FDA公布自动扣留的中国食品目录

上一篇 / 下一篇  2008-11-19 10:59:56

IA #99-30, 11/12/2008, 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"


TYPE OF ALERT: Detention Without Physical Examination (Countrywide)

               (Note: This import alert represents the Agency's current
               guidance to FDA field personnel regarding the
               manufacturer(s) and/or products(s) at issue.  It does not
               create or confer any rights for or on any person, and does
               not operate to bind FDA or the public).

PRODUCTS:      All milk products
               All milk derived ingredients
               Finished food products containing milk

PRODUCT
CODES:         03[][][][]     Bakery Products/Doughs/Mixes/Icings

               05Y[][][] Cereal Preparations
               05A[][][] Breakfast Food Ready to Eat
               05B[][][] Breakfast Food Quick Cook

               07[][][][]     Snack Foods

               09[][][][]     Milk/Butter/Dried Milk Products

               12[][][][]     Cheese/Cheese Products

               13[][][][]     Ice Cream Products

               14[][][][]     Filled Milk/imitation Milk Products

               29A[][]70 Soft Drink, Milk Based (Chocolate Flavored),
                         Noncarbonated
               29A[][]99 Noncarbonated Soft Drink, N.E.C.
               29Y[][]99 Soft Drink/Waters N.E.C.
               29B[][]70 Soft Drink, Milk Based (Chocolate Flavored,
                         Etc.) Carbonated
               29B[][]99 Carbonated Soft Drink, N.E.C.

               30F[][][] Beverage Base N/Fruit (Cola Rootbeer Etc)
               30G[][][] Beverage Base Non-Fruit Liquid

               33G[][][] Soft Candy w/ Nut, seeds, w/out Coconut
               33H[][][] Soft Candy w/ Coconut
               33J[][][] Soft Candy w/ Fruit
               33K[][][] Soft Candy w/ Nuts & Fruits
               33L[][][] Soft Candy, w/out Nut/Fruit
               33S[][][] Candy Specialties
               33Y[][][] Candy w/out Chocolate, N.E.C.

               34[][][][]     Chocolate/Cocoa Products

               35C[][][] Custard Pudding mix
               35D[][][] Pudding Mix (Not Custard)

               40[][][][]     Baby Food Products

               67A[][]28 Iodinated Casein (Cat. I, Type A med. Article)
               67C[][]28 Iodinated Casein (Combo Cat. I& II, type A, med)

               69A[][]28 Iodinated Casein (Cat. I med. feed)
               69C[][]28 Iodinated Casein (Combo Cat. I & II, med. feed)

               71C[][][] Dairy Byproducts for Animals
               71E[][][] Animal Waste Feed Products
               71Y[][][] Byproducts for Animals, N.E.C.

               72A[][][] Pet Cat Foods
               72B[][][] Pet Dog Foods
               72D[][][] Pet Fish Foods
               72E[][][] Other Pet Foods, N.E.C.
               72L[][][] Laboratory Animal Feeds
               72Y[][][] Pet and Laboratory Animal Foods, N.E.C.

PROBLEM:       Unsafe Food Additive
               Poisonous or Deleterious Substance
               Unfit For Food

PAF:           PES

COUNTRY:       China (CN)

MANUFACTURER/
SHIPPER:       All

CHARGES:       "The article is subject to refusal of admission pursuant to
               Section 801(a)(3) in that it appears to bear or contain a
               food additive, namely melamine and/or a melamine analog,
               that is unsafe within the meaning of section 409
               [Adulteration, section 402(a)(2)(C)(i)]"
               OASIS charge code: MELAMINE

                              and/or

               "The article is subject to refusal of admission pursuant to
               section 801(a)(3) in that it appears to bear or contain a
               poisonous or deleterious substance which may render it
               injurious to health [Adulteration, section 402(a)(1)]"
               OASIS charge code: POISONOUS

                              and/or

               "The article is subject to refusal of admission pursuant to
               section 801(a)(3) in that it appears to be unfit for food
               [Adulteration, 402(a)(3)]"
OASIS charge
code:               UNFIT4FOOD

RECOMMENDING
OFFICE:        Division of Import Operations and Policy, HFC-170
               Center for Food Safety and Applied Nutrition, HFS-600

REASON FOR
ALERT:         In September, 2008, FDA became aware of thousands of infant
               illnesses in China due to the consumption of infant formula
               reported to contain melamine. Reports indicated over 53,000
               illnesses, including almost 13,000 hospitalizations, and at
               least four deaths of infants.  The illnesses involved the
               formation of kidney stones and crystals and related
               complications.

