Home >>

Microbial Product Regulatory Compliance

Antimicrobial and 'Green' Products Regulatory and Product Claims Compliance

Compliance with microbial product regulations for both antimicrobial additives and the finished product claims, are key to the legal use of your formulations or finished product.

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.

There is no single roadmap for regulatory compliance.

As a hypothetical example, the following table illustrates some of the differences in regulatory requirements.

Example of a single type of chemistry used in a coating application

Note:  The range of potential regulatory needs can depend on several factors: application, use environment, product claims, and geographic region.

	Application	General Regulatory Category	Regulatory Agency
1.	Paint Preservative (no antimicrobial claims)	Industrial application	EPA for non-food applications, limits additive type and use level.
2.	Paint Preservative (no antimicrobial claims)	Industrial application	EPA for non-food, but FDA has potential limits for food contact use environments.
3.	Paint additive with antimicrobial claims	Industrial or consumer product	EPA and/or FDA depending on use environment.  Required demonstration of performance to validate claims.
4.	Paint Additive with antimicrobial claims	Hospital environment - for use in 'infection control'	FDA - requires 510K (class 1) and product is regulated as a type of medical device.
5.	Paint Additive -Export to Europe	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. 

 

Independent Microbial Product Testing, Claims, and Regulatory Compliance

Regulatory agencies such as the US EPA, FDA and the European BPD provide guidance on registration and legal requirements for the use of antimicrobials. 

Standards agencies, such as ASTM, ISO, AATCC or AOAC, provide a range of methods for evaluation and certification of the product performance. 

The needs of a given product are not necessarily detailed by the Testing  or Standards Agency.  It is the Regulatory Agency which dictates the requirements of a given product for a specific application.

Compliance is a mixture of satisfying both the regulatory needs and the performance requirements of your microbial formulation or product.

Get the information you need to be in compliance.