pellets) of crustacean fit for human consumption. Prepared or canned crustaceans.

ii. Includes: a.Bivalve mollucs, including those separated from their valves, living, fresh refrigerated, frozen, dry, salted or in brine. b.Bivalve molluscs prepared or in brine

(v) In the case of echinoderms, gasteropods and tunicates, and considering the absence of standard regulations, the levels applied to bivalve molluscs shall be applied. Includes prepared or canned.

(vi) Fresh weight not applicable to fish oil.


Page 50 of 80

Mercury

Product Maximum

Level

mg/kg (ppm)

fresh weight (v)

a. Fisheries products (i). 0,5

b. Crustaceans (meat from appendix and abdomen) (ii) 0,5

c. Fish meat (iii) (iv), except species detailed in point d. 0,5

d. Meat of the following fish (iii)(iv): anglerfish (Lophius

spp), atlantic catfish (Anarhichas lupus), bonito (Sarda sarda),

eel (Anguilla spp.), emperor, orange roughy, rosy soldierfish

(Hoplostethus spp.), grenadier (Coryphaenoides rupestris),

halibut (Hippoglossus hippoglossus), marlin (Makaira spp.),

megrim (Lepidorhombus spp.), mullet (Mullus spp.), pike (Esox

lucius), plain bonito (Orcynopsis unicolor), poor cod (Trisopterus

minutus), portuguese dogfish (Centroscymnes coelolepis), rays (Raja

spp.), redfish (Sebastes marinus, S. mentella, S. viviparus), sail fish

(Istiophorus plarypterus), scabbard fish (Lepidopus caudatus,

Aphanopus carbo), seabream or pandora (Pagellus spp.), shark

(all species), snake mackerel or butterfish (Lepidocybium

flavobruneum, Ruvettus pretiosus, Gempylus serpens), sturgeon

(Acipenser spp.), swordfish (Xiphias gladius), tuna (Thunnus

spp., Euthynnus spp., Katsuwonus pelamis), pink cusk eel

(Genypterus blacodes) and kingklip (Genypterus capensis).

1,0

(i)Includes: a. Molluscs in general, including those separated from their valves, living, fresh

refrigerated, frozen, dry, salted or in brine. b.Aquatic invertabrae, living, fresh, refrigerated, frozen, dry salted or in brine. c.Molluscs and other prepared or canned invertabrae. (ii)It includes the following categories:

a.Crustaceans, including pealed, living, fresh, refrigerated, frozen, dry, salted or


Page 51 of 80

in brine; unpealed crustaceans, cooked with water or vapor, including, refrigerated, frozen, dry, salted or en salmuera; flour, dust and aglomerados** (pellets) of crustacean fit for human consumption. Prepared or canned crustaceans.

b.Prepared or canned crustaceans

(iii) Includes the following categories:

a. Living fish. b. Fresh or refrigerated fish, except fillets and other fish meat detailed in d. c. Frozen fish, except fillets and other meat detailed in d. d. Filets and other fish meat (including diced meat) fresh, refrigerated or frozen.

(iv)If the fish is intended to be consumed whole, the maximum content shall

apply to whole fish. (v)Fresh weight not applicable to fish oil.

If the product is destined for Italy, the following conversion factors shall be

applied to the results obtained for the determination of mercury in the

publication of the Gazzetta Ufficiale Nº21/1994:

Salted products (wet) 0,5

Salted products (dried) 0,4

Smoked products 0,4

Canned products 0,7

Cooked products 0,6

The result of the multiplication shall be compared to the community

standards.


Page 52 of 80

Polycyclic Aromatic Hydrocarbon (PAH) - Benzopyrenes (i)

Product

Maximum Level

Benzopyrene

(mg/kg (ppm))

Maximum Level Sum

of benzopyrene,

benzoanthracene,

benzofluranthine and

chrysene

(mg/kg (ppm))

a. Muscle meat

of smoked

fish (ii) (iii)

0,005 (until 31.08.2014)

0,002 (from 01.09.2014)

0,03 (until 31.08.2014)

0,012 (from 01.09.2014)

b. Smoked

fisheries

products (iv)

except

fisheries

products

detailed in

points c, d and

e.

0,005 (until 31.08.2014)

0,002 (from 01.09.2014)

0,03 (until 31.08.2014)

0,012 (from 01.09.2014)

c. Smoked

Crustaceans

(meat in

appendix and

abdomen)

0,005 (until 31.08.2014)

0,002 (from 01.09.2014)

0,03 (until 31.08.2014)

0,012 (from 01.09.2014)

d. Bivalve

molluscs (v)

(vi)

0,005

0,03

e. Smoked

bivalve

molluscs (vi)

0,006

0,035

f. Fish oil 0,002 0,01 (i) Used as markers for the occurrence and effect of carcinogenic PAH. (ii) If the fish is intended to consume as a whole, the maximum content

shall apply to the whole fish. (iii) Smoked fish, including cooked prior or subsequent to smoking. (iv) Includes any type of aquatic invertebrates.