               The milk used in the infant formula has been implicated as
               the source of the melamine contamination.  According to
               sources, at a bulk fluid milk collection point, water is
               added to the bulk fluid milk to increase the apparent volume
               of product.  Melamine is added to the water/milk mixture to
               increase the nitrogen content in order to inflate the
               apparent protein content found in the product.  Milk is
               transported from the collection centers to milk processing
               facilities.

               The problem of melamine contamination is not limited to
               infant formula products.  Chinese government sources
               indicate contamination of milk components, especially dried
               milk powder, which are used in the manufacture of a variety
               of finished foods.  These contaminated milk components
               appear to have been dispersed throughout the Chinese food
               supply chain.

               FDA analyses have detected melamine and cyanuric acid in a
               number of products that contain milk or milk-derived
               ingredients, including candy and beverages.  In addition,
               information received from government sources in a number of
               countries indicates a wide range and variety of products
               from a variety of manufacturers have been manufactured using
               melamine-contaminated milk or milk-derived ingredients,
               including: fluid and powdered milk, yogurt, frozen desserts,
               biscuits, cakes and cookies, taffy-like soft candy products,
               chocolates, and beverages. These products appear to contain
               at least one milk-derived ingredient and they are of Chinese
               origin.  Reports of contamination have come from more than
               thirteen countries in Asia, Europe, and Australia, in
               addition to the United States.  Additional products from
               various manufacturers continue to be found to be
               contaminated with melamine.

               The problem of melamine contamination in Chinese food
               products is a recurring one. In 2007, bulk vegetable protein
               products imported from China were contaminated with melamine
               and melamine analogs, apparently from deliberate
               contamination.


GUIDANCE:      Districts may detain without physical examination all milk
               products, all milk derived ingredients, and finished food
               products containing milk from China.

               Appropriate screening criteria have been set.

               For questions or issues concerning science, science policy,
               sample collection, analysis, preparation, or analytical
               methodology, contact Mr. Thomas Savage, Division of Field
               Science, at 301-827-1026.

               In order to secure release of an individual shipment
               detained pursuant to this Import Alert, the importer should
               provide either:

               1.   Results of a third-party laboratory analysis, of a
                    representative sample of the lot, which verifies the
                    product does not contain melamine or cyanuric acid.
                    Third-party laboratories may use any method that is
                    found acceptable to FDA and which meets the method
                    performance of the LC-MS/MS methods available at
                    http://www.cfsan.fda.gov/~comm/labmeth.html#melamine

                                   OR

               2.   Documentation supplied in English which shows there
                    are no milk or milk-derived ingredients in the
                    product, to include product formulation and product
                    labeling (for example; process or batch records from
                    the manufacturer, and the actual product labeling or a
                    facsimile of the product labeling).

               If a firm, shipper or importer wishes to request removal
               from detention without physical examination, they should
               forward information supporting their request to FDA at the
               following address:

               Food and Drug Administration
               Division of Import Operations and Policy (HFC-170)
               5600 Fishers Lane, Room 12-36
               Rockville, MD 20857

               The request should include information for FDA to adequately
               assess whether a manufacturer has appropriate controls and
               processes, including:

               1.   Documentation showing a minimum of five (5)
                    consecutive non-violative shipments have been released
                    by FDA based upon results of third party laboratory
                    analyses, using methods found acceptable to FDA of a
                    representative sample of the lot, that verify the
                    products do not contain melamine or cyanuric acid.

                                   AND

               2.   Documentation from a third-party, in whom FDA has
                    sufficient confidence, which demonstrates controls are
                    in place such that products will not be contaminated
                    with melamine and melamine analogs.  To gain
                    sufficient confidence in a third party, FDA may
                    determine it needs to conduct a paper or on-site
                    review of the work of the third party.

