近日,美國食品和藥品管理局(FDA)發布了通過美國食品接觸材料通告(FCN)的11個物質,其中包含瑞歐代理申報的物質,詳細信息如下:
FCN No. | Food Contact Substance | Manufacturer/Supplier | Effective Date |
2209 | Butanedioic acid, hydroxy-, polymer with butanedioic acid, 1,4-butanediol and 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (CAS Reg. No. 864132-20-7), optionally reacted with 1,6-diisocyanatohexane (CAS Reg. No. 822-06-0). | Chang Chun Plastics Company, Ltd. | March 24, 2022 |
2181 | 1,3-Benzenedicarboxylic acid, polymer with 1,3-benzenedimethanamine and hexanedioic acid (CAS Reg. No. 28628-75-3). | Mitsubishi Gas Chemical Co., Inc. | March 23, 2022 |
2207 | 1-Decene, homopolymer, hydrogenated (CAS Reg. No. 68037-01-4). | BYK-Chemie GmbH | March 17, 2022 |
2184 | Siloxane and Silicones, di-Me, Me hydrogen polymers with di-Me, Me vinyl siloxanes, 1,1’-(1-methylethylidene)bis[4-(2-propen-1-yloxy)benzene]-2,4,6,8-tetramethylcyclotetrasiloxane reaction products, vinyl group-terminated di-Me siloxanes and hydrogen-terminated di-Me siloxanes. | Shin-Etsu Chemical Co., Ltd. | March 15, 2022 |
2206 | Chromium iron oxide (C.I. Pigment Brown 29; CAS Reg. No. 109414-04-2 and CAS Reg. No. 12737-27-8). | The Shepherd Color Company | March 12, 2022 |
2183 | Bis(4-tert-butylbenzoate-O)hydroxyl aluminum (CAS. Reg. No. 13170-05-3). | Shandong Rainwell New Materials Technology Company, Ltd. | March 10, 2022 |
2201 | Glycidyl methacrylate (CAS Reg. No. 106-91-2). | Akzo Nobel Coatings Inc. | March 2, 2022 |
2199 | Ethylene propylene copolymer (CAS Reg. No. 9010-79-1). | ExxonMobil Chemical Company and its stewarded affiliates around the world | February 25, 2022 |
2200 | Ethylene propylene copolymer (CAS Reg. No. 9010-79-1). | ExxonMobil Chemical Company and its stewarded affiliates around the world | February 25, 2022 |
2197 | N,N'-dioleoylethylenediamine (CAS. Reg. No. 110-31-6). | SK Functional Polymer S.A.S. | February 19, 2022 |
2191 | 2-Propenoic acid, 2-methyl-, 2-(dimethylamino)ethyl ester, polymers with 2-(C16-18-acylamino)ethyl acrylate and 4-hydroxybutyl acrylate, acetates (salts) (CAS Reg. No. 2374117-56-1). | Daikin America, Inc. | February 1, 2022 |
美國FCN申報
FCN(Food Contact Notifications) 即為食品接觸通告。為了保證食品的安全,1958 年法規規定所有食品添加劑(直接、間接)都需要經過 FDA(美國食品藥品監督局)的批準才能使用。對于食品間接添加劑(食品接觸物質),FDA 建立了一套食品接觸通告程序,法規規定未經 FDA 批準的且未被禁止允許使用的物質需要準備詳細的材料,向 FDA 提交通告,該通告即為食品接觸通告(FCN)。FCN 的專屬性:美國的 FCN 通告僅對提出申請的物質生產商 / 供應商有效,其他的生產商 / 供應商即使對于同樣的物質,需要向FDA 申報,申報通過之后才能使用 / 銷售。
瑞歐食品接觸材料團隊目前已經對美國食品接觸材料法規(FDA 21CFR/FCN)、歐盟食品接觸材料法規((EU)No. 10/2011、(EC) No.1935/2004)、中國食品接觸材料法規(GB9685、GB4806系列)、德國BfR、加拿大LONO、南方共同市場食品接觸材料法規(Mercosur GMC No.39/19)、瑞士食品接觸材料法規(SR 817.023.21)等相關法規進行了深度研究,具有豐富的項目經驗,可為企業提供上述國家及地區新物質申報、符合性聲明(DoC)和物質查詢等合規服務。
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