Page 53 of 80

(v) Fresh, refrigerated, frozen, dry, salted or brine, and canned bivalve mollusks.

(vi) For echinoderms, gasteropods and tunicates, and considering the absence of standard regulations, the levels required for bivalve mollusks shall apply.

When applying the maximum contaminant levels set out in letter f) of point

1.2.2 to foodstuffs which are diluted, processed or composed of more than

one ingredient, the following shall be taken into account:

a) changes of the concentration of the contaminant caused by drying or

dilution processes;

b) changes of the concentration of the contaminant caused by processing;

c) the relative proportions of the ingredients in the product and

d) the analytical limit of quantification.

The specific concentration or dilution factors for the dried, diluted,

processed and/or compound foodstuffs concerned shall be provided and

justified by the food business operator, when the competent authority

carries out an official control at destination.

This shall apply in so far as no specific maximum content levels are fixed for

these dried, diluted, processed or compound foodstuffs.

If there had been changes of the concentration of a certain processing line

to be justified, the food business operator should provide a study carried out

by a Sernapesca’s authorized laboratory, clearly indicating the correction

factor to be applied.

Such study must be filed for approval with the regional office of the

corresponding jurisdiction of the establishment, this applicable only for the

purpose of controlling unfavorable verifications of the Quality Assurance

Program (clearance of a product following an unfavorable result).


Page 54 of 80

It shall be the responsibility of each food business operator to present such

factors to the Member State concerned corresponding to the entrance of the

consignment to the EU and its final destination within the EU.

Furthermore, European authorities should be able to assess the proper

application of the correction factor presented, and to reject a study at their

discretion.

Melamine and its structural analogues

Product Maximum Level

(mg/kg (ppm))

Foodstuff 2,5

e)Microbiological requirements: food safety and process hygiene

criteria (Regulation (CE) Nº 2073/2005 on microbiological criteria for

foodstuff)

Food category

Micro-organisms/their

toxins, metabolites

Sampling-plan (1)

Limits

n c m M

Ready-to-eat frozen foods able to support the growth of L. Monocytogenes (2) (3)

Lysteria monocytogenes

5 0 100 cfu/g

Ready-to-eat fresh or smoked foods able to support the growth of L. Monocytogenes (3)

Lysteria monocytogenes

5 0 10 cfu/g

Cooked crustaceans and mollusks.

Salmonella 5 0 Absence in 25 g

Peeled headless products of cooked crustaceans and mollusks(4)

E. coli 5 2 1

NMP/g 10

NMP/g

Coagulase-positive

staphylococci 5 2

100 cfu/g

1000 cfu/g


Page 55 of 80

(1) n = number of units comprising the sample; c = number of sample units giving values exceeding limit that can be accepted or number of sample units giving values between m and M.

(2) It shall be guaranteed that the limit of 100 cfu/g is not exceeded at the end of the lifespan.

(3) Foodstuffs that do not comply with the following criteria described are considered to belong to this category:

- Products which have received heat treatment or other processing effective to eliminate L. monocytogenes, when recontamination is not possible after this treatment (e.g. products heat treated in their final package), and in live bivalve mollusk.

- Products with pH ≤ 4,4 or Aw ≤ 0,92, products with pH ≤ 5,0 and Aw ≤ 0,94, and products with a lifespan of less than five days.

(4) The test results demonstrate the microbiological quality of the process tested.

Additionally, microbiological analysis specified in Technical Rule No. 2 of

the Certification Program (CER/NT2) Sanitary Requirements and Sampling

Plans for Health Certification of Fisheries Product intended for export shall

be carried out according to the product’s packaging.

Interpretation of the test results:

1. The limits given refer to each sample unit tested.

2. L. monocytogenes:

- Satisfactory: if all the values observed are ≤ 10 or 100

cfu/gr as appropriate according to the presentation of the

product.

- Unsatisfactory: if the presence of the bacterium is detected at

levels of >10 or 100 cfu/gr, according to the presentation of

the product.

3. Salmonella

- Satisfactory: if all values observed indicate the absence

of the bacterium

- Unsatisfactory, if there is presence of the bacterium in

any of the sample units.


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4. E. coli:

- Satisfactory, if all observed values are ≤ to m or if a

maximum of c over n values are between m and M and the

rest observed values are ≤ m

- Unsatisfactory, if one of many values observed are > M or

more than c over n values are between m and M

5. Staphylococci coagulase-positives in cooked and peeled

crustaceans and molluscs:

- Satisfactory, if all observed values are ≤ to m or if a

maximum of c over n values are between m and M and the

rest observed values are ≤ m

- Unsatisfactory, if one of many values observed are > M or

more than c over n values are between m and M.

h) Parasites: fisheries products that are clearly contaminated with

parasites shall not be placed in the market for human consumption.

