Threshold of regulation

Based on this finding, the FDA developed 21 CFR 170.39, Threshold of regulation for substances used in food-contact articles, which specifies the conditions under which a substance used in a food-contact article that migrates or can be expected to migrate into food will be exempt from regulation as a food additive. One requirement is that the substance has not been shown to be a carcinogen in humans or animals, and there is no reason, based on the chemical structure of the substance, to suspect that the substance is a carcinogen. Additionally, the substance must present no other health or safety concerns because 

There is also a provision for higher limits for a substance that is currently regulated as a direct food additive. In addition, the regulation requires that the substance 

Not every user of an exempted substance must request FDA approval. If other prospective users determine that their applications meet the FDA guidelines under which an exemption was granted, they can proceed with the use. Of course, if they err and there is any hazard resulting from such use, they can be held liable. If the FDA later rescinds an exemption for a substance, in addition to notifying the requesters, a notice will be published in the Federal Register, so that other manufacturers using the exempted substances under similar conditions will be aware of the change. 

While we have discussed packaging materials only, the regulations for indirect food additives are written for food contact articles and it is clearly stated that they also apply to food processing equipment. Therefore, plastic food contact surfaces in processing equipment must meet the same requirements as plastic food packages. Migration limits, however, are often different for single-use and multiple-use items. 

There is sometimes confusion within the industry about why the food contact surfaces of eating utensils, receptacles, paper towels, and other kitchen appliances do not fall under the same regulations as food packaging. These were excluded from the 1958 Food Additives Amendment from the beginning, and the FDA has reaffirmed this in many letters. This does not mean that the maker of an item that is considered a houseware can ignore the public safety issues of the plastics and additives used. It would be advisable for any manufacturer to follow similar guidelines as must food packagers, but such practice is voluntary. 

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The extractable contamination concentration from 100% recycled PET bottles into all kinds of foodstuffs (aqueous, alcoholic and fatty) was shown to be several orders of magnitude below the FDA threshold of regulation, even if the initial contaminant concentration was significantly above the values found in the waste stream [136],... 

The general TTC concept, covering also carcinogenic effects, was introduced by Rulis (1986, 1989) as a Threshold of Regulation. Rulis used data on a subset of 343 oral carcinogens from animal smdies compiled in the Carcinogenic Potency Database (CPDB) (Gold et al. 1984). 

The stmcmre-based, tiered TTC approach as outlined by Munro et al. (1996, 1999) is used by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in a procedure for the evaluation of flavoring substances in food, including an acceptance of the general TTC of 1.5 pg/person/day, i.e., the US-FDA Threshold of Regulation (Section 4.13.1). The European Food Safety Authority (EFSA) also uses this approach for evaluation of flavoring substances, except that the general TTC of 1.5 pg/person/day is not accepted (Larsen 2006). 

Cheeseman, M.A., E.J. Machuga, and A.B. Bailey. 1999. A tiered approach to threshold of regulation. Food Chem. Toxicol. 37 387 12. 

Federal Register. 1993. Food additives Threshold of regulation for substances used in food-contact articles Proposed rule. 58 52719-52729. 

Rulis, A.M. 1986. De minimis and the threshold of regulation. In Eelix, C.W. (Ed.) Food Protection Technology 29-37. Chelsea, Michigan Lewis Publishers Inc. 

On the basis of the results of these analyses, FDA concluded that the noncarcino-genic toxic effects caused by the majority of unstudied compounds would be unlikely to occur below dietary concentration of 1 mg/kg. To provide an adequate safety margin, however, the dietary concentration chosen as a level that presents no regulatory concern should be well below 1 mg/kg. Therefore, FDA established a dietary concentration of 0.5 pg/kg (0.5 ppb) as the threshold of regulation for substances used in food contact articles. A 0.5 pg/kg (0.5 ppb) threshold is 2000 times lower than the dietary concentration at which the vast majority of studied compounds are likely to cause noncarcinogenic toxic effects and 200 times lower than the chronic exposure level at which potent pesticides induce toxic effects. FDA believes that these safety margins,... 

FDA also concluded that establishing a 0.5 pg/kg dietary concentration as the threshold of regulation is appropriate because it corresponds to a migration level that is above the measurement limit for many of the analytical methods used to quantify migrants from food-contact materials. Thus, decisions are usually made based on dietary concentrations that result from measurable migration into food or food-simulating solvents rather than on worst-case estimates of dietary concentration based on the detection limits of the methods used in the analysis. 

Rulis, A., 1989, Establishing a Threshold of Regulation. Risk Assessment in Setting National Priorities, Edited by Bonin, J., and Stevenson, D., Plenum Publishing Corp., 271-278. 

Rulis, A. 1992. Threshold of Regulation Options for Handling Minimal Risk Situations. Food Safety Assessment, Edited by J.W. Finley, S.F. Robinson, and D.J. Armstrong (American Chemical Society, Symposium Series 484), 132-139. 

An increasing number of colored inorganic pigments are FDA-compliant. Historically, yellow iron oxide, red iron oxide, black iron oxide, zinc ferrite, burnt umber, raw and burnt sienna, channel carbon black, chromium oxide green, ultramarine blue, cobalt blue and copper chrome black have enjoyed FDA—compliant status, under 21 CFR 178.3297, Colorants for Polymers . More recently, the FDA has been successfully petitioned with regard to nickel titanium yellow, chrome titanium yellow, and cobalt green under 21 CFR 170.39, Threshold of Regulation for Substances Used in Food-Contact Articles . 

First, it is critical to know the amount and composition of your raw materials and other substances you have on site. Do not forget your facility s maintenance area, where toxic and reportable materials are often used and stored. Most environmental laws have thresholds of regulation if you use less than the threshold amount of material, you do not fall under the regulation. 

Table 2.2 Regulatory options relevant to food contact materials with regard to the food additive petition (petition), food contact notification (FCN) and threshold of regulation (TOR) exemption processes...

FDA s threshold of 1.5 fig/p/d is an example of the threshold of toxicological concern approach. Below this threshold level of consumer exposure, FDA does not consider specific testing necessary to identify compounds with significant carcinogenic potential. This threshold of regulation is not meant to be a level below which no chemicals could be harmful. FDA s threshold... 

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