                                   AND

               3.   Documentation that the firm is in compliance with all
                    Chinese government requirements for exporting the
                    products to the U.S. Documentation should include
                    copies of any registration that may be required by the
                    Chinese government.

               All requests for removal from detention without physical
               examination will be referred by DIOP to CFSAN (HFS-606) or
               CVM (HFV-232) for evaluation.

PRIORITIZATION
GUIDANCE:      I

FOI:           No purging required

KEYWORDS:      Human food, pet food, animal feed, melamine, milk, milk-
               derived ingredients

PREPARED BY:   John E. Verbeten, DIOP, HFC-170, 301-594-3853
               Sal Evola, CFSAN, HFS-606, 301-436-2164
               Linda Wisniowski, CVM, HFV-232, 240-276-9233

DATE LOADED
INTO FIARS:         November 12, 2008

TAG:

引用 删除 zzliyh   /   2008-11-19 15:41:52
仅供参考!

IA#99-30,进口预警#99-30,2008年11月12日,美国FDA未经物理检测扣留来自中国的所有奶制品、含奶成分的食品以及一些含奶的成品,这些产品含有三聚氰胺或其类似物。
预警类型:没有经过理化检查就被扣留。
(注意;该进口预警表明了对于公布的生产商或产品,当局会对FDA的工作人员给予指导。除此之外,不授权给任何其他人,没有对FDA或公众有任何的约束力。
产品:所有的奶制品
      所有含奶成分的食品
      含奶成分的成品
产品
编码:
03[][] 焙烤产品/面包/mixes/icings
05Y[][] 谷物制品
05A[][]  即食早餐
05B[][]  Breakfast Food Quick Cook
07[][]   小食
09[][]  牛奶/黄油/干奶制品
12[][]  奶酪/奶酪制品
13[][]  冰激凌产品
14[][]  添加配料的乳制品/人造乳制品
29A[][]70 软饮料、乳饮料(巧克力口味)及其非碳酸饮料
29A[][]99 非碳酸软饮料, N.E.C.
29Y[][]99 软饮料/水 N.E.C.
29B[][]70 软饮料, 乳饮料 (巧克力口味.) 碳酸饮料
29B[][]99 碳酸软饮料, N.E.C.
30F[][][] 饮料 N/水果 (Cola Rootbeer)
30G[][][] 非水果口味饮料
33G[][][] 软糖 w/ 坚果 w/out coconut
33H[][][] 软糖 w/ 椰子
33J[][][] 软糖 w/ 水果
33K[][][]软糖w/ 坚果 & 水果
33L[][][]软糖, w/out Nut/Fruit
33S[][][] 糖果 Specialties
33Y[][][]软糖w/out Chocolate, N.E.C.
34[][][][] 巧克力/可可产品
35C[][][] 奶油布丁粉
35D[][][] 布丁粉 (非蛋糕)
40[][][][]婴儿产品
67A[][]28碘化酪蛋白(Cat. I, Type A med. Article)
67C[][]28碘化酪蛋白(Combo Cat. I& II, type A, med)
69A[][]28碘化酪蛋白(Cat. I med. feed)
69C[][]28碘化酪蛋白(Combo Cat. I & II, med. feed)
71C[][][] 动物食用的牛奶副产品
71E[][][] 动物饲料产品
71Y[][][] 动物副产品, N.E.C.
72A[][][] 宠物猫饲料
72B[][][] 宠物狗饲料
72D[][][] 宠物鱼饲料
72E[][][] 其他宠物食品, N.E.C.
72L[][][] 实验用动物饲料
72Y[][][] 宠物和实验动物食品, N.E.C.
问题:  不安全的食品添加剂;
       有毒或有害物质;
       不适宜食用物质。
PAF:   PES
国家:   中国
制造商/发货人: 所有
CHARGES:  根据409(掺假,402条(a)(2)(c)(i)),这些商品可能含有食品添加剂,即三聚氰胺或其类似物,违反了810(a)(3)条的规定,因此被拒绝。  
OASIS charge code:三聚氰胺
根据(掺假,402条(a)(1)),这些产品可能含有有毒或有害物质,会对健康造成损害,违反了810(a)(3)条的规定,因此被拒绝。   

