【2016-4-7】FDA 新增18種物質(zhì)至有效食品接觸材料清單中
截至2016年4月，FDA新批準了通過(guò)了18種物質(zhì)的FCN申請，并將這18種物質(zhì)增加到有效FCN通告列表中。
具體物質(zhì)如下：
1574 | Poly(1,4-butylene glycol-co-succinic acid), cross-linked with malic acid. | PTT MCC Biochem Company Ltd. | Jan 1, 2016 |
1599 | 1-Propanaminium, N,N,N-trimethyl-3-[(1-oxo-2-propen-1-yl)amino]-, chloride (1:1), polymer with ethenamine and 2-propenamide, hydrochloride (CAS Reg. No. 1659307-53-5). | Solenis LLC | Jan 6, 2016 |
1600 | A solution of silver dihydrogen citrate stabilized with sodium lauryl sulfate and citric acid. | Pure Bioscience, Inc. | Jan 7, 2016 |
1562 | Carbon monoxide-ethylene-propylene terpolymer (CAS Reg. No. 88995-51-1). | Hyosung Corporation | Jan 9, 2016 |
1604 | Isotridecanol phosphite condensation product with butylidenebis(2-(1,1-dimethylethyl)-5-methyl-4,1-phenylene). | ADEKA Corporation | Jan 9, 2016 |
1605 | Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3). | BASF Corporation | Jan 9, 2016 |
1583 | Polyester-polyurethane adhesive formulated from the following: (a) Polyurethane component prepared from allophanate-modified methane diphenyl diisocyanate, 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), propylene oxide, ethylene oxide, 1,2-propanediol, hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2) and hexamethylene diisocyanate (CAS Reg. No. 8222-06-0) and (b) Polyester/polyol component, prepared from adipic acid, diethylene glycol, methyloxirane polymer, and 1,1,1-tris(hydroxymethyl)propane. | Henkel, Inc. | Jan 15, 2016 |
1584 | Polyester-polyurethane adhesive formulated from the following: (a) Polyurethane component prepared from polypropylene glycol, toluene diisocyanate, allophanate-modified methane diphenyl diisocyanate and 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), and (b) Polyester/polyol component, prepared from adipic acid, diethylene glycol, methyloxirane polymer, and 1,1,1-tris(hydroxymethyl)propane. | Henkel, Inc. | Jan 15, 2016 |
1578 | Chlorine dioxide (CAS Reg. No. 10049-04-4). | Selective Micro Technologies, LLC | Jan 26, 2016 |
1580 | An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), and 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4). | Brainerd Chemical Company, Inc. | Jan 26, 2016 |
1594 | An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9). | Valley Chemical Solutions | Jan 26, 2016 |
1609 | Agarose, polymer with 2‐(chloromethyl)oxirane, 2‐hydroxy‐3‐(2‐propen‐1‐yloxy)propyl ether, polymer with 1‐ethenyl‐2‐pyrrolidinone, graft (CAS Reg. No. 1613113‐98‐6). | GE Healthcare Bio-Sciences AB | Jan 26, 2016 |
1587 | Tris(2-ethylhexyl) trimellitate (CAS Reg. No. 3319-31-1). | BASF Corporation | Jan 27, 2016 |
1615 | Hexanoic acid, 3,5,5-trimethyl-, 1,1-[oxybis[2,2-bis[[(3,5,5-trimethyl-1-oxohexyl)oxy]methyl]-3,1-propanediyl]] ester (CAS Reg. No. 65870-97-5). | NYCO | Feb 3, 2016 |
1618 | 2,6-naphthalenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, [1,1'-biphenyl]-4,4'-diol and 4-hydroxybenzoic acid (CAS Reg. No. 126710-16-5). | Chang Chun Plastics Co., Ltd. | Feb 5, 2016 |
1595 | An aqueous mixture containing peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP, CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9). | PeroxyChem LLC | Feb 16, 2016 |
1596 | Polyester-polyurethane adhesive formulated from the following: (a) Polyurethane component prepared from allophanate-modified methane diphenyl diisocyanate, 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), propylene oxide, ethylene oxide, 1,2-propanediol, hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2) and hexamethylene diisocyanate (CAS Reg. No. 8222-06-0). (b) Polyester component (CAS Reg. No. 1429057-80-6) prepared by the reaction of 1,3-benzenedicarboxylic acid and diethylene glycol, trans-esterified with castor oil. | Henkel, Inc. | Feb 18, 2016 |
1597 | Polyester-polyurethane adhesive formulated from the following: (a) Polyurethane component prepared from polypropylene glycol, toluene diisocyanate, allophanate-modified methane diphenyl diisocyanate and 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8). (b) Polyester component (CAS Reg. No. 1429057-80-6) prepared by the reaction of 1,3-benzenedicarboxylic acid and diethylene glycol, trans-esterified with castor oil. | Henkel, Inc. | Feb 18, 2016 |
美國奧巴馬總統簽署的2016年財政預算中5,000,000美元用于食品接觸材料通告（FCN）的提交和審核。這意味著(zhù)企業(yè)至少在2016年能受利于該財政撥款，免于食品接觸通告提交的行政費。但是，在過(guò)去幾年曾經(jīng)出現過(guò)沒(méi)有財政撥款導致FCN項目停滯的情況。
HQTS提醒廣大企業(yè)，若有意進(jìn)行食品接觸通告（FCN）提交，建議盡快啟動(dòng)相關(guān)項目，以防美國官方有新的政策出臺，同時(shí)完成食品接觸通告的提交能占得市場(chǎng)先機。
HQTS在應對美國食品接觸材料(FDA /FCN /21 CFR)方面有豐富的經(jīng)驗，可以為企業(yè)量身定制合規服務(wù)，提供合規解決方案。企業(yè)如果有進(jìn)一步的疑問(wèn)，歡迎咨詢(xún)400-888-1563。
