Fortunately, a combination of government, business and societal oversight exists to prevent an unsafe food from reaching the consumer. Still, few people actually know how this system works – and that it covers ancillary items such as lubricants.

The first food standards date back the earliest days of civilization and are written into the texts of major religions. Even now, modern authorities interpret these guidelines in the context of the modern world of industrial food processing. The Malaysian Department of Standards, for example, recently published Malaysian Standard MS 1500:2009 to document the Halal rules.

Today, many foods carry Kosher and Halal certifications which show that the food was prepared according to the appropriate guidelines, as expected by religious consumers, and have not been in contact with forbidden materials. Lubricant manufacturers can obtain Kosher and Halal certifications to verify that their products do not contain forbidden ingredients, allowing these lubricants to be used on equipment which will prepare Kosher and/or Halal food.

Of more recent vintage is the Codex Alimentarius Commission, created in 1963 by the World Health Organization and Food and Agriculture Organisation to develop harmonized international food standards, guidelines, and codes of practice to protect the health of the consumers and ensure fair practices in the food trade. This is a truly global standard as 99 percent of the worlds population live in countries accepting the Codex Alimentarius.

Additives are covered under The Codex General Standard for Food Additives (GSFA Codex Standard 192-1995). Most recently revised in 2014, this standard is 372 pages long and provides extensive guidance on the acceptable uses of edible products.

How is this relevant to lubricants? Many food-industry lubricants are based on fully edible products. The Codex document goes to great lengths to describe edible products. Unsurprisingly, vegetable oils, tallow, lard and similar products are edible and can also act as lubricants. Perhaps fewer people realize that petroleum-derived products such as white mineral oil and microcrystalline wax are also acceptable additives for some types of food. Even talc, iron oxide, stannous chloride, ferrocyanides and other inorganic chemicals are considered perfectly safe food additives.

It would be easy to assume that any acceptable food additive would be allowed for a non-contact food lubricant. However that isnt necessarily true. Conversely, there are many substances which are acceptable as incidental contact food machinery lubricants that are not considered food additives.

Industry learned long ago that edible oils have significant deficiencies that limit their usefulness as lubricant base oils. Edible oils tend to solidify at low temperatures, smoke when heated, and polymerize when kept hot. Industrial machinery often demands higher performance and the lubricants of choice are based on refined petroleum and synthetic chemistries that can withstand the severe conditions.

Modern food-processing plants use the same types of equipment used in other industries and can operate under similar severe conditions. Therefore, the food industry relies on high-performance lubricants in preference to edible oils. The products must perform as industrial lubricants with the added requirement that they be non-toxic and harmless in case of incidental food contact.

Producers and users need to be especially alert to applications where incidental contact between the lubricant and the food may occur, because lubricants should not knowingly become part of the food supply.

Now, a truly rigorous food-safety investigation would determine the quantity of lubricant which could possibly be incorporated in the food and ensure that there are no negative effects in the safety and quality of the food at that level. Unfortunately, this is difficult to determine and may vary for every situation; for each process, each factory, possibly each consumer. This has led to a pragmatic approach, in which toxicologists and other experts determine a practical maximum quantity and apply an appropriate safety margin.

In the United States, the most widely referenced government document for food-processing lubricants is the Code of Federal Regulations, Title 21 section 178.3570. This document provides guidance on ingredients approved for food-contact lubricants and includes a list of specific compounds and additives. It also establishes a 10 parts-per-million limit as the amount of mineral oil (and several other potential lubricant base oils) that can be present in food. There have been no known health incidents from exposures below this limit, so the toxicologists margin of safety appears sufficient at this 10 ppm level.

The 10 ppm limit has generally been accepted as the standard for all types of incidental-contact lubricants. If detected above that level in foodstuffs, the lubricant becomes a contaminant and must be addressed as such.

However, 21CFR 178.3570 is not specific about the measurement and testing protocols, which has led to further debate. For example, if a factory makes 1 million cookies daily and each weighs 10 grams, in theory the factory can use up to 100 grams of lubricant at the 10 ppm limit. Does this mean that every cookie must contain no more than 100 micrograms of lubricant? Since it is impossible to test every cookie, does the factory meet the standard if they top up the lubricant sump with less than 100 grams of fresh lubricant every day? In cases such as this, companies must use their best judgment to minimize the probability of shipping any contaminated (over the limit) product.

Industry should act responsibly to eliminate incidents that can be reasonably avoided. The principles of Hazard Analysis and Critical Control Point can help manage the process and determine if further action is warranted.

Hazard Analysis and Critical Control Point plans, commonly known as HACCP, are used throughout the food industry to manage risks in the food chain. The earliest roots of HACCP can be traced back to The Pillsbury Co. and its work with NASA to provide food for the manned space program in the 1960s. The basic principle is to analyse the entire process and anticipate all the steps where hazards may exist. Preferably, the steps can be reengineered to eliminate the hazard. All remaining potential hazards become the critical control points, which must be continually monitored and controlled to ensure that the hazard is safely managed.

A properly functioning HACCP plan will be supported with detailed documentation and reviewed regularly. It is usually the first point of reference for auditors, so it should be written clearly and provide ample evidence of worker involvement. A plan which stays in the corporate file cabinet will have little value.

HACCP principles have been widely adopted in the food industry and can actually be used for any operation. HACCP is specifically referenced by the Codex Alimentarius, the U.S. Department of Agricultures Food Safety and Inspection Service, the National Academy of Sciences, the International Commission on Microbiological Specifications for Foods, and many others.

