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Container Coding Requirments (21 CFR 113.60)

US FDA requires that containers be properly coded in the event of a product recall.  The US FDA requires in its code of Federal Regulations (21 CFR section 113.60(c)) the following:

21 CFR 113.60(c) Coding. Each hermetically sealed container of low-acid processed food shall be marked with an identifying code that shall be permanently visible to the naked eye. When the container does not permit the code to be embossed or inked, the label may be legibly perforated or otherwise marked, if the label is securely affixed to the product container. The required identification shall identify in code the establishment where packed, the product contained therein, the year packed, the day packed, and the period during which packed. The packing period code shall be changed with sufficient frequency to enable ready identification of lots during their sale and distribution. Codes may be changed on the basis of one of the following: intervals of 4 to 5 hours; personnel shift changes; or batches, as long as the containers that constitute the batch do not extend over a period of more than one personnel shift.

 

Let's take a look at this requirement in detail...

  • Permanently visible to the naked eye -- this can be accomplished by ink jetting or embossing the code onto the container.  Ink jet markings can be placed at any location on the container as long as it is readable (this is normally done on the top or bottom lid of a can). 
  • Establishment where packed -- you can choose a code to identify what plant the product was packed, as long as this code is used consistently.  For example, you may want to identify the "TechniCAL Canning Company" as "TC”.  You can choose either an alpha or numeric code for identification purposes.   
  • Product contained therein -- you can choose either an alpha or numeric representation as the code for this identification factor.  An example of this would be to code each product type packed with a different letter or number.  For example, "Mushrooms Pieces & Stems in Brine" could be number “1” or designated by letters “MPSB”.  You simply need to record and be able to access the coding system used and it must be consistent
  • Year packed -- this can be easily identified by using the numeric representation of the year.  The year 1999 can be referred to as “99” or simply “9”.   
  • Day packed -- this can be easily identified by using the numeric representation of the date in one of two ways. You can take the date March 11 and identify it as “0311”  03 for March and 11 for the 11th day of the month.  You can also use the Julian date system, which is based on the number of days in a year.  For example; January 1 is represented as “001” and December 31 is represented as “365” in a non-leap year.   
  • Period during which packed -- (if you use period shifts in the factory) this can be an alpha or numeric representation of the shift, batch or interval in which the product is packed.  The code must not continue unchanged between shifts.  We recommend the code at least include the shift in which the product was packed.  You can use the numeric representation of the shift as “1”, “2” ect. to represent the first shift, second shift, etc.

 We can now create our one line code to be either embossed or ink jetted onto our container.   Using the examples listed above we will code the following product:

  • Mushrooms, Pieces & Stems in brine ( coded as MPSB)
  • packed at the TechniCAL Canning Company (coded as TC)
  • on February 1, 2017(coded as 17032; 17 for the year, 032 day packed)
  • during the first shift of production.(coded as 1)

 The code on this product should be displayed as follows: 

TC

MPSB

17032-1

Please note, the order in which the code is displayed is not a requirement, however, it must be consistent. 

CG = facility packed

MPSB = product identification

17 = year packed

032 = day packed

1 = shift during which product was packed 

This code meets the intent of the regulations as stipulated in the US FDA Code of Federal Regulations Title 21 Part 113.60(c).  The US FDA requires this code be affixed to all Low-Acid foods packaged in hermetically sealed containers specifically for recall purposes.  

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