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"Comparing Food Safety Regulations in the United States and European Union: An Analysis of Food Labeling Criteria" by Angela Novak

Comparing Food Safety Regulations in the United States and European Union: An Analysis of Food Labeling Criteria

Angela Novak, Ramapo College of New Jersey




Abstract: The United States and the European Union have adopted unique food labeling systems for the purpose of regulation and product identification within their respective regions. Through the use of bibliographic research, this study will investigate the possible reasons as to why these differences exist given that everyone has the right to eat safe and healthy food. A main factor of consideration is that the EU already omits ingredients it perceives as harmful, where the U.S does not. Origin labeling also implies the significance of culture for each region and the U.S and EU also engage in a “cost-benefit analysis” based on what will work best for their respective systems. 


Keywords: food, regulations, health


 

Introduction 


Food is a multidisciplinary area of study in that it not only holds significant cultural and traditional value, but it can also be explored in scientific, economic, and even political contexts. There is an element of freedom in food; where groups may use it as a form of expression or as a means to connect with one another, such as in the act of shopping for ingredients, preparing a dish, or eating together as a group. Food is also necessary for survival, and in this aspect, it is crucial that all people have access to nutritious forms of sustenance, where the issue of food security is often discussed. An aspect of food which is just as important but not as openly discussed are food laws which regulate “the production, trade and handling of food and hence covers the regulation of food control, food safety, quality and relevant aspects of food trade across the entire food chain” (Food and Agriculture Organization of the United Nations, n.d.). 


First identified in the 1948 Declaration of Human Rights, the concept of food safety has evolved over time and is now recognized in international law. This declaration outlines food as a human right, where “[a]dequacy means that the food must satisfy dietary needs… Food should be safe for human consumption and free from adverse substances, such as contaminants from industrial or agricultural processes…” (Office of the United Nations High Commissioner for Human Rights, 2008). Between the United States and the European Union, there are many differences in the laws and regulations of food safety in the respective regions, specifically in the requirements of food labels and additives. If safe food is considered a human right, why do different standards for food labeling exist? Should not all consumers be aware of what is in their food, and given equal opportunity to make informed decisions? This paper will explore the underlying factors of history and economics, as well as the cultural relationship that exists between products and its consumers, to discover which region has stricter policies and why this may be the case. 


The United States and Genetically Modified Organisms (GMOs)


It was not until the mid-2000s that products produced with genetically modified ingredients were required to disclose this information. Pressure on the FDA to publish this method of production was based on the interpretation of the 1938 Food Drug and Cosmetic Act, specifically pertaining to its stance on “adulterated food” and additives. Adulterated food, “contains any poisonous or deleterious substance that may render it deleterious to health, [where additives] include any substance [that may] becom[e] a component or otherwise affect[] the characteristics of any food” (Acosta, 2024).  The FDA policy focuses on the completed food product itself and not the processes of production or the creation of different plant varieties. They ruled that foods produced with genetically modified materials did not present any “different or greater” safety concerns than those produced with traditional crops and “the FDA concluded that it had no legal or scientific basis to require labels for GM food unless the food itself differed materially (for example, by presence of an allergen) from similar foods” (Knežević & Grbavac, 2019). However, consumers and non-governmental organizations grew increasingly concerned about the presence of laboratory developed crops in their foods and pushed for mandatory labeling. In early July of 2016, the state of Vermont passed their own laws requiring mandatory labeling pertaining to GMOs, and by late July of that same year, Congress implemented the National Bioengineered Food Disclosure Standard. Largely in an effort to ensure that universal standards existed for GMO disclosure for less confusion, this legislation superseded state and local labeling laws. In 2018, it was finalized as the National Bioengineered Food Disclosure Law and labeling regulations regarding GMOs, or “bioengineered foods (BE)” as they are now referred to, were provided. An important component of this law is the definition of “bioengineered,” which the Standard says are “foods […] that contain detectable genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature” (USDA, 2022). Relatively vague in its definition, it fails to clarify differences in editing and modification where the former is a “technique to create specific changes to part of a living thing's DNA to improve existing characteristics [and g]enetic modification is used to artificially insert DNA from one living thing into the DNA of another living thing, introducing a new or different characteristic” (Whitworth, 2021). Since a majority of bioengineered foods are found in the agricultural sector in crops such as corn and wheat, the United States Department of Agriculture (USDA) and the FDA work together to manage and label food products accurately. 


