A treatise on food additives would be incomplete without a discussion of the risks and benefits associated with their use. Any risks associated with the use of food additives should be placed, in perspective, with other food-associated risks and with the risks associated with the use of alternative additives or specific additive-free formulations.
This article will focus on the risks and benefits associated with food additives as well as generally recognized as safe (GRAS) and prior sanctioned food ingredients, emphasizing their role in processing agricultural products.
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Functions and Applications of Food Additives in Food Processing
Hundreds of chemical additives are incorporated into foods directly or migrate into foods from the environment or packaging materials. A food additive can sometimes be defined as a substance whose intended use will lead to its incorporation into the food or will affect the characteristics of the food.
These additives generally provide some type of benefit to the food producer, processor, or consumer. For the consumer, additives can improve organoleptic qualities of foods, improve the nutritive value, or ease the preparation of ingredients and meals. Typical additive benefits to the food producer or processor include improving product quality, safety, and variety.
1. Key Functions of Food Additives
Additives may be found in varying quantities in foods, perform different functions, provide ingredients, and function synergistically with other additives. Their functions can usually be classified as one of the following:
- Maintain or improve nutritional quality,
- Maintain or improve product safety or quality,
- Aid in processing or preparation, and
- Enhance sensory characteristics (FDA, 1979, 1992).
Additives that affect nutritional quality are primarily vitamins and minerals. In some foods, these may be added to enrich the food or replace nutrients that may have been lost during processing. In other foods, vitamins and minerals may be added for fortification in order to supplement nutrients that may often be lacking in human diets.
Preservatives or antimicrobial substances are used to prevent bacterial and fungal growth in foods. These additives can delay spoilage or extend the shelf life of the finished product.
Antioxidants are additives that also can extend the shelf life of foods by delaying rancidity or lipid oxidation. Additives that maintain product quality may also ensure food product safety for the consumer.
Additives that are used as processing or preparation aids usually affect the texture of ingredients and finished foods. Some of these are classified as emulsifiers, stabilizers, thickeners, leavening agents, humectants, and anti-caking agents.
Chemicals in this group of food additives are also used to adjust the homogeneity, stability, and volume of foods. The fourth major function of food additives is to enhance the flavor or color of foods to make them more appealing to the consumer.
Flavoring chemicals may be used to magnify the original taste or aroma of food ingredients or to restore flavors lost during processing. Natural and artificial coloring substances are added to increase the visual appeal of foods, to distinguish flavors of foods, to increase the intensity of naturally occurring color, or to restore color lost during processing.
2. Usage Patterns of Food Additives
Chemicals that are added to foods may be manmade or derived from natural plant or animal sources. Also, additives may be synthesized for foods that are chemically or functionally identical to those that may be derived from natural sources.
In the case of color additives, synthetic colors are also identified as certifiable colors. Each batch of these coloring chemicals is tested by the manufacturer and the regulatory body concerned to ensure the safety, quality, consistency, and strength of the color additive prior to its use in foods.
Color additives that are exempt from the certification process include pigments derived from natural sources such as vegetables, minerals, or animals, or the manmade equivalents of naturally derived colors. Examples include annatto extract, paprika, turmeric, and beet powder.
If an additive from a natural source is added to a food, then its package label should indicate that. Additives are further classified by how they are added to foods.
Some additives are directly added to foods and ingredients, while others may be added indirectly through contact with packaging materials, for example, the preservatives BHA and BHT on the inside of breakfast cereal bags. Some undesirable food additives may be unintentionally added to foods.
For example, pesticides and fumigants may come in contact with produce and grains during growing, harvesting, and storage. While these chemicals may have permitted uses for some crops, they may be illegal for use on others. Sometimes pesticides are mistakenly or unintentionally applied at the wrong concentration or too soon before harvest.
Pesticides have been found, infrequently, on certain crops and at certain concentrations that are not permitted by the Environmental Protection Agency.
Other examples of unintentional addition of food chemicals are those that migrate into foods from packaging materials, especially plastics, and those that occur from poor storage practices.
Numerous chemicals may find their way into foods through contamination from the environment. Frequently cited examples include dioxin, polychlorinated biphenyl compounds (PCBs), and heavy metals such as lead and mercury.
Food additives are generally intended to provide important benefits to the producer or consumer of foods. But sometimes these additives cause unwanted or unhealthful effects.
Often these undesirable effects of food additives are due to their excessive or accidental use; usage at an inappropriate stage of production, processing, or storage; or from a lack of purity or quality.
Extensive research has been conducted on many additives to show they are safe for consumption and are effective for their prescribed function. For other additives, widespread and long-term use by food processors has demonstrated safety and efficacy.
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Regulatory Framework for Food Additives in Agriculture
1. Federal Oversight of Food Additives
Numerous research studies have confirmed that appropriate use of many additives is safe for human health and provides a benefit to the processor, preparer, or consumer.
Other additives are considered safe and efficacious due to successful widespread use over many years. Multiple federal agencies, laws, and regulations work together to ensure the safety and efficacy of thousands of food additives, but there are great differences in how many of these additives are regulated.