(EC Regulation Nº 853/2004 sets specific health safety rules for foods

of animal origin).

i) Toxins harmful for human health:

1. Fisheries products obtained from poisonous fish from the

following families: Tetraodontidae, Molidae, Diodontidae y

Canthigasteridae (these families are not subject to catch,

processing or export statistics in Chile.)

2. Fisheries products that contain biotoxins such as ciguatoxin or

muscle-paralyzing toxins.

3. Fisheries products obtained from bivalve mollusks, echinoderms

and tunicates may be exported if they comply with the technical

procedures and requirements set forth in the Sanitary Program

for Bivalve Mollusks intended for the EU (SMB/MP2 y NT/2).

Marine gastropods and pectinids from natural banks are


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excluded from this requirement.

4. Plus, bivalve mollusks, echinoderms, tunicates and gastropods

shall not contain marine biotoxins in total quantities (whole

body or any edible part) that exceed the following limits for:

a) Paralytic Shellfish Poison: (PSP), 800 micrograms per kilogram;

b) Amnesic Shellfish Poison, (ASP), 20 miligrams of domoic acid

per kilogram;

c) Ocadaic acid, dinophysistoxins and pectenotoxins, 160

micrograms of equivalent ocadaic acid per kilogram;

d) Yessotoxins, 3,75 miligram of yessotoxin per kilogram,

according to the biological method or alternative detection

methods, and

e) Azaspiracids, 160 micrograms of equivalent azaspiracid per

kilogram.

5. To ensure the compliance of point 4 above, in the case of

farmed marine gastropods, the company must make regular

verifications of the finished product. If the gastropods or

pectinids products originate from natural banks, marine toxins

controls for each exported lot must be performed, in accordance

to the sampling plans in annex 6 of technical rule CER/NT2.

1.2.3 Composite product

Composite products are those that contain processed products of

animal origin and products of vegetable origin, where half of its

substance or more are processed fishery products, must be

accompanied by a sanitary certificate in accordance with the model

sanitary certificate set forth in annex 6 of Sernapesca’s CER/MP1

manual and comply with the requirements described above in points

1.1 and 1.2. The submission of this certificate is bound to the

compliance of the requirements set forth in point 1. Requirements for

sanitary certification.


Page 58 of 80

Restrictions

Exports of whole farmed fish with viscera are prohibited, except for Turbot

(Scopthalmus maximus) and Pacific Salmon (Onorhynchus kisutch).

32. Uruguay


“Sanitary Certificate for Argentina, Brazil and Uruguay”, available in PDF format

at www.sernapesca.cl.

A statement indicating the absence of Vibrio parahaemolyticus, must also be

included. To this end, the requirements set forth in Sernapesca regulations

must be complied.



a) The manufacturing facility must be authorized to export to Uruguay.

b) The manufacturing facility must have a Quality Assurance Program

(QAP) on the basis of HACCP and its products must be certified in accordance with the QAP by means of an Authorization at Origin for Sanitary Certification (AOCS).




for Export, in accordance to the product’s packaging.

d) The facility must submit a process monography to DINARA for each

product intended for this market. Monographies shall be submitted in accordance with Procedures Manual CER/MP1.

e) Veterinarian’s signature.

Additionally, the sanitary certificate must include the following zoosanitary



Page 59 of 80

declarations, as appropriate to each product:

a) Os animais utilizados como matéria-prima para fabricação do produto não foram obtidos a partir de cultivo e não apresentaram lesões atribuíveis à doença/infecção no momento da recepção da matéria prima */ los animales utilizados como materia prima en la fabricación del producto no fueron obtenidos de cultivo y no presentaron lesiones atribuibles a enfermedad/infección en el momento de la recepción de la materia prima;*

b) Os produtos certificados não incluem espécies de camarão*/ los productos certificados no incluyen las especies de camarones, langostinos o gambas;*

c) Os produtos certificados não incluem animais vivos, nem material de

reprodução viável*/ los productos certificados no incluyen animales vivos ni material de reproducción viable;*

In case of live bivalve mollusks and gastropods exports, the following declaration must be included:

d) Conforme a los resultados del Programa Sanitario Específico de

Vigilancia de enfermedades de moluscos bivalvos, no existe evidencia de la presencia en (nombre del país), de los agentes causales de las siguientes enfermedades:

Bonamia exitiosa

Bonamia ostrae


Mikrocytos mackini

Perkinsus marinus

Perkinsus olseni

33. Vietnam

Shipments of raw bivalve molluscs and scallops with coral, must be





Page 60 of 80



a) The manufacturing facility must be authorized by the Ministry of

Agriculture and Rural Development of Vietnam to export to this

market. The request must be made through the appropriate regional

office.

b) Products not intended for domestic consumption in Vietnam, as in

the case of landings intended for re-exportation (intended or not for

re-processesing) or that are in transit, shall not be required to be

registered in the Vietnam list. In this case, the exporter shall submit a

simple declaration stating that the product shall not be consumed in

Vietnam, at the time of submitting the supporting documents for

sanitary certification (AOCS or SMAE).




for Export, in accordance to the product’s packaging.

d) To add new species to the list in Vietnam, the company must send a

new documentation for each processing line to be included.


