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      美洲認證
      首頁全球認證美洲認證

      美國食品和藥物管理局(Food and Drug Administration)簡稱FDA,是美國政府在健康與人類服務部 (DHHS) 和公共衛生部 (PHS) 中設立的執行機構之一。

        作為一家科學管理機構,FDA 的職責是確保美國本國生產或進口的食品、化妝品、藥物、生物制劑、醫療設備和放射產品的安全。它是最早以保護消費者為主要職能的聯邦機構之一。該機構與每一位美國公民的生活都息息相關。在國際上,FDA 被公認為是世界上最大的食品與藥物管理機構之一。其它許多國家都通過尋求和接收 FDA 的幫助來促進并監控其本國產品的安全。

        食品和藥物管理局(FDA)主管:食品、藥品(包括獸藥)、醫療器械、食品添加劑、化妝品、動物食品及藥品、酒精含量低于7%的葡萄酒飲料以及電子產品的監督檢驗;產品在使用或消費過程中產生的離子、非離子輻射影響人類健康和安全項目的測試、檢驗和出證。根據規定,上述產品必須經過FDA檢驗證明安全后,方可在市場上銷售。FDA有權對生產廠家進行視察、有權對違法者提出起訴。根據監管的不同產品范圍,可分為以下幾個主要監管機構:

        1、食品安全和實用營養中心(CFSAN):

        該中心是FDA工作量最大的部門。它負責除了美國農業部管轄的肉類、家禽及蛋類以外的全美國的食品安全。盡管美國是世界上食品供應最安全的國家,但是,每年還是有大約有七千六百萬食源性疾病發生,三十二萬五千人因食源性疾病需要住院治療,五千左右人死于食源性疾病。食品安全和營養中心致力于減少食源性疾病,促進食品安全。并促進各種計劃,如:HACCP計劃的推廣實施等。

        該中心的職能包括:確保在食品中添加的物質及色素的安全;確保通過生物工藝開發的食品和配料的安全;負責在正確標識食品(如成分、營養健康聲明)和化妝品方面的管理活動;制定相應的政策和法規,以管理膳食補充劑、嬰兒食物配方和醫療食品;確保化妝品成分及產品的安全,確保正確標識;監督和規范食品行業的售后行為;進行消費者教育和行為拓展;與州和地方政府的合作項目;協調國際食品標準和安全等。

        2、藥品評估和研究中心(CDER):

        該中心旨在確保處方藥和非處方藥的安全和有效,在新藥上市前對其進行評估,并監督市場上銷售的一萬余種藥品以確保產品滿足不斷更新的最高標準。同時,該中心還監管電視、廣播以及出版物上的藥品的廣告的真實性。嚴格監管藥品,提供給消費者準確安全的信息。

        3、設備安全和放射線保護健康中心(CDRH):

        該中心在確保新上市的醫療器械的安全和有效。因為在世界各地有兩萬多家企業生產從血糖監測儀到人工心臟瓣膜等超過八萬種各種類型的醫療器械。這些產品都是同人的生命息息相關的,因而該中心同時還監管全國范圍內的售后服務等。對于一些象微波爐、電視機、移動電話等能產生放射線的產品,該中心也確定了一些相應的安全標準。

        4、生物制品評估和研究中心(CBER):

        該中心監管那些能夠預防和治療疾病的生物制品,因此比化學綜合性藥物更加復雜,它包括對血液、血漿、疫苗等的安全性和有效性進行科學研究。

        5、獸用藥品中心(CVM):

        該中心監管動物的食品及藥品,以確保這些產品在維持生命,減輕痛苦等方面的實用性、安全性和有效。

        1.食品接觸材料FDA認證

        食品接觸類材料指一切用與加工生產包裝存儲運輸食品過程中與食品能夠接觸到的材料.常見的材料包括各種塑料金屬陶瓷玻璃竹木制品等,這些與食品能夠接觸到的材料的環保安全情況直接事關使用者的飲食安全和健康,所以對這類產品出口到美國需要按照FDA標準進行相關的檢測認證。

        2.常見與食品接觸材料FDA認證檢測項目如下:

        有機涂層,金屬和電鍍制品要求U.S. FDA CFR 21 175.300.

        water extractives 去離子水浸取法

        8% alcohol extractives 8%酒精浸取法

        n-heptane extractives 正庚烷浸取法

        紙制品要求 U.S. FDA CFR 21 176.170

        Net chloroform soluble extractives for water fraction 氯仿可溶萃取物(去離子水浸取法).

        Net chloroform soluble extractives for 8 % alcohol fraction 氯仿可溶萃取物(8%酒精浸取法)

        Net chloroform soluble extractives for 50 % alcohol fraction 氯仿可溶萃取物(50%酒精浸取法)

        Net chloroform soluble extractives for n-heptane fraction 氯仿可溶萃取物(正庚烷浸取法)

        木材要求U.S. FDA CFR 21 178.3800

        Pentachlorophenol and its salt 五氯苯酚PCP

        ABS要求U.S. FDA CFR 21 181.32 or 180.22.

        in water 去離子水浸取法

        in 3% acetic acid 3%醋酸浸取法

        in 8% ethanol 8%酒精浸取法

        in n-heptane 正庚烷浸取法



       
       
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