1. Introduction

The contemporary food sector is significantly dependent on additives to enhance product texture, extend shelf life, and improve visual appeal. Despite the fact that numerous additives incorporated in food items have received the Generally Recognized as Safe (GRAS) classification from the US Food and Drug Administration (FDA) and are typically regarded as safe when utilized as directed, there are apprehensions regarding certain substances, especially those employed in elevated concentrations or lacking extensive long-term studies, which may pose potential long-term health risks.[1]. However, there are still concerns that consumption of certain substances, especially those used in high concentrations or with limited long-term research, may cause long-term health effects. Approximately 1,000 substances are utilized under the Generally Recognized as Safe (GRAS) classification without prior authorization or notification to the U.S. Food and Drug Administration (FDA) [2]. The focus of this article is on the regulation of food additive use, specifically examining the role of aluminium-containing bulking agents and their potential impact on human health. This research inquiry examines the deficiency in knowledge regarding the chronic impacts of aluminum exposure through food, taking into account the short-term physiological consequences and the efficacy of the existing regulatory framework. Using a literature review approach, this study will analyse existing research on the occurrence of aluminium in food, the mechanism of action of aluminium in the human body, and current government policies to regulate aluminium use. The findings of the research will enhance the discourse surrounding food safety concerns and underscore the necessity for more robust regulatory frameworks to alleviate potential health hazards linked to food additives.

2. Occurrence of aluminum in bulking agents and its causes

Aluminium, primarily encountered as aluminium sulphate, aluminium ammonium sulphate, or sodium aluminium phosphide, serves a crucial, though indirect, function in various leavening agents. Unlike baking soda or baking powder, it does not produce gas itself. In the case of aluminium sulphate, it is usually used in baking powder as an acidic ingredient, reacting with sodium bicarbonate (baking soda) to release carbon dioxide gas. Nevertheless, it is occasionally incorporated directly into various food products to enhance texture. The aluminum ions present in aluminum sulfate do not generate gas on their own; rather, they engage with other components within the food matrix to influence the structural integrity of the dough or batter, resulting in a lighter and more stable foam. The aluminium content of foods is highly variable and is strongly influenced by the type and amount of leavening agent used, the efficiency of the processing method and other ingredients. The extensive utilization of aluminium-based leavening agents in the baking industry suggests that bakery items incorporating these agents, such as cakes, pastries, and certain types of bread, are likely to exhibit elevated concentrations of aluminium. The concentration of aluminium depends on the amount of leavening agent used in the preparation process and the efficiency of its reaction, and in general the higher the concentration of leavening agent, the higher the likelihood of aluminium accumulation in the final product. Processed cheeses are another category in which aluminium compounds can be used as emulsifiers or stabilisers, and in which the aluminium content is influenced by differences in processing techniques between brands and different formulations for different varieties. Aluminium concentrations exhibit significant variability across different regions, influenced by diverse agricultural practices, regulatory standards, and various environmental conditions. In the United States, aluminium levels in food products can range dramatically, from less than 1 mg/kg to as high as 27,000 mg/kg. For instance, cheeses used in frozen pizzas may contain up to 14 mg of aluminium, primarily sourced from sodium aluminium phosphate, while comparable cheeses found in restaurant pizzas typically contain only 0.03 to 0.09 mg of aluminium. Non-dairy creamer packages may contain 50-600 mg aluminium/kg (from sodium aluminium silicate), providing up to 1.5 mg aluminium per serving. Baking powders and some pancake/waffle mixes and frozen products contain the highest levels of aluminium, up to 180 mg per serving. These concentrations are markedly elevated compared to the standard daily aluminum consumption (3-12 mg/day) documented in dietary research across numerous other nations.[3]. It is therefore important to understand that while aluminium contributes significantly to the texture of food, its potential long-term health effects also need to be continually researched and the levels of aluminium in food carefully monitored. This should take into account both the intentional addition of aluminium through leavening agents and potential sources of contamination throughout the food production process.

3. The role of aluminum in product softening and fluffing

Aluminium does not directly ferment food as baking soda (sodium bicarbonate) does through a chemical reaction that produces carbon dioxide gas. Instead, aluminium-containing compounds in ferments mainly affect the *structure* and *stability* of the bubbles produced by other ferments, giving a softer, fluffier texture. They act as a structural support for the gas, preventing the bubbles from collapsing. This phenomenon is accomplished through various mechanisms: aluminum compounds typically function as acids in leavening agents (such as sodium aluminum phosphate and aluminum sulfate). These substances interact with a base (baking soda) to generate carbon dioxide, the gas responsible for fermentation.[4]. However, aluminium ions are not directly involved in the production of the gas, but interact with the components of the batter or dough. This interaction affects the formation of the protein network (in baked goods) and thus the final texture. On the other hand, aluminium ions can interact with starch and protein molecules in the food matrix. This process modifies the configuration of these molecules, enhancing their capacity to encapsulate and hold air bubbles. Consequently, the resulting framework attains greater stability and is less prone to collapse, leading to a softer end product. Notwithstanding this certain aluminium compounds (e.g. aluminium sulphate) may also affect the crystallisation process in the food matrix. This affects the size and distribution of air bubbles and may result in a finer, more uniform crumb structure.

