Standardising Functional Ingredients

Standardising Functional Ingredients Jim Bahn
Ensuring the quality and authenticity of functional ingredients is important both for business practices and the health of consumers. The dramatic growth of this segment means increase the importance of universal standards with greater definition of composition and health claims. By Markus Lipp, director of food standards, USP

As consumers become more aware of the food they eat, they are increasingly seeking out products that offer perceived health benefits.

Ingredients such as probiotics, stevia and krill oil claim to offer certain benefits, but their growing popularity is drawing increased regulatory scrutiny—particularly because they are sourced from all over the world via long and complex supply chains.

As functional foods experience dramatic growth, regulators and manufacturers alike require scientifically sound means by which to demonstrate and measure the efficacy of ingredients making health claims.

One important way to do this is through rigorous public standards for the quality, identity, purity and strength of ingredients. Such standards, used to establish an agreed-upon basis for functional claims, help instil confidence in manufacturers, regulators and consumers alike.

Given the widely varying and often confusing array of practices and regulations regarding functional foods, universal standards can play an important role.

Food Standards

Ensuring the quality, ie: the identity and purity, of the food ingredients that make up so much of our global food supply is not only part of responsible business practice, but is critical to the health of consumers.

Current regulations can be confusing to all parties, and interpretation is often inconsistent. At the consumer level, one would have to be extremely well-informed to decipher the nuances of allowable marketing claims for functionality.

In the US, these claims fall under the categories of Significant Scientific Agreement, Health Claims Based on Authoritative Statements, Qualified Health Claims and Structure/Function Claims.

From an international perspective the situation becomes even more complicated as regulations differ significantly from country to country, with some countries lacking adequate regulations. The science supporting health benefits is complex and still evolving—adding further confusion to the already challenging regulatory environment.

Gaps in current science include misunderstanding of the mechanisms of the claimed health benefit (for example, ‘enhances cognitive functions’); functional properties that occur in the laboratory may not provide the same effect in the human body; a lack of adequate characterisation for materials evaluated in efficacy studies; and a lack of generally accepted and validated biomarkers to measure the alleged health benefits properly, making measurements difficult to interpret and almost impossible to compare.

As manufacturers look for new ways to differentiate their products and appeal to consumers, the demand for novel ingredients and those of proven popularity is unrelenting.

This draws new ingredient suppliers from all over the world into the market. The choice of global suppliers is often based on their ability to provide lower-cost ingredients, but there are other reasons as well.

Certain natural ingredients, for instance, may be indigenous only to specific parts of the world and therefore, are acquired from suppliers in those regions. But as manufacturers source raw materials from around the globe to find the lowest prices or newest ingredients, they are challenged to ensure the authenticity—ie: the identity, quality and purity—of what they are purchasing.

In considering ingredient suppliers, manufacturers may be presented with less expensive items that claim the same authenticity as a higher-priced one, but how can they know it is actually an equivalent ingredient?

Standards to establish the identity, quality and purity of food ingredients are necessary to help ensure that the purchaser is acquiring the expected product.

While periodic supplier quality checks seem a basic requirement, particularly in the food industry that has so many quality and safety systems, this practice is not employed as often as would be expected.

Food Chemical Codex

The Food Chemicals Codex (FCC) is a compendium of internationally used standards designating the identity, quality and purity of more than 1,100 food ingredients.

Any food ingredient legally marketed in the world is eligible to be added to the compendium. In addition to ingredient specifications, the codex provides test methods suitable for the verification of these standards, and physical reference standards that allow parties to verify the appropriate execution of the test method.

FCC standards can be an indispensable resource to manufacturers, regulators and others. These standards are useful in a variety of ways, including conducting day-to-day business transactions as part of mutual agreements and contracts between food manufacturers and ingredient suppliers, and for maintaining regulatory compliance in jurisdictions that have adopted the standards in whole or in part.

In a globalised industry, in which the size and sophistication of suppliers vary widely, independent public standards can serve as a valuable resource. Manufacturers and other parties are encouraged to comment on these standards through the FCC Forum—a free online vehicle for public review and comment on draft standards.

Krill Oil

Originally proposed in 2010, a draft monograph for the popular omega-3 fatty acids source was deferred from advancement into final monograph status based on public comments received that indicated the monograph needed to be strengthened with quantitative test requirements for phospholipids.

