International Standards

The Codex Alimentarius, or “Food Code,” is a list of standards and guidelines adopted by the Codex Alimentarius Commission (CAC), part of the Joint Food and Agricultural Organization of the United Nations (FAO)/World Health Organization (WHO) Food Standards Programme constructed to protect consumer health and promote fair food trade practices. The complete list of standards is available for download at the following web page: https://www.fao.org/fao-who-codexalimentarius/codex-texts/list-standards/en/. The General Standard for the Labeling of Prepackaged Foods is a standard established by the Codex Alimentarius and requires that the following be declared on prepackaged foods: name of the food, list of ingredients, name and address of the manufacturer, exporter, importer, packer, distributor or vendor, country of origin, lot identification, and instructions for use [8]. Per the General Standard for the Labelling of Prepackaged Foods, the name of the food should not be misleading. It should state the true nature of the food and be specific. Apart from single-ingredient products, all ingredients should be listed. Paragraph 4.2.1.1 of the General Standard for the Labelling of Prepackaged Foods also states that the term “Ingredient” should be used before the list of ingredients is declared. The ingredients in the ingredient list shall be listed in order of descending weight. When a product has compound ingredients, the ingredients within the compound ingredient shall be immediately declared in brackets [8].

Paragraph 4.2.1.4 also recognizes the following ingredients as allergens and requires them to be declared at all times: “cereals containing gluten; i.e., wheat, rye, barley, oats, spelt or their hybridized strains and products of these; crustacea and products of these; egg and egg products; fish and fish products; peanuts, soybeans, and products of these; milk and milk products (lactose included); tree nuts and tree nut products; and sulphites in concentrations of 10 mg/kg of food or more.” Furthermore, paragraph 4.2.2 of the General Standard for the Labelling of Prepackaged Foods also states that “if it is not possible to provide adequate information on the presence of an allergen through labeling, the product containing the allergen should not be marketed” [8].

Paragraph 4.6 of the document requires that the lot identification information be declared. Paragraph 4.7 requires date marking and storage instructions, providing manufacturers with details on how to specify a product’s expiration date [8]. Paragraph 4.8 lists how the instructions for the use of the product should be declared if necessary [8]. The document states the following regarding exceptions to mandatory allergen labeling: “With the exception of spices and herbs, small units, where the largest surface area is less than 10cm [2], may be exempted from the requirements of paragraph 4.2 and 4.6 to 4.8” [8]. As of March 2022, the Codex Alimentarius Commission consists of 188 Member Countries and 1 Member Organization (The European Union) (Table 1). Despite these guidelines and regulations, each nation’s respective laws vary.

Table 1 Members of the Codus Alimentarius CommissionNorth America Food Labeling Laws in the U.S.

A 2019 study found that at least 1 in 10 adults are food allergic in the United States (U.S.) [9]. As of 2018, the U.S. Food and Drug Administration (FDA) estimates that about 30,000 Americans are sent to the emergency room because of allergies; 150 die from allergic reactions to food [10]. The FDA is the major U.S. government organization regulating nutrition and allergen information on food products, cosmetics, and drugs. In 1999, research conducted by the FDA on the effects of food allergens in businesses found that in a random selection of sweets, goods, and candies in Wisconsin and Minnesota, 25% of the randomly selected products failed to list peanuts or eggs as allergens on the food labels [10].

The U.S. Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) which identifies eight major food allergens: milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. While Crustacean shellfish are recognized as a major food allergen (such as crab, lobster, or shrimp), molluscan shellfish (such as oysters, clams, mussels, or scallops) are not [11]. While more than 160 foods have been identified to cause food allergies in the U.S., these eight major allergens account for ninety percent of documented food allergies in the U.S. [10]. On April 23, 2021, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act declared sesame as the ninth major food allergen. The law will become effective on January 1, 2023 [12]. If a product has tree nuts as one of the ingredients, the specific type of nut must be listed. For example, rather than only writing “tree nut,” a manufacturer must write whichever type of nut may be in the product, such as “almond” or “pecan.” The same policy applies to Crustacean shellfish and fish, for which the species must be declared [12].

