Regulations for Antimicrobial and 'Green' Products

Microbial Product Regulations -Situ Biosciences

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.

Antimicrobial and Biodegradation Regultations -Situ Biosciences

Regulations and Quality Control

Understanding the regulations in testing a material and in ultimately bringing the product to market is crucial. It is important at each step of the development process to ensure the products compliance with the relevant authorities. Given the complexity of the global supply chain, lean production scheduling and evolving industrial standards its important to know what to test for and when. For an overview of how Regulations and Quality Control are interrelated click here.

There is no single roadmap for regulatory compliance

As a hypothetical example, the following illustrates some of the differences in regulatory requirements. The range of potential regulatory needs can depend on several factors: application, use environment, product claims, and geographic region.

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

Application	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.

The Wily Microbe

Microbial Resistant Fabric Development and Testing -Situ Biosciences

Compliance Regulatory Compliance

Even the U.S. Mint is not immune from microbes. The image above shows actual microbial degradation on a Jefferson Nickel.

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.