Certification Requirements - European Union

---

European Union (EU) Requirements

Please see Industry Notice: 2009-12-22 - Changes to the Certification Requirements for Exportation of Bivalve Molluscs, Echinoderms, Tunicates and Gastropods to the European Union

Please note that the following information is provided to support CFIA inspectors in their activities for the certification of fish exported from Canada to the EU. Maintenance of the official text for EU legislation, and the interpretation of that legislation, is the responsibility of the European Commission. Further, member states may adopt additional country specific requirements that are not addressed by EU legislation. All exporters should confirm product requirements before commencing full scale production for export. The CFIA assumes no liability for the accuracy of this information.

The following countries are member states of the EU: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France (including Guyana, Martinique, Guadeloupe and Réunion), Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain (including Andorra and Canary Islands), Sweden, and the United Kingdom. While Norway and Iceland are not official EU Member States, they have adopted EU requirements and fish exported to those countries are subject to the same requirements listed below. Products landed in either Norway or Iceland may proceed to EU Member States without any additional import controls.

European Union Legislation

• Commission Regulation EC No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs
• Regulation EC No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
• Regulation EC No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs
• Regulation EC No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin
• Regulation EC No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption
• Commission Regulation EC No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs
• Commission Regulation EC No 1664/2006 of 6 November 2006 amending Regulation EC No 2074/2005 as regards implementing measures for certain products of animal origin intended for human consumption and repealing certain implementing measures

1. Labelling Requirements:

1.1 Labelling and Packaging Requirements for Live Bivalve Molluscs

All parcels in a consignment of live bivalve molluscs must be labelled so that the original dispatch centre may be identified at all times during transport and distribution until retail sale. The following information must be displayed in a permanent and legible manner:

• the country of dispatch,
• the species of bivalve mollusc (common name and scientific name),
• the plant's registration number,
• the date of wrapping, comprising at least the day and the month.

Labels should include other applicable information required for all fish products. The date of durability may be replaced by the entry these animals must be alive when sold.

This information may be printed on the wrapping material or be put on a separate label which is then affixed to the wrapping material or put inside the wrapping. It may also be of a twist-tie or staple design; self-adhesive labels must not be used, unless they are not detachable. All types of labels must be for single use only and may not be transferred.

The label must be durable and waterproof, and the information presented must be legible in easily decipherable characters and indelible.

Live bivalve molluscs must be wrapped under satisfactory conditions of hygiene. The wrapping material or container must:

• not impair the organoleptic characteristics of the live bivalve molluscs,
• not be capable of transmitting substances harmful to human health to the live bivalve molluscs,
• be strong enough to give adequate protection to the live bivalve molluscs.

Oysters must be wrapped with the concave shell downwards.

All wrappings of live bivalve molluscs must be sealed and remain sealed from the dispatch centre until delivery to the consumer or retailer.

All such products must be clearly labelled with the statement: Live molluscs for immediate human consumption. Not to be relayed in Community waters.

All such products must be packed in packages of a size suitable for retail sale to restaurants or directly to the consumer.

Other member states may have additional requirements. Exporters should contact their buyers to determine if there are any additional country-specific requirements applied to live bivalve molluscs, echinoderms, tunicates or marine gastropods exported from Canada.

1.2 Labelling and Packaging Requirements for All Other Fish and Seafood Products

Inner packages and containers for all fishery products exported to the EU must be labelled to indicate:

1. Approved Canadian Establishment Number; and
2. Canada.

This information must be in close proximity, easy to understand and marked in a conspicuous place in such a way as to be easily visible, clearly legible and indelible. The information must be placed so that it is not confused with the product coding information. The approved Canadian establishment number and the word Canada must be printed on all packaging materials for all products exported to the EU, including wrappers, liners, or any other material used to contain and protect products.

2. Tolerances/Guidelines

2.1 Drug Residues

As found in the Annexes to Council Regulation (EEC) No. 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin.

