Food grade lubricants and the ELGI – NLGI

Lubricants to be used in the production, processing, packaging and distribution of food, beverages, pharmaceuticals, personal care products and any other ‘clean’ products may be registered as meeting certain criteria that make them safe for use in these industries. A lubricant qualifies as food grade when, in the event of contamination, it is present in no more than 10 milligrams per kilogram of the foodstuff in question. It must also not cause any physiological hazard or affect the food’s odour and taste in any way.

Food grade lubricants are special blends of base fluids and additives and should be approved by the US FDA and registered by NSF International (in USA) and more recently by InS Services Ltd (in Europe) in the H1, HT1 and 3H category. ‘Food grade’ is the most common term used to describe such lubricants, however, lubricants are only considered to be food grade if they are ‘classified’ as such by independent organisations such as the NSF and InS Services.

Background

The use of lubricants and their formulation reviews for the meat and poultry establishments were monitored by the United States Department of Agriculture’s Food Safety and Inspection Service (FSIS) Division through inspections for a number of years. This Prior Approval Program resulted in the industry standard for determining food grade lubricants. The USDA list of ‘Proprietary Substances and Nonfood Compounds’ was the standard reference for food grade and nonfood grade lubricants through designations H1, H2 and H3 for food and beverage processors worldwide. In February 1988, the USDA Approval Program ended and the FSIS significantly altered their approach to facility inspections, eliminating the USDA product evaluation. FSIS moved away from prescriptive regulation to performance-based reviews. This new approach was driven by the established system of Hazard Analysis and Critical Control Point (HACCP) facility operation. Under HACCP, all meat and poultry establishments must identify and manage critical control points for food processing. Control points are defined as those where chemical, physical and microbial contamination may occur. For nonfood compounds and proprietary substances, the facility operators must select the appropriate product to meet their operational needs as well as their HACCP requirements. In this way, food grade lubricants would be manufactured with FDA Title 21 CFR, 178.3570 approved ingredients.

Lubricant definitions

H1 – Lubricants with incidental food contact (so-called food grade lubricants)
Preparations permitted for use as lubricants and anti-rust agents, or as release agents on gaskets or seals of tank closures where there is a possibility of incidental food contact, must be formulated in compliance with FDA Title 21 CFR, 178.3570 and other sections referenced therein. The amount used should be the minimum required to accomplish the required technical effect on the equipment so treated. When a product is used as an anti-rust film, it shall be removed by washing or wiping before putting the equipment back into service.

H2 – Lubricants with no food contact

These products are used on equipment and machine parts in locations where there is no possibility of the lubricant or lubricated part contacting edible products. There is no specific list of substances that may be used as lubricants where there is no possibility of food contact. Most substances generally used for this purpose in the industry would be acceptable. There may be other substances that are not acceptable because of unfavourable toxicology or other considerations. Therefore, each preparation will be evaluated on its own merit.

3H – Release agents

These products are used on grills, loaf pans, cutters, boning benches, chopping boards or other hard surfaces in contact with meat and poultry products to prevent food from adhering during processing. Products containing edible oils such as corn oil, cottonseed oil, soybean oil and mineral oil comply with Title 21 CFR, Part 172, Section 172.878.

H3 – Soluble oils

These products are used to prevent rust on hooks, trolleys and similar equipment. Treated equipment which comes into contact with edible products shall be cleaned by washing or wiping before putting the equipment back into service. Products may be composed of any of the following:

• Edible oils (corn oil, cottonseed oil, soybean oil) complying with Title 21 CFR, Section 172.860
• Mineral oil complying with Title 21 CFR Section 172.878
• Generally Recognised As Safes (GRAS) substances complying with Title 21 CFR Part 182 (multipurpose only) or Part 184

HT1 – Heat transfer fluids with incidental contact

These products are used as heat transfer fluids in primary and secondary heating and cooling systems in food processing facilities. Preparations permitted for use as heat transfer fluids where there is a possibility of incidental food contact must be formulated in compliance with Title 21 CFR, Section 178.3570 and other sections referenced therein; ingredients may also comply with Title 21 CFR Part 172. The amount used should be the minimum required to accomplish the required technical effect on the equipment so treated.

