Clarifying Statements

As information on Antimicrobial Copper enters the market, there is obvious potential for misinterpretation or erroneous statements concerning the efficacy and proper use of Antimicrobial Copper. The Copper Development Association is mandated by U.S. EPA to publish and correct claims or statements about antimicrobial copper alloys that are potentially false, misleading or otherwise unapproved by U.S. EPA. A list of such potentially false or misleading statements is below, including a description of the statement and a clarifying response. Inclusion on this list does not mean that the listed company or product is in violation of U.S. EPA or other federal or state regulations, but only that the statements warrant clarification to ensure a proper understanding of the claims that may be made for and appropriate uses of Antimicrobial Copper.

 

Proper Use and Care

Copper and copper alloys of at least 60% copper concentration are the only solid, touch surface material to have obtained EPA registration to claim inherent "antimicrobial" characteristics.  The below PDF file explains the terms and conditions to the EPA's registration.  Certain claims are approved and some are not approved by the EPA when marketing Antimicrobial Copper products.  Guidelines for what makes both an acceptable and unacceptable claim are laid out within this PDF file.  The file also provides commentary on how to properly care for your Antimicrobial Copper products.

Click the below link to learn more.

View [PDF 89kB]

 

Antimicrobial Copper Kitchen & Bathroom Products (Website)

The following potentially misleading statements and omissions were found on a website marketing kitchen and bathroom products made from copper alloys as antimicrobial:

• "Copper can also help to keep the home clean and safe by reducing the risk of spreading harmful bacteria. Studies have shown that copper has remarkable natural antibacterial properties which actually kill dangerous bacteria such as E. coli in a matter of hours, while stainless steel and other traditional surfaces allow them to survive for weeks."

EPA does not allow any antimicrobial product to claim that it makes the home or other use site "safe," and also does not allow "natural" claims (which they believe implies safety; we use the term "inherent" instead).  In addition, EPA requires Antimicrobial Copper product advertising and labeling to indicate that while they have been shown to reduce microbial contamination, they do not necessarily prevent cross-contamination.  Claims cannot be made regarding protection from the actual acquisition or transmission of infectious pathogens.

EPA also requires that advertising and labeling clearly indicate that the use of Antimicrobial Copper surfaces is a supplement to, but not a substitute for routine cleaning of the product.

Further, Antimicrobial Copper surfaces are only registered to make public health claims against the following five bacteria: Vancomycin-resistant Enterococcus faecalis(VRE), Methicillin-resistant Staphylococcus aureus, Enterobacter aerogenes, Pseudomonas aeruginosa, Staphylococcus aureus, and Escherichia coli O157:H7.  No claim of antimicrobial effectiveness can be made, either express or implied, with regard to organisms (including bacteria in general) other than those identified above.

Finally, Antimicrobial Copper surfaces are only permitted to claim a greater than 99.9% reduction of the six aforementioned bacteria within two hours of contact.  Any claims regarding kill times shorter than two hours have not been validated by EPA-approved testing.  The website statement should include a note indicating that 99.9% of the six specified bacteria are killed within two hours of contact.

 

Antimicrobial Copper Pens (Website)

The following potentially misleading statements and omissions were found on the website of a California-based manufacturer marketing pens made from copper alloys as antimicrobial:

• The claims on the website fail to specify the critical information that the copper alloy surfaces kill 99.9% of bacteria* within two hours of contact.

• The website should indicate clearly that the copper surfaces offer antimicrobial activity so long as the pen is cleaned as necessary to be free of dirt or grime that could inhibit contact with the surface.

• "[Website name omitted], committed to providing Copper based, bacteria free surfaces."

EPA does not allow Antimicrobial Copper surfaces to claim they are "free" of bacteria. The claim must be limited to achieving a 99.9% bacteria* kill within two hours, when cleaned regularly.

• "This surface prevents the buildup of disease-causing bacteria*."

The approved claims language is that the surface "inhibits" - not "prevents" - the buildup and growth of bacteria* within two hours of exposure between routine cleaning and sanitizing steps.

• The website should include an "*" after each mention of the term bacteria, to make clear the six bacteria against which the copper alloy surfaces have been shown to be effective.

• "With the rapid transfer of everyday germs and deadly bacteria, it makes sense to protect employees, customers and yourself from acquiring, or passing along unhealthy bacteria."

Antimicrobial Copper surfaces have been shown to reduce microbial contamination, but do not necessarily prevent cross-contamination. Claims cannot be made regarding protection from the acquisition or transmission of infectious pathogens.

• The information provided in the "Terms and Conditions" section included the principles below which U.S. EPA requires marketers of Antimicrobial Copper products to convey clearly to the customer or potential customer. This section should appear on the main website page. EPA requires this information to be presented in a conspicuous manner, consistent with how other claims language is presented. Inclusion in the "Terms and Conditions" section buries this required language.
  • Antimicrobial Copper surfaces are a supplement to and not a substitute for standard infection control practices.
  • Users must continue to follow all current infection control and cleaning practices.
  • Routine cleaning to remove dirt and grime is necessary for good sanitation and to assure the effective performance of the antimicrobial copper alloy surface.
  • Antimicrobial Copper surfaces must not be coated in any way (i.e. with waxes, paints, lacquers, etc.) in order to be effective. The natural tarnishing of copper alloys does not compromise their antimicrobial property.

