Safety of food additives

As noted above, the FFDCA tasks FDA with determining whether a food contact notification has demonstrated the safety of the proposed use. The food additive Delaney clause of the FFDCA 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... . Therefore, demonstration of carcinogenicity in any animal species is deemed sufficient to prohibit approval as a food additive. 

JECFA has been meeting since 1956, initially to evaluate the safety of food additives. Its mandate has been expanded to contaminants, natural toxins, and residues of veterinary drugs in food. The Committee has also developed principles for the safety assessment of chemicals in food that are consistent with the current thinking on risk assessment, and take account of recent developments in toxicology and other relevant sciences. These principles were originally published in 1987, as Environmental Health Criteria 70 Principles for the safety assessment of food additives and contaminants in food. 

Principles and Procedures for Evaluating the Safety of Food Additives. Food Protection Committee, Food and Nutrition Board, National Academy of Sciences, Publ. No. 750, December 1.959. 

JECEA is an independent expert committee established (and jointly administered) by the FAO and the WHO in 1956 to evaluate the safety of food additives. Uie work has since expanded to include the evaluation of the safety of contaminants, naturally occurring toxicants and residues of veterinary drugs in food. JECFA serves as the risk assessor for the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF), establishing an acceptable daily intake (ADI) for a veterinary drug when sufficient information is available, recommending maximum residue limits (MRLs) for consideration by... 

Green, S. 1977. Present and future uses of mutagenicity tests for assessment of the safety of food additives. J. Environ. Pathol. Toxicol. 1 49. 

Green, S., Present and Future Uses of Mutagenicity Tests for Assessment of the Safety of Food Additives, ... 

Acceptable daily intake (ADI) The amount of a food additive that can be ingested daily in the diet without appreciable risk, determined on the basis of all facts known at the time. Without appreciable risk refers to the practical certainty that injury will not result, even after a lifetime of experience. The ADI is a practical approach to determining the safety of food additives and is a means of achieving some uniformity of approach in regulatory control. It serves to ensure that the actual human intake of a substance is well below toxic levels. In the United States, ADIs are determined by the U.S. Food and Drug Administration (FDA). 

A flurry of reports in the media exaggerating doubts about the safety of food additives led many retailers and food manufacturers to eliminate certain additives or reposition existing products as free from one or more food additives or classes of food additives. 

Under current regulations, no measures of efficacy (i.e., health benefits) for the substance in question are required. Section 409 deals with safety of food additives independent of efficacy because efficacy has traditionally been considered a property of drugs and inappropriate for foods unless accompanied by an authorized health claim. Interestingly, many of the components of human milk have drug-like effects (e.g., prevention of disease) and are not considered classic nutrients. 

FDA does not require petitioners to conduct human clinical studies to support the safety of food additives or color additives used in food, but, if deemed necessary, it recommends that the studies conform to guidelines presented in section VI.A. of the Redbook (OFAS, 2001, 2003). These guidelines are comprehensive and relevant for the clinical testing of ingredients new to infant formulas. 

The assessment of the safety of food additives and their control-in-use by legislation and by the Industry are also discussed, as well as the close co-operation which exists in practice between the Ministry of Agriculture, Fisheries and Food, and the Food Industry and its various Trade Organisations. 

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