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ALINORM 04/27/18

APPENDIX IX

PROPOSED DRAFT STANDARD FOR LIVE AND [RAW] BIVALVE MOLLUSCS

(At Step 3 of the Procedure)
1. SCOPE
This standard applies to live and [raw] bivalve molluscs excluding scallop adductal muscle only, intended for direct human consumption or further processing.
2. DESCRIPTION
2.1 Product Definition
Live bivalve molluscs are products that are alive immediately prior to consumption. Presentation includes the shell. [Rawbivalve molluscs are products that are no longer alive immediately prior to consumption but were alive immediately prior to the commencement of processing or to shucking, freezing or other treatment that did not eliminate the sensory characteristics of live products.]
2.2 Process Definition
[Live bivalve molluscs shall be organisms which are harvested alive for direct human consumption from an approved growing area and/or from an another appropriately classified area followed by an approved purification process such as natural container (raft, float or tank) relaying or depuration or from an approved purification centre.] The approval mentioned in this subsection must be given by the official agency having jurisdiction.
Frozen bivalve molluscs shall after suitable preparation be derived from organisms which meet the requirements for live bivalve molluscs and the product shall, after any suitable preparation [deshelling], be subjected to a freezing process and shall comply with the conditions laid down hereafter. The freezing process shall be carried out in appropriate equipment in such a way that the range of temperature of maximum crystallization is passed quickly. The freezing process shall not be regarded as complete unless and until the product temperature has reached -18C or colder at the thermal centre after thermal stabilization. The product shall be kept deep frozen so as to maintain the quality during transportation, storage and distribution. Frozen bivalve molluscs shall be processed and packaged so as to minimize dehydration and oxidation.
Processed bivalve molluscs shall be derived from organisms which meet the requirements for live bivalve molluscs.
Canned bivalve molluscs are packed in hermetically sealed containers and shall have received a processing treatment sufficient to ensure commercial sterility.
Other approved processes including heat processing (other than canning) may be applied to provide sterilisation.
Covered in Code of Practice.
[Post-harvest treated bivalve molluscs shall be organisms that meet the requirements for live bivalve molluscs, either because they are derived from organisms that meet these requirements or because they have received post-harvest treatment, or because of a combination of the two. The post-harvest treatment shall assure the elimination, reduction, or limitation of the target organisms to the satisfaction of the official agency having jurisdiction.]
2.3 PRESENTATION
Any presentation of the product shall be permitted provided that it:
• meets all requirements of this standard; and
• is adequately described on the label to avoid confusing or misleading the consumer.
The bivalve molluscs may be packed in count per unit of weight or per package.
In the case of live bivalve molluscs, they may be packed by weight, count, count per unit of weight, volume or per package.
3. ESSENTIAL COMPOSITION AND QUALITY FACTORS
3.1 Live Bivalve Molluscs
Bivalve molluscs intended for direct consumption or intended to be processed shall be alive immediately prior to consumption or prior to the commencement of processing and of a quality fit for human consumption.
Bivalve molluscs must respond adequately to percussion and must contain a normal quantity of intravalvular liquid as determined by product specialists familiar with the species.
3.2 Glazing (for frozen bivalve molluscs)
If glazed, the water used for glazing or preparing glazing solutions shall be clean water. (Clean water defined in the Code.)
3.3 Other Ingredients
The packing medium and all other ingredients used shall be of food grade quality and conform to all applicable Codex standards.
3.4 Final Product
Products shall meet the requirements of this standard when lots examined in accordance with Section 9 comply with the provisions set out in Section 8. Products shall be examined by the methods given in Section 7.
4. FOOD ADDITIVES
Only the use of the following additives is permitted in processed bivalve molluscs

