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`STANDARD FOR FISH OILS
`
`CODEX STAN 329-2017
`
`Adopted in 2017.
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`RIMFROST EXHIBIT 1147 Page 0001
`
`

`

`CODEX STAN 329-2017
`
`1.
`
`SCOPE
`
`2
`
`
`
`This Standard applies to the fish oils described in section 2 that are presented in a state for human consumption.
`For the purpose of this Standard, the term fish oils refers to oils derived from fish and shellfish as defined in
`section 2 of the Code of Practice for Fish and Fishery Products (CAC/RCP 52-2003)1. This standard only
`applies to fish oils used in food and in food supplements where those are regulated as foods.
`
`2.
`
`DESCRIPTION
`
`
`
`
`
`
`
`Fish oils means oils intended for human consumption derived from the raw material as defined in Section 2 of
`the Code of Practice for Fish and Fishery Products (CAC/RCP 52-2003). Processes to obtain fish oil for human
`consumption may involve, but are not limited to, extraction of crude oil from raw material and refining of that
`crude oil. Fish oils and concentrated fish oils are primarily composed of glycerides of fatty acids whereas
`concentrated fish oils ethyl esters are primarily composed of fatty acids ethyl esters. Fish oils may contain
`other lipids and unsaponifiable constituents naturally present.
`
`Crude fish oils and crude fish liver oils are oils intended for human consumption after they have undergone
`further processing, e.g. refining and purification and have to comply with section 3.1, as applicable, as well as
`with sections 4, 6.1 and 7. Fish oils intended for direct human consumption shall comply with all sections of
`this standard.
`
`The refined fish oil production process typically includes several steps such as repeated heating at high
`temperatures as well as alkali/ acid treatments and repeated removal of the water phase. Fish oils may also
`be subjected to processing steps (e.g. solvent extraction, saponification, re-esterification, trans-esterification).
`
`2.1 Named fish oils are derived from specific raw materials which are characteristic of the major fish or shellfish
`taxon from which the oil is extracted.
`
`2.1.1 Anchovy oil is derived from Engraulis ringens and other species of the genus Engraulis (Engraulidae).
`
`2.1.2 Tuna oil is derived from the species of the genus Thunnus and from the species Katsuwonus pelamis
`(Scombridae).
`
`2.1.3 Krill oil is derived from Euphausia superba. The major components are triglycerides and phospholipids.
`
`2.1.4 Menhaden oil is derived from the genera Brevootia and Ethmidium (Clupeidae).
`
`2.1.5 Salmon oil is derived from the family Salmonidae.
`
`2.2 Fish oils (unnamed) are derived from one or more species of fish or shellfish. This includes also mixtures
`with fish liver oils.
`
`2.3 Named fish liver oils are derived from the livers of fish and are composed of fatty acids, vitamins or other
`components that are representative of the livers from the species from which the oil is extracted.
`
`2.3.1 Cod liver oil is derived from the liver of wild cod, Gadus morhua L and other species of Gadidae.
`
`2.4 Fish liver oil (unnamed) are derived from the livers of one or more species of fish.
`
`2.5 Concentrated fish oils are derived from fish oils described in Sections 2.1 to 2.4 which have been subjected
`to processes that may involve, but are not limited to, hydrolysis, fractionation, winterization and/or re-
`esterification to increase the concentration of specific fatty acids.
`
`2.5.1 Concentrated fish oil contains 35 to 50 w/w % fatty acids as sum of C20:5 (n-3) eicosapentaenoic acid (EPA)
`and C22:6 (n-3) docosahexaenoic acid (DHA).
`
`2.5.2 Highly concentrated fish oil contains more than 50 w/w % fatty acids as sum of EPA and DHA.
`
`2.6 Concentrated fish oils ethyl esters are derived from fish oils described in Section 2.1 to 2.4 and are primarily
`composed of fatty acids ethyl esters.
`
`2.6.1 Concentrated fish oil ethyl esters contain fatty acids as esters of ethanol of which 40 to 60 w/w % are as
`sum of EPA and DHA.
`
`2.6.2 Highly concentrated fish oil ethyl esters contain fatty acids as esters of ethanol of which more than 60
`w/w % are as sum of EPA and DHA.
`
`
`1 Fish: Any of the cold-blooded (ecothermic) aquatic vertebrates. Amphibians and aquatic reptiles are not included. Shellfish:
`Those species of aquatic molluscs and crustaceans that are commonly used for food.
`
`
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`RIMFROST EXHIBIT 1147 Page 0002
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`

