규격 · Standard · CXS 1-1985

General Standard for the Labelling of Pre-packaged Foods

채택 1985 · 개정 2018 · 수정 2026

Codex 식품규격 검색 › CXS 1-1985

소관 위원회
식품표시 CCFL
채택
1985
최종 개정
2026
개정
2018
수정
2026
분량
20쪽 · 절 89개
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STANDARD

GENERAL STANDARD FOR THE LABELLING OF PRE-PACKAGED FOODS CXS 1-1985

ADOPTED 1985 CXS 1-1985 AMENDED 2026

History of the standard 2026 Amendments Following decisions taken at the Forty-ninth Session of the Codex Alimentarius Commission in 2026, this standard was revised to update Sections 4.2.2, 4.3.4, and 4.7.1(vii), and Section 8.1.3.1. In addition, an annex on the guidelines on the use of precautionary allergen labelling was added. This publication was reformatted and published in 2026. 2024 Revisions Following decisions taken at the Forty-seventh Session of the Codex Alimentarius Commission in December 2024, this standard was revised to address food allergen labelling through changes/additions to Section 2: “Definition of terms”, Section 6: “Exemptions from mandatory labelling requirements”, Section 8: “Presentation of mandatory information”, and Sections 4.2.1.3, 4.2.1.4, 4.2.3, 4.2.3.1 and 4.2.4.2. Amendments and revisions made prior to 2024: Amended in 1991, 1999, 2001, 2003, 2005, 2008 and 2010. Revised in 2018. Adopted in 1985.

1Scope

This standard applies to the labelling of all pre-packaged foods to be offered as such to the consumer or for catering purposes and to certain aspects relating to the presentation thereof.

2Definition of terms

For the purpose of this standard: Allergenic food means a food (including ingredients, food additives and processing aids) that can elicit immunoglobulin class E (IgE)-mediated or other specific immune-mediated reactions in susceptible individuals. Claim means any representation which states, suggests or implies that a food has particular qualities relating to its origin, nutritional properties, nature, processing, composition or any other quality. Coeliac disease means a chronic immune-mediated intestinal disease in genetically predisposed individuals induced by exposure to dietary gluten proteins that come from wheat, rye, barley and triticale (a cross between wheat and rye). Consumer means persons and families purchasing and receiving food in order to meet their personal needs. Container means any packaging of food for delivery as a single item, whether by completely or partially enclosing the food and includes wrappers. A container may enclose several units or types of packages when such is offered to the consumer. For use in date marking of pre-packaged food: Best-before date or best quality-before date means the date which signifies the end of the period, under any stated storage conditions, during which the unopened product will remain fully marketable and will retain any specific qualities for which implied or express claims have been made. However, beyond the date the food may still be acceptable for consumption. Date of manufacture means the date on which the food becomes the product as described. This is not an indication of the durability of the product. Date of packaging means the date on which the food is placed in the immediate container in which it will be ultimately sold. This is not an indication of the durability of the product. Use-by date or expiration date means the date which signifies the end of the period under any stated storage conditions, after which the product should not be sold or consumed due to safety and quality reasons. Food means any substance, whether processed, semi-processed or raw, which is intended for human consumption, and includes drinks, chewing gum and any substance which has been used in the manufacture, preparation or treatment of food but does not include cosmetics or tobacco or substances used only as drugs. Food additive means any substance not normally consumed as a food by itself and not normally used as a typical ingredient of the food, whether or not it has nutritive value. The intentional addition of which to food for a technological (including organoleptic) purpose in the manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food results, or may be reasonably expected to result, (directly or indirectly) in it or its by-products becoming a component of, or otherwise affecting the characteristics of such foods. The term does not include “contaminants” or substances added to food for maintaining or improving nutritional qualities.

Food allergen means the substance in an allergenic food, usually a protein or protein derivative that can elicit IgE-mediated or other specific immune-mediated reactions in susceptible individuals. Food allergy means a reproducible adverse health effect arising from an IgE antibody or non-IgE antibody immune-mediated response following oral exposure to a food. Foods for catering purposes means those foods for use in restaurants, canteens, schools, hospitals and similar institutions where food is offered for immediate consumption. Ingredient means any substance, including a food additive, used in the manufacture or preparation of a food and present in the final product although possibly in a modified form. Label means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed or impressed on, or attached to, a container of food. Labelling includes any written, printed or graphic matter that is present on the label, accompanies the food, or is displayed near the food, including that for the purpose of promoting its sale or disposal. Lot means a definitive quantity of a commodity produced essentially under the same conditions. Pre-packaged means packaged or made up in advance in a container, ready for offer to the consumer, or for catering purposes. Processing aid means a substance or material, not including apparatus or utensils, and not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients, to fulfil a certain technological purpose during treatment or processing and which may result in the nonintentional but unavoidable presence of residues or derivatives in the final product.

