§114.80 酸化食品加工(杀菌)和控制(Processes and controls)

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　　   § 114.80   Processes and controls.

　　（a） Processing operations. The manufacturer shall employ appropriate quality control procedures to ensure that finished foods do not present a health hazard.

　　（1） Acidified foods shall be so manufactured, processed, and packaged that a finished equilibrium pH value of 4.6 or lower is achieved within the time designated in the scheduled process and maintained in all finished foods. Manufacturing shall be in accordance with the scheduled process. Acidified foods shall be thermally processed to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of nonhealth significance capable of reproducing in the food under the conditions in which the food is stored, distributed, retailed and held by the user. Permitted preservatives may be used to inhibit reproduction of microorganisms of nonhealth significance （in lieu of thermal processing）.

　　（2） Sufficient control, including frequent testing and recording of results, shall be exercised so that the finished equilibrium pH values for acidified foods are not higher than 4.6. Measurement of acidity of foods in-process may be made by potentiometric methods, titratable acidity, or colorimetric methods. If the finished equilibrium pH of the food is above 4.0, the measurement of the finished equilibrium pH shall be by a potentiometric method, and the in-process measurements by titration or colorimetry shall be related to the finished equilibrium pH. If the finished equilibrium pH is 4.0 or below, then the measurement of acidity of the final product may be made by any suitable method. Special care should be taken when food ingredients have been subjected to lye, lime, or similar high pH materials.

　　（3） Procedures for acidification to attain acceptable equilibrium pH levels in the final food include, but are not limited to, the following:

　　（i） Blanching of the food ingredients in acidified aqueous solutions.

　　（ii） Immersion of the blanched food in acid solutions. Although immersion of food in an acid solution is a satisfactory method for acidification, care must be taken to ensure that the acid concentration is properly maintained.

　　（iii） Direct batch acidification, which can be achieved by adding a known amount of an acid solution to a specified amount of food during acidification.

　　（iv） Direct addition of a predetermined amount of acid to individual containers during production. Liquid acids are generally more effective than solid or pelleted acids. Care must be taken to ensure that the proper amount of acid is added to each container.

　　（v） Addition of acid foods to low-acid foods in controlled proportions to conform to specific formulations.

　　（4） Testing and examinations of containers shall occur often enough to ensure that the container suitably protects the food from leakage or contamination.

　　（b） Coding. Each container or product shall be marked with an identifying code permanently visible to the naked eye. If the container does not permit the code to be embossed or inked, the label may be legibly perforated or otherwise marked, as long as the label is securely affixed to the product container. The required identification shall specify in code the establishment where the product was packed, the product contained therein, and the year, day, and period during which it was packed. The packing period code shall be changed often enough to enable ready identification of lots during their sale and distribution. Codes may be changed periodically on one of the following bases: intervals of 4 to 5 hours; personnel shift changes; or batches, as long as the containers constituting the batch do not represent those processed during more than one personnel shift.

　　§114.80　加工（杀菌）和控制

　　（a）加工（杀菌）：制造商必须采用一套有效的质量控制程序以确保食品成品不构成对健康的损害。

　　（1）酸化食品的制造、杀菌、包装要使食品在工艺规程规定的时间内，其平衡的pH达到4.6或小于4.6，并在食品成品中保持这一pH。制造必须符合工艺规程。酸化食品必须经过热杀菌。热杀菌要足以杀灭对公众健康有危害的有生长力的微生物细胞，以及对健康虽无影响但在食品贮藏、分销、零售和消费者存放情况下可能繁殖的微生物细胞。可以使用准许使用的防腐剂，以抑制对健康无害的微生物的繁殖（以替代热杀菌）。

　　（2）必须进行适当的控制，包括经常测试和记录测试结果，以确保酸化食品的最终平衡pH不高于4.6。用电位法可滴定酸度或者比色法测量加工中食品的酸度。如果食品的最终平衡pH高于4.0，用电位法测量最终平衡pH，用滴定法或比色法测量加工中食品的pH。如果最终平衡pH等于或低于4.0，那么可以用任何合适方法测量最终产品的酸度。当食品配料遭受过碱液、石灰或类似的pH高的物质影响时，应特别当心。

　　（3）在最终食品中获得需要的平衡pH的酸化方法如下（不仅限于此）：

　　（i）食品配料在酸化水溶液中热烫（预煮）。

　　（ii）热烫后的食品在酸溶液中浸渍。虽然在酸溶液中浸渍食品是一种理想的酸化方法，但必须注意保持酸的浓度。

　　（iii）直接分批酸化，即在规定量的食品中加入已知量的某种酸溶液进行酸化。

　　（iv）在生产中，在单个容器中直接添加事先定量的酸。液态酸一般比固态或粒状酸更有效。注意在每只容器内加入适量的酸。

　　（v）以控制好的比例在低酸性食品中添加酸性食品以达到规定的配方。

　　（4）要经常进行测试和检验，以确保容器内食品不渗透、不被污染。

　　（b）编号：每只容器或每件产品上都必须打上永久性的、肉眼可见的供识别的代号。如果容器上不允许打上凸纹的或印上油墨的代号，则在标签上用穿孔或其它方式打上这一代号，但要将标签牢固地黏着在产品容器上。在代号中要识别出产品罐装和包装的企业、年、月、日和包装的时间段。包装时间段代号要经常改变，使销售中易于识别批次。这一代号根据下述中一种情况定期改变：间隔4～5h；工作人员换班或者批量生产的一批产品，但不超过一个工作班次内生产的产品。

　　更多关于美国FDA酸化食品HACCP法规，请详见美国FDA酸化食品HACCP法规第113和114部分汇总