The Food, Drug, and Cosmetic Act of 1938 gives the U.S. Food and Drug Administration authority to regulate foods, ingredients, and their labeling. The 1958 Food Additives Amendment to the FD&C Act requires FDA approval for the use of new additives prior to their inclusion in food.
Also, this Amendment requires the additive manufacturer to prove an additive’s safety for its recommended use.
Food additives are defined as substances which may, by their intended uses, become components of food, either directly or indirectly, or which may otherwise affect the characteristics of the food.
The term specifically includes any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding the food, and any source of radiation intended for any such use (FDA, 1998a).
This definition does not include some classes of additives such as pesticide chemicals for raw agricultural products, new animal drugs, certified colors, or colors exempt from certification.
These additives are similarly regulated, but under other laws or acts. Additionally, food additives that have a history of safe usage are exempted from the regulation process described in the Food Additives Amendment.
One group of these additives is known as “GENERALLY RECOGNIZED AS SAFE” (GRAS), (e.g., salt, vitamins, etc.). They have been generally recognized, by experts, as safe based on their extensive history of use in foods before 1958, or based on published scientific evidence.
Another group of exempted additives is designated as prior sanctioned additives. These are substances that the FDA or U.S. Department of Agriculture (USDA) had determined were safe for use in specific foods prior to 1958 (e.g., sodium nitrite to preserve meat).
Other important federal regulation of food and color additives is described in the 1960 Color Additive Amendment to the FD&C Act, the 1990 Nutrition Labeling and Education Act, and the 1996 Food Quality Protection Act.
Current good manufacturing practice (CGMP) regulations can limit the quantity of food and color additives used in production. Manufacturers may only use the amount of an additive necessary to achieve a desired effect.
2. Monitoring Pesticide Use in Agriculture
In the case of pesticides for foods and animal feeds, the U.S. Environmental Protection Agency and the FDA have regulatory responsibilities for the approval and monitoring of pesticide use. Three major legislative acts describe the authority of the EPA and FDA to regulate pesticide chemicals (EPA, 1998).
The Federal Insecticide, Fungicide, and Rodenticide Act prescribes that the EPA is responsible for registering or licensing pesticide products for use in the United States. The Federal Food, Drug, and Cosmetic Act governs the maximum level of pesticide residues allowed in or on specific human foods and animal feeds.
In 1996, the Food Quality Protection Act (FQPA) amended these two acts in several respects. For example, to assess the risks of pesticide residues in foods or feeds, the FQPA requires that the combined exposure from dietary and other non-occupational sources be considered.
Also, when setting new or adjusted tolerances for pesticides, the EPA must consider any special risks to infants and children.
3. NAFDAC’s Food Additives Regulations in Nigeria
NAFDAC’s Food Additives Regulations 2019 repealed the Food Additives Regulations 2005. According to NAFDAC, “the repeal of these Regulations specified in Regulation 17(1) shall not affect anything done or purported to be done under the repealed Regulations”. Some details of the 2019 regulations are as follows:
i. Scope: These Regulations shall apply to:
- The labelling of food additives sold as such whether by retail or other than by retail, including sales to caterers and food manufacturers, and
- Food processing aids; any reference to food additives shall include food processing aids.
ii. Prohibition: No person shall manufacture, import, export, distribute, advertise, display for sale, or use any food additives, except food additives set out in the prescribed standards.
- Food additive shall be incorporated in the food in a quantity within the limits prescribed for such food and food additive in the National Standards for the particular food and Codex standards where applicable and as prescribed by the Agency.
- Where the limit prescribed for a food additive in the Codex standard is stated to be “Good Manufacturing Practice”, the amount of the food additive added to a food in the manufacturing and processing shall not exceed the amount required to accomplish the purpose for which that additive is required in that food.
iii. Food Additives Labeling Requirements: Food additives not to be described or presented on any label or in any labeling:
- In a manner which is false, misleading, or is likely to create an erroneous impression regarding its character in any respect.
- By words, pictorials, or other devices, which refer to or are suggestive directly or indirectly of any other product with which such food additives might be confused, or in such a manner as to lead the purchaser or consumer to suppose that the food additive is connected with or derived from such other product.
- Food additives with a shelf life not exceeding 18 months shall carry the date of minimum durability using words such as ‘will keep at least until…’. The words ‘for food use’ or a statement substantially similar thereto shall appear in a prominent position on the label.
iv. Labeling of Synthetic Colors: The risks or benefits of food additives and ingredients must be clearly displayed on labels for consumers. The FD&C Act requires, in virtually all cases, a complete listing of all the ingredients of a food.
The Nutrition Labeling and Education Act, which amended the FD&C Act, requires most foods to bear nutrition labeling and requires food labels that bear nutrient content claims and certain health messages to comply with specific requirements.
v. NAFDAC’s Regulation on Labeling of Synthetic Color and Mixture of Colors in Food: The aspect of this regulation clearly states that: No person shall manufacture, import, export, distribute, advertise, display for sale, or sell synthetic color, or a mixture of colors, for use in food, unless the label carries the:
- Lot number of the mixture,
- Words “food grade colour”, and
- Common name of the individual colors (synthetic or inorganic) in the mixture.
