Food-grade lubricants are specialized industrial lubricants designed for use in environments where there is potential for incidental contact with food or beverages. These lubricants are used to ensure both the proper functioning of machinery and the safety of the products being processed. Their applications span food processing, pharmaceuticals, cosmetics, and animal feed industries. These lubricants are tightly regulated to ensure they do not contaminate food products and pose a health risk. [1]
The most common standards and certifications in this space are NSF International's H1 certification and ISO 21469. If a lubricant meets the requirements for ISO 21469, it automatically satisfies all the requirements of NSF's H1 certification, as ISO 21469 is more comprehensive. Conversely, achieving NSF's H1 certification can serve as a foundational step toward obtaining ISO 21469 certification, simplifying the process for manufacturers who wish to meet the higher standard. [2]
The NSF International is a leading organization that sets standards for food-grade lubricants. NSF International standards ensure that lubricants meet stringent safety and quality requirements. The primary classifications for food-grade lubricants under NSF standards are:
Standard | Description | Use Case |
---|---|---|
H1 | Incidental food contact (<10 ppm). | Equipment near food that may accidentally touch it. |
H2 | Products approved for food-adjacent use. No food contact allowed. | Machinery parts that do not touch food. |
H3 | Soluble oils for rust prevention. | Hooks and trolleys in food processing plants. |
HX-1 | Additives for H1 lubricants (incidental contact). | Enhancing properties of H1 lubricants. |
HX-2 | Additives for H2 lubricants (no contact). | Enhancing properties of H2 lubricants. |
HX-3 | Additives for H3 lubricants (soluble oils). | Enhancing properties of H3 lubricants. |
Once registered, products are listed in the NSF White Book, a publicly accessible directory of certified nonfood compounds. "NSF White Book". NSF International.
There are more than 12,000 H1 food-grade lubricants registered globally, with an average yearly growth rate of 7% for H1 lubricants registered by NSF. [4]
ISO 21469:2006, titled "Safety of machinery—Lubricants with incidental product contact—Hygiene requirements," is an internationally recognized certification that specifies hygiene requirements for the formulation, manufacture, and handling of food-grade lubricants.ISO 21469: Safety of Machinery – Lubricants with Incidental Product Contact – Hygiene Requirements (Report). ISO. 2006.
Key aspects of ISO 21469 certification include:
ISO 21469 certification requires prior ISO 9001 certification, which establishes a quality management system (QMS) foundation. Products certified under ISO 21469 demonstrate a manufacturer’s commitment to food safety and regulatory compliance.Nonfood Compounds Program: Food-Grade Lubricants (Report). NSF International. April 2024.
Food-grade lubricants exported into or imported out of Brazil must be certified to ISO 21469. [5] A database of all ISO 21469 certified lubricants is maintained at the NSF's website. [6]
It is noteworthy that ISO 21469 has not been updated since 2006.
The U.S. FDA’s Code of Federal Regulations Title 21 Section 178.3570 (21 CFR) specifies an ingredient whitelist that both NSF and ISO standards abide by. The lubricant must also be:
There is a 10 parts per million (ppm) limit for lubricant base oils (e.g., mineral oil) that can be present in food if incidental contact occurs. To get new food contact substances (FCSs) approved by the FDA, manufacturers must either submit a Food Contact Notification (FCN) filing or apply for a Threshold of Regulation (TOR) exemption.
There is a common misconception that lubricants are registered through the USDA. [7] However, the USDA discontinued its registration program for lubricants in 1999. [8]
While the European Food Safety Authority provides advice on food safety risks, the EU doesn't formally regulate lubricants themselves, instead typically following the U.S. restrictions. [9]
A lubricant is a substance that helps to reduce friction between surfaces in mutual contact, which ultimately reduces the heat generated when the surfaces move. It may also have the function of transmitting forces, transporting foreign particles, or heating or cooling the surfaces. The property of reducing friction is known as lubricity.
Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specification, technical standard, contract, or regulation. Testing is often either logical testing or physical testing. The test procedures may involve other criteria from mathematical testing or chemical testing. Beyond simple conformance, other requirements for efficiency, interoperability, or compliance may apply. Conformance testing may be undertaken by the producer of the product or service being assessed, by a user, or by an accredited independent organization, which can sometimes be the author of the standard being used. When testing is accompanied by certification, the products or services may then be advertised as being certified in compliance with the referred technical standard. Manufacturers and suppliers of products and services rely on such certification including listing on the certification body's website, to assure quality to the end user and that competing suppliers are on the same level.