3General principles

3.1

Pre-packaged food shall not be described or presented on any label or in any labelling in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character in any respect.i

3.2

Pre-packaged food shall not be described or presented on any label or in any labelling by words, pictorial or other devices which refer to or are suggestive either directly or indirectly, of any other product with which such food might be confused, or in such a manner as to lead the purchaser or consumer to suppose that the food is connected with such other product.

4Mandatory labelling of pre-packaged foods

The following information shall appear on the label of pre-packaged foods as applicable to the food being labelled, except to the extent otherwise expressly provided in an individual Codex standard:

4.1Name of the food

4.1.1

The name shall indicate the true nature of the food and normally be specific and not generic:

4.1.1.1

Where a name or names have been established for a food in a Codex standard, at least one of these names shall be used.

i Examples of descriptions or presentations to which these general principles refer are given in the General guidelines on claims (CXG 1-1979).

4.1.1.2

In other cases, the name prescribed by national legislation shall be used.

4.1.1.3

In the absence of any such name, either a common or usual name existing by common usage as an appropriate descriptive term which was not misleading or confusing to the consumer shall be used. 4.1.1.4 A “coined”, “fanciful”, “brand” name or “trade mark” may be used provided it accompanies one of the names provided in sections 4.1.1.1 to 4.1.1.3.

4.1.2

There shall appear on the label either in conjunction with, or in close proximity to, the name of the food, such additional words or phrases as necessary to avoid misleading or confusing the consumer in regard to the true nature and physical condition of the food including but not limited to the type of packing medium, style, and the condition or type of treatment it has undergone; for example: dried, concentrated, reconstituted, smoked.

4.2List of ingredients

4.2.1

Except for single ingredient foods, a list of ingredients shall be declared on the label.

4.2.1.1

The list of ingredients shall be headed or preceded by an appropriate title which consists of or includes the term “ingredient”.

4.2.1.2

All ingredients shall be listed in descending order of ingoing weight (m/m) at the time of the manufacture of the food.

4.2.1.3

Where an ingredient is itself the product of two or more ingredients, such a compound ingredient may be declared, as such, in the list of ingredients, provided that it is immediately accompanied by a list, in brackets, of its ingredients in descending order of proportion (m/m). Where a compound ingredient (for which a name has been established in a Codex standard or in national legislation) constitutes less than

5percent of the food, the ingredients need not be declared, except for the foods and ingredients listed in Section 4.2.1.4, Section 4.2.1.7 and, where applicable, Section 4.2.1.5 and food additives which serve a technological function in the finished product, need not be declared.

4.2.1.4

The following foods and ingredients are known to trigger food allergy or coeliac disease and shall always be declared as allergenic foods using the specified name in addition to or as part of the ingredient name,ii when intentionally present in the food:

Foods and ingredients                                                           Specified name

Cereals containing glutena
− wheat and other Triticum species                                              Wheat
− rye and other Secale species                                                  Rye
− barley and other Hordeum species and products thereofb                        Barley

Crustacea and products thereof                                                  Crustacea

Eggs and products thereof                                                       Egg

Fish and products thereof                                                       Fish

Peanuts and products thereof                                                    Peanut

Milk and products thereof                                                       Milk

Sesame and products thereof                                                     Sesame

Specific tree nuts
− almond (Prunus amygdalus)                                                     Almond
− cashew (Anacardium occidentale)                                               Cashew
− hazelnut (Corylus spp.)                                                       Hazelnut
− pecan (Carya illinoinensis)                                                   Pecan
− pistachio (Pistacia vera)                                                     Pistachio
− walnut (Juglans spp.) and products thereof                                    Walnut

Notes: a Includes spelt, Khorasan, and other specific cereals containing gluten that are species or hybridized strains under the genus names of Triticum, Secale and Hordeum. Specified names are to be used according to the associated genus. Hybridized strains are to use specified names in conjunction with all of the parent genera (e.g. wheat and rye for triticale). b In addition to the specified name of wheat, rye, and barley, the word “gluten” may be used.

ii In accordance with Section 4.1.1, the ingredient declaration should specify the true nature of the food and be specific and not generic.

4.2.1.5

In addition to the foods and ingredients listed in Section 4.2.1.4, the declaration of any other foods and ingredients as allergenic foods, including those listed below, may also be required,iii using a specified name in addition to or as part of the ingredient name.iv This shall be based on available risk assessment data for the respective population(s),v taking into account risk management considerations.

