近日,美国食品和药品管理局(FDA)发布了通过美国食品接触材料通告(FCN)的11个物质,其中包含瑞欧代理申报的物质,详细信息如下:
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 |
美国FCN申报
FCN(Food Contact Notifications) 即为食品接触通告。为了保证食品的安全,1958 年法规规定所有食品添加剂(直接、间接)都需要经过 FDA(美国食品药品监督局)的批准才能使用。对于食品间接添加剂(食品接触物质),FDA 建立了一套食品接触通告程序,法规规定未经 FDA 批准的且未被禁止允许使用的物质需要准备详细的材料,向 FDA 提交通告,该通告即为食品接触通告(FCN)。FCN 的专属性:美国的 FCN 通告仅对提出申请的物质生产商 / 供应商有效,其他的生产商 / 供应商即使对于同样的物质,需要向FDA 申报,申报通过之后才能使用 / 销售。
瑞欧食品接触材料团队目前已经对美国食品接触材料法规(FDA 21CFR/FCN)、欧盟食品接触材料法规((EU)No. 10/2011、(EC) No.1935/2004)、中国食品接触材料法规(GB9685、GB4806系列)、德国BfR、加拿大LONO、南方共同市场食品接触材料法规(Mercosur GMC No.39/19)、瑞士食品接触材料法规(SR 817.023.21)等相关法规进行了深度研究,具有丰富的项目经验,可为企业提供上述国家及地区新物质申报、符合性声明(DoC)和物质查询等合规服务。
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