FDA Food Contact Testing: 21 CFR 170–189 Compliance Guide for Plastic, Silicone, and Metal

Pi lacat wil ma cwalo jami ma mako cam i lobo Amerika, "temo jami ma mako cam pa FDA" winye calo gin acel ma ki cwalo — ripot me temo ma waco ni jami ni "ki yee ki FDA." Lok ada tye ma ki yubu maber. Cik me lobo Amerika ma ki lwongo ni Federal Regulations Title 21 (21 CFR), dul 170 nio wa i 189, keto yub ma ki poko ma kwako jami, jami ma ki tiyo kwede, ki kit ma gi twero rwate kwede ki cam. Gin ma ki yubu ni pe obedo temo acel keken — en tye tam ma ki moko i kom dul mene ma tiyo, jami mene ma ki kwano, kit me temo ni omyera obed nining, ki coc ango ma obi bedo kacel ki pwony ni. Pwony man loko i kom jami ma pire tek pi plastic, silicone, ki metal FCMs, yoo adek ma FDA oye, ki tyen lok ma pol kare gi juku cwalo jami i US customs.

Pingo 21 CFR 170-189 obedo dul ma ki kwano marac loyo i cik pa FDA pi lucat wil me FCM

21 CFR 170-189 tye dul ma pol kare ki waco ki lucat wil ma calo "cik ma mako rwate ki cam pa FDA," ento pe ki kwano ne i kit ma ki yubu kwede. Dul ni ki yubu kit ma lubo ni:

• 21 CFR 170 — cik ki cik ma kwako jami ma ki medo i cam, medo ki gonyo lok me "jami ma ki medo i cam" ki yub pi jami ma ki medo i cam ma pe rwate.
• 21 CFR 171–180 — jami ma ki medo i cam ki jami ma ki medo i cam.
• 21 CFR 174 — jami ma ki medo i cam ma pe ki ngeyo: jami weny.
• 21 CFR 175 — jami ma ki medo i cam ma pe ki ngeyo: jami ma mako ki jami ma ki keto i kom gin ma ki umu kwede.
• 21 CFR 176 — jami ma ki medo i cam ma pe ki ngeyo: karatac ki jami ma ki keto i karatac.
• 21 CFR 177 — jami ma ki medo i cam ma pe rwate: polymers (dul ma dit loyo, ki dul matino tino ma ki keto i dul pa polymer).
• 21 CFR 178 — jami ma ki medo i cam ma pe ki ngeyo: jami ma konyo, jami ma konyo yubu jami, ki jami ma konyo lwoko kom.
• 21 CFR 179 — jami ma ki medo i kom cam ma ki yubu ki mac (ma tidi ki ma tiyo maber).
• 21 CFR 180–189 — jami ma ki weko, jami ma ki medo i cam ma ki yer i cam pi kare manok, ki jami mogo ma pat pat.

Pi jami ma ki yubu ki jami ma ki yubu ki plastik, silicone, onyo nyonyo, jami ma pire tek ma tiyo kwede tye 174, 175, 176, ki 177. FDA's kikome neno i kom yub man — medo ki kit ma ki keto kwede jami ni ki kit ma ki medo kwede — ki coyo i pot karatac pa FDA i kom jami ma ki keto i cam ki cik me keto ne, ma tiyo calo ka donyo pa lwak pi cik ni.

Jami adek ma pol kare ki kwano marac omyera ki lok iye:

1. "FDA-kiye" ki "FDA-kiye." Coc ma ki coyo i 21 CFR pe obedo cwak pa FDA bot lacat wil — en tye cik ma ye ni ki tic ki jami ni i te cik mogo. Lacat wil onyo lacat wil tye ki twero me nyutu ni jami ni rwate ki cik.
2. "FDA-grade me cam." Pe tye lanyut mo ma nyutu "FDA food-grade". Yub ni mito gin ma ki keto ki gin ma ki keto ki gin ma ki keto me nyutu ni lubu cik. Lok pa lacat ni gin ma ki lwongo ni resin ni tye "rwom me cam pa FDA" obedo lok me cato wil, ento pe lok ma ki moko ki cik.
3. 21 CFR 170–189 ki NSF/ANSI 51. CFR ni kwako jami ma ki tiyo kwede ki kit me tic kwede; NSF/ANSI 51 kwako jami ma ki tiyo kwede me cato wil i kit ma ki tyeko kwede. Gin ma ki coyo ma rwate ki 21 CFR twero bedo ni mito NSF/ANSI 51 me bedo ma ki yer ki bot lacat wil me US.