Substance	Animal Species	Tissue	Level (if applicable)
Sulphonamide group*	All food producing species	Muscle	Combined total residues of all substances within the sulfonamide group should not exceed 0.1 ppm.
Trimethoprim*	All food producing species	Muscle+	0.05 ppm
Amoxicyllin	All food producing species	Muscle+	0.05 ppm
Ampicillin	All food producing species	Muscle+	0.05 ppm
Benzylpenicillin	All food producing species	Muscle+	0.05 ppm
Cloxacillin	All food producing species	Muscle	0.3 ppm
Dicloxacillin	All food producing species	Muscle	0.3 ppm
Oxacillin	All food producing species	Muscle	0.3 ppm
Danofloxacin	All food producing species	Muscle+	0.1 ppm
Difloxacin	All food producing species	Muscle+	0.3 ppm
Enrofloxacin (sum of enrofloxacin and ciprofloxacin)	All food producing species	Muscle+	0.1 ppm
Flumequine	Fin fish	Muscle+	0.6 ppm
Oxolinic Acid	Fin fish	Muscle+	0.1 ppm
Sarafloxacin	Salmonidae	Muscle+	0.03 ppm
Erythromycin	All food producing species	Muscle+	0.2 ppm
Tilmicosin	All food producing species	Muscle+	0.05 ppm
Tylosin	All food producing species	Muscle	0.1 ppm
Florfenicol*	Fin fish	Muscle+	1 ppm
Chlortetracycline (sum of parent drug and its 4-epimer)	All food producing species	Muscle	0.1 ppm
Oxytetracycline* (sum of parent drug and its 4-epimer)	All food producing species	Muscle	0.1 ppm
Tetracycline	All food producing species	Muscle	0.1 ppm
Lincomycin	All food producing species	Muscle	0.1 ppm
Neomycin (including framycetin)	All food producing species	Muscle	0.5 ppm
Paromomycin	All food producing species	Muscle	0.5 ppm
Spectinomycin	All food producing species	Muscle	0.3 ppm
Azagly-nafarelin	Salmonidae	n/a	Not subject to MRL
Colistin	All food producing species	Muscle	0.15 ppm
Deltamethrin	Fin fish	Muscle+	0.01 ppm
Cypermethrin	Salmonidae	Muscle+	0.05 ppm
Diflubenzuron	Salmonidae	Muscle+	1 ppm
Teflubenzuron*	Salmonidae	Muscle+	0.5 ppm
Azamethipos	Salmonidae		Not subject to MRL
Emamectin	Salmonidae	Muscle+	0.1 ppm
Bronopol (for use only on farmed fertilised eggs)	Salmonidae		Not subject to MRL
Somatosalm	Salmon		Not subject to MRL
Tricaine mesilate* (for water-borne use only)	Fin fish		Not subject to MRL
Tosylchloramide sodium (for water-borne use only)	Fin fish		Not subject to MRL
Formaldehyde*	All food producing species		Not subject to MRL
Hydrogen Peroxide	All food producing species		Not subject to MRL

⁺ For finfish, this MRL relates to muscle and skin in natural proportions.

* These substances correspond to those described in Appendix 1(A) of the Fish Products Standards and Methods Manual, on the subject of Therapeutic Substances for Aquaculture Use. Processors preparing aquaculture fish for export to the EU must ensure that therapeutic substances used to treat fish are also approved for use in Canada and that proper holding times are followed such that the products do not exceed the levels quoted above.

2.2 Additives (Excluding Colouring agents and Sweeteners)

Additive	Product	Limit
Benzoic or Sorbic Acid*	Semi-preserved fish products including fish roe	2000 ppm
Benzoic or Sorbic Acid*	Cooked Shrimp	2000 ppm
Benzoic or Sorbic Acid*	Salted, dried fish	200 ppm
Sulphites**	Dried, salted fish of Gadidae species	200 ppm
Sulphites**	Fresh and frozen cephalopods	150 ppm
Sulphites**	Crustaceans of the families Penaeidae, Soleneridae and Aristedae up to 80 units between 80 and 120 units over 120 units cooked	150 ppm 200 ppm 300 ppm 50 ppm
Sulphites**	Fresh and frozen crustaceans not included above	150 ppm
Phosphates***	Surimi	1000 ppm
Phosphates***	Frozen Fillets of unprocessed fish (****)	5000 ppm
Phosphates***	Frozen molluscan shellfish (excluding scallop meats)	5000 ppm
Phosphates***	Frozen Crustaceans	5000 ppm
Phosphates***	Fish and Crustacean pastes	5000 ppm
Calcium disodium EDTA	Canned and bottled fish, frozen crustaceans and molluscs	75 ppm
Boric Acid	Caviar (sturgeon's eggs)	4 ppm
Citrates	Unprocessed fish, crustaceans and molluscs	GMP*****
Nitrates	Pickled Herring and sprat	200 ppm
Sorbitol, Mannitol, Isomalt, Maltitol, Lactitol, Xylitol	Frozen unprocessed fish, crustaceans, molluscs and cephalopods (for purposes other than sweetening).	GMP*****

* Benzoic or Sorbic Acid may be used singly or in combination. If used in combination, total of both additives may not exceed the limit shown.
** Sulphites expressed as sulphur dioxide (SO₂)
*** Phosphates expressed as P₂O₅
**** Unprocessed fish refers to fish in its raw state, excluding products such as smoked or marinated fish.
***** GMP - in line with good manufacturing practices.