Foods and ingredients                                                          Specified name

Buckwheat and products thereof                                                 Buckwheat

Celery and products thereof                                                    Celery

Oats and other Avena species (and their hybridized strains) and                Oats
products thereof*

Lupin and products thereof                                                     Lupin

Mustard and products thereof                                                   Mustard

Soybean and products thereof                                                   Soy

Specific tree nuts
− Brazil nut (Bertholletia excelsa)                                            Brazil nut
− Macadamia (Macadamia spp.)                                                   Macadamia
− Pine nut (Pinus spp.) and products thereof                                   Pine nut

Note:

-Oats can be tolerated by most but not all people who are intolerant to gluten. Therefore, the allowance of oats that are not contaminated with wheat, rye or barley in foods covered by this standard may be determined at the national level.

4.2.1.6

Regional or national competent authorities may exempt ingredients derived from foods listed in Section 4.2.1.4, and where applicable Section 4.2.1.5, from being declared as allergenic foods. Such exemptions shall be subject to a risk assessment to establish the safety of the allergenic food derivative.vi

4.2.1.7

Sulphite when present in concentrations of 10 mg/kg or more in a food,vii shall always be declared using the specified name “sulphite” or “sulfite” in addition to or as part of the ingredient name.

4.2.1.8

Added water shall be declared in the list of ingredients except when the water forms part of an ingredient such as brine, syrup or broth used in a compound food and declared as such in the list of ingredients. Water or other volatile ingredients evaporated in the course of manufacture need not be declared.

4.2.1.9

As an alternative to the general provisions of this section, dehydrated or condensed foods which are intended to be reconstituted by the addition of water only, the ingredients may be listed in order of proportion (m/m) in the reconstituted product provided that a statement such as “ingredients of the product when prepared in accordance with the directions on the label” is included.

4.2.2

For pre-packaged foods subject to Section 8.1.3.1, where the information is provided on the outer packaging, either separate lists of ingredients for each type of individually packaged food that makes up the container, or a combined list of ingredients shall be declared, as appropriate to the nature of the food such as whether the individually packaged foods are intended to be consumed separately or together.

iii These foods and ingredients are not included in Section 4.2.1.4 but have been recommended to be considered for risk management at the regional or national level (see FAO and WHO Risk assessment of food allergens: Part 1: Review and validation of Codex Alimentarius priority allergen list through risk assessment https://doi.org/10.4060/cb9070en). iv In accordance with Section 4.1.1, the ingredient declaration should specify the true nature of the food and be specific and not generic. v The assessment of risk in the respective population(s) to be based on the evidence criteria of prevalence, potency and severity of immune-mediated adverse reactions to the food or ingredient as established by FAO and WHO Risk assessment of food allergens: Part 1: Review and validation of Codex Alimentarius priority allergen list through risk assessment. https://doi.org/10.4060/cb9070en vi For example, FAO and WHO (2024). Risk assessment of food allergens: Part 4: Establishing exemptions from mandatory declaration for priority food allergens https://doi.org/10.4060/cc9554en vii Sulphite measured on a sulphur dioxide (SO2) equivalents basis.

4.2.3

The presence in any food or food ingredients obtained through biotechnology of a food allergen transferred from any of the foods and ingredients listed in Section 4.2.1.4 and where applicable Section 4.2.1.5 shall be declared. When it is not possible to provide adequate information on the presence of these food allergens through labelling, the food containing the allergen should not be marketed.

4.2.4

Foods and ingredients as listed in Section 4.2.1.4, Section 4.2.1.7 and where applicable Section 4.2.1.5 must be declared using the specified name in addition to or as part of the ingredient name. All ingredients in the list of ingredients shall be declared in accordance with the provisions set out in Section 4.1: “Name of the food” except that:

4.2.4.1

Unless a general class name would be more informative, the following class names may be used. When a class name is used, for the foods and ingredients listed in Section 4.2.1.4, Section 4.2.1.7 and, where applicable, Section 4.2.1.5, the specified name shall be declared in addition to or as part of the class name.

