FDA Metal Detection Critical Limits: A Complete Guide

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assorted fruits vegetables salmon grains and meat

Production facilities in the food industry know how many things can go wrong during each manufacturing phase. From foreign materials entering the product to improper sealing causing contamination, you must worry about ongoing issues to ensure you deliver safe, consistent, and hazard-free items. The FDA metal detection critical limits are guidelines your facility must follow to keep metal fragments out of your food products so you can prevent safety hazards for consumers.

At TDI Packsys, we offer a range of state-of-the-art metal detectors for food industry production, packaging, and manufacturing facilities to help you adhere to critical limits in an efficient way. Below, we share everything you should know about the FDA’s critical limits on metal detection so you can implement the right practices at your facility.

What Are the FDA’s Metal Detection Critical Limits?

The U.S. Food and Drug Administration (FDA) began regulating foreign metallic materials in food products over half a century ago after conducting the Total Diet Study (TDS), which found radioactive contamination in numerous types of food. As the industry has evolved since the 1960s to conform with FDA safety standards, manufacturers now must limit the number of plastics, metals, chemicals, and other contaminants in food products to protect consumer safety. With the FDA’s “Closer to Zero” plan, new research and regulations place stricter guidelines in an attempt to remove all contaminants from food in the future.

The FDA’s metal detection standards implement critical limits on acceptable and unacceptable types of metal in food products. According to the Health Hazard Evaluation Board, the FDA prohibits metal fragments between 0.3 inches and 1 inch in size. Foreign objects smaller than 0.3 inches may also cause serious harm to high-risk consumers, such as surgery patients, infants, and the elderly.

Are There International Standards for Metal Detection Critical Limits?

The International Food Safety and Quality Network (IFSQN) operates similarly to the FDA, though on a global scale. Most IFSQN forums imply that the organization has not set international critical limits but recommends that facilities follow pre-set standards, such as the U.S. FDA guidelines.

The U.S. FDA’s requirement on the metric system is a 7-millimeter minimum, while other nations, like Canada and a few European countries, have 2-millimeter minimums. Unfortunately, you cannot find all this information in actual government legislature, only on IFSQN forums.

Why Are FDA Metal Detection Critical Limits Important?

quality control and food safety team inspecting bottled product

Acute or chronic exposure to toxic heavy metals can cause all sorts of severe effects. The consumer could experience kidney dysfunction, nervous system disorders, skin lesions, immune system dysfunction, congenital disabilities, cancer, gastrointestinal dysfunction, choking, and more. As a result, your facility could face lawsuits, class-action claims, and other major consequences.

Many assume metal contamination is rare and doesn’t warrant concern. Unfortunately, small pieces of metal can easily enter food products during manufacturing. Whether a sliver of metal from a can enters the food during production or comes with the ingredients from the farm, you likely wouldn’t notice it with the naked eye.

Metal detection critical limits are important because they ensure your manufacturing facility doesn’t let hazardous materials hit the shelves. Following strict standards can keep your consumers safe and protect your business from severe financial consequences.

Which Metals Are Regulated by FDA Metal Detection Critical Limits?

FDA metal detection critical limits regulate the three main types of metals that metal detectors can locate:

  • Ferrous metals: Ferrous metals are conductive and magnetic, allowing machines to detect them easily. Any metal that includes iron is a ferrous metal. A few common examples include chromium, molybdenum, nickel, vanadium, and manganese.
  • Non-ferrous metals: Non-ferrous metals are conductive but not magnetic, making them simple to detect. Common non-ferrous metals include lead, tin, zinc, copper, aluminum, gold, and silver.
  • Stainless steels: Stainless steels are neither conductive nor magnetic, making them the hardest category to detect. The advanced metal detectors from TDI Packsys can locate stainless steel and the above types of metal using electromagnetic induction for the most reliable inspections.

Implementation of FDA Critical Limits for Metal Detection in Production

inspection team checking the production

Implementing the FDA’s metal detection critical limits correctly is the only way to prevent metal contamination hazards. To do so, follow these steps:

1. Assess Risks

The FDA describes the first steps in implementing critical metal detection limits as understanding potential hazards and determining whether they are significant. When assessing risks, you’re essentially considering if and when metal fragments may come into contact with food products. For example, risks may include transporting ingredients to the facility, using mixing machines and conveyor belts, canning products, and more.

2. Establish Critical Limits

Next, you must establish critical control points with limits. Critical control points are the areas where you will test the products. Choosing the right control points is essential to hazard aversion, as using a metal detector before continuing the product through production with added risks would be useless.

3. Select Appropriate Equipment

Selecting the right equipment for your facility will help you achieve the most accurate and reliable readings. For example, liquid products will require a different machine than solids. At TDI Packsys, we provide a variety of metal detectors for all kinds of applications.

4. Calibration and Validation

When you set your critical limit for each preventative measure, you will use calibration tools to ensure your equipment works properly. You can adjust sensitivity levels depending on your critical limit target with different-sized calibration balls. You will likely need to adapt the test ball depending on the type of food product you’re testing so you don’t get false alarms.

5. Train Employees

Training your employees on the new standards can prevent errors, reducing wasted resources. You’ll need to teach team members how to use the equipment, though training them on the proper protocols for preventing hazards can improve how your facility runs. Be sure to cover the critical control points, risks, limits, calibration requirements, and why these measures are so important.

6. Implement Documentation and Record Keeping

Documentation and record-keeping prevent singular contamination cases from ruining entire batches. As you develop your critical limit process, be sure to create plans for how you’ll find the source and proceed after each test.

If you detect metal, your team should know to remove it, test the equipment, and proceed. When batches come through negative, you should continue documenting everything to maintain records.

Are There Different Metal Detection Critical Limits for Different Food Types?

different types of food in conveyor belt

The FDA only enacts one primary metal detection critical limit for food, regardless of food type, as 0.3 inches to 1 inch-sized metal can be a choking or injury hazard in any scenario. With that being said, different foods will require different types of metal detectors for accurate results.

What Are the Consequences of Failing To Comply With FDA Metal Detection Critical Limits?

Failing to comply with the FDA’s metal detection critical limits can cause serious injuries to the consumer. The FDA prohibits adulterated foods that do not follow the “Compliance Policy Guide.” Your facility could face severe penalties if it allows hazardous products to reach the shelves.

At TDI Packsys, our advanced metal detectors make complying with FDA metal detection critical limits easy. Call TDI Packsys today at (877) 834-6750 to learn more about our metal detectors.

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