`

`CODEX STAN 329-2017
`
`3
`
`3.
`
`ESSENTIAL COMPOSITION AND QUALITY FACTORS
`
`3.1 GLC ranges of fatty acid composition (expressed as percentages of total fatty acids)
`
`Sample of fish oils described in sections 2.1 and 2.3 shall fall within the appropriate ranges specified in Table
`1. Supplementary criteria, for example national geographical and/or climatic variations may be considered, as
`necessary, to confirm that a sample is in compliance with the Standard.
`
`3.2 Other essential compositional criteria
`
`For oil from Engraulis ringens (2.1.1) the sum of EPA and DHA has to be at least 27 % (expressed as
`percentage of total fatty acids).
`
`For krill oils (2.1.3) the content of phospholipids shall be at least 30 w/w %.
`
`Concentrated fish oils (2.5.1) and highly concentrated fish oils (2.5.2) shall contain at least 50 w/w % of fatty
`acids as sum of EPA and DHA in the form of triglycerides and/or phospholipids.
`
`3.3 Quality parameters
`
`Note: this section does not apply to flavoured fish oils where the added flavourings may interfere with the
`analytical determination of oxidation parameters.
`
`3.3.1 Fish oils, fish liver oils, concentrated fish oils, and concentrated fish oils ethyl esters (Section 2.1. to
`2.6) with the exception of oils dealt with in Section 3.3.2 shall comply with the following:
`
`Acid value
`
`
`
`≤ 3 mg KOH/g
`
`Peroxide value
`
`≤ 5 milliequivalent of active oxygen/kg oil
`
`Anisidine value
`
`≤ 20
`
`Total oxidation value (ToTox)2
`
`≤ 26
`
`3.3.2 Fish oils with a high phospholipid concentration of 30% or more such as krill oil (Section 2.1.3) shall
`comply with the following:
`
`Acid value
`
`≤ 45 mg KOH/g
`
`Peroxide value
`
`≤ 5 milliequivalent of active oxygen/kg oil
`
`3.4 Vitamins
`
`Fish liver oils except of deep sea shark liver oil (Sections 2.3 and 2.4) shall comply with following:
`
`Vitamin A
`
`≥ 40 µg of retinol equivalents/ml of oil
`
`Vitamin D
`
`≥ 1.0 µg/ml
`
`Losses during processing may be restored (see Section 2.4. of CAC/GL 9-1987) by the addition of:
`
`Vitamin A and its esters
`
`Vitamin D
`
`Maximum levels for vitamins A and D should be in accordance with the needs of each individual country
`including, where appropriate, the prohibition of the use of particular vitamins.
`
`4.
`
`FOOD ADDITIVES
`
`
`
`Antioxidants, sequestrants, antifoaming agents, and emulsifiers used in accordance with Tables 1 and 2 of the
`General Standard for Food Additives (CODEX STAN 192-1995), in food category 02.1.3 Lard, tallow, fish oil,
`and other animal fats are acceptable for use in foods conforming to this standard.
`
`
`2 Total oxidation value (ToTox) = 2 x Peroxide value + 1 x Anisidine value
`
`Explanatory note: Oxidation of fish oils is a sequential process: following an initial raise of peroxide value, the anisidine value
`rises. The peroxide value is therefore a parameter for primary oxidation products, the anisidine value for secondary oxidation
`products. The parameter ToTox, which means "total oxidation of oil", was established to avoid that both of these oxidation
`products are present at maximum levels. The maximum allowed ToTox value is set separately and lower than the sum of the
`individual possible maximum limits set for peroxide and anisidine values.
`
`
`
`RIMFROST EXHIBIT 1147 Page 0003
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`

