Recognizing the exhaustive challenge in developing monographs for complex food ingredients, USP last year proposed the creation of FCC Identity Standards, which will, more than other FCC Monographs, not only establish ingredient identity, but also include tests for substances that should not be present in certain complex ingredients (in the case of pomegranate juice, artificial sugars or compounds that are not usually found in pomegranate, but may be found in other fruit juices with which pomegranate juice has historically been adulterated).
FCC Identity Standards are intended as a trigger to perform additional tests to make sure users are not unknowingly purchasing an adulterated product. If an ingredient fails the specifications in an FCC Identity Standard, it could as well be due to natural variability of that particular ingredient. However, results that show a particular material is compositionally very different from the majority of the products in that category should raise concerns, or at least questions.
It is important to emphasize that the FCC is limited to providing a routine measure to aid in the establishment of food integrity for ingredients that are commercially available. It’s not the goal of an FCC Identity Standard for pomegranate juice, for example, to represent the composition of pomegranate juice that is obtained from non-commercial processes or sources of the fruits themselves that are not intended for the production of pomegranate juice as a commercial food ingredient.
The intent is to reflect products that are used for commercial formulations, and not all pomegranate juice is commercially viable. Part of the challenge for USP is that our standards are not meant to exclude legitimate products. However, the specifications cannot be so broad that an unreasonable number of illegitimate ingredients suddenly become FCC-compliant.
Previous test methods to measure the protein content of skim milk powder have proved not sufficient to keep adulterators at bay.
Risk-Based Assessment
Sometimes, asserting food integrity requires sound judgment paired with appropriate tests and reference materials. Skim milk powder is a widely used complex food ingredient that consists of variable compounds (proteins as a group, which in itself can be divided in numerous fractions, sugars, non-protein nitrogen, fats and lipid-like substances, water, etc.) and could also present natural variability dependent on the species, animal’s lactation period, animal’s nutrition, as well as processing conditions—heat treatment for instance.
Food analysis is an intrinsic and essential part of helping to ensure the integrity of food ingredients, but it is not sufficient by itself. It is impossible to test an ingredient to safety, and good supply chain management practices are essential components complementing testing. Yet, better tools to help establishing integrity for skim milk powder, for example, and therefore asserting that it is as safe an ingredient as possible is crucial, as instances of adulteration, such as the one in China in 2008, have put public health at risk.
For ingredients such as skim milk powder, USP, in conjunction with industry and academy experts that comprise the Skim Milk Powder Expert Panel, is developing a risk-based testing structure, which is designed to provide guidance to analysts to decide under which conditions more tests might be necessary to gain confidence in the ingredient’s integrity and under which conditions the load of testing may be reduced.
An aspect of risk-based assessment for skim milk powder, for example, takes into account that nitrogen-rich adulterants other than melamine may present a new risk. Previous test methods to measure the protein content of skim milk powder have proved not sufficient to keep adulterators at bay. To help offset the limitations of this test method, USP is coordinating the development of additional tests that are less vulnerable to the presence of adulterants, as well as methods for the non-targeted detection of adulterants and the development of reference materials, or physical samples, adulterated with melamine.
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