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低酸罐头食品FDA认证

时间:2021-08-12 16:17文章来源:澳恒第三方检测公司 作者:澳恒实验室

低酸罐头食品FDA认证 . 低酸罐头食品FDA认证
一、酸化和低酸罐头食品FDA认证

罐头食品是指将符合要求的原料经处理、分选、修整、烹调(或不经烹调)、装罐(包括马口铁罐、玻璃罐、复合薄膜袋或其 他包装材料容器)、密封、杀菌、冷却而制成的具有一定真空度的罐藏食品。

随包装材料和形式的扩大,除用马口铁罐、玻璃罐、铝合金罐外,其它如用铝塑复合包装材料制成的各种软罐头和无菌大包 装;先经灭菌再包装制成的利乐包如各种果汁、菜汁、果冻、沙司、蛋白饮料等等;
       可耐热杀菌的塑料罐,塑料肠衣制成 的各种  火腿肠均应视为罐头食品。

低酸性罐头食品指除酒精饮料以外,凡杀菌后平衡pH值大于4.6、水活性值大于0.85的罐头食品,原来是低酸性的水果、蔬菜 或蔬菜制品,为加热杀菌的需要而加酸降低pH值的,属于酸化的低酸性罐头食品。

低酸罐头食品的工厂不仅仅需要做普通的FDA工厂注册,还需要做低酸罐头厂和产品注册,这样才能保证顺利清关。

二、如何判断产品为酸化和低酸罐头食品
  1. Is the product stored, distributed, and retailed under refrigerated or frozen conditions? If yes, go to 1(a). If no, go to 2.
    产品是否在冷藏或冷冻下储存,分发和零售条件?如果是,请转到1(a)。 如果不是,请转到2。
    1. The product is not covered by 21 CFR Part 113 or 21 CFR Part 114.
      21 CFR Part 113或21 CFR Part 114不涵盖该产品。
  2. Is the product processed under the continuous inspection of the meat and poultry inspection program of the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act or the Poultry Products Inspection Act? (Such food contains a statement on the label that it has been inspected by USDA.) If yes, go to 2(1). If no, go to 3.
    是否在肉类和家禽的连续检查下加工产品美国食品安全检验局检验计划根据联邦肉类检验法案或家禽产品的农业 (USDA)检查法?(这种食品在标签上有一个声明美国农业部检查。)如果是,请转到2(1)。 如果不是,请转到3。
    1. The product is not covered by 21 CFR Part 113 or 21 CFR Part 114.
      21 CFR Part 113或21 CFR Part 114不涵盖该产品。
  3. Is the water activity of the finished product less than or equal to 0.85? If yes, go to 3(1). If no, go to 4.
    成品的水分活度是否小于或等于0.85? 如是, 转到3(1)。 如果不是,请转到4。
    1. The product is not covered by 21 CFR Part 113 and 21 CFR Part 114.
      21 CFR Part 113或21 CFR Part 114不涵盖该产品。
  4. Is the finished equilibrium pH of the product 4.6 or lower? If yes, go to 5. If no, go to 4(1).
    产品的最终平衡pH值是4.6还是更低? 如果是,请转到5.如果否,请转到4(1)。
    1. Is the product an alcoholic beverage? If yes, the product is not covered by 21 CFR Part 113 or 21 CFR Part 114.
      该产品是否为酒精饮料? 如果是,则该产品不在21 CFR的保障范围内第113或21部分CFR第114部分。
    2. Is the product a tomato or tomato product with a finished equilibrium pH less than 4.7? If yes, the product is not covered by 21 CFR Part 113 or 21 CFR Part 114.
      该产品是番茄或番茄产品,其最终平衡pH值小于4.7? 如果是,则产品不受21 CFR Part 113或21 CFR Part 114的保护。
    3. If you answered “no” to 4 and “no” to 4(a) and 4(b), your product is a low-acid food covered by 21 CFR Part 113.
      如果您回答“否”为4而“否”回答4(1)和4(2),那么您的产品是低酸 21 CFR第113部分涵盖的食品。
  5. Is the natural pH of the product 4.6 or lower without any added acid? If yes, go to 5(1) . If no, the product is an acidified food covered by 21 CFR Part 114.
    产品的天然pH值是否为4.6或更低,没有添加任何酸? 如果是,请转到5(1)。 如果不是,该产品是21 CFR Part 114所涵盖的酸化食品。
    1. Does the product contain low-acid ingredients? If yes, go to 5(2). If no, the product is an acid food that is not covered by 21 CFR Part 113 or 21 CFR Part 114.
      该产品是否含有低酸成分? 如果是,请转到5(2)。 如果没有,那么产品是21 CFR Part 113或21 CFR Part 114未涵盖的酸性食品。
    2. Is the product predominantly an acid or acid food that (1) contains only small amounts of low-acid food(s) and (2) has a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food? You may consult FDA if you need help with this evaluation. If yes, go to 5(2)-(1). If no, go to 5(2)-(2).
      该产品主要是酸性或酸性食品(1)仅含有少量低酸食品和(2)产生的最终平衡pH不会与主要酸或酸性食物有显 着差异? 你可以咨询FDA如果您需要帮助进行此评估。
    3. 如果是,请转到5(2) - (1)。 如果不是,请转到 5(2) - (2)。
      1. The product is not covered by 21 CFR Part 113 or 21 CFR Part 114. However, you can voluntarily submit a process filing as referenced in Figure 1.
        该产品不在21 CFR Part 113或21 CFR Part中114.但是,您可以自愿提交流程归档。
      2. The product is an acidified food covered by 21 CFR Part 114.
        该产品是21 CFR Part 114所涵盖的酸化食品。

If the product is a fermented food with a finished equilibrium pH of 4.6 or lower, then the product is not covered by 21 CFR Part 113 or 21 CFR Part 114. However, you can voluntarily submit a process filing as referenced in Figure 1.

如果产品是发酵食品,其最终平衡pH值为4.6或更低,那么产品不在21 CFR Part 113或21 CFR Part 114中。 但是,您可以自愿提交流程归档。

If the product is a fermented food with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85, then the product is a low-acid food covered by 21 CFR Part 113.

如果产品是发酵食品,其最终平衡pH大于4.6和水分活度大于0.85,则该产品为21 CFR Part 113中所涵盖的低酸食品。

三、酸化和低酸罐头食品FDA认证流程
  1. 客户填写酸化和低酸罐头食品FDA注册申请表 
  2. 产品资料进行评估
  3. 客户详细沟通产品细节
  4. 提交资料到信智驻美办事处
  5. 信智团队完成注册