With an ever increasing focus on food safety, food manufacturers are taking additional measures to create a safe and hygienic environment during processing. One direct result of this is the inclusion of secondary processes and peripherals when reviewing how safe an environment is.
For instance, the focus does not only revolve around ingredients or points where direct contact with food occurs. Instead, it is extended to potential contact points, and for some, the entire facility is made food-safe just in case accidental contamination occurs.
This in turn has driven the adoption of food grade lubricants, which are designed specifically for use in food and beverage (F&B) processing and packaging. There is always the possibility that oils and greases used for maintaining machinery like seals and gear boxes, conveyor belts, chains, hydraulics or refrigerators could drip or leak into food items during processing.
In general, the use of food grade lubricants is encouraged as it prevents the need for product recalls when incidental contact occurs. Contamination incidents can be extremely costly, both in terms of recalling products and opportunity costs, but more importantly, with the loss of consumer confidence as well.
Such scandals create negative branding and can cause companies to lose their market share. For instance, the horsemeat scandal in the UK has led to consumers reconsidering purchases of processed beef products. A ComRes poll has revealed that 31 percent of those surveyed have stopped eating frozen ready-to-eat meals due to this incident.
Meanwhile, in an example of how it is possible for seemingly innocuous sources to cause contamination, Genetic ID Europe, a German laboratory test company, found several samples of halal food to be contaminated when animal fat-based lubricants used for producing the paper packaging were leached into the food product. It is therefore important to consider the entire food processing chain when reviewing safety procedures.
More Than Food Grade
Klaus Post, Aalborg, Denmark
When choosing a suitable lubricant, users should consider performance features such as fluid life, wear protection, antimicrobial protection and its suitable temperature ranges. For instance, it should be able to protect surfaces from factors like corrosion, wear, friction, heat and deposits, while providing a certain level of pumpability, oxidation stability, hydrolytic stability, and thermal stability.
Some users may also require the lubricant to be resistant to degradation, especially when placed in contact with certain food products, chemicals, bacteria or water. In addition, some of the newer equipment designs that have greater velocities and temperatures can affect food grade lubricants as well, such as smaller oil sumps creating a higher stress on lubricants.
While the functions expected of food grade lubricants are similar to its non-food grade counterparts, a lot of ingredients that fulfill those requirements are not allowed in food grade lubrications for safety reasons.
That is a challenge that manufacturers have to work around, along with the need to ensure that the lubricants are not only food grade, but also hygienic and produced in a clean environment that is free of contaminants.
Certified For UseThe standards for food grade lubrications and the designations for which it can be categorised were first initiated by the US Department of Agriculture (USDA), but certification and compliance duties have now been passed on to two third party certification bodies—NSF and InS.
Food processors and manufacturers have long been encouraged to use food grade lubricants, especially those certified as H1, as the US Food and Drug Administration (FDA) has clearly indicated a zero tolerance for non-food grade lubrication contamination.
It is illegal to sell food that has been adulterated with alien components, but it is considered harmless if food grade lubricants are ingested in quantities that are below 10 parts per million (ppm).
Food grade lubricants are broken down into three main categories that are based on the likelihood of food contact. It is important to note that while three different designations—H1, H2 and H3—exist for food grade lubricants, only one is suitable for contact with food.
H1 lubricants are approved for use in food processing environments where there is a possibility of incidental food contact, and may be composed of one or more approved basestocks, additives and thickeners.
On the contrary, H2 lubricants are not for contact with food, but used on equipment and machine parts in locations where there is no possibility for the lubricated surface or lubricant to contact food.
Due to the low risk of contact with food, H2 lubricants are not bounded to a defined list of acceptable ingredients, and are essentially like any other industrial lubricant. However, they cannot contain heavy metals like arsenic, antimony, cadmium, lead, mercury and selenium, nor can they contain carcinogens, mutagens, teratogens or mineral acids.
Meanwhile, H3 lubricants refer to soluble oils that are used to clean and prevent rust on hooks, trolleys and other similar equipment, but it must be wiped off before the equipment is used and contact with food is not allowed.