Name of classes                                                    Class names

Refined oils other than olive “Oil” together with either the term “vegetable” or “animal”, qualified by the term “hydrogenated” or “partially hydrogenated”, as appropriate

Refined fats                                                       “Fat” together with either the term “vegetable” or “animal”, as
                                                                   appropriate

Starches, other than chemically modified starches                  Starch

All species of fish where the fish constitutes an ingredient of Fish another food and provided that the labelling and presentation of such food does not refer to a specific species of fish

All types of poultry meat where such meat constitutes an Poultry meat ingredient of another food and provided that the labelling and presentation of such a food does not refer to a specific type of poultry meat

All types of cheese where the cheese or mixture of cheeses Cheese constitutes an ingredient of another food and provided that the labelling and presentation of such food does not refer to a specific type of cheese

All spices and spice extracts not exceeding 2% by weight either “Spice”, “spices”, or “mixed spices”, as appropriate singly or in combination in the food

All herbs or parts of herbs not exceeding 2% by weight either      “Herbs” or “mixed herbs”, as appropriate
singly or in combination in the food

All types of gum preparations used in the manufacture of gum       Gum base
base for chewing gum

All types of sucrose                                               Sugar

Anhydrous dextrose and dextrose monohydrate                        “Dextrose” or “glucose”

All types of caseinates                                            Caseinates

Milk products containing a minimum of 50% of milk protein          Milk protein
(m/m) in dry matter*

Name of classes                                                       Class names

Press, expeller or refined cocoa butter                               Cocoa butter

All crystallized fruit not exceeding 10% of the weight of the food Crystallized fruit

Note:

*Calculation of milk protein content: Kjeldahl nitrogen × 6.38.

4.2.4.2

Notwithstanding the provision set out in Section 4.2.3.1, pork fat, lard and beef fat shall always be declared by their specific names.

4.2.4.3

For food additives falling in the respective classes and appearing in lists of food additives permitted for use in foods, the following functional classes shall be used together with the specific name or recognized numerical identification such as the Class names and the international numbering system for food additives (CXG 361-989) as required by national legislation.

• Acidity regulator                                                  • Flour treatment agent

• Anticaking agent                                                   • Foaming agent

• Antifoaming agent                                                  • Gelling agent

• Antioxidant                                                        • Glazing agent

• Bleaching agent                                                    • Humectant

• Bulking agent                                                      • Preservative

• Carbonating agent                                                  • Propellant

• Colour                                                             • Raising agent

• Colour retention agent                                             • Sequestrant

• Emulsifier                                                         • Stabilizer

• Emulsifying salt                                                   • Sweetener

• Firming agent                                                      • Thickener

•Flavour enhancer

4.2.4.4

The following class titles may be used for food additives falling in the respective classes and appearing in lists of food additives permitted generally for use in foods:

• Flavour(s) and flavouring(s)                     • Modified starch(es)

The expression “flavours” may be qualified by “natural”, “nature identical”, “artificial” or a combination of these words as appropriate.

4.2.5Processing aids and carry-over of food additives

4.2.5.1

A food additive carried over into a food in a significant quantity or in an amount sufficient to perform a technological function in that food as a result of the use of raw materials or other ingredients in which the additive was used shall be included in the list of ingredients.

4.2.5.2

A food additive carried over into foods at a level less than that required to achieve a technological function, and processing aids, are exempted from declaration in the list of ingredients. The exemption does not apply to food additives and processing aids that contain the foods and ingredients listed in Section 4.2.1.4, and where applicable Section 4.2.1.5, and subject to Section 4.2.1.6.

4.3Net contents and drained weight

4.3.1

The net contents shall be declared in the metric system (“système international” units).viii

4.3.2

The net contents shall be declared in the following manner:

i)for liquid foods, by volume;

ii)or solid foods, by weight; and

iii)for semi-solid or viscous foods, either by weight or volume.

4.3.3

In addition to the declaration of net contents, a food packed in a liquid medium shall carry a declaration in the metric system of the drained weight of the food. For the purposes of this requirement, liquid medium means water, aqueous solutions of sugar and salt, fruit and vegetable juices in canned fruits and vegetables only, or vinegar, either singly or in combination.ix

4.3.4

For pre-packaged foods that are subject to Section 8.1.3.1, where the information is required to be provided on the outer packaging, or where the number of individually packaged foods in the container cannot be easily counted, the net contents shall be declared on the outer packaging by indicating: the total net contents of the pre-packaged food sold as a single unit; and/or the number of individually packaged foods per type and their respective net contents.

4.4Name and address

The name and address of the manufacturer, packer, distributor, importer, exporter or vendor of the food shall be declared.

4.5Country of origin

4.5.1

The country of origin of the food shall be declared if its omission would mislead or deceive the consumer.

4.5.2

When a food undergoes processing in a second country which changes its nature, the country in which the processing is performed shall be considered to be the country of origin for the purposes of labelling.

4.6Lot identification

Each container shall be embossed or otherwise permanently marked in code or in a clear manner to identify the producing factory and the lot.

