How Registrations Prove Lubricants Are Food Grade

Can Only Ingredients Regulated by 21 CFR 178.3570 Be Used?

• Ingredients with generally recognized as safe (GRAS) status are also considered acceptable for food-grade lubricants by the FDA.
• Food contact notifications (FCNs) are another way to get a food contact substance (FCS) accepted by the FDA. They are used for FCSs that are: 1) not listed in 21 CFR for food contact end use, or 2) already listed in 21 CFR for food contact end use, but the manufacturer needs to expand the end-use parameters. FCNs are only applicable to the manufacturer of the FCS.
• Threshold of regulation (TOR) exemptions are an alternative to FCNs. While the application requires less information, a lubricant manufacturer can use a competitor’s TOR exemption.

Regulators worldwide refer to 21 CFR to define what they consider a food-grade lubricant. There is a misconception that lubricants are registered through the U.S. Department of Agriculture (USDA). This is not true. The USDA discontinued its registration program in 1998.

The European Food Safety Authority (EFSA) does not have any official rules governing the definition of food grade; however, it is important to know:

• H1 registered and ISO 21469 certified lubricants are generally accepted as food-grade lubricants by EU regulators and food processors.
• No regulatory actions in the EU have been taken in regard to Mineral Oil Saturated Hydrocarbons (MOSH) and Mineral Oil Aromatic Hydrocarbons (MOAH).
• In the EU, titanium dioxide (TiO₂) is not considered safe as a food additive. Consequently, TiO₂ is banned from food-grade lubricants intended for European markets.
  • As part of the registration or certification process, NSF can review formulations for TiO₂. If the oxide is not found, NSF can provide supplemental documentation verifying a lubricant does not contain TiO₂.

Food-grade lubricants manufactured in, imported into or exported out of Brazil must be certified to ISO 21469.

The Food Hygiene Law of the People’s Republic of China has no specific regulations about food-grade lubricants used in the country. Nevertheless, food-grade lubricants exported from China should be H1 registered or ISO 21469 certified for greater product acceptance in global markets.

To verify a lubricant is food-grade, food and beverage processors around the world reference a registration program’s listing like the NSF White Book™.