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</html>";s:4:"text";s:10260:"Classifications for food-types and conditions of use that may be helpful are given in Appendix V. Sponsors should address the stability of the FCS under the proposed conditions of use. It may be expected that this low concentration in food would lead to a commensurately low dietary concentration for the FCS. If the intended use of the FCS involves contact with food at temperatures higher than room temperature, tests should be conducted at the highest use temperature for the maximum expected time period. and Appendix IV. Office of Food Additive Safety The concentration of an FCS in the daily diet may be determined from measured levels in food or in food simulants. Table 1, CF = 0.8) should be used with the migration data to calculate the concentration of the FCS in the daily diet. Validation experiments are carried out with the set of test simulants exhibiting the highest level of antioxidant migration. For such applications, FDA's recommended migration protocols call for short-term accelerated testing designed to simulate FCS migration that may occur during the entire food-contact period. McNeal, T. P. and Hollifield, H. C., 1993, Determination of volatile chemicals released from microwave-heat-susceptor food packaging. SELECTED MIGRATION TESTING PROTOCOLS, APPENDIX III. In cases where a polymer adjuvant is the subject of interest, test solutions of the polymer formulated without the adjuvant may serve as the matrix for fortification and recovery measurements. Sponsors should report results in terms of milligrams of substance extracted per square inch (mg/in2) of surface area. FDA recommends the use of the protocol outlined in an article by McNeal and Hollifield (McNeal and Hollifield, 1993) for the identification and quantification of volatiles from susceptors. Food Cosmetics Toxicology, 11, 975-988. FDA will calculate the concentration of the FCS or other components that might migrate to food expected in the daily diet based on analyzed or estimated levels in food or food simulants. 15. Although FDA always has accepted reliable analyses of FCS in real foods, in practice, many analytes are difficult to measure in food. C.   Hot filled or pasteurized above 66 ºC (150 ºF). are intended to provide estimates of the highest level of migration to food that might result from the anticipated use of the FCS. relating to FDA's development of the use of food simulants. Recommended protocols for selected situations are given in Appendix II. Arthur D. Little, Inc., August 1990: High Temperature Migration Testing of Indirect Food Additives to Food. Spectra or chromatograms of the "blank" will facilitate the verification of the absence of interferences. Chemical Abstracts Service (CAS) Registry Number. The specific protocol depends on the particular uses anticipated. In some cases an infrared (IR) spectrum is sufficient, but occasionally other information, such as visible and ultraviolet absorption spectra or nuclear magnetic resonance (NMR) spectra, are more useful. For high-temperature oven use (conventional and microwave*), migration testing should be performed at the maximum intended cooking temperature for the longest intended cooking time, using a food oil, or a fatty-food simulant (such as Miglyol 812). Chemical equations for known or likely side reactions occurring during manufacture of the FCS, including catalyst degradation reactions. In general, under identical testing conditions, levels of migrants from low-density polyethylene (LDPE) are higher than from high-density polyethylene (HDPE) or polypropylene (PP). In general, a lower calculated concentration in the daily diet will result if a series of representative polymers are separately tested and individual consumption factors are applied (refer to the examples in Appendix IV.). APPENDIX I. FATTY-FOOD SIMULANTS FOR SPECIFIC POLYMERS, APPENDIX II. 							Rockville, MD 20852. Solvents should be added to the test samples at 100°C (212°F), held for 30 minutes, and then allowed to cool to 40°C (104°F). Therefore, when total nonvolatile extractives or solvent-soluble8 total nonvolatile extractives are determined for a paper coating, do not subtract the corresponding extractives from uncoated paper as a blank correction. Hildebrand solubility parameters for polymer/solvent systems can be found in the Polymer Handbook, 4th Edition, J. Brandrup (Editor), Edmund H. Immergut (Editor), Eric A. Grulke, Akihiro Abe, Daniel R. Bloch, John Wiley & Sons. Schwope, A. D., Till, D. E., Ehntholt, D. J., Sidman, K. R., Whelan, R. H., Schwartz, P. S., and Reid, R. C., 1987, Migration of BHT and Irganox 1010 from low-density polyethylene (LDPE) to foods and food-simulating liquids. FDA Contract No. 16. If migration test solutions are fortified, they should be fortified before analytical workup but after the prescribed test time, e.g., 240 hours. J. AOAC International, 76 (6), 1268-1275. Industrial & Engineering Chemistry, Fundamentals, 