Page 61 of 80

III. Products not intended for human consumption

Specific requirements by destination market

1. Argentina

Shipments must be accompanied by a “Single Sanitary Certificate for products,

subproducts and/or by-products, obtained from fishing and/or aquaculture intended

exclusively as Bait, Animal Feed and other Uses Not Intended for Human

Consumption, traded between the Republic of Argentina, The Federative Republic of

Brazil, the Republic of Chile and the Eastern Republic of Uruguay”, available in PDF

format at www.sernapesca.cl.



Fish meal and fish oil


Sernapesca’s Health Control Program and classified at least in

Category D.

b) The applicant facility must register it’s product, by submitting an

application before SENASA for the approval and registration of

by-products of animal origin to export to Argentina, and also

attaching a label project in accordance with the Service

requirements.

c) The manufacturing facility must be included in the SENASA

Registry of Argentina, which must be verified in the List of

Companies under Sernapesca’s Sanitary Control Program.

d) The product must comply with Sernapesca’s sanitary requirements

described in Technical Rule CER/NT2 for fish oil and fish meal,

as appropriate.



Page 62 of 80

Dry algae for industrial use

The product must comply with the sanitary requirements established by the

Service in Technical Rule Nº 2 of Certification Program (CER/NT2).

The applicant must submit the following documents to the Office of

General Quarantine at SENASA:

a) Algae process monography

b) Attach the analysis of moisture percentage of finished product.

Bait

The product must comply with the sanitary requirements established by the


2. Australia

Shipments of fish oil and fish meal must be accompanied by a “Health

certificate for fishery products not intended for human consumption for export to

Australia”, available in PDF format at www.sernapesca.cl..



a)The facility must be included in the List of Companies under Sernapesca’s

Health Control Program and classified at least in Category D.

b)The product must comply with the sanitary requirements set forth by the

Service in Technical Rule No. 2 of Certification Program (CER/NT2) for

fish meal and fish oil, as appropriate.

Restrictions

Exports of fish meal and fish oil from salmon species are prohibited.



Page 63 of 80

3. Brazil

Shipments must be accompanied by a “Single Sanitary Certificate for products,

subproducts and/or by-products, obtained from fishing and or aquaculture intended

exclusively as Bait, Animal Feed and other Uses Not Intended for Human

Consumption, traded between the Republic of Argentina, The Federative Republic of

Brazil, the Republic of Chile and the Eastern Republic of Uruguay”, available in PDF

format at www.sernapesca.cl.




Sernapesca’s Sanitary Control Program and classified at least in

Category D, in accordance with rules PER/NT1 and procedures

set forth in rule PER/MP1.

b) The facility must be listed in the DIPOA registry of Brazil, which

must be verified in the List of Companies under Sernapesca’s

Sanitary Control Programs.

c) The product must comply with the sanitary requirements set forth

by the Service in Technical Rule No. 2 of Certification Program

(CER/NT2) for fish meal and fish oil, as appropriate.

Products must also be accompanied by a special certificate in the Spanish

and Portuguese Language, additional to the sanitary certificate stating the

following:

1) Los animales utilizados como materia prima fueron procesados en un establecimiento bajo supervisión veterinaria oficial y habilitado para exportación. Os animais utilizados como matéria-prima, foram processados em um estabelecimento sob supervisão veterinário oficial e habilitado para exportação.



Page 64 of 80

2) Los productos no contienen proteína de rumiantes en su composición. Os produtos não contêm proteínas de ruminantes em sua composição.

3) La materia prima fue sometida a una temperatura mínima de 90ºC por

un período mínimo de 25 minutos. A matéria prima foi submetida a uma temperatura mínima de 90º C por um período mínimo de 25 minutos.*

4) Los animales nacieron y fueron criados en Chile. Os animais nasceram e

foram criados em Chile.** 5) La planta elaboradora no utiliza proteínas de rumiantes en sus

productos. A planta fabricante não utiliza proteínas de ruminantes em seus produtos.

6) Los productos fueron envasados directamente en la planta de

elaboración. Os produtos foram embalados diretamente na planta de fabricação. 7) Los productos debidamente embalados fueron transportados

directamente de la planta elaboradora hasta el lugar del embarque, y acondicionados en un contenedor sellado bajo supervisión del Servicio Veterinario Oficial. Os produtos devidamente embalados foram transportados diretamente da fábrica até o local de embarque e acondicionados em container lacrado sob supervisão do Serviço Veterinário Oficial.