There are, of course, exceptions to the law, where restaurants, smaller establishments and production facilities are not required to label foods as “produced with” or “containing” BE ingredients. The standards implemented also do not apply to animal feed; therefore, although a cow may have ingested food made with a BE crop, its milk would not have a “bioengineered” label requirement. Highly refined foods are also exempt from labeling requirements, as this process is considered to render any traces of a bioengineered ingredient undetectable. “Regulated entities that produce or use refined foods may rely on processing records alone to prove the absence of detectable modified genetic material [and] would not require additional laboratory testing to prove the lack of modified genetic material.” (National Bioengineered Food Disclosure Standard, 2020). The level of detectable genetically modified material is also fairly high, at 5%, compared to the EU which has a much lower threshold. The Standard also strictly applies to foods under the labeling requirements of the Federal Food, Drug, and Cosmetic Act (FDCA) or the USDA Food Safety Inspection Service. An alternative is if the product falls under the regulations of the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), or the Egg Products Inspection Act (EPIA) and the primary ingredient, by weight, in the product is subjected to the regulations of the FDCA. If not, then the standards do not apply; as well as if the predominant ingredient in a given product is of the nature of broth or water and the second ingredient is subject to the FDCA. An example of this labeling requirement is if there are two cans of soup with broth listed as the first ingredient, but in “Soup A” the second  ingredient is listed as chicken and for “Soup B” the second ingredient is carrots; only “Soup B” would be subject to the BE labeling standards since carrots fall under the regulations of Food Safety and Inspection Services or FSIS, where chicken is not. There are also critiques regarding the change from “genetically modified” to “bioengineered,” since it is a term that consumers are unfamiliar with, as well as the type of labels companies are required to use on products to disclose this information. Giving the ability for companies to choose their method of disclosure, or labeling methods, has also been regarded as problematic, due to the shift towards QR codes and other labels of digital nature which not everyone may have access to. Overall, steps have been taken by the government to address public consumer concerns but have still left much ambiguity. 


The European Union and Genetically Modified Organisms (GMOs)


The European Union takes a much different approach to the concept of GMOs. Where the United States tends to focus more on the final product, which is where many of their labeling requirements are decided upon, the EU places more emphasis on the actual process by which the product is created. Initially, this is observed in the rigorous risk assessment processes that a genetically modified crop must undergo in order to be considered for use in the European Union. “Authorization is depending on a thorough risk assessment and on the availability of a validated method for detecting, identifying, and quantifying the GMO in food or feed. Biotech companies, who wish to bring their product to the market, need to submit an application for each GM launch. Part of the application dossier includes a very specific method of detection of each particular GMO” (European Commission, 2020). A second key difference is that the EU has a maximum of 0.9% traceable GMO material in order for a product to not require a GMO label, compared to the US, which was 5%. Furthermore, in order to prove that GMO contact was unavoidable, production companies must provide adequate information to prove that they took every precaution. Regarding labels themselves, for “pre-packaged products consisting of, or containing GMOs, the words ‘This product contains genetically modified organisms’ or ‘This product contains genetically modified [name of organism(s)]’ appear on a label” (Food Safety Authority of Ireland, 2019). 


