By Debbie Sniderman
Key concepts
- In the U.S., food-grade lubricant products must be formulated in accordance with Title 21 Code of Federal Regulations (21CFR) 178.3570.
- Third-party registration is used widely by food-grade lubricant manufacturers around the world to show compliance.
- H1 registered and ISO 21469 certified lubricants help food processors mitigate risks and comply with HACCP plans.
Lubricants in food processing
As more processes are automated in food production and reliance on machinery increases, there are more pressures on food processors operating with reduced work staff. These companies have higher goals for yields and waste reduction in production facilities while plants and operators are under time pressures with less emphasis on personnel training and education.
There are customer pressures to those sourcing food products around private labeling, contract manufacturing and retailers putting regulatory and additional testing requirements on products. The need to focus on food safety now is growing.
Lubricants used in production processes offer the possibility of cross-contamination into food. The growing concern for food-safe lubricants raises questions about whether food safety regulations and standards also apply to food-grade lubricants and how food manufacturers meet operational requirements without introducing new chemical hazards.
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The importance of risk mitigation
Hazard control in food processing reduces the potential for contamination from both biological agents such as pathogens or spoilage organisms and chemical agents like toxins, carcinogens or mutagens. In order to be effective, hazard control must extend to the following:
- Processing areas: Includes receiving, storage, lethality, assembly, packaging, storage and shipping.
- Includes equipment design and construction, surface treatments and coatings and plant steam and water.
- Maintenance activities: Includes cleaning, pest control, water treatment and lubrication.
Hazards can be controlled by having effective Hazard Analysis Critical Control Point (HACCP) plans and ensuring they are implemented. They also can be controlled by making sure equipment is designed in a way that is sanitary and doesn’t harbor additional bacteria or cleaning agents in areas where they are undesired and by using third-party verified lubricants.
It is important to control against hazards in order to avoid the following:
- Public health crises and foodborne illness outbreaks
- Brand destruction, media attention and consumer litigation
- Product recalls, public notice and product disposition
- Regulatory enforcement, penalties and criminal charges.
Food recalls can affect millions of people depending on where the food is distributed. Repercussions of recalls are significant and can destroy a brand’s reputation in the industry.
International regulations for food-grade industries
The U.S. is heavily regulated and has specific criteria about how to evaluate products with consideration for food safety. Regulation is established by the U.S. Food and Drug Administration (FDA) with NSF International acting as the product certification body.
In the U.S., products must be formulated in accordance with Title 21 Code of Federal Regulations (21CFR) 178.3570. Or the ingredients in the lubricant must be listed as safe in (21CFR) 178.3570 where there is a list of acceptable components including oils, antioxidants, surfactants, etc., along with use limitations. Another option to comply with the regulation could be through an approved contact notification from the FDA.
European Union (EU): In the EU the European Food Safety Authority (EFSA) provides advice on food safety risks and publishes scientific opinions on certain compounds (e.g., mineral oils). Today there is no formal EU regulation for lubricants like there is in the U.S. Typically the U.S. compliance requirements are accepted in the EU.
Canada: The Canadian Food Inspection Agency (CFIA) enforces that country’s regulations. It maintains a list of CFIA-approved chemical compounds but has scaled back the scope of the reviews for the last two years. It used to operate a program similar to the NSF program in the U.S. with similar criteria, but now it applies only to meat processing. It is uncertain whether CIFA will ramp up the scope or scale it back again in the future.
China: The Food Safety authority in China is the Food Hygiene Law of the People’s Republic of China. This law ensures food hygiene and protects food products from contamination of harmful substances. It doesn’t cover products themselves but instead covers the premises, processing facilities and environments where products are produced.
It doesn’t specify hygiene standards for lubricants but says that harmful substances must not be introduced to processing areas. Rather than focus on the hygiene side, it focuses more on potential harmful substances being added into the products that could contaminate the final lubricant.
Australia: In the past, the Australian Quarantine and Inspection Service (AQIS) operated a program similar to the one in Canada, reviewing and listing products as compliant and mirroring the U.S. criteria for ingredient review. In Australia lubricants with incidental contact are called Lubricants Type A. Two years ago they also suspended their acceptance review program and are no longer adding products to their list of accepted foods.
Asia-Pacific. Several Asia-Pacific countries are strengthening their food safety regulations and expanding laws for food processing. In time more countries in the region may start to focus further on the lubricant sector, but no regulations exist now.
Excerpted and reprinted with permission from the January 2016 issue of Tribology and Lubrication Technology (TLT), the official monthly magazine of the Society of Tribologists and Lubrication Engineers, an international not-for-profit technical society headquartered in Park Ridge, Illinois. You can purchase an STLE University webinar on this topic, “Food-Grade Lubricants and Their Regulation,” at www.stle.org.
About the author
Debbie Sniderman is an engineer and CEO of VI Ventures, LLC, an engineering consulting company. You can reach her at info@vivllc.com.
About STLE
The Society of Tribologists & Lubrication Engineers (STLE) is the premier technical society serving the needs of over 12,000 individuals and 250 companies and organizations that comprise the tribology and lubrication engineering business sector. STLE members are employed by the world’s leading corporations, academic institutions and by governmental agencies dealing with science and technology. STLE supports these distinguished technical experts with a variety of professional education and certification programs.
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We currently have a H1 Aluminium Complex grease that we are looking at transferring from 180kg drums into 450gm grease carts via an air operated grease pump. My question is are there any regulations whether that be American, Australian etc as to what sort of grease pump is to be used, a standard pump or stainless steel, I cannot find any regulations for this at all.
Hi, Tony. We received your message and would like to suggest that you check out our regulatory services for assistance and guidance. You can contact an expert here – https://psi.ul.com/en/talk-to-an-expert/.