*Treatments that do not comply with this condition, in point 3) shall briefly

describe the thermal treatment, indicating temperature and time for each

step of the process, prior submission and approval by the Ministério da

Agricultura, Pecuária e Abastecimento of Brazil (MAPA).

** Only in case of products manufactured on the basis of raw material from

aquaculture.

Bait

The product must comply with the sanitary requirements set forth by the



Page 65 of 80

4. Canada

Shipments of fish oil and fish meal must be accompanied by the certificate

“Health certificate for fishery products not intended for human consumption for export to

Canada”, available in PDF format at www.sernapesca.cl.





Category D.

b) The product must comply with the sanitary requirements set forth by

the Service in Technical Rule No. 2 of Certification Program

(CER/NT2), for fish meal and fish oil, as appropriate.

c) For fish meal, once the shipment is notified, the notification copy of

the moisture determination results performed by IFOP, indicating

moisture below 10%, shall be included.

d) The facility shall include the container seals on the second sheet of

the certificate, in the appropriate field.

Fish meal shipments, unlike fish oil, should present its import permit along

with the “Annex A - Facility Questionnaire: Importation of Non-Ruminant Rendered

Products From Countries of Controlled Risk for BSE” signed by a Sernapesca

Veterinary Inspector. Each consignment should go with a copy of the

authorization and present it at the first border port of entry into Canada.

5. China

Fish meal and Fish Oil

Shipments of fish oil and fish meal must be accompanied by a “Health

certificate for fishery products not intended for human consumption for export to the



Page 66 of 80

People's Republic of China”, which is available in PDF file at

www.sernapesca.cl.




Sernapesca’s Health Control Program, and previously registered and

authorized to export to this market.

b)The manufacturing facility must have a Quality Assurance Program

(QAP) on the basis of HACCP and its products must be certified in

accordance with the QAP by means of an Authorization at Origin for

Sanitary Certification (AOCS).

c)Comply with the following specific requirements (sampling must be

made in accordance with technical rule LAB/NT1).


Fish meal

Mercury (Hg) ≤0,5 mg/kg

Cadmium (Cd) ≤2,0 mg/kg

Lead (Pb) ≤10 mg/kg

Chromium (Cr) ≤8,0 mg/kg

Fungus ≤20.000 cfu/g


Shigella Absence in 25 g

Enterobacteria n=5, c=2, m=10,

M=300 cfu/g

RAM ≤2.000.000 cfu/g

Melamina ≤2,5 mg/kg

Fish oil not

intended for human

consumption (*)


Total Coliforms ≤300 MNP/g

Sampling plan:

- Fish meal: n=5, c=0 for microbiological analysis, except


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Enterobacteria. A composite and one determination are required for

chemical analysis.

- (*) Fish oil: microbiological analysis n=6, c=0, with 6 analysis.

Execution frequency: Heavy metals and microbiological parameters

determinations shall be included in biweekly verifications, in the case of

facilities with Quality Assurance Programs (QAP).

Melamine determinations shall be made only in official verifications, in the

case of facilities with QAP.

Malachite Green applies only to farmed fish and is covered by controls

performed under the Residue Control Program described in document

FAR/MP1.

Dioxins analysis shall be made on the basis of the Annual Dioxins Control

Program.

Algae

Where a sanitary certification for algae intended for this market is required,

they shall be accompanied by a “Fitosanitary Certificate”, available in PDF


The submission of the certificate is bound to the compliance of the specific

requirements in Technical Rule No. 2 of Certification Program (CER/NT2),

in accordance with the product’s packaging.

Restrictions

Only fishmeal and fish oil manufactured on the basis of species harvested in

Chilean waters is authorized to be exported.



Page 68 of 80

6. Japan

Shipments of fish oil and fish meal must be accompanied by a “Certificate for

fish meal and fish oil for animal feed for products destined to Japan”, which is





Sernapesca’s Health Control Program and classified at least in Category

D.

b) The product must comply with the sanitary requirements set forth by the

Service in Technical Rule No. 2 of Certification Program (CER/NT2),

for fish meal and fish oil, as appropriate.

7. Mexico

Fishmeal, crustaceans and mollusks

Shipments must be accompanied by a “Health certificate for fishery and

aquaculture products not intended for human consumption”, available in PDF file at

www.sernapesca.cl.





Category D.

b) The product must comply with the sanitary requirements set forth

by the Service in Technical Rule No. 2 of Certification Program




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c) The product must comply with the following conditions:

- Absence of Salmonella spp. And Shigella spp.

- Humidity under 10%

- Absence of bones and slivers from mammals, insects and strange

substances.

