What's required for food-grade lubricants, and what isn't? Winding your way through the labyrinth of regulations and registrations that impact nonfood compounds, such as lubricants, can be tedious. Here's a quick tour.
There are three main categories of lubricants used in the food industry.
H1 lubricants - Lubricants that could have incidental food contact are sometimes referred to as "above the line" lubricants. These may be used on food-processing equipment as a protective antirust film, as a release agent on gaskets or seals of tank closures, and as a lubricant for machine parts and equipment in locations where the lubricated part is potentially exposed to food. The amount used should be the smallest needed to accomplish the desired technical effect on the equipment. If used as an antirust film, they must be removed from the equipment surface. Ingredients for use in H1 lubricants are designated HX-1.
H2 lubricants - These are lubricants with no possibility of contacting food. These compounds may be used as a lubricant, release agent or antirust film on equipment and machine parts or in closed systems in locations where there is no possibility of the lubricant or lubricated part contacting edible products.
H3 soluble oils - These products may be applied to hooks, trolleys and similar equipment to clean and prevent rust. The portions of the equipment that contact edible products must be clean and free of the oil before reuse.
Historically, the United States Department of Agriculture (USDA) approved incidental food-contact lubricants used in meat and poultry facilities. This approval relied on the Food and Drug Administration (FDA) guidelines set forth in the Code of Federal Regulation (21 CFR 178.3570), which defines approved components for use in incidental food-contact lubricants, H1.
These approvals became industry-accepted and carried over to other food-industry segments. The agency evaluated product formulations and reviewed labels but seldom conducted testing. For products in compliance, the USDA issued a letter of authorization. Manufacturers and suppliers typically obtained authorization before marketing their lubricants to the food industry.
The USDA authorization program came to a halt in February 1998, mainly due to lack of resources. Since 1999, NSF International has been satisfying the risk management needs of food product manufacturers, processors and regulators. NSF manages a registration process for nonfood compounds, including lubricants, used in and around food processing. It continues to rely on the FDA guidelines mentioned previously.
The term registration sounds ominous and obligatory. In fact, it is neither. At present, there are no legal requirements in the United States to register—with NSF or anyone else—a lubricant used in food processing. However, a company may determine compliance and self-certify its product. Although not required, NSF registration is becoming an industry standard in the United States and globally. An ISO standard (ISO 21469) is also being developed for lubricants, but there is debate about the value of imposing another standard that appears to only add cost.
In addition to these guidelines, food plants often want to manufacture food that addresses the needs of specific segments of the population, including kosher and halal foods. Typically, the lubricant used to produce these products also must be kosher or halal certified.
While the guidelines may seem daunting, it is in the best interest of food companies and lubricant blenders to make every effort to comply with them to minimize risk exposure. Additionally, additive component and lube suppliers must follow good manufacturing practice protocols while manufacturing these lubricants. These protocols include having a dedicated plant (vessels, piping, and storage and packaging equipment) so there is no risk of contamination from nonfood approved lubricants. Additionally, the protocols require extensive flushing and metal analysis to ensure that products are free from heavy metals and zinc, which are not permitted in H1 lubricants.
Table 1. Lubricant Challenges
It is estimated that a significant proportion (60 percent or greater) of U.S. food and beverage companies are not using incidental food-contact lubricants. Also, companies that do comply tend to use both H1 and H2 lubricants in their plants, increasing the possibility of using an H2 lubricant whether an H1 lubricant is required. They may use both lubricants in a location because they do not know about the requirements and have performance concerns. One of the accomplishments of the NSF program is that it has heightened awareness within the industry about using H1 lubricants.
Certain food equipment manufacturers (OEMs) have begun offering their own branded H1 lubricants that are recommended for use in their machinery for warranty purposes. There is also discussion of an ISO 21469 standard for incidental food-contact lubricants, which may become effective in early 2008 or 2009.
Finally, growing affluence in countries such as India and China is driving up demand for prepared foods. The demand, in turn, has spurred global companies to set up shop in these countries. Localized, manual food operations are turning into large, mechanized operations. So far, food processors in these countries tend not to use H1 lubricants.