Plastic (21 CFR 174–177): PP, PE, ki Polyolefins mukene — ngo ma weko ki miiyo ngec i kom cam

Jami ma ki yubu ki jami acama ma ki yubu ki plastik aye gin ma ki cwalo ki China ki lucat wil mukene ma gibedo i Asia me donyo i cuk me Amerika. Kit ma ki yubu kwede jami ma ki yubu ki plastik ni 21 CFR Dul me 177 (Jami ma ki medo i cam: Polymers), ma tye ki dul matino tino ma lubu dul pa polymer. Dul ma ki tiyo kwede pol kare tye:

Pi jami mapol ma ki yubu ki plastik, lubo cik ki keto kun ki nyutu ni dul acel acel ma ki yubu ni tye ki 21 CFR listing (e.g., 21 CFR 177.1520 pi resin ma ki keto), ki ni jami ma ki kwanyo ki i te cik ma kiketo i cik ni tye i kin rwom ma kiketo. Gin FDA tye ka temo jami ma ki yubu ki jami ma ki lwongo ni PP, PE, ki OP kwako temo jami ma ki kwanyo ki i kom ler ma ki lwongo ni workhorse ma tye i te cik me 21 CFR 177.1520, medo ki jami ma ki tiyo kwede me nyutu cam ki rwom me lyeto ma tye.

Awene ma ki miiyo iye ngec me rwate ki cam (FCN)? FCN mitte ka jami ma ki coyo ni tye ki gin mo ma pe ki keto i 21 CFR ma tye — pol kare gin manyen ma ki medo iye, gin manyen ma ki lwongo ni resin grade ma aa ki bot ngat ma pe ki keto i kin jami ma ki coyo, onyo jami ma ki tiyo kwede ma pe ki keto i te cik ma ki keto. Lok ma ki coyo ni ki keto i FDA ki, ka dong ocako tic, ki medo i kom Kwano jami ma mako cam ma tiyo maber. Gin ma ki lwongo ni Inventory obedo ka gwoko ngec pa lwak ma luwil ma gi tye piny gi moko ni jami moni dong ki neno.

Silicone (21 CFR 177.2600): Gin ma ki yubu ki moo ma ki yubu me tic kwede kare ki kare — Temo jami ma ki kwanyo

Silicone ki jami mukene ma ki yubu ki rubber ma mako cam ma ki yubu me tic kwede kare ki kare (gaskets, baking mats, seals, tubing) ki doro gi 21 CFR 177.2600 (Jami ma ki yubu ki moo ma ki yubu me tic kwede tyen mapol). Cik ni tito jami aryo ma ki twero temo ma lubu kodi cam:

Jami ma ki yubu ki silicone ma okato i kin jami ma ki kwanyo ki i pii ki moo ki twero tic kwede i kom jami acama weny. Jami ma ki temo i kom jami acama acel keken ki keto i dul cam meno keken. Kit me tic kwede tyen mapol i cik ni pire tek — gin ma ki lwongo ni silicone baking mat ma ki tiyo kwede tyen 100 tye ki kit ma ki kwanyo kwede jami ma pat ki gin ma ki tiyo kwede acel acel. Gin ma ki lwongo ni 177.2600 ni ki yubu me temo kit ma ki cwalo kwede i nge tic kwede tyen mapol, ento pi i kare me rwate mukwongo keken.

Pi lucat wil ma gi cwalo jami me tedo ma ki yubu ki silicone onyo jami ma ki yubu ki silicone ma mako cam i lobo Amerika, yub me temo ne tye ma kato pi gin ma ki tiyo kwede ki plastik ma ki tiyo kwede acel keken. Gin ni omyera ki yub, ki kwanyo i te reflux pi cawa 7 mukwongo, ki ki kwano wel ne. Ot ma ki kwano iye jami omyera obed ki ngec ma mako jami ma ki lwongo ni reflux ki kit ma ki tiyo kwede me temo (pol kare gravimetric pi jami ma ki kwanyo weny).

