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. Silver Zeolite, Silver Zinc Zeolite and Silver Cooper Zeolite are notified “existing” biocidal active substance under Directive 98/8/EC on Biocidal Products (BPD).

Your Guide Through Regulatory Requirements

Like many products touched and used by people, Agion antimicrobial solutions involve government regulations. Through our many years of experience, Sciessent 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 Sciessent's portfolio of regulatory approvals and supporting documents
  • Regulatory training
  • Support (and presence) for regulatory reviews with agencies

With Sciessent 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 Canada - Food Contact
California 65 Article 95 listing under the BPR for product type 4 (food and feed areas)
Antimicrobial For Medical Device