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Put H2 Lubes in Their Place

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Many end users and lubricant marketers face a conundrum regarding how to select and apply H1 and H2 food plant lubricants. As explained in the July issue of Lubes’n’Greases, H2 is not food grade, and those with any level of experience providing lubricants for food and beverage processors know the difference.

Having marketed into the food industry long enough to grasp the intent and meaning of the two categories, I believe both are vital and necessary. But some key information was missing from that July article. Start by noting that the issues cover used incorrect wording, possibly misleading the casual observer into believing that H1 and H2 lubricants are both food grade. H2 is not food grade.

The term food grade is not found in the regulations first promulgated by the U.S. Department of Agriculture in the early 1960s. I do not believe that the term is used to this day in any regulatory application, or by industry in a technically correct way. We often call lubes food grade because they pass H1 or 3H requirements, as spelled out by the U.S. Food and Drug Administration. Yet, only 3H release agents actually are suitable for direct contact with food.

What, then, are H1 and H2 lubricants?.

H1 lubricants are intended for use where incidental food contact may occur and go undetected. They are non-food compounds made only from FDA-approved substances or those Generally Regarded As Safe (GRAS).

Where there is no possibility of food contact, H2 lubricants may be used. Most substances generally used as lubricants may be included, but federal regulations emphasize that some substances are considered categorically unacceptable for such use.

USDA discontinued its H1 and H2 guidelines in 1998, but the categories were kept, mostly but not completely, intact by NSF International and other nongovernmental organizations. However, would any of us really consider adding them directly to our food and serving it to our family? Yes, H1 is food grade in the sense that no great harm will come from consuming the raw product, but it is not food. There are reasonable limits set for known contamination, but any responsible processor would consider the limit for lubes in their product to be zero. The real reason the H1 safety factor is in place is for the undetected or unknown contamination incident.

The first actual designations used by USDA for these products were AA (now H1) and BB (now H2), and they applied only to lubricants for use in USDA-inspected facilities – meat and poultry plants, for example. Other regulators and producers later adopted these standards because USDAs Food Safety Inspection Service, with the FDAs assistance, did such a good job of laying out the guidelines for these products. It even published a White Book listing lubricant products which met the H1 standard. However, there was never any regulatory oversight in food plants outside USDA jurisdiction.

The confusion over food grade has been solely caused by those in the lubricant or food processing industries that have tried to convince others that H2 means something other than industrial-grade lubricants. It does not. The important dividing line between H1 and H2 is in the types of component lists used to determine suitability for either class. One is very specific; one is general by intent.

H1 ingredients come from what we could term a specific, inclusive list. That is, anything that appears in the ingredient list of an H1 lube needs to appear somewhere on an appropriately legislated list that would indicate its safety, at a prescribed level, in a lubricant intended for areas of possible incidental food contact. These lists are generally found in FDA guidelines, in various chapters of the Code of Federal Regulations (e.g. 21 CFR 178.3750), or in lists of GRAS substances. That is all. One cannot formulate lubricants outside of those boundaries and still have them considered H1, or receive the aforementioned, distorted title food grade. NSF created a listing for ingredients that it calls HX1, but this is not an original USDA category.

As a brief aside, in the years since USDA dropped its White Book program, there has arisen an alternate method of gaining H1 approval for new substances. Many reputable companies still go through rigorous testing according to FDA toxicity standards to verify the suitability of new ingredients for H1 lubricants. This is an extended and expensive process, but it is in line with the standards as set in the old USDA days. However, over the last decade the concept of expected exposure limits has given some companies an avenue, through independent registration companies, to get products approved that may or may not have gone through the exhaustive FDA toxicology testing protocols. How do we know which ingredients or products have taken the shortcut process to get on the list? We cannot know from the approval designation. We can only get that information from the suppliers themselves when asked to supply the appropriate FDA approval. Yet, we still have an expectation of the product safety of H1 food grade approvals.

H2 is what we would term a broad, exclusion list. The original and ongoing intent of the H2 category was to make sure that ingredients that might kill, harm or cripple someone were excluded and never introduced into the food plant. It is the gatekeeper classification. This applies not only to lubricants, but to any USDA authorized non-food compound.

In my early days in the industry, one could still find SCL (sulfur-chlorine-lead) compounded gear lubricants. These were darn good lubes in their intended applications, but letting them migrate into food plants from the truck shop was a real and genuine concern. Thus the USDA put together a list of substances that if present in any non-food compound, including lubricants, would preclude their use in a food plant. Period. These substances included ingredients such as lead, antimony, arsenic, mercury, selenium or other materials such as carcinogens, mutagens and teratogens classified as hazardous substances.

According to the 1979 USDA Guidelines for Obtaining Authorization, the general excluded list is even broader: There may be other substances which are not acceptable because of unfavorable toxicology or other consideration. Therefore, each preparation will be evaluated on its own merit.

Contrary to the statements seen in LubesnGreases July article, some or many such raw materials still find their way into a wide array of current industrial lubricant formulations intended for applications outside of the food industry. These products would not pass the H2 requirements.

Most of us have heard the stories of a tough guy football player drinking a quart of motor oil on a dare. He survived his ill-advised bravado because the motor oil he drank did not contain any of the substances on the USDA non-food compound exclusion list. Had it been otherwise, the story would likely be an obituary, not an urban legend.

We at JAX Inc. disagree with those who say that H2 has no place in modern food plants. Although as a company we are leaders in research and development of new H1 lubricant technologies, there are areas where the sacrifice of equipment life using H1 lubes, with their highly restricted list of ingredients, would not serve to enhance consumer safety one iota.

We are aware that certain pockets of the food processing industry in Europe have taken steps to mandate only H1 lubes be used in their plants, but I wonder what they plan to run in their fork-lift engine crankcases and the brake lines on those units. Will H1 products run effectively in their power plants and other mission-critical areas away from food processing, that have zero concerns of food product contamination?

Weve all heard the refrain that not having H2 lubricants in the plant will mean it cannot accidentally be put into an H1 application, but isnt this really a matter of better training and understanding of Hazard Analysis and Critical Control Points (HACCP)?

In addition, given the fact that the bad actors are prohibited in H2 products, will anyone really state that an H1 product after extended use in a gear box, heat transfer system or hydraulic reservoir is any cleaner, safer or more pure than an H2 product out of the barrel?

In summary, there is a place and need for H2 products in the food and beverage processing industries. Yes, like other companies, we would like to promote and sell the higher-priced H1 alternatives, but when placed in areas that are properly addressed with an H2 solution, can we really say we are putting our customers best interest at heart?

Ultimately, of course, the insurance companies and attorneys will sort out the liabilities associated with these choices. But statements conferring some type of food grade status on H2 lubricants by the less-responsible in our industry just contribute to the confusion.

There is no classified H2 food-grade lubricant; it is an industrial-grade product. However its ingredients are purged, by regulation, of known harmful, toxic or fatal components.