Jami ma ki yubu ki nyonyo (21 CFR 175.300 + NSF/ANSI 51): Gin ma ki umu kwede, nyonyo ma pe mako nyal, ki Aluminum

Jami ma ki yubu ki nyonyo ma mako cam bedo i dul ma pat pat me 21 CFR framework. Pe tye gin mo maber ma nyutu jami ma ki yubu ki nyonyo ma pe mako nyal onyo aluminum alloys; ma ka meno, FDA kwano gin ma ki tyeko ni ma rwate ki cam. Dul aryo me 21 CFR pire tek:

• 21 CFR 175.300 (Resinous ki polymeric coatings). Man umo gin ma ki keto i kom gin ma ki yubu ki nyonyo — me labolle, gin ma ki lwongo ni enamel ma ki keto i kom gin ma ki yubu ki nyonyo, gin ma ki keto i kom gin ma ki lwongo ni aluminum frypan, onyo gin ma ki lwongo ni food-grade lacquer i kom gin ma ki yubu ki nyonyo. Gin ma ki umu kwede omyera ki kwany ma pat ki gin ma ki keto piny ni.
• 21 CFR 177 (dul matino tino pi jami ma ki lwongo ni food-contact polymers). Gin ma ki lwongo ni plastic coatings, plastic linings, ki plastic gaskets i kom jami ma ki yubu ki nyonyo gi donyo i dul me 177.

Pi gin ma ki lwongo ni bare metal substrate, rwom pa FDA tye ni austenitic 300-series stainless steel (304, 316, ki jami ma rom kwede) ki aluminum ma tye i jami me tedo ki jami ma ki tiyo kwede i cam ki ngeyo ni ber ka ki tiyo kwede i kom cam ma rwate ki kit cam meno. Jami ma ki deyo kwede, jami ma gengo lanyut cing, jami ma ki keto i kom ler, ki jami mukene ma ki tiyo kwede i kom kom ki kwano acel acel — gin ma ki keto piny ni keken pe miyo gin ni bedo maber.

Pi jami ma ki tiyo kwede me cato wil — jami ma cito i ot tedo me cato wil, ento pi me gang — rwom me tic tye NSF/ANSI 51. Cik ni keto cik ma miite pi yot kom pa lwak ki lengo pi jami ma ki tiyo kwede me yubu jami ma ki tiyo kwede me cato wil (ka gwoko ringo, jami amata, bao me ngolo, jami ma ki keto iye jami, ki jami ma tye iye — tubing, sealants, gaskets, valves). NSF okati ki rwom me tic; NSF's Food Equipment Standards portfolio obedo gin ma dano weny gi ngeyo ma rwom me tic ni tiyo i kom jami tic mene. Lucat wil mapol me US ki lutic ma miiyo cam pe gubi ye jami ma pe ki twero me NSF/ANSI 51 pi dul ma miite.

Pi meno, yoo me FCM ma ki yubu ki cuma ni tye ki dul ma ki yubu: 21 CFR umu gin ni ki gin ma ki umu kwede; NSF/ANSI 51 kwako jami ma ki tiyo kwede me cato wil i kit ma ki tyeko kwede. Lacat wil ma tye ka cwalo gin ma ki lwongo ni metal frypan ki gin ma pe moko i cuk me cato wil i lobo Amerika mito 21 CFR clearance pi gin ma ki lwongo ni coating ki NSF/ANSI 51 certification pi gin ma ki tiyo kwede.

Jami adek ma ki temo ma nyutu ka jami ni tye ma rwate ki cik

Pi jami ma ki yubu ki plastik ma ki temo i te cik me 21 CFR 177.1520, jami adek ma ki temo aye kelo adwogi pa Tem me cito kabedo mukene. Gin acel acel omyera ki yer me rwate ki gin ma ki miito me tic kwede i agiki me pwony ni.

1. Cawa me lok. Jami ma ki tiyo kwede acel keken (filim, kikopo ma ki bolo) ki temo pi kare me rwate kikome. Jami ma ki tiyo kwede kare ki kare (konteina, jami me ot tedo ma ki twero tic kwede tyen mapol) ki temo pi kare me rwate marac ki rwom me gonyo ne. Jami ma ki mako pi kare malac (ka gwoko jami) lubu yub me temo ma pat.
2. Lyeto me rwate. Lyeto me ot, lyeto ma opong (pol kare 70-100 °C), lyeto (100 °C), ki lyeto me tedo (ma kato 100 °C) kelo yoo me temo ma pat pat. Gin ma ki yubu me gwoko i fridge keken tye ki rwom me lyeto ma nok loyo ma ki yubu me gwoko i microwave.
3. Kit cam. Cam ma tye ki pii, ma tye ki acid, ma tye ki kongo, ki ma tye ki moo weko cam ma pat pat bedo calo cam. Pi polyolefins ma tye ite 21 CFR 177.1520, jami ma FDA tiyo kwede me nyutu cam ma ki lwongo ni distilled water (aqueous), 10% ethanol (acidic), 50% ethanol (higher-alcohol), ki moo ma ki pito onyo 95% ethanol substitute (moo). Yero gin ma ki lwongo ni simulant ma pi opore obedo tyen lok acel ma weko gin ma ki temo ni pe nyutu ni tye ka tic maber.