The U.S. currently requires that companies and manufacturers list their ingredients clearly on packaging (Fig. 1). According to a 2013 Food Labeling Guide published by the FDA, the labeling must be easy to read for consumers [13]. The sizing of the letters is based on the letter “o,” and the letters must be 1/16th of an inch, at the minimum. The height of the letters cannot be more than three times their width. Furthermore, the labeling must not be blocked or crowded with artwork or labeling that is unnecessary. The ingredients are to be listed in descending order of prevalence by weight. Therefore, the ingredient that weighs the most must be listed in the beginning, while the ingredient that weighs the least must be listed towards the end. If a product has an ingredient that consists of other ingredients, the “subingredients,” as the FDA refers to them, must be listed parenthetically. Subingredients can also be listed by “dispersing each ingredient in its order of predominance,” but the original ingredient cannot be listed again [13].

Fig. 1

U.S. food allergen labeling showing ingredients in decreasing order of amount and allergen labeling of a U.S. food product, provided by author LE

The 2002 and 2008 Farm Bills and the 2016 Consolidated Appropriations Act, which amended the Agricultural Marketing Act of 1946, require retailers to “inform consumers of the country of origin of muscle cuts and ground lamb, chicken, goat, wild and farm-raised fish and shellfish, perishable agricultural commodities, peanuts, pecans, ginseng, and macadamia nuts” [14]. The Perishable Commodities Act of 1930 (PACA) defines “retailers” include any person who sells any perishable agricultural commodity at retail. There are no stipulations on exact size or placement of country of origin declarations, but statements should be “legible and placed in a conspicuous location where they are likely to be read and understood by a customer” [14]. Country of origin labeling statements can be presented in different forms, including a placard, sign, label, sticker, band, twist tie, or pin tag [14]. Abbreviations approved under Customs and Border Protection rules, regulations, and policies are the only abbreviations that can be used in country of origin labeling and must “unmistakably indicate the name of the country of origin” [14]. For example, “P.R. China” and “China” are acceptable abbreviations for the People’s Republic of China. However, “America” is not an acceptable abbreviation because it does not specify whether the country of origin is North America, Central America, or South America [14]. More information on country of origin labeling requirements can be found on the U.S. Department of Agriculture’s Agricultural Marketing Service website: https://www.ams.usda.gov/rules-regulations/cool/questions-answers-consumers#:~:text=The%202002%20and%202008%20Farm,and%20shellfish%2C%20perishable%20agricultural%20commodities%2C.

Multiple domestic organizations aim to improve the lives of people with food allergies in the U.S. On November 30, 2016, a review titled Finding a Path to Safety in Food Allergy: Assessment of the Global Burden, Causes, Prevention, Management, and Public Policy was published to examine the “prevalence and severity of food allergy and its impact on affected individuals, families, and communities; and current understanding of food allergy as a disease, and in diagnostics, treatments, prevention, and public policy” [15]. There were several federal sponsors: the Food and Drug Administration, the Food and Nutrition Service of the U.S. Department of Agriculture, and the National Institute of Allergy and Infectious Diseases, and nonfederal sponsors: the Asthma and Allergy Foundation of America, the Egg Nutrition Center, Food Allergy Research and Education, the International Life Sciences Institute North America, the International Tree Nut Council Nutrition Research and Education Foundation, the National Dairy Council, the National Peanut Board, and the Seafood Industry Research Fund [15]. Another organization that has had significant involvement in the food allergy community is Food Allergy Research and Education (FARE). Instructions for reading US food labels can be found on the FARE website and are accessible to the public: https://www.foodallergy.org/living-food-allergies/food-allergy-essentials/free-downloadable-resources. Throughout its tenure, FARE has been vital to pushing significant changes in legislation. As a result of their efforts, over one million epinephrine auto-injectors have been provided in K-12 schools. Former U.S. President Barack Obama signed the School Access to Emergency Epinephrine Act into law in 2013. Under the law, schools are encouraged to plan in the event that a severe asthma attack or allergic reaction occurs [16]. States such as Indiana, New Hampshire, New Jersey, Texas, and Virginia also have laws that require colleges to have epinephrine accessible on their campuses. In New York, Pennsylvania, and West Virginia, bus drivers are allowed to administer epinephrine. In Illinois, Massachusetts, Maryland, Rhode Island, and Virginia, restaurants are by law required to train their staff regarding food allergy preparedness. Some restaurants have begun to put up signs with food allergy warnings (Fig. 2). An example of such a sign in a New York City establishment is illustrated in Fig. 2.

