Safety assessment of food additives

101 Toxic Food Ingredients

101 Toxic Food Ingredients

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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.

As discussed in FDA's Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations (FDA, 2002), FDA has set forth minimum testing recommendations for tiered levels of expected consumer exposure. These recommendations are based on the general principle that the potential risk is likely to increase as exposure increases. In addition, submitters are encouraged to discuss the structural similarity of their food contact material or its constituents to known mutagens or carcinogens. This analysis is termed structure-activity relationship (SAR) analysis and is recommended for all exposures (discussed further below). Table 7.1 summarizes

Table 7.1 Toxicology testing recommendations for food contact substances based on dietary concentration (DC) and corresponding estimated daily intake (EDI) values. Note that the cumulative exposures are based on non-biocidal chemicals; biocidal tiers are one-fifth the cumulative dietary concentration (CDC) and cumulative estimated daily intake (CEDI) values expressed

Exposure

Recommendation

mg/kg

(CEDI of > 1.5 mg/person/day but < 150 mg/person/day)

(CEDI of > 150 mg/person/day but < 3 mg/person/day)

CDC of > 1000 mg/kg (EDI of > 3 mg/person/day)

• No toxicity testing recommended.

• Available information on potential mutagenicity and carcinogenicity, published and unpublished, should be submitted and discussed.

• Structural similarity of the substance to known carcinogens or genotoxic chemicals should be discussed, if appropriate.

Recommendations for DC of < 0.5 mg/kg and:

• Genetic toxicity tests on the substance

1. A test for gene mutations in bacteria

2. An in vitro cytogenetic test in mammalian cells or an in vitro mouse lymphoma tk± assay.

Recommendations for DC of < 0.5 mg/kg and:

• Genetic toxicity tests on the substance

1. A test for gene mutations in bacteria

2. An in vitro cytogenetic test in mammalian cells or in vitro mouse lymphoma tk ± assay.

3. An in vivo test for chromosomal damage using rodent hematopoietic cells.

• Potential toxicity of the substance should be evaluated by two subchronic (90-day) oral toxicity tests, one in a rodent species and the other in a non-rodent species.

• Results from these studies or other available information may trigger the need for longer term (1-year or 2-year) or specialized (e.g. reproductive/developmental toxicity, neurotoxicity, etc.) tests.

Recommended food additive petition containing the data listed above for lower exposures and:

• Two-year carcinogenicity bioassays in two rodent species (one study should include in utero phase)

• A two-generation reproductive study in rats with a teratology phase.

• other specialized studies, as appropriate.

FDA's recommendations. The regulations for submitting food contact notifications stipulate that all relevant toxicity data available to the notifier be made available to FDA. The rationale and utility of the recommended genetic toxicity tests are discussed in detail by the FDA's Redbook (FDA, 2004).

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