Food Additives - Are They Safe?

Food Additives: Are They Safe?

As much as we may not like the idea, food additives play a role in today's food supply. There are both advantages and disadvantages to their use. They do allow a growing urban population to have a variety of foods year-round. And, they make possible an array of convenience foods without the inconvenience of daily shopping.  But are they safe?

Back to the main Food Safety page

Although salt, baking soda, vanilla and yeast are commonly used in foods today, many people tend to think of any additive added to foods as complex chemical compounds. Most food additives are regulated by federal authorities and various international organizations. The purpose of this page is to provide helpful background information about food additives, why they are used in foods and how regulations govern their safe use in the food supply.

What are food additives used for?

There are some good reasons for the use of food additives; especially naturally-derived additives. They can be used to:

With the help of our food additive list, you can look up various additives to find out what they are, what they do and whether they are safe!

What do food additives do?

Some food additives have more than one use. Food additives are often listed according to their functional or class names. Examples of the most common functions are:


  Food Additives: Pro and Con


BACKGROUND

The Federal Food, Drug and Cosmetic Act of 1938 (FFDCA) gives FDA the authority to regulate food additives. Food additives are any substance or mixture of substances other than the basic foodstuff which are present in a food as a result of any phase of processing, packaging, or storage. (2) Food additives have different functions. The food industry uses additives to maintain consistency, palatability and wholesomeness, to improve nutritional value, to control acidity or alkalinity, to enhance flavor or impart a desired color, and to keep food wholesome and appealing while in route to markets. FDA approval of a food additive is not a product license limited to a single sponsor, but is generic in that anyone can manufacture or use an additive consistent with any existing patent protection. (3)

In regulating food additives, FDA classifies the additives in four categories:

  1. prior-sanctioned substances which were approved either by FDA or the U.S. Department of Agriculture (USDA) before the passage of the 1958 Food Additives Amendments;
  2. GRAS additives (generally-recognized-as-safe) which are exempt from regulation because their extensive use has produced no known harmful effects;
  3. direct additives which are intentionally added to foods such as lemon flavoring in cookies; and
  4. indirect additives which are often trace substances that leach from packaging materials and migrate to food during processing or storage.

Congress is actively debating proposals to reform several aspects of the Food and Drug Administration's (FDA) process for regulating consumer products including its approval process for food additives. During two days of recent hearings on this process, concerns were raised about lag times in approval of food additive petitions, and about FDA regulations stifling innovation.  FDA officials responded that food additives are potentially consumed by everyone in the population, including the most vulnerable populations such as children or the elderly. Consequently food additives must be carefully tested before approved for the market because they could cause deleterious health effects. This report


 

FDA'S CONCEPT OF "SAFETY"

The degree of health risk of a food additive is determined in FDA's pre-market testing and approval process. Manufacturers must prove in its petition for pre-market approval to FDA that its additives are safe. FDA regulates the type of food in which an additive can be used, the maximum quantity that can be used, and the information that must appear on the label about the additives Regulations known as Good Manufacturing Practices (GMP) limit the amount of food and color additives used in foods. Manufacturers use only the amount of an additive necessary to achieve the desired result.

The legislative history of the "Food Additives Amendments of 1958" interpreted what Congress meant by safety. It said that a "reasonable certainty of no harm" would be the standard. The amount of data necessary to demonstrate this safety standard to the FDA reflects the proposed conditions of use of the additive. An additive may be consumed by all citizens for all ages and in all health conditions for a lifetime. In approving petitions, FDA must ensure that the data will legally support the agency's decision and that the administrative record developed must provide the basis for defending any resulting food additive approval in court. At the same time, Congress created a separate, more stringent standard for preventing cancer-causing substances from being added to foods. It included a clause, the Delaney Clause, which banned any food additive shown to cause cancer in man or animal. It basically set up a "zero-cancer-risk" standard for food additives. Later, Congress added the same zero-cancer-risk clause for amendments governing new animal drugs, and color additives. (5)