4.7Date marking and storage instructions

4.7.1

If not otherwise determined in an individual Codex standard, the following date marking shall apply, unless Section 4.7.1(vii) applies:

viii The declaration of net contents represents the quantity at the time of packaging and is subject to enforcement by reference to an average system of quantity control. ix The declaration of drained weight is subject to enforcement by reference to an average system of quantity control.

i)When a food must be consumed before a certain date to ensure its safety and quality the “Useby date” or “Expiration date” shall be declared.x

ii)Where a “Use-by date” or “Expiration date” is not required, the “Best-before date” or “Best qualitybefore date” shall be declared.

iii)The date marking should be as follows:

•on products with a durability of not more than three months, the day and month shall be declared and in addition, the year when competent authorities consider consumers could be misled; and

•on products with a durability of more than three months at least the month and year shall be declared.

iv)The date shall be introduced by the words:

•“Use-by <insert date>” or “Expiration date <insert date>” or “Best before <insert date>” or “Best Quality-Before <insert date>” as applicable where the day is indicated; or

•“Use-by end <insert date>” or “Expiration date end <insert date>” or “Best before end <insert date>” or “Best quality-before end <insert date>” as applicable in other cases.

v)The words referred to in paragraph (iv) shall be accompanied by:

•either the date itself; or

•a reference to where the date is given.

vi)The day and year shall be declared by uncoded numbers with the year to be denoted by 2 or 4 digits, and the month shall be declared by letters or characters or numbers. Where only numbers are used to declare the date or where the year is expressed as only two digits, the competent authority should determine whether to require the sequence of the day, month, year, be given by appropriate abbreviations accompanying the date mark (e.g. DD/MM/YYYY or YYYY/DD/MM).

vii)For pre-packaged foods subject to Section 8.1.3.1, where the information is provided on the outer packaging, at least the earliest best-before date, best quality-before date, use-by date, or expiration date shall be declared. If the individually packaged foods have more than one type of date marking, the earliest date of the foods that fall under Section 4.7.1(i) must be declared.

viii)Provided that food safety is not compromised, the provision in Section 4.7.1(i) or Section 4.7.1(ii) is not required for a food if one or more of the following criteria apply:

1.where safety is not compromised, and quality does not deteriorate because the nature of the food is such that it cannot support microbial growth (e.g. alcohol, salt, acidity, lowwater activity) under intended or stated storage conditions;

2.where deterioration is clearly evident by physical examination at the point of purchase, such as raw fresh produce that has not been subject to processing and presented in a manner that is visible to the consumer;

3.where the key/organoleptic quality aspects of the food are not lost;

x Consideration should be given to other Codex texts.

4.where the food by its nature is normally consumed within 24 hours of its manufacture, such as some bakers’ or pastry-cooks’ wares:

For example, foods such as:xi

•fresh fruits and vegetables, including tubers, which have not been peeled, cut or similarly treated;

•wines, liqueur wines, sparkling wines, aromatized wines, fruit wines and sparkling fruit wines;

•alcoholic beverages containing at least 10 percent alcohol by volume;

•bakers’ or pastry-cooks’ wares, which given the nature of their content, are normally consumed within 24 hours of their manufacture;

•vinegar;

•non-iodized food grade salt;

•non-fortified solid sugars;

•confectionary products consisting of flavoured and/or coloured sugars; and

•chewing gum. In such cases, the “date of manufacture” or the “date of packaging” may be provided.

ix)A “date of manufacture” or a “date of packaging” may be used in combination with Section 4.7.1(i) or Section 4.7.1(ii). It shall be introduced with the words “date of manufacture” or “date of packaging”, as appropriate, and use the format provided in Section 4.7.1(vi).

4.7.2

Any special conditions for the storage of the food shall be declared on the label where they are required to support the integrity of the food and, where a date mark is used, the validity of the date depends thereon.

4.8Instructions for use

Instructions for use, including reconstitution, where applicable, shall be included on the label, as necessary, to ensure correct utilization of the food.

5Additional mandatory requirements

5.1Quantitative ingredients declaration

5.1.1

The ingoing percentage of an ingredient (including compound ingredients,xii or categories of ingredients),xiii by weight or volume as appropriate, at the time of manufacture, shall be disclosed for foods sold as a mixture or combination where the ingredient:

a)is emphasized as present on the label through words or pictures or graphics; or

b)is not within the name of the food, is essential to characterize the food and is expected to be present in the food by consumers in the country where the food is sold if the omission of the quantitative ingredient declaration would mislead or deceive the consumer.

xi This is an illustrative list. xii For compound ingredients the ingoing percentage means the ingoing percentage of the compound ingredient as a whole. xiii For the purposes of quantitative ingredient declaration, “category of ingredients” means the generic term which refers to the class name of an ingredient and/or any similar common term(s) which are used in reference to the name of a food.

