Document DDyELdzbVOz7MpgXkNNX8wZ04

/V 4ie<l ' qjJjJx < May 30, 1989 Sally Kline Avon Lake Tech Center SUBJECT: PVC/EVOH Regulation' 177.1360 permits the use of EVOH as articles or components of articles intended for use in contact with food. The phrase "as components of articles", would permit its use in the system you describe assuming the EVOH copolymer meets the specification as described in paragraphs (a)(1),(2) and/or (3). This is also assuming the wt. % of EVOH times the thickness of the end use article would not exceed 0.005, 0.003 and/or 0.007 inch as described in paragraphs (b), (c) and (d) respectively. The EVOH copolymer in film form would have to meet the extractive limitations imposed for the particular type used. The end food contact article would be -restricted to the food types and use conditions as described. VI am enclosing copies of tables 1 and 2 from 21 CFR 176.170 for your information. I hope this answers your questions, if not, please call. W. C. Bachtel 90530-1/jp cc: D'Lane Wisner - CL-OTM-3 BFG18826 22105001 ") ted i in MS Of WW xte ind 9ht E. <2. iy d TO Itct l ar w l food and Drag Administration, HHS Ust of Vinyl eWorld# copolymers produosd by oopolymsrfednQ vinyl cNorfds wNfi ons or mans of tfw wonomsrs scryfoWWs; tumeric add and Ns mathyl ethyl propyl, butyl amyl hexyl heptyl or octyl ostara; maiaio add and Ns methyl ethyl propyi* omyif wnyi nwyi, nopiys or ociyi omto* mOMC anfqdrlda; 8-norbomana 2. 3-WcwboxySc add; wowwhbutyl 6moi vaiyf dwi^mono wiywMno ononwi ino mWiN oopoynwi ra oonwn mi so wopn povooni o poiynra unn osnvoQ nwn wiyi ururik mi oonvn no irom SfutfrBwadica aUmM/foijur nwm oon wot amr Iin^olnapji wryt, prepyi butyi orwyi hopor oc^ monooMoro or from moltie onhydrtdo or from mono-*buty1 ootw of S-norbornono-2, HMVDQKyo6 wo mowooor, oi wry cooo mo iwv paroant of total pofyvnar unlti dartvad bom aonaaMfl ooior or o-noroomono-s^-aaoooKyK ach/. vinyi craonoovoiyi vomm iijfuuiyHnoiiniti wmwyfwoi....a.H.. Vinyl chloride vtnyl aeatati hydrcBtyl-modMsd oopofytnata re- acrylamide aetyde add; ecrytoWb'Se. butyl acrylate, butyl mmcrym onyi onymm* raip mnoBiomi wonc kni wocorwc oon* mmnocryoo oom, irmiyi vryooi vnooiyi melhacrytele, ootadaeyl madworylala, propyl soya** propyl mathaeryfata. vtnyl cWorlda and vinyl adlonio add. The monOQ ooporymom onoo oomooi m ooo w oops poimw of potyrnar utda derived from dnyddsna cNortde. and shad contain no mom than 8 weight paroant of totai polymer units dartvad from acrylamlda. aoryde add, hamate add. vinyl auNoWe add 176.170 id 3f (c) The food-contact surface of the paper and paperboard in the finished form in which it la to contact food, when extracted with the solvent or solvents characterizing the type of food, and under conditions of time and temperature characterizing the condi tions of its intended use as determined from Tables 1 and 2 of this paragraph, shall yield net chloroform-soluble ex tractives (corrected for wax, petrola tum, mineral oil and zinc extractives as zinc oleate) not to exceed 0.5 milli m. Aqueous, add or nonadd products con taining free oil or fat; may contain salt, and indudlng 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. . Low-moisture fats and oil. VL Beverages: A. Containing up to 8 percent of alcohol. B. Nonalcoholic. C. Containing more than 8 percent alco gram per square inch of food-contact hol. surface as determined by the methods VIL Bakery products other than those in described in paragraph (d) of this sec cluded under Types VHI or DC of this