◆森維國際認證集團◆
◆Sanwei International Certification Ltd◆
電話 : +886-2-2918-1959
傳真 : +886-2-2918-1872
郵箱:sanwei.twn@gmail.com
品質: 專業 、 公平 、 公正
態度: 誠信 、 嚴謹 、 熱誠
食品,藥品,化妝品和醫療器械中的顏色添加劑需要美國FDA批准。批准的形式和頻率取決於具體的顏色添加劑。對於大多數顏料添加劑,相應的審批流程是美國FDA批准的批號認證程序,需要批准每個批次。
對於顏色批次認證,製造商向美國FDA提供每種顏料添加劑批次的代表性樣品以及所需的文件。美國FDA分析顏色添加劑樣品,以確保其符合認證顏料添加劑所要求的規格。對於一些顏色添加劑,顏色批次認證可能不合適。
森維幫助許多公司遵守美國FDA廣泛的色彩添加劑要求,通過在“聯邦法規”中的數千頁面以及美國FDA發布的聯邦註冊局,EAFUS數據庫,GRAS通知,標籤指南和警告信函中 。註冊商公司的顏料添加劑服務提供:
由我們的監管專家團隊編寫的詳細報告(通常為15-20頁),該專家審查了Color Additive的化學特性,預期用途,限制,標籤要求和允許的稀釋劑的各個要素;
關於批處理方案,記錄保存要求和推薦最佳做法的指導意見;和與美國FDA協商提交彩色批次認證,以及記錄和註冊保留,以便能夠為未來批次的相同顏色進行更快的認證。
Color Additives in food, drugs, cosmetics, and medical devices require approval by U.S. FDA. The form and frequency of approval depends on the particular Color Additive. For most Color Additives, the appropriate approval process is U.S. FDA's Color Batch Certification program, which requires approval of each batch.
For Color Batch Certification, manufacturers provide U.S. FDA with a representative sample of each Color Additive batch along with the required documentation. U.S. FDA analyzes the Color Additive sample to ensure that it meets the specifications required for certifiable Color Additives. For some Color Additives, Color Batch Certification may not be appropriate.
Registrar Corp helps companies comply with U.S. FDA's extensive Color Additive requirements by cross referencing your coloring against thousands of pages within the Code of Federal Regulations as well as the Federal Register, EAFUS Database, GRAS Notices, Labeling Guides, and Warning Letters issued by U.S. FDA. Registrar Corp's Color Additive service provides:
A detailed report (typically 15-20 pages) prepared by our team of Regulatory Specialists who scrutinize every element of your Color Additive's chemical identity, intended use, restrictions, labeling requirements, and permitted diluents;
Guidance on batch treatment protocol, record-keeping requirements, and recommended best practices; and
Assistance filing for Color Batch Certification with the U.S. FDA, as well as record and registration retention to enable quicker certifications for future batches of the same color.
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