Although in the United States regulations and laws regarding genetically modified foods take precedence over state and local governments, laws regarding GMOs in the European Union may sometimes face challenges from individual countries. This type of situation can be seen in the example of France’s 2008 ban on the cultivation of MON810 genetically modified maize varieties, with claims that it possessed “environmental risks” after having been cleared for use by the EU. The ban was eventually declared unlawful by the EU Courts; yet France continued not to produce MON810 crops. To amend similar issues such as this, in 2015, the European Commission passed new legislation which granted more authority to individual countries within the Union to choose if and how GMOs will be used in their nation. This also coincides with the strong sense of nationalism that the individual countries within the European Union have. Culture and tradition of each nation play a significant role in development of food labeling policies as well; despite its efforts to create harmony among all involved, it does not change the fact that each country had operated on its own for centuries prior to the EU’s formation.


Nutrition Labels in The United States


Prior to the 1960s, nutritional labels on pre-packed food products were far and few, with the occasional calorie or sodium content looked at as information for someone with particular dietary needs due to a medical condition rather than the general population. Additionally, at this time, much of the food consumed was prepared locally or at home, so there were not many questions regarding the ingredients in a meal. As food production became more of a commercial process, the separation between the product and the consumer was concerning for the public, along with a growing number of health issues associated with obesity. In 1973, some of the first regulations regarding the voluntary labeling of nutrients in processed foods were passed. It specified that when companies chose to make claims regarding their FDA-regulated product, it must “include the number of calories; the grams of protein, carbohydrate, and fat; and [at the manufacturer’s discretion] the percent of the U.S. Recommended Daily Allowance of protein, vitamins A and C, thiamin, riboflavin, niacin, calcium, and iron, sodium, saturated fatty acids, and polyunsaturated fatty acids…” (Wartella et al., 2010). These voluntary labels remained unchanged until the late 1980s, when new scientific studies pertaining to health and diet sparked public interest for more accurate labels and the FDA was urged to take a new approach in this aspect.


Two reports were published that marked a change in the way that consumers thought about food and its ingredients; first The Surgeon General’s Report on Nutrition and Health in 1988 and the National Research Council’s (NRC’s) report Diet and Health: Implications for Reducing Chronic Disease Risk the following year. The findings indicated that a more balanced diet and reduced consumption of fats and cholesterol could deter the chances of some chronic diseases. The current labels were inadequate in presenting this information accurately, so 1989 marked the start of an overhaul of the current system by consulting scientists and working in favor of public opinion. The Nutrition Labeling and Education Act, or NLEA, was passed in 1990, and gave the FDA “explicit authority to require nutrition labeling on most food packages and specified the nutrients to be listed in the nutrition label [and]... required that nutrients be presented in the context of the daily diet” (Wartella et al., 2010). It also required standard definitions regarding the level of nutrients, as well as the establishment of general rules for “health claims” on behalf of pre-packaged food production companies. Exceptions include foods produced in bulk, those that are not a significant source of calories, and smaller restaurants.


In 2016, the labels were updated once again to reflect scientific research and health discoveries. Listed requirements of calorie amounts, total fat, saturated fat, cholesterol, sodium, sugars, protein, calcium, iron, and dietary fiber remain. As an exception to the rule, if there were insignificant amounts, 2% or less, of certain nutrients and no explicit health claims regarding them, then “a footnote [is] added at the bottom of the list of nutrients stating ‘Not a significant source of ____’ with the blank filled in by the name of the nutrients(s) omitted” (Wartella et al. 2010). Changes in the label today include a larger and more bold calorie count, as well as an updated serving size which is reflective of the amounts the population has actually consumed compared to what they should consume. By law, “serving sizes must be based on amounts of foods and beverages that people are actually eating, not what they should be eating” (Food and Drug Administration, 2022).  Additionally, the percent Daily Values have been updated to reflect scientific research regarding consumer health. Some values may now be higher or lower on labels (5% being low; 20% is high), as well as the listings of Vitamin D and potassium now required, since there is a large underconsumption of these nutrients. Added sugar is also a requirement, different from initial sugar in the product; it refers to those added in the production of the product, syrups, or sugars from a fruit extract, etc. The Food Allergen Labeling and Consumer Protection Act of 2004 was added as an amendment to the FDCA and required the mandatory labeling of the 8 major allergens: milk, eggs, fish, shellfish, tree nuts, wheat, peanuts and soybeans. 