Such disclosure is not required:

c)where the ingredient is used in small quantities for the purpose of flavouring; or

d)where commodity-specific standards of Codex Alimentarius conflict with the requirements described here.

With respect to Section 5.1.1(a):

e)a reference in the name of the food to an ingredient or category of ingredients shall not of itself require quantitative ingredient declaration if:

•that reference would not mislead or deceive or would not be likely to create an erroneous impression to the consumer regarding the character of the food in the country of marketing because the variation in quantity of the ingredient(s) between products is not necessary to characterize the food or distinguish it from similar foods.

5.1.2

The information required in Section 5.1.1 shall be declared on the product label as a numerical percentage. The ingoing percentage, by weight or volume as appropriate, of each such ingredient shall be given on the label in close proximity to the words or pictures or graphics emphasizing the particular ingredient, or beside the name of the food, or adjacent to each appropriate ingredient listed in the ingredient list as a minimum percentage where emphasis is on the presence of the ingredient and a maximum percentage where emphasis is on the low level of the ingredient. For foodstuffs which have lost moisture following heat or other treatment, the percentage (by weight or by volume) shall correspond to the quantity of the ingredient(s) used, related to the finished product. When the quantity of an ingredient or the total quantity of all ingredients expressed on the labelling exceeds 100 percent, the percentage may be replaced by the declaration of the weight of the ingredient(s) used to prepare 100 g of finished product.

5.2Irradiated foods

5.2.1

The label of a food which has been treated with ionizing radiation shall carry a written statement indicating that treatment in close proximity to the name of the food. The use of the international food irradiation symbol, as shown below, is optional, but when it is used, it shall be in close proximity to the name of the food.

5.2.2

When an irradiated product is used as an ingredient in another food, this shall be so declared in the list of ingredients.

5.2.3

When a single ingredient product is prepared from a raw material which has been irradiated, the label of the product shall contain a statement indicating the treatment.

6Exemptions from mandatory labelling requirements

With the exception of spices and herbs, small units, where the largest surface area is less than 10 cm², may be exempted from the requirements of Section 4.2: “List of ingredients”, Section 4.6: “Lot identification”, Section 4.7: “Date marking and storage instructions” and Section 4.8: “Instructions for use”. This exemption does not apply to the declaration of foods and ingredients listed in Section 4.2.1.4, Section 4.2.1.7 and where applicable Section 4.2.1.5.

7Optional labelling

7.1

Any information or pictorial device written, printed, or graphic matter may be displayed in labelling provided that it is not in conflict with the mandatory requirements of this standard and those relating to claims and deception given in Section 3: “General principles”.

7.2

If grade designations are used, they shall be readily understandable and not be misleading or deceptive in any way.

8Presentation of mandatory information

8.1General

8.1.1Labels for pre-packaged foods shall be applied in such a manner that they will not become separated from the container.

8.1.2Statements required to appear on the label by virtue of this standard or any other Codex standards shall be clear, prominent, indelible and readily legible by the consumer under normal conditions of purchase and use.

8.1.3Where the container is covered by a wrapper, the wrapper shall carry the necessary information or the label on the container shall be readily legible through the outer wrapper or not obscured by it.

8.1.3.1A container of pre-packaged food that is sold as a single unit and consists of more than one identical or different individually packaged foods, whether intended to be consumed together or separately, shall include on the outer packaging the mandatory labelling information for that container, as set out in Section 4: “Mandatory labelling of pre‑packaged foods” and Section 5: “Additional mandatory requirements”, unless the mandatory labelling information is readily legible and discernible on at least one of each type of the individually packaged foods that make up the container.

8.1.4The name and net contents of the food shall appear in a prominent position and in the same field of vision.

8.2Language

8.2.1

If the language on the original label is not acceptable to the consumer for whom it is intended, a supplementary label containing the mandatory information in the required language may be used instead of relabelling.

8.2.2

In the case of either relabelling or a supplementary label, the mandatory information provided shall be fully and accurately reflect that in the original label.

8.3Declaration of certain foods and ingredients

8.3.1

The specified name for the foods and ingredients listed in Section 4.2.1.4, Section 4.2.1.7, and where applicable Section 4.2.1.5, shall be declared in a clear and distinct manner such as through the use of font type, style or colour that contrasts from the surrounding text.

8.3.2

The specified name for the foods and ingredients in Section 4.2.1.4 , Section 4.2.1.7, and where applicable Section 4.2.1.5 , shall be declared in the list of ingredients or in a separate statement or in both as determined by the competent authority.

