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H1 lubricants, also known as incidental contact lubricants, are not expected to but may occasionally come into contact with food under normal use conditions. As per requirements established by the US Food and Drug Administration (FDA) H1 lubricants must comply with 21 Code of Federal Regulations (CFR) 178.3570 to be approved. This regulation establishes formulary requirements for greases and lubricants intended for use in food processing and handling applications where incidental contact may occur. The approval for H1 was introduced by the United States Department of Agriculture (USDA) and was until 1998 administered by them.

Certification is however not required, except in the US, some countries do not use third-party certifications, instead this is federally regulated. Although, with that stated, certification is generally recognized as a minimum requirement in the industry and therefore there is a need for recognized certification bodies. Up until 2008 the NSF had a monopoly on certifications since they had been appointed to take over the process by the USDA in 1999. In 2008 INS Services started in Europe and has since then been a recognized counterpart to the NSF, but this ended abruptly in the summer of 2019 when NSF acquired the UK-based organization.

European union legislation states that it is unfair practise to leave an entire market to one supplier the demand for a new certification body is clear. 2Probity is a Sweden-based company owned by SDG Invest AB, that now is now a recognized third party for the registrations according to the FDA’s regulations 21 CFR.

Food grade lubricating greases must meet food standards and should not generate harm in case of contact with foodstuffs. Therefore, the compositions for food grade lubricant formulations should be selected and compiled in accordance with stringent specifications.

The authorised substance list for food grade lubricants is annually established and regulated by the FDA through Title 21 of the CFR. As far as food grade lubricants are concerned, these substances are mainly listed in the 178.3570 paragraph of the 21 CFR and in the GRAS (Generally Recognized As Safe) List, but also some other parts of the regulation. Some of the most common ingredients in food grade lubricants are:

Base oils – both synthetic and petroleum-based

• White oils
• Polyalphaolefins (synthetic lubricant) or PAO
• Esters
• Polyglycols (poly alkene glycols) or PAG
• Silicones (Dimethylpolysiloxane)

Thickeners mainly used for grease

• Complex soaps: Aluminium, Calcium, Calcium Sulfonate
• Metallic soaps: Calcium
• Non-soap thickeners: Silica, Clay, Polyurea, PTFE

Additives

• Mainly listed in the 178.3570 paragraph of the 21 CFR

Greases are lubricating oils that have a thickening agent added to the formulation. Aluminium complex is the most common H1 food-grade grease thickener since they can withstand high temperatures and are water resistant which are important properties for food processing applications.

H1 is not the only incidental food contact lubricant and there are other categories that 2Probity also can verify your products against. If you have any questions regarding the categories or something likned to this we are here to hel you and do not charge you for asking a question.

Here is some more examples of categories 2Probity is verifying grease products according to the FDA:

• H1 lubricants are food-grade lubricants used where there is a possibility of incidental food contact.
• H3 lubricants are soluble/edible oils used to prevent rust and to clean equipment such as hooks, knives, trolleys etc during storage. H3 must be cleaned off the equipment before use since it is not an incidental lubricant classification.
• 3H release agents are oils defined as food additives made from pharmaceutical-grade white oils and their maximum levels in food are defined in 21 CFR 172.
• HX-1 are approved ingredients for use in H1 lubricants.
• HT-1 are heat transfer fluids used where there is incidental food contact in areas where high temperatures are required.
• HTX-1 are approved ingredients for use in HT-1 heat transfer fluids.

There are also other categories linked to other applications for products that can be used in the food industry, like:

• A1 acceptable for use as general cleaner for food processing areas.
• J1  acceptable for use as an absorbent or anti-slip agent on floors to correct a hazardous condition in food processing areas.

The Hazard Analysis and Critical Control Point (HACCP) program was implemented by the USDA and can be used to evaluate each lubrication point where contamination might occur to ensure the safety of the food production. Many major food-producing companies are currently using the HACCP system, but they do not always recognize the risks of not including evaluation of lubrication points. Several lubricant suppliers offer assistance to companies in this procedure and can help set up and implement a HACCP plan including numbering systems or color coding’s to help match the correct lubricant with its application point.

To ensure that the hygiene requirements for oil and lubricants with occasional contact with food or pharmaceuticals are met, a recognized global standard, the ISO 21469, is used. ISO 21469 refers to the specification of regulations for the composition (21 CFR 178.3570), manufacture, handling and use of lubricants that may come into contact with foodstuffs. The standard covers the following topics;

• Hygiene requirements
• Correct product description and packaging
• Risk assessment in the whole production process

ISO 21469 is suitable for any organization that produces and/or uses lubricants that come into, (incidental) contact with food, feed, medicines or cosmetic products. To obtain ISO 21469 certification, producers must submit to thorough testing of lubricant formulation, toxicology and product use. Annual unannounced plant audits are also part of the certification process.

Certifying your organization in accordance with the ISO 21469 shows that the lubricant components have been assessed as food-safe, that the product and packaging descriptions are complete and correct and that a food-safe production is guaranteed.

A combination of ISO 21469 with ISO 9001 and/or ISO 22000 is very common.