This incident highlights how employing a non-food-grade lubricant for food processing or manufacturing can lead to health hazards as well as tens of thousands of dollars in lost revenue and a major hit to a brand’s reputation. 

So how can companies operating in the food and beverage spaces be confident that the lubricants they are using are food-grade? 

The simple answer is that those companies should select lubricants with food-grade certifications and approvals. And fortunately, organizations like NSF can help them to do just that. 

NSF is an independent, not-for-profit organization that is dedicated to public health, safety and protection of the environment. It meets these goals by developing standards, providing education and offering superior third-party conformity assessment services, all while representing the interests of all stakeholders. 

NSF’s Non-Food Compounds Program

NSF deployed its Non-food Compounds Program, known as NFC, in 1999 after the USDA concluded its management of the program. 

According to NSF’s Registration Guidelines for Proprietary Substances and Non-food Compounds, the “Nonfood Compounds voluntary Registration and Listing program has established evaluation criteria for proprietary substances and non-food compounds used in food and beverage processing and food handling facilities and other facilities.” 

The NFC program covers toxicology, odor potential and intended use classifications of a wide range of products, including lubricants. 

“We have set guidelines that we use for non-food compounds,” said Ismael Martinez, manager of non-food compounds, green chemistry & food contact materials product certification, for NSF. “The non-food compounds program actually includes over 100 different category codes. Lubricants, by far, is the most popular category of products within the non-food compounds program.” 

In the specific case of lubricants, products can be registered as H1, meaning that they are safe for incidental food contact. Individual lubricant components—such as base oils, additives or grease thickeners—can obtain HX-1 registration. 

All products registered with NSF are then listed in the organization’s White Book. 

The NSF White Book

When the U.S. Department of Agriculture stopped managing what is now NSF’s Non-food Compounds Program in the late 1990s, NSF took over the program. The NSF White Book is a public listing in which all of the organization’s registered products are compiled. It can be found on the NSF website and is updated on a daily basis. 

“If it’s in the White Book, it is currently registered,” Martinez said. “It’s a really useful tool—not just to our clients, the manufacturers, but to the ends users and anyone performing audits at the food processing facility. They come into the White Book, and it’s a good place to verify that registration.”

Are H1-registered products the only thing listed in the White Book? The simple answer is no, the White Book also lists a significant portion of ISO 21469 certifications as well. 

“The H1 registration products are listed in the White Book. We had a separate listing for the ISO 21469, but we’ve actually started incorporating those into the White Book as well, so it can kind of act as a one-stop shop for lubricant manufacturers and other users,” Martinez said. “The majority of the ISO 21469 products are already incorporated into the White Book, but we’re not quite at 100%. That is the end goal, to have everything in one place, so end users and regulatory bodies don’t have to hop around checking the different certifications in several different locations.”

ISO 21469 Certification

The ISO 21469 certification is an internationally recognized certification for lubricants mandated by many leading brands and recognized in the animal feed, pharmaceutical and cosmetics industries.

“The ISO 21469 certification is pretty similar to the Non-food Compounds registration, but that’s kind of a separate evaluation. It’s a different set of requirements,” Martinez said. “The ISO 21469 does share a piece, or a requirement, with our non-food compounds H1 lubricants, which is highly recognized and typically referred to as food-grade lubricants. So from a formulary requirement, the ingredients kind of meet the same criteria—H1 and ISO.” 

So what does ISO 21469 certification require that H1 registration does not?

“The added pieces to the ISO 21469 certification is an audit of the manufacturing facility,” Martinez said. “There’s also a thorough risk assessment of the manufacturing facility, where we’re looking for things like contamination points and also following up with the manufacturer to make sure that those points are being addressed not just during the initial audit but on an annual basis.” 

Product testing is also an important part of obtaining an ISO 21469 certification, Martinez added. He also emphasized that product testing is not included in the H1 registration process. “That registration piece is mainly formulary based, so we look at the product labels. The ISO certification is not just the formulation requirement; it also includes the facility audit, the risk assessment, the testing, and we also look at the labels.”

However, H1 registration is often a precursor to ISO certification. “Once you get that non-food compounds registration, that kind of gets your foot in the door because we know that the formulation meets the criteria. Pretty much, if it meets Non-food Compound registration from a formulary standpoint, it’s going to meet the criteria of ISO 21469. But then ISO includes those other components that are really giving the lubricant manufacturers as well as the end users that additional assurance that the product is safe all the way through and is also being monitored in a way that the Non-food Compounds program is not.” 

Figure 1. Food-Grade Lubricant Programs at a Glance

As mentioned above, ISO 21469 certification requires annual facility audits. In addition to those audits, the products themselves must be tested—and pass those tests—every four years to maintain certification. 

“That testing is really intended to verify consistency between the different batches,” Martinez said. “We’re testing the product four years later and comparing it to that original product to make sure that they are still the same.” 

Martinez noted that the ISO 21469 was updated last year. How does the revised standard differ from its predecessor?

“One major change is we updated our risk assessment. We knew that that was kind of a pain point in the certification process, so we came up with a different format to make it a bit easier for the manufacturers in terms of how the document is completed,” Martinez explained. “You still need the same amount of information. We still need the potential contamination points; we need to make sure that those are being addressed. It’s more of a documentation type of update.” 

Another change made to the certification include an update to policies. “We made some updates to the policies as well to try to identify some outdated or redundant language,” Martinez said. 

The remaining updates include a simplified application form and product level certificates. “The Non-food Compounds Program has always had these registration letters, which are publicly available in our White Book. The ISO-certified products did not previously have the same certificates or the letters for each product,” Martinez said. “So as we incorporated these ISO products into the White Book, we started also generating these letters for the ISO products. One of the advantages for the end user and for regulatory bodies is that each product has its own unique letter, and that makes it a little bit easier to verify the certification status.”

Ultimately, the ISO 21469 certification is the global gold standard for non-food compounds, as it can be applied not just to the food and beverage segments but also to cosmetics, pharmaceuticals, pet food and more. “It’s not just a food-focused product. It definitely expands the market, and that’s a reason why a lubricant manufacturer might seek out the ISO 21469 certification,” Martinez said. 

A Major Trend in Food-Grade Lubes

Perhaps the most significant trend in food-grade lubricants is a change to formulation components—particularly the phasing out of increasingly regulated chemicals, such as MOSH (mineral oil saturated hydrocarbons), MOAH (mineral oil aromatic hydrocarbons) and PFAS (per- and polyfluoroalkyl substances).

“In general, manufacturers, suppliers and consumers are becoming a lot more critical about what’s in everything that they’re using,” said Anj Oto, senior specialist, communications, for NSF. “So I think we’ll continue to see greater pressure in the MOSH/ MOAH and PFAS areas.”

Martinez agreed: “We’re seeing different limitations on things like PFAS—even how PFAS is defined is changing. There are so many different variations, so there are definitely a lot of ways we could go in trying to find a middle point on that.”  

Sydney Moore is managing editor of Lubes’n’Greases magazine. Contact her at Sydney@LubesnGreases.com