Reasonable Certainty of No Harm

The "reasonable certainty of no harm" standard stems from the legislative history of the Food Additives Amendment of 1958 [P.L. 85-929]. The amendments created Section 409 of the FFDCA. In the report of the House Committee on Interstate and Foreign Commerce, which amended and favorably reported H.R. 13254, the Committee stated:

The concept of safety used in this legislation involves the question of whether a substance is hazardous to the health of man or animal. Safety requires proof of a reasonable certainty that no harm will result from the proposed use of an additive. It does not--and cannot--require proof beyond any possible doubt that no harm will result under any conceivable circumstance.

This was emphasized particularly by the scientific panel which testified before the subcommittee. The scientists pointed out that it is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of any chemical substance.

In determining the "safety" of an additive, scientists must take into consideration the cumulative effect of such additive in the diet of man or animals over their respective life spans together with any chemically or pharmacologically related substances in such diet. Thus, the safety of a given additive involves informed judgments based on educated estimates by scientists and experts of the anticipated ingestion of an additive by man and animals under likely patterns of use.

Reasonable certainty determined in this fashion that an additive will be safe, will protect the public health from harm and will permit sound progress in food technology.

The legislation adopts this concept of safety by requiring the Secretary to consider in addition to information with regard to the specific additive in question, among others, the following relevant factors: (1) the probable consumption of the additive and of any substance formed in or on food because of the use of such additive; (2) the cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substances in such diet; and (3) safety factors which qualified experts consider appropriate for the use of animal experimentation data..."

In addition, FDA has incorporated this concept of safety into its color additive regulations. Under 21 CFR 70.3(i), a color additive is "safe" if "there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive." Therefore, the general safety clause prohibits approval of a color additive if doubts about the safety of the additive for a particular use are not resolved to an acceptable level in the minds of competent scientists.

The Delaney Clause

The Delaney Clause is contained in Section 409 [348(c)(3)(A)] of the FFDCA. Section 409 lays out requirements for the use of all additives in foods, including pesticide residues that could concentrate from levels in raw products in their processed form, or that are added during processing. The Delaney Clause states:

That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal....

The Delaney Clause does not allow consideration of whether the cancer risk is "negligible" (extremely small), or whether there are other characteristics of the product such as benefits of product use. The Delaney Clause establishes a "zero-cancer-risk" standard for food additives, including pesticide residues. If residues of carcinogenic pesticides are found to concentrate in processed foods, the Environmental Protection Agency (EPA) cannot set a tolerance or maximum legal limit for that pesticide/food combination. Since 1958, science has developed methods to detect smaller and smaller quantities of residues. Thus, when FDA monitors processed foods with more sophisticated equipment and finds residues of carcinogenic pesticides in parts per billion, these processed foods must now be considered adulterated under the law.

Over time, as the following chronology shows, the Delaney Clause "zero-cancer-risk" provision has led to the cancellation of about eight different additives: a veterinary drug; a veterinary feed additive, a flavoring agent, saccharin; indirect food additives from packing materials; and several color additives. All these additives had substitutes available at the time except for saccharin. Consequently, there was little impact on the food supply.

horizontal rule

CURRENT DEBATE OVER FOOD ADDITIVE POLICIES

Congress, in the process of debating proposed reforms of the Federal Government's regulatory policies, has been looking at two aspects of food additive regulations:

  1.  the lag time in the review of food additive petitions; and
  2.  changing the risk standard by which to judge the safety of food additive petitions.

The House Committee on Government Reform and Oversight, Subcommittee on Human Resources and Intergovernmental Relations, held two days of hearings (June 22 and 29, 1995) on FDA delays in reviewing food additive petitions. FDA claims that lag times in approving food additive petitions are often caused by two factors: 1) the submissions by the petitioners do not include data that adequately support a conclusion that a specific additive is safe; or 2) the FDA keeps the petition file open with the clock running rather than rejecting the petition outright to allow petitioners to add supplemental information about additional safety studies. FDA claims this approach is less adversarial than simply denying petitions. Some petitioners from the industry support this cooperative process, while others complain that they are moving their businesses overseas because of the expense incurred from waiting for FDA approval.

