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              輸美企業關注:美國FDA新增食品分析實驗室認可計劃(LAAF) 新網頁端

              近期,FDA在其數據庫網頁新增了一個食品分析實驗室認可計劃網頁端 。 根據FDA食品安全現代化法,FDA認定認可機構,認可機構可以對食品分析實驗室進行認可,這些認可的實驗室可以服務于FDA專門要求的實驗室檢測,如解除進口警告等。這個網頁端將不斷更新列出FDA認定的認可機構所認可的食品檢測實驗室以及每個實驗室的檢測范圍。以下為美國FDA駐華辦公室提供的英文介紹及翻譯,請廣大輸美企業關注。

               

              英文介紹:

               

              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.

               

               

              翻譯:

               

              食品分析實驗室認可計劃(LAAF) 新網頁端

               

              FDA 食品安全現代化法案(FSMA) 中關于食品分析實驗室認可 (LAAF) 的最終法規,建立了在某些情況下食品檢測實驗室的認可計劃。根據 LAAF 計劃,FDA 將認定認可機構(AB),這些認可機構將根據最終法規中建立的標準來認可實驗室(以下稱為 LAAF 認可的實驗室)。

               

              最終法規規定了希望參與該計劃的 AB 和實驗室需要滿足的要求,以及FDA 如何管理和監督該計劃的程序。在某些情況下,企業所有者和收貨人將被要求使用 LAAF 認可的實驗室進行食品檢測。 FDA 將發布一個面向公眾的在線登記列表,列出 FDA 認定的認可機構和 LAAF 認可的實驗室。

               

              LAAF 計劃的建立旨在通過統一標準和加強 FDA 對參與實驗室的監管來提高某些食品檢測的準確性和可靠性。

               

              LAAF 最終法規涵蓋哪些檢測內容?

               

              LAAF 最終法規全面實施后,企業所有者和收貨人將被要求使用 LAAF 認可的實驗室進行食品檢測:

               

               進行連續檢測從而被移出進口警報名單(例如,將食品或公司從紅名單中移除);

               當進口食品例如人類或動物食品,以及作為食品被退回的美國商品在邊境被扣留,原因是它違反了或疑似違反了聯邦食品、藥品和化妝品法例如,含有或疑似含有未經批準的食品添加劑的產品,包括未經批準的食品接觸物質);

               根據現有 FDA 食品安全法規要求,用于解決已確定的或疑似的食品安全問題即,與帶殼蛋、豆芽和瓶裝飲用水相關的某些檢測);

               根據食品實驗室規定的要求,該最終法規中正在實施的新程序將允許 FDA 在特定的、罕見的情況下要求使用 LAAF 認可的實驗室來解決已確定或疑似的食品安全問題;以及

               與某些行政程序相關(例如,與行政扣留令申訴相關的檢測)。

               

               

              一個新的食品分析實驗室認可計劃網頁端已添加到 FDA 數據庫網頁端中,作為在線公共登記列表,用于提供有關食品分析實驗室認可計劃 (LAAF) 參與者的信息。 LAAF 計劃的建立旨在通過統一的標準和加強 FDA 對參與實驗室的監管來提高某些食品檢測的準確性和可靠性。 LAAF 網頁端的功能包括搜索、查看和導出 FDA 認定的認可機構、LAAF 認可的實驗室和每個實驗室檢測范圍的列表。

               

              有興趣的認可機構可以通過電子門戶網站申請 LAAF 計劃的認定。數據將根據參與者的添加或更改進行更新。有興趣的實驗室可以直接向已被 FDA 認定的認可機構來申請獲得 LAAF 認可。

               

               

              有關 LAAF 計劃的問題,請聯系 FDALAAFInquiry@fda.hhs.gov。對于網頁端的問題或反饋, 請發送電子郵件至 FDADataDashboard@fda.hhs.gov 或通過聯系我們頁面發送消息。

               

               

              相關信息請參考:

              · FSMA 食品分析實驗室認可最終法規 (LAAF)

              · FDA 發布食品分析實驗室認可最終法規

              · 認可機構在 LAAF 計劃中申請和管理認定狀態的用戶指南

              · FSMA 常見問題

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