Raw Materials: Selection, Specifications, Certificate of Analysis Part 2

Raw materials (ingredients, processing aids, and packaging materials) are the foundation of finished food products. As such, they must meet regulatory requirements (safe and legal for your intended use) and your specifications (contribute to the functionality and quality of your process and product).

Part 2

After the team has discussed and agreed upon the key characteristics for the raw material, the next step is to document these expectations. This can be as simple using as the dated Technical Data Sheet from the supplier. A purchase order should list the supplier’s specific name and item number for the material. A recommendation is to include the revision date of the Technical Data Sheet (with associated specifications).

As a company grows, or your requirements become more complex, the supplier’s information is expanded upon within your own specifications. At a minimum, the information should include technical and food safety information, including:

• The name of the product and the supplier’s item number.
• Components or composition of the material.
• The presence of regulated or customer-recognized food allergens.
• Organoleptic information (appearance, flavor, and aroma).
• Pertinent physical, chemical, and microbiological information.
• Shipping and storage information.
• Shelf life.
• Handling directions.

Product Name

General name 
Material identification can be general for commodity-type products or those with a standard of identity, such as salt, granulated sugar, FD&C Yellow #5, and so forth. General names or descriptors ease use and sharing specifications, especially when soliciting and comparing prices between multiple suppliers.

Material-specific name 
A product-specific name or number may be assigned by the supplier when the item is a unique or proprietary material (such as with most flavors).

Item number 
This is the number you assign to the purchased item in order to track materials within your system.

Components 
The ingredient/material composition is listed in decreasing order of presence or as outlined in labeling regulations. For packaging materials, the specific composition of the packaging material would be specified, such as glass, polyethylene (PET), polypropylene (PPE), and so forth.

Food Allergens 
It is not unusual for a supplier’s Technical Data Sheet to state that the material does not contain an allergen; however, most U.S.-based suppliers are only considering U.S.-regulated allergens. If you are controlling more than these, ensure you receive written confirmation of the presence/absence of the allergens you are managing.

Organoleptic Information 
Organoleptic characteristics are tested with your senses, including visual appearance, aroma, and flavor. This brief description is typically used during the receipt or pre-use at the plant to confirm that basic expectations are met or identify issues that can be readily checked by appearance (puree rather than whole fruit), aroma (off odors such as musty or chemical), or flavor (caramelization with high fructose corn syrup or rancidity with oils).

Analytical Information 
Analytical characteristics typically require testing with instruments rather than your senses. For example, an organoleptic description of a product could be “red liquid” and the analytical information would be the colorimeter reading.

Characteristics to be outlined include those affiliated with functionality, quality, and food safety. You do not necessarily need a Certificate of Analysis or in-house testing for all of the listed characteristics, rather, these characteristics are outlined as an agreement about what you are purchasing and as a basis for discussion if concerns are identified.

As described earlier, determining the key biological, chemical, and physical parameters requires R&D and plant management to review historic information about the material, regulatory requirements, and the supplier history, as well as how the material will be handled in-house.

Food safety parameters or tolerances could include biological, chemical, or physical characteristics.

• Biological – Microbiological limits for pathogens, such as Salmonella and Listeria monocytogenes.
• Chemical – Fortification levels, sulfite levels, heavy metal content, etc.
• Physical – Size and foreign material (rocks, glass, metal, bones, etc.)

Functionality or quality parameters would include characteristics that can impact the functionality of the material or adversely impact your product.

• Biological – Microbiological limits for spoilage organisms or indicators of poor sanitation, including total plate count, yeast, mold, and coliform.
• Chemical – Characteristics such as concentration levels or purity.
• Physical – Characteristics such as viscosity, color, granulation size, insect parts, crush strength, physical measurements, etc.

Outline the appropriate conditions for shipping and storing the material. Include any special storage or handling directions, such as “do not freeze” or “store in a flame-resistant cabinet.”

Following the supplier’s storage recommendations, describe the product’s shelf-life (the supplier’s safety and quality guarantee for the product).

Determine if there are special directions for handling the material, such as if employees need to wear a face mask or other personal protective equipment (PPE) or if the material needs to be shaken before use.

Additional information about a new or revised material may be vital to your company and customer. You may wish to stipulate these requirements in the raw material specification, such as:

• Packaging size and composition (such as a 25-pound, multi-layered paper bag; poly-lined corrugated box; Super Sak; bulk tanker).
• Religious dietary requirements such as halal or kosher as well as clarification if dairy or pareve.
• Where the material has been approved within regulations. This information can be found in the Code of Federal Regulations (CFR) for the U.S. This information can be received from the supplier or you can conduct a web search for “CFR + name of the raw material.”
• Colors – Is it a “certified color” (i.e., Yellow #5, Red #40) or “exempt from certification”?
• Flavors – Is the flavor artificial and/or natural?
• Organic – Does it meet the National Organic Program (NOP) specifications, as regulated by the USDA (7 CFR 205)?
• Restrictions or limits – If there are defined maximum levels, what are they?
• California Proposition 65 – Does the product or components within the product meet the declaration requirements as outlined in California Proposition 65 (carcinogens)?
• Heavy metal composition or warranty – Heavy metals, specifically lead, mercury, cadmium, and hexavalent chromium are not purposefully added to material. For packaging materials, this warranty typically stipulates that the material contains less than a combined total of 100 ppm of heavy metals, regardless of how introduced.

Certificate of Analysis (COA) 
A certificate of analysis (COA) is the supplier’s test results on the specific lot being provided to you. Before requiring a COA, determining the key characteristics that can fluctuate, past concerns, and compliance to specifications is essential to your product or process.

You may find that many of your raw materials, such as packaging materials and refined oils, may not need a COA, however, ensure that you are following any requirements outlined in customer or audit standards (such as Global Food Safety Initiative audits).

There may be upfront or hidden costs with requiring a COA. Ask suppliers what tests they routinely conduct or for a specified analysis if you are asking for this. There also may be costs for your receipt or review, for potentially holding the material while waiting for a result, and for an action plan if the results identify that the material does not meet your specifications.

Validation and Documentation 
The standards for validation and documentation are: Prove it, scientifically (validation) and If it is not documented, it was not done (documentation). These encompass the research information, meetings, and the team’s conclusions. For web searches, document dates, the name of the person who did the search, key words used, and the findings. Meeting documentation should capture dates, participants, the scope of the discussion, conclusions, and potential action plans.

A clear understanding of the materials being purchased is vital for suppliers and customers alike. Materials that do not meet your expectations can significantly reduce productivity, increase costs due to additional testing, rework, or destruction; and can place your product, company, customers, and consumers at risk for hazardous issues.

On the other hand, understanding the material and appropriate handling practices, as well as obtaining those that meet your expectations, increases productivity, decreases potential food safety risks, and is a key building block toward making a consistent, high-quality finished product.

In the next article in this series we will look at : Plant Discussions and Trials  - what questions should we answer?