Phospholipids are important biological chemicals—and krill phospholipids contain the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA).

Considerable outside research is being conducted on these types of phospholipids and their potential health benefits in the areas of heart and cardiovascular health, joint health, women’s health and brain health.

Many of these purported benefits are associated with the specific DHA and EPA fatty acids that are attached to phospholipids in krill oil. The revised version of this monograph, reflecting comments received, proposes both qualitative and quantitative tests for total phospholipid content as well as one of the key phospholipids—phosphatidylcholine—which is believed to be linked to certain health benefits.

Steviol Glyosides

First proposed in December 2011 in the forum, a revised monograph proposal incorporating comments and suggestions from stakeholders for the naturally derived sweetener provides a more simplified approach for separating and measuring all nine glycosides present in the stevia leaf.

There is also a monograph for high purity Rebaudioside A, the first stevia-based sweetener widely used in the US and Europe. A range of steviol glycosides, including mixtures of different glycosides, are now being used in a variety of products in addition to Rebaudioside A.

For regulatory compliance, formulation considerations (for example, different glycosides may have different sweetener profiles) and other reasons, it is critical for manufacturers to be able to accurately identify the material they have sourced.

According to the International Stevia Council, more than 56 million households in the US have stevia and stevia-sweetened products in their homes. The new proposal uses two new reference standards: Rebaudioside A and Steviol Glycosides System Suitability for identification and measurement of individual glycosides.


Proper identification with probiotics is important because safety studies are most often based on the genus/species or strain level, so it is critical that manufacturers know exactly which microorganism they are incorporating into their food product to ensure safety.

Identification is also important in supporting purported health claims. Given that many different strains of microorganisms are cultured and have been tested and used in foods, any supporting studies for justifying health claims are at the specific strain level.

For any claimed health benefit, manufacturers should be able to confirm that what they are using in a probiotic food product is indeed the strain tested. Enumeration is similarly important because any claimed health effects supported by study trial data would also be specific to the level of intake.

Essential quality specifications such as identification and enumeration (microbe count), as well as intended uses in food, safety, regulatory status, and purity of probiotics and other microbial food cultures, are included in a new Appendix, titled ‘Microbial Food Cultures Including Probiotics’.

Food Fraud

Food fraud is a collective term that encompasses the deliberate substitution, addition, tampering or misrepresentation of food, food ingredients or food packaging, or false or misleading statements made about a product for economic gain.

A more specific type of fraud, intentional or economically motivated adulteration of food ingredients, has been defined as the fraudulent addition of unauthentic substances or removal or replacement of authentic substances without the purchaser’s knowledge for economic gain to the seller.

While food fraud has been around for centuries, with a handful of notorious cases well documented, we suspect that what we know about the topic is just the tip of the iceberg.

Economically motivated adulteration is a particular concern with functional ingredients, given that they are of high value. While standards help guard against adulteration, all standards have limits.

A Food Fraud Database was recently developed to assist manufacturers, regulators and others in determining specific adulterants that have been used for particular ingredients, and serve as a resource for risk management activities.

This free, searchable database comprises scholarly articles and media reports documenting instances of food fraud.

Future Ahead

Functional ingredients are shaping the future of the food, beverage and dietary supplement industries in many ways, but achieving some degree of agreement on the science related to such ingredients is critical to preserve their reputation and integrity.

The need for functional ingredients will continue to grow as consumers demand products with perceived benefits to health and wellness. The authenticity of these ingredients should remain a key focus and manufacturers must take steps to verify supplier claims.

How are identity and function intertwined? To what extent? How is this measured? With more and more functional ingredients entering the market, there is a pressing need for manufacturers, regulators, and standards-setting bodies to come to some level of agreement on these types of questions.

Public standards play a critical role with functional ingredients and can also assist legitimate suppliers that may be competing with those offering lower-priced substances of questionable quality.

Furthermore, with many functional ingredients, industry, regulators, and standards-setting bodies are still in uncharted territory. To preserve the reputation of these products, greater clarity on a number of fronts related to identity and functionality must be achieved. If not, functional claims may become unreliable and meaningless.

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  • Last modified on Thursday, 14 November 2013 12:01
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