Changes are anticipated in the approval system for food industry lubricants

Citation

(1999), "Changes are anticipated in the approval system for food industry lubricants", Industrial Lubrication and Tribology, Vol. 51 No. 1. https://doi.org/10.1108/ilt.1999.01851aab.001

Changes are anticipated in the approval system for food industry lubricants

Changes are anticipated in the approval system for food industry lubricants

Keywords Food industry, Lubricants

The system which for many years has been universally accepted as the basis for evaluating lubricants as being suitable for use in the food industry is that of the US Department of Agriculture (USDA). Their Food Safety and Inspection Service, "Guidelines for Obtaining Authorisation of Compounds to Be Used in Meat and Poultry Plants", details the requirements placed on suppliers of such products. The USDA list of approved products is also recognised by the US department of Commerce and the National Marine Fisheries Service.

A list of food-grade products, published on an annual basis by USDA, includes some 115,000 compounds and substances including cleaning compounds, laundry compounds, sanitisers, pesticides, hand care products, potable water treatment chemicals, boiler water treatment chemicals, and lubricants in addition to many other categories of compounds.

However, notice has now been served that this system is to be discontinued according to a recent statement from USDA announcing their intention to close the division charged with evaluating the formulations of food-grade products.

In the USA, two Federal laws require the maintenance of safe and sanitary conditions in federally inspected meat and poultry plants. These two laws are the Federal Meat Inspection Act as amended by the Wholesome Meat Act of 1967 and the Poultry Products Inspection Act as amended by the Wholesome Poultry Products Act of 1968. These Acts are enforced by the Food Safety and Quality Service through the Meat and Poultry Inspection Program (MPI).

The inspection program calls for authorisation of the use of substances and compounds in the plants, because misuse of such material may result in adulteration or unwholesomeness of meat and poultry being processed. Food Ingredient Assessment Division, Science evaluates compounds proposed for use in plants and authorises, where appropriate, the use of safe compounds.

The scope of the compound evaluation program is national and international in significance. All chemicals produced anywhere within the USA for marketing to federally inspected meat and poultry plants must be evaluated by USDA. In addition, chemicals produced outside of the USA for marketing to US plants or to plants exporting meat or poultry products to the USA may require such evaluation. Though USDA deals mainly with firms supplying chemicals to federally inspected meat and poultry plants, their primary responsibility is to the federal inspectors in those plants. In that respect, their primary consideration is to provide inspectors with continual assurance that chemicals used in federally inspected plants are authorised for use and that their proper use will not result in the adulteration or contamination of food products.

Section 5.15 of the "Guidelines for Obtaining Authorisation of Compounds to Be Used in Meat and Poultry Plants" deals specifically with Lubricants and is divided into two parts:

(A) Preparations consisting of one or more of the materials listed below, others subsequently appearing in the appropriate regulation, or those generally recognised as safe (CFR, Title 21, Part 182) are 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. The amount used should be the minimum required to accomplish the required technical effect on the equipment so treated (also see Section 6.4 (D)).

Amongst the materials listed are the following (with any limitations in italics):

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  Acetylated monoglycerides.

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  Aluminum stearate.

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  Aluminum stearoyl benzoyl hydroxide. For use as a thickening agent in mineral oil lubricants at a level not to exceed 10 percent by weight of the mineral oil.

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  BHA

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  BHT

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  alpha-butyl-omega-hydroxypoly (oxyethylene) poly (oxypropylene) having a minimum molecular weight of 1,500. Addition to food not to exceed 10 parts per million. Must comply with CFR, Title 21, Part 178, Section 178.3570(a)(3).

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  alpha-butyl-omega-hydroxypoly (oxypropylene) having a minimum molecular weight of 1,500. Addition to food not to exceed 10 parts per million.

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  Castor oilCastor oil, dehydrated

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  Castor oil, partially dehydrated

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  ;Dialkyldimethylammonium aluminum silicate where the alkyl groups are derived from hydrogenated tallow fatty acids (C14-C18) and where the aluminum silicate is derived from bentonite. For use only as a gelling agent in mineral oil lubricants at a level not to exceed 7 percent by weight of the mineral oil.

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  Dimethylpolysiloxane (viscosity greater than 300 centistokes)

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  Fatty acids derived from animal orvegetable sources, and the hydrogenated forms of such fatty acids, alpha-hydro-omega-hydroxypoly (oxyethylene ) poly (oxypropylene) having a minimummolecular weight of 1,500. Addition to food not to exceed 10 parts per million. Must comply with CFR, Title 21, Part 178, Section 178.3570 (a)(3).

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  12-hydroxystearic acid

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  Isopropyl oleate. For use only as an adjuvant to improve lubricity in mineral oil lubricants.

