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输美企业关注:美国FDA新增食品分析实验室认可计划(LAAF) 新网页端

近期,FDA在其数据库网页新增了一个食品分析实验室认可计划网页端  根据FDA食品安全现代化法,FDA认定认可机构,认可机构可以对食品分析实验室进行认可,这些认可的实验室可以服务于FDA专门要求的实验室检测,如解除进口警告等。这个网页端将不断更新列出FDA认定的认可机构所认可的食品检测实验室以及每个实验室的检测范围。以下为美国FDA驻华办公室提供的英文介绍及翻译,请广大输美企业关注。

 

英文介绍:

 

New Dashboard for Laboratory Accreditation for Analyses of Foods (LAAF) Program

 

The FDA Food Safety Modernization Act (FSMA) final rule on Laboratory Accreditation for Analyses of Foods (LAAF) establishes a laboratory accreditation program for the testing of food in certain circumstances. Under the LAAF program, FDA will recognize accreditation bodies (ABs) that will accredit laboratories to the standards established in the final rule (referred to as LAAF-accredited laboratories).

 

The final rule specifies eligibility requirements that ABs and laboratories wishing to participate in the program will need to satisfy, as well as procedures for how the FDA will manage and oversee the program. In certain circumstances, owners and consignees will be required to use a LAAF-accredited laboratory for food testing. FDA will maintain an online public registry listing recognized accredited bodies and LAAF-accredited laboratories.

 

The establishment of the LAAF program is intended to improve the accuracy and reliability of certain food testing through the uniformity of standards and enhanced FDA oversight of participating laboratories.

 

What testing is covered under the LAAF final rule?

 

After the LAAF final rule is fully implemented, owners and consignees will be required to use a LAAF-accredited laboratory for food testing:

 

 to support removal from an import alert through successful consecutive testing (e.g., to get a food product or firm removed from the red list);

 to support admission of an imported food (e.g., articles of human or animal food, and

U.S. goods returned that are articles of food) detained at the border because it is or appears to be in violation of the Federal Food, Drug, and Cosmetic Act (e.g., products that contain or appear to contain unapproved food additives, including unauthorized food contact substances);

 required by existing FDA food safety regulations, when applied to address an identified or suspected food safety problem (i.e., certain tests related to shell eggs, sprouts, and bottled drinking water);

 required by a directed food laboratory order, a new procedure being implemented in this final rule that will allow FDA to require use of a LAAF-accredited laboratory to address an identified or suspected food safety problem in certain, rare circumstances; and

 

 conducted in connection with certain administrative processes (e.g., testing submitted in connection with an appeal of an administrative detention order).

 

A new LAAF Daslhboard has been added to the FDA Data Dashboard to serve as the online public registry listing for information on participants in the Laboratory Accreditation for Analyses of Foods Program (LAAF). The establishment of the LAAF Program is intended to improve the accuracy and reliability of certain food testing through the uniformity of standards and enhanced FDA oversight of participating laboratories. The functionality of the LAAF Dashboard includes searching, viewing, and the ability to export the lists of recognized accreditation bodies, LAAF-accredited laboratories, and each laboratory’s testing scopes.

 

Interested accreditation bodies may apply for recognition under the LAAF program through an electronic portal. The data will be refreshed as participants are added or changed. Interested laboratories may apply directly to one of the recognized accreditation bodies to seek LAAF- accreditation.

 

For questions about the LAAF Program, contact FDALAAFInquiry@fda.hhs.gov. For questions or feedback specific to the Dashboard, email FDADataDashboard@fda.hhs.gov or send a message via the Contact Us page.

 

For Additional Information:

 

· FSMA Final Rule on Laboratory Accreditation for Analyses of Foods (LAAF)

· FDA Issues Final Rule for Laboratory Accreditation for Analyses of Foods

· User Guide for Accreditation Bodies to Apply for and Manage Recognition Status in the LAAF Program

· Frequently Asked Questions on FSMA

 

Please do let us know if you have any questions not covered in the information provided and we will do our best to reply. We will update you when more information becomes available. Thank you for your continued partnership.

 

 

翻译:

 

食品分析实验室认可计划(LAAF) 新网页端

 

FDA 食品安全现代化法案(FSMA) 中关于食品分析实验室认可 (LAAF) 的最终法规,建立了在某些情况下食品检测实验室的认可计划。根据 LAAF 计划,FDA 将认定认可机构(AB),这些认可机构将根据最终法规中建立的标准来认可实验室(以下称为 LAAF 认可的实验室)。

 

最终法规规定了希望参与该计划的 AB 和实验室需要满足的要求,以及FDA 如何管理和监督该计划的程序。在某些情况下,企业所有者和收货人将被要求使用 LAAF 认可的实验室进行食品检测。 FDA 将发布一个面向公众的在线登记列表,列出 FDA 认定的认可机构和 LAAF 认可的实验室。

 

LAAF 计划的建立旨在通过统一标准和加强 FDA 对参与实验室的监管来提高某些食品检测的准确性和可靠性。

 

LAAF 最终法规涵盖哪些检测内容?

 

LAAF 最终法规全面实施后,企业所有者和收货人将被要求使用 LAAF 认可的实验室进行食品检测:

 

 进行连续检测从而被移出进口警报名单(例如,将食品或公司从红名单中移除);

 当进口食品例如人类或动物食品,以及作为食品被退回的美国商品在边境被扣留,原因是它违反了或疑似违反了联邦食品、药品和化妆品法例如,含有或疑似含有未经批准的食品添加剂的产品,包括未经批准的食品接触物质);

 根据现有 FDA 食品安全法规要求,用于解决已确定的或疑似的食品安全问题即,与带壳蛋、豆芽和瓶装饮用水相关的某些检测);

 根据食品实验室规定的要求,该最终法规中正在实施的新程序将允许 FDA 在特定的、罕见的情况下要求使用 LAAF 认可的实验室来解决已确定或疑似的食品安全问题;以及

 与某些行政程序相关(例如,与行政扣留令申诉相关的检测)。

 

 

一个新的食品分析实验室认可计划网页端已添加到 FDA 数据库网页端中,作为在线公共登记列表,用于提供有关食品分析实验室认可计划 (LAAF) 参与者的信息。 LAAF 计划的建立旨在通过统一的标准和加强 FDA 对参与实验室的监管来提高某些食品检测的准确性和可靠性。 LAAF 网页端的功能包括搜索、查看和导出 FDA 认定的认可机构、LAAF 认可的实验室和每个实验室检测范围的列表。

 

有兴趣的认可机构可以通过电子门户网站申请 LAAF 计划的认定。数据将根据参与者的添加或更改进行更新。有兴趣的实验室可以直接向已被 FDA 认定的认可机构来申请获得 LAAF 认可。

 

 

有关 LAAF 计划的问题,请联系 FDALAAFInquiry@fda.hhs.gov。对于网页端的问题或反馈, 请发送电子邮件至 FDADataDashboard@fda.hhs.gov 或通过联系yabo亚搏网页版页面发送消息。

 

 

相关信息请参考:

· FSMA 食品分析实验室认可最终法规 (LAAF)

· FDA 发布食品分析实验室认可最终法规

· 认可机构在 LAAF 计划中申请和管理认定状态的用户指南

· FSMA 常见问题