4. The harmful effects of aluminum on the human body and the government's attitude and policy towards aluminum in food products

4.1. Short-term effects

The potential health effects of aluminum ingestion are a subject of ongoing research and debate. Although it is generally accepted that aluminum is not readily absorbed by the body, concerns about its potential toxicity remain, particularly in the context of short-term exposure.The gastrointestinal absorption of aluminum is typically minimal, often accounting for less than 1% of the total intake. However, factors such as the acidity of the stomach and the presence of chelating agents can affect the rate of absorption. Short-term exposure may lead to gastrointestinal disturbances, such as nausea, vomiting, and diarrhea. Additionally, aluminum may interfere with the immune response, potentially diminishing immune function. The Risk Assessment Report on Dietary Aluminium Intake indicates that the consumption of aluminium from food additives containing aluminium has surpassed the provisional tolerable weekly intake (PTWI) for children aged 7 to 14 years, with levels ranging from 105.2 to 126.7 percent of the PTWI. Within this demographic, puffed foods were the primary source of aluminium exposure, accounting for 29 percent of intake in children aged 7 to 10 years, 21 percent in boys aged 11 to 14 years, and 23 percent in girls aged 11 to 14 years, all of which are significantly elevated compared to other age groups [5]. Children may be particularly vulnerable to these compounds due to their greater dietary intake per pound and developing metabolic systems [6].

4.2. Long-term effects

Prolonged aluminum exposure poses significant health risks, potentially leading to chronic conditions. Absorbed aluminum disperses in the body, primarily accumulating in bones, with lesser concentrations in the brain, liver, and kidneys. While most of the ingested aluminum is excreted, aluminum may still accumulate in certain organs and tissues, especially with prolonged exposure. Research indicates a possible connection between aluminum consumption and neurodegenerative disorders like Alzheimer's. Additionally, aluminum disrupts bone metabolism, potentially causing bone disease, especially in those with renal issues. Accumulation of aluminum in the bones can lead to osteochondrosis and reduced bone mineral density. Moreover, evidence indicates potential associations between aluminum exposure and anemia, immune dysfunction, and other health issues, with children's developing organ systems being especially vulnerable.

4.3. Government policy

Despite the multiple effects of aluminum on the human body, governments have taken action in regulating acceptable levels of aluminum in food products. These regulations vary widely among countries and usually focus on specific food categories where the use of aluminum compounds is more prevalent. Maximum limits on the amount of aluminum permitted in foods are often based on risk assessments conducted by food safety agencies. These agencies continually review and update their regulations in light of new scientific evidence. The effectiveness of these regulations in protecting public health varies from country to country, depending on factors such as enforcement, monitoring, and public awareness. In light of the findings from the most recent aluminium risk assessment conducted by JECFA and Chinese authorities, alongside the actual application of aluminium-based food additives in various products, the regulations governing aluminium additives have undergone significant revisions. These amendments entail a more precise definition of applicable food categories, modifications to the maximum permissible levels of potassium aluminium sulphate and ammonium aluminium sulphate, the elimination of nine aluminium-containing food additives in puffed products, and the prohibition of sodium aluminium phosphate, sodium aluminium silicate, and aluminium amylopectin octenyl succinate across all food items. By updating the regulations surrounding aluminium food additives, it is anticipated that the weekly dietary aluminium intake for the Chinese population will be reduced to a safer threshold.[5]

5. The likelihood of zero aluminum in bulking agents

5.1. Alternative leavening agents

The feasibility of attaining zero aluminum levels in fermenters presents a multifaceted challenge, encompassing technical, economic, and consumer acceptance considerations. While complete elimination of aluminium may be difficult in the short term, significant progress can be made in minimising its presence, and several alternative leavening agents are available. Many recipes rely on the classic combination of baking soda (sodium bicarbonate) and acids (e.g. cream of tartar or citric acid) for fermentation, which are aluminium-free, although their performance characteristics may differ from those of aluminium-containing compounds. Enzymes are increasingly being used as leavening agents. Specific enzymes catalyze the hydrolysis of starches or proteins in dough or batter, resulting in the production of carbon dioxide, which contributes to a lighter texture. Nevertheless, the economic implications and ideal utilization of these enzymes necessitate additional investigation. The 1983 publication discusses various alternative options for aluminum-based food additives, noting that calcium oxide can serve as a substitute for the curing agent traditionally used in vegetable pickling, which is typically alum. Furthermore, aluminum is increasingly being substituted in both industrial and household pickling methods. Additionally, there is a shift from aluminum-containing antacids to those formulated with calcium carbonate [7].

