Signed into law over seven years ago, the US Food Safety Modernization Act (FSMA) is now well down the road to implementation. FSMA has generated some of the biggest changes to food safety seen in the last 70 years – shifting the food industry’s emphasis from reaction to the prevention of foodborne diseases. In this article, we look at how this shift affects food labeling in relation to allergens.


The step change from responding to outbreaks of foodborne disease to actively preventing their occurrence is a cornerstone of FSMA. It demands greater emphasis on:

  • Records control
  • Registration of food facilities
  • Hazard analysis and risk-based preventive controls
  • Training
  • Supply chain management
  • Standards for produce safety
  • Sanitary transportation of food
  • Prevention of misbranding with respect to allergen labeling

Although labeling is covered by many different aspects of FSMA, in particular it prescribes specific preventive controls for allergens.

Risk from Allergens

According to the US Department for Agriculture’s (USDA) Food Safety and Inspection Service, allergens remained the primary cause of food recalls in 20171. Most reactions to allergens are mild and self-limiting but, in about 20 percent of cases, the reactions can lead to anaphylaxis – the systemic reaction to an allergen that can cause breathing passages to swell and shut, and blood pressure to plummet. Anaphylaxis can result in shock and even death.

In the US, around 30,000 cases of anaphylaxis are reported each year. This results in hospitalization for around 2,000 sufferers, of whom around 150 will tragically lose their lives. When someone presents at an emergency room with anaphylaxis, the most likely cause is a food allergy, which most commonly will have been triggered by nuts or sesame seeds.

Preventive Controls

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) defined the labeling requirements relating to the ‘Big 8’ allergens – milk, eggs, fish, shellfish, nuts, peanuts, wheat and soybeans2. These allergens, which account for about 80% of all food allergies, can be introduced into a food product in many ways, from human error to accidental cross-contact. With the introduction of FSMA and its emphasis on undeclared allergens, these are now described as hazards that should be controlled.

Since food allergies are so serious and an allergic consumer must avoid any allergen found in certain foods, clear and accurate labeling is a must. Our research into label design has shown that inaccurate or unclear labeling contributes to about 45% of incidents. This is largely because the labeling process is a manual one that depends entirely upon human skill and competence. On top of this, the task involves many independent jobs and the transference of data, both of which can result in inaccuracies. There are no shortcuts to the job, no automated or mechanized cross-checks designed to identify mistakes at their origin, and no way to compare old and new. This means that, without expert oversight, the risk of inaccurate labeling can be high.

The change in emphasis introduced by FSMA means companies are now required to invest in systems and technologies designed to improve the labeling process to reduce risk and improve overall efficiency. According to the FDA, the estimated annual cost of performing label controls to prevent allergen mislabeling varies from around USD 7,000 for a small facility to more than USD 120,000 for a large establishment3.

Compliance Labelwise

Compliance Labelwise is our system to support businesses with food labeling and product information reviews. Augmenting human expertise with state-of-the-art Artificial Intelligence, it provides an extra layer of support in the reduction of risk in a company’s internal processes.

Compliance Labelwise can validate declared allergens, provide alerts when missing information is detected and monitor online content to spot misalignments on e-retailers webpages. In addition, our label compliance teams have the expertise and experience to review your product labels against FSMA and other labeling requirements.

For the complete range of SGS services and support, visit or send an email to us.

Nicola Colombo
Head of SGS Digicomply
t: +41 215520976


1Summary of Recall Cases in Calendar Year 2018
2Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)
3Part 117 FSMA Final Rulemaking for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food