- Fishmeal has been exposed to a heat treatment at a temperature of

minimum 70° c during 5 minutes or equivalent combinations in

time/temperature that demonstrate inactivation of viral agents.

The following statements shall be included at the end of section IV of the

“Sanitary Certificate for fisheries and aquaculture products not intended for

human consumption”:

1) El producto y la materia prima corresponden al país indicado en este

documento como de origen. 2) La planta en la que se elaboró el producto a exportar, no procesa proteínas de

origen rumiante.

8. New Caledonia

Fish meal

Shipments of fish meal must be accompanied by a “Veterinary Certificate

regarding food for aquatic animals exported to New Caledonia”, available in PDF file

at www.sernapesca.cl.





D.


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the Service in Technical Rule No. 2 of Certification Program


9. Peru


aquaculture products not intended for human consumption”, available in PDF file at

www.sernapesca.cl.




Health Control Program and classified at least in Category D.

b)The product must comply with the sanitary requirements set forth by the

Service in Technical Rule No. 2 of Certification Program (CER/NT2).

10. Tahiti (French Polynesia)


aquaculture products intended for Tahiti”, available in PDF file at

www.sernapesca.cl.





D.


Page 71 of 80


the Service in Technical Rule Nº 2 of Certification Program


c) Comply with the sanitary and zoosanitary statements within the

sanitary certificate:

Shrimp and decapods crustacean have been:

i. Totally pealed (without shell or head), de-vained, frozen, manufactured

and packaged for direct retail and the packaging includes a label

indicating: “Ne pas utiliser comme appat pour la peche” (do not use as

bait for fishing).

ii. Cooked or pasteurized in accordance with heat treatment set forth in the

OIE’s sanitary code for aquatic animals according to pathogen agent,

species and sanitary status of the country, zone or area or origin;

iii. Frozen at temperatures under or equal to -20° during at least 72 hours in

case of by-products of river crabs.

Pearl oysters have been subject to a sterilization treatment.

11. Customs Union (Russian Federation, Kazakhstan, Belarus)

Fish Meal

Shipments of fish meal must be accompanied by a “Veterinary certificate for

fodder fish meal, exported from the Republic of Chile into the Russian Federation”,




a) The facility must be included in the Rosselkhoznadzor registry of

Russia, which must be verified in the List of Companies under



Page 72 of 80

b) The manufacturing facility must have a Quality Assurance Program

(QAP) on the basis of HACCP and its products must be certified in

‡accordance with the QAP by means of an Authorization at Origin for

Sanitary Certification (AOCS).

c) Comply with the sanitary requirements set forth by the Service in

Technical Rule Nº 2 of Certification Program (CER/NT2), in

accordance the product’s packaging.

12. European Union and Norway

Fish meal and fish oil

The following requirements shall be made to the following countries that

are part of the community market:

Germany Slovakia Greece Lithuania Czech

Republic

Austria Slovenia Holland Luxembourg Romania

Belgium Spain Hungary Malta Sweden

Bulgaria Estonia Ireland Poland Croatia

Cyprus Finland Italy Portugal

Denmark France Latvia United Kingdom

Fish meal and fish oil not intended for human consumption in this market

shall be accompanied by the following certificates, respectively; “Sanitary

certificates for processed animal protein not intended for human consumption, included the

mixtures and products other than animal feed for pet animals that contain them, that

shall be sent to the European Union or transit through them” and a “Sanitary

Certificate for fish oil not intended for human consumption, to be used as

an ingredient for feed or with technical purposes that shall be sent to the

‡ Regardless of the official controls realized by Sernapesca for the authorization of shipments or



- Decision No. 317, June 18th


by the Decision No. 342 from August 17th

2010, No. 455 from November 18th

2010, No. 569

and No. 570 from March 2nd

2011, No. 623 from April 7th

2011, No. 724 from June 22th 2011

and No. 726 July 15th

2011.


Page 73 of 80

European Union or transit through them”. Such models, in the appropriate

languages, are available in PDF file at www.sernapesca.cl.

The certificates must be drafted in at least one of the official languages of

the Member State of the EU in which the inspection takes place at the

border point and the Member State of final destination. Nonetheless, such

Member States may authorize the use of other languages, where appropriate,

with an official translation.

1. Requirements to obtain sanitary certification

The submission of the above certificates is bound to the compliance of the


1.1 Administrative technical requirements:


Health Control Program and classified at least in Category B.

b) Fish meal and fish oil processing plants must be registered as facilities

authorized to export to the European Union, as provided in the List of

Companies included in Sernapesca’s Sanitary Control Programs.

c) In the specific case of France, Italy and Greece, the facility must be

included in the list of authorized facilities, as required by such countries.

d) The manufacturing facility must have a Quality Assurance Program

(QAP) based on HACCP, in accordance with document PER/NT2.

e) The product’s packaging or container must be labelled indicating as

follows: fish meal or fish oil (as appropriate), batch number, production

date, plant’s registry number, the word “Chile” and the text “not suitable

for human consumption”. Such packaging or container must also have a

visible and clear distinctive green and blue colour to ensure that it clearly

stands out from other colours.

f) In the case of fish meal intended for feed of farm non-ruminant animals


Page 74 of 80

different than furriery animals, the commercial document that goes with

the fish meal, as with any packaging that contains this product, shall be

marked clearly with the text “Contains fish meal. Not fit for ruminant feed’’.

