Regulations for Antimicrobial and 'Green' Products
Regulatory and Product Claims Compliance
For antimicrobial or green products the regulatory requirements vary. Government agencies such as the Environmental Protection Agency (EPA) or the Food and Drug Administration (FDA) regulate different aspects of the additive use and/or application.
In addition, import/export regulations, such as the European Union REACH initiative and Biocidal Products Directive (BPD) governance, further require very specific compliance for a given product so that it can be legally used or sold within the EU.In addition to regulatory compliance, product claims based on microbial performance such as for antimicrobial, antibacterial, antifungal, antialgal, improved hygiene, reduced odor or for biodegradation; also require compliance to avoid 'false or misleading' claims by Trade governance such as the FTC.
Regulations and Quality Control
There is no single roadmap for regulatory compliance
Example of a single type of chemistry used in a coating application:
|Industrial application||EPA for non-food applications, limits additive type and use level.|
|Industrial application||EPA for non-food, but FDA has potential limits for food contact use environments.|
|3. Paint Additive
|Industrial or consumer product||EPA and/or FDA depending on use environment. Required demonstration of performance to validate claims.|
|4. Paint Additive
(for use in 'infection control')
|FDA - requires 510K (class 1) and product is regulated as a type of medical device.|
|5. Paint Additive
|Consumer product, house paint||Additive must be Registered with EU-Biocidal Products Directive (EU-BPD) and the formulation must be REACH compliant.|
The global regulatory environment is continually evolving. Although the process is increasingly transparent, it is challenging.Situ Biosciences are experts at navigating the regulatory landscape for industrial and consumer antimicrobial and biocide treated products and can help your company meet the compliance needs of your products.