Antioxidants

For fresh shucked molluscs any antioxidant listed in food category 09.1.2 (Fresh Mollusks, crustaceans and echinoderms) of the General Standard for Food Additives (CODEX STAN 192-1995) at levels not to exceed good manufacturing practices (GMP).
For fresh raw frozen molluscs any antioxidant listed in food category 09.2.1 (Frozen fish, fish fillets, and fish products, including mollusks, crustaceans, and echinoderms) of the General Standard for Food Additives (CODEX STAN 192-1995) at levels not to exceed good manufacturing practices (GMP).
For fresh raw frozen molluscs any antioxidant listed in food category 09.2.2 (Frozen battered fish, fish fillets and fish products, including mollusks, crustaceans, and echinoderms) of the General Standard for Food Additives (CODEX STAN 192-1995) at levels not to exceed good manufacturing practices (GMP).
For fresh raw frozen molluscs any antioxidant listed in food category 09.2.5 (Smoked, dried, fermented, and/or salted fish and fish products, including mollusks, crustaceans, and echinoderms) of the General Standard for Food Additives (CODEX STAN 192-1995) at levels not to exceed good manufacturing practices (GMP).
5. HYGIENE AND HANDLING
5.1 The final product shall be free from any foreign material that poses a threat to human health.
5.2 Live bivalve molluscs intended for direct consumption should possess visual characteristics associated with freshness and viability, including shells free of dirt, an adequate response to percussion, and normal amounts of intravalvular liquid as determined by product specialists familiar with the species.”
5.3 When tested by appropriate methods of sampling and examination prescribed by the Codex Alimentarius Commission (CAC), the following requirements shall be met:
(i) Live bivalve mollusc shall be free from micro-organisms or substances originating from micro-organisms or virus in amounts which may present a hazard to health in accordance with standards established by the CAC.
(ii) [Live bivalve molluscs must not contain more than 300 faecal coliforms or more than 230 E.coli per 100 g of mollusc flesh and intravalvular liquid. Determination by the 5 tube, 3 dilution MPN testing method or any other method equivalent.]
AND/OR – for discussion
[Live bivalve molluscs must not contain more than 330 fecal coliforms. In an analysis involving five (5) samples, none may contain more than 330 fecal coliforms; and if two (2) or more of the five (5) contain between 230 and 330 fecal coliforms, the five samples must be analyzed for E coli. In that analysis, no sample may contain more than 330 E coli, and not more than one (1) of the five (5) samples may contain between 230 and 330 E coli.]
(iii) [Live bivalve molluscs and products thereof must not contain Salmonella in 25 g flesh.]
[(iv) [In the edible parts of bivalve molluscs (the whole part or any part intended to be eaten separately.) the total Paralytic Shellfish Poison (PSP) content must not exceed 80 microgrammes of saxitoxin equivalent per 100 g of mollusc flesh
(v) [In the edible parts of the bivalve molluscs (the whole part or any part intended to be eaten separately) the Diarrhetic Shellfish Poison (DSP), using the customary biological testing methods (on rats or mice) there must not be a positive result.
In the edible parts of the bivalve molluscs (the whole part or any part intended to be eaten separately) the maximum level of Okadaic acid, Dynophysistoxins and Pectenotoxins together, must not exceed 160 microgrammes of Okadaic equivalents per kg.
(vi) [In the edible parts of bivalve molluscs (the whole part or any part intended to be eaten separately)the content of Amnesic Shellfish Poisoning (ASP) must not exceed 20 microgrammes domoic acid per g of mollusc flesh.
(vii) [In the edible parts of bivalve molluscs (the whole or any part intended to be eaten separately) the total Neurotoxic Shellfish Poison (NSP) content must not exceed 20 mouse units.
(viii) In the edible parts of bivalve molluscs (the whole or any part intended to be eaten separately) the level of Azaspiracid (AZP) must not exceed16 microgrammes per 100g.
(ix) In the edible parts of bivalve molluscs (the whole or any part intended to be eaten separately) the level of Yessotoxins must not exceed 100 microgrammes per 100g.]
(Note – comments on methodology is transferred to Section 7.)
(x) The product must not contain any other substance in amounts which may present a hazard to health in accordance with standards established by the CAC.
5.4 It is recommended that the product covered by the provisions of this standard be prepared and handled in accordance with the following Codes: the appropriate sections of the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 3 (1997));
• the Code of Practice for Fish and Fishery Products1;
6. LABELLING
In addition to the provisions of the Codex General Standard for the Labelling of Prepackaged Foods (CODEX STAN 1-1985, Rev. 1, 1991) the following specific provisions apply:
6.1 The Name of the Food
The name of the product as declared on the label shall be [the name of the species of bivalve molluscs [the common or usual name of the species of bivalve molluscs] according to the law, custom or practice in the country in which the product is to be distributed.]
6.1.1 There shall appear on the label, reference to the presentation provided for in Section 2.3-Presentation in close proximity to the name of the product in such descriptive terms that will adequately and fully describe the nature of the presentation of the product to avoid misleading or confusing the consumer.
6.1.2 In addition to the specified labelling designations above, the usual or common trade names of the variety may be added so long as it is not misleading to the consumer in the country in which the product will be distributed.
6.2 Content Declaration
Live bivalve molluscs shall be labelled by weight, count, count per unit weight, or volume as appropriate to the product.
Processed bivalve molluscs shall have a net weight declaration in accordance with:- Refer to other codex standards.
6.3 Storage Instructions
The label shall specify the conditions for storage and/or temperature that will maintain the quality/viability during transportation, storage and distribution.
6.4 Labelling of Non-Retail Containers (for bulk transport of live and raw shucked bivalve molluscs)
Information shall specify on the container and in accompanying documents,
• the name of the food,
• lot identification,
• harvesting location,
• date of harvest and/or
• date of processing and
• the name and address and authorisation or registration number of packer or manufacturer, and
• [storage instructions, as appropriate].
However, lot identification, and the name and address may be replaced by an identification mark, provided that such a mark is clearly identifiable with the accompanying documents in which this information is given.
6.5 Other Labelling Requirements
6.5.1 For live bivalve molluscs this product shall declare the date of minimum durability, harvest date or packing date.or a statement to this effect.
6.5.2 [For live and raw shucked bivalve molluscs] OR [For live and processed bivalve molluscs], identification of the establishment approved by the official agency with the jurisdiction, for the production of the product.
6.5.3 [Safety claims made for post-harvest treated bivalve molluscs should be specific to the target organisms that have been eliminated, reduced, or limited by the post-harvest treatment.]