A HACCP plan will list all hazardous chemicals on site and develop a system to document their use to ensure that there has been no contact with the food. Lubricants would be considered hazardous chemicals – unless they have been approved for use in food processing, and can be present at trace levels in the food. Thus, using approved incidental contact lubricants may eliminate a layer of documentation and allow the plants staff to focus on other critical control points.

This may be why we see many companies preferring to use approved food-processing lubricants exclusively throughout their plant. Because their HACCP plan does not count these lubricants as hazardous chemicals, it eases the burden of documenting and tracking every gram used.

How do you know if a product passes this hurdle? The most widely recognized approvals for food-processing lubricants are encapsulated in the H categories which cover lubricants and related products.

In the 1970s, the U.S. Dept. of Agriculture began a non-food compounds program for various process chemicals including lubricants. This led to the development of a white book list of approved incidental contact lubricants. However, the USDA stopped publishing their list in 1998, leaving the industry uncertain about the future. Soon NSF International took over the White Book and gave continuity to the process. Today, NSF International and InS Services have assumed a prominent role by providing third-party confirmation that lubricant formulations contain only ingredients that the authorities have determined are safe for the intended use.

At present, as InS Services advises, non-food lubricants can fit into one or more of six finished product categories:

H1. Lubricant acceptable for incidental food contact.

H2. Lubricant where NO food contact is permissible.

HT1. Heat transfer fluid; incidental food contact.

HT2. Heat transfer fluid; NO food contact.

H3. Soluble oil; to be cleaned off prior to food contact.

3H. Mold-release agent; direct food contact allowed.

There are also sub-categories such as HX1 and HTX1 which are used for lubricant additives, base oils and other ingredients. For example an antioxidant that is approved at 1 percent additive level in an incidental contact lubricant would receive an HX1 certification. This listing allows formulators to easily determine which additives they can use to maintain their certification.

Products in each of the six categories have been marketed as food grade although there can be significant differences between the requirements. The sheer number of categories is often cited as a cause for confusion; to provide an example, several presenters at the recent ICIS/ELGI Food Grade Lubricants conference in Berlin reversed the 3H and H3 categories. If experts are unclear, there are doubtless many more people involved in food operations and handling who just remember whether a product is food grade or not food grade, without attention to the specific categories. Therefore, well-meaning companies that insist on buying food-grade lubricants may still use inappropriate products.

This has led several within the industry to propose a significant simplification of the naming structure; this ongoing debate is not settled as we begin 2015. The most common proposal is to combine H1 and HT1 into a single category and rename 3H to avoid the letter H. Since H2, HT2 and H3 are not allowed to contact food at any level, these products would no longer have a category and would not be part of the food-grade registration scheme.

This would leave H1 as the only category for food-grade lubricants. A clear advantage is that this definition means that lubricants are either food-grade (H1) or they are not.

One way of obtaining H1 status is to use ingredients that are Generally Regarded as Safe for food. The U.S. Food and Drug Administration states that any such compound is an acceptable ingredient for incidental food contact lubricants. Since 1997, the FDA has allowed ingredient companies to make their own GRAS determination without sharing safety data or alerting federal authorities when a new ingredient will be used in the food chain.

According to the Natural Resources Defense Council, there are 275 ingredients used in food today that do not have adequate information available for review. This could potentially allow wide latitude in selecting lubricant ingredients, but GRAS status is a matter of some debate.

In February 2014, the Center for Food Safety, a public interest group, filed a lawsuit against the FDA to require federal oversight of this process. Meanwhile, the Grocery Manufacturers Association is working toward an industry-sponsored set of guidelines for determining when materials can be considered GRAS. At present, the courts have not settled the CFS lawsuit.

How can lubricant suppliers and food manufacturers become more familiar with the requirements of food-processing lubricants? First, there have been many papers, articles, and presentations on food-grade lubricants over the years. NSF International hosts an annual Nonfood Compounds Steering Committee meeting at its headquarters in Ann Arbor, Mich. And ICIS and ELGI recently co-sponsored a conference in Berlin that dealt strictly with food-grade lubricants.

Another industry forum for discussion and debate are the Food Grade Working Group meetings which are jointly sponsored by the ELGI and NLGI. They give lubricant suppliers an opportunity to develop an industry perspective on a working definition of food-grade lubricants and establish recommended practices for suppliers. Developing a consensus position will allow industry to build on government safety initiatives while using the expertise of members to provide products that are safe for use and also effective lubricants.

These working groups are currently discussing an industry code of conduct, especially regarding labeling and marketing of food-grade lubricants. One of the key points to address is minimizing confusion around the various H categories discussed above.

Another working group goal is to educate the supply chain to ensure that best practices and correct products make their way to the shop floor. Regulations and documents are useless if they are locked in a book or on a website somewhere. The people working in the factory must understand and follow best practices.

The global economy provides safe food to a greater number of people than ever before. For most, there is an implicit trust in the food available. It is important for all parts of the supply chain to act responsibly so that trust is maintained.

For their part, it is important for food lubricant suppliers to hold food safety above all other concerns. Therefore, lubricant manufacturers should continue to work together to define best practices and ensure that food-processing lubricants are properly manufactured and applied. This is the best way for our businesses keep the trust of the consumers.

Tyler Housel is a Certified Lubrication Specialist and vice president of the Lexolube Division of Inolex Incorporated, a maker of complex esters, polyol esters, simple esters and oleates that are used in making lubricants for a number of demanding applications, including food-processing equipment. For information about this article, he can be reached by e-mail at thousel@inolex.com or phone (215) 847-6333.