A key factor in food safety: food grade lubricants

Of primary concern to today’s food manufacturers is the threat of food contamination resulting in regulatory enforcement, product recalls and consumer litigation. Food retailers and their branded suppliers fear instances of food contamination resulting in public notices, widespread food recalls, or even worse, consumer illness. Even before causation is demonstrated in a court of law, production down time, regulatory scrutiny and litigation fees can cost a manufacturer millions in lost revenue. In today’s world, instant media exposure and negative publicity can destroy a once trusted product brand overnight. Several recent, highly publicised cases of foodborne illness outbreaks in the US and Europe have heightened the awareness of consumers and regulators alike.

Earlier this year, the UK-based Food Standards Agency (FSA) taskforce published a guidance document to help manufacturers improve the safety of their food products and effectively deal with contamination incidents. While not legally binding, the guidance document includes recommendations for controls and procedures for monitoring supplier competence, quarantine requirements and foreign body control.

Clearly, with the potential to impact public health and safety on a global scale and with enormous revenues at stake, food processors are continually seeking ways to effectively balance regulatory requirements, production risks and rising costs. Today’s processors are proactively searching for better ways to systematically reduce hazards in their plants. Food processors are investing in new technologies, safer materials and improved process design as the means of bringing these risks to acceptable levels.

Food grade lubricants and HACCP

A multitude of compounds or agents may be used at food processing plants to facilitate the safe and efficient preparation of consumer food products. Examples of these types of compounds include: cleaners, sanitisers, boiler treatment compounds, lubricants for incidental food contact ­(i.e., food grade lubricants) and others.

The machinery and equipment used for food and beverage processing requires lubrication to protect against wear and corrosion, to dissipate heat caused by friction and to provide sealing effects. Proper use of lubricants in a food facility by trained personnel allows maximum utilisation of food equipment under harsh environmental conditions. Lubricants are essential components of food handling equipment but may pose a potential health risk if cross-contamination with food products occurs. One method of mitigating this risk is to incorporate sanitary equipment design into facility planning. However, in many instances of food and beverage processing, the potential for contact of the lubricant with the product cannot be entirely negated. The use of properly evaluated lubricants, therefore, plays a critical role in effectively controlling chemical hazards plants and should be incorporated into each food or beverage facility’s Hazard Analysis and Critical Control Points (HACCP) plan.

HACCP is a systematic, science-based process control system for identifying food safety hazards and establishing ways to control them. An effective HACCP system focuses on prevention, resulting in the elimination or reduction of potential biological, chemical and physical hazards that can adversely impact food safety. Under HACCP, food processors must identify and manage critical control points (CCPs), or points at which controls can be put into place to prevent, eliminate or reduce hazards. For food grade lubricants, facility operators must select the appropriate lube to meet both their operational needs and HACCP requirements. Food regulators in various countries throughout the world have incorporated HACCP principles into their facility inspection requirements.

International regulation of food grade lubricants

Few governments regulate the use of food grade lubricants, but two that do are the Australian Quarantine Inspection Service (AQIS) and the Canadian Food Inspection Agency (CFIA).

The AQIS is Australia’s agency responsible for import and export product inspection and certification. AQIS requires the use of approved chemical compounds in registered export red meat establishments. As there is no Australian legislation pertaining to food grade lubricants, the AQIS typically accepts US criteria established in Title 21 of the US Code of Federal Regulations (CFR). Approval with the AQIS extends for five years.

In Canada, the Canadian Food Inspection Agency helps implement HACCP systems in all federally registered food establishments. CFIA’s scope of responsibility includes facilities preparing meat, poultry, fish, dairy, egg, and fruits and vegetables. The agency requires the use of CFIA approved chemical compounds as a prerequisite for the application of HACCP programs by these food manufacturers. Similar to AQIS, there are no Canadian regulations for food grade lubricants, thus the US criteria established in Title 21 of the US Code of Federal Regulations are typically accepted.