6.5.4 [Every package containing purified bivalve molluscs must be provided with a label certifying that all molluscs have been purified.]
7. SAMPLING, EXAMINATION AND ANALYSES
7.1 Sampling
(i) Sampling of lots for examination of the product shall be in accordance with the Codex Alimentarius Sampling Plans for Prepackaged Foods (AQL - 6.5) (CODEX STAN 233-1969).
(ii) Sampling of lots for examination of net weight shall be carried out in accordance with an appropriate sampling plan meeting the criteria established by the CAC.
7.2 Sensory and Physical Examination
Samples taken for sensory and physical examination shall be assessed by persons trained in such examination and in accordance with procedures elaborated in Sections 7.3 through 7.6, and Guidelines for the Sensory Evaluation of Fish and Shellfish in Laboratories" (CAC/GL 31-1999).
7.3 Determination of Net Weight and Drained Weight
The net weight and drained weight of all sample units shall be determined by the procedures described or mentioned in sections 7.3.1, 7.3.2, 7.3.3 and 7.3.4..
7.3.1 Determination of Net Weight
(i) Weigh the unopened container;
(ii) Open the container and remove the contents;
(iii) Weigh the empty container, (including the end) after removing excess liquid and adhering meat;
(iv) Subtract the weight of the empty container from the weight of the unopened container.
(v) The resultant figure will be the total net content.
7.3.2 Determination of Net Weight of Frozen Products not Covered by Glaze
The net weight (exclusive of packaging material) of each sample unit representing a lot shall be determined in the frozen state.
7.3.3 Determination of Net Weight of Products Covered by Glaze
AOAC official method 963.18, Net Contents of Frozen Seafoods
7.3.4 The AOAC official method 963.26 should be used to determine the net weight of products with water added that is inside a "block-frozen" product.
7.3.5 Determination of Drained Weight
7.4 Determination of Count per Unit Weight or Volume
When declared on the label, the count of bivalve molluscs shall be determined by counting the numbers of bivalve molluscs in the container or a representative sample thereof and dividing the count of bivalve molluscs by the actual weight/volume to determine the count per unit weight or volume.
7.5 Sample Preparation
7.5.1 Procedures for Thawing
For frozen product, the sample unit is thawed by enclosing it in a film type bag and immersing in water at room temperature (not greater than 35 C). The complete thawing of the product is determined by gently squeezing the bag occasionally so as not to damage the texture of the bivalve molluscs, until no hard core or ice crystals are left.
7.5.2 Cooking Methods
The following procedures are based on heating the product to an internal temperature of 65-70 C.
The product must not be overcooked. Cooking times vary according to the size of the product and the temperature used. The exact times and conditions of cooking for the product should be determined by prior experimentation.
Baking Procedure: Wrap the product in aluminium foil and place it evenly on a shallow flat pan.
Steaming Procedure: Wrap the product in aluminium foil and place it on a wire rack suspended over boiling water in a covered container.
Boil-in-Bag Procedure: Place the product into a boilable film-type pouch and seal. Immerse the pouch into boiling water and cook.
Microwave Procedure: Enclose the product in a container suitable for microwave cooking. If plastic bags are used, check to ensure that no odour is imparted from the plastic bags. Cook according to equipment instructions.
7.6 MPN Method For Analyses of E.Coli/Faecal Coliforms
(to be elaborated)
Method for E. coli proposed by Germany:
Donavan et al. (1998): Modification of the standard UK method for the enumeration of Eschericia coli in live bivalve molluscs. Communicable Disease and Public Health 1. 188-196.
In the absence of routine virus testing procedures and the establishment of virological standards, an assessment of the risks from viruses must be based on faecal bacteria counts and sanitary shoreline survey.
This indicator may be amended or replaced in the future by more suitable indicators like bacteriophage.
7.7 Determination of Biotoxins
(to be elaborated)
PSP - biological testing method in association if necessary with a chemical method for detection of Saxitoxin.
DSP - customary biological testing methods (on rats or mice).
Okadaic acid, Dynophysistoxins and Pectenotoxins – measurement of Okadaic acid equivalent. – biological methods (mouse bioassay, rat bioassay), authorised alternative chemical methods ELISA, HPLC, LCMS.
ASP - HPLC testing method.
NSP - current American Public Health Association Inc. method or other method approved by the official agency having jurisdiction.
AZP – HPLC or other method approved by the official agency having jurisdiction.
Yessotoxin – biological method or other method approved by the official agency having jurisdiction.
The above methods may be replaced by other acceptable chemical methods as they become available and approved for use.
8. DEFINITION OF DEFECTIVES
The sample unit shall be considered as defective when it exhibits any of the properties defined below.
8.1 Deep Dehydration (Frozen Products)
Greater than 10% of the weight of the bivalve molluscs in the sample unit or greater than 10% of the surface area of the block exhibits excessive loss of moisture clearly shown as white or abnormal colour on the surface which masks the colour of the flesh and penetrates below the surface, and cannot be easily removed by scraping with a knife or other sharp instrument without unduly affecting the appearance of the bivalve molluscs.
8.2 Foreign Matter
The presence in the sample unit of any matter which has not been derived from bivalve molluscs, does not pose a threat to human health and is readily recognized without magnification or is present at a level determined by any method including magnification, that indicates non-compliance with good manufacturing and sanitation practices.
8.3 Odour/Flavour
Bivalve molluscs affected by persistent and distinct objectionable odours or flavours indicative of decomposition or rancidity.
8.4 Texture
Textural breakdown of the flesh, indicative of decomposition, characterized by muscle structure which is mushy or paste-like.
8.6 Dead or Damaged Product
For bivalve molluscs sold live, the presence of dead or damaged product. Dead product is characterised by no response to percussion. Damaged product includes product that is damaged to the extent that they can no longer function biologically. Sample shall be rejected if dead or damaged product exceed 5% by count.
9. LOT ACCEPTANCE
A lot shall be considered as meeting the requirements of this standard when:
(i) the total number of defectives as classified according to section 8 does not exceed the acceptance number (c) of the appropriate sampling plan in the Sampling Plans for Prepackaged Foods (AQL-6.5) (CODEX STAN 233-1969);
(ii) the total number of sample units not meeting the count designation as defined in section 2.3 does not exceed the acceptance number (c) of the appropriate sampling plan in the Sampling Plans for Prepackaged Foods (AQL - 6.5) (CODEX STAN 233-1969);
(iii) the average net weight of all sample units is not less than the declared weight, provided there is no unreasonable shortage in any individual container;
(iv) the Food Additives, Hygiene and Labelling requirements of Sections 4, 5.1, 5.2, 5.3 and 6 are met.

