Traceability: Whats the Point?

Traceability is an industry buzzword, quality issue and regulatory requirement for products intended for human consumption, with the latest focus fueled by adulteration of baby formula with melamine in 2008 and the subsequent signing of the Food Safety Modernization Act (FSMA). Quality issues that can be solved by traceability systems date back at least 2,000 years ago, when Dioscorides developed methods to differentiate Balsamodendron (balsam), Commiphora (myrrh) and Boswellia (frankincense) gum resins. Likely due to early traceability and quality systems, the Magi were able to differentiate among these valuable materials with similar visual and sensory attributes:

Balthazar: Melchior, you say this material is frankincense, but how do you know for sure?

Melchior: This material has met the basic quality requirements of our time: it is easily flammable, with clear smoke and pleasant, characteristic fragrance. Also, my supplier harvested it from his Boswellia tree just this morning. This information is written on parchment with his signature.

Balthazar: Your argument is convincing, and you have established adequate traceability. Let us approve this material fit for its intended purpose.

Today, there is no definition or standard for traceability. Traceability systems are intended to track the flow of materials through the supply chain, and are mainly made of documentation and the supporting legwork done to create and verify the documents. The ISO 9000:2000 guidelines define traceability as the “ability to trace the history, application or location of that which is under consideration." For some food systems, traceability is maintained back to the farm or even the seed, while in others it is maintained back to a point in a manufacturing process intended to control a key quality attribute—microbial load, for example.

Traceability requirements depend on the type of product and the regulations of various countries. In Europe, documentation is required to identify suppliers of ingredients of foods. In the United States, FSMA requires the country of origin to be labeled. However, for the U.S. dietary supplement industry, ingredient traceability systems at reputable firms go beyond country of origin, requiring the name and address of ingredient manufacturing facilities, and product quality and traceability information that in many cases requires a chain of custody back to the farm.

In general, the requirements for traceability in the industry differ widely, depending on the type of product and market demands. For example, a small volume of conventional chamomile tea made only from dried chamomile flowers sourced from a single farm and sold at a single local market can have a very simple (yet effective) traceability system: “I know the farmer who grew and dried these flowers."

On the other hand, coffee that is mass-marketed in high volumes for attributes like shade-grown and fair-trade will require a relatively complex and resource-intensive system, particularly as higher volumes are demanded. This is because of the multiple steps in the supply chain and the fact that many coffee farms are small—so a large number of farmers need to be supervised and documented, which can be a costly endeavor. However, coffee that is labeled simply as Arabica need not have any traceability other than that required to maintain product quality and safety.

Even within a traceability system, there are different strengths of the supporting documentation. Statements from the raw material buyer that a fair price was paid to the harvesters serves as one layer of support, but solid verification of this claim may require an in-person audit of the system and periodic visits with the individual farmers and harvesters. How far does a brand want to go?

Ultimately, “full traceability" is difficult to achieve for agricultural products (until we can figure out a way to bar code each individual plant). So, the objectives and costs of an adequate traceability system depends on the nature of the product and market demands. Three main objectives for traceability systems include:

1. To effectively manage the supply chain: Supply chain management aims to determine the most efficient way to produce and procure products. Documentation of the products throughout the cycle from start to finish is key to understanding how they are made and how much they should cost.

2. To support marketing claims: Today’s discerning consumer demands many attributes from their products, which they are not able to taste or otherwise perceive in the product. For example, dolphin-safe tuna can only be verified through the supporting documentation; no analytical test is available to test that the tuna is dolphin safe.

3. To provide information for quality assurance systems or food safety investigations: When product quality issues occur, traceability documents are integral to track back to the root cause of the issue and correct it.

In the world of botanical ingredients, traceability may extend all the way to the farm, while for agro- or petrochemicals, it may extend back to the manufacturing level. Regardless of the level to which a material is traced, one of the key requirements for any system is based on the concept of segregation, which for the purpose of determining GMO (genetically modified organism) status is known as identity preservation. In proper systems, materials have discrete lot number and sizes, and are kept physically separate from other materials or inputs.

In determining lot size, there is a balance that takes into account the level of “precision" required for a product. Too few lots for a given amount of material, and the amount of material may be too large to control and keep consistent; too many lots require legwork and testing that may be too costly. Ultimately, the customer sets the expectation for traceability and will value (and pay for) the benefits and peace of mind that it can offer.

Visit INSIDER’s Contract Manufacturing Content Library for more tips regarding regulatory and formulation challenges.

Blake Ebersole is technical director at Verdure Sciences, where he has led botanical quality initiatives and formed collaborations with dozens of universities and research centers focused on preclinical and clinical development of botanical extracts. Originally trained in analytical and biochemistry, Ebersole also holds graduate degrees in marketing and international business. Follow him on Twitter, @NaturalBlake.