There are a lot of unique challenges faced by lubricant formulation engineers, equipment designers, plant lubrication engineers, and lubricant manufactures due to the food processing industry. Lubricants shouldn’t ever be allowed to contaminate raw materials, finished products or work-in-progress. However, the food processing industry has acutely faced the consequences of lubricant-contaminated products.Therefore, all food lubricants have performance expectations, protocols and requirements that aren’t applied to any other industrial lubricants. We are going to cover the basic differences between different types of lubricants, specifically H1, H2, and H3 lubricants. We will also discuss their formulations, requirements, along with proper selection of lubricants, which is integral to machine reliability and food safety.

Food Safety

Drink, drug, and food manufacturers must all prioritize safety and health, as standards of hygiene and cleanliness are important in hospital operating rooms as well as shop room floors. However, in production equipment, the lubrication helps healing and feeding the nation on track. All industries must sustain standards of lubricant maintenance and leakages, since lubricants don’t discriminate against the material they meet.Therefore, the pharmaceutical and food processing industries have harder challenges to select the right lubricants for the job. We are going to cover all previous, current, and future standards related to the food grade lubrication industry.

What is a Food-Grade Lubricant?

Just like any other lubricant, food-grade lubricants have the same technical functions, which include the following:

• Provide a sealing effect
• Be compatible with other sealing materials and rubber
• Transfer power and dissipate heat
• Provide protection against oxidation, corrosion, friction, and wear

Apart from that, various applications in the drugs and food business want lubricants to dissolve sugars, exhibit neutral behavior to elastomers and plastics, and resist degradation from water/steam, chemicals, and food products. The lubricant must be internationally approved, odorless, tasteless, physiologically inert, and compliant with food/health and safety regulations.Lubricants must also withstand intense environmental contaminants. For instance, a corn-milling environment creates a lot of dust, which is a big problem when it comes to filtration. A meat plant must always have the strictest steam cleaning, which means there is a higher risk of water contamination. In some plants there is more than 15% contamination.Another factor of lubrication contamination that is a big risk for food-grade lubricants is the growth of microorganisms like fungi, yeast, and bacteria. All these can be riskier in industrial environments, but the chances for contamination in the food-production environment are still greater.

Food-Grade Categories

The original food-grade designations were created by the United States Department of Agriculture (USDA), and are assigned as H1, H2, and H3. Any new lubricant that needs to be registered and approved in any of these categories is based on the list of ingredients. Here is the breakdown of the different food-grade categories:

H1 lubricants

These food-grade lubricants are used in food-processing environment, where there are higher chances of incidental food contact.

H2 lubricants

These food-grade lubricants are used on machine parts and equipment in places where there is no chance of any possible contact with food.

H3 lubricants

These food-grade lubricants are generally edible oils, which are used to prevent rust on trolleys, hooks, and other equipment.It is extremely difficult to decide between these three lubricants where there is a chance of contact. In fact, this has resulted in numerous errors made in terms of safety especially when there is a selection between H1 and H2 lubricants.

Approval and Compliance

The United States Department of Agriculture is responsible for the compliance and approval of food-grade lubricants. The USDA is an internationally recognized authority on consumer safety issues in the food-processing industry. They initially covered federally inspected poultry and meat facilities, but other sectors like retail food operations and fisheries quickly adopted their regulations.Lubricant manufacturers must prove that all ingredients in the formulation were allowable substances, to gain approval from the USDA. Allowable substances are those, which have been listed by the USFDA in compliance with the Guidelines of Security Code of Federal Regulations (CFR) Title 21, §178.3570. That doesn’t cover lubricant testing, but the approval is based on formulation of ingredients in the lubrication. However, the USDA, hasn’t been issuing any registration of food-grade lubricants currently.

Challenges Facing Food-Grade Lubricants

The food-process industry puts forward some very different lubrication challenges for manufacturers. In large-scale food processing, machinery like conveyor belts, chain drives, hoses and pipes are needed. The machinery being used in food processing facilities must overcome a lot of lubrication challenges that don’t even figure in other non-food processing plants. The lubricants must provide protection to the internal surfaces to control deposits, heat, corrosion, wear, and friction.They must also provide great thermal stability, hydrolytic stability, oxidation stability, and pumpability, where required. Apart from that, certain applications in the food and drug manufacturing plans want lubricants to resist impaired performance and degradation when they come into contact with bacteria, water, process chemicals, and food products. The bad news is that most of the raw materials used in creating the formula of these lubricants, which can overcome these challenges, don’t qualify as allowable substances in food applications due to safety concerns.