Temo me loko jami ni tye ki tyen lok ka jami adek ni weng rwate ki tic me agiki. Ripot me temo ma jenge i kom gin ma ki lwongo ni aqueous cam ma ki temo i rwom me lyeto me ot pe nyutu ni cam ma tye ki moo tye ka rwate ki rwom me lyeto me tedo — ki lucat wil onyo lucat wil ma gineno waraga ni gubi kwero ripot ni pi tyen lok eni.

Waraga ma ki keto ki ma pe ki kwero ki FCN: 3 yoo me yer pa FDA ma ki gonyo

Pi gin ma ki tiyo kwede i kom cam ento pe tye i kin 21 CFR ma kiketo, lacat wil tye ki yoo adek ma FDA oye me yero ki iye. Yero ni cung i kom gin ma ki tiyo kwede, kit ma ki camo kwede, ki lok macon ma ki tiyo kwede i kom gin ni.

Pi pol pa jami ma ki yubu ki plastik ma ki cwalo ki China ki lucat wil mukene ma gibedo i Asia, yoo mukwongo (21 CFR listing) tye gin ma ki tiyo kwede. Lacat wil ni moko ni rwom me resin, gin ma ki medo iye, ki gin mo keken ma ki dwoko cen tye i kin jami ma ki coyo — ma pol kare 21 CFR 177.1520 pi polyolefins — ki yub me temo ni moko ni jami ma ki kwanyo ni tye i kin rwom ma ki keto. Yo me aryo ki me adek ki tiyo kwede ka gin manyen, lacat manyen, onyo plastik ma ki tiyo kwede odoco tye ka tic.

Pi jami ma ki tiyo kwede ma ki tiyo kwede, FDA tiyo ki yoo mukene kit ma ki tiyo kwede ki jami ma ki yubu ki plastik ma ki tiyo kwede odoco ma medo rwom me tic (jami ma ki keto iye, kit me tic kwede odoco, peko me jami ma balo kwo) ki temo ngwec. Yub ni tek loyo yoo me virgin-plastic, ki lucat wil ma gi cwalo jami ma ki yubu ki PCR i lobo Amerika omyera gu yub pi neno ne pi kare malac.

Tyen lok ma pol pa FDA kwero: Bal 5 ma gengo cwalo jami i US Customs

Cake i rwom me neno i RTS, bal abic okelo pol pa FDA-ma lubu kwero cwalo jami ma waneno i customs me US onyo ki lucat wil me US. Ki keto gi i kit ma gi rwate kwede:

1. Pe tye onyo lok macon ma pi tiyo. Jami weny ma mako cam ma ki kelo i lobo Amerika mito ngec ma pwod peya ki cwalo. Lok ma kimiyo con omyera obed ki ngat ma oyubu, ngat ma ocwalo, lobo ma oa ki iye, ki kit ma ki yubu kwede. Lok ma pe tye kakare onyo ma pi tye kakare juku cwalo jami i dog nam.
2. Peko me coc ma kubbe ki lok ma ki coyo ni ki FCN ma tiyo maber onyo 21 CFR ma ki yer. Luwil twero penyo lacat wil me nyutu ni gin ni tye ki FCN ma tiyo maber onyo 21 CFR ma ki coyo. Ka waraga ni pe, gin ma ki cwalo ni ki gwoko nio ka lacat wil ni okelo ne.
3. Coc ma pe nyutu ngat ma oyubu ne onyo lobo ma oa ki iye. Cik ma ki keto i US Customs ki FDA tiyo kadi wa i kom jami ma mako cam ma pe ki cato i cuk. Labol ni omyera onyut ngat ma oyubu ne ki lobo ma oa ki iye. Coc ma ki coyo i leb mapol labongo leb Munu obedo peko ma pol kare time.
4. Nongo gin mo ma tye i rwom ma kato rwom me kwanyo ma ki coyo ni onyo SML. Temo ma kitimo i ot yat ni pe orwate ki kit ma ki tiyo kwede i agiki (cam ma pi opore, rwom me lyeto ma pi opore, cawa ma pi opore), onyo gin ma ki coyo ni tye ki gin mo ma pe tye i kin jami ma ki coyo ni. Adwogi me temo ma pe rwate gengo donyo pa lucat wil ki gamo lucat wil madongo.
5. Coc ni tye gin ma ki coyo ma ki kwero con labongo coc ma ki yubu. Ka cwalo jami acel-lu macon ki kwero ki lacat wil tye ka temo kelo gin acel-lu labongo coc ma ki yubu, cwalo manyen ni ki tero calo gin acel-lu ki ki kwero pi tyen lok acel-lu.

