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§107.230 婴儿配方粉的召回注意事项(Elements of an infant formula recall)

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放大字体  缩小字体 2011-08-20 23:09:55  来源:GPO  浏览次数:3396
核心提示:婴儿配方粉召回时需注意:召回产品的商行必须以书面形式,就食用该婴儿配方粉对人体健康造成危害做出评估;召回产品的商行必须考虑一个适于召回个案的具体情况的计划,此计划包括:召回范围、必要时将婴儿配方粉中存在的危害公之于众、被召回的婴儿配方粉的处理以及对执行情况的核实。召回产品的商行必须立即将召回一事通知有关的直接账户。对人的健康存在危险的食品,必须指示各个销售企业张贴召回通知。
发布单位
FDA
FDA
发布文号 69 FR 17291
发布日期 2004-04-02 生效日期 暂无
有效性状态 废止日期 暂无
备注 婴儿配方粉召回时需注意:召回产品的商行必须以书面形式,就食用该婴儿配方粉对人体健康造成危害做出评估;召回产品的商行必须考虑一个适于召回个案的具体情况的计划,此计划包括:召回范围、必要时将婴儿配方粉中存在的危害公之于众、被召回的婴儿配方粉的处理以及对执行情况的核实。召回产品的商行必须立即将召回一事通知有关的直接账户。对人的健康存在危险的食品,必须指示各个销售企业张贴召回通知。

       更多关于婴儿配方粉的法规,请详见美国FDA 21 CFR 第107部分关于婴儿配方粉的法规汇总

  § 107.230   Elements of an infant formula recall.

  A recalling firm shall conduct an infant formula recall with the following elements:

  (a) The recalling firm shall evaluate in writing the hazard to human health associated with the use of the infant formula. This health hazard evaluation shall include consideration of any disease, injury, or other adverse physiological effect that has been or that could be caused by the infant formula and of the seriousness, likelihood, and consequences of the diseases, injury, or other adverse physiological effect. The Food and Drug Administration will conduct its own health hazard evaluation and promptly notify the recalling firm of the results of that evaluation if the criteria for recall under §107.200 have been met.

  (b) The recalling firm shall devise a written recall strategy suited to the individual circumstances of the particular recall. The recall strategy shall take into account the health hazard evaluation and specify the following: The extent of the recall; if necessary, the public warning to be given about any hazard presented by the infant formula; the disposition of the recalled infant formula; and the effectiveness checks that will be made to determine that the recall is carried out.

  (c) The recalling firm shall promptly notify each of its affected direct accounts about the recall. The format of a recall communication shall be distinctive, and the content and extent of a recall communication shall be commensurate with the hazard of the infant formula being recalled and the strategy developed for the recall. The recall communication shall instruct consignees to report back quickly to the recalling firm about whether they are in possession of the recalled infant formula and shall include a means of doing so. The recalled communication shall also advise consignees how to return the recall infant formula to the manufacturer or otherwise dispose of it. The recalling firm shall send a followup recall communication to any consignee that does not respond to the initial recall communication.

  (d) If the infant formula presents a risk to human health, the recalling firm shall request that each establishment, at which such infant formula is sold or available for sale, post at the point of purchase of such formula a notice of such recall at such establishment. The notice shall be provided by the recalling firm after approval of the notice by the Food and Drug Administration. The recalling firm shall also request that each retail establishment maintain such notice on display until such time as the Food and Drug Administration notifies the recalling firm that the agency considers the recall completed.

  (e) The recalling firm shall furnish promptly to the appropriate Food and Drug Administration district office listed in part 5, subpart M of this chapter, as they are available, copies of the health hazard evaluation, the recall strategy, and all recall communications (including, for a recall under §107.200, the notice to be displayed at retail establishments) directed to consignees, distributors, retailers, and members of the public.

  [54 FR 4008, Jan. 27, 1989, as amended at 66 FR 17358, Mar. 30, 2001; 69 FR 17291, Apr. 2, 2004]
 

 地区: 美国 
 标签: 销售 配方 评估 召回 
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