CODEX STAN 292-2008 Page 1 of 7

STANDARD FOR LIVE AND RAW BIVALVE MOLLUSCS

1. SCOPE
This standard applies to live bivalve molluscs and to raw bivalve molluscs that have been shucked and/or
frozen, and/or processed to reduce or limit target organisms while essentially retaining the sensory
characteristics of live bivalve molluscs. Raw bivalve molluscs are marketed either in a frozen or chilled
state. Both live and raw bivalve molluscs may be intended for direct consumption or further processing.
The standard does not apply to scallops when the final product is the adductor muscle only.
Part I below applies to live bivalve molluscs while Part II applies to raw bivalve molluscs.
PART I – LIVE BIVALVE MOLLUSCS
I-2. DESCRIPTION
I-2.1 Product Definition
Live bivalve molluscs are products that are alive immediately prior to consumption. Presentation includes
the shell.
I-2.2 Process Definition
Live bivalve molluscs are harvested alive from a harvesting area either approved for direct human
consumption or classified to permit harvesting for an approved method of purification, e.g. relaying or
depuration, prior to human consumption. Both relaying and depuration must be subject to appropriate
controls implemented by the official agency having jurisdiction.
I-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 by weight, count, count per unit of weight, volume or per package.
I-3. ESSENTIAL COMPOSITION AND QUALITY FACTORS
I-3.1 Bivalve Molluscs
Live bivalve molluscs should possess organoleptic characteristics associated with freshness, as well as an
adequate response to percussion (i.e. the shellfish will close by themselves when tapped) and freedom from
extraneous matter, as determined by specialists familiar with the species concerned.
I-3.2 Final Product
Live bivalve molluscs shall meet the requirements of this standard when lots examined in accordance with
Section I-10 comply with the provisions set out in Section I-9. Live bivalve molluscs shall be examined by
the methods given in Section I-8.
I-4. FOOD ADDITIVES
Food additives are not permitted in live bivalve molluscs.
I-5. CONTAMINANTS
I-5.1 The products covered by this Standard shall comply with the Maximum Levels of the Codex General
Standard for Contamination and Toxins in Foods (CODEX/STAN 193-1995) and the maximum residue
limits for pesticides and/or veterinary drugs established by the CAC.
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I-5.2 The following provisions apply to the edible parts of live bivalve mollusc (the whole part or any part
intended to be eaten separately)

Name of biotoxin groups Maximum level /kg of mollusc flesh

Saxitoxin (STX) group ≤0.8 milligrams (2HCL) of saxitoxin

equivalent
Okadaic acid (OA) group ≤0.16 milligrams of okadaic equivalent
Domoic acid (DA) group ≤20 milligrams domoic acid
Brevetoxin (BTX) group ≤200 mouse units or equivalent
Azaspiracid (AZP) group ≤0.16 milligrams

I-6. HYGIENE AND HANDLING

I-6.1 It is recommended that the products covered by 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 – 1969), the Code of Practice for Fish and Fishery Products
(CAC/RCP 52-2003) and other relevant Codex texts such as Codes of Hygienic Practice and Codes of
Practice.
I-6.2 The products should comply with any microbiological criteria established in accordance with the
Principles for the Establishment and Application of Microbiological Criteria for Foods (CAC/GL 21-1997).
I-6.3 Growing area monitoring programs, irrespective of the type of indicator bacteria used, must ensure that
live bivalve molluscs destined for direct human consumption meet the E.coli limit as identified below when
tested in accordance with an MPN method specified in ISO 16649-3 or equivalent.
I-6.4 In analysis involving five (5) 100g samples of the edible parts (the whole part or any part intended to be
eaten separately), none may contain more than 700 E. coli and not more than one (1) of five (5) samples may
contain between 230 and 700 E.coli, or equivalent as decided by the competent authority having jurisdiction
Microorganism = Escherichia coli n=5 c=1 m=230 M=700 3 Class Plan

where ‘n’= the number of sample units, ‘c’= the number of sample units that may exceed the limit ‘m’, and
‘M’is the limit which no sample unit may exceed.

I-6.5 In analysis involving five (5) 25g samples of the edible parts (the whole part or any part intended to be
eaten separately), no sample may indicate the presence of Salmonella when tested using a method validated
against the reference method ISO 6579.
Microorganism = Salmonella n=5 c=0 m=0/25g 2 Class Plan

where n = number of samples that must conform to the criteria; c = the maximum allowable number of
defective sample units; m = a microbiological limit which separates good quality from defective quality.