Fig. 2

A food allergy warning in a New York City food establishment, provided by author LE

Food Labeling Laws in Canada

The prevention of food allergies has become a public health issue in Canada, with almost 600,000 children under 18 years reported to have food allergies [17]. Canada recognizes the following as substances most frequently associated with food allergies and allergic-type reactions: peanuts, tree nuts, sesame, milk, egg, soy, wheat and triticale, crustaceans and mollusks, mustard, fish, and sulfites [18]. Food Allergy Canada was founded in 2001 with the goal of making it safer for those living with food allergies. The organization has led to changes in Canadian legislation. In 2012, the Canadian government passed legislation requiring manufacturers to list ingredients in pre-packaged foods in common language (Fig. 3). Consequently, companies could no longer label ingredients such as “milk” under the name “casein” as some consumers may not know that casein is milk [19].

Fig. 3

A label for Perigord Duck Rillettes from Amazon, showing the use of common English terms only

Although Canadian manufacturers can use precautionary statements, Health Canada, the organization responsible for national public health, does not require them to do so. Health Canada also does not regulate precautionary statements. If labeling ingredients run the risk of cross-contamination, companies that add the “may contain” statement must be truthful and not misleading.

In 2003, Sabrina Shannon suffered fatally from an anaphylactic reaction in her first year of high school. Before her death, she advocated for adolescents living with food allergies. In 2005, Sabrina’s law was passed to help children with severe allergies in public schools in Ontario. The law requires that schools implement an anaphylaxis policy to serve students with allergies better. Schools must also construct a plan for each student prone to anaphylaxis. Since the law was passed, schools have created thousands of plans and educational programs catered to their students [20].

The Canadian Food Inspection Agency (CFIA) is dedicated to food safety and works to ensure Canadians are protected from preventable health risks. Manufacturers can label ingredients using either an ingredient list or a “contains” statement. According to the CFIA’s website, if the food contains Canada’s priority allergens, gluten sources, or added sulfites, these ingredients must be listed at least once in the ingredient list and when they are part of an ingredient. A “contains” statement can also be used to identify food allergens, gluten sources, or added sulfites. The “contains” statements must list the allergens regardless of whether they were previously listed in the ingredient list [21].

Health Canada and the CFIA have shared responsibility for monitoring food labeling. Health Canada is responsible for overseeing labeling, claims regarding nutrients, and expiration dates relating to safety. The CFIA regulates labeling, standards of identity, and grades [22]. Regulatory amendments published in the Canada Gazette Part II on December 14, 2016, will change how prepackaged foods are labeled. These amendments dictate that “1. The “contains” statement (if used) will have to comply with legibility requirements as with the list of ingredients and 2. When used, any precautionary allergen statements will have to appear immediately following the list of ingredients or the “contains” statement if one is provided” [23]. The regulatory amendments will make it easier and faster for consumers to find the appropriate allergen information on labels.

South America

Not much information is available about the prevalence of food allergies in Latin America [24], which may contribute to the variation of food allergen labeling regulations. Some Latin American countries require allergen labeling, while others have no regulations. In recent years, Argentina (Fig. 4) and Brazil (Fig. 5) transitioned into new legislation that would require manufacturers to add food allergen labels to their foods. Examples of labels from Argentina (in Spanish) and Brazil (in English) are illustrated in Figs. 4 and 5, respectively. Colombia and Chile also require mandatory allergen labeling. Mexico, Bolivia, and Peru mostly follow the same guidelines established in Codex Alimentarius [25].

Fig. 4

A food label from Argentina for veganeamos. bizcochos 9 de oro light — 170 g from open food facts; 2020. Notice that this label is in the native language of Argentina, Spanish

Fig. 5

A label from Brazil of a soft drink. The label is in English because the product is made in Brazil and imported and distributed in the U.S. Guaraná Antarctica, The Brazilian Original Guaraná Soda, Amazon

In Argentina, any regulations must be published in the Official Bulletin to become active. This would remove “cereals containing gluten; i.e., wheat, rye, barley, oats, spelt, or their hybridized stains and products” from having to be listed, and it would be replaced with “wheat, rye, barley, oats, spelt, or their hybridized strains and products.” Consequently, manufacturers would not be required to write “gluten” in their allergens list explicitly [26].

