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Introduction

ISO 21469 concerns hygiene requirements for the formulation, manufacture, usage, and handling of food-safe lubricants that may come into incidental contact with consumables, including food, beverages, tobacco, medicine, supplements, and animal feed, including pet food. It is a voluntary certification.

ISO 21469

In 2006, the ISO developed ISO 21469, a certification relating to the hygiene of the manufacture of food-safe lubricants.

ISO 21469 relates only to H1 lubricants, which are intended for incidental contact only. The limit for H1 contamination of foodstuffs is 10 parts per million (ppm).

Prior to ISO 21469, there was NSF H1 certification. However, H1 does not address issues concerning manufacture of food-safe lubricants, specifically verification that labels on lubricant containers are accurate and honest. It also offers no protocol for the testing of contamination.

There is also FDA 21 CFR Section 178.3570, a section of federal law governing lubricants with incidental food contact. However, this also fails to address measurement or testing protocols, which contain numerous variables that are difficult to account for in food manufacture.

ISO 21469 addresses these key issues:

  • Reviews label and formula of lubricant in order to ensure that ingredients are safe and label is accurate
  • Reviews risk assessment related to lubricant manufacture and use
  • Audit of production facility
  • Analysis of product to prove that labeling is accurate and honest
“ISO 21469:2006 specifies hygiene requirements for the formulation, manufacture, use and handling of lubricants which, during manufacture and processing, can come into incidental contact (e.g. through heat transfer, load transmission, lubrication or the corrosion protection of machinery) with products and packaging used in the food, food-processing, cosmetics, pharmaceutical, tobacco or animal-feeding-stuffs industries. It is not applicable to substances used as product additives or to those in direct product contact, but confines itself to hygiene without addressing occupational health and safety matters.”
–From ISO.org

Steps to Achieving ISO 21469 Certification

  1. Interflon submits details to ISO, including:
    • product name
    • ingredients
    • place of manufacture
    • container size
    • shelf life
    • risk assessment documents
    • Hazard Analysis and Critical Control Point (HACCP) plan
  2. Review by third-party assessor (such as NSF personnel) of these details, including ingredient suppliers, and verifying that ingredient amounts in the final product fall within acceptable ranges.
  3. Onsite audit of Interflon manufacturing facility. This includes:
    • recordkeeping
    • assessment of quality control policies and procedures
    • assessment of manufacturing processes
    • lubricant sample collection
    • review of protocol around hygiene risk assessment
    • verification that the facility meets workplace standards of ISO 9001
  4. Samples from batches of Interflon product are subjected to Fourier Transform Infrared (FTIR) Spectroscopy. This is a method of analysis that uses infrared scanning to identify ingredients and observe their properties. The most scientifically rigorous of the steps in the application process, it assures that labeling is honest and accurate, and that ingredients are indeed safe.
  5. Issuance of certificate.
  6. Annual, unannounced follow-up visits to repeat any of the above steps will be carried out.

Why is ISO 21469 Important?

ISO 21469 is important because it shows that Interflon is willing to comply with standards that are much higher than those required by government regulation. Because so much of the food we consume today travels across state and international borders, a global standard is vital for consumer safety. Interflon is committed to ensuring that all its food-safe products exceed federal guidelines.

Because it is a voluntary standard, ISO 21469 can be seen as a sign that the manufacturer is willing to go the extra mile to earn customer trust.

ISO 21469 means that every ingredient in a lubricant can be traced to its point of origin. This removes the worry that unsafe ingredients have been added, whether intentionally or accidentally.

Since 1997, the FDA has allowed ingredient manufacturers to self-regulate, removing the requirement to share safety data or alert federal authorities when a new ingredient will be used in the food manufacturing process as long as it holds Generally Recognized as Safe (GRAS) status. Obviously, this leaves the door open for abuse of the system. When the general health of the population is at stake, it’s up to industry leaders to show that they take ingredient safety seriously. Interflon is proud to be one of them.

What Does This Mean For Businesses?

Interflon prides itself on its relationships with businesses across a range of industries, including food, beverage, medicine, tobacco, cosmetics, and animal feed processors and manufacturers. All these industries are required to use food-safe lubricants, but the manufacturers of these lubricants are not required to attain ISO 21469 certification. Doing so means Interflon take their responsibilities extremely seriously and are willing to go to great lengths to ensure consumer safety.

Background: What is the ISO?

The International Organization for Standardization (ISO) was formed in 1947. Its predecessor, the International Federation of the National Standardizing Associations (ISA), was founded in 1926, but was disbanded because of the onset of World War II. It is an international standards-regulating body that has become increasingly important in the age of globalization, because it helps ensure adherence to standards that surpasses the boundaries of language, politics, or culture.

Comprised of 162 member countries, the ISO governs various standards in a wide range of industries and sectors. This is accomplished by awarding certification to businesses or organizations who meet the requirements set out by experts in their field. It involves rigorous examining, testing, and inspection, and certification can be revoked if it is determined that an organization no longer meets those standards.

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ISO certification is voluntary. It shows that an organization is willing to comply with the highest standards in their field. ISO certifies a very broad range of standards. You can see a complete list here.

Timeline of Food Safety Regulation

1862: Founding of United States Dept. of Agriculture (USDA)
1906: Founding of Food and Drug Administration (FDA)
1944: Founding of National Sanitation Foundation (NSF)
1947: Founding of International Organization for Standardization (ISO)
1998: NSF takes over H1 certification from USDA
2006: ISO 21469 addresses the manufacture of food-safe lubricants
2011: Food Safety Modernization Act, a more proactive measure to food safety that includes packaging as well as ingredients, and includes food imported into the U.S., is enacted
2018: Most recent update of FDA 21 CFR Section 178.3570, governing lubricants with incidental food contact