8.3.2.1

If used, the separate statement shall commence with the word “contains” (or equivalent word) and be placed directly under or in close proximity to the list of ingredients when present.

8.3.2.2

If a separate statement is used on the label, the specified name for each of the foods and ingredients in Section 4.2.1.4, Section 4.2.1.7, and where applicable, Section 4.2.1.5, must be declared in the statement even if that specified name is already shown in the list of ingredients.

8.3.3

Where a food is exempt from declaring a list of ingredients, and no list of ingredients is present, the specified names of the foods and ingredients listed in Section 4.2.1.4, Section 4.2.1.7, and where applicable Section 4.2.1.5, shall be declared in a separate statement made in accordance with Section 8.3.2.1.

8.3.4

For single ingredient foods, Section 8.3.3 does not apply where the specified names of the foods and ingredients listed in Section 4.2.1.4, Section 4.2.1.7, and where applicable Section 4.2.1.5, are declared as part of, or in conjunction with, the name of the food.

ANNEXAnnex

Guidelines on the use of precautionary allergen labelling

1Purpose

To facilitate a consistent and harmonized approach to the effective use of precautionary allergen labelling (PAL) for communicating to consumers with food allergy or coeliac disease about the risk from the unintended presence of a food allergen(s) due to cross-contacti with allergenic food(s).

2Scope

These guidelines apply to PAL when used in the labelling of pre-packaged foods to indicate the risk from the unintended presence of a food allergen(s) caused by cross-contact with allergenic food(s).

3Definitions

For the purpose of these guidelines, the following definition shall be used in conjunction with the definitions in Section 2 of the General standard for the labelling of pre-packaged foods (CXS 1-1985):2 “Precautionary allergen labelling” is a statement made in the labelling of pre-packaged foods to indicate a risk from the unintended presence of a food allergen(s) due to cross-contact with an allergenic food(s) that has been identified by a risk assessment.

4General principles

4.1

Effective food allergen management practices, including controls to prevent or minimize the unintended presence of a food allergen(s) caused by cross-contact with allergenic foods, shall be implemented in accordance with the Code of practice on allergen management for food business operators (CXC 80-2020).3 The use of PAL shall be restricted to those situations in which the unintended presence of a food allergen(s) cannot be prevented or controlled using these allergen management practices.

4.2The decision to use PAL should be based on the findings of a risk assessment, which begins with ii,4,5

qualitative risk assessment and may be supplemented with quantitative risk assessment of unintended food allergen presence.

4.3

PAL shall be used when, following the application of appropriate mitigation measures, it is demonstrated that unintended presence of a food allergen(s) is above the action leveliii for the allergenic food based on the reference doses in Table A1 for IgE-mediated food allergy and Table A2 for coeliac disease. PAL should not be used when unintended presence of a food allergen(s) is at or below the action level.

i Allergen cross-contact as defined in Code of practice on allergen management for food business operators (CXC 80-2020).

See FAO and WHO parts 3 and 6 of the Risk assessment of food allergens (Sections 3.3.1 to 3.3.6 provide guidance for the risk assessment of unintended food ii

allergen presence).

Action level (mg total protein from the allergenic food / kg food) = Reference dose (mg total protein from the allergenic food) / amount of the food iii

consumed (kg). The amount of food consumed should be established based on the quantity that can reasonably be expected to be consumed on a single

14eating occasion preferably using the 50th percentile.

Table A1: Reference doses for allergenic foods relevant to IgE-mediated food allergy risk analysis

Allergenic food                                    Reference dose (RfD)
(IgE-mediated food allergy)                        (mg total protein from the allergenic food(s))

Almond                                             1.0

Brazil nut                                         1.0

Cashew                                             1.0

Pistachio                                          1.0

Macadamia                                          1.0

Pine nut                                           1.0

Walnut                                             1.0

Pecan                                              1.0

Celery                                             1.0

Mustard                                            1.0

Peanut                                             2.0

Egg                                                2.0

Milk                                               2.0

Sesame                                             2.0

Hazelnut                                           3.0

Wheat                                              5.0

Fish                                               5.0

Buckwheat                                          10.0

Lupin                                              10.0
Soy                                                10.0

Crustacea                                          200.0

Table A2 Reference dose for gluten relevant to coeliac disease risk analysis

Allergenic food(s)                                                        Reference dose (RfD)
(Coeliac disease)                                                         (mg of total gluten from all relevant sources)

Cereals containing gluten: * 4.0 − wheat and other Triticum species − rye and other Secale species − barley and other Hordeum species and products thereof†

*Oats have been listed in the General standard for the labelling of pre-packaged foods (CXS 1-1985) as an allergenic food (Section 4.2.1.5 within Section 4.2: “List of ingredients”). However, no specific RfD for gluten has been established for oats because individuals with coeliac disease may react to the ingestion of oats due to either wheat, barley or rye cross-contact.

