Maintaining food security and safety depends on protecting the integrity of the entire food supply chain. While our food has become multinational, diverse, and nonseasonal, these improvements have come with a reduction in supply chain transparency. At the same time, industry and governments have become increasingly aware that transparency is fundamental for ensuring safety, quality, and food defense. Consumer interest in the origin of foods as well as in production practices for food products continues to grow. All of these factors have combined to create unprecedented information needs.
Complex supply chains pose a risk to food quality and integrity because they include many touchpoints and material manipulations, each of which creates an opportunity for misunderstanding, misrepresentation, and adulteration. And the longer the supply chain, the more difficult it is to ensure that the information needed to maintain traceability and transparency is accurate and complete. When products move between nations, for example. different regulatory requirements and enforcement policies can result in critical documentation gaps.
Finding Fraud
Economic pressure on supply chain integrity occurs when prices fluctuate or when there are rapid changes in demand. Because production is often slow to respond to these changes, suppliers may be tempted to adulterate or misrepresent products to take advantage of market opportunities. Even when supply and demand are relatively stable, there are economic incentives for adulteration, such as when an ingredient can be replaced or diluted with a less expensive non-food-grade substitute or when a generic form of an ingredient can be substituted for a more valuable form (e.g., conventional produce labeled as organic).
Given these economic incentives and the many opportunities for things to go wrong in food supply chains, it is not surprising that fraud occurs. A report from the Grocery Manufacturers Association (GMA) estimated that various forms of fraud have a $10 billion to $15 billion negative impact on the industry each year. Recent data suggest that up to 25 percent of some high-value products, such as spices, are adulterated.
The results of the joint Interpol/Europol OPSON program indicate the widespread nature of the problem. Each year, this program carries out coordinated multinational operations for about four months. As shown in Table 1, products worth €150 million to over €200 million have been seized during these brief, yearly periods. Clearly, fraud and adulteration are significant ongoing and issues.
Even when fraud and adulteration are not problems, suppliers and manufacturers need to have a common understanding of the expected identity and purity of the ingredients they use. As with all commercial transactions involving physical goods, it is important that the parties involved agree on acceptable characteristics for the material involved. Just as there are standards that define measures for size and weight, composition standards can be used to describe the appropriate characteristics of food-grade ingredients.
Creating Common Understanding
The best way to define acceptable ingredient characteristics, minimize fraud, and facilitate information continuity is by establishing and using public ingredient standards. According to the GMA, “ingredient standards provide a solid basis for identifying and classifying raw materials.” Ingredient standards act as a dictionary to create a common vocabulary that facilitates clear and consistent communication. Because standards describe what a substance should be, including what it means for a substance to be food-grade, they can be used to determine when a sample of an ingredient is not what is expected. When this happens, it could be an indication of quality problems, adulteration, or other kinds of fraud.
Referring to a publicly available standard when manufacturing, testing, selling, or purchasing an ingredient creates a level playing field for everyone along the supply chain. Standards also play an important role in protecting transparency and traceability by fostering the use of consistent (or at least interchangeable) terminology through multiple transactions.
Ingredient standards describe substances as they are used in the real world, not as abstract chemical entities, and are intended to be for material that is legally used in food or food production. Because regulatory requirements differ around the world, however, the existence of a standard does not necessarily mean that the substance described is allowed in specific jurisdictions or for all potential uses. Safety and toxicologic evaluations can be used to inform some components of a standard, such as limits on byproducts or contaminants.
Writing Standards
Standards are developed by entities called standards development organizations (SDOs). There are several organizations that develop standards for foods and food ingredients (see Table 2). These organizations collaborate and exchange information with each other to maximize consistency. The range of foods and substances covered by each organization, however, the depth of information provided, the process used to develop standards, and the organizational mandates differ.