2.3 Mercury

Analysis for mercury is performed on a homogenised mixture of the sample.

1. A tolerance of 1.0 ppm total mercury, in edible tissue based on 10 samples taken from 10 different individual fish representative of the lot is set for the following species:
   • Sharks (all species)
   • Tuna (Thunnus spp.)
   • Little tuna (Euthynnus spp.)
   • Bonito (Sarda spp.)
   • Plain bonito (Orcynopsis unicolor)
   • Swordfish (Xiphias gladius)
   • Sailfish (Istiophorus platypterus)
   • Marlin (Makaira spp.)
   • Eel (Anguilla spp.)
   • Bass (Dicentrarchus labrax)
   • Sturgeon (Acipenser spp.)
   • Halibut (Hippoglossus hippoglossus)
   • Redfish (Sebastes marinus, S. mentella)
   • Blue ling (Molva dipterygia)
   • Atlantic catfish (Anarhichas lupus)
   • Pike (Esox lucius)
   • Portuguese dogfish (Centroscymnes coelolepis)
   • Rays (Raja spp.)
   • Scabbardfishes (Lepidopus caudatus, Aphanopus carbo)
   • Anglerfish (Lophius spp.)
   • Emperor or Orange roughy (Hoplostethus atlanticus)
   • Bonito (Sarda sarda)
   • Grenadier (Coryphaenoides rupestris)
   • Plain bonito (Orcynopsis unicolor)
   • Snake mackerel or Butterfish (Lepidocybium flavobrunneum, Ruvettus pretiosus, Gempylus serpens)
2. A tolerance of 0.5 ppm total mercury, in edible tissue, based on 5 samples taken from 5 different individual fish is set for all other species of fish.

2.4 Lead

Product	Maximum Level (ppm)
Muscle meat of fish, excluding those listed below.	0.2
Muscle meat of: bonito (Sarda sarda), common two banded seabream (Diplodus vulgaris), eel (Anguilla anguilla), grey mullet (Mugil labrosus labrosus), grunt (Pomadasys benneti), horse mackerel or scad (Trachurus trachurus), sardine (Sardina pilcardus), sardinops (Sardinops spp.), spotted seabass (Dicentrarchus punctatus), tuna (Thunnus spp. and Euthynnys spp.), wedge sole (Dicologoglossa cuneata)	0.4
Crustaceans, excluding brown meat of crab	0.5
Bivalve molluscs	1.5
Cephalopods (without viscera)	1.0

2.5 Cadmium

Product	Maximum level (ppm)
Muscle meat of fish, excluding those listed below	0.05
Muscle meat of: bonito (Sarda sarda), common two banded seabream (Diplodus vulgaris), eel (Anguilla anguilla), European anchovy (Engraulis encrasicolus), grey mullet (Mugil labrosus labrosus), horse mackerel or scad (Trachurus trachurus), louvar or luvar (Luvarus imperialis) sardine (Sardina pilcardus), sardinops (Sardinops species), tuna (Thunnus spp. and Euthynnys species), wedge sole (Dicologoglossa cuneata)	0.1
Crustaceans, excluding brown meat of crab and excluding head and thorax meat of lobster and similar large crustaceans (Nephropidae and Palinuridae)	0.5
Bivalve molluscs	1.0
Cephalopods (without viscera)	1.0

2.6 Dioxin

Products	Maximum levels (PCDD + PCDF) (pg WHO-PCDD/F-TEQ/g fat or product)
Muscle meat of fish and fishery products (excluding the brown meat of crab and to cephalopods without viscera) and products thereof	4 pg WHO-PCDD/ F-TEQ/g fresh weight
Fish oil intended for human consumption	2 pg WHO-PCDD/ F-TEQ/g fat

2.7 Histamine Tolerance:

For fish species of the families: Scombridae, Clupeidae, Engraulidae and Coryphaenidae:

• Based on 9 samples, the mean value must not exceed 100 ppm, but 2 samples may exceed 100 ppm but no sample may exceed 200 ppm.
• Fish belonging to these families which have undergone enzyme-ripening treatments in brine may have higher levels but not more than twice the above values.

