食品添加剂、肝、 and food contact compliance – USA

联邦食品, Drug and Cosmetic Act (FFDCA) requires that human food and animal feed be safe for consumption, prepared in sanitary conditions free from harmful substances, 并贴上正确的标签. 

The Center for Food Safety and Applied Nutrition (CFSAN), a branch within Food and Drug Administration (FDA) is responsible for regulating food ingredients, 添加剂, 包装材料, 食品接触物质, and foodstuff products that enter the country. The Center for Veterinary Medicine (CVM) regulates animal feed.

钱柜平台 routinely assists 公司 with GRAS notifications and self-determinations, Food/Feed Additive Petitions, Food 联系 Notifications, end-use testing of 食品接触物质, and other technical and regulatory issues.

Food 添加剂 and 食品接触物质 are subject to premarket approval by FDA unless they are Generally Recognized As Safe (GRAS) by qualified experts for a particular use. Companies may submit a Food Additive Petition or a Food 联系 Notification (FCN), 分别, to meet the appropriate regulatory requirements for these product types. These submissions require substantial toxicological, 化学, and environmental data as well as dietary exposure and risk modeling.

GRAS substances are exempt from the definition of “food additive” and instead are defined as “substances that are generally recognized, among experts qualified by scientific training and experience to evaluate their safety as having been adequately shown through scientific procedures...to be safe under the conditions of their intended use.” Standards for safety of GRAS substances are as rigorous as for food 添加剂.

Food contact substances include food 包装 and 包装 添加剂, meat and poultry sanitizers and food 处理 equipment. FDA regulates these materials in the U.S. by requiring compliance with existing specifications or, 为新材料, notifications or other regulatory submissions.  

次数可以帮助

  • Prepare and submit Food 联系 Notifications (FCN) and other submissions related to food contact materials
  • Develop food additive petitions
  • Prepare GRAS notices/assessments, convene expert panels
  • Create dietary exposure models
  • 评审材料
  • Submit establishment registration

Need help 准备 and submitting a Food 联系 Notification?

为什么次数

钱柜平台 provides 公司 with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. 钱柜平台's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.

钱柜手机版的专业人员

Our food compliance 咨询顾问 can help you with GRAS self-determination, GRAS notification submission, Food 联系 Notifications and 更多的. The team is led by 莱斯利·巴顿, who has 更多的 than a decade of experience in regulatory toxicology. 莱斯利·巴顿 specializes in food 添加剂 and food contact, pesticides, consumer products, and cosmetics. She has extensive experience working with industries to successfully register pesticides with the U.S. Environmental Protection Agency and Health 加拿大 and submit new food contact notifications (FCN) with the U.S. Food and Drug Administration (FDA).

有用的信息

Frequently asked questions

GRAS status can be achieved through a self-determination process or via notification to FDA. Either pathway involves establishing the safety of the ingredient for its intended use.   

A food contact substance may contact food during production, 制造业, 包装, 处理, 准备, 治疗, 包装, 运输, 或持有, although by definition it is not intended to have a technical effect in food. Such substances, unless they are already regulated under 21 CFR or are GRAS, typically require a FCN.

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We help 公司 navigate the regulatory landscape a交叉 a range of geographies and jurisdictions. 读 about the comprehensive range of services we offer.

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We work in various different markets, including agriculture, industrial, consumer and medical.

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