Regulatory / CFR Code Reporting - Dual Source of Supply

I apologize if this question was not posted in the appropriate forum. There is a discussion within our company about reporting of CFR codes on our compliance documentation. We may use multiple sources for our raw materials (plastics, metals). Each supplier provides a statement of compliance to the applicable CFR code for the product provided. Several suppliers would add additional information in regards to the processing aides used to produce these materials, with their applicable CFR compliance codes. Due to variance in manufacturing processes, one supplier may require a processing aide, another would not. In regards to reporting to our customer, should we be reporting the processing aides an the applicable CFR codes? Not every supplier would use these processing aides so when we switch back and forth to suppliers, this may or may not apply? Has anyone else out there come across this and how did they address? Thanks in advance!

Good afternoon! Ultimately this will be decided by your company policy and the standards regarding transparency in labeling. Internally, we try to report the information as it is provided by our supplier first and foremost. However, if a variance in ingredients occurs, we will inquire with the supplier to get their feedback and many times they will resolve the question for us. If the issue stands unresolved after the supplier feedback, we attempt to determine if it is legally necessary to list the processing aid for any reason (allergen etc...) and normally we find that the ingredient listings are a match on ingredients we consider to be substitutes for one another in our processing.

This issue tends to be a gray area in many ways in many companies and often we find that the some suppliers simply did not list the processing aid in question.

Best of luck!

Thanks Foster. To clarify we are a food packaging manufacturer. We do not manufacturer food, food ingredients, or perform any packaging. For food companies, what information do you expect from a packaging supplier? We provide all the applicable CFR codes the raw material meets, but don't list our manufacturing processing aids, although we ensure they are all food grade and FDA approved.

This is a great question. I am assuming we are talking about packaging due to the nature of your raw materials. It's important that your suppliers are as transparent as possible. Maybe some are more than others. It may be a good idea to reach out to the other suppliers to ask if they are using the same processing aids i.e. resin, coating, epoxy, etc. More than likely they are. As far as your customers you can see what they require lay out all the CFR codes and use the infamous phrase "may contain"

Normally we request the following list of documents from new packaging vendors:

Spec/ TDS (listing production materials, dimensions)

MSDS

Letter of Guarantee/food grade material assertion

Certificate of liability insurance

3rd party audit cert/report (preferably GFSI)

Prop 65 statement

21 CFR Reference

Lot trace ability system description

BPA/ Plthalates Stmt

RG3,

Yes we are talking about packaging. We are explicit and require as part of our specification resins, epoxies, coatings, anything that is an expected material of the product and we include this in our CFR compliance statement. However, a supplier may use a processing material (mineral oil, machine lubricant). Some supplier will list the CFR code for these processing materials, others do not. Although manufacturing of the raw materials may be similar between suppliers, I can not confidently say each one uses processing aids. Thanks for the feedback.

Foster, thanks for the list. This list is what we provide our customers. On the CFR codes, do you expect all processing materials used in a manufacturing plant? For example, we use FDA approved sanitation wipes to clean our injection molds or a mineral oil to stamp our metal. Are you expecting the CFR codes for these materials?

I would expect only CFR codes specific to the material or process for that item. If I am understanding the question, as analogy in our company would be if we were to provide the quat or sanitizer used in the clean up prior to our production run. We most definitely would not make this information known unless a customer asked during an onsite inspection of the facility. I would only expect the CFR codes for the items making up the packaging itself. I hope this helps!

Thank you Foster and everyone else who responded. This helps immensely. I am thinking of a compliance statement for items making up a packaging, but another statement, using the infamous "may contain" statement above. Since there is always a risk some of these processing aides may contact and have trace remnants of these materials.

^{I work for a company that makes packaging for direct food contact.  I face the same situation:  alternate materials that manufacturing considers to be equivalent don't always have the same set of 21 CFR codes cited by the supplier.}

^{The FDA does not require you to list all the appropriate CFR codes in your compliance letter to your customers.  However, some customers may demand that you list all the appropriate CFR codes.}

^{What I do is the following:     Material A complies with 21 CFR A, B, C, D and/or E.  This covers all the CFR codes that the various suppliers are citing.}