tion. table: Tabu 1--Tms or Raw ass Pkocesszd Foods A. Moist bakery products with surface containing free fat or oil. B. Moist bakery products with surface I. Nonacid, aqueous products; may contain mtitairiinf no free fat or oiL salt or sugar or both (pH above 5.0). Vm. Dry solids with the surface containing n. Add, aqueous products; may contain salt no free fat or oil (no-end test required). or sugar or both, and including oil-in- DL Dry solids with the surface containing water emulsions of low- or high-fat con tent. free fat or oiL 22105002 BFG18827 185  176.170 21 CF* Ch. I (4-1-SO Edition) Table 2--Test Procedures with Time Temperature Conditions for Determining Amount of Extractives From the Food-Contact Surface of Uncoated or Coated Paper and Paperboaro, Using Solvents Simulating Types of Fooos and Beverages CondMonof uw Typeaof tood (aee Table 1) Water* Food-oimuloOng advents Heptanek> 0 percent alcohol* 50 parcant alcohol* A High temperature heat-atartknd (e.g.. over 212* F). B. Boiling water atariBied___ .... C. Hot (Wed or peeteurtnd above ISO* F. 0. Hot Med or peeteurtnd below ISO* F. 1. IV-fl, Vtl-B III..... 250* F. 2 hr..... IV-A. Vll-A_____ ....do___ it. vtua.............. 212* F, 30 Ill, Vll-A_______ min. 150* F, 2 hr 120* F, 30 --do---------- min. II, IV-B, VH-8___ FBboSng. cool to 100* F. III. IV-A, Vll-A___ __ do______ 120* F, 15 V, IX.................. min. II. IV-B, VI-8, vtua 150* F, 2 fir__ --do. 100* F, 30 III, IV-A Vll-A.. min. -- -- : E. Room temperature IMed end etored (no thermal treatment In the oontakv er). V, IX.................. vi-A................... 150* F. 2 hr__ Vl-C .. __ . 150* F. 2 hr. 1, II. IV-B, VI-8, 120* F, 24 hr- Vtt-8. 70* F, 30 mk- Ill, IV-A Vll-A___ r. nimQifiiia wmi (no mennei treatment in the container). V. IX- ______ A* .... vi-A................... 120* F, 24 hrTM vuc 120* F. 24 hr. III. IV-A Vll-A___ 70* F, 45 hr..... 70* F, 30 min-. 1, II. IV-B. Vt-B, --do---------- vit-a \A_A wi_r Q. Frown otofOQO (no OMfiMl twi* i. ii. iv-a, vit-a..... 70* If, 24 hr moa n mo oonwnws* IN, vn-A_______ tki 70* F. 45 hr..,,. 70* F. 45 hr. 70* F. 30 min-. nOOOf^fOpVOQ 10000 voonooo o 00 rohootod in oonMior ol Omo of uooe. 1. Aqueoue or oi In warn emutoton ol high- or low-fat 2. Aqueoue. high* or low baa ol or fat 1. II, IV-8, VH-B ..... 212* F, 30 min. IB, IV-A Vll-A IX.. 120* F, 30 min. -- 1 Heptane wtactaMNy reaulto muat to dMded by a factor onto in arriving al tto axtractabiWy tar a tood product having water-kvoa emutoton or tree ol or tel Hoptano tood emulating aotont la not roquirad in lha caee of wax-polymer bland coadnga tor corrugatad papatboatd contoinare Mended tor uaa In bulk packaging of toad meat lead Hah, and ioad poutoy. * Time and tempwatn. (d) Analytical methods--(1) Selection of extractability conditions. First as certain the type of food product (Table 1, paragraph (c) of this section) that is being packed commercially in the paper or paperboard and the normal conditions of thermal treat ment used in packaging the type of food involved. Using Table 2, para graph (c) of this section, select the food-simulating solvent or solvents and the time-temperature exaggera tions of the paper or paperboard use conditions. Having selected the appro priate food-simulating solvent or sol vents and the time-temperature exag geration over normal use, follow the applicable extraction procedure. (2) Reagents--(i) Water. All water used in extraction procedures should be freshly demineralized (deionized) distilled water. BFG18828 22105003