`

`CODEX STAN 329-2017
`
`The following additives may be used in addition:
`
`INS
`
`Additive name
`
`Maximum level
`
`4
`
`Antioxidant
`
`300
`
`Ascorbic acid, L-
`
`304, 305
`
`Ascorbyl esters
`
`307a, b, c
`
`Tocopherols
`
`GMP
`
`2500 mg/kg, as ascorbyl stearate
`
`6000 mg/kg, singly or in combination
`
`Emulsifier
`
`322 (i)
`
`471
`
`Lecithin
`
`Mono- and di-glycerides of fatty acids
`
`GMP
`
`GMP
`
`The flavourings used in products covered by this standard should comply with the Guidelines for the Use of
`Flavourings (CAC/GL 66-2008).
`
`5.
`
`CONTAMINANTS
`
`The products covered by this Standard shall comply with the Maximum Levels of the General Standard for
`Contaminants and Toxins in Food and Feed (CODEX STAN 193-1995).
`
`The products covered by this Standard shall comply with the maximum residue limits for pesticides and/or
`veterinary drugs established by the Codex Alimentarius Commission.
`
`6.
`
`HYGIENE
`
`6.1 General hygiene
`
`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 General Principles of Food Hygiene (CAC/RCP 1-1969), the
`Code of Practice for Fish and Fishery Products (CAC/RCP 52-2003), and Code of Hygienic Practice for the
`Storage and Transport of Edible Fats and Oils in Bulk (CAC/RCP 36-1987).
`
`6.2 Microbiological criteria
`
`The products should comply with any microbiological criteria established in accordance with the Principles and
`Guidelines for the Establishment and Application of Microbiological Criteria Related to Foods (CAC/GL 21-
`1997).
`
`7.
`
`LABELLING
`
`The requirements of the General Standard for the Labelling of Prepackaged Foods (CODEX STAN 1-1985)
`and of the Guidelines on Nutrition Labelling (CAC/GL 2-1985) apply to this standard.
`
`7.1 Name of the food
`
`The name of the fish oil shall conform to the descriptions given in Section 2 of this Standard. For salmon oil
`the label shall specify the source of the raw material (wild or farmed).
`
`7.2 Labelling on non-retail containers
`
`Information on the above labelling requirements shall be given either on the container or in accompanying
`documents, except that the name of the food, lot identification and the name and address of the manufacturer
`or packer shall appear on the container.
`
`However, lot identification and the name and address of the manufacturer or packer may be replaced by an
`identification mark, provided that such a mark is clearly identifiable with the accompanying documents.
`
`For crude fish oils and crude fish liver oils the label shall indicate that these oils are intended for human
`consumption only after they have undergone further processing.
`
`7.3 Other labelling requirements
`
`For fish liver oils (Sections 2.3 and 2.4) the content in vitamin A and vitamin D, naturally present or restored,
`shall be given if required by country of retail sale.
`
`For all fish oils covered by this standard the content of EPA and DHA shall be given if required by country of
`retail sale.
`
`
`
`RIMFROST EXHIBIT 1147 Page 0004
`
`

`

`CODEX STAN 329-2017
`
`5
`
`8.
`
`METHODS OF ANALYSIS AND SAMPLING
`
`For checking the compliance with this standard, the methods of analysis and sampling contained in the
`Recommended Methods of Analysis and Sampling (CODEX STAN 234-1999) relevant to the provisions in this
`standard, shall be used
`
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`RIMFROST EXHIBIT 1147 Page 0005
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`

