United Science offers FCN 772 Premarket Submission UV/EB polymeric migration testing services for FCN 772 coating migration compliancy. Coatings or adhesives based on UV or EB cure polymers are considered safe if they are used in accordance with food additive regulations or clearance. Food Contact Notification (FCN) 772 is a substance that was cleared by the FDA on March 7, 2008 and defines a mixture of one or more polymers including: TPGDA, TMPTA, TMPEOTA, BADGEDA, and photo initiator ESACURE ONE. The mixture can be formulated as food contact coatings that can be applied as inks, adhesives or polymeric coatings to cans, foils, paper, cardboard, or polymeric substrates. Key requirements for compliance determination include defined condition of use and food type.
The finished polymer is cured with either EB or UV radiation such that the finished coating or adhesive show migration levels of photoinitiator or monomer that do not exceed 10 micrograms per square inch and a total level of nonvoatile extractables derived from the food contact substance not to exceed 10 micrograms per square inch, after correction for the migration levels for each monomer and photoinitiator used.
Verification Analysis for Premarket Submission
There are three separate services offered by United Science. They include:
- Determine the total volatile and non-volatile content including monomer extractables, photoinitiator extractables and non-volatile extractables for a single coating on a single substrate for one food type at a specified condition of use.
- Determine FCN 772 compliancy at three cure levels (undercure, normal, overcure).
- Correlation of FCN 772 extraction method with infrared optical analysis method for low cost quality compliance control.
A typical verification analysis involves the following steps:
The customer will supply United Science with a cure ladder at 3 cure levels ranging from over cure to under cure conditions on desired backing polymer and on foil backing. We will extract the samples including controls according to customer specified Food Type and Condition of Use as per Tables 1,2 in 21 CFR 176.170(c). We will then analyze the amount of monomer/initiator that has eluted from the samples at the specified time points. We will also analyze for total nonvolatile extractables and calculate the total extractables as per the requirements of the regulation.
There are three easy ways to get a quote:
1. Call 651.321.8361
2. Email firstname.lastname@example.org
3. Fill out our contact form and we will contact you.
Frequency Asked Questions
Q. How do I determine my food type?
A. You can match your food type to this table:
TABLE 1—TYPES OF RAW AND PROCESSED FOODS
I. Nonacid, aqueous products; may contain salt or sugar or both (pH above 5.0).
II. Acid, aqueous products; may contain salt or sugar or both, and including oil-in-water emulsions of low- or high-
III. Aqueous, acid or nonacid products containing free oil or fat; may contain salt, and including water-in-oil emulsions
of low- or high-fat content.
IV. Dairy products and modifications:
A. Water-in-oil emulsions, high- or low-fat.
B. Oil-in-water emulsions, high- or low-fat.
V. Low-moisture fats and oil.
A. Containing up to 8 percent of alcohol.
C. Containing more than 8 percent alcohol.
VII. Bakery products other than those included under Types
VIII or IX of this table:
A. Moist bakery products with surface containing free fat
B. Moist bakery products with surface containing no free
fat or oil.
VIII. Dry solids with the surface containing no free fat or oil
(no end test required).
IX. Dry solids with the surface containing free fat or oil.
Q. How do I choose my condition of use?
A. Match your condition of use to the following table:
A. High temperature heat-sterilized (e.g., over 212 °F).
B. Boiling water sterilized
C. Hot filled or pasteurized above 150 °F
D. Hot filled or pasteurized below 150 °F
E. Room temperature filled and stored (no thermal treatment in the container).
F. Refrigerated storage (no thermal treatment in the container).
G. Frozen storage (no thermal treatment in the container).
H. Frozen or refrigerated storage: Ready prepared foods intended to be reheated in container at time of use:
1. Aqueous or oil-in-water emulsion of high- or low-fat.
2. Aqueous, high- or low-free oil or fat.
Q. How do I know if my cure conditions meet the FCN specifications?
A. You will need to test migration from cured film for the specified food type and condition of use. United Science has validated methods for determining the level of monomer and photoinitiator. Typically, the customer will create a cure ladder for testing. The cure ladder involves a normal cure, an under cure, and an over cure. That way, you can determine migration as a function of degree of cure. The test will also examine migration from the substrate and from solvent blanks. All equipment and instrumentation used for this work is under strict quality control protocols.
Q. What do I do for quality control?
A. United Science will correlate migration test results with low cost optical methods for your FCN substance and substrate. That way, there is no need to use costly migration and separation techniques for repetitive QC of your coating. Periodically, United Science will recalibrate or verify the correlation for accuracy at intervals requested by the customer. If nothing changes with the process, typically, retesting is completed at the 6 month mark. If you have a new formulation, you will need to do the full migration testing.
Q. Do I need to run quality control measurements on the supplied FCN 772 material?
A. You may require your supplier to provide you certificates of analysis for the FCN materials. Since these are blends, it is necessary that absolute techniques be used to measure the concentration of each monomer, initiator, and must also test for the presence of contaminants. This is best done by a third party on a lot by lot basis. Infrared or UV techniques in this case do not provide sufficient selectivity to determine if the FCN substance is adulterated. United Science has GC/MS and LC/MS methods established to help you determine if there are contaminants and also determine the absolute amount of monomer and initiator in the formulation.
Q. What is the maximum limit of migration?
A. 10 ?g/in2 per acrylate, for the photoinitiator and for total extractables (TE)