Venezuela has also recently updated its laws. According to the Venezuelan Standard for the General Labeling of Prepackaged Foods (COVENIN 2952:2001-1st Revision), Venezuelan law requires food allergen labeling. However, this regulation prohibits manufacturers from using precautionary statements on their labels [25]. Other nations, including Brazil, Colombia, Costa Rica, Guatemala, Honduras, El Salvador, Nicaragua, Chile, and Mexico, have begun to establish regulations. Most countries with food allergen labeling laws require that the allergens listed come from the Codex Alimentarius. These are as follows: cereals with gluten, crustacea, and crustacean products; egg and egg products; fish and fish products; peanuts, soybeans, and products of peanuts and soybeans; milk and milk products, including lactose; tree nuts and their products; and sulfites when the concentration consists of 10 mg/kg or more. The list may vary by country due to the prevalence of intolerances to other foods and the above-mentioned allergens. Unfortunately, an accurate reporting of food allergies in Latin America is still being determined due to the limited number of studies done in Latin America. As of 2018, eight countries in Latin America do not have established food allergen labeling laws, including Bolivia, Dominican Republic, Haiti, Honduras, Panama, Paraguay, Peru, and Uruguay [26].

MERCOSUR, officially known as the Southern Common Market, an economic and political bloc that includes Argentina, Brazil, Paraguay, and Uruguay, strives to ensure that the laws in Latin America work in unison, including food allergen labeling regulations [26]. In 2011, there were discussions within MERCOSUR to implement mandatory labeling. However, due to some unresolved issues, the conversations never continued beyond 2015 [26]. MERCOSUR’s Technical Regulation on the Labeling of Packaged Foods states that packaged foods cannot be labeled in any manner that would make it unclear for the consumer to comprehend [27]. The legislation also requires that the ingredients are listed in the language of the respective nation, which would be either Spanish or Portuguese, the two primary languages in South America. It is also required that an ingredient list be included, but the legislation does not mention that food allergens be identified separately [27]. If the product has a compound ingredient that has been established by the Codex Alimentarius but comprises less than 25% of the product, the ingredients of the compound ingredient do not need to be declared. In June 2015, Brazil passed the Resolução da Directoria Colegiada (RDC) 26/2015, which required mandatory food allergen labeling. MERCOSUR also allows manufacturers to use precautionary statements. However, they must submit a “Declaración Jurada.” This requires manufacturers to add a statement declaring that even though “good manufacturing practices” were employed, there may be some cross-contamination [26].

Brazil has added latex as one of the allergens to be declared, but sulfites have yet to be added. The Brazilian Health Regulatory Agency (ANVISA) stated that sulfites cannot be considered allergenic and, therefore, cannot be listed as “allergenic.” However, companies may still emphasize in their ingredient list that sulfites may be present in their product as long as they adhere to the general rules of the ingredient list [22].

Europe Food Labeling Laws in the UK

The United Kingdom (UK) also has its own laws regarding food allergen labeling. Manufacturers must list the name of the food; expiration date; warnings; net quantity information; ingredients if there are more than one; name and address of the manufacturer, packer, or seller; country of origin; lot number; any special storage conditions; and cooking instructions if applicable [28]. UK law requires that the country of origin be listed for beef, veal, lamb, mutton, pork, goat, poultry, fish, shellfish, honey, olive oil, wine, and fruit and vegetables imported from outside the European Union (EU) [29]. If a product has two or more ingredients, manufacturers are required to list all the ingredients. The ingredients must be listed by order, and the main ingredient is to be listed first. The percentage of an ingredient must be listed if it is emphasized by the packaging, mentioned in the name, or the name commonly known by the consumer. Allergens must be listed in a different font, style, or background color. UK law requires that manufacturers list the following: celery, cereals with gluten (including wheat, rye, barley, and oats), crustaceans (including prawns, crab, and lobster), eggs, fish, lupin, milk, mollusks (including squid, mussels, cockles, whelks, and snails), mustard, nuts, peanuts, sesame seeds, soya beans, and sulfur dioxide or sulfites that have more than 10 mg/kg or 10 L [28]. However, food made on-premise in the United Kingdom that has been wrapped was once optional to have allergen advice. In 2015, 15-year-old Natasha Ednan-Laperouse purchased a sandwich from Pret a Manger, a popular chain in Europe, at Heathrow International Airport in England. Because restaurants were not required to label food when prepared on the premises at the time, Ms. Ednan-Laperouse died of anaphylaxis secondary to an allergy to sesame. Since the incident, the British government declared that it would consider revising its labeling laws. In October 2021, Natasha’s law became effective in the UK, requiring retailers to display full ingredient and allergen labeling on every food item made on the premises and pre-packed for direct sale [30].