† Includes spelt, Khorasan, and other specific cereals containing gluten that are species or hybridized strains under the genus names of Triticum, Secale and Hordeum.

4.3.1

Where a reference dose is not established for a particular allergenic food in the Table A1 above, regional/ national competent authorities can establish a reference dose consistent with recognized principles for the purposes of determining an action level.

4.3.2

If a PAL statement for cereal(s) containing gluten (wheat, barley, and rye) is necessary, then the term “gluten-free” shall not be used.iv

4.4

PAL shall be complemented by effective education and information programs supported by competent authorities to promote appropriate use of PAL by food business operators and proper understanding by consumers, health care providers and other stakeholders.

5Presentation of PAL

5.1

Sections 8.1.1, 8.1.2, and 8.1.3 and 8.2: “Language” of the General standard for the labelling of prepackaged foods (CXS 1-1985) apply to PAL labelling.

5.2

PAL shall appear as a separate statement directly under or in close proximity to the ingredient list (when present).

5.2.1

Where a food is exempt from declaring a list of ingredients, and no list of ingredients is present, PAL shall be declared in a prominent position on the label. Where a separate statement made in accordance with Section

8.3.2.1of the General standard for the labelling of pre-packaged foods (CXS 1-1985) exists on the label, the PAL statement should appear directly under or in close proximity to the separate statement.

5.2.2

A PAL statement shall commence with the words “may contain” (or equivalent words such as “may be present”, as determined by the competent authorities) and declare the allergenic food(s) using the specified names for the foods and ingredients as listed in Section 4.2.1.4 and, where applicable, Section 4.2.1.5 of the General Standard for the labelling of pre-packaged foods (CXS 1-1985).

5.2.3

When gluten is present above the action level and the source of the gluten cannot be verified by risk assessment, the specified names of all cereals containing gluten (i.e. wheat, barley, and rye) shall be included in the PAL statement.v

5.2.4

A PAL statement shall be declared in a clear and distinct manner such as through the same font type, style or colour that contrast from the surrounding text in accordance with Section 8.3.1 of the General Standard for the labelling of pre-packaged foods (CXS 1-1985). Where both a PAL statement and an allergen declaration are present, these shall be declared using the same clear and distinct manner.

iv "Gluten-free” foods as defined in the Standard for foods for special dietary use for persons intolerant to gluten (CXS 118-1979). v In addition to the specified name of wheat, barley, and rye, the word “gluten” may be used. Where permitted, the words “cereals containing gluten” or “gluten” may be used in place of the specified names barley and rye.

REFERENCED TEXTS

1Class names and the international numbering system for food additives (CXG 36-1989).

2General standard for the labelling of pre-packaged foods (CXS 1-1985).

3Code of practice on allergen management for food business operators (CXC 80-2020).

4FAO and WHO. 2023. Risk assessment of food allergens – Part 3: Review and establish precautionary labelling in foods of the priority allergens, Meeting report. Food Safety and Quality Series No. 16. Rome. https://doi.org/10.4060/cc6081en

5FAO and WHO. Forthcoming. Risk assessment of food allergens – Part 6: Guidance for risk assessment.

6FAO and WHO. 2022. Risk assessment of food allergens – Part 2: Review and establish threshold levels in foods of the priority allergens. https://doi.org/10.4060/cc2946en.

Codex Alimentarius

A collection of international food standards developed to protect consumer health and ensure fair practices in the food trade. Codex standards are adopted by the Codex Alimentarius Commission, an intergovernmental body with 189 Members, established by FAO and WHO. The standards are recognized by the World Trade Organization as the benchmark for the safety of internationally traded food.

Codex Secretariat Contacts

codex@fao.org codexalimentarius.org x.com/FAOWHOCodex youtube.com/@UNFAO

Food and Agriculture Organization of the United Nations Rome, Italy

FAO and WHO. 2026. General standard for the labelling of pre-packaged foods. Codex Alimentarius Standard, No. CXS 1-1985. Codex Alimentarius Commission. Rome. https://openknowledge.fao.org/handle/20.500.14283/ce0073en

The designations employed and the presentation of material in this information product do not imply the expression of any opinion whatsoever on the part of the Food and Agriculture Organization of the United Nations (FAO) or the World Health © FAO and WHO, 2026

Organization (WHO) concerning the legal or development status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.

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