ALINORM 04/27/18

APPENDIX X

PROPOSED DRAFT STANDARD FOR GRANULAR [STURGEON] CAVIAR
(At Step 3 of the Procedure)

1. SCOPE

This standard shall apply to granular sturgeon caviar.

2. DESCRIPTION

2.1. Definitions

The following definitions are used in this standard:

2.1.1 Fish eggs: product obtained from ovules separated from the connective tissue of ovary.

2.1.2 Granular caviar: The product made from fish egg of the sturgeon family by treating with salt or mixture of salt with a food additive.

2.1.5 Caviar lot: An amount of caviar taken from one biological fish species, treated in the same manner and packed in similar containers by the same producer for delivery to the same customer.

2.1.10 Primary package: (primary container). Metal cans or glass jars or other suitable containers in which caviar is packed directly.
2.1.11 Secondary package: (secondary container). Package containing one or several primary containers.
2.2 Product Definition

The product is prepared from fish eggs of sturgeon fishes belonging to the Acipenseridae family (four genus Acipenser, Huso, Pseudoscaphirhynchus and Scaphirhynchus and hybrids of these species)

The product is made with, or without food additives, and is intended for direct human consumption.

2.3 Process Definition

2.3.1 The product shall be prepared by using appropriate preliminary processing of caviar-grain to be salted with food grade salt, with or without food additives, packed in containers, and chilled to the temperatures so as to maintain the quality during storage, transportation and marketing.

The product shall be packed in:

- metal tins coated inside with stable food lacquer or enamel;
- glass jars.
- other suitable containers.

2.3.2 Industrial re-packaging of the product from larger to smaller containers under controlled conditions shall be permitted without mixing caviar from different [lots] species and quality (including from the same species but different in colour). The product shall be packaged so as to minimize the time that the caviar remains unpacked in order to prevent its warming and microbial contamination, as well as physical contamination.

2.4 HANDLING PRACTICE

- Granular caviar is produced from fish ovary reached maturation stage IV and extracted from sturgeon fishes without impairing their integrity, and under stringent sanitary conditions without disturbing the entirety of fish ovary. The roe is separated from the connective tissue of ovary. When the roe is delivered in large quantities it is kept until processing in closed containers in a refrigerating chamber at a temperature from minus 1C to plus 2o C for no more than 8 h.

- Caviar-grain is sorted by quality, colour and size. Before salting it is washed out in clean cooled water to remove clots of blood, squashed eggs and film pieces. Washed roe is immediately directed to the drained.
- Then it is treated with food grade salt with/without preservatives. All the above mentioned technological operations shall be performed without delay to avoid microbial spoiling.
- Preparation of granular caviar shall comply with the International Code of Practice for Sturgeon Caviar (to be elaborated).

3. ESSENTIAL COMPOSITION AND QUALITY FACTORS

3.1 Raw Material

Granular caviar shall be prepared from ovaries extracted from sturgeons of the biological species described in Section 2.2, which are of a quality necessary for human consumption.

3.2 Other Ingredients

Potable water and salt shall be of food grade quality and conform to all applicable Codex Standards.

3.3 Final Product

3.3.1 By its sensory and chemical characteristics the product shall comply with the requirements prescribed in Table 1

- Table 1

Index

Characteristics and norms

Appearance

Eggs of one size

Color

Even and characteristic of roe from the given biological species: from light gray to black, or from light yellow to yellowish gray. Yellowish and brownish shades are permissible

Consistence and state

Eggs can be easily separated from each other

Taste and odour

Characteristic of roe from the given biological species; without foreign taste and odour

Salt, %

3.5 – 5.0

Foreign admixtures

Unacceptable

3.3.2 The product shall meet the requirements of the present Standard, when a lot examined in accordance with the requirements described in Section 10 complies with the provisions set out in Section 9.

The product shall be examined by the methods given in Section 8.
4. FOOD ADDITIVES

4.1 (to be additionally developed)

4.2 A complete list of permitted food additives shall be approved by the Codex Committee for Food Additives and Contaminants.

