Market Topics

Simmering Over Food-grade Lubes


Food, feed and pharmaceutical manufacturers are among the most tightly regulated in the world, and that oversight extends to the lubricants they use as well. Rigid laws cover the base oils allowed, the additive chemistries and treat rates that formulators can use, and how to apply the finished lubricants to equipment. A lubricant might call itself food-grade but its absolutely not food, and any foodstuff found to be contaminated with it must be destroyed and/or swiftly removed from distribution.

The U.S. Food & Drug Administration years ago designated what ingredients may be used in food-grade lubricants, under 21 CFR 178.3570, 21 CFR 182 and 21 CFR 184, so that at least is clear. And the U.S. Department of Agriculture established the main categories of lubricants used in the various stages of food production:

H1 lubricants are required wherever incidental exposure to the food may occur, such as if a hydraulic hose were to break and spray oil onto the product, or if a gear oil were to drip onto the food line. Ideally such incidents wouldnt occur at all, but they do in real life, and if the food is exposed to more than 10 ppm, the batch must be condemned. H1 lubricants must be colorless, odorless and nontoxic, cause no harm if ingested accidentally by consumers, and be applied with good manufacturing practices in mind.

H2 lubricants are intended for use in equipment and processes where no food contact can occur. The air conditioning units outside a food factory might be lubricated with H2 lubricants, for example, or the forklift trucks in its warehouse.

3H lubricants are considered safe for those spots where food contact occurs, such as rust preventives used on hooks and knives; they must be wiped off prior to equipment use.

Those designations appear pretty straight-forward, and two organizations, NSF International and InS Services, maintain online listings of lubricant products that theyve reviewed and registered as conforming to the FDA rules.

When it comes to how such lubricants are labeled and promoted though, things get a lot more fuzzy, according to industry participants in Europe and North America. Its not uncommon, these players say, for lube marketers to invoke safe-sounding but empty phrases and buzzwords like FDA approved, pure or food grade on products that are not. Efforts are under way now to alert both lube marketers and end users to these miscues.

The first of these efforts was advanced in late April at the Food Grade Lubricants Working Group of the European Lubricating Grease Institute. The working groups chairman, Andre Adam of Fragol GmbH in Mulheim, Germany, urged ELGI to collaborate on a document to guide end users in their lubricant choices.

Theres a lot of confusion around the designations for H1, H2, 3H lubricants and so on, Adam pointed out. One reason for this, he said, is that the category names themselves are so undistinguished. In addition to the three categories above, he pointed out, there are HT1 lubes, which are heat transfer fluids created from the same restricted list of ingredients as H1 lubricants, and HX-1 products, a category invented by NSF to cover ingredients cleared for use in H1 lubes.

To help users maneuver through this alphanumeric thicket, the proposed document would outline European Union laws covering food producers, list the key definitions for each lube category, and suggest helpful resources, such as the European Hygienic Equipment Design Groups publications on how to manufacture and use H1 lubricants (

The guidance also advises users to verify that any H1 lubricant they buy is listed in the NSF Whitebook ( or at InS ( It stresses good practices, i.e. use dedicated lubricant storage and filling equipment and avoid cross-contamination with non-food-grade lubricants. It also reminds end users that responsibility for buying and applying the right lubricant rests 100 percent with the equipment operator, and that the FDA limit for any mineral oil or polyalphaolefin based lubricant is as low as 1 kilo of lubricant in 100,000 kilos of food.

Working group members voiced enthusiasm for the idea, and after further input and editing the working group aims to deliver a one-page guidance that could be endorsed by ELGI, EHEDG and other stakeholders.

Meanwhile, in mid-June in Tucson, Ariz., a working group of the National Lubricating Grease Institute got an early peek at a guidance document being created by NSF International. It lists dos and donts for food-grade lubricant labels, advertisements and product literature.

We are seeing lots of labeling issues, where in this very competitive market lubricant manufacturers are making claims for their products or having information displayed that is not accurate, said Ashlee Breitner of NSFs Nonfood Compounds Program, who chairs NLGIs working group. If youre an NSF licensee, she added, this becomes a real problem, when youre trying to do things right and you see your competitor putting wrong information out there.

NSFs guidance could develop into a brochure, be posted on the NSF Whitebook website, or be used in a webinar aimed at educating users, Breitner suggested. The proposed guidance includes examples of the allowed NSF logos, suggested language, common labeling errors, and practical examples.

The NSF document says, for example, that these statements are acceptable for describing only H1 or incidental contact lubricants:

Food grade.

Ingredients meet FDA Regulation 178.3570; or 21 CFR 178.3570 (note: all ingredients must comply).

NSF H1 registered, or Registered with NSF as H1.

Meets USDA 1998 guidelines.

Suitable for use in the food industry.

Labeling is important, commented Sarah Krol of NSF, who is based in Ann Arbor, Mich., and mislabeling is the leading cause cited by FDA in recalls of food and pharmaceuticals. With that in mind, NSFs draft also stresses that the following statements should be avoided on lubricant labels:

Unforeseen or unexpected contact.

Occasional or indirect contact.

Authorized for use in meat and poultry plants. Food approved.

Food lubricant.

USDA approved, FDA approved, or FDA approved for incidental contact.

This last error is pretty common, but FDA and USDA do not review, approve or register food-grade lubricants. USDA did at one time, but stopped doing so 15 years ago.

One point on which both the ELGI and NLGI guidances agree is that the words food grade do not belong on any H2 lubricants. ELGI is inclined to be a bit stricter on this subject, and some in its working group feel the term should never be used for lubricants of any kind. But NSFs Krol noted that there is no regulatory reason the words should not be used for H1 products.

While conceding the term is much misused, Krol said the words food grade are acceptable on H1 lubricants and greases. It should not appear on labels or literature for H2 lubricants because those products are strictly for use where no food contact can possibly occur. Calling H2 lubricants food grade could lead to product misuse, NSF cautions.

Breitner said the guidance will have a selection of frequently asked questions, and description of enforcement actions for misuse of the NSF logo.

The ELGI groups Andre Adam said the NSF guidance is definitely a step in the right direction, and suggested improvements. Mostly, hed like to see more prominence given to the standards H1, H2, 3H, rather than the NSF logo. Customers today see the NSF logo, and assume that means the product is suitable for all food industry applications, but since the same logo can appear on H1 and H2 products, thats not so. In the case of products registered at InS, the H1 or H2 designation fills the logos center, so the chance of misuse is lessened.

The next big question before us is how to inform industry better on the risks of lubricant contamination and possible consumption, how to measure and how to calculate the quantity of lubricants that may be consumed over the entire food chain, Adam said. An ongoing puzzle for food processors is how to determine if their food has been contaminated with mineral oils, and if so, how much of that might be due to an accidental release of lubricants during the manufacturing process. The question is murky because mineral oils often are used as additives or processing agents all along the food chain and in food packaging as well.

This debate was reengaged last December, Adam said, when chocolates sold in Advent calendars around Germany were found to be contaminated with mineral oil. Initial speculation was that the mineral oil had migrated from the candys labels; the inks in the labels were oil-free though, so that idea didnt pan out. Meanwhile, sales of the candy, usually a holiday favorite, plunged 30 percent in Germany last year.

Unfortunately, this was not a rare occurrence, said Adam, and more than 9,000 food incidents were reported in the EU in 2011 alone. Some of these incidents involved lubricants, and have led to calls for a deeper look at how much mineral oil can be allowed in foods, how and if the oil can migrate from packaging, and whether more restrictions are needed.