2.8 Shellfish Toxins

Toxin	Tolerance
Paralytic Shellfish Poison	80 µgrams per 100 grams product
Diarrhetic Shellfish Poison	Okadaic Acid, Dinophysistoxins and Pectenotoxins together - 160 µg/kg of okadaic acid equivalents per kg Yessotoxins - 1 mg/kg equivalent per kg Azaspiroacids - 160 µg/kg of azaspiracid per kg
Amnesic Shellfish Poison (Domoic Acid)	20 µgrams per gram product

3. Microbiological Guidelines

3.1 RTE Fish and Fishery Products

3.1.1 RTE foods able to support growth of Listeria monocytogenes, criteria apply to products placed on market during their shelf life.

Listeria monocytogenes
n=5, c=0, m=M=100 cfu/g

3.1.2 RTE foods unable to support growth of Listeria monocytogenes *, criteria apply to products placed on market during their shelf life.

Listeria monocytogenes
n=5, c=0, m=M=100 cfu/g

* Products with pH 4.4 or a_w 0.92, products with pH 5.0 and a_w 0.94, products with a shelf life of less than 5 days are automatically considered to belong to this category.

3.2 Cooked crustaceans and molluscan shellfish

Criteria applies at the end of the manufacturing process.

Free from salmonella in 25 grams of product.

3.2.1 Shelled and shucked products of cooked crustaceans and molluscan shellfish (stage where criterion applies: end of the manufacturing process)

E. coli
n=5, c=2, m=1 cfu/g, M=10 cfu/g

Coagulase - positive staphylococcus
n=5, c=2, m=100 cfu/g, M=1000 cfu/g

3.3 Live Bivalve Molluscs

E. coli

Less than less than 230 E. coli per 100 g of mollusc flesh and intravalvular liquid based on a five-tube, three-dilution MPN test or any other bacteriological procedure shown to be of equivalent accuracy

Free from salmonella in 25 g of mollusc flesh.

4. Parasites

Parts of fish which contain visible live or dead nematodes are to be removed and must not be marketed. Processors should make every effort to achieve this through a non-destructive examination of the fish and fish products during processing by qualified personnel. The procedure must be performed under good light conditions, including, if necessary, candling. When processing conditions do not allow for the examination of each individual fish (e.g., mechanical evisceration and/or filleting operations), the processor must develop a sampling plan for each batch of processed fish. The sampling plan for mechanically eviscerated fish must include a representative number of samples of not less than 10 fish per batch.

The following fish products must be subjected to freezing at a temperature of not more than -20°C in all parts of the product for not less than 24 hours:

1. fish to be consumed raw or almost raw;
2. the following species, if they are to undergo a cold-smoking process at which the internal temperature of the fish is less than 60°C:
   • herring;
   • mackerel;
   • sprat;
   • (wild) Atlantic and Pacific salmon; and
3. marinated and/or salted herring where this process is insufficient to destroy the larvae of nematodes.

It is recommended that for salted fish, the ratio of minimum salt content in the fish tissue and the minimum storage time comply with the following:

Salt Content	Storage Time
20% 15% 12% (with sugars)	21 days 28 days 35 days

The required storage time does not include transportation time.

It is recommended that for marinated fish, the salt content, vinegar content, and duration of marination must comply with the following: the water contained in the tissue of the fish must contain at least 2.4% vinegar (as acetic acid) and 6% salt (sodium chloride), and the PH must not exceed 4.2. The fish must have been marinated for at least 35 days prior to further processing.

The manufacturer may have to supply documentation indicating the type of process that the above fishery products have undergone.

5. Fish Health and Aquaculture Fish

The EU has set certification requirements affecting the marketing of fishery products harvested from aquaculture operations to prevent the introduction and spread of diseases within its territories.

5.1 Fish and Fish Products intended for Human Consumption

Fish health requirements apply only if the fish are:

• of aquaculture origin;
• whole, uneviscerated fish;
• not packaged for retail.

If the fish in the consignment meet all three criteria, see Instructions for Part II.2 of Health Certificate for Imports of Fishery Products Intended for Human Consumption related to fish health. These instructions are found in section 6.6 c) below.

5.2 Fish and Fish Products not intended for Human Consumption

Live aquaculture and wild fish not intended for human consumption will require Fish Health certificates. Requirements for these certificates are not included in this document. Please contact the Canadian Food Inspection Agency before shipping any live aquaculture or wild fish products that are not intended for human consumption.

