Safety Evaluation of Food Additives

John R. Lupien

Substances have been added to foods for many years to help preserve the food, improve food appearance, alter the texture of the food, and carry out other functions in processed foods. Packaging materials for foods have also been developed containing substances than can migrate to the foods within packaged products. While basic processing of foods such as use of salt have been used for many centuries, the development of other substances added to food products such as preservatives, emulsifiers, thickening agents, nutrients and coloring agents took place mainly from the end of the 1800s until the present days.

With the development of more complex additives for foods in the 1940s and 1950s, concerns grew at the national and international level about the safety of food additives. At the international level the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) in the mid-1950s established the Joint FAO/WHO Expert Committee on Food Additives (JECFA) to carry out basic safety evaluation of substances added to foods for their food additive effect. In 1962 the FAO/WHO Codex Alimentarius Commission was established to elaborate food standards for foods moving in international trade, including standards for food additives. These international programs have continued to the present, and the publications and websites of FAO and WHO contain extensive information on specifications and safety evaluations for food additives, and on additives allowed in specific Codex food standards, or allowed for general use in either standardised or non-standardised food products.

At the national level, concern about food additives led to new laws and regulations designed to assure safety in use of substances already in use in foods, and required pre-market approval of new additives that were proposed for use in foods. The 1958 Food Additive Amendment to the US Food, Drug and Cosmetic Act required the US Food and Drug Administration (FDA) to evaluate all substances used in foods to determine if they were generally recognised as safe (GRAS), or needed a specific food additive clearance and regulation for their use. In addition, systems were developed for the safety evaluation and pre-market clearance and approval for new additives. Similar systems were established in the European Union, Japan, and other developed countries. In developing countries systems based on utilisation of JECFA and Codex were put into place.

In order to evaluate the safety of a food additive, a number of steps are required. First a clear specification of the substance must be developed stating its chemical structure and testing systems for the substance, and in most cases tests for the substance in food products. Specifications for food additives can be found in the US Food Chemical Codex, and similar national publications in Japan and the European Union.

With a clear specification for the substance, a wide range of toxicological procedures can be done on test animals such as mice, rats, rabbits, dogs and pigs to establish safe limits for the substance. In practice these tests establish a level of use called the No Adverse Effect Level (NOEL), taking into account this level in the most sensitive species of animal used in the testing. A safety factor, usually of 100, is used is setting an acceptable daily intake (ADI) of the substance by national authorities and JECFA experts. This safety factor is used to reflect the relative longevity of humans in comparison to the test animals used in establishing the No Adverse Effect level.

In utilising the ADI at the national level, it is necessary to have data on dietary habits, and average intakes of various foods by different age groups (young children, adolescents, adults, males, females). This data is needed so that regulations specifying how much of a particular additive can be used in specific foods will not result in exceeding the ADI with regard to overall dietary intake. Thus, while JECFA, Codex and food additive limits are very helpful, specific dietary information from each country helps assure that ADIs for different additives are not exceeded.

All systems used for the safety evaluation of food additives are based on the premise that the use of these substances in food products will not have any adverse effects in humans. While there are occasional criticisms of additives, examination and re-evaluation of such additives by national authorities, academia, and JECFA have shown in virtually all cases that the substance in question was safe and that the data or other information on which the criticism was based was not well founded.

Safety evaluations exist for virtually all additives and are available from the FAO/WHO JECFA websites, and from national websites such as that of the [US] FDA, the European Food Safety Authority (EFSA) and other countries. Since evaluation of food additives requires extensive and expensive research, many countries developing food additive regulations and control systems can benefit by using information and data contained in JECFA, Codex a monosodium glutamate (MSG),nd national / EU publications, rather that go to the time-consuming and expensive development of data using scarce national resources.

Example: Safety Evaluation of Monosodium Glutamate

Dr John R. Lupien is Adjunct Professor of Food Science at the University of Massachusetts, Amherst, MA, USA, a former (1986-2000) Chief of the FAO/WHO Codex Alimentarius Commission, and a former Director of the FAO Food and Nutrition Division. He is a Fellow of the International Academy of Food Science and Technology (IAFoST), a former Member of the Editorial Advisory Board for The World of Food Science, and is a regular correspondent for IUFoST; E-mail: john@jrlupien.net