Food labeling plays a crucial role in protecting consumer health by providing information relating to food sources, nutrition and safety. Accurate and informative food labeling allows consumers to make informed dietary choices. Compliance with food labeling regulations is not only a legal requirement but also impacts brand reputation. And yet compliance with regulations can present a challenge to manufacturers, especially for companies operating internationally with many different regulations.
Key Challenges in Food Labeling
Compliance with different regional standards
The Food and Agriculture Organization (FAO) of the United Nations plays an active role in promoting harmonized regulations for food Labeling throughout the world. [1] Its CODEX STAN 1-1985 forms part of various guidelines, standards and codes aimed at international harmonization of food safety and quality. Yet standards still differ considerably between countries and jurisdictions. The challenge of meeting requirements has been reduced to some extent by regional harmonization (e.g. in the European Union or in the MERCOSUR common market in Latin America). And although EU regulations on food Labeling are very much modelled on US requirements, significant difference are still found. One example of this is calories, which in the US are typically based on serving size (i.e. consumption pattern, such as the number of biscuits) and in the EU are based on weight or mass (e.g. 100 grams). [2] Other regions, such as Canada, Japan, and Australia, also maintain distinct labeling requirements that necessitate careful review and adaptation.
Nutrient content claims and health claims
These two claims are strictly regulated across many jurisdictions, and also lead to mistakes among producers. In the US, for instance, the Nutrition Labeling and Education Act of 1990 (NLEA) allows companies to use nutrient content claims on approved food labels, but claims must follow specific guidelines. [3] These might describe the amount of a nutrient in a food (e.g. “high,” “low,” “free,” or “lite”) or compare the nutrient levels between different foods (e.g. “more” or “reduced”). A label may make a quantitative statement such as “200 mg of sodium” as long as it does not imply a specific nutrient level. However, if the label states “only 200 mg of sodium”, then it must also meet certain criteria either for being low sodium, or bear a disclaimer that it is not low sodium.
In contrast, health claims on labeling create a relationship between the food or ingredient and a particular reduction in the risk of disease or health-related event. The aim of regulations such as this is to ensure consistency across labeling and avoid confusing consumers. Health claims are science-based and closely regulated by the FDA. In the EU, nutrition and health claims are governed by Regulation (EC) No 1924/2006 [5] and its associated directives. The EU keeps a list of claims it permits, and establishes permitted phrasing.
Due to the very high level of regulation, nutrition and health claims are often the cause of labeling non-compliance, especially when food is marketed across different jurisdictions.
Common mistakes made with nutrient content or health claims [6]:
1. Misinterpreting or misusing nutrient content claims
Using nutrient content terms like “source of calcium” or “high in fiber” without meeting the specified conditions in the FDA Codex table or the requirements for synonymous claims. Or misusing the word “light” without clarifying what makes the food lighter (e.g., lower fat, calories), as this term must follow the criteria for “reduced.”
2. Using imprecise comparative claims or comparative claims without the context
Making comparative claims (e.g., “reduced” or “less than”) without clearly specifying the percentage or amount of difference in nutrient or energy content, failing to identify the reference food, not clearly indicating which food the comparison is made to, or comparing unrelated food types instead of different versions of the same or similar foods.
3. Implying health cures or disease prevention
Using nutrient function claims that imply a nutrient will cure, treat, or protect against disease, which is not permitted. Such claims must be supported by scientific data and approved by regulatory authorities to ensure compliance and avoid misleading consumers.
4) Inaccurate claims on healthy diets or dietary guidelines
Making “healthy diet” or dietary guideline-related claims without referencing an official dietary guideline or failing to use wording that accurately reflects these guidelines. Or highlighting one nutrient to claim the food is part of a “healthy diet” without considering other key nutrients that should meet the dietary guidelines.
5. Implying that food alone provides health benefits
Describing the food as being part of a healthy diet is acceptable under certain provisions but may not be described as being healthy “in and of itself.”
Ingredient labeling and allergen disclosure
Accurate ingredient labeling and allergen disclosure are crucial to consumer safety, helping consumers with food allergies or intolerances to make informed choices. Regulatory bodies have set standards requiring clear labeling of ingredients and the identification of common allergens, which may include peanuts, shellfish, gluten, and dairy. Furthermore, the ingredient list on the label should directly reflect the actual formulation used in production. A list of eight allergens categories are often referred to in the US as “The Big 8.” These are crustacean shellfish, eggs, fish, milk, peanuts, soybean, tree nuts and wheat. This means that U.S. regulations do not provide a definitive, exhaustive list of allergen ingredients. Instead, it is the manufacturer’s responsibility to identify and label all allergen ingredients within the defined categories. For example, this includes specifying each type of “nut” in its various forms, such as “extract,” “oil,” or “powder,” as well as identifying all possible types of shellfish.