Nutrition Labels in The European Union


Where the United States had mandatory labels as early as the 1990s, the European Union did not implement a similar system until decades later. Although a specific reason for this initial decision is unclear, standard regulations were proposed for several reasons, including “unjustified burdens on food business because of unclear requirements, and failure of the legislation to adapt to changing markets and consumers’ legitimate demands” (​​The Commission of European Communities, 2008). In 2014, the EU implemented the Food Information Regulation, which outlined the requirements in the way that pre-packaged food should be labeled and the minimum requirements the label must contain. However, the section regarding nutrition labeling specifically did not go into effect until December 13, 2016. Although the EU mandates certain components of the label, member states have a general amount of freedom in its application and there is some flexibility for each country given their consumer populations, economy, culture etc. Mandatory nutrition declaration is sometimes referred to as “The Big 7” since there are seven requirements in total: calories, saturated fatty acids, carbohydrates, sugar, protein and salt. Calorie counts must be measured in 100g or 100ml increments, and salt is also labeled according to grams; however, there is no serving size recommendation mandated. Other nutritional information such as fiber and vitamins are also required, but only if claims regarding them are made on the label, such as “a great source of fiber.” 


The ingredients must also list any additives or food colorings in the pre-packaged product with its “E number,” or its chemical designation and purpose; common preservative sodium nitrate would be referred to by its E number, E25. This type of labeling presents issues in the aspect of trade, since the FDA does not allow imports of food that does not specify the given name of a preservative, so products containing E numbers are not permitted in (Entis, 2015). An interesting comparison is also the type of additives and preservatives allowed in pre-packaged foods of either region, where the EU tends to be more strict. An example of this may be seen in the EU and Northern Ireland’s ban of the additive Titanium Dioxide (E171), where concerns were introduced regarding its safety following a reevaluation by the European Food Safety Authority (EFSA) back in 2016. After testing, experts were unable to rule out the potential of genotoxicity in E171, or the ability of the chemical to alter DNA and potentially lead to cancer (European Food Safety Authority, 2021). In food, it is used to make products more “visually appealing” by restoring color and bringing color to foods that might not otherwise have any, and it is also found in cosmetics and paints. According to Grantham-Philips (2022), a consumer filed a complaint against the Mars company in the United States for allowing a “known toxin” in their products, which he specifically referenced as the hard color coating on the candy “Skittles,” used to give shine to the product as well as many others. Foods in the U.S cannot contain more than 1% of this additive; it may be difficult for consumers to ascertain whether it is present in certain products, since the FDA does not require the explicit labeling on all products containing Titanium Dioxide. Where it is required when used for color, it may sometimes be listed under the general label of “artificial color” or “color additive.” The Skittles lawsuit was dropped in November, but this instance illustrates the contrasting standards regarding additives and preservatives between the regions. 


There are also 14 allergens that are mandated on European labels, which include mustard, sesame, sulphites, celery, lupin, and mollusks in addition to the eight required in the United States. Indicating the individual interpretations of EU member states, is voluntary front-of-pack (FOP) labeling. While the European Union does not require this information, the EFSA has an ongoing program looking into its effectiveness which will provide more information to the EU Commission on if they should “harmonize” FOP labels across the Union and if one universal scheme will be applied. Currently, some countries such as France, Germany, and Belgium implement the “Nutri-Score” system, the “Key-Hole Logo” in Finland, Denmark and Lithuania, as well as Italy’s proposed “Nutrinform Battery” system (Septia Irawan et. al, 2022). Each one of these represents a system the government of each country believes functions the best given their country’s specifications, although they all aim to achieve the same goal of providing consumers with more information to make healthier choices based on FOP options. 