5. CONTAMINANTS

5.1 Pesticide residues

The product covered by this standard should comply with those maximum residue limits established by the Codex Alimentarius Commission for these products.

5.2 Other contaminants

The product shall comply with the provisions of the Codex General Standard for Contaminants and Toxins in Food (Codex Stan 193-1995).

6. HYGIENE

[6.1. The final product shall be free from any foreign material that poses a threat to human health.

6.2. When tested by appropriate methods of sampling and examination prescribed by the Codex Alimentarius Commission, the product shall be free from microorganism or substances originating from microorganism in amount which may present a hazard to health in accordance with the Principles for the Establishment and Application of Microbiological Criteria for Foods (CAC/GL 21-1997).

6.3. It is recommended that the product covered by the provision of this standard be prepared and handled in accordance with the appropriate sections of the Recommended International Code of Practice – General Principles of Food Hygiene (CAC/RCP 1-1969,Rev.3-1997).]

7. LABELLING

7.1 Labelling of the product and the name of granular caviar shall be in accordance with the provisions of the Codex General Standard for the Labelling of Prepackaged Foods (CODEX STAN 1-1985, Rev. 1-1991).

The name of the product shown on the label shall be “Granular caviar” or “Caviar”, and may precede or follow the common or established name of the biological species of sturgeon in compliance with the laws and traditions of the country where the product is distributed to avoid misleading of the customer. The information on the salient feature (characteristic) of caviar (granular) may be placed in the immediate vicinity of the product name.

7.2 The following provisions in respect of the labelling of this product are subject to endorsement by the Codex Committee on Food Labelling:

The package shall bear clear directions for the regime and time of keeping the product, including the following information:

- the name of the biological species of fish in English; e.g. beluga, kaluga, sturgeon, sevruga and sterlet;
- the storage time should be calculated as from the date of making, and the marking should include the “storage time”, and a reference to the place of the label where the date of making is shown.

The information on the salt share index, e.g. malossol, should be shown in the label when the weight share of salt in the product shown is less than 3.5%.

It is allowed to show the information on the container of granular caviar at one or several places, suitably legibly, as well as to use the background on the labels, or on lithographed containers, according to the species of raw material, as follows: blue for beluga and kaluga, yellow for sturgeon, red for sevruga, green for starlet in accordance with the information in Annex C.

7.3. The granular caviar of sturgeons should be labelled for identification with disposable sticker labels according to the CITES guidelines for a uniform system of labelling caviar for trade or identification:
- information on the source of caviar: not to be given for “wild” sturgeons; for aquaculture – grown fish the label should read “Aquaculture product” (to be marked near the biological name of the species);
- the three-letter code for the biological species according to Annex B should be given as a sign over the line on the level of the upper edge of script, with the name of the fish in English, e.g. belugahus, sturgeonper, sturgeongue;
- the two-letter Alpha – 2 code of the country of origin in Latin according to ISO 3166-97;
- international standard code;
- data on the food value of product in accordance with the guidelines for marking of food products CAC/GL 2-1985 (Rev. 1-1993);
- the official registration code (up to four symbols – xxxx) of the producing plant, or code of the caviar repackaging plant; when caviar is repackaged in the importing country the code should include the two-letter ISO code, and the official registration code of the plant, e.g. when the granular caviar is repackaged in France: FR – xxxx;
- the date of making the product should be marked as a sequence of digits; one digit for the ten day period, two digits for the month, the last digit of the year for the year.

8. SAMPLING, EXAMINATION AND ANALYSES

8.1 Sampling

8.1.1 Sampling of lots for examination of the product shall be in accordance with the FAO/WHO Codex Alimentarius Sampling Plans for Prepackaged Foods (AQL6.5) (CODEX STAN 233-1969).

A lot of granular caviar shall mean a volume of product prepared in accordance with Section 2.1.5.

8.2 The methods of analysis and sampling described hereunder are to be endorsed by the Codex Committee on Methods of Analysis and Sampling.

8.2.1.Sensory and Physical/Chemical Examination

Samples taken for sensory and physical/chemical examination shall be assessed by experts trained in such examination and in accordance with methods elaborated in Sections 8.2.1- 8.2.2 and the Codes of Practice for the Sensory Evaluation of Caviar and Caviar Products (to be developed).

8.2.2.Determination of Net Weight

The net weight of each sample unit shall be determined in accordance with the following procedure:

• container filled with the product shall be swept dry and weighed;
• container shall be opened, and freed from caviar;
• empty container with a lid, (and packing material, if available), cleaned of the product, washed and dried, shall be weighed;
• subtract the weight of the empty container with a lid (and packing material, if available) from the weight of the container with the product, and determine the net weight of product.

8.2.3. The weight share of salt shall be determined using the method developed for salted fish.

9. DEFINITION OF DEFECTS

The sample unit shall be considered as defective when it exhibits any of the properties defined in Sections 9.1-9.3.

9.1 Foreign admixtures

The presence in the sample unit of any matter which has not been derived from sturgeon eggs, does not pose a threat to human health, is readily recognized without magnification; or when it is present at a level determined by any method including magnification, that indicates non-compliance with good manufacturing practices and sanitation rules.