6. Certification Requirements

6.1 General Information

Each shipment must be accompanied by a single, original, fully completed EU Health certificate. Certificates must be signed and stamped in ink that is a different colour than the remaining text on the certificate. EU Health certificates may only be issued for product processed in establishments that are listed on the relevant EU Approval List for the product being exported. Canadian exporters should ensure that their products are accompanied by the proper EU documentation prior to being exported from Canada if transhipped via another country.

The certificate must provide an accurate description of the identity of the approved processor of the goods, the type of fish being shipped, the quantity of product being shipped, and the final destination of the goods. The details of the product description must indicate whether the product originated from an aquaculture operation or is classified as a fishery product. The certificate must be completed in an official language for the country where the shipment will be subject to import controls.

The EU requires certification of any samples of fish and fish products destined for human consumption.

The certificate for fish and fishery products is different from the certificate for live bivalve molluscs, echinoderms, tunicates and marine gastropods. The process to complete these certificates is similar with a few exceptions.

6.2 Rules concerning the introduction into the European Community of personal consignments of products of animal origin (Commission Regulation (EC) No 206/2009)

Travellers may only bring in or send to the EU personal consignments of fishery products (including fresh, dried, cooked, cured or smoked fish, and certain shellfish such as prawns, lobsters, dead mussels and dead oysters) provided that:

• Fresh fish are eviscerated.
• The weight of the fishery products does not exceed, per person, 20 kilograms or the weight of one fish, whichever weight is the highest.

Travellers may only bring in or send to the EU other animal products such as live oysters, live mussels and snails provided that:

• Their combined weight does not exceed two (2) kilograms per person.

Fishery products that meet the requirements for personal consignments are exempt from certification requirements.

6.3 Certification of Sport Caught Fish in excess of twenty (20) kilograms from Recognized British Columbia Sport Fish Lodges

European Union requirements specify that citizens of the EU require a health certificate issued by the inspection authorities in the country of origin if they return home with more than twenty (20) kilograms of certain types of fish for their own personal consumption.

In order to aid sport fishing establishments and travellers visiting Canada from the European Union, the following procedures are in place.

6.3.1 Raw sport caught fish such as frozen steaks and fillets weighing more than twenty (20) kilograms

The Canadian Food Inspection Agency has made arrangements with the British Columbia Ministry of Agriculture and Lands (BCMAL) for the certification of sport caught fish. BCMAL has identified the fishing lodges which are able to prepare sport caught fish under the conditions that are necessary to satisfy the requirements set by the EU. Operators of Sport Fish Lodges seeking more information on British Columbia's role in sport fish certification should contact British Columbia Ministry of Agriculture and Lands or visit their web site at: www.agf.gov.bc.ca/fisheries/licences/main.htm#EUexport

Fish caught by a person holding a valid recreational fishing licence may be certified for export to the EU for personal consumption of that person if:

• the fish was caught in Canadian waters while the licence is valid, in accordance with Canadian regulations on sport fishing and that possession limits have been respected;
• the fish has been eviscerated under sanitary conditions;
• the fish is not a toxic species nor a species that may contain biotoxins;
• the fish arrives in the European Union within one month following the last date of validity of the recreational fishing licence and is not intended to be marketed.

The traveller must include a copy of the recreational fishing licence with the accompanying certificate.

6.3.2 Canned, smoked and other preparations of sport caught fish weighing more than twenty (20) kilograms

A person who wishes to receive a certificate for sport fish that is canned, smoked or processed in any other form of ready-to-eat fish, must have the fish processed at a federally registered establishment. As an option, the operator of the fishing lodge may partner with a CFIA registered fish processing establishment to have sport caught fish custom processed as a means of obtaining a fish export certificate.

Information regarding Canadian Establishments Approved for Export to the European Union (EU) can be found at: www.inspection.gc.ca/english/fssa/fispoi/export/pageeuuee.shtml

The CFIA is responsible for issuing certificates for sport caught fish that is custom processed at a federally registered establishment as canned, smoked or any other form of ready-to-eat fish. A person requesting a fish export certificate from CFIA should contact the nearest inspection office as soon as possible with the details of the consignment to make arrangements for the fish to be certified.

Please note that a person requesting a fish export certificate from CFIA is required to pay the appropriate inspection service fee for that certificate.

