Regulatory Guidance
Regulatory Statement
Agion® antimicrobials are EPA-registered for a broad range of uses including food and water contact, HVAC and building products, appliances, fibers and textiles, and cosmetic and personal products. They are FDA-listed under the FDA food contact substance notification for use in all types of food contact polymers in 21 CFR, Parts 174 through 186. They are USDA listed for non-food compounds maintained by NSF for food processing plants.
Your guide through the regulatory requirements
Like many products touched and used by people, Agion antimicrobial solutions involve government regulations. Through our many years of experience, Agion is an expert at understanding and complying with all the relevant regulations. As your partner, we act as your guide through the "regulatory maze," making sure your product and marketing are fully in line with the relevant laws. Our services include:
- Regulatory assessment during project planning phase
- Regulatory review of claims & language
- Access to Agion’s portfolio of regulatory approvals and supporting documents
- Regulatory training
- Support (and presence) for regulatory reviews with agencies
With Agion as your partner, you can take your product to market with complete confidence.
Global Registrations:
| EPA |
BPD (Biocidal Product Directive) |
| EPA - HVAC |
EFSA (European Food Safety) |
| EPA - Food Contact |
Swiss |
| FDA - Food Contact |
New Zealand |
| FDA – Medical |
Singapore |
| USDA |
REACH (pre-auth) |
| NSF 51 |
PCPC (CTFA) Personal Care Products |
| NSF 42 |
Cradle To Cradle Gold |
| California 65 |
Canada - Food Contact |