Do I Need a Certificate of Analysis for My Products

[XopherB]

Soon, I will producing compound (i.e., flavored) butters myself from within a commercial kitchen. Then I will be selling my jarred products (six SKUs) via retail grocers (specialty and local markets) as well as online from my own website/webstore. I'm registered with the FDA and will be inspected by my state's Dept. of Agriculture.

Will I need to generate a Certificate of Analysis for each of my products? If so, what's the best way for a small producer to do so?

TIA!
Chris

[Sarah Masoni]

On 3/14/2022 at 5:47 PM, XopherB said:

Soon, I will producing compound (i.e., flavored) butters myself from within a commercial kitchen. Then I will be selling my jarred products (six SKUs) via retail grocers (specialty and local markets) as well as online from my own website/webstore. I'm registered with the FDA and will be inspected by my state's Dept. of Agriculture.

Will I need to generate a Certificate of Analysis for each of my products? If so, what's the best way for a small producer to do so?

TIA!
Chris

Hi Chris

Thank you for asking this question during the share group on March 15th.  Certificate of Analysis is typically required for ingredients going into the food that you are manufacturing.  I believe that you can have a local food testing lab do routine microbiology testing for large orders, and perhaps include the cost of analysis to the buyer that is requesting the COA.  Common tests may include:  Standard Plate Count, Yeast & Mold, Coliform/E. Coli.  Best to ask the buyer what information they are looking for before having your product tested for information they do not need.  You should always have your ingredient specifications on hand from your ingredient vendors, just in case you need to evaluate an ingredient shipment that seems to be out of specification, you can of course reject ingredients that do not meet the specification that the supplier provided you with.  If you would like additional help please feel free to reach out.

 

[Victoria J Ho]

Hi Chris,

How refreshing to hear that you're being so diligent with food safety standards from Day Zero--your compound butters sound luscious! The short answer to your question is "no." In your capacity as a manufacturer of finished CPG products, a COA is not a required or even common document to be requested by your retail/distribution partners, much less your D2C customers; nor is it required by any state or federal entity to successfully distribute your product in the majority of domestic wholesale channels. If your products begin to find traction as an ingredient used in other CPG products, institutional foodservice or export, then a COA may become relevant as a statement of consistency parameters that you are promising to meet with each delivered lot of goods.

In general, COAs will come into heavy play in your own supply chain management. For example, you'll be obtaining COAs for each inbound lot of individual raw materials (ingredients) you will be using make your finished products, from cream to salt. There are many commodity ingredients and pharmaceutical ingredients that must show a regulated level (or absence) of elements in order to fit a national/global standard of purity or industry application. That won't quite be the case for a compound butter.

A product specification sheet should accompany the COA, along with any other necessary third-party certification documents. Make a point of asking your vendors whether the COA is truly lot-specific, or whether they are simply submitting a COA to state what you should expect, rather than submitting confirmation that the paperwork correlates to what you actually received.

What I would recommend you put into motion for each of your SKUs following the initial successful run is a comprehensive lab analysis, and an accelerated shelf life study (if not already completed at benchtop). Having a solid HACCP plan developed would also go a long way in building retailer confidence in your brand, while you are scaling up to a co-packer. Your wholesale partners are very likely going to look more closely at your operational diligence and fulfillment capacity, than at a COA.

All that said, if you want to explore some digital platforms that support COA generation and management, I recommend a system like Quality Essential Suite ( https://www.qualityessentialssuite.com/ ) or Doxcellent ( https://docxellent.com/ ) There's a lot of bells and whistles, as usual, that you won't need right away, but having a digital document chain is extremely valuable in 2022 and beyond.

FWIW, a quick rundown of COA basics (from Doxcellent). Also: a COA becomes a legal document should any issues trigger a traceability event. So I'd also run this by your legal counsel to ensure that you're not opening any cans of worms by striving to do the right thing.

The Food and Drug Administration (FDA) lists specific requirements for each COA document your company produce. These include; 

• Supplier Information: This section contains data regarding the material supplier, including their name, address, and other contact information.
• Materials Identification: The content in this section identifies the material being verified by this COA. And it usually contains common terms such as lot numbers, product codes and descriptions.
• Transportation Data: This area generally includes the customer name and address, original purchase order, or other details such as the item’s destination. This content is provided to meet shipping requirements and to help the receiver in confirming the material is authorized and its delivery is anticipated.
• Evidence of Conformance: This section holds the most important information in the COA. It states the specific characteristics, test results or other evidence in terms of industry standards, regulatory requirements or customer-specific request. In some cases, the performance standards expected will also be noted for reference.
• Signature Data: This last section of the COA includes a signature indicating that the evidence presented was reviewed by a qualified and authorized product inspector.

Hope this helps!

Best,

Victoria

 

[XopherB]

Wow... Thanks, Victoria! That's a lot of great information!