6.4 Certification Requirements Specific to Bivalve Molluscs, Echinoderms, Tunicates and Marine Gastropods (Excluding the Adductor Muscle of Pectinidae)

a) Product Origin

Note: The EU Health Certificate for export of live bivalve molluscs is also to be used for export of live bivalve molluscs, echinoderms, tunicates and marine gastropods.

The EU Health Certificate for export of Fish and Fishery Products is to be used for export of frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods.

Shipments of these products exported from Canada must originate from an establishment that is registered with the CFIA in accordance with the Fish Inspection Act and Regulations.

Shipments of these products must originate from establishments identified on the List of Canadian Establishments and Harvest Areas Approved to Export Bivalve Molluscs, Echinoderms, Tunicates and Marine Gastropods to the European Union.

The harvest area for these products must also appear on the List of Canadian Establishments and Harvest Areas Approved to Export Bivalve Molluscs, Echinoderms, Tunicates and Marine Gastropods to the European Union, and must be indicated, as it appears on the list, in box I.8 (Region of Origin) on the certificate.

b) Animal Health Attestations

These sections are not applicable to products that are packaged and labelled for direct distribution to consumers or the restaurant trade and must be struck out.

These sections must be completed for any other shipments of market size live bivalve molluscan shellfish, echinoderms, and marine gastropods. Please note that these products must not be wet stored or relayed in the European Community.

Please contact the CFIA before shipping live bivalve molluscan shellfish, echinoderms and marine gastropods that are not packaged and labelled for direct consumption in the European Community.

6.5 Certification of Gelatine, Collagen and Fish By-products used to Prepare Collagen and Gelatine

6.5.1 Gelatine

Shipments of gelatine made from fish and exported from Canada must originate from an establishment registered with the CFIA and listed on the List of Canadian Establishments Approved to Export Gelatine for Human Consumption to the European Union.

Each shipment must be accompanied by a fully completed EU Health Certificate for Gelatin, signed and stamped in ink that is a different colour than the remaining text on the certificate.

6.5.2 Collagen

Shipments of collagen made from fish and exported from Canada must originate from an establishment registered with the CFIA.

Each shipment must be accompanied by a fully completed EU Certificate for Collagen, signed and stamped in ink that is a different colour than the remaining text on the certificate.

6.5.3 Fish by-products to be used to prepare collagen or gelatine

Shipments of fish by-products (such as fish bones, skins, etc.) to be used in the preparation of collagen or gelatin and exported from Canada, must originate from an establishment registered with the CFIA and must be on the List of Canadian Establishments Approved to Export Fishery Products to the European Union

Each shipment must be accompanied by one of the following applicable EU Health Certificates: Raw Materials for the Production of Gelatine or Raw Materials for the Production of Collagen, fully completed, signed and stamped in ink that is a different colour than the remaining text on the certificate.

6.6 Certification Requirements for all other Fish and Seafood Products (Including the Adductor Muscle of Pectinidae)

a) Approval of Exporting Establishments

EU Health certificates may only be issued for fishery products processed in establishments that are listed on the List of Canadian Establishments Approved to Export Fishery Products to the European Union.

The name and number of the establishment where the fishery products were processed for export to the EU must be recorded on the EU Health Certificate.

Information published on the List of Canadian Establishments Approved to Export Fishery Products to the European Union must match the information about the exporting establishment that is listed on the certificate and the product labels.

b) Product Description

The details of the product description must indicate whether the product originated from an aquaculture operation or is classified as a fishery product.

The fish health attestations must be completed if fish originated from an aquaculture operation.

c) Animal Health Attestation for Fishery Products of Aquaculture Origin

Instructions for Part II.2 of Health Certificate for Imports of Fishery Products Intended for Human Consumption related to fish health.

Not relevant for wild-caught fish. Delete all attestations under section II.2

Not relevant for products in packages that are intended for direct human consumption. Delete all attestations under section II.2

All other products of aquaculture origin must be eviscerated. Delete appropriate conditions from section II.2 to indicate that the fish have been slaughtered and eviscerated.

1. Part II.2 is not relevant for consignments intended for retail, provided they comply with the rules applying to packaging and labelling laid down in Regulation (EC) No 853/2004.
2. Aquacultured finfish must be eviscerated.
3. If fish susceptible to EHN and/or ISA (see list of known susceptible species) strike out the statement:

• originate from a source considered free from ISA and/or EHN in accordance with the relevant EU legislation or OIE Standard.

4. If fish susceptible to VHS and/or IHN (see list of known susceptible species) strike out the statement:

• originate from a source considered free from VHS/ IHN in accordance with the relevant EU legislation or OIE Standard.

