Food-grade lubricants are specialized industrial lubricants designed for use in environments where there is potential for incidental contact with food or beverages. These lubricants are used to ensure both the proper functioning of machinery and the safety of the products being processed. Their applications span food processing, pharmaceuticals, cosmetics, and animal feed industries. These lubricants are tightly regulated to ensure they do not contaminate food products and pose a health risk.
The most common standards and certifications in this space are NSF International's H1 certification and ISO 21469. If a lubricant meets the requirements for ISO 21469, it automatically satisfies all the requirements of NSF's H1 certification, as ISO 21469 is more comprehensive. Conversely, achieving NSF's H1 certification can serve as a foundational step toward obtaining ISO 21469 certification, simplifying the process for manufacturers who wish to meet the higher standard.
The NSF International is a leading organization that sets standards for food-grade lubricants. NSF International standards ensure that lubricants meet stringent safety and quality requirements. The primary classifications for food-grade lubricants under NSF standards are:
Once registered, products are listed in the NSF White Book, a publicly accessible directory of certified nonfood compounds.
There are more than 12,000 H1 food-grade lubricants registered globally, with an average yearly growth rate of 7% for H1 lubricants registered by NSF.
ISO 21469:2006, titled "Safety of machineryâÂÂLubricants with incidental product contactâÂÂHygiene requirements," is an internationally recognized certification that specifies hygiene requirements for the formulation, manufacture, and handling of food-grade lubricants.
Key aspects of ISO 21469 certification include:
ISO 21469 certification requires prior ISO 9001 certification, which establishes a quality management system (QMS) foundation. Products certified under ISO 21469 demonstrate a manufacturerâÂÂs commitment to food safety and regulatory compliance.
Food-grade lubricants exported into or imported out of Brazil must be certified to ISO 21469. A database of all ISO 21469 certified lubricants is maintained at the NSF's website.
It is noteworthy that ISO 21469 has not been updated since 2006.
The U.S. FDAâÂÂs Code of Federal Regulations Title 21 Section 178.3570 (21 CFR) specifies an ingredient whitelist that both NSF and ISO standards abide by. The lubricant must also be:
There is a 10 parts per million (ppm) limit for lubricant base oils (e.g., mineral oil) that can be present in food if incidental contact occurs. To get new food contact substances (FCSs) approved by the FDA, manufacturers must either submit a Food Contact Notification (FCN) filing or apply for a Threshold of Regulation (TOR) exemption.
There is a common misconception that lubricants are registered through the USDA. However, the USDA discontinued its registration program for lubricants in 1999.
While the European Food Safety Authority provides advice on food safety risks, the EU doesn't formally regulate lubricants themselves, instead typically following the U.S. restrictions.