( 重要通知 ) 美国FDA 2009年1月15日，发布进口警告，修正2008年11月12日的通知。由于三聚氰胺及三聚氰胺类似物污染，所有从中国进口的奶制品(All milk products)、奶品原料(All milk derived ingredients)和成品食物含有奶成份(Finished food products containing milk)，在美国入关时，将全数面临 “未经检验的自动扣留”（DWPE）的程序。 请点击这里查看 紧急建议：受到本次进口预警通知的公司、企业、生产商应当尽快查询FDA官方网站，了解具体所涉及该“DWPE--检验前自动扣留”名单上的产品信息。 全美科技集团系美国政府认可的独立第三方检测、认证及咨询机构。多年专业背景，为中国多家出口企业提供各項有关FDA进口货物通知、质疑及扣留有关的紧急应急处理咨询服务。全美集团在美国专门为中国企业开办的特需服务已经为多家出口企业及时处理了以往难以解决的FDA有关应对事宜，我集团将继续扩大我们为中国企业在关于美国FDA有关的应急处理咨询服务。希望有迫切需要的各企业单位及时与我们取得联系。我们定将以专业的服务与技术为您们排忧解难。

美国FDA扣留 紧急处理 食品、产品安全 培训、咨询 Emergency Response & Consultation Services for FDA Refusal List and Food、Product Safety For details: 登录: http://www.amerisci.com.cn/ e-mail: sxu@amerisci.com 86-21-6426-2517 传真:86-21-6426-3996 想知道更多?

月刊专题

美国对婴儿配方奶粉及婴儿食品的管制

婴儿奶粉是美国管制最严格的食品。在奶粉能够上市之前，美国食品药物管理局（FDA）都需要经过一定的审批程序，以确保所有在美国销售的配方奶粉符合营养要求以及生产过程的质量管理规规范。依据规定，生产商在销售新配方奶粉之前必须事先通告FDA，通告必须包含有关配方，营养和生产保证的详细信息。婴儿配方奶粉生产商必须保证该配方将提供足够的营养使婴儿健康成长，也会依照当 前生产质量管理规规范（包括质量控制程序）进行。

如果生产商不提供新配方或重新配方通告里要求的内容和保证，该批婴儿奶粉会被认为是掺假，FDA有权采取强制行动。

一旦生产商配制婴儿配方奶粉，在销售该配方奶粉之前，生产商必须向美国FDA提供关於指定配方的营养质量保证。 FDA制定了一系列规定，包括对某些标记，营养含量，生产商的质量控制程序（以保证婴儿配方的养分含量），以及公司的记录和报告的种种要求。 FDA对婴儿配方奶粉的营养规格包括29种营养的最低含量和其中9种营养的最高含量。如果一个婴儿配方奶粉不含有这些营养成分或不达到起码要求的含量，又或者不在指定的范围内，将被视为是掺假的产品。

FDA对所有生产婴儿配方奶粉的设备及设施进行年度检查；并收集并分析婴儿配方奶粉的样品。此外，如果FDA认为掺假或冒牌的婴儿配方奶粉对人类健康造成威胁，即可启动强制性召回行动。

虽然其它婴儿食品没有像婴儿配方奶粉那样受到大规模的管制，但是它们接受的检验和审查在美国市场范围内是属於最认真和最仔细的。美国政府和生产商对它们的安全和营养质量的标准要求都非常高。

本全美科技集团（AmeriSci Group）可以提供有关婴儿配方奶粉及其它婴儿食品的监管框架和生产环境的专家指导。指导的主旨，系为帮助中国生产者去理解这些严格的要求，然后加强对这些食品在中国或其他地区生产的规范的参考。通过本集团的贡献，期待在中国的婴幼儿能够受益于既安全 又营养的配方奶粉和食品。

全美科技集团
协助解决各种美国FDA有关问题

• 关于FDA扣留的紧急协助, 案例评估，应急对策
• 协调、安排符合FDA要求的第三方独立检测机构申请
• 关于FDA乳制品进口警告的各细节要求及规定咨询
• FDA最新法规、政策咨询
• 协助中国厂商尽快采取应变美国FDA最近食品安全要求的对策
• 专业应急培训：如何重建中国乳业品牌形象及稳定扩大未来市场

• 针对现有的出口货物，协助确保满足美国FDA的具体进口要求，并证明货物不含未经准许范围内的三聚氰胺
• 紧急协助、以避免FDA扣留的货物变成被拒绝入关
• 协助申请从美国FDA进口警报得到“豁免”的要求
• 针对奶制品安全及乳制品的生产卫生管理的专业培训

FDA的测试方法（三聚氰胺方法）
LC-MS/MS方法在婴儿配方奶中测定三聚氰胺和氰尿酸残留
使用LC-MS/MS的临时方法测定在食品中三聚氰胺和氰尿酸残留
GC / MS法测定三聚氰胺和类似物

中国市场供应乳制品均符合三聚氰胺限量值规定

中国市场销售新生产的主要品种乳制品均符合三聚氰胺临时管理限量值规定

中国加快修订现行乳品工业产业政策和行业准入条件

新加坡恢复进口中国乳及含乳食品

中国发布国家标准《乳品设备安全卫生》

中国农业部通知：全面贯彻落实乳品质量安全监管条例

English Edition:

(Important Notice) REVISED 1/15/2009, IMPORT ALERT #99-30, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF ALL MILK PRODUCTS, MILK DERIVED INGREDIENTS AND FINISHED FOOD
PRODUCTS CONTAINING MILK FROM CHINA DUE TO THE PRESENCE OF MELAMINE AND/OR
MELAMINE ANALOGS"

The revised FDA Import Alert is essentially the same as that previously notified on November 12, 2008. The January 15, 2009 revision slightly changes the listing of products that are subject to the Import Alert and the associated Detention Without Physical Examination (DWPE). Companies affected by the Import Alert should visit the FDA web site linked above to view the products subject to DWPE.