5. If fish is not included in the list of species known to be susceptible to EHN, ISA, VHS, and/or IHN, strike out all applicable statements except for the general health attestation regarding clinical health and transportation.

List of known susceptible species

Disease	Susceptible host species
EHN	Redfin perch (Perca fluviatilis), rainbow trout (Oncorhyynchus mykiss)
ISA	Atlantic salmon (Salmo salar), rainbow trout (Oncorhyynchus mykiss), brown trout (Salmo trutta)
VHS	Atlantic cod (Gadus morhua), Atlantic herring (Clupea harengus), brown trout (Salmo trutta), Chinook salmon (Oncorhyynchus tshawytscha), coho salmon (O. kisutch), grayling (Tymallus thymallus), haddock (Melanogrammus aeglefinus), Pacific cod (Gadus macrocephalus), Pacific herring (Clupea harengus pallasi), pike (Esox lucius), rainbow trout (Oncorhyynchus mykiss), rockling (Rhinonemus cimbrius), sprat (Sprattus sprattus), turbot (Scopthalmus maximus), whitefish (Coregonus sp.)
IHN	Rainbow or steelhead trout (Oncorhyynchus mykiss), the pacific salmon species (Chinook salmon (Oncorhyynchus tshawytscha), sockeye salmon (O. nerka), chum salmon (O. keta), masou salmon (O. masou), pink salmon (O. rhodurus), and coho salmon (O. kisutch) and Atlantic salmon (Salmo salar)

6.7 Information required to Complete the EU Health Certificate

General: Please complete the certificate in capitals. To positively indicate any option, please tick or insert an X.

Where mentioned, the ISO codes use the two-letter country code in compliance with the international standard ISO 3166 alpha-2.

Part I - Information on the consignment shipped

Country: Please indicate the third country issuing the certificate

Box I.1:
Consignor: Please give the name and address (street, town and region/province/state, as applicable) of the physical or legal person who sends the consignment. The consignor must be located outside of the European Community. It is recommended that telephone and fax numbers or the email address be given.

Box I.2:
Certificate Reference Number: The certificate reference number is the number that the CFIA assigns in accordance with its own classification.

Box I.2a:
Reserved for the EU's TRACES notification. The TRACES number of the certificate is a unique reference number assigned by the TRACES system.

Box I.3:
Competent Central Authority: The name of the Central Authority of the country of dispatch which is responsible for certification (i.e., CFIA).

Box I.5:
Consignee: Please give the name and address (street, town and post code) of the physical or legal person to whom the consignment is shipped in the Member State of destination.

Box I.7:
Country of origin: Please give the name and ISO Code of the third country in which the finished products were produced, manufactured or packaged (i.e., Canada - CA).

Box I.8:
Region of origin: Only applicable for live, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods, excluding the adductor muscle of Pectinidae. Indicate the production area exactly as it appears on the List of Canadian Establishments and Harvest Areas Approved to Export Bivalve Molluscs, Echinoderms, Tunicates and Marine Gastropods to the European Union.

Box I.9:
Country of destination: Please give the name ISO Code of the Member State of destination of the animals or products.

Box I.11:
Place of origin: place from which the products come. Only the establishment shipping the products or by-products is to be named and the country of dispatch if different from the country of origin. Please give the name, address (street, town and region/province/state, as applicable) and the approval or registration number of these structures.

Box I.13:
Place of loading: For products, please indicate the place of loading.

Box I.14:
Date of departure

Box I.15:
Means of transport: Registration number (railway wagons or container and Lorries), flight number (aircraft) or name (ship). Separate information is to be provided in the event of unloading and reloading

Box I.16:
BIP of entry into the EU: Please enter the name (column 1) and the number (column 2) of the BIP. To locate the correct BIP information, please consult the most recent document under the Consolidated Versions heading on the Commission Decision 2009/821/EC website that is available on the world wide web at: http://eur-lex.europa.eu/Notice.do?val=503764:cs&lang=en&list=503764:cs,&pos=1&page=1&nbl=1&pgs=10&hwords=. [Note: this is a link to the Eur-lex bibliographic notice page. Consolidated decisions and annexes are available from this page. The exporter should contact their importer in the European Union for any information on updated Border Inspection Posts (i.e., annexes to decision).]

This information can be changed until the Common Veterinary Entry Document is completed.

