Food-simulating solvent

An extractive study of one can enamel in the presence of food-simulating solvents to determine how gamma radiation from a cobalt-60 source altered the nature and amount of extractives of this enamel. 

The migration of package ingredients directly into a food product is often difficult to analyze instrumentally because of interference from food ingredients. Some of these analyses have been made, but it is generally preferable to use food simulating solvents listed in FDA regulations and to carry out extraction tests under the conditions described. 

Tests have been conducted with Monsanto high barrier nitrile resins using the common food simulating solvents (Table X) plus some typical beverages. Conditioning times and temperatures were based on applicable FDA regulations and guidelines (16). 

McNeal T, Brumley WC, Breder C, et al. 1979. Gas-solid chromatographic-mass spectrometric confirmation of low levels of acrylonitrile after distillation from food-simulating solvents. J Assoc Off Anal Chem 62 41-46. 

P. Murphy, D. MacDonald, and T. Lickly, Styrene migration from general-purpose and high-impact polystyrene into food-simulating solvents, Food Chem. Toxicol, 30(3) 225-232, March 1992. 

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. 

Using certain kinds of solvents called food simulated solvents, migration from PS food containers was investigated [4]. Distilled water, an aqueous solution of... 

Polypropylene Aqueous food-simulating solvents Capillary SEC. Column 10 m x 50 mm i.d. SB-Biphenyl-30, 0.25-pm film. Mobile phase = CO2, linear flow rate 3 cm/sec. Pressure program, 100-400 bar temperature program, 55-100°C. 1-pL injection using solvent venting with gas purging. Retention gap was 1.8 m x 100 pm deactivated fused silica. Detection by FID and MS. Pentaerythrityl-tetrakis((3-(3,5-di-rert-butyl-4-hydroxy-phenyl) propionate) (V,A -bis(2-hydroxyethyl)-C 12.C14-amine) Tris-2,4-di-tert-butylphenyl)phosphite 32... 

To model migration of minor constituents from a polymeric film to a food-simulating solvent requires knowledge of (1) the equilibrium distribution of a migrant between polymer and solvent phases, l.e., the distribution or partition coefficient (K) and... 

Acrylonitrile is used in the production of acrylic fibers, resins, and surface coating as an intermediate in the production of pharmaceuticals and dyes as a polymer modifier and as a fumigant. It may occur in fire-effluent gases because of pyroly-ses of polyacrylonitrile materials. Acrylonitrile was found to be released from the acrylonitrile-styrene copolymer and acrylonitrile-styrene-butadiene copolymer bottles when these bottles were filled wifh food-simulating solvents such as water, 4% acetic acid, 20% ethanol, and heptane and stored for 10 days to 5 months (Nakazawa et al. 1984). The release was greater with increasing temperature and was attributable to the residual acrylonitrile monomer in the polymeric materials. 

Migration studies can use food-simulating solvents, such as 10% ethanol to represent aqueous, acidic and low-alcohol foods, or food oil or 50% or 95% ethanol to represent fatty foods. Experimental temperature and duration are set at the most extreme anticipated conditions. For example, the most extreme condition requires heating at 121°C for 2h, followed by 10 days at 40°C, in a special cell designed to withstand the extremes of temperature and pressure. The FDA uses migration data to estimate consumer exposure to the substance. In the previous system, an application could take several years to get approval. With the FCN system, the FDA has 120 days to review the application and object based on safety grounds, or the substance may be marketed. Expectations were that the new system would result in many more applications for new products from companies that otherwise would not have tried marketing in food applications. ... 

The decision between single or double sided extraction is based upon the construction of the test material, and its thickness. Structures greater than 0.05 cm thick are considered by the FDA to be infinitely thick. Single-sided extractions are most often used for coated materials or structures less than 0.05 cm thick. Two pieces of materials are separated by an inert spacer, thus defining a volume. This layered construction is secured so that the volume can be filled with the food simulating solvent. Donble-sided extractions are by far the most common type, i.e., when specimen thickness exceeds 0.05 cm. FDA requirements stipulate that the ratio of food simulating solvent volume to surface area of extracted material must be near to 0.3 ml/cm. ... 

The amount of packaging components that may be leached by food or food simulating solvents depends on the original concentration of the particular component or migrant in the polymer, its solubility in the solvent and/or the partition coefficient between the polymer and solvent as well as temperature and time [4]. 

In the design of a migration experiment, several key decisions are made at the outset. What substances are expected to migrate from the food contact material This question is answered with knowledge of the synthesis and or manufacturing of the food contact material. What food simulating solvent is appropriate This qnestion is answered by understanding the intended use of the food contact material, and the raw materials used in its construction. 

When these decisions have been made, the appropriate migration, or extraction experiments can be conducted. These extraction experiments yield samples of food simulating solvent (matrix) that contain some quantity of the migrating substance (analyte). Assay for these analytes in food simulating matrices is often quite challenging. 

Double-sided extractions are by far the most common type. The test material is simply immersed in the food simulating solvent in a container that is capable of withstanding... 

Concentration over steam, or evaporative concentration at reduced pressure are very commonly used for non-volatile analytes. This is true for aqueous/ethanolic food simulating solvents. When food oil simulants are used, aqueous buffers or acetonitrile are used to partition the analj e out of the oil and into a more volatile matrix for subsequent evaporative concentration. 

Another topic that merits discussion is the consideration of residual monomer in polymer formulations. Whole polymer samples, rather than food simulating solvent extracts of the polymeric material are sometimes assayed for residual monomer. The thought here is that if the amount of residual monomer in a formulation is low enough, and if one assumes that all of the residual monomer migrates into food, the human health impact... 

The raw migration data are expressed as mass of migrant per unit volume of food simulating solvent. The conversion to mass of migrant per unit surface area of test material extracted is as follows ... 

Orlando, FL, 7th-llth May, 2000, paper 438 ANALYTICAL METHODOLOGIES EMPLOYED EVA COMPREHENSIVE FDA FOOD CONTACT COMPLIANCE INVESTIGATION ANALYSIS FOR RESIDUAL MONOMERS, RESEV OLIGOMERS, ADDITIVES AND MODIFIERS IN SEVERAL FOOD SIMULATING SOLVENTS Eberhard J S McCort-Tipton M M Covance Laboratories (SPE)... 

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