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  Magnesium ricinoleate. For use only as an adjuvant in mineral oil lubricants at a level not to exceed 10 percent by weight of the mineral oil.

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  Mineral oil. Must comply with CFR, Title 21, Part 178, Section 178.3620 (a) or (b).

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  Petrolatum. Must comply with CFR, Title 21, Part 178 Section 178.3700.

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  Phenyl-alpha- and/or phenyl-beta-naphthylamine. For use only singly or in combination, as antioxidants in mineral oil lubricants at a level not to exceed a total of 1 percent by weight of the mineral oil.

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  Polybutene (minimum average molecular weight 80,000).

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  Polybutene, hydrogenated. Must comply with CFR, Title 21, Part 178 Section 178.3740(b).

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  Polyethylene.

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  Polyisobutylene (average molecular weight 35,000-140,000). For use only as a thickener in mineral oil lubricants.

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  Polysorbate 60. As a thickener and stabiliser, at a level not to exceed 2 percent by weight of lubricants. Must comply with CFR, Title 21, Part 178, Section 178.3400.

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  Polyurea, having a nitrogen content 9-14 percent based on the dry polyurea weight, produced by reacting toluene diisocyanate with tall oil fatty acid (C₁₆ and C₁₈) amine and ethylene diamine in a 2:2:1 molar ratio. For use as an adjuvant in mineral oil lubricants at a level not to exceed 10 percent by weight of the mineral oil.

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  Sodium nitrite. For use only as a rust preventive in mineral oil lubricants at a level not to exceed 3 percent by weight of the mineral oil.

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  Sorbitan monooleate. For use as a rust preventive in mineral oil lubricants. Must comply with CFR, Title 21, Part 178, Section 178.3400

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  Tetrafluoroethylene fluorocarbon polymers. Must comply with CFR, Title 21, Part 177, Section 177.1550.

(B) There is no specific list of substances which may be used as lubricants where there is no possibility of food contact (H2 classification). Most substances generally used for the purpose in industry would be acceptable. Substances which are categorically unacceptable for such use are listed among the substances in Part 7 of the Guide. However, USDA also state that there may be other substances which are not acceptable because of unfavorable toxicology or other considerations. Each preparation would therefore be evaluated on its own merit.

In order to gain approval, the supplier is required to provide evidence to the inspection service in the form of suitably completed application forms, samples, copies of product labelling and supporting evidence. Such evidence will include the gaining of a Food and Drug Administration (FDA) clearance on all ingredients, which would have already required the supplier of the ingredients to have submitted extensive details on the ingredients to the FDA, including toxicological test results. A fee is charged by the FDA for providing this service, the extent of the charges being dependent on the amount of work undertaken by the FDA. (The FDA is to continue to provide this service in contrast to the USDA intention to withdraw.) If all is satisfactory, products will then receive approvals to either H1 (incidental foodcontact) or H2 (no contact). No charges are involved in gaining such status. Suppliers are then entitled to incorporate the phrase "Authorised by USDA for use in federally inspected meat and poultry plants" in a discreet manner on the label. The use of the phrase "USDA approved" is not allowed since it may connote an endorsement of the product by USDA. The scope of the categorisation is limited to products used in machinery associated with meat, poultry, fish processing plants and therefore does not include, for example, beverages, confectioneries, etc. although in practice lubricants to USDA specification are habitually specified and used in all areas associated with food.

However, as mentioned earlier, this system, which has operated satisfactorily for many years and is recognised world-wide, is about to end. Although the reason given by the USDA was the requirement to move from a stifling prescriptive command and control system to one which provides greater flexibility and responsibility to the industry to produce safe products for customers, many suppliers have a different viewpoint. If individual suppliers and users need to perform their own research and evaluation in future, costs to the private sector will inevitably increase, and there is also a possibility of the customer being put at risk if this independent system of arbitration is lost. It is also understood that the USDA do not intend publishing a final list of approved products. The situation has already caused widespread concern in the USA; those suppliers who are in the process of developing new products suitable for use in the food industry rightly claiming that they will now suffer a competitive disadvantage against established products as a result of no longer being able to claim USDA approvals, which contravenes the strict US laws on competitive issues. This in turn could lead to suppliers of established products seeking higher prices, and could also stifle the development of newer products which may well be superior in terms of performance and in health and safety terms. Also, smaller companies could be unfairly disadvantaged if the costs of entry into the market are increased.

As a result, there has been a flurry of activity to endeavour to establish a new body. One of the prime movers has been the European Lubricating Grease Institute (ELGI). Greases are one of the major classes of compound which are often associated with incidental contact food machinery lubricants, and they are currently evaluating the degree of support for establishing a replacement approval system.