The Future of Food-Grade Approval

Most of the registrations that were approved, will still be in effect, and the USDA H1 and H2 lubricants will still be recognized as approved for use in food and drug manufacturing facilities. Most lubricant manufacturers still try to meet the USDA H1 and H2 categories, and supply certification, and approval processes from their board to guarantee those claims. The Klüber Lubricants of Germany, created a new standard, known as DIN V 0010517, 2000-08 (Food-Grade Lubricants – Definitions and Requirements), which has been approved at a higher DIN level.The German Institute for Standardization (DIN) has submitted this German standard as a draft to International Organization for Standardization (ISO) in Geneva. It is expected to take around three years for the application to be accepted as an international standard and then applied everywhere.The USDA has been succeeded globally by the National Sanitation Foundation (NSF). The NSF International, The Public Health and Safety CompanyTM, is an independent, nonprofit organization that is dedicated to the safety and protection of the environment and public health for more than 55 years. The organization has been awarded the Collaborating Center designations by the World Health Organization (WHO) for both drinking water safety and food safety and treatment. It is administered and conceived as a public service company, which serves as a neutral and independent body that resolves problems between the public, industry, business, and regulatory bodies.The NSF has adopted the DIN Standard V 0010517, 2000-08 as its own guideline for food-grade lubricant registration. They also use the previous USDA H1 and H2 classifications, and submitted their draft standard, known as, NSF 116-2000 (nonfood compounds used in food-processing facilities – food- grade lubricants) to the American National Standards Institute (ANSI). The draft standard covers the previous USDA H1 and H3 categories.The DIN standard V 0010517, 2000-08 has also been adopted by the European Lubricating Grease Institute (ELGI) and National Lubricating Grease Institute (NLGI) as their guideline.

NSF 116-2000 Draft Standard in Detail

This standard has been established to ensure that all food safety evaluation criteria for food-grade lubricants that are used in storage, handling, packaging, and food-processing are suitable. It offers a mechanism that validates the claims of the manufacturer, which can’t be achieved through labeling. The scope doesn’t cover the overall evaluation of operation criteria and product performance that are used in food-processing facilities.However, it does highlight requirements and definitions for food-grade lubricants in corrosion protection, load transmission, heat transfer, and lubrication of equipment and machinery in food processing and manufacturing facilities. The draft standard only covers H1 and H3 only, because the scope is food-grade lubricants.The main requirements of the draft standard cover formulation and labelling, but specifically requires that in labeling the directions regarding use, category code, manufacturer’s code, and name of product be displayed clearly.The directions of use must mention the minimum required amount to achieve the technical effect or required purpose of the product. All references made to the name of the company on the label, should be in accordance with the disclosure information on the formulation.

Formulation Guidelines

There are different formulation requirements, and the draft standard dictates that the product shouldn’t contain any heavy metals, or ingredients that have been classified as teratogens, mutagens, or carcinogens.

Ø Teratogen

This is an agent that raises the occurrence of congenital malformations

Ø Mutagen

This substance causes mutations

Ø Carcinogen

When ingested, this substance may cause cancerFor some lubricants, these ingredients must be neutral in odor and taste, and must be added to ensure that the lubricant can withstand mechanical, thermal, biological, chemical, and temporal stresses without any impact to its neutral state or premature degradation.The evaluation standards cover three main parts:

1. Food-grade lubricants
2. Evaluation requirements
3. Ingredients

All food-grade lubricants must meet the requirements of the draft standard and the CFR Title 21 §178.3570. They must also comply with sections 172.860 for vegetable oils and 172.878 for mineral oils. Ingredients and/or compounds must comply with 21 CFR parts 182 and 184. The evaluation requires the following information from suppliers or manufacturers:

• The name of the product
• A qualitative/quantitative identification of all constituents
• The Chemical Abstract Service (CAS) number where applicable
• The chemical ingredient names based on the International Union of Pure and Applied Chemistry (IUPAC) rules
• Suppliers or sources of each ingredient
• Any previous product approval from a state or country regulatory authority
• Any appropriate FDA regulatory reference for each ingredient.

When it comes to the ingredients, all separate confirmations that are made by the USDA or FDA, and must be displayed, and shouldn’t be shown in any list of nonallowable substances.

Selecting Which Machines Require Food-Grade Lubricants

It can be extremely challenging to choose between an H1 or H2 lubricant to use. If you are using a lubricant on a conveyor system that is running a food line, you must use an H1 category oil. However, if the conveyor system is running under a food line, you can use the H2 oil safely. The Hazard Analysis and Critical Control Point (HACCP) program that was implemented by the USDA, states that every lubrication point where contamination may occur should be evaluated.A lot of major food-producing organizations currently use the HACCP system, but the results of their plans don’t always meet with the results of lubrication surveys. Most lubricant suppliers tend to help with surveys related to food-grade lubricants. In general, H1 lubricants are limited by the types of additives, and previously were only used for mineral oil base stocks.H1 lubricants have shorter lubricant life and offer less protection, but with synthetics, the H1 lubricant performance exceeds those of non-food grade lubricants. This is extremely important in avoiding accidental cross-contamination and consolidation of H1 and H2 oils and contamination of H2 oils with food.

Other Issues Surrounding Food-Grade Lubricants

If you want great maintenance and design, you can’t use H1 food-grade lubricants as a substitute, since the lubricants have only been approved for incidental and minimal contact. Any facility that uses food-grade lubricants has been restricted by the FDA to lubrication contamination of 10 parts per million or 0.001% contamination. The process for lubricant certification doesn’t involve any sample testing and plant audits to guarantee whether the formulation meets every criterion.

What Does All This Mean?

To break things down, all suppliers and manufacturers can take advantage of a potential new standard, for approval and categorization of food-grade lubricants. The safety and supply can be assured, since all requirements and categories still exist in the USDA. However, end-users must select lubricants based on their original categories of H1, H2, and H3. The NSF draft standard now assures that all compliance and regulations are met. This is great news for consumers, who are assured that the food and drug industries, and all lubricant manufacturers are forced to maintain strict standards of health and safety.