Currently, no European regulations exist for formulation of incidental contact lubricants used in food processing facilities. Most lubricant manufacturers today rely on formulary criteria established in Title 21 of the US Code of Federal Regulations (CFR).

Previously, in the United States, the US Department of Agriculture (USDA) reviewed and authorised lubricants acceptable for use in food processing and handling facilities. These lubricants were evaluated against the requirements of the U.S. Code of Federal Regulations Title 21 (21 CFR), Food and Drugs, which establishes the requirements for food grade or incidental food contact lubricants.

In 1999, NSF International, an independent, not-for-profit organisation took over the responsibility of evaluating food grade lubricants and other food processing substances. Working with the USDA, NSF captured all previous review requirements and launched a third-party registration and listing programme for food grade lubricants. Under the current scheme, lubricants acceptable for incidental food contact are identified or categorised as “H1” lubricants.

Food grade lubricant evaluation

To achieve NSF Registration, lubricants are reviewed against the requirements of the U.S. Code of Federal Regulations Title 21 (21 CFR), Food and Drugs, which establishes the requirements for food grade or incidental food contact lubricants. These products must be formulated using ingredients listed under 21 CFR Section 178.3570, which also references Generally Recognised As Safe (GRAS) substances listed under parts 182 and 184. In addition to being specifically listed in 21 CFR, a substance can be acceptable for use in a H1 lubricant if there is a food contact notification (FCN), threshold of regulation (TOR) exemption or GRAS notification where the indicated use is as an ingredient in a lubricant with incidental food contact. Further, a substance might be acceptable if there is a letter of opinion from the FDA or a qualified legal firm. Again, the use indicated in the opinion letters must be as an ingredient in lubricants with incidental food contact. In addition to the formulary requirements, product labeling must be true and accurate, make no inappropriate claims and bear appropriate end-use instructions. Product labels must also be traceable to the registered company and bear the NSF Registration Mark, including the H1 category code and unique product Registration number. Currently, over 450 H1 lubricant manufacturers worldwide, with over 4,700 products are registered and publicly listed in the NSF White BookTM for identification by end-users and regulatory inspectors.

In addition to H1, an ingredient category designated as H1-X exists for lubricant components meeting the formulary requirements of 21 CFR Section 178.3570.

Food grade lubricant certification

In recognising the greater need for international standardisation of the requirements for food grade lubricants, the International Organisation for Standardisation (ISO) developed and published a new, voluntary ISO standard for lubricants in 2006. This document, ISO 21469: 2006(E) – Safety of machinery – Lubricants with Incidental Product Contact, was drafted by the Technical Committee ISO/TC 199, Safety of Machinery, and specifies the hygiene requirements for the formulation, manufacture and use of lubricants which may come into contact with products during manufacturing or processing. This international standard applies to lubricants intended for use in the food, cosmetic, pharmaceutical, tobacco and animal feeding stuff industries.

ISO 21469 requires lubricant manufacturers to develop a hygiene strategy and to consider chemical, physical and biological hazards in the context of the lubricant use. The lubricant must be formulated in such a manner that if cross-contamination with the product occurs, the residues would be innocuous with respect to the health of the consumer.

The ISO standard also requires that the lubricant manufacturer completes a risk assessment considering various sources of lubricant contamination including: packaging material, biological agents, the product being manufactured and water.

The future of food grade lubricants

In the future, food manufacturers will face savvy consumers demanding a greater variety of specialised food and beverage products. There is no doubt that the conventional mass food production model is changing. Increasingly, food manufacturers are using equipment capable of making rapid production line changes with minimal interruption of operation. Today’s processors also generate more foodstuffs under shorter lead and production times, placing a greater demand on equipment and machinery. The global focus on environmental sustainability and waste reduction is also forcing food manufacturers to identify leaner, more efficient practices.

Challenged as never before, the food industry must proactively identify and control food safety hazards in order to prevent public health incidents. The use of appropriately evaluated food grade lubricants within an effective food safety and quality plan provides manufacturers with reasonable assurance that the food they produce is safe for consumption.