3H lubricants are another category that often gets confused with H3 lubricants. The difference between the two is that unlike H3 lubricants, 3H lubricants are suitable for direct contact with food, such as lubricating machine parts like blades in mincing machinery or bearings.
According to Andre Adam, global sales director at Fragol, 3H lubricants are typically “mould release agents, like those used in the bakery industry. The maximum level of lubricant in the food stuff is not to exceed 0.15 percent of the bakery product (as stated under 21 CFR 172.878). This is in most cases straight base oils, with no additives.”
Mark Phang, technical manager at Tecsia Lubricants also added that “such lubricants can also be used as food additives. These products are used on grills, loaf pans, cutters, boning benches, chopping boards, or other hard surfaces in contact with meat and poultry food products to prevent food from adhering during processing.”
Basestocks & AdditivesH1 approved lubricants can either be bio-based (natural), mineral or synthetic, depending on the oil base used, as long as it is in the list of approved food-safe ingredients.
Base fluids typically make up 90 to 99.5 percent of a lubricant formulation, said John Sander, VP of technology at Lubrication Engineers. He shares that mineral oils qualify as natural occurring base fluids, “because crude oil is taken from the ground, heated and separated into factions.” Fluids from vegetables and animals are also from natural sources, but undergo secondary processes to remove undesirable parts.
Synthetic lubricants on the other hand, are chemically converted into something else even though they are derived from naturally occurring substances.
“This synthesis process often results in a very unique lubricating base fluid. Each synthetic base fluid has its own strengths and weaknesses that dictate the resulting type of lubricant formulation,” Mr Sander reveals.
For instance, polyalphaolefins (PAO) have greater oxidation stability and a wider range of operating temperatures as compared to while mineral oils. Meanwhile, polyalkylene glycols (PAG) are used in high temperature applications and favoured for its ability to provide lubrication even when water is present. It also leaves lesser residue behind.
When To Use WhatExplaining that lubricants are divided into groups of one to five according to the most commonly used groups, Mr Adam shared that in general, oils from group four onwards are considered synthetic, although some might start from group three. Users might opt for lubricants from group three and onwards if a mineral lubricant cannot perform at a given application.
Additives and thickeners can also be blended with base oils to enhance the lubricant’s performance, especially under demanding food processing work environments. Additives may include antioxidants, corrosion and rust inhibitors, but are limited by 21 CFR 178.3750. There is also a limitation to the volumetric amount of additives that can be added, which makes getting the right mix or formulation all the more important.
While mineral base fluids can be utilised for general applications, synthetics take centre stage when applications require a customised lubricant. Nonetheless, the choice of lubricants will ultimately depend on the environment that it will be used in.
“There are many factors that can have an impact on the selection of the lubricant, not only the base oil, but also the additive selection,” said Mr Adam.
This includes factors like temperature, loads, aggressive gases, the presence of water, contaminants, speed, lubricant quantities, miscibility, types of metals, paint seals, packing material, as well as cost and availability.
Greater Focus On EnvironmentIn today’s context, having H1 approved lubricants no longer makes the cut for food safety. Other factors like hygiene and potential contamination risks matter as well, which eventually led to the birth of ISO 21469:2006—essentially a HACCP approach for H1 lubricants.
This certification standard deals with the cleanliness and contamination limitation of H1 lubricant producers, and looks beyond the ingredient list to include the manufacturing environment and level of quality control, in the areas of manufacturing, distribution and storage.
tokyofoodcast, Tokyo, Japan
Currently, H1 is the only registration available for lubricants approved for incidental food contact. Manufacturers need only ensure that components used are approved.
“A less responsible producer could produce H1 lubricants for incidental food contact without taking proper hygiene measures to ensure cleanliness or correct administration on traceability and so on,” said Mr Adam. The ISO 21469 on the other hand, assures customers that proper hygiene measures have been taken.
The ISO system requires audits to be performed on the lubricant formula and plant, which can be a costly and time consuming affair that is solely in place for the consumers’ benefit.
Mr Sander added that “the benefit to the end users is that they know that a third party auditor has evaluated the lubricant plant’s processes as well as the product formulas, therefore holding the plant accountable for producing products safe for incidental food contact.”