ELGI – NLGI Food Grade Lubricants Working Group and other players

The European Lubricating Grease Institute (ELGI) is an independent institute active in the field of tribology, dealing with lubricating greases and related products. The ELGI puts a strong emphasis on the technical, ecological and legislative aspects of grease-related matters in Europe. The NLGI is an international association based in the USA which serves the lubricating grease industry. It promotes research and testing for the development of improved lubricating greases and exploring means for better lubrication engineering and methodology. Within the NLGI, there exist various technical committees whose responsibility it is to keep abreast of new technology and information on grease-related research, standards and government regulations.

The Working Groups within the ELGI and NLGI bring manufacturers and consumers to the same playing field to discuss various elements of lubricants and lubrication with respect to selected application types.

Concerns were raised when the industry learned that the USDA would end their food grade lubricant evaluation program. In Europe, grease manufacturers were concerned as to who would address the requirements of the food grade greases. As a result, in 1998 the ELGI formed its Food Grade Lubricants Working Group with a view to seeking potential establishments and alternative programs to the USDA H1 for their members. At the time, there were no known activities in the grease industry on food grade lubricants besides those of the NLGI together with ELGI. With the disbanding of the department within the USDA that granted authorisations for products with incidental food contact, there were concerns regarding competitive distortions if a succeeding organisation was not found in a reasonable time. It transpired that the FDA would continue with the list of approved substances, so that there was a chance for a new organisation to follow the procedure of the USDA. These situations led to the formation of the ELGI-NLGI Food Grade Lubricants Working Group with a common goal to address alternatives to the USDA H1 initiative.

In 1998, NSF, well positioned in the USA, created its Nonfood Compounds Registration Program which replaced the program formerly administered by the USDA. The purpose of this program, which is now globally accepted and recognised by the USDA, is to establish global standards for nonfood compounds used in and around food processing areas, including food grade lubricants. NSF did an excellent job of developing, implementing and promoting the current H1 Registration Program after the USDA ceased their program. The NSF H1 Nonfood Compounds Registration Program is now generally accepted in the market. In 1998, when the USDA ceased their program, the working group members were very happy to have NSF develop a similar program and they felt strongly that the program should be based someday on an International (ISO) Standard. NSF registration assures inspection officials and end users that formulation and labels meet the appropriate food safety regulations. More recently, another company, namely InS Services Ltd, has been established in Europe with a view to facilitating the registration of food grade H1 lubricants and addressing related requirements for the food and beverage industry.

In its development, the International Standard became a full certification program (ISO 21469). ISO 21469:2006 specifies hygiene requirements for the formulation, manufacture, use and handling of lubricants which, during manufacture and processing, can come into incidental contact (for example, through heat transfer, load transmission, lubrication or the corrosion protection of machinery) with products and packaging used in the food, food processing, cosmetics, pharmaceutical, tobacco or animal-feeding-stuffs industries. The ISO Standard is not applicable to substances used as product additives or to those in direct product contact, but confines itself to hygiene without addressing occupational health and safety matters.

The role of the ELGI-NLGI Food Grade Lubricants Working Group

The ELGI-NLGI Food Grade Lubricants Working Group meets twice a year at the ELGI and NLGI Annual General Meetings held in Europe and USA respectively. The Working Group aims to address, discuss and communicate effectively on topical issues that affect the use of food grade lubricants while working collectively as suppliers and end users for potentially effective solutions. Major lubricant and additive suppliers and end users participate at these meetings with a view to keeping up with developments within the NSF and InS Services and other developments with respect to the registration and use of food grade lubricants as well as potential implementation and implications of ISO 21469. The overall aim of the Working Group is to provide a forum for the collection and dissemination of suitable information for the requirements of the global grease community. The Working Group is currently focusing on the ISO 21469 Standard with a view to getting a better understanding of the Standard itself, the certification process and its potential implications in relation to its implementation within industry.