Hazard analysis and critical control points, or HACCP, is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level. In this manner, HACCP attempts to avoid hazards rather than attempting to inspect finished products for the effects of those hazards. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc. The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) require mandatory HACCP programs for juice and meat as an effective approach to food safety and protecting public health. Meat HACCP systems are regulated by the USDA, while seafood and juice are regulated by the FDA. All other food companies in the United States that are required to register with the FDA under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as well as firms outside the US that export food to the US, are transitioning to mandatory hazard analysis and risk-based preventive controls (HARPC) plans.
The National Lubricating Grease Institute is an international trade association that serves the grease and gear lubricant industry. It exists to promote research and development of lubrication technology. It also publishes industry standards for greases.
Quality Assurance International (QAI) is a U.S.-based international organic certification company that is authorized by the United States Department of Agriculture (USDA) as "a USDA-accredited certifying agent that operates globally to certify organic operations to National Organic Program standards." It is a for-profit corporation, established in 1989, and headquartered in San Diego, California. It is one of the world's largest certifiers, operating in the United States, Canada, Latin America, European Union, and Japan.
AMSOIL Inc. is an American corporation based in Superior, Wisconsin that primarily formulates and packages synthetic lubricants, fuel additives, and filters. Company founder Albert J. Amatuzio developed several synthetic motor oil formulations throughout the mid-to-late 1960s. He was commercially selling synthetic motor oil by 1968. In 1972, AMSOIL 10W-40 Synthetic Motor Oil became the world's first synthetic motor oil to meet American Petroleum Institute requirements, which prompted the company to adopt "The First in Synthetics" as its tagline. The company introduced several other synthetic lubricants that represented industry firsts throughout the 1970s and early 1980s. It distributes products in North America via a network of independent dealers paid commissions on sales.
Grease is a solid or semisolid lubricant formed as a dispersion of thickening agents in a liquid lubricant. Grease generally consists of a soap emulsified with mineral or vegetable oil.
Oil analysis (OA) is the laboratory analysis of a lubricant's properties, suspended contaminants, and wear debris. OA is performed during routine predictive maintenance to provide meaningful and accurate information on lubricant and machine condition. By tracking oil analysis sample results over the life of a particular machine, trends can be established which can help eliminate costly repairs. The study of wear in machinery is called tribology. Tribologists often perform or interpret oil analysis data.
Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications.
Mohawk Innovative Technology, Inc. is an American product and research and development technology company that develops oil-free foil bearings, magnetic bearings and non-contacting foil seals for high-speed rotating machinery, such as gas turbine engines, turbochargers, compressors, cryogenic pumps, variable high-speed motors/generators and machines.
ISO 22000 is a food safety management system by the International Organization for Standardization (ISO) which is outcome focused, providing requirements for any organization in the food industry with objective to help to improve overall performance in food safety. These standards are intended to ensure safety in the global food supply chain. The standards involve the overall guidelines for food safety management and also focuses on traceability in the feed and food chain.
ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.
Food safety is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent foodborne illness. The occurrence of two or more cases of a similar illness resulting from the ingestion of a common food is known as a food-borne disease outbreak. This includes a number of routines that should be followed to avoid potential health hazards. In this way, food safety often overlaps with food defense to prevent harm to consumers. The tracks within this line of thought are safety between industry and the market and then between the market and the consumer. In considering industry-to-market practices, food safety considerations include the origins of food including the practices relating to food labeling, food hygiene, food additives and pesticide residues, as well as policies on biotechnology and food and guidelines for the management of governmental import and export inspection and certification systems for foods. In considering market-to-consumer practices, the usual thought is that food ought to be safe in the market and the concern is safe delivery and preparation of the food for the consumer. Food safety, nutrition and food security are closely related. Unhealthy food creates a cycle of disease and malnutrition that affects infants and adults as well.
Dental laboratories manufacture or customize a variety of products to assist in the provision of oral health care by a licensed dentist. These products include crowns, bridges, dentures and other dental products. Dental lab technicians follow a prescription from a licensed dentist when manufacturing these items, which include prosthetic devices and therapeutic devices. The FDA regulates these products as medical devices and they are therefore subject to FDA's good manufacturing practice ("GMP") and quality system ("QS") requirements. In most cases, however, they are exempt from manufacturer registration requirements. Some of the most common restorations manufactured include crowns, bridges, dentures, and dental implants. Dental implants is one of the most advanced dental technologies in the field of dentistry.
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Dry lubricants or solid lubricants are materials that, despite being in the solid phase, are able to reduce friction between two surfaces sliding against each other without the need for a liquid oil medium.
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