21 (2), 161-168. For example, the retortable pouch initially was treated as a replacement for coated metal cans and was assigned a CF of 0.17. Therefore, FDA recommends that migration studies be conducted in a manner similar to that outlined in the article by Begley and Hollifield. Prior to entering the driers, the slurry is mechanically concentrated to contain approximately 33% pulp and 67% water. If technical effect is dependent on particle size, sponsors should present data that demonstrate the specific properties of the particles that make them useful for food-contact applications. In the absence of appropriate limitations, FDA may be required to use assumptions in estimating exposure that would result in more conservative values for certain classes of FCSs. Polymer antioxidants, by their nature, would be expected to partially decompose during thermal processing of the resin or food-contact article to which they have been added. ASTM, West Conshohocken, PA 19428-2959. Helmroth, E., Rijk, R., Dekker, M., Jongen, W., 2002, Predictive modeling of migration from packaging materials into food products for regulatory purposes. For other polymers, sponsors should consult with FDA concerning use of an appropriate fatty-food simulant before performing migration experiments. Recent studies by FDA, however, have shown little difference in migration levels at 49°C and 40°C (104°F). For high-temperature oven use, migration testing should be performed at the maximum intended conventional oven cooking temperature for the longest intended cooking time, using a food oil, or fatty-food simulant (such as Miglyol 812). As noted above, FDA encourages the submission of information that may be used to subdivide the market(s) anticipated for articles manufactured from the FCS. This value corresponds to 0.080 mg/kg in food if it is assumed that 10 grams of food contacts 1 in2 of film. For a new adjuvant in paper coatings, the test solutions should be analyzed for the unregulated adjuvant. A more complete discussion of this topic is given in Section II.E. Please consult with FDA to discuss recommended protocols for this use. The mixed unit, mg/in2, is preferred, however, to facilitate conversion to concentrations in food. Sponsors should submit representative spectra or chromatograms from validation analyses of fortified and blank samples. The choice of a particular catalyst technology for the synthesis of polyolefins such as LLDPE, HDPE, and PP determines their unique physical properties, such as molecular weight and melt flow index. If quantitation of individual migrants is not possible, sponsors should determine the distribution of the extractives between organic and inorganic fractions by solvent fractionation (i.e., the fraction of the TNE residue that is soluble in chloroform or other suitable solvent[9]). Keith, L. H., Crummett, W., Deegan, Jr., J., Libby, R. A., Taylor, J. K., and Wentler, G., 1980, Principles of environmental analysis. Sponsors should examine general use limitations in effective notifications and regulations for similar FCSs and should include a comprehensive set of limitations on the intended use. Recommended sampling times for a ten-day test are 2, 24, 96, and 240 hours. Migration Modeling (See FDA Form 3480 ( PDF format | Word Template )- Part II, Section F, item 2). After each time interval, each solution from one set was evaporated to dryness, the residue dissolved in an appropriate organic solvent, and a known aliquot injected into a gas chromatograph. If analysis or calculation shows that the final adjuvant concentration in paper cannot exceed 1 mg/kg and the basis weight of the finished paper is 50 pounds/3000 ft2, or 50 mg/in2, then the maximum weight of adjuvant per unit area of paper is 1 x 10-6 g adjuvant/g paper x 50 mg/in2 = 0.000050 mg/in2[4]. D.   Hot filled or pasteurized below 66 ºC (150 ºF). Each solution was worked up and analyzed as described above. Baner, A., Brandsch, J., Franz, R. and Piringer, O., 1996, The Application of a predictive migration model for evaluating the compliance of plastic materials with European food regulations. CONCENTRATION IN THE DAILY DIET AND EDI. This should include chemical formulae, structures, and molecular or formula weights for single compounds or components of commercial mixtures. may be appropriate for evaluating the level of migration from non-food-contact layers of some laminate structures. Miglyol 812 is derived from coconut oil (see main text and Appendix I.). As noted, FDA generally makes estimates based on the assumption that a new product will capture the entire market. and Breder, C.V., 1985. Section 409(b) of the Act sets forth the statutory requirements for data in an FAP to establish the safety of a food additive. Begley, T. and Hollifield, H., 1991. Table I). A food oil is the most extreme example of a fatty food. This is most likely due to a large difference in solubility between the polymer/migrants and chloroform. 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