EPA-Registered Products
EPA-registered antimicrobial products are formulated to control microorganisms on environmental surfaces, equipment, and—when specifically approved—food-contact surfaces. These products carry public health claims such as “kills bacteria” or “sanitizes food-contact surfaces” and must display an EPA Registration Number.
Regulatory Authority
Environmental Protection Agency (EPA)
Purpose
EPA registration is required for any product that makes public health antimicrobial claims, including killing or reducing bacteria, viruses, or fungi on surfaces.
This includes food-contact sanitizers, non-food-contact sanitizers, and disinfectants.
Scope
Depending on its label and approved claims, an EPA-registered product may be designed for:
- Food-contact surface sanitizing (e.g., equipment, processing tables, utensils)
- Non-food-contact surface sanitizing
- General environmental disinfection and sanitation
Food-contact sanitizers must meet strict efficacy requirements and are typically designed for no‑rinse applications at specified dilutions.
FDA-Accepted Products
FDA-Accepted products are formulated for direct or indirect contact with food and must comply with the applicable requirements under Title 21 of the Code of Federal Regulations (21 CFR). These regulations ensure that any substance used during food processing, handling, or preparation is safe and will not adulterate food.
Regulatory Authority
Food and Drug Administration (FDA)
Purpose
FDA compliance ensures that chemicals, processing aids, and food-contact materials are safe for use in situations where they may touch food directly or transfer to food indirectly, such as through equipment, surfaces, or packaging.
Scope
FDA oversight covers a wide range of food-contact applications, including:
- Ingredients and substances used on food-contact surfaces
- Processing aids that may migrate into food
- Indirect food additives, including coatings, polymers, and sanitizing rinse agents
- Substances used in meat and poultry plants, in coordination with USDA requirements
Products must meet stringent safety standards outlined in 21 CFR Parts 170–199, including limits on residues, exposure levels, and permitted active ingredients.
Why Does This Matter?
Choosing the right product for the right application is critical to ensuring safety, compliance, and operational efficiency.
- EPA‑registered products protect public health by controlling pathogens on environmental and surface areas.
- FDA‑accepted products safeguard food safety by ensuring substances used in food environments are compliant and safe for direct or indirect contact.
Selecting the appropriate regulatory pathway reduces risk, strengthens audit readiness, and protects both public health and food safety. Whether your facility requires environmental sanitation solutions or food‑contact‑safe products, Biosan provides clear guidance and a portfolio aligned with your industry’s regulatory standards.