5.2. Future work

Technological advances could make air-infusion or mechanical mixing techniques more effective, resulting in lighter textures in foods and reducing or eliminating the need for chemical leavening agents. The primary difficulty lies in the necessity to identify substitutes for aluminum-based leavening agents that can either replicate or surpass their functional properties, which encompass achieving the intended leavening ability, texture, and longevity of the product. Therefore future research into new materials with better fermentation properties and minimal impact on health and the environment is essential. Although the expense associated with certain alternatives may be elevated, the enduring economic advantages stemming from enhanced public health and diminished healthcare expenditures could surpass the initial rise in production costs. Therefore future research into new materials with better fermentation properties and minimal health and environmental impacts is essential. Optimising food processing techniques has the potential to minimise the need for chemical fermenters. Also seller acceptance can be a major challenge, and consumers may be hesitant to switch to unfamiliar leavening agents, especially if they perceive a change in flavour or texture. It is essential to inform consumers regarding the safety and advantages of alternatives that do not contain aluminum. Raising consumer awareness of the potential health benefits of reducing aluminium intake and the availability of alternatives is essential. Meanwhile government policies and regulations can stimulate the development and adoption of aluminium-free alternatives.Achieving a complete absence of aluminum in fermentation processes is a progressive endeavor. Although the total removal of aluminum may not be feasible in the short term due to various technical and economic constraints, transitioning to safer and more sustainable alternatives is attainable through ongoing research, technological advancements, and supportive regulatory frameworks.

Such a shift requires a multifaceted approach that combines scientific advances, consumer education and policy changes.

6. Mechanism and policy

The regulation of food additives involves a complex interplay between scientific evidence, regulatory oversight and economic factors. Agencies such as the United States Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA) play a crucial role in assessing the safety of food additives, including aluminium compounds used in leavening agents. This evaluation is contingent upon robust scientific data demonstrating the safety of the additive at the specified usage level. Typically, this process encompasses comprehensive toxicological research to evaluate the potential hazards to human health [1]. A key concept is the ‘Generally Recognised as Safe’ (GRAS) determination. Substances meeting this criterion are exempt from the formal food additive approval process. Nevertheless, the responsibility to establish GRAS (Generally Recognized as Safe) status lies with the manufacturer, who is required to provide evidence to the regulatory authority that a consensus among qualified experts has been achieved to validate the safety of the substance for its designated application. The FDA clarified the requirements for substances added to foods, including beverages and dietary supplements, in a 2014 guidance document. The FDA emphasises that under its food additive regulations (21 CFR 170.3(g)), even common food products used as ingredients are still considered ‘substances’. This indicates that even ingredients that appear harmless must adhere to applicable regulatory standards or obtain a Generally Recognized as Safe (GRAS) designation [2]. A strong example of the consequences of using unapproved food additives is the warning letter issued by the FDA to Arden's Garden in 2015. Arden's Garden's ‘True Energy’ product contains ginkgo biloba, which, due to the use of ginkgo biloba as a food additive lacking a Food Additives Regulations and GRAS determinations, and was therefore found to be adulterated. This case underscores the rigorous standards necessary for establishing the safety of any substance incorporated into food, be it a traditional food item or a dietary supplement [8]. Current policies on aluminium in food usually focus on setting maximum permitted levels for specific food categories. These limits are usually set on the basis of a risk assessment that takes into account the potential health effects of aluminium exposure. The regulations themselves vary from country to country, reflecting different scientific assessments and policy priorities. Furthermore, consumer awareness and advocacy significantly impact regulatory measures. Public apprehension regarding possible health hazards linked to certain food additives can sway regulatory choices, resulting in more stringent regulations or heightened examination of particular substances. Labelling requirements for aluminium in food vary from region to region, so it is important that consumers are aware of the regulations in their area.

7. Conclusion

This article has explored the prevalence, modes of action, and possible health consequences of aluminum-based bulking agents in food items, in conjunction with an evaluation of existing governmental regulations and policies. The research reveals that while aluminum is widely used in food processing, its long-term health effects require further investigation. The existing literature indicates potential adverse effects, highlighting the need for continuous monitoring and the exploration of safer alternatives. The existing regulatory frameworks exhibit a harmonious equilibrium between facilitating industry operations and safeguarding public health; nevertheless, enhancements are essential to optimize the risk assessment and regulatory mechanisms to more effectively address long-term health implications. Further research should focus on developing effective and affordable alternative bulking agents with minimal health risks and conducting comprehensive long-term studies to accurately assess the impacts of aluminum exposure from dietary sources. The existing regulatory frameworks exhibit a harmonious equilibrium between facilitating industry operations and safeguarding public health; nevertheless, enhancements are essential to optimize the risk assessment and regulatory mechanisms to more effectively address long-term health implications. The current regulatory frameworks demonstrate a balanced approach that supports industry activities while ensuring public health protection; however, improvements are necessary to refine the risk assessment and regulatory processes to better tackle long-term health consequences.