Monthly Newsletter Feature Article

Regulation of Infant Formula and Infant Foods in the United States

Infant formulas are the most strictly regulated foods in the United States. FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula. Before a new infant formula can be marketed in the United States, the infant formula manufacturer must provide FDA with a notification about the proposed infant formula. This pre-market infant formula notification must contain detailed information about the formulation and nutritional and manufacturing assurances. The infant formula manufacturer must provide assurance that the formula will provide adequate nutrition for infants to thrive, that the formula will be manufactured under current good manufacturing practices including quality control procedures, and that every batch of the formula will meet all of the nutrient requirements.

If an infant formula manufacturer does not provide the elements and assurances required in the notification for a new or reformulated infant formula, the formula is defined as adulterated and FDA has the authority to take compliance action if the new infant formula is marketed in the United States.

Once an infant formula product is formulated, the manufacturer must provide FDA assurance of the nutritional quality of that particular formulation before marketing the infant formula. FDA has provisions that include requirements for certain labeling, nutrient content, manufacturers quality control procedures (to assure the nutrient content of infant formulas), as well as company records and reports. FDA is also working to finalize a proposed rule for good manufacturing practice, quality control procedures, quality factors, notification requirements, and reports and records, for the production of infant formulas.

FDA has requirements for nutrients in infant formulas. These nutrient specifications include minimum amounts for 29 nutrients and maximum amounts for 9 of those nutrients. If an infant formula does not contain these nutrients at or above the minimum level or within the specified range, it is an adulterated product

FDA conducts yearly inspection of all facilities that manufacture infant formula. FDA also inspects new facilities during early production runs. As part of the inspection, FDA collects and analyzes samples of infant formula. In addition, FDA can initiate a mandatory recall if the agency determines that an adulterated or misbranded infant formula presents a risk to human health.

While other infant foods are not regulated as extensively as infant formula, they are among the most intensely inspected and scrutinized foods in the American market place. Their safety and nutritional quality are held to a very high standard by both government authorities and manufacturers.

AmeriSci International can provide expert guidance in the regulatory framework and manufacturing environment for infant formulas and other infant foods. This guidance is not necessarily intended to lead to market access gains in the already saturated U.S. market for these products, rather, it is intended to assist Chinese producers with understanding the stringent requirements and to strengthen manufacturing practices in China associated with these critical foods. In this way, infants in China can benefit from the availability of safe and nutritious formulas and foods.

AmeriSci can assist on this and
other FDA Issues

• Assistance to urgent current FDA import alerts, Case assessments, Emergency Responses.
• Coordinate and arrange testing requests via certified third party independent testing laboratories which are in compliance with FDA requirements.
• Consulting and advisory services regarding detailed information and requirements for this latest FDA Import Alert pertaining to dairy/milk-containing products
• Guidance and training concerning the latest FDA regulations and policy
• To assist Chinese manufacturers in a timely manner to take contingency plans in response to U.S. FDA food safety regulations and requirements
• Professional emergency response training: How to rebuild Brand Image in China Dairy Industry

• Assistance with existing shipments to demonstrate to FDA that the products do not contain unacceptable levels of melamine
• Assistance to try to prevent a “detention” from becoming a “refusal”
• Petition FDA to become "exempt" from requirements of the Import Alert
• Professional training on milk safety and dairy sanitation management
  

The AmeriSci Group is a U.S.-based corporation that provides a wide range of services in the food, consumer product and environmental sectors. In the area of food safety and quality, we provide among other services, analytical testing of foods for chemical and microbiological safety, expert consultation on compliance issues for foods imported into the United States, and training in the technical, administrative and managerial practices and approaches bearing on the safety and quality of foods. Our staffs have extensive background and experience in FDA regulatory matters and broad experience in China's food manufacturing and government regulatory systems.

AmeriSci stands ready to work with individual food manufacturers, trade associations and government agencies in China to assist with any and all issues related to food safety and quality. We invite China's food producers and exporters to learn more about us by visiting our web site at www.amerisci.com.cn and by contacting us through our offices in Shanghai and Maryland USA.

AmeriSci's simple goal is to help enable Chinese food manufactures to proudly state that their products are ....

®

News Updates:

In USA:
FDA's Testing Methods (Melamine Methodology)
Determination of Melamine and Cyanuric Acid Residues in Infant Formula using LC-MS/MS
Interim Method for Determination of Melamine and Cyanuric Acid Residues in Foods using LC-MS/MS
GC/MS method for melamine and analogues

China’s market supply of dairy products are in line with the provisions of melamine limits

China’s new production of the main varieties of dairy products in the market are in line with melamine limits from the provisions of the interim regulation and administration
China's dairy industry to speed up amendments to the existing industrial policy and market entry conditions

Singapore to resume imports of milk and food product with milk ingredient from China
China released national standard of “Safety and Health of Dairy Equipment, "

Notice of Ministry of Agriculture: Comprehensive Implementation of the Quality and Safety of Dairy Regulations and administrations