美国FDA颜色添加剂法规
发布人： 发布时间：2017-5-1 点击：800次
美国FDA颜色添加剂法规
食品，药品，化妆品和医疗器械中的颜色添加剂需要美国FDA批准。批准的形式和频率取决于具体的颜色添加剂。对于大多数颜料添加剂，相应的审批流程是美国FDA批准的批号认证程序，需要批准每个批次。
对于颜色批次认证，制造商向美国FDA提供每种颜料添加剂批次的代表性样品以及所需的文件。美国FDA分析颜色添加剂样品，以确保其符合认证颜料添加剂所要求的规格。对于一些颜色添加剂，颜色批次认证可能不合适。
森维帮助许多公司遵守美国FDA广泛的色彩添加剂要求，通过在“联邦法规”中的数千页面以及美国FDA发布的联邦注册局，EAFUS数据库，GRAS通知，卷标指南和警告信函中 。注册商公司的颜料添加剂服务提供：
由我们的监管专家团队编写的详细报告（通常为15-20页），该专家审查了Color Additive的化学特性，预期用途，限制，标签要求和允许的稀释剂的各个要素;
关于批处理方案，记录保存要求和推荐最佳做法的指导意见;和与美国FDA协商提交彩色批次认证，以及记录和注册保留，以便能够为未来批次的相同颜色进行更快的认证。
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.
食品，药品，化妆品和医疗器械中的颜色添加剂需要美国FDA批准。批准的形式和频率取决于具体的颜色添加剂。对于大多数颜料添加剂，相应的审批流程是美国FDA批准的批号认证程序，需要批准每个批次。
对于颜色批次认证，制造商向美国FDA提供每种颜料添加剂批次的代表性样品以及所需的文件。美国FDA分析颜色添加剂样品，以确保其符合认证颜料添加剂所要求的规格。对于一些颜色添加剂，颜色批次认证可能不合适。
森维帮助许多公司遵守美国FDA广泛的色彩添加剂要求，通过在“联邦法规”中的数千页面以及美国FDA发布的联邦注册局，EAFUS数据库，GRAS通知，卷标指南和警告信函中 。注册商公司的颜料添加剂服务提供：
由我们的监管专家团队编写的详细报告（通常为15-20页），该专家审查了Color Additive的化学特性，预期用途，限制，标签要求和允许的稀释剂的各个要素;
关于批处理方案，记录保存要求和推荐最佳做法的指导意见;和与美国FDA协商提交彩色批次认证，以及记录和注册保留，以便能够为未来批次的相同颜色进行更快的认证。
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.