For food and beverage producers, pharmaceuticals manufacturers, and producers of containers used to package food-related products, there’s no more important lubrication issue than the use of what are typically referred to as “food-grade lubricants”. In the United States, lubricants intended for use in food production are registered with the National Sanitation Foundation (NSF) as either H1, H2 or H3, depending on the intended application and formulation. Registration is voluntary and simply requires a review of the product ingredients with a list of compounds known to be “safe” for incidental food contact at low levels.
Of the three, H1 is by far the most important classification and is typically referred to as a lubricant designated for “incidental food contact”. This relates to applications where it is possible for the lubricant to touch the product (food, beverage, pharmaceutical, etc.) in low concentrations due to leakage or over-lubrication. (You will find more details on the difference between H1, H2 and H3 lubricants, together with information on the selection and application of food-grade lubricants, in Stephen Sumerlin’s article found on Page 28 of this edition of Machinery Lubrication.)
Recently, a new terminology has entered the vernacular of food-grade lubricants: ISO 21469 certification. ISO 21469 is not a new standard; in fact, it came into effect in February 2006. Like many voluntary standards, it has taken a while for mainstream adoption. However, a number of major suppliers of food-grade lubricants recently have been successful in obtaining ISO 21469 certification, which is why the timing for an article such as this is now appropriate.
Like the pre-existing NSF H1, H2 and H3 designations, ISO 21469 is all about trying to insure that consumers are protected from the deleterious effects of contaminating food and food-related products with the lubricant. However, the first important distinction is that ISO 21469 only addresses products intended for “incidental contact” (so-called H1 products in the old terminology). It does not cover the NSF H3 category of lubricants where product contact is inevitable (e.g., a meat hook), nor does it address H2 lubricants. Second, unlike the NSF H1 designation, which simply addresses the potential toxicological, carcinogenic and mutagenic effects of the lubrication by comparing a list of the lubricant’s “ingredients” with a list of approved food-safe products (per 21.CFR 178.3570), ISO 21469 addresses the whole process of lubricant design, manufacturing, packaging and transportation.
Key to achieving ISO 21469 certification is conducting a thorough “hygiene risk assessment” to address not just the chemical safety of the lubricant (non-toxic, non-carcinogenic, non-mutagenic) but also the potential for physical risk from the ingression of dirt, dust or metals, or biological risk due to the formation of pathogens or other biologically active agents from long-term storage, spoilage, etc.
Achieving ISO 21469 certification is a six-step process.
Step 1 is simply an administrative step whereby the manufacturer submits details such as product name, manufacturing locations, container size, shelf life, etc., along with the completed risk assessment documents.
Step 2 requires a review by the assessing body (e.g., NSF) of product details, including a list of ingredients (e.g., additives), their suppliers and the acceptable range of those ingredients in the finished product. Products are classified based on related product families (e.g., anti-wear fluid, gear oil, etc.). Grouping products into classes based on their chemical constituents helps to reduce the amount of compliance testing required as part of obtaining and maintaining ISO 21469 certification. Just like the H1 classification, ingredients must come from the list of known food-safe products according to an appropriate listing such as Food and Drug Administration (FDA) regulation 21.CFR 178.3570.
Step 3 is an onsite audit of the lubricant manufacturing facility to look at recordkeeping, quality control policies and procedures, overall “good manufacturing processes” (GMP), and to allow for representative product samples to be collected. As part of the onsite audit, the manufacturer’s hygiene risk assessment protocol is reviewed and verified. The onsite audit is conducted by a qualified representative of the assessing body such as NSF.
Step 4 requires that a representative baseline be established using Fourier transform infrared (FTIR) analysis. Samples are taken from different manufacturing batches as well as any repackaged products to verify that the supplier has appropriate control over the manufacturing process. Sample baselines are used to compare with future samples to insure continued quality control compliance and formulation stability.
Step 5 allows for the issuance of accredit certification. In the U.S., certification is provided through the American National Standards Institute (ANSI) based on the findings of the assessing body such as NSF. A list of certified suppliers and products can be found online at http://www.nsf.org/Certified/iso_21469.
In order for a manufacturer to retain ISO 21469 certification, it is required to update its risk assessment policy. Each facility also is subjected to an annual unannounced audit, at which time product samples are collected that must match the product baselines established during the initial certification process (Step 6).
Since ISO 21469 is a voluntary standard, it is not required that a manufacturer of food-grade lubricants goes through this process; in fact, many have yet to do so. NSF continues to provide the conventional H1, H2 and H3 designations for food-grade lubricants; and indeed, both ISO 21469 certification and H1 registration can be held by the same lubricant.
So, what’s the benefit of ISO 21469? Both the NSF H1 and ISO 21469 designations help to insure that the ingredients in any lubricant are “safe” in the event of incidental food contact. But with ISO 21469, there’s an added layer of oversight that looks not just at the makeup of a given product but the manufacturing process and level of quality control applied to the formulation, manufacturing, distribution and storage of the lubricants. Because of this, it’s likely that manufacturers of food-grade lubricants will continue to strive to attain ISO 21469 certification as an added measure of comfort to both the end-users of food-grade lubricants and, most importantly, to all of us as consumers!