While not compulsory, having a sound HACCP plan will also benefit food grade lubricant manufacturers. Such a plan, according to Mr Phang, will prevent contamination as manufacturers develop and implement safety measures along with a system to intercept potential contamination points.
It will also ensure that H1 lubricants are manufactured according to safe, accurate and organised procedures, with correct labelling and the immediate removal of damaged packaging.
Steps To Achieving ISO21469 Certification
- The manufacturer submits details such as product name, manufacturing locations, container size and shelf life, along with completed risk assessment document
- The assessing body will then review the product details, including a list of ingredients, their suppliers, and the acceptable range of those ingredients in the finished product. The products will be grouped into classes based on their chemical makeup, which helps to reduce the amount of compliance testing required. Like the H1 classification, ingredients must be from the list of known food-safe products (eg: 21 CFR 178.3570).
- An onsite audit of the lubricant manufacturing facility will be conducted by the assessing body, to review recordkeeping, quality control policies and procedures, overall good manufacturing processes (GMP), and to collect product samples. The manufacturer’s hygiene risk assessment protocol will also be reviewed and verified.
- The fourth step requires a representative baseline to be established using Fourier transform infrared (FTIR) analysis. Samples will be taken from various manufacturing batches and repackaged products to ascertain that the manufacturer has adequate control over the process. Future samples will also be compared to the baselines to ensure continued quality control compliance and formulation stability.
- Manufacturers can then opt for accredit certification. In the US for instance, the American National Standards Institute (ANSI) provides certification based on the assessing body’s findings.
- To retain the ISO 21469 certification, manufacturers must update their risk assessment policy. There will also be an annual unannounced audit at each facility, during which product samples will be collected and expected to match the product baselines that were established during the initial certification process.
Creating A HACCP PlanDespite using the best food grade lubricants, contamination may still occur if the food production facility lacks sound design and maintenance. Users of food grade lubricants are therefore encouraged to adopt the seven HACCP principles, the first step of which is to identify critical control points (CCP).
This includes conducting a hazard analysis and identifying potential hazards and preventive measures. For instance, Mr Sander has suggested that food manufacturers consider whether the lubricated part is above or below the food preparation area before deciding on whether to use a H1 lubricant.
Meanwhile, Mr Adam mentioned that some operators prefer using H1 lubricants throughout the plant, to eliminate risks of using the wrong lubricants in sensitive areas.
He added that “one of the most basic actions could be as simple as having dedicated cans for topping up lubricant in the machines. Color coding of filling cans with lubricant points can also help avoid cross contamination.”
Other preventive measures include locating oil-lubricated equipment further away from critical production areas, ascertaining that lubricant properties match their use, and that containers are used for only one lubricant.
The second step is to establish critical limits for each control point, such as making sure that machinery components are not over or under lubricated. This is followed by the third principle of establishing monitoring requirements for the set CCPs. Monitoring is integral in ensuring that the process is under control at each point.
Thereafter, the fourth step sets out to establish corrective actions in the event that deviations from the established critical limits occur. These measures must be specified in the plan, which are in place to prevent harmful or contaminated products from entering the market.
The fifth principle calls for record keeping procedures, and for all plants to maintain certain documents such as its hazard analysis, written HACCP plan, records that document the monitoring of CCPs, critical limits, verification activities, as well as the handling of deviations during processing.
Last but not least, the sixth principle requires operators to establish procedures that can validate the HACCP plans. Operators should be able to determine if their HACCP system is adequate and working as intended. Some actions could include a review of existing plans, CCP records, critical limits, as well as microbial sampling and analysis.
Once a plan is developed, it does not mean that it will be set for life. Rather, it should be an ongoing process that is constantly being refined and improved on for greater effectiveness.
Likewise, the categorisation and review of food grade lubricants should also be an ongoing process where improvements are continuously made to reduce confusion.
For starters, the use of ‘food grade lubricants’ as a term should be tightened. Often times, it is used loosely for products that are in actual fact, unsuitable for contact with food. This in turn, could lead to misconceptions and safety gaps that will eventually undermine the quality of the food industry as a whole.