9.2 Odour and Flavour

The product affected by persistent and distinct objectionable odour and/or flavour indicative of decomposition, oxidation, or taste of feed (in sturgeon reared in aquaculture), or contamination by foreign substances (such as fuel oil).

9.3 Consistency and Condition

Hard cover of caviar grains is not easily chewable, or tenuous, destroyed when the grains are separated from one another.

[9.4. Extraneous material

Membranes and fats clusters shall be absent from finished granular caviar]

10.

LOT ACCEPTANCE

A lot shall be considered as meeting the requirements of this standard when:

7 1. The total number of defectives as classified according to Section 9 does not exceed the acceptable number of the appropriate sampling plan given in the Sampling Plans for Prepackaged Foods (AQL – 6.5) (CODEX STAN 233-1969).
8 2. The average net weight of all sample units is not less than the declared weight, provided no individual container is less than 95% of the declared weight.
9 3. The Food Additives, Hygiene, Packing and Labelling requirements of Sections 4, 2.3, 5, 6, 7 and 8 are met.

ANNEX A

SENSORY AND PHYSICAL EXAMINATION

The samples used for sensory evaluation should not be same as that used for other examination.
1.Examine the sample unit for foreign matter, bones and discolouration.

2. Assess the odour in the uncooked sample in accordance with the Guidelines for the Sensory Evaluation of Fish and Shellfish in Laboratories (CAC/GL 31-1999).

3. Assess the flavour in cooked sample in accordance with the Guidelines for the Sensory Evaluation of Fish and Shellfish in Laboratories (CAC/GL 31-1999).

ANNEX B

IDENTIFICATION CODES OF STURGEON SPECIES

- Table B.1

Denomination of sturgeon fishes
Scientific names

Code

Huso huso

HUS

Huso dauricus

DAU

Acipenser naccari

NAC

Acipenser transmontanus

TRA

Acipenser schrenkii

SCH

Acipenser sturio

STU

Acipenser baerii baikalensis

BAI

Acipenser sinensis

SIN

Acipenser dabryanus

DAB

Acipenser persicus

PER

Acipenser brevirostrum

BVI

Acipenser fulvescens

FUL

Acipenser oxyrhynchus

OXY

Acipenser oxyrhynchus desotoi

DES

Acipenser gueldenstaedtii

GUE

Acipenser medirostris

MED

Acipenser baerii

BAE

Acipenser micadoi

MIK

Acipenser stellatus

STE

Acipenser ruthenus

RUT

Acipenser nudiventris

NUD

ANNEX C

INFORMATION ANNEX
Figure 1
Undisplayed Graphic

Figure 2
Undisplayed Graphic

ANNEX C

Continuation of INFORMATION ANNEX

Figure 3
Undisplayed Graphic

Figure 4
Undisplayed Graphic

ALINORM 04/27/18
APPENDIX XI

PROPOSED DRAFT STANDARD FOR
HOT SMOKED AND PRE-PACKED COLD SMOKED FISH

(At Step 3 of the Procedure)

1. SCOPE

This standard applies to chilled or frozen, ready-to-eat hot and cold smoked fish and to sliced and similar transformed products thereof. It does not apply to speciality products where hot or cold smoked fish constitutes only a part of the edible contents, nor to mince products based on hot or cold smoked fish. It does not apply to speciality products where hot or cold smoked fish has been marinated or covered with herbs or spices prior to smoking.

2. DESCRIPTION

2.1 Product definition

Cold smoked fish is prepared from fresh or frozen fish of any suitable species and treated with smoke generated from smouldering wood at a temperature which will not cause visible coagulation of the flesh. The fish can either be salted or be non-salted before smoking.

Hot smoked fish is prepared from fresh or frozen fish of any suitable species and treated with smoke generated from burning and or smouldering wood at a temperature which will cause visible coagulation of the flesh. The fish can either be salted or be non-salted before smoking.

2.2 Process definition

The fish after any suitable preparation destined for hot smoking may be subjected to a salting process and shall comply with the conditions laid down hereafter.

The fish after any suitable preparation destined for cold smoking may be subjected to a salting process and shall comply with the conditions laid down hereafter.

2.2.1 Salting of smoked fish
2.2.1.1 Salting of cold smoked fish
Salting according to custom and usually to a content of between 3% and 6% NaCl in the water phase (w/w) and possibly drying. Smoked to taste with cold/cooled smoke at a lower temperature than to cause visible coagulation.
The product is either refrigerated [to below 4.4 C (40 F)] or [quick] frozen. The product is packaged in materials that will not transmit harmful substances to the product. If the salt content of the product is less than 3% in the water phase and the product is packaged to the exclusion of oxygen (e.g. vacuum packed) the product shall be presented [deep] frozen.
2.2.1.2 Salting of hot smoked fish
Salting according to custom and usually to a content of between 0% and 6% NaCl in the water phase (w/w) and drying.
The product is either refrigerated [to below 5 C] or [quick] frozen. The product is either packed in paper in boxes, air packed or vacuum packaged in materials that will not transmit harmful substances to the product. If the salt content of the product is less than 3% in the water phase and the product is packaged to the exclusion of oxygen (e.g. vacuum packed) the product shall be presented [deep] frozen.
2.2.1 Procedure for killing off parasites in cold smoked fish
Any species of fresh fish originating from waters infested with human pathogenic parasites must be frozen either before or after the cold smoking to sufficiently kill the living parasites. This process must be performed at -20 c for 24 hours or -35 C for 15 hours.