`

`CODEX STAN 329-2017
`
`6
`
`Table 1: Fatty acid (FA) composition of named fish oil and fish liver oil categories as determined by
`gas liquid chromatography from authentic samples (expressed as percentage of total fatty acids) (see
`Section 3.1 of the Standard)
`
`Fatty acids
`
`Anchovy
`(Section
`2.1.1)
`
`Tuna
`(Section
`2.1.2)
`
`Krill
`(Section
`2.1.3)
`
`Menhaden
`(Section
`2.1.4)
`
`Salmon
`(Section 2.1.5)
`
`Wild
`
`Farmed
`
`Cod
`Liver
`(Section
`2.3.1)
`
`C14:0 myristic acid
`
`2.7-11.5
`
`ND-5.0
`
`5.0-13.0
`
`8.0-11.0
`
`2.0-5.0
`
`1.5-5.5
`
`2.0-6.0
`
`C15:0 pentadecanoic
`acid
`
`ND-1.5
`
`ND-2.0
`
`NA
`
`ND-1.0
`
`ND-1.0
`
`ND-0.5
`
`ND-0.5
`
`C16:0 palmitic acid
`
`13.0-22.0 14.0-24.0 17.0-24.6 18.0-20.0
`
`10.0-16.0
`
`6.5-12.0
`
`7.0-14.0
`
`4.0-12.6
`
`ND-12.5
`
`2.5-9.0
`
`9.0-13.0
`
`4.0-6.0
`
`2.0-5.0
`
`4.5-11.5
`
`ND-2.0
`
`ND-3.0
`
`NA
`
`NA
`
`ND-1.0
`
`ND-1.0
`
`ND-0.5
`
`NA
`
`2.5-4.0
`
`2.0-5.0
`
`2.0-5.0
`
`1.0-4.0
`
`C16:1 (n-7) palmitoleic
`acid
`
`C17:0 heptadecanoic
`acid
`
`C18:0 stearic acid
`
`1.0-7.0
`
`ND-7.5
`
`C18:1 (n-7) vaccenic
`acid
`
`1.7-3.7
`
`ND– 7.0
`
`4.7-8.1
`
`2.5-3.5
`
`1.5-2.5
`
`NA
`
`2.0–7.0
`
`C18:1 (n-9) oleic acid
`
`3.6-17.0
`
`10.0-25.0
`
`6.0-14.5
`
`5.5-8.5
`
`8.0-16.0
`
`30.0-47.0 12.0-21.0
`
`C18:2 (n-6) linoleic acid
`
`ND-3.5
`
`ND-3.0
`
`ND-3.0
`
`2.0-3.5
`
`1.5-2.5
`
`8.0-15.0
`
`0.5-3.0
`
`C18:3 (n-3) linolenic
`acid
`
`C18:3 (n-6) γ-linolenic
`acid
`
`ND-7.0
`
`ND-2.0
`
`0.1-4.7
`
`ND-2.0
`
`ND-2.0
`
`3.0-6.0
`
`ND-2.0
`
`ND-5.0
`
`ND-4.0
`
`NA
`
`ND-2.5
`
`ND-2.0
`
`ND-0.5
`
`NA
`
`0.5-4.5
`
`C18:4 (n-3) stearidonic
`acid
`
`ND-5.0
`
`ND-2.0
`
`1.0-8.1
`
`1.5-3.0
`
`1.0-4.0
`
`0.5-1.5
`
`C20:0 arachidic acid
`
`ND-1.8
`
`ND-2.5
`
`C20:1 (n-9) eicosenoic
`acid
`
`C20:1 (n-11) eicosenoic
`acid
`
`C20:4 (n-6) arachidonic
`acid
`
`C20:4 (n-3)
`eicosatetraenoic acid
`
`C20:5 (n-3)
`eicosapentaenoic acid
`
`C21:5 (n-3)
`heneicosapentaenoic
`acid
`
`ND-4.0
`
`ND-2.5
`
`NA
`
`NA
`
`0.1-0.5
`
`ND-0.5
`
`0.1-0.5
`
`NA
`
`ND-0.5
`
`2.0-10.0
`
`1.5-7.0
`
`5.0-17.0
`
`ND-4.0
`
`ND-3.0
`
`NA
`
`0.5-2.0
`
`NA
`
`NA
`
`1.0-5.5
`
`ND-2.5
`
`ND-3.0
`
`NA
`
`ND-2.0
`
`0.5-2.5
`
`ND-1.2
`
`ND-1.5
`
`ND-2.0
`
`ND-1.0
`
`NA
`
`NA
`
`1.0-3.0
`
`0.5-1.0
`
`ND-2.0
`
`5.0-26.0
`
`2.5-9.0
`
`14.3-28.0 12.5-19.0
`
`6.5-11.5
`
`2.0-6.0
`
`7.0-16.0
`
`ND-4.0
`
`ND-1.0
`
`NA
`
`0.5-1.0
`
`ND-4.0
`
`NA
`
`ND-1.5
`
`C22:1 (n-9) erucic acid
`
`ND-2.3
`
`ND-2.0
`
`ND-1.5
`
`0.1-0.5
`
`ND-1.5
`
`3.0-7.0
`
`ND-1.5
`
`C22:1 (n-11) cetoleic
`acid
`
`C22:5 (n-3)
`docosapentaenoic acid
`
`C22:6 (n-3)
`docosahexaenoic acid
`
`ND-5.6
`
`ND-1.0
`
`NA
`
`ND-0.1
`
`1.0-1.5
`
`NA
`
`5.0-12.0
`
`ND-4.0
`
`ND-3.0
`
`ND-0.7
`
`2.0-3.0
`
`1.5-3.0
`
`1.0-2.5
`
`0.5-3.0
`
`4.0-26.5
`
`21.0-42.5
`
`7.1-15.7
`
`5.0-11.5
`
`6.0-14.0
`
`3.0-10.0
`
`6.0-18.0
`
`ND = non-detect, defined as ≤0.05%
`NA = not applicable or available
`
`
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`RIMFROST EXHIBIT 1147 Page 0006
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