1.2 Specific Sanitary Requirements

Fish meal and fish oil processing plants, must ensure the compliance of the

following sanitary requirements, by means of the regular verifications

envisaged in their respective Quality Assurance Programs:

1.2.1 Microbiological requirements for fish meal

Salmonella: n = 5 Maximum level = absence in 25 g

Enterobacteriaceae: n = 5 c = 2 m = 10 M = 3x102 cfu/g.

Where:

n: number of units that comprise the sample;

m: threshold value for number of bacteria; the result shall be considered

acceptable if the number of bacteria in one or more units is equal or greater

than M;

M: maximum value of bacteria number; the result shall be considered not

acceptable if the number of bacteria in one or more units do not exceed m;

c: number of sample units in which the bacterial count may be between m

and M, the sample still being considered acceptable if the bacterial count of

the other samples is equal to m or less.

1.2.2 Requirements for undesirable chemical substances in fish meal

and fish oil

As established in Directive 2002/32/CE, products intended for animal feed

which contain undesirable substances in a greater level than the maximum

set in this document, shall not be mixed for dilution effects, with the same

product or with other products intended for animal feed.


Page 75 of 80

Maximum levels of heavy metals and nitrates for fish meal

Substance Maximum Level (mg/kg (ppm))

(standardized weight 12% moisture)

Lead 10,0

Mercury 0,5

Nitrates 30,0

Cadmium 2,0

Maximum levels of heavy metals for fish oil

Substance Maximum Level (mg/kg (ppm)) (standardized weight 12%

moisture)

Lead 10,0

Mercury 0,50

Cadmium 2,0


Page 76 of 80

Maximum Levels of organochlorides for fish meal

Substance

Maximum Level (mg/kg (ppm))


Aldrin (alone or combined expressed as dieldrin) 0,01

Camphechlor (toxaphene) (sum of indicator congeners CHB 26, 50 and 62) 0,02

Chlordane sum of cis and trans isomers and oxichlordane expressed as clordane) 0,02

DDT (sum of isomers DDT, DDD and DDE expressed as DDT) 0,05

Endosulfan (sum of alta and beta isomers and endosulfan sulphate, expressed as endosulfan) 0,10

Endrin (sum of endrin and deltacetoendrin, expressed as endrin) 0,01

Heptachlor (sum of heptachlor and heptachlorepoxide, expressed as heptachlor) 0,01

Hexachlorocyclohexane (HCH) alfa isomers 0,02

Hexachlorocyclohexane (HCH) beta isomers 0,01

Hexachlorocyclohexane (HCH) gamma isomers 0,20


Page 77 of 80

Maximum Levels of organochlorides for fish oil

Substance

Maximum Level (mg/kg (ppm))


Dieldrin (alone or combined expressed as dieldrin) 0,1

Camphechlor (toxaphene) (sum of indicators congeners CHB 26, 50 and 62) 0,2

Chlordane sum of cis and trans isomers and oxichlordane expressed as clordane) 0,05

DDT (sum of isomers of DDT, DDD and DDE expressed as DDT) 0,5

Endosulfan (sum of alta and beta isomers and endosulfan sulphate, expressed as endosulfan) 0,1

Endrin (sum of endrin and deltacetoendrin, expressed as endrin) 0,05

Heptachlor (sum of heptachlor and heptachlorepoxide, expressed as heptachlor) 0,2

Hexachlorocyclohexane (HCH) alfa isomers 0,2

Hexachlorocyclohexane (HCH) beta isomers 0,1

Hexachlorocyclohexane (HCH) gamma isomers 2

1.3 Special Sanitary Requirements

Shipments of fish meal and fish oil intended for France must be

accompanied by a special certificate with additional statements, depending

on the use of the product at the point of destination, as follows:

Products intended as feed for pet animals

Le sous-produit animal ne contient pas et n’est pas dérivé de matériels d’origine bovine,


Page 78 of 80

ovine et caprine autres que ceux provenant d’animaux nés, élevés en permanence et abattus

dans un pays ou une région classé comme présentant un risque d’ESB négligeable par une

décision arrêtée conformément à l’article 5, paragraphe 2.