2.3 Presentation

Any presentation of the product shall be permitted provided that it:

2.3.1 Any presentation of the product shall be permitted provided that:
• it meets all requirements of this standard, and
• is adequately described on the label to avoid confusing or misleading the consumer.

3. ESSENTIAL COMPOSITION AND QUALITY FACTORS

3.1 The raw material

Smoked fish shall be prepared from sound and wholesome fresh or frozen fish of any suitable species, which are of a quality to be sold fresh for human consumption after appropriate preparation. If salted fish is used for smoking purposes it shall comply with the standard for salted fish.

3.2 Salt and other ingredients

Salt and all other ingredients used shall be of food grade quality and conform with all applicable Codex standards.

3.3 Wood for generation of smoke

Wood for generation of smoke must not have been treated with any chemicals such as paint or impregnating materials.

Liquid smoke or other preparations are not permitted.

3.4 Final product

Products shall meet the requirements of this standard and any other relevant standards.

4. FOOD ADDITIVES

No food additive is permitted in these products.

5. HYGIENE AND HANDLING

5.1 It is recommended that the products covered by the provisions of this standard be prepared and handled in accordance with the appropriate sections of the recommended international code of practice – general principles of food hygiene (CAC/RCP 1-1985, rev. 3, 1997) and other relevant codex texts such as codes of practice and codes of hygienic practice, as follows;

(i) the recommended international code of practice for fresh fish (CAC/RCP 9-1976)

(ii) the Recommended International Code of Practice for Frozen Fish

(CAC/RCP 16-1978)

(iii) the Recommended International Code of Practice for Salted Fish

(CAC/RCP 26-1979)

5.2 The products shall comply with any microbiological criteria established in accordance with the Principles for the Establishment and Application og microbiological Criteria in Foods (CAC/RCP 21-1997).
5.3 The products shall not contain any other substance in amounts, which may present a hazard to health in accordance with standards established by the Codex Alimentarius Commission.
5.4 Parasites
Fish flesh from cold smoked products shall not contain living larvae of parasites (nematodes).
5.5 Listeria monocytogenes
Cold smoked fish products consistently free from Listeria monocytogenes cannot be produced; however, by adhering to GMPs (including training staff), it is possible to reduce prevalence. Smoke houses with strict adherence to GMPs are capable of producing cold smoked products with very low levels of Listeria monocytogenes often less than 1 cell per gram. Although not eliminated, such low levels would ensure that the number of Listeria monocytogenes does not increase to above 100 cfu / g at time of consumption given that appropriate temperature (5 C) and time (3-4 weeks) limits are met.
5.6 Clostridium botulinum
This section is to be elaborated further
Based on a rage of model studies in broth and in inoculation studies with hot or cold smoked fish, it can be concluded that a combination of 3,5% NaCl (WPS) and chill storage (4.4 C, 40 F), allowing for short periods of elevated temperatures up to 10 c (50 F), will prevent toxin formation in reduced oxygen packaging cold smoked fish for several weeks beyond its sensory shelf life.

The formation of Clostridium botulinum toxin can be controlled through an application of science-based options involving packaging type, storage temperature, and the use of salt in the water phase. Countries where the products are to be consumed can be expected to make their science-based risk management choices within this framework, i.e., select some options and exclude others, based on conditions within the country (e.g., nature and enforcement of refrigeration and shelf life controls; transportation times and conditions; variability in amount of salt in the water phase that could occur despite best efforts to achieve a required percentage, etc.), and the level of protection that the country chooses for itself for this particular risk. The table shown in Annex 1 addresses these control options.

5.6 Histamine

The products shall not contain histamine that exceeds 200 mg/kg in any sample unit and the average of a sampling set shall not exceed the average of 100 mg/kg.

6. LABELLING

In addition to the provisions of the Codex General Standard for the Labelling of Pre-packed Foods CODEX STAN 1-85, Rev. 1-1991) the following specific provisions apply.

6.1 Name of the Food

6.1.1 The name of the product as declared on the label shall contain the words "Smoked" in combination with the name of the fish appropriate to the species of the fish in accordance with the law, custom or practice in use in the country of distribution.

6.1.2 In addition to the specified labelling designations above, the usual or common trade names of the variety may be added so long it is not misleading to the consumer in the country in which the product will be distributed.

6.3 Storage Instructions

The label shall contain storage conditions for the product.

It must be clearly stated on the labelling, if the product has been kept in storage in frozen condition, but is then thawed prior to sale and sold as a fresh refrigerated product.

6.4 Labelling of Non-retail Containers

Information on the above mentioned provisions should be given on the container as well as the lot identification and the identification of the manufacturer and the country of origin.

7. SAMPLING, EXAMINATION AND ANALYSIS

7.1 Sampling

(i) Sampling of lots for examination of the product for quality shall be in accordance with the FAO/WHO Codex Alimentarius Sampling Plans for Prepacked Foods (AQL-6.5) CODEX STAN 233-1969).
A sample unit is the primary container or for individually packed products at least a 1 kg portion of the sample unit.
(ii) The average net weight of all sample units is not less than the declared weight, provided that there is no unreasonable shortage in any container;
(iii) The sampling of lots for microbial and parasitical analysis will be in accordance with the principles in the guidelines for sampling under development by CCMAS.