One example of how these standards are developed and structured is the approach used by the Food Chemicals Codex (FCC). The FDA and the Institute of Medicine created the FCC in 1966 to “define the quality of food-grade chemicals in terms of identity, strength, and purity.” FCC standards are developed by a committee of expert volunteers working with FCC scientific staff and are based on the best scientific information available. Each draft standard undergoes an open and transparent public review and comment process through publication in the FCC Forum before being finalized and published.
The FCC is an independent SDO and the only one where standards are developed by independent experts, not organizational representatives. The FCC currently contains over 1,250 standards in the form of monographs and identity standards. Each standard includes specifications, the methods needed to determine if a sample of the substance meets these specifications, and any reference materials that are required to implement these methods.
FCC monographs and identity standards have several sections (see Figure 1). The first section provides general information such as the name of the substance, synonyms, the chemical formula, the chemical structure (if relevant), CAS number(s), INS numbers, and a qualitative description of the substance. This description can include information on how the ingredient is produced and how it should be stored. An identification section includes tests that can be used to determine if a sample of the substance is what it claims to be.
These tests use many analytical techniques, including chromatography and spectrophotometry, and include in detail all the information needed to run each test. Each test is accompanied by acceptance criteria, which may, for example, include a spectrum or a table of high-performance liquid chromotagraphy (HPLC) peak retention times. An assay section includes analytical tests to determine purity.
In addition to determining overall purity, each standard provides information on tests and acceptance criteria for relevant impurities. In this context, impurities include both organic and inorganic substances, such as heavy metals or residual solvents. Finally, tests for marker compounds and for properties that can affect functional quality (such as moisture content) are found in the specific tests section.
Because the utility and applicability of the analytic methods are critical for ensuring that FCC standards are practicable, many of the methods in the FCC are developed or evaluated by USP laboratories. This evaluation is carried out using multiple samples of the substance obtained from different sources. The lab ensures that the methods work as intended for each specific substance and that they are adequately described. In some cases, validated methods from recognized authorities such as the Joint FAO/WHO Expert Committee on Food Additives, International Organization for Standardization, or AOAC International have been adapted for use in the FCC. In other cases, FCC methods have been adopted by these other organizations.
The test methods described in a standard may require the use of well-characterized materials as reference materials, calibration standards, or system suitability standards to ensure accurate results. A reference material, for example, can be used to generate an HPLC chromatogram for comparison with a chromatogram from a test substance analyzed using the same equipment and reagents to allow identification and quantitation of analytes of interest. The use of these materials meets the requirement of ISO17025:2017 Section 7.7 on ensuring the validity of results by “use of reference materials or quality control materials.”
The Importance of Ingredient Standards
There are several reasons why the wider application of technically sound standards is critical for developing improved information systems to support transparency and traceability in the food supply.
First, as discussed above, standards ensure the use of consistent terminology at all steps in the production process, a fundamental requirement for effective communication. Second, standards ensure consistent expectations for product identity and quality for all participants in the supply chain. Third, standards provide a verifiable physical underpinning for the information contained in food-related data systems (such as a blockchain). This is extremely important because the value of a data system is limited by the quality of the information that it contains. The food industry makes and sells physical materials in the form of ingredients and foods. Electronic records are like paper records in that they can become inconsistent with the physical materials that they purport to represent. Standards that include specifications and test methods provide the tools needed to ensure accurate correspondence between records and materials.
Public standards for foods, food ingredients, and for all substances used in food production play a critical role in protecting the integrity of the food supply. Standards support commerce, help combat fraud and adulteration, and facilitate transparency and traceability. Unfortunately, many individuals and companies in the food industry are not aware of these standards or mistake information on a supplier certificate of analysis for standard information. Others use part of a standard, such as the specifications, but not the methods needed to assess adherence to the standard. Understanding where to find standards and what they contain is an important skill for mitigating business, quality, and legal risks in an increasingly interconnected and interactive world.
Dr. Gendel is the senior director for food science for the FCC, which is published by the United States Pharmacopeia. He has over 30 years of experience in food safety and policy. Reach him at [email protected].
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