Origin Labels in the European Union


As mentioned, culture and tradition play a significant role in the aspect of food labeling, which can be demonstrated in the concept of origin labeling. Prior to the implementation of The European Regulation of Food Information to consumers, the EU had a more “vertical approach” which required the mandatory disclosure “of the country of origin only for specific foodstuffs which characteristics and qualities were deemed to depend on their geographical origin or which traceability was required by specific safety considerations” (Carbonnelle et al., 2016). Some member states held their own origin labeling schemes to signify quality as well as geographical location, intended to protect traditional production practices and authenticity; and targeted for specific products, such as cheese, pasta, or wine. Under the Geographic Indication (GI) Label, a product has a specific link to the location in which it is created and is further comprised of more specialized labels: Protected Designation of Origin (PDOs) ensure “traditional” techniques used to make a food associated with a specific geographical area; Protected Geographical Indication (PGIs) ensure a food comes from its “traditional” place of production; and Traditional Specialty Guaranteed (TSGs) place importance on upholding traditional techniques, though the product can be made anyplace in its home country. Once the FIC Regulation was set in place, it mandated the origin label state where a product was from, whether it was created in one singular country, or list the final country where it was completed. If the primary ingredient is from an alternative location different from the place of production, that origin should be placed on the label. Aside from these specific criteria, member states have freedom to implement their own regulations, which can be stricter than those of the EU but not less. 


To illustrate the role of tradition and culture in origin labeling, Juliette Rogers of Brown University was consulted for her knowledge. Writing her dissertation on the cheese industry in France, she undertook extensive research on the production of Camembert de Normandie, Livarot, and Pont-l’Evêque cheeses in France. Brown writes about the importance of L’Appellation d’origine contrôlée (AOC), or the French system of origin designation, which had originally been created for wine but now applies to other industries such as dairy. This development added another layer of work for everyone involved with French products under appellation. While the EU implementation of its GI system was a positive idea in theory, it also presented some challenges as France “now had to bring the national system into agreement with the European Union’s, which, though heavily influenced by the French system, was still the product of compromise with other member-states” (A. Novak, personal communication, December 19, 2022). The Appellation d’origine Protégée (AOP) label was the larger, EU-approved label that existed parallel to the AOC label of France and was met with some reluctance by the people as the former label “felt more French.” In our discussion, Juliette shared how from a young age, French children attend dairy festivals and education programs regarding the cheese production process in order to see the way in which it is produced and develop a greater appreciation for French cheese. In its shift to a more “harmonized system,” the EU worked with the member states who already had their own individual PDO labels and standards in order to develop a more universal system that had the same meaning throughout the EU, and a more “solid foundation.” Her dissertation took place over a decade ago, and in our discussion, she shared how a compromise with France and the EU is ongoing: “I’d say that the main challenges in this revision process are that the new requirements require that people change the way they work, which can feel insulting; changes are also expensive (requiring major investments, new training) and require a real change of mindset, which is very difficult to impose from the outside” (A. Novak, personal communication, December 19, 2022). There is much conflict between smaller farms and large corporations in a traditional vs more mechanized means of production, and debates on the authenticity of Camembert produced in factories. Raw milk from dairy cows is also a highly debated issue, where it is a crucial component in the production of authentic French cheese but does not necessarily coincide with the general safety regulations of the EU. 


