// September 23, 2014

What’s USP’s Role in Helping Ensure Food Ingredients Safety?

How safe are food ingredients listed on the label?

The debate about the safety of food additives and ingredients has been revived recently, with the Grocery Manufacturers Association's initiative to make safety data for food ingredients available to regulators and other interested parties.

This initiative, designed to boost confidence in consumers through increased transparency regarding safety assessments conducted by industry to demonstrate that a food ingredient is safe to consume, is certainly a step in the right direction.

These safety assessments are based on the notion that food ingredients can be proved to be “Generally Recognized as Safe” (GRAS). And interested parties have the option, but not the obligation, to notify the FDA about such safety assessments.

Safety Assessments and the Need for Transparency

The U.S. Food and Drug Administration (FDA) has observed they “simply do not have the information to vouch for the safety of many of these chemicals.” This concern has fueled the conversation about the safety assessments that are performed by industry.

FDA has welcomed GMA’s step towards more transparency but is also encouraging industry to notify the agency regarding these GRAS assessments for new food ingredients.  Ultimately, however, the responsibility of making sure the ingredients used in all the various food applications have gone through the appropriate safety assessments rests with industry.

The U.S. Pharmacopeial Convention (USP), as an independent organization whose major role is to develop specifications for the authenticity and integrity of medicines, food ingredients and dietary supplements, supports any effort to increase transparency, be that to help regulators in making sure their safety evaluations and recommendations rely on science-based data, or to help industry in conducting their own safety assessments that they may make available in the new GMA database.

To me, of particular interest to both regulators and industry is the close relationship between food ingredients integrity and safety. Without proper specifications for the identity, purity and quality of food ingredients, how can anyone assert their ingredients are safe for use, and how can others trust the information made available to them or take measures to ensure food safety? That’s where USP plays a crucial role.

The Food and Chemicals Codex

Through monographs and reference materials in the Food Chemicals Codex (FCC), USP provides a public definition on how to identify food ingredients for what they are supposed to be.

These standards defining the identity of a food ingredient, as well as acceptable levels of impurities are the foundation for any successful safety assessment. In the end, we all have to agree first on a definition, before we agree on anything else. In this regard, the FCC serves as a “dictionary” for food trade, providing a common definition throughout the food supply chain.

Whether these definitions are used in GRAS assessments that are notified to the FDA or not, at their very core either pathway requires definitions that are agreed upon and public specifications. These definitions and specification can, in turn, be used to verify that the integrity of the ingredient has not been altered, allowing safety assessments to be conducted on well-defined ingredients.

Increasing Confidence in Food Ingredients Safety

For the new GMA initiative to most effectively work as a tool to increase confidence that food ingredients are safe for consumption and for regulators to trust the information, and even for industry itself to be able to conduct safety assessments in a meaningful way, there needs to be an understanding that proper characterization of food ingredients is essential.

USP does not account for all aspects of food safety. That is a task no single organization can take on its own. What USP does believe is that it can contribute with the science to properly identify a food ingredient for what it is and add credibility that food ingredients are tested for other safety measures for what they truly are.

I firmly believe food safety is a pre-competition consideration and we have demonstrated it at USP, where more than a few times we have gathered industry competitors in the same room to discuss industry-wide issues and the results are standards and tools all of them can use to help ensure their food ingredients are well characterized and possess at least minimum quality attributes.

That’s why we encourage industry, regulators and other parties to learn how USP works to develop food ingredients standards and to partner in an concerted effort to help ensure consumers and their families are enjoying food that is, in fact, safe.

For more information on USP’s work in developing food ingredients quality standards, visit: http://www.usp.org/food-ingredients.

Markus Lipp, Ph.D. is senior director of food ingredients at USP.