Toxicology testing recommendations

Table 2.7 Toxicology testing recommendations for food contact substances based on dietary concentration (EXT) 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. DC and CDC values are in units of mass of migrant per mass food consumed. EDI and CEDI values are in units of mass of migrant per person per day. Abbreviations are as follows p,g (microgram), kg (kilogram), mg (milligram), < (less than or equal to), < (less than), > (greater than), and > (greater than or equal to)...

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...

Toxicity classification is based on recommended exposure limits provided by chemical suppliers. This rating is provisional and will be reviewed when toxicological testing is completed. 

The JECFA (Joint FAO/WFIO Expert Committee on Food Additives/FAO Food and Nutrition Paper No. 30 Rev. 1 and amendments (Food and Agriculture Organisation of the UN, Via della Terme di Caracalla, Rome/Italy)) has made recommendations for the ADI (acceptable daily intake (in mg/kg body weight)) of food additives based on toxicological tests these include flavoring substances. 

Table 1 Recommended Pharmacology and Toxicology Testing for New Excipients...

Information and data from toxicological tests are essential requirements of the food additive petition. The Redbook 2000 Toxicology Principles for the Safety Assessment of Food Ingredients (16) provides guidance to industry concerning the appropriate tests for the determination of safety. The Redbook discusses concern levels as a method to determine recommended toxicology tests for food and color additives. A level of concern can be assigned based on the potential health risk of the food additive. 

U.S. Food and Drug Administration. 2006. Guidance for industry. Summary table of recommended toxicological testing for additives used in food. Rockville, MD U.S. FDA. 

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... 

Coecke S, Ahr H, Blaauboer BJ, et al. Metabolism A bottleneck in in vitro toxicological test development. The report and recommendations of ECVAM workshop 54. Altern Lab Anim. 2006 34(l) 49-84. 

Should toxicological testing be required to assess the safety of biogenerated aromas, the procedure recommended by stofberg and Kirschman will facilitate the setting of priorities (27). With... 

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