Origin Labels in the United States


In the United States, origin labels hold a more functional purpose, rather than significant cultural values. If a prepackaged product is imported from another country, then it must state explicitly where that product originated from. Working closely with the FDA, Customs and Border Patrol (CBP) is strict regarding the final location of manufacturing of a product entering the United States where “[i]f a food goes through processing that results in a ‘substantial transformation’ resulting in the article having a name, character, or use differing from that of the imported article, the country where that processing occurs becomes the country of origin that must be identified” (Carbonnelle et al., 2016). A label simply stating “E.U.” would not be conducive, since it does not state what country the product is from; this is where labels such as “Made in Italy” are used. If a product manufactured entirely in the United States uses imported ingredients, it is not required to list the origin of these other ingredients. Labels do require the production address of prepackaged foods made within the United States; there are some cases where the “primary location of business” may be used rather than the actual site of production, packaging, or distribution. A “Made in the USA” label may be applied if it follows the standards set by the Federal Trade Commission, which is that “virtually all” of the product has been made in America. 


Theoretical Context


Emile Durkheim’s sociological theory of functionalism is visible in the process of implementing food labeling regulation regarding both the United States and the European Union. The concept of functionalism follows the idea that various structures work together to create a balanced and functioning society, as the name would suggest (Nickerson, 2024). Looking at the Department of Health and Human Services, it is divided into several sectors, each with a different focus such as the FDA and its prioritization of safe and regulated food as well as drugs. Cohesive policies are made in coordination with the FDA, USDA, and other outside organizations such as the FTC and even FBI. Each of the parts in the “patchwork system” work together in an effective manner to uphold food safety regulations, thus an example of the functionalist theory in work. The European Union was created with the intent of developing a sense of unity and cohesiveness, similar to how states would interact in the U.S; however, this did not play out as expected. Because each country had its own structure before becoming a member state in the EU, it was difficult to now have another entity such as the EU Commission as well as the other member states to contend with when attempting to implement new “universal” regulations, especially regarding food. 


Many of the food labeling laws can also be looked at in an economic sense, specifically in terms of a “cost-benefit analysis.” For either region, trade has played a significant role in the move towards more universal labels, where each country or state may have a minimum set of standards that have to be met. In the EU, smaller producers often have a more difficult time when it comes to adjusting their products to coincide with new regulations. Juliette Rogers shared how many small cheese producers were left “out of the loop” on issues regarding raw dairy milk, and other health standards the EU was looking to mandate. As a smaller organization, their main priority is maintaining traditional means of production; although some larger and more industrialized producers may be more willing to and able to comply with proposed standards, local farmers would not be able to sustain their products. In a more literal sense, the FDA publishes annual cost and benefit reports where other costs could be associated with higher prices for consumers, or too much information on a label could overwhelm consumers and deter them from a product (FDA.gov, 2022). The U.S and EU also engage in this cost-benefit analysis to judge whether labeling would be the most effective means of action. In non-life-threatening cases, an announcement or a higher tax on a product are enough to dissuade people from purchasing, without a complete overhaul of the system. 


Conclusion 


Food labels are a complex area of the law, impacting not only public health, but also the economy, cultures, and traditions. The United States and the European Union have their own policies regarding food labels, which can be examined in the three aspects of GMO, Nutritional, and Origin distinctions. The United States has more organized and universal regulations regarding prepackaged food, where information is clearly displayed and consumers across the country are able to effectively make informed decisions regarding their food, no matter what geographical state they are in. As a whole, the labels in the European Union do not present as much nutritional information as those in the United States, instead placing emphasis on origin. This could be due in part to the heavy restrictions that the EU holds on preservatives, additives and GMOs already; where consumers already know they do not need to concern themselves in that aspect of what is in their food so much as where their food comes from. On the other hand, in the U.S there are not as many laws pertaining to the inclusion of preservatives and GMOs in prepackaged foods, as production companies are required to notify consumers of these additives in their nutrition labels, which are more extensive. So why do different food safety standards exist, specifically in the context of labeling? Ultimately, it seems as if labels in the U.S are stricter than the EU because they contain elements already omitted in foods of the other region. Where both regions work towards the same goal of public health, in terms of health, the U.S continues to take a more reactive approach of food labeling and nutrition than the EU, although new policies such as the Food Modernization Act are being implemented to address this. 



Works Cited


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