Environmental Protection Agency (EPA), regulates all antimicrobial product labels and any associated efficacy claims. The language and claims contained on each label must be supported with extensive scientific data that is submitted to EPA in the pesticide registration approval process. These labels govern usage rates, applications and directions for use. End users of chemicals must ensure compliance with the label and should understand the meaning behind differing label claims. This is the first in a series of posts that will look at EPA label language and what it means to the end-user.
The words sanitizer and disinfectant are often used interchangeably in the food processing industry. The Environmental Protection Agency (EPA), however, has distinct definitions for each term.
Sanitizer: a substance, or mixture of substances, that reduces the bacteria population in the inanimate environment by significant numbers, but does not destroy or eliminate all bacteria.
Disinfectant: a substance or mixture of substances, that destroys or irreversibly inactivates bacteria, fungi, and viruses, but not necessarily bacterial spores, in the inanimate environment.
Source: EPA Website, 40 CFR 158.2203
Definitions in Practice
For commercial products, this simply means that disinfectants provide a higher level of demonstrable microbial load reduction than sanitizers. Product performance guidelines are outlined by EPA in Product Performance Test Guidelines OCSPP 810.2300 (sanitization) and OCSPP 810.2200 (disinfection). These guidelines are summarized in Table 1, with minimum surface contact times indicated in parentheses.
|Microbial Load Reduction:
Non-Food Contact Surfaces
99.9% (5 min)
99.9999% (10 min)
|Microbial Load Reduction:
Food Contact Surfaces
99.999% (30 sec)
|Fungi & Viral Control||NO||YES|
On the Label
In some instances, the same product can be both a sanitizer and a disinfectant when used at different concentrations, or on a different surface, or with longer surface contact time. Sterilex® Ultra Disinfectant Cleaner Solution 1, when used with Sterilex® Ultra Activator Solution, and FortiSolve are both examples of this type of product
The label for Sterilex Ultra Disinfectant Cleaner Solution 1 (EPA Reg. No. 63761-8, accepted 9/22/16), contains a claim that allows the product to be used as both a rinsed disinfectant on food contact surfaces, and as a non-rinsed surface sanitizer on non-food contact surfaces. This section of the label is highlighted below.
DISINFECTION AND NON-FOOD CONTACT SURFACE SANITIZATION OF FOOD PROCESSING EQUIPMENT AND HARD SURFACES IN FOOD PROCESSING FACILITIES: Apply Sterilex Ultra Disinfectant Cleaner Solution 1 and Sterilex Ultra Activator Solution as a disinfectant, per General One Step Disinfection and Cleaning Directions, or as a sanitizer, per General Sanitization Directions. Use product within 8 hours of mixing Sterilex Ultra Disinfectant Cleaner Solution 1 and Sterilex Ultra Activator Solution.
“Disinfection” and “non-food contact surface sanitization” are separate statements and claims, an important differentiation. Per Food and Drug Administration (FDA) requirements, a no-rinse sanitizer must be used on food contact surfaces as the final step prior to production. For this reason, Sterilex specifically differentiates between disinfection claims (followed by a rinse) on food contact surfaces, and non-rinsed surface sanitization claims for non-food contact surfaces.
Therefore, on food contact surfaces, this product has demonstrated an ability to kill ≥ 6 logs of the organisms on its label on food contact surfaces, whereas products marketed as sanitizers on food contact surfaces have demonstrated an ability to kill at least 5 logs of the organisms on their label on food contact surfaces.
Please see the product label for complete directions for use.
Both EPA registered sanitizers and disinfectants can effectively reduce or remove bacterial load from surfaces in food processing facilities. However, when used in accordance with the label, disinfectants offer processing facilities a more complete inactivation/removal of microbial load than sanitizers.