Assessing Risks of Food Additives in Agricultural Products
1. Determining Safe Quantities for Food Additives
For some additives, especially vitamins and minerals, the quantity added to a finished food product may not be sufficient to achieve an intended health benefit.
Some foods that are commonly consumed by the majority of the population may be supplemented with various vitamins or minerals.
A single serving of a fortified food may not provide the same health benefit as regular consumption of a fortified food. For example, iodine is added to table salt to provide a regular source of this important mineral.
Table salt is regularly consumed, and iodine is often lacking in typical diets. The determination of a beneficial, yet safe, quantity of iodine to add to table salt must consider the typical consumption of salt over the lifetime of the consumer.
While a food additive may provide a benefit to a processor or a consumer when used as intended, the use of an inappropriate quantity may be deleterious to the food or to the consumer.
If an additive is used in excess to process a product, then the desired effect may not be achieved, or else there may be an undesirable quality defect attributed to the product.
For example, if an artificial sweetener such as aspartame is added to a beverage in a high concentration, then the product may be too sweet and rejected by consumers.
Safety determinations of additive use should consider the effects of accidental or intentional consumption of a high quantity of an additive that is beyond its prescribed use level.
Toxicological principles for assessing the safety of food additives have been developed (FDA, 1993). Also, an additive may be injurious to health when consumed in moderate doses over extended time periods.
When the risks or benefits of food additive use are considered, estimation must be made of the long-term or lifetime consumption of the additive.
These substances may have cumulative effects on health, may interact with other biological or chemical compounds in the body, or may elicit different responses in consumers of different ages or health status.
2. Risk Assessment Process for Food Additives
The determination of the appropriate uses and concentrations of additives to allow in foods can be a complex process. Directly or indirectly added additives may have a demonstrated usefulness to a food processor or consumer, but they may also have harmful toxicological effects when consumed in excess quantities or by sensitive population groups.
In order to determine if a food additive can become a health hazard to the consumer, the inherent toxicity of the additive and the typical consumer consumption or exposure must be estimated.
Both the short-term and the lifetime cumulative exposures should be considered, since some additive usage may result in acute or chronic effects that are detrimental to health.
To protect individuals from the possible adverse effects of these substances, studies to assess the risk of exposure to chemical residues should be performed.
The basic components of a risk assessment include hazard identification, dose-response assessment, exposure assessment, and risk characterization (NRC, 1980, 1983).
3. Hazard Identification: This is the process where specific chemicals are causally linked to the exhibition of particular health effects. These may include illnesses, birth and developmental defects, and reproductive abnormalities.
Also, it must be determined if consumption of a chemical could lead to the development of cancer. Cancer usually develops after long-term exposure to a carcinogenic substance.
Other adverse health effects may be observed after a short-term or high-level exposure to an additive. In other words, the use of some additives may only be hazardous when consumed in specific quantities.
4. Dose-Response Assessment: This is used to predict the relationship between human exposure to the chemical and the probability of adverse effects. For carcinogens, it is assumed that no threshold level of exposure may exist, which implies that carcinogens may be hazardous when consumed in any quantity.
For non-carcinogenic hazards, toxic effects will not generally be observed until a minimum or threshold dose is reached.
5. Exposure Assessment: This is necessary to predict the likely amount of human exposure to an additive. For many foods and food additives, it can be difficult to determine how much may be consumed by a particular population and how consumption varies among individuals.
Some population subgroups may be exposed to greatly different quantities of food additives. Food consumption patterns vary greatly due to consumer age, gender, ethnicity, socioeconomic status, health status, and so on.
6. Risk Characterization: This describes the origin, magnitude, and uncertainties of estimates of the health risk.
Considerations for evaluating the overall risk of using a food additive must include whether it has specific hazardous properties, a prediction of the likelihood of adverse effects based on exposure, and an estimation of the amount of exposure.
Balancing Risks and Benefits of Food Additives
1. Risks of Food Additives
The GRAS ingredients would be included in this classification. Although GRAS ingredients are not legally food additives, the public perceives no distinction. This class includes thousands of substances. Any potential hazard to humans from a certain food additive depends on the toxicity of the food additive and the level at which the additive is ingested.
Human exposure to indirect additives is difficult to measure, but this exposure is minimal. The majority of direct food ingredients are used on the basis of a determination that they are GRAS or prior sanctioned.
Review of some items on the GRAS list has indicated that the majority present no significant hazard with normal use. The other direct food additives used in foods have been approved, and their uses are regulated by the FDA.
2. Benefits of Food Additives in Food Supply
The benefits derived from the food supply generally fall into four categories:
- Health benefits that reduce some health risk or provide some health benefits such as improved nutrition,
- Supply benefits relating to abundance, diversity, and economic availability,
- Hedonic benefits that provide sensory satisfaction, and
- Benefits that lead to increased convenience (Darby, 1980; Food Safety Council, 1980).
Food additives can play an important role in each of these categories of benefits by improving health, increasing supply, enhancing appeal, or improving convenience.
Of these benefits, health benefits should be given the greatest consideration, while supply benefits are second in importance. Increased convenience and improved appeal are the least important.
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