I-6.6 Where the microbiological criteria are not met, actions should be taken as deemed appropriate by the
competent authority. In following up, consideration should be given to detention, recall and further
processing in a manner to eliminate the hazard from implicated lots. In addition, assessment of the status of
harvesting areas and/or establishment controls should be undertaken.
I-7. LABELLING
In addition to the provisions of the Codex General Standard for the Labelling of Prepackaged Foods
(CODEX STAN 1-1985) the following specific provisions apply:
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I-7.1 The Name of the Food
The name of the food to be declared on the label shall be the common or usual name of the species of bivalve
molluscs in accordance with the law and custom of the country in which the food is sold and in a manner not
to mislead the consumer.
I-7.1.1 There shall appear on the label, reference to the presentation provided for in Section I-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.
I-7.1.2 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.
I-7.2 Content Declaration
Live bivalve molluscs shall be labelled by weight, count, count per unit weight, or volume as appropriate to
the product.
I-7.3 Storage Instructions
The label shall specify the conditions for storage and/or temperature that will maintain the product
safety/viability during transportation, storage and distribution.
I-7.4 Labelling of Non-retail Containers
Labelling for live bivalve molluscs shall contain the following information::
(i) Identification of the product by common and/or scientific names as determined by the
competent authority. The country where the product is sold can determine if the scientific name
must be indicated on the label.
(ii) Information that might be needed in the event of a food safety problem, including lot
identification which could be lot code or date and location of harvest, information about harvest area,
date of harvesting, purification or relaying as appropriate, as well as identification of the despatch
centre or other establishment from which they were shipped.
(iii) Durability or shelf life.
Date of minimum durability may be replaced by the statement “Bivalves must be alive when sold”.
I-8. SAMPLING, EXAMINATION AND ANALYSES
I-8.1 Sampling
(i) Each sample shall contain a sufficient number of bivalve molluscs to ensure that the sample is
representative.
(ii) The portion of the bivalve mollusc analysed should be the edible part. This is generally the whole tissue.
Where whole-tissue analysis is not possible or practical, the most contaminated tissue (e.g. the digestive
gland) may be dissected and analysed and the results converted to an edible tissue basis. The conversion
factor should be supported by adequate data.
I-8.2 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 I-7.3 through I-7.5, and Guidelines for
the Sensory Evaluation of Fish and Shellfish in Laboratories" (CAC/GL 31-1999).
I-8.3 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.
I-8.4 Method of Analysis of Escherichia coli in bivalve molluscs
The ISO/TS 16649-3 – Horizontal method for the enumeration of beta-glucuronidase-positive Escherichia
coli – Part 3: Most probable number technique using 5-bromo-4-chloro-3-indolyl-beta-D-glucuronide or
other validated methods in accordance with the protocol set out in the ISO 16140 or other internationally
accepted similar protocol.
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I-8.5 Method of Analysis of Salmonella in bivalve molluscs
The methods to be employed for Salmonella should be ISO 6579, or other validated methods that provide
equivalent sensitivity, reproducibility and reliability.
I-8.6 Determination of Biotoxins

Provision Methodology Principle Type

Saxitoxin group AOAC Official Method LC-FL II
2005.06 (Paralytic
Shellfish Poisoning
Toxins in Shellfish) four
matrices and 12 toxins