7.2 Sensory and Physical Examination

• Samples taken for sensory and physical examination shall be assessed by persons trained in such examination and in accordance with procedures elaborated in Sections 6.3 through 6.5 and the "Code of Practice for the Sensory Evaluation of Fish and Shellfish" (under elaboration)
• “Histamine gives a very characteristic sensation on the tongue and in the mouth. Therefore a special training of people (a panel) should be set up, so that they, by tasting the fish and fishery products, are able to determine the possible presence of histamine below the limits. Whenever a sensory evaluation gives a suspicious result chemical analysis shall be carried out.”

7.3 Determination of Histamine

AOAC 977.13 (15th Edition, 1990).

7.4 Determination of Parasites

The entire sample unit is examined non-destructively by the naked eye for the presence of parasites and trace of their activity such as gelatinised parts of the flesh.

7.5 Determination of Net Weight

7.5.1 The net weight is determined as the weight of the product as presented to the consumer exclusive packaging material, interleaving material, glaze etc.

7.5.2 Net contents

Where sliced products are interleaved with sheets of paper/other material the net weight is determined by subtracting from the gross weight of the package the weight of the packaging material including the interleaving sheets.

7.5.2 If glazed the net weight is the weight without glaze.

9.6 Procedure for thawing
To be elaborated on:
Frozen raw fish ….
Frozen smoked fish....

8. DEFINITION OF DEFECTIVES

A sample unit shall be considered as defective when it exhibits properties defined below.

8.1 Foreign matter

The presence in the sample unit of any matter, which has not been derived from the fish or the smoke, does not pose a threat to human health, and is readily recognised without magnification or is present at a level determined by any method including magnification that indicates non-compliance with good manufacturing practice.

8.2 Parasites

(The presence of any visible live parasites in a sample of the edible portion of the sample unit detected by normal visual inspection of the fish flesh)

8.3 Odour and Flavour

Smoked product affected by persistent and distinct objectionable odours or flavours characteristic for decomposition, rancidity, burning sensation or other sensorial impressions not characteristic for the product.

9. LOT ACCEPTANCE

A lot will be considered as meeting the requirements of this standard when:

(i) The total number of defectives as classified according to Section 8 does not exceed the acceptance number (c) of the appropriate sampling plan in the Sampling Plans for Pre-Packed Foods (AQL-6.5) - (CODEX STAN 233-1969)
(ii) The average net contents of all packages examined are not less than the declared weight, provided there is no unreasonable shortage in any package, and
(iii) The Food Additives, Hygiene and Handling and Labelling requirements of Sections 4, 5 and 6 are met.

ANNEX 1
To be elaborated on:

Packaging

Storage Temp

Water Phase Salt

Comments

Air Packaged

To be defined

4C (40F)

No minimum water phase salt is needed for safety.

Nonetheless, where there is a reasonable possibility of severe time/temperature abuse, the country where the product is being consumed might choose a water phase salt barrier of at least 3 -3.5% as a precautionary measure.

Storage temp is for the control of pathogens generally and for quality. In air-packaged products, aerobic spoilage organisms provide sensory signs of spoilage before the formation of toxin by C. botulinum. However, even in air packaging it is possible for anaerobic micro-environments to exist and toxin may form if the product is subject to severe time/temperature abuse. For that reason, the country where the product is consumed may still require water phase salt as a barrier to growth of non-proteolytic strains of C. botulinum if there are concerns about the ability of transporters, retailers or consumers to maintain time/temperature control.

Reduced Oxygen

Frozen

No minimum water phase salt is needed for safety.

C. botulinum toxin cannot form when product is frozen. Because toxin production can occur after thawing, labelling information about the need to keep frozen, to thaw under refrigeration, and to use the product immediately after thawing is important.

Reduced Oxygen

4C (40F)

Water phase salt at minimum level of between 3 -3.5% may be selected by the country where the product is to be consumed.

Water phase salt at a minimum level of between 3 and 3,5% (water phase salt) in combination with chilling will significantly delay (or prevent) toxin formation.

As an alternative to water phase salt, time/temperature controls may be used. C botulinum cannot grow and produce toxin at or below 3C (38F). Other time/temperature combinations exist that similarly control the formation of toxin (Skinner and Larkin, 1998). Where enforcement of shelf life as well as consumer acceptance of shelf life are norms, the country may select a system that relies on the combination of existing storage temperature conditions (i.e. during transport, retail storage, and consumer storage) and shelf life limitations.

However, in countries where consumer acceptance and regulatory enforcement of shelf life are not norms, continuous monitoring, such as that provided by time/temperature integrators on consumer packages, may be selected as a control by the country where the product will be consumed. The necessity for time/temperature integrators exists because, unlike freezing, temperature control through refrigeration is not a visual condition and cannot be determined without an additional monitoring control.

ANNEX 2

END PRODUCT SPECIFICATIONS

Contaminants

?

Microorganisms

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1 Reference to be inserted