In response to an influx of inquiries, CDA has developed the following guidance for entrepreneurs and companies seeking to develop new antimicrobial copper products or advertise existing copper-based products with antimicrobial effectiveness claims. Companies are encouraged to engage qualified regulatory consultancies and commercial laboratories for direct assistance with antimicrobial product testing and regulatory approval.
It is not CDA’s intent to limit the ability of companies to market copper-based products with antimicrobial effectiveness claims. Rather, our intent is to ensure that companies are aware of the U.S. regulations that govern all antimicrobial products, and to fulfill our U.S. EPA-mandated Stewardship obligations established to educate the marketplace on the proper use and care of antimicrobial copper alloy materials and the products made from them.
For detailed, step-by-step guidance on EPA antimicrobial product registration requirements and the application process, please refer to the following official resources on EPA’s website: http://www.epa.gov/pesticide-registration/antimicrobial-pesticide-registration
- Uncoated copper and copper-based alloys (e.g. brass, bronze, copper-nickel) are solid metals that are inherently antimicrobial. This is an intrinsic property of the materials, like electrical conductivity and corrosion resistance.
- Many companies produce copper and copper alloy raw materials in a variety of forms, including sheet, strip, plate, foil, rod, bar, tube and ingot.
- Copper alloy raw materials are made according to tightly controlled industry standards to ensure consistent chemistry and performance across the supply chain.
- While all uncoated copper alloys are antimicrobial, the act of advertising these materials and the products made from them with express or implied antimicrobial effectiveness claims in the U.S. market triggers certain federal and state regulatory requirements.
- All products advertised and sold in the U.S. with antimicrobial effectiveness claims are regulated by the U.S. Environmental Protection Agency (EPA) under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA).
- EPA FIFRA regulations ensure that antimicrobial products are rigorously tested for efficacy, safe to use and advertised responsibly with EPA-approved label claims.
- The EPA registration requirement for copper alloy raw material suppliers and Original Equipment Manufacturer (OEMs) is triggered by the act of making of antimicrobial effectiveness claims in marketing materials which includes websites, brochures, press releases, social media posts and other collateral.
- This requirement applies to all copper alloy material/product suppliers regardless of whether their non-registered copper alloy materials/products are identical to EPA-registered copper alloy materials/products produced by EPA-registered suppliers.
- Referencing independent, peer-reviewed studies about copper alloys in marketing materials is considered an implied product claim which triggers EPA registration requirements. This includes making references to a variety of high quality, independent studies that have been published in peer-reviewed journals and elsewhere discussing the antimicrobial effectiveness of copper alloys in laboratory and clinical settings.
- Suppliers of copper alloy raw materials (e.g. sheet, tube, foil, etc.) must secure independent federal and state EPA registrations before their materials can be sold to OEMs intending to advertise finished products with antimicrobial effectiveness claims.
- OEMs seeking to advertise copper alloy-based products with antimicrobial effectiveness claims in the U.S. market must source EPA-registered copper alloy compositions from EPA-registered raw material suppliers.
- OEMs using EPA-registered antimicrobial copper alloy materials in product designs must also secure an EPA Establishment Registration and report shipment data to EPA.
- Referencing the generic EPA registrations for copper alloys secured by Copper Development Association (EPA Reg. Nos. 82012-1 through 82012-6) does not satisfy the requirement for copper alloy raw material suppliers to obtain their own independent EPA company registrations before antimicrobial advertising claims can be made for their materials and the products made from those materials by their OEM partners.
- CDA’s experience and subject matter expertise is centered around solid, wrought and cast copper alloys for use in touch surface applications (e.g. door hardware, countertops, I.V. poles, etc.).
- CDA has limited knowledge on the efficacy and use of copper-infused textiles (e.g. for face masks), coatings (e.g. paints, electro-platings, chemical vapor deposition) and solutions (e.g. colloidal copper). These alternative material forms may warrant further scientific study and/or regulatory approval.
- CDA does not provide direct assistance to third parties in securing EPA registration for their copper-based materials and products.
- There are a number of qualified regulatory consultancies with the appropriate competencies that provide this service to manufacturers seeking to understand or pursue EPA antimicrobial product registrations.
- CDA recommends Technology Sciences Group which has direct experience with antimicrobial copper alloy materials and products: https://www.tsgconsulting.com/geography/pesticide-compliance-fifra-usa/
- CDA is not a testing laboratory and does not evaluate copper-based products for antimicrobial efficacy. There are a number of commercial laboratories with capabilities to test antimicrobial materials and treated surfaces including the following:
- Analytical Lab Group: https://www.analyticallabgroup.com/services/antimicrobial-services/
- Biosan Laboratories: https://www.biosan.com/index.php/microbiological-laboratory/antimicrobial-testing/
- For detailed, step-by-step guidance on EPA antimicrobial product registration requirements and the application process, refer to the following official resources on EPA’s website: http://www.epa.gov/pesticide-registration/antimicrobial-pesticide-registration.
- For detailed guidance on permissible advertising claims for antimicrobial products, refer to the following chapter from EPA’s product labeling guidance which shows examples of antimicrobial efficacy claims for registered products that are (and are not) acceptable: https://www.epa.gov/sites/production/files/2017-10/documents/chap-12-nov-2013.pdf
- A list of EPA-registered copper alloy compositions identified by Unified Numbering System (UNS) designations is available at https://www.copperalloystewardship.com/sites/default/files/upload//media-library/files/pdfs/us/master_epa_registered_cu_alloy_list_2018.pdf
- The CDA website includes a searchable database of copper alloys that can be filtered by specific material properties (e.g. strength, hardness) and EPA-registered compositions: https://alloys.copper.org/?fq=antimicrobial%3A%22true%22
- A list of known EPA-registered copper alloy raw material suppliers is available at https://www.copperalloystewardship.com/node/14698