But that will change as Asia's food processors invest in new plants and equipment and want to use the appropriate lubricants. Once food manufacturers have invested in quality equipment, they'll also want to ensure that it runs efficiently. That means using the right lubricant. The growth in Asia is an emerging trend, and we may not see its impact for two or three years.
Table 2. Wear Protection in an Eaton-Vickers Vane Pump Performance Test
What role does the lubricant play? The food industry uses lubricants ranging from hydraulic fluids, gear oils, oven chain oils, compressor oils, and vacuum pump oils to specialty lubricants such as can seamer oils. Plant managers realize that a single lubricant cannot handle all these needs.
Also, plant owners and managers are demanding increased reliability, less downtime and higher throughput from their equipment to meet growing demand. Preventing breakdown in order to increase output and lower costs is on every plant manager's mind. Until recently, H1 lubricants often fell short on performance compared to H2 lubricants.
Also, H1 lubricants were not as extensively tested as H2 lubricants in common industry standard tests, such as OEM-specified vane pump tests for hydraulic fluids. The food industry also can present challenges to the lubricants, as shown in Table 1.
Working on new lubricants takes creativity because the formulator must balance component compliance with performance demands. Additives are used to boost lubricant performance, but blenders have a limited pool of H1-registered additives from which to choose. They have a wider selection of H2 additives, which can include components based on zinc, a highly effective antiwear agent.
NSF-registered HX-1 additives that impart antiwear and antioxidant protection, rust or corrosion inhibition, friction modification, etc., are available as individual components or as premixed additive packages. Use of packages simplifies plant operations because they can be stored in a single vessel dedicated to food-grade lubricants.
Recently introduced lubricant additive packages can allay performance concerns. They are intended to deliver superior wear protection and thermal and oxidative stability and are kosher and halal certified. Tables 2 and 3 show an example of a hydraulic fluid based on an HX-1-approved hydraulic additive package that provides outstanding wear protection to vane pumps as well as maintains excellent thermal and oxidative stability.
This means that food manufacturers can improve plant reliability and performance and ultimately save costs. It also means that plant managers can reduce complexity by using H1 lubricants throughout the plant without having to rely on H2 lubricants (or separate kosher or halal lubricants) for performance.
Instead of being formulated with white mineral oils that have lower solubilization and lubricity, today's incidental food-contact H1 lubricants are made with synthetic base oils such as polyalphaolefins, polyalkylene glycols and esters. These base oils, coupled with new additive packages, can deliver premium performance.
So, although finding the answers about properly using food-grade lubricants isn't as easy as some food equipment manufacturers and plant operators might wish, the answers are there. Listings of NSF-Registered Nonfood Compounds, including lubricants and the ingredients (additives) that may be used in those lubricants, are available free on the NSF Web site (www.nsf.org).
Finished lubricants are registered as H1; H1 ingredients/additives are registered as HX-1. A special category, HT-1, is used for heat transfer fluids. You can search the database a variety of ways. For example, you may request the list of all H1 registrations, which are sorted alphabetically by registrant.
Most important is the fact that new lubricant technologies can now answer the need for safe food processing coupled with meeting the desires for increased output and prevention of equipment breakdown.
Table 3. Oxidative Stability
Kosher is Yiddish, meaning "sanctioned by Jewish law"; ritually fit for use; or selling or serving food ritually fit according to Jewish law.
Halal is Arabic for permissible. It means sanctioned by Islamic law, especially; ritually fit for use according to Islamic law. Source: www.m-w.com/dictionary.
For 60 years, NSF has been committed to public health, safety and protection of the environment. While focusing on food, water, indoor air and the environment, NSF develops national standards, provides learning opportunities through its center for public health education, and provides third-party conformity assessment services while representing the interests of industry, the regulatory community, and the public at large. NSF is widely recognized for its scientific and technical expertise in the health and environmental sciences.
Its professional staff includes engineers, chemists, toxicologists and environmental health professionals with broad experience both in public and private organizations. Serving manufacturers operating in 80 countries, NSF was founded in 1944 and is headquartered in Ann Arbor, Michigan. The NSF mark is recognized for its value in international trade around the world and is respected by regulatory agencies at the local, state and federal levels. Source: www.nsf.org