I-9 DEFINITION OF DEFECTIVES

Asample unit shall be considered as defective when it exhibits any of the properties defined below.
I-9.1 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.
I-9.2 Dead or Damaged Product
The presence of dead or damaged product. Dead product is characterised by no response to percussion (i.e.
shellfish will close by themselves when tapped). Damaged product includes product that is damaged to the
extent that it can no longer function biologically. A Sample unit shall be considered defectiveif dead or
damaged bivalve molluscs exceed 5% by count.
I-10 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 I-8 does not exceed the acceptance
number (c) of the appropriate sampling plan in the General Guidelines on Sampling (CAC/GL 50-2004);
(ii) the total number of sample units not meeting the count designation as defined in section I-7.3 does not
exceed the acceptance number (c) of the appropriate sampling plan in the General Guidelines on Sampling
(CAC/GL 50-2004);
(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, Contaminants, Hygiene and Labelling requirements of Sections I-4, I-5, I-6 and I-7
are met.
PART II – RAW BIVALVE MOLLUSCS
II-2 DESCRIPTION
II-2.1 Product Definition
Raw bivalve molluscs processed for direct consumption or for further processing are products that were alive
immediately prior to the commencement of processing and comply with Section I-2.2 relating to harvesting,
purification and relaying. They have been shucked and/or frozen and/or processed to reduce or limit target
organisms while essentially retaining the sensory characteristics of live bivalve molluscs. Raw bivalve
molluscs are marketed in a frozen or chilled state.
II-2.2 Process Definition
Raw bivalve molluscs must meet the process definition in I-2.2 before they can be processed for direct
consumption or further processing.
Bivalve molluscs that have been processed to reduce or limit target organisms while essentially retaining the
CODEX STAN 292-2008 Page 5 of 7
sensory characteristics of live bivalve molluscs are ones that have been processed to assure reduction or
limitation of the target organisms to the satisfaction of the official agency having jurisdiction.
II-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 by weight, count, count per unit of weight, volume or per package.
II-3 ESSENTIAL COMPOSITION AND QUALITY FACTORS
II-3.1 Raw Bivalve Molluscs
Raw bivalve molluscs shall be of a quality fit for human consumption.
II-3.2 Ingredients
The packing medium and all other ingredients used shall be of food grade quality and conform to all
applicable Codex standards.
II-3.3 Final Product
Raw bivalve molluscs shall meet the requirements of this standard when lots examined in accordance with
Section II-9 comply with the provisions set out in Section II-8. Raw bivalve molluscs shall be examined by
the methods given in Section II-7.
II-4 FOOD ADDITIVES
Only the use of the following additives is permitted in raw bivalve molluscs.
Antioxidants
For chilled shucked molluscs any antioxidant listed in food category 09.1.2 (Fresh Molluscs, crustaceans and
echinoderms) of the General Standard for Food Additives (CODEX STAN 192-1995).
For raw frozen molluscs any antioxidant listed in food category 09.2.1 (Frozen fish, fish fillets, and fish
products, including molluscs, crustaceans, and echinoderms) of the General Standard for Food Additives
(CODEX STAN 192-1995).
II-5 CONTAMINANTS
Raw bivalve molluscs should meet the requirements of I-5
II-6 HYGIENE AND HANDLING
Raw bivalve molluscs should meet the requirements of I-6
II-7 LABELLING
In addition to the provisions of the Codex General Standard for the Labelling of Prepackaged Foods
(CODEX STAN 1-1985) the following specific provisions apply:
II-7.1 The Name of the Food
The name of the food to be declared on the label shall be the common or usual name of the species of bivalve
molluscs in accordance with the law and custom of the country in which the food is sold and in a manner not
to mislead the consumer.
II-7.1.1 There shall appear on the label, reference to the presentation provided for in Section II-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.
II-7.1.2 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.
II-7.2 Content Declaration
Raw bivalve molluscs shall be labelled by weight, count, count per unit weight, or volume as appropriate to
the product.
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II-7.3 Storage Instructions
The label shall specify the conditions for storage and/or temperature that will maintain the food safety and
characteristics of the product during transportation, storage and distribution including date of minimum
durability and for date of shucking.
II-7.4 Labelling of Non-retail Containers
Refer to I-6.4 Labelling of Non-retail Containers.
II-7.4.1 Every package containing bivalve molluscs that have been processed to reduce or limit target
organisms must be provided with a label certifying that all molluscs have been processed to reduce the target
organism to levels acceptable to the official agency having jurisdiction.
II-7.4.2 Safety claims for bivalve molluscs processed to reduce or limit target organisms should be specific
to the target organisms that have been reduced or limited as described in the Code of Practice. II-8.
SAMPLING, EXAMINATION AND ANALYSES
II-8.1 Sampling
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.
II-8.2 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 II-7.3 through II-7.7, and Guidelines
for the Sensory Evaluation of Fish and Shellfish in Laboratories" (CAC/GL 31-1999).
II-8.3 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 II-7.3.1 through II-7.3.5.
II-8.3.1 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.
II-8.3.2 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.
II-8.3.3 Determination of Net Weight of Products Covered by Glaze
AOAC official method 963.18, Net Contents of Frozen Seafoods
II-8.3.4 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.
II-8.3.5 Determination of Drained Weight
In the case of shucked bivalve molluscs, the drained weight shall be determined according to AOAC official
method 953.11.
II-8.4 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.
II-8.5 Sample Preparation
II-8.5.1 Procedures for Thawing
For frozen product, the sample unit is thawed by enclosing it in a film type bag and immersing in water at
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room temperature (not greater than 35 ºC). 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.
II-8.6 Methods of Analysis of Escherichia coli
Refer to I-8.4 Methods of Analysis of Escherichia coli
II-8.7 Method of Analysis of Salmonella
Refer to I-8.5 Method of Analysis of Salmonella
II-8.8 Determination of Biotoxins
Refer to I-8.6 Determination of Biotoxins
II-9 DEFINITION OF DEFECTIVES
The sample unit shall be considered as defective when it exhibits any of the properties defined below.
II-9.1 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.
II-9.2 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.
II-9.3 Odour/Flavour
Persistent and distinct objectionable odours or flavours indicative of decomposition or rancidity.
II-9.4 Texture
Textural breakdown of the flesh, indicative of decomposition, characterized by muscle structure that is
mushy or paste-like.
II-10 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 II-8 does not exceed the acceptance
number (c) of the appropriate sampling plan in the General Guidelines on Sampling (CAC/GL 50-2004);
(ii) the total number of sample units not meeting the count designation as defined in section II-2.3 does not
exceed the acceptance number (c) of the appropriate sampling plan in the General Guidelines on Sampling
(CAC/GL 50-2004);
(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, Contaminants, Hygiene and Labelling requirements of Sections II-4, II-5, II-6 and
II-7 are met.