OASIS charge code:有毒物质
根据(掺假,402条(a)(3)),这些产品可能不适宜做食品,违反了810(a)(3)条的规定,因此被拒绝。
OASIS charge code: UNFIT4FOOD
提供建议部门:
进口实施和政策部门 HFC-170
食品安全和应用营养中心 HFS-600
警告原因:2008年9月,FDA得知中国数千婴儿由于食用了含有三聚氰胺的婴儿奶粉生病。报道指出,至少53,000人生病,包括13000住院以及至少4人死亡。症状包括形成肾结石和晶体及相关的并发症。
婴儿奶粉中的原料奶受到三聚氰胺污染。在收奶时,加入水以增加总量,在水中或奶混合物中加入三聚氰胺以增加氮含量,使产品蛋白含量符合,之后,牛奶又被从奶站运送到加工厂。
三聚氰胺污染问题并不是只限于婴儿奶粉。中国政府指出是原料奶受到污染,特别是在各种加工食品中大量使用的奶粉受到污染。这些受污染的奶已经遍及中国食物链。
FDA在许多含奶或含奶原料中检测到三聚氰胺和三聚氰酸,包括糖果和饮料。此外,其他国家也表明很多生产商使用了含有三聚氰胺的奶或含奶原料生产了大量产品,包括:液态奶和奶粉、酸奶、冷冻甜点、饼干、蛋糕、糖果产品、巧克力以及饮料。这些产品至少含有一种来自中国的含奶原料。亚洲、欧洲的13个国家、澳大利亚以及美国都有污染方面的报道。来自不同生产商的产品也陆续发现受三聚氰胺污染。
中国食品受三聚氰胺污染问题是第二次发生。2007年,来自中国的大批蔬菜蛋白产品受三聚氰胺及相似物污染,而且显然是蓄意的污染。
指导:     
扣留未经物理检查的中国产品,包括乳制品、奶品原料和成品含奶食物。
恰当的筛选指标已经建立
    有关样品收集、分析、准备、方法方面的事宜,请联系Mr. Thomas Savag301-827-1026.e,
进口商需要提供以下任一种材料:
1、        第三方实验室分析结果。其分析方法是FDA认可的,符合LC-MS/MS方法,详情请登陆
http://www.cfsan.fda.gov/~comm/labmeth.html#melamine
2、标明所进口产品不含有牛奶或者牛奶衍生成分的英文资料。进口商可按以下地址向FDA递送材料,这些材料可确保未经物理检查的货物免遭扣押。
     Food and Drug Administration
     Division of Import Operations and Policy (HFC-170)
     5600 Fishers Lane, Room 12-36
     Rockville, MD 20857
所要提交的材料有:
1、至少连续5个批次船舶货物经第三方实验室检测没有违反FDA要求,即不含有三聚氰胺或三聚氰酸。
2、FDA 需要对第三方实验室进行评审,以获得FDA的信任。           
3、所出示的文件要符合中国对美出口产品各项要求。文件包括中国政府所要求的卫生注册登记复印件。
所有请求将参照DIOP 至CFSAN (HFS-606)或者CVM (HFV-232)进行评估。
优先指导级:I
信息传递或使用自由:无清洗要求
关键词:人类食品,宠物食品,动物饲料,三聚氰胺,奶,奶源配料
处理人:John E. Verbeten, DIOP, HFC-170, 301-594-3853
        Sal Evola, CFSAN, HFS-606, 301-436-2164
        Linda Wisniowski, CVM, HFV-232, 240-276-9233
DATE LOADED
INTO FIARS:2008年11月12日
热力杀菌 引用 删除 qlfangcn   /   2008-11-19 15:22:24
没来得及翻译了。那位大侠有时间就给大伙译了。俺明儿还要出差了。
东海钓夫的小船 引用 删除 东海钓夫   /   2008-11-19 15:13:11
有无中文版?
 

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