« Le produit désigné ci-dessus ne contient pas et n’a pas été préparé à partir :

- de tout ou partie du crâne, y compris les yeux mais à l’exclusion de l’encéphale, d’ovins

et de caprins âgés de moins de six mois ;

- de tout ou partie du crâne, y compris l’encéphale et les yeux, d’ovins et de caprins âgés de

six mois et plus ;

- d’amygdales d’ovins et de caprins quel que soit leur âge ;

- de la moelle épinière des ovins et caprins âgés de douze mois et plus ;

- de tout ou partie du crâne, y compris l’encéphale et les yeux, et d’amygdales d’ovins et de

caprins nés ou élevés au Royaume-Uni. »

Products intended as feed for ruminant animals:

Les produits contenant ou préparés à partir de matières d’origine animale destinés à

l’alimentation ou à la fabrication d’aliments des animaux d’élevage ne contiennent pas ou

n’ont pas été préparés à partir :

a) De protéines et de phosphates d’origine animale interdits par le règlement (CE) n°

999/2001 ;

b) De graisses de ruminants autres que :

– les graisses collectées avant la fente de la colonne vertébrale des carcasses de ruminants ;

– les graisses collectées après la fente de la colonne vertébrale des bovins âgés de moins de

12 mois ;

– les graisses collectées après la fente de la colonne vertébrale des bovins âgés entre 12 et 24

mois, sous réserve de la réalisation du retrait de la moelle épinière préalablement à la fente

longitudinale de la carcasse selon les modalités définies à l’annexe XI de l’arrêté du 17

mars 1992 ;

– les graisses issues de la transformation des os de ruminants destinés à la production de

gélatine de qualité alimentaire humaine, sous réserve de l’exclusion des os de la colonne

vertébrale de petits ruminants de plus de 6 mois ou dont le poids net de la carcasse est de

12 kg et plus ;

– les graisses contenant ou préparées à partir d’autres tissus osseux, sous réserve de

l’exclusion des os de la colonne vertébrale de petits ruminants de plus de 6 mois ou dont le

poids net de la carcasse est de 12 kg et plus.

Products intended as feed for non-ruminant farm animals


Page 79 of 80

Les produits contenant ou préparés à partir de matières d’origine animale destinés à

l’alimentation ou à la fabrication d’aliments des animaux d’élevage ne contiennent pas ou

n’ont pas été préparés à partir :

a) De protéines et de phosphates d’origine animale interdits par le règlement (CE)

n° 999/2001 ;

b) De graisses de ruminants autres que :

– les graisses collectées avant la fente de la colonne vertébrale des carcasses de ruminants ;

– les graisses collectées après la fente de la colonne vertébrale des bovins âgés de moins de

12 mois ;

– les graisses collectées après la fente de la colonne vertébrale des bovins âgés entre 12 et 24

mois, sous réserve de la réalisation du retrait de la moelle épinière préalablement à la fente

longitudinale de la carcasse selon les modalités définies à l’annexe XI de l’arrêté du 17

mars 1992;

– les graisses issues de la transformation des os de ruminants destinés à la production de

gélatine de qualité alimentaire humaine, sous réserve de l’exclusion des os de la colonne

vertébrale de petits ruminants de plus de 6 mois ou dont le poids net de la carcasse est de

12 kg et plus ;

– les graisses contenant ou préparées à partir d’autres tissus osseux, sous réserve de

l’exclusion des os de la colonne vertébrale de petits ruminants de plus de 6 mois ou dont le

poids net de la carcasse est de 12 kg et plus.

(2) Specific requirements for the control of Bovine Spongiform

Encephalopathy (BSE)

The interested party shall realize a microscopy analysis for each

consignment for exportation to guaranty absence of terrestrial animal

proteins, in accordance to Regulation (EC) Nº 999/2001.

Sernapesca shall not require of this back up for the authorization of

shipment and later sanitary certification. Nevertheless, the exporter shall

assure that the results are available for its presentation in destination at the

moment of entry, if it is required.


Page 80 of 80

13. Uruguay

Shipments must be accompanied by a “Unique Single Sanitary Certificate for

products, subproducts and/or by-products, obtained from fishing and/or aquaculture

intended exclusively as Bait, Animal Feed and other Uses Not Intended for

Human Consumption, traded between the Republic of Argentina, The Federative

Republic of Brazil, the Republic of Chile and the Eastern Republic of Uruguay”, which

is available in PDF file at www.sernapesca.cl.



a) The facility must be included in the List of Participating Companies

under Sernapesca’s Sanitary Control Programs, and must be classified

at least in Category D.

b) The product must comply with Sernapesca’s sanitary requirements

described in Rule CER/NT2 for fishmeal and fish oil, as appropriate.

Bait

The product must comply with the sanitary requirements set forth by the

Service in Technical Rule No. 2 of Certification Program (CER/NT2).

14. Vietnam

Is not required for processing establishments to be registered in the market.


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