Gin aryo ma okwongo ni gi pol loyo i kin jami ma wa kato ki iye. Kit me cobo peko pi gin aryo ni weng tye me gwoko waraga — gin mo kiken ma ki cwalo omyera ocit ki (a) lok ma ki ngeyo con, (b) lok ma ki waco ni rwate ki cik, (c) ripot me temo ma tye piny, ki (d) lok ma ki coyo i FCN onyo 21 CFR ma ki coyo.

RTS FDA Food Contact Test Plan: Cake i neno gin ma ki miito nio wa i miyo waraga me lubo cik

Pi lacat wil ma tye ka wot i yoo pa FDA pi tyen mukwongo, gurup wa tiyo ki yub me temo ma tye ki dul angwen ma diyo yub me cabit 8-12. Kit ma ki lubo kwede tye:

1. Dul me acel — neno ki kit ma ki yubu kwede. Kit ma ki coyo kwede, rwom me resin, gin ma ki medo iye, ki kit ma ki yubu kwede (kit cam, rwom me lyeto, kare me rwate) ki neno i kom dul ma rwate ki 21 CFR. Kabedo mo keken ma tye i kin kit ma ki yubu kwede ki kit ma ki keto kwede ki nyutu ma peya ki cako temo.
2. Dul me 2 — Gin ma ki twero kwanyo / temo loko ne. Gin ma ki coyo ni ki kwanyo ki i te jami ma ki lwongo ni cam simulants ki kit ma ki waco kwede i 21 CFR 177.1520 (pi olefin polymers) onyo 21 CFR 177.2600 (pi jami ma ki yubu ki silicone ki rubber). Gin ma ki kwanyo ki ikom jami ma ki kwanyo ki ikom gin ma ki lwongo ni gravimetrical ki adwogi ne ki poro ki rwom ma kiketo.
3. Dul me 3 — neno ka jami ma ki keto i kom dano. Gin acel acel ma ki medo ki miti ki moko i kom 21 CFR ma rwate onyo FCN inventory. Pi jami manyen, yoo me FCN ki cako; pi jami ma ki tiyo kwede, cik pa FDA ma ki tiyo kwede me tic ki jami ma ki tiyo kwede.
4. Dul me 4 — waraga me lubo cik ki waraga ma miiyo kony. Karatac me lubo cik kimiyo pi pwony ni, ma nyutu 21 CFR ma ki coyo ki adwogi me temo. Coc ma miiyo kony — lok ma ki coyo, ripot me temo, gin ma ki coyo con — ki keto i karatac ma lacat wil twero nyutu i custom onyo bot lucat wil.

Pi pwony ma tye ki NSF/ANSI 51 ma rwate (jami ma ki tiyo kwede me cato wil), dul me 4 medo ki yoo me moko NSF, ma obedo yoo ma pat. Yub me temo 21 CFR ni juku lok ma mako lubo cik; waraga me NSF ni juku yoo me gamo jami tic ni.

Pi lok ma mako yub me temo cam pa FDA, lucat wil gi twero lok ki dul ma tye ka temo RTS ki lok ma ki coyo, gin ma ki miito me tic kwede, ki kama ki cito iye i lobo Amerika (cik mogo ma ki keto i rwom me PFAS tye). Gin Yub me temo jami ma ki yubu ki plastik pa FDA kwako jami ma ki kwanyo ki i tic ma ki kwanyo ki i te cik me 21 CFR 177.1520; ma lac yub me temo jami ma mako cam kwako silicone, nyonyo, ceramic, ki FCMs ma ki yubu ki papara.

Lara Hong

Lara Hong tye latela ma neno lok kom biacara i Zhejiang RTS Test Co., Ltd., ngat ma oyabo lok ma mako neno, temo, ki miiyo ngec bot dano mukene pi cato wil i wilobo ki cato wil i intanet. Ki ngeyo i konyo luyub jami ki lucat wil me lubo cik, rwom me temo jami, ki cik me donyo i cuk. Ki keto cwinye me miiyo gen pi kwo maber — me cobo apokapoka ma tye i kin luwil ki luwil me wilobo kun tiyo ki tic me temo ma tye kakare, ma atir, ki ma rwate.