As of 2022, one restaurant in England prepared and marked food for consumers who reported food allergens. The food came with a flag denoting that the food was “made with care” with the hashtag “allergen aware” (Fig. 6). Although labeling prepared foods at restaurants is not required by law, the restaurant’s actions demonstrate a growing awareness of food preparation for consumers with food allergens.

Fig. 6

A food allergen marker provided by a restaurant in England after a consumer reported a food allergy, provided by author FC

Because of Brexit, there were changes to some labeling laws. On October 12, 2020, the UK government updated its guidance on the food and drink labeling rules applicable from January 1, 2021. Previous guidance had indicated that foods sold in Great Britain (GB) required labeling changes from January 1, 2021, but according to the updated guidance, the requirements for particular labeling changes will instead apply to food placed on the GB market from October 1, 2022 [31]. Moreover, Northern Ireland will not follow the specific food labeling rules applicable in GB but will instead continue to follow the food labeling rules applicable in the EU [31].

Food Labeling Laws in the European Union

The European Union requires that allergens are emphasized in the ingredient list so consumers can easily identify them. As of March 2022, the 27 members of the European Union include Germany, France, Italy, Sweden, Poland, Spain, Ireland, Romania, Netherlands, Denmark, Bulgaria, Belgium, Croatia, Portugal, Austria, Greece, Czech Republic, Hungary, Finland, Luxembourg, Malta, Lithuania, Republic of Cyprus, Slovenia, Slovakia, Estonia, and Latvia. The EU allows manufacturers some flexibility in deciding how to emphasize the allergens. According to an EU notice relating to Annex II of Regulation (EU) No 1169/2011, if a substance consists of multiple words, the only word that must be emphasized is the allergen [32]. In instances where allergens are present in compound ingredients, the substances must be listed in the ingredient list. For example, the word”egg “ must be emphasized if a sandwich has mayonnaise that contains egg [32].

If a food has a product as an ingredient that does not require an ingredient list, the manufacturer must list the allergen and emphasize it on the product. For example, wine does not require an ingredient list per European Union regulations. However, if another food contains wine, the manufacturer must list it as an ingredient and should write, “ingredients […] wine (contains sulphites) […]” [32]. Furthermore, if a product has the same allergen multiple times, the manufacturer need not repeatedly list the allergen. Instead, it can be listed collectively as long as it is emphasized [32]. For example, the manufacturer can include a footnote at the end of each ingredient and put the allergen at the bottom of the list. When foods such as cream or cheese are an ingredient, the manufacturer is not required to list the allergen — in this instance, milk — because the allergen is already clearly identified. Even so, if a food is sold or marketed under a trademark or brand name and the name does not specifically refer to the allergen, the allergen must be identified with additional information. Furthermore, if a food has a clearly identifiable allergen on the front of the product, the allergen must still be emphasized in the ingredient list. In the European Union, if nuts are present in the product, the manufacturer must clarify which type of nut is present. For example, if the product has almonds, rather than writing “tree nut,” the manufacturer should write “almond.” This regulation applies in other countries as well. Finally, the European Union does not have any legislation that addresses “may contain” or “free from” claims to suggest that something is convenient for those with food allergies [33].

Although Switzerland is not a member of the European Union, in November of 2013, the Swiss government published changes to the Ordannance du DFI sure l’etiquetage et la publicité des denrées alimentary (817.022.21). This ordinance has similarities to Article 21 of the EU’s Labeling Directive. The EU’s Labeling Directive requires that allergens be easily identifiable through a special font, size, or background color [25]. Switzerland follows the same list of allergens that the European Union declares [34]. Macedonia, Iceland, Norway, and Liechtenstein, all members of the European Economic Area (EEA), follow the same rules that have been established under EU regulations [25].

On April 1, 2020, a new regulation on the indication of primary ingredients of different origins was implemented throughout the EU. It requires manufacturers to indicate the origin of primary ingredients if they differ from the product’s origin. The origin of the primary ingredients must now be indicated in case it does not correspond to the indicated country of origin or place of provenance of the food [35].

Food Labeling Laws in Ukraine

Little information is known about the prevalence of food allergies in Ukraine. In a 2022 cross-sectional study on food hypersensitivity in children aged 0–3 years of the Lviv region, the most common allergens were milk, egg, and wheat [