FSMA’s Ready-to-Eat Guidance and Impact on Color Ingredients


Dozens of food and beverage products have been recalled in the United States already in 2022, 18% of which are related to Listeria (FDA 2022). Risk mitigation and food safety is a major focus for food manufacturers and government bodies with the shared goal of protecting consumers in mind. This goal is what largely prompted the Food Safety Modernization Act (FSMA) that became legally effective in 2011 and finalized by the FDA in 2015. The idea behind FSMA is to protect public safety by requiring mandatory food safety training and risk prevention controls for all food manufacturers. The ultimate goal is to proactively prevent foodborne illness. FSMA includes various guidance components that help manufacturers take better precautions in preventing foodborne illnesses.

According to the FDA, “the FSMA rules are designed to make clear specific actions that must be taken at many different points in the global supply chain for both human and animal food to prevent contamination.” As of today, FSMA has seven major rules and various programs in place to ensure the safety of the nation’s food supply.

One rule, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Human Food,” includes guidance on how to reduce the risk of Listeria monocytogenes in ready-to-eat (RTE) foods.

18% of 2022 food
and beverage recalls

have been related to Listeria contamination

US FDA 2022

Listeria monocytogene is a pathogenic organism found in moist environments—the bacteria species can also grow at refrigeration temperatures, and freezing will not eliminate or reduce the pathogen. It can also cross-contaminate food prepared, processed, cut, served, or stored in the same area.

FSMA’s ready-to-eat guidance is intended to not only help manufacturers but also ingredient suppliers minimize and or prevent the contamination of Listeria monocytogene. This organism is of particular concern because it is the only food pathogen able to cross the placental barrier in pregnant individuals and may cause miscarriage.

My team has recently been receiving many questions on ready-to-eat guidance, and we thought it may be useful to share some of the most frequently asked ones…

What type of food, beverage, and pet categories should RTE ingredients like food colors be of greatest concern?

Any food product that does not have a reduction step or kill-step would be a Listeria concern. Reduction steps typically include things like heating, acidification, irradiation, or ultrafiltration. Food colors, specifically food colors from natural sources, are often added after this reduction due to stability challenges with heat or pH.

Why do RTE requirements apply to ingredients like food colors and not just the finished good?

Ingredients can be a source of pathogenic bacteria. If ingredients that have a high risk for pathogenic bacteria are used in a product that does not have a microbial reduction step, then the risk passes on to that finished good.

FSMA states that manufacturers need to validate a reduction step has occurred to have a 5-log decrease of pathogenic organisms.

Do all food colors need to be RTE compliant?

If a product has validated 5-log decrease step after a food color is added, then the color does NOT have to be RTE compliant. Vice versa, if an RTE product does not have this step, then the color, as well as other ingredients, should be RTE compliant to prevent passing the risk on to the customer.

What is Sensient’s RTE strategy?

Sensient implements reduction “kill steps” during color processing when high microbial risk is present to alleviate our customers of that additional labor needed for FSMA compliance.


Finished good manufacturers and product developers should ask ingredient suppliers about their RTE procedures that enable manufacturers to thoroughly ensure product and consumer safety.

In an effort to provide food manufacturers with greater transparency and peace of mind, Sensient is now clearly identifying which Sensient colors are ready-to-eat compliant with FSMA guidelines. If you see the following brand logo, then the color is ready-to-eat.

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