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With the emergence of Hazard Analysis and Critical Control Points (HACCP) protocol for food safety monitoring, the USDA in 1998 decided to discontinue authorisation program for proprietary substances and nonfood compounds and shifted the responsibility of approvals to the food processors. Lubricants manufacturer in such scenario could either self-certify their lubricants or use third party certification body like NSF.
NSF Registration Program In 1999 the National Sanitary Foundation (NSF), a non-profit and non-governmental organisation, launched its proprietary substance and nonfood compounds registration and listing program which is based on previous USDA guidelines. Food grade lubricants in the nonfood compounds category fall into the following three sub-categories where H1 is by far the most significant: • H1 Lubricants: Lubricants used in the food processing area where there is a possibility of incidental food contact. Incidental contact here refers to the contact with food which is not intentional but preventive.
• H2 Lubricants: Non-food grade lubricants used on equipment and machine parts where there is no possibility of contact (Non-process area)
• H3 Lubricants: Soluble oils, typically edible oils, used to prevent rust on hooks, trolleys and similar equipment.
Another alternate registration body is InS Services which also adopts the similar USDA / FDA guidelines.
ISO 21469 Certification
ISO 21469 certification, like many other standards, is a voluntary standard for food grade lubricants that came into effect in 2006. Unlike NSF or InS, ISO 21469 addresses only products intended for ‘incidental contact’ or H1 products and do not cover H2 and H3 category products. The other important distinction is, unlike NSF H1 certification which addresses the potential toxicological, carcinogenic and mutagenic effect of lubricants from the approved list of food-safe products (
21.CFR 178.3570); ISO 21469 involves the whole process right from lubricant formulation, plant manufacturing, packaging and transportation.
Besides these certifications, there could be certain country specific certifications/registration required for use of these lubricants; like food machinery lubricants for use in Canada, need additional registration with the Canadian Inspection Food Agency (CIFA). In addition to certain performance and regulatory requirements, there may be some additional requirements from certain religious organisations like Kosher- Pareve, Halal etc.
Formulators’ Blues In order to achieve NSF or any other organisation registration, the formulators have to use only permitted ingredients in their product. For instance, the NSF registration program require lubricants to be reviewed against the requirements of the US Code of Federal Regulations Title 21 (21 CFR). For H1 lubricants the products must be formulated using ingredients listed under 21 CFR Section 178.3570. In addition to being specifically listed in 21CFR, a substance can also be accepted if there is a food contact notification (FCN), threshold of regulation (TOR) exemption or generally recognised as safe (GRAS) notification. In lack of either of these, a substance can only be accepted if there is letter of opinion from the FDA (US Food and Drug Administration) or a qualified legal firm. This implies that though food grade lubricants are expected to perform similar or better but can only be formulated with only listed materials that are really limited in numbers and thus giving only limited choice for formulators to experiment with. Additionally, from a thickeners stand point, most widely used lithium thickeners are not in the list of approved materials. Similarly regular mineral base stocks cannot be used to formulate food grade lubricants,
10 LUBE MAGAZINE No.110 AUGUST 2012
though certain white mineral oils, synthetic polyalphaoliffins (PAO’s), some esters and vegetable oils can be used to formulate food grade lubricants.
Trends in Food Grade (FG) Greases The conventional approved thickeners for formulating food grade greases are calcium, aluminium stearate, clay and silica based. However, these greases possess some performance limitations. Calcium and aluminium stearate based greases cannot be used in high temperature applications and clay base greases, though good for high temperature application, do not perform satisfactorily at extreme pressure and in water ingress conditions. More recently, some Polyurea greases which also have food grade approval but by far the most popular grease leading the chart is aluminium complex based food grade greases. Aluminium complex based greases have an advantage of wide temperature operability, excellent water resistance and reasonably good extreme pressure performance. The limiting factor on of this grease is its compatibility with other greases.
Though not as new, FG overbased calcium sulfonate greases have recently emerged superior to aluminium complex grease. In applications like a feed mill where food grade aluminium complex greases could not provide satisfactory performance, FG overbased calcium sulfonate greases have performed better. FG overbased calcium sulfonate grease provides superior inherent extreme-pressure , rust preventive and water resistant properties compared to aluminium complex greases. FG overbased calcium sulfonate greases, in general, exhibit better compatibility compared to FG aluminum complex greases. So far, there were only limited numbers of companies having H1 approval for overbased calcium sulfonate grease, more companies have recently come up with such approvals and therefore, it is expected that this grease will have better availability at competitive prices. FG overbased calcium sulfonate greases have overall been projected as grease for future for food process industry.
LINKS
www.royalmfg.com
Dr Anoop Kumar, Director R&D, Royal Mfg Co LP, USA
About Author Dr Anoop Kumar, Ph.D. in Chemistry has over 20 years’ experience in the field of lubricants. He has been accredited with many national and international awards in the lubricants area and has the credit of authoring over 70 technical papers and over 20 worldwide patents.
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