Allergens must be declared in a way that is easily readable, typically in bold or highlighted in a separate “Contains” statement near the ingredient list. Some jurisdictions also mandate the allergen to be named specifically within the ingredient list (e.g. “whey [milk]”).
Serving size and nutrition facts panel
As part of a 2016 update on food labels in the US, serving sizes were adjusted to reflect actual consumption habits rather than recommended amounts, based on data showing changes in how much people eat since 1993. For instance, the serving size for ice cream increased from 1/2 cup to 2/3 cup, and soda from 8 fluid ounces to 12 fluid ounces. Additionally, packages between one and two servings, such as a 20-fluid ounce soda [drink], must now list calories and other nutrients as one serving since they are typically consumed in a single sitting. Larger products that could be consumed over multiple sittings require “dual column” labels, displaying nutritional information per serving and per package (e.g., a pint of ice cream). This helps consumers more easily assess their intake if they consume the entire package at once. [7]
Sustainability and ethical claims
Beyond nutritional and health Labeling, manufacturers are increasingly facing the challenge of understanding and complying with regulations designed to avoid greenwashing. While eco-labels help identify products that conform to certain sustainability and environmental criteria, these certifications may be governed at a formal regulatory level, by commercial organizations, or non-profit organizations. It is therefore important not only to comply with regulations, but with the certification requirements of other bodies.
Within the EU, the proposed EU Green Claims Directive aims at creating rules for substantiating and communicating explicit environmental claims. [8] In 2020, around 230 active eco-labels were circulating in Europe, some of these relating to food.
Changes in consumer preferences and expectations
Consumer expectations of food labels have evolved significantly, driven by increased awareness of health, wellness, and sustainability. Consumers now demand clearer information on nutritional content, sourcing, and production methods, prompting regulatory bodies to tighten labeling standards accordingly. This shift has also led to the reformulation of products to meet updated consumer preferences, such as reducing added sugars or highlighting natural ingredients.
Digital and front-of-package labeling
To enhance transparency and accessibility, digital and front-of-package (FOP) labeling have emerged as growing trends in the food labeling industry. Digital labeling, often through QR codes or mobile apps, provides consumers with instant access to detailed product information, including ingredient sourcing, allergen data, and nutritional information. This approach is particularly useful for companies wanting to offer additional context or engagement with the consumer without cluttering the physical label.
FOP labeling, which provides at-a-glance nutritional information on the front of the package, has also gained popularity as a tool to support informed choices. The Nutri-Score system in Europe, for example, assigns a color-coded score to products based on their overall nutritional profile. The FDA is proposing a Nutrition Info box that complements the Nutrition Facts label. [9] As these digital and FOP labeling trends grow, businesses need to keep pace with advancements to enhance transparency and meet consumer expectations.
Conclusion
Navigating the regulatory consideration components of a food label to avoid nutrition labeling errors can be daunting, but professionals can streamline the process and ensure compliance with the right tools. Schlafender Hase offers a user-friendly software solution, TVT, designed to assist with label proofreading, reducing the time spent checking for errors and inconsistencies. By catching even the smallest deviation early in the process, TVT significantly improves the accuracy and quality of your labeling documents.
Whether you are dealing with regional labeling variations, verifying ingredient and allergen disclosures, or ensuring accurate nutrient claims, our solution provides the precision and efficiency needed to stay compliant. With TVT, food industry professionals can confidently meet the demands of evolving regulations while avoiding costly mistakes and delays in product labeling.
Get in touch with us to find out more about how TVT can help you remain compliant.
1. https://openknowledge.fao.org/server/api/core/bitstreams/71b7d4e0-966e-45c5-9f74-da5ebc133f66/content
2. https://www.daymarksafety.com/news/some-fundamental-differences-between-food-labeling-in-the-us-and-europe/
3. https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/label-claims-conventional-foods-and-dietary-supplements
Also see the FDA’s final rule on “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy’” at https://www.federalregister.gov/documents/2024/12/27/2024-29957/food-labeling-nutrient-content-claims-definition-of-term-healthy
4. https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/label-claims-conventional-foods-and-dietary-supplements
5. https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32006R1924
6. https://www.fao.org/4/y2770e/y2770e07.htm
7. https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/changes-nutrition-facts-label
8. https://www.europarl.europa.eu/RegData/etudes/BRIE/2023/753958/EPRS_BRI(2023)753958_EN.pdf
9. https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/front-package-nutrition-labeling