FDA responded to many complaints about their lag time with a proposal on June 22, 1995, to streamline the pre-market approval process by: reorganizing their food center, the Center for Food Safety and Applied Nutrition (CFSAN); increasing the food additive petition review staff through shifting personnel; setting a timetable and goals to complete reviews for additives, depending on the degree of risk shown by the additive; and establishing new approaches to petition review whereby they develop a notification procedure only for noncarcinogenic packaging substances and GRAS substances. A major policy shift was announced also at the hearing. FDA stated that within the year, it will award two separate contracts: 1) to an independent third-party scientific review group to review indirect food additive petitions (components of food packaging) for safety; and 2) to another review panel to review specific types of studies such as classical, standard toxicity studies which are routinely submitted to FDA to support food additive petitions. In both cases, the FDA will reserve for itself the final decision on whether the food additive meets the "reasonable certainty of no harm" safety definition.

During the 1980s, FDA received 655 food additive petitions, of which 141 or 22 percent were for substances added directly to foods. The rest, or 78 percent were for indirect food additives. FDA currently has 151 applications pending, almost all of which are for indirect additives. Table 1 shows FDA's actions on food additive petitions over the last five years.

TABLE 1. Direct and Indirect Food Additive Petitions Received by the Food and Drug Administration, October 1, 1989, to March 31, 1995.

         
Fiscal Years Petitions Received Petitions Approved Petitions Withdrawn Petitions Pending
1990 50 22 15 13
1991 50 17 7 26
1992 44 15 5 24
1993 56 12 3 41
1994 3 1 1 28
1995 (to 3/31/95) 19 0 0 19

Source: Food and Drug Administration. Attachment AB. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 1996. Hearings before a Subcommittee of the Committee of Appropriations. House of Representatives. Part 6. Agricultural Programs. p.663-664.

Congress is currently considering legislation on regulatory reform as well as amendments to appropriations bills that could limit the Delaney Clause influence over food and color additives and new animal drugs policies. One bill (S. 343) contains a provision which would establish a risk standard so that: "No agency shall prohibit or refuse to approve a substance or product on the basis of safety where the substance or product presents a negligible or insignificant foreseeable risk to human health resulting from its intended use." Other bills such as H.R. 1627, the Food Quality Protection Act of 1995, would amend the FFDCA and create a new Section 408. The new section, Title [V in this bill, would establish a single negligible risk standard for pesticide residue tolerances in raw and processed foods, reforming the inconsistent provisions in these statutes that govern the use of pesticides on foods by rewriting Section 408 of the FFDCA to cover both raw and processed foods. It effectively eliminates the Delaney Clause "zero-cancer-risk" criteria from the tolerance-setting process. It would allow EPA to determine what level of risk will be adequate to protect the public health as long as the dietary risk posed to food consumers is negligible.

 

Database of Food Additive  regulations and Information : This is an informational database maintained by the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) under an ongoing program known as the Priority-based Assessment of Food Additives (PAFA). It contains administrative, chemical and toxicological information on over 2000 substances directly added to food, including substances regulated by the U.S. Food and Drug Administration (FDA) as direct, "secondary" direct, and color additives, and Generally Recognized As Safe (GRAS) and prior-sanctioned substances. In addition, the database contains only administrative and chemical information on less than 1000 such substances. The more than 3000 total substances together comprise an inventory often referred to as "Everything" Added to Food in the United States (EAFUS).

This list of substances contains ingredients added directly to food that FDA has either approved as food additives or listed or affirmed as GRAS. Nevertheless, it contains only a partial list of all food ingredients that may in fact be lawfully added to food, because under federal law some ingredients may be added to food under a GRAS determination made independently from the FDA. The list contains many, but not all, of the substances subject to independent GRAS determinations.

This page was updated on 23-Mar-2017