Box I.18:
Description of goods: Give a description of the goods or use the titles as they appear in the World Customs Organisation's Harmonised System. This customs description shall be supplemented, if necessary, by any information required to classify the goods (species, processing, etc.).

Box I.19:
Use the appropriate HS codes: 03.01, 03.02, 03.03, 03.04, 03.05, 03.06, 03.07, 05.11.91, 15.04, 15.18.00, 16.03, 16.04, 16.05.

Use the HS code 0307 for live bivalve molluscs.

Box I.20:
Quantity: Please give the total gross and net weights in kg.

Box I.21:
Temperature of the product: please tick the appropriate temperature for transport/storage of the product.

Box I.22:
Number of packages: Please indicate the total number of packages for products.

Box I.23:
Identification of container/Seal Number: If shipping containers are used to transport the fish, please indicate the identification number(s) of the container(s), and the seal(s) used to secure the container(s).

Box I.24:
Type of packaging: only for products.

Box I.25:
Goods certified for the purposes of Human consumption.

Box I.27:
Final import

Box I.28:
Identification of goods: Identification of the commodities: specify if aquaculture or wild origin. Treatment type: live, chilled, frozen, processed. Manufacturing plant: includes factory vessel, freezer vessel, cold store, processing plant.

Part II - Certification

Box II.a.:
Certificate Reference number: cf. Box I.2.

Box II.b.:
TRACES reference number: cf. Box I.2a

7. EU Traceability Requirements

The EU has established a system to prevent, deter and eliminate illegal, unreported and unregulated (IUU) fishing. It is formally known as Regulation (EC) No 1005/2008. Complete information about the EU IUU regulation can be found at:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:286:0001:0032:EN:PDF

The EU IUU regulation will require exporting countries (such as Canada) to provide the EU with a government-validated catch certificate attesting that fish and fish products originate from non-IUU (legal) fisheries. Compliance with the EU regulation is mandatory for anyone in the fishing industry who exports their products to the EU.

The regulation will apply to catch landed after January 1, 2010 (i.e. not inventory in holding that was caught prior to this date). It generally includes all marine fishery products including live, fresh, chilled, frozen, prepared and preserved product forms. All freshwater fisheries and aquaculture products are exempt from this regulation, as well as some forms of mollusks such as scallops, mussels, oysters and snails. Annex I of the Regulation (EC) No 1005/2008 has the list of fishery products excluded from the scope of implementation of the catch certificate.

7.1 Obtaining a Catch Certificate

In Canada, Department of Fisheries and Ocean's (DFO) Catch Certification Office (CCO) is the competent authority that issues Catch Certificates, including the Foreign Catch Export Certificate (in compliance with the Annex IV requirement of the European Union's, Illegal, Unreported and Unregulated catch regulation) via the Fisheries Certification System (FCS). For more information on the process and to register in the Fisheries Certification System, please visit: http://fcs-scp.dfo-mpo.gc.ca/FCSWeb/

It is important for all exporters to register and create their company profiles in the Fisheries Certificate System well in advance of applying for a catch certificate. The approval of registration and company profiles can take up to 2-3 weeks to be entered in the system. Applications for Catch Certificates will not be accepted from a company that has not previously registered in the system.

The Catch Certification Office can be reached using one of the following methods:

• Telephone toll-free in North America: 1-888-641-6464
• Telephone: 613-998-8100
• Fax: 613-990-5301
• Email: CCO-BCC_Info@dfo-mpo.gc.ca

We also encourage you to visit the Fisheries Renewal website, under the Tracking and Traceability section, for the most up-to-date information on the EU IUU Regulation and the Catch Certification Office.

7.2 Fish Processed from Imported Raw Materials for Export to the EU

Within DFO's Fisheries Certificate System (FCS), the Foreign Catch Export Certificate is used to meet the Annex IV requirements of the European Union's Illegal, Unreported and Unregulated (IUU) catch regulation.

Canadian exporters who import raw materials or fishery products from a third country, and export them to the EU can use the FCS to apply for a Foreign Catch Export Certificate. Canadian exporters must be registered in the FCS, and obtain an EU Health Certificate number prior to submitting their request.

7.3 Exports to Third Countries which will Subsequently be Exported to the EU

If a Canadian company is exporting their products to a third country, which in turn will export them to the EU (i.e. indirect export to the EU), the Canadian company needs only to provide a Canadian Catch Certificate to the third country exporter. It is the responsibility of the final exporter to obtain the Annex IV documentation from their competent authority prior to sending any consignments to the EU.