The production of food, drinks and beverages requires a very high degree of cleanliness and industrial hygiene measures to prevent any hazards to consumer health.
In order to minimise biological, chemical or physical risks, the Hazard Analysis and Critical Control Points (HACCP) concept was developed and implemented into the industrial environment as a preventative system to ensure consumer safeness.
Following this concept, as the first step, a complete hazard analysis is carried out. Based on these results, in the second step, all points, steps or operational sequences in the manufacturing process where controls have to be conducted must be determined.
The intention is a prevention or reduction of threats to food safety to an acceptable degree. This concept puts international legislation into practice, the example, the Feed Hygiene Regulation (EC) No 852/2004 in the European Community or FDA 21 CFR 110 regulations in the US for the food and beverages industries.
It also considers the European Machinery Directive 2006/42/EC, instructing (Annex I, Section 2.1.1.) that “machinery must be designed and constructed in such a way that no ancillary substances hazardous to health, including the lubricants used, can come into contact with foodstuffs”.
As a result, NSF H1 approved lubricants are mandatory for all lubricating points where incidental product contamination is technically unavoidable (risk class A) or possible, but unlikely (risk class B). Even if product contact is utterly impossible (risk class C), H1 lubricants are recommended, due to the probability of confusion. Formerly, NSF H2 approved lubricants were mandatory for these lubricating points.
NSF Registration Procedure
NSF International was founded in 1944 with the mission to protect and improve global human health. This independent, accredited organisation supports manufacturers, regulators and consumers by developing public health standards and certifications that help protect food, water, consumer products and the environment.
The organisation works closely with the US Food and Drug Administration (FDA), US Department of Agriculture (USDA) and World Health Organization (WHO).
The certification process for nonfood compounds, category H1 (lubricants–-General incidental contact) is based on a ‘positive list’ of HX-1 compounds (ingredients for use in H1 lubricants), published by FDA under the Code of Federal Regulations (CFR) Title 21.
For successful approval of lubricants, all ingredients must appear in this list within the given concentration limits. Certified compounds in all intended end use category codes—both proprietary substances and non-food compounds—are published in the NSF White Book, a non-food compounds listing directory. Here, all H1 registered lubricants can be found easily via company name, product name or registration number.
In the meantime, InS Services (UK) was created in the UK by Sid Stone and Eric Gard to fill the market need for an alternative H1 registration body. Lubricant manufacturers can now register their products online to H1, H2, H3 and associated standards.
Threats Of Microbial Contamination
Bo Nash, Texas, US
LUBRICATING GREASES ARE WELL BALANCED, COMPLEX SYSTEMS TO COVER A BROAD RANGE OF PERFORMANCE ASPECTS.
Roshnii Rose, Brighton, UK
The European Machinery Directive 2006/42/EC also regulates (Annex I, Section 2.1.2.) that “instructions must indicate recommended products and methods for cleaning, disinfecting and rinsing”.
However, in the case of lubricated bearings, it is nearly impossible to clean and disinfect the inside space properly once microbial organisms have penetrated the bearings and started growing within the grease.
Such contamination cannot be excluded. Polluted and contaminated water from washing vegetables, fish processing or brewery, for example, can enter the bearings, transporting microorganisms into the grease.
Comparable situations exist in all wet environments, like liquid filling, washing, or cleaning. Flour-dust, ubiquitous in bakeries, provides germs with a good breeding ground and can also permeate into bearings. Other dirty environments, typically found in malting and food grinding processes or vegetable transport, create the same problem. Moreover, microbial survival and growth in lubricants is well known in scientific literature.
Numerous types of microbial organisms can metabolise selected ingredients of the lubricants. As a consequence, a degradation process starts, followed by gradual deterioration of specific performance aspects. Eventually, the result is early failure of the bearings. This creates unplanned machine downtimes, additional maintenance costs and loss of production.
Microbial contamination in the environment of food, drinks and beverages production, however, is in particular of concern for gram positive and gram negative pathogens, such as escherichia coli, pseudomonas aeruginosa, staphylococcus aureus, legionella pneumophilia and fusarium oxysporum.
Incidental food contact with such germ-ridden grease can cause contamination of complete production batches, resulting in serious health risks for the consumers. Usually, it takes some time before such a contamination is detected and the failure cause—a polluted bearing—is identified.
In the meantime, large product quantities can be affected that must be disposed at high costs.
Ultimately, the need for a product recall campaign is also a severe damage to the company’s image.
ANTIMICROBIAL ADDITIVES PROTECT LUBRICATING GREASES FROM DEGRADATION OR CONTAMINATION BY FOODBORNE MICROORGANISMS.
In order to avoid these complicated situations, the application of H1 lubricants containing selected antimicrobial additives is highly recommended. Such lubricants are so-called bio-treated products and therefore by definition, not biocidal products according to the Regulation (EU) No 528/2012.
The development of H1 approved long life lubricating greases for wide operating temperature ranges containing effective antimicrobial additives has been a very complex task. Antimicrobial additives for general industrial lubricants are predominantly not HX-1 certified—not allowed as ingredients for use in H1 lubricants.
On the other hand, most HX-1 grade raw materials do not show any antimicrobial effectiveness. Therefore, the selection of appropriate antimicrobial additives with high stability in the lubricant, even at elevated temperatures, was a first challenge.
Lubricating greases are well balanced, complex systems to cover a broad range of performance aspects. Each additional ingredient can severely interfere with the product stability or any performance aspect.
For product development, this includes time-consuming processes such as preparation of many different samples and an extensive number of subsequent performance tests. Nevertheless, after successfully finishing these efforts, new products have been introduced into the market and are now available for customers.
The effectiveness of preventing pathogens from growth in these lubricants can be demonstrated in incubation tests by an independent microbiological laboratory. This gives the secureness to the customer that bearings in the production lines are eliminated as potential biological nutrient media for pathogens which—once contaminated—cannot be cleaned and disinfected effectively.
Potential applications for these new H1 lubricants in the production of food, drinks and beverages are in particular, all processes where special measures for germ control like heat, radiation, sterilisation, addition of preservatives are excluded. One of the finest examples is the aseptic cold filling of fruit juice.
Other application areas are large-scale catering establishments, pet food and animal feed production, tobacco industry, pharmaceutical and cosmetic industries, medical devices, hospitals and medical practices.
It shall be pointed out here that antibacterial additives, protecting the lubricating greases from degradation or contamination by foodborne microorganisms, do not protect users or any other humans against these pathogens, such as by a unintended use of the lubricant as skin cream or the like.