 

Consider Copper in the Kitchen for a Healthy New Year

A press release discovered online advertised a kitchen cutting board made out of copper as antimicrobial. Claims made in the press release are not consistent with the registrations granted to Antimicrobial Copper alloys and warrant clarification. A summary of the claims in question is provided below with the company information removed:

• "Consider a gift for the kitchen that saves energy and stops germs at the same time, a gift of antimicrobial copper from [Company]."

• "Copper is well known for its beauty, functionality and durability but now consumers can add documented germ-killing properties to its list of household benefits."

The statements above are erroneous and misleading for several reasons:

1. Antimicrobial Copper surfaces are not registered to make public health claims for food contact or preparation surfaces, such as cutting boards, and therefore, public health claims cannot be made about the product in question. At this time, Antimicrobial Copper alloys are only registered for a wide variety of indoor touch, non-food contact applications.
2. Antimicrobial Copper alloys are only registered to make public health claims against the following five bacteria: Vancomycin-resistant Enterococcus faecalis (VRE), Methicillin-resistant Staphylococcus aureus, Enterobacter aerogenes, Pseudomonas aeruginosa, Staphylococcus aureus, and Escherichia coliO157:H7. Any reference to effectiveness against other organisms has not been proven by U.S. EPA-approved testing. No claim of antimicrobial effectiveness can be made, either express or implied, with regard to organisms other than those identified above.

 

Adhesive-Backed Copper Foil Patches

A Texas based entrepreneur selling adhesive, antimicrobial copper foil patches was found to be making several health claims on a marketing website that are not consistent with the EPA registration for Antimicrobial Copper alloys.

To make antimicrobial claims when marketing Antimicrobial Copper products, the vendor must ensure that the claims language is consistent with the EPA-approved label for Antimicrobial Copper. At minimum, the EPA-approved label requires marketers to indicate the following:

1. That laboratory testing has shown that Antimicrobial Copper kills 99.9% of bacteria* within two hours, when cleaned regularly;
2. That the use of copper alloys is a supplement and not a substitute for standard infection control practices;
3. That users must continue to follow all current cleaning and infection control practices; and
4. That while Antimicrobial Copper surfaces have been shown to reduce microbial contamination, they do not necessarily prevent cross-contamination.

This labeling language must be presented with at least the same prominence (i.e. font size, emphasis, location, etc.), as other label claims.

Further, in order to legally sell Antimicrobial Copper products in the U.S., a vendor must buy material from a registered supplier of Antimicrobial Copper alloys (i.e., sheet, strip, foil, rod, etc.). The vendor must also apply for an EPA establishment number which appears on product labels for tracking purposes. These product requirements are mandated by EPA and are necessary to ensure product performance and regulatory compliance.

The vendor has been contacted and informed of the requirements associated with selling Antimicrobial Copper products.

*Testing demonstrates effective antibacterial activity against Vancomycin-ResistantEnterococcus faecalis (VRE), Staphylococcus aureus, Enterobacter aerogenes, Methicillin-Resistant Staphylococcus aureus (MRSA), Escherichia coli O157:H7, and Pseudomonas aeruginosa.

 

Copper-based Electroplating

A press release was issued in February 2009 from a company with the capabilities to electroplate a variety of substrates with a thin, copper based layer. The press release uses direct language from the U.S. EPA registration of Antimicrobial Copper alloys to advocate claims that their products are antimicrobial and can make public health claims. Information regarding the efficacy, registration, and approved uses of Antimicrobial Copper was taken out of context, and a summary of the erroneous or misleading claims is included below for clarification. The company and product name has been removed.

1. The product is not a Unified Numbering System (UNS) alloy. One of the registration requirements for Antimicrobial Copper alloys is that the material must be a recognized Unified Numbering System (UNS) alloy. A combination of 282 Wrought and Cast UNS copper alloys are currently registered with EPA as antimicrobial. In contrast, the product is a plating process that will produce surfaces that are not, and cannot be UNS alloys and therefore, are not registered.
2. The product contains less than 60% nominal copper content. Copper alloys must contain at least 60% nominal copper content in order to be eligible for EPA registration. According to the press release, the product "is an alloy that is comprised of approximately 50% copper..."
3. References to killing "germs," "germicidal," or general bacteria. The press release cites copper's ability to kill "germs" or unspecified bacteria on several occasions. The EPA registration for Antimicrobial Copper alloys only permits public health claims against six specific bacteria: Vancomycin-Resistant Enterococcus faecalis (VRE), Staphylococcus aureus, Enterobacter aerogenes, Escherichia coli O157:H7, Pseudomonas aeruginosa, and Methicillin-resistant Staphylococcus aureus (MRSA). These specific bacteria must be clearly identified when referencing the antibacterial properties of copper.
4. References to fighting the "spread of infection." The title of the press release states that their products "fight the spread of infection." No antibacterial product can make claims related to preventing the spread of infections; rather the claims must refer to fighting bacteria that are associated with or can cause infections. In addition, EPA requires that marketing materials for Antimicrobial Copper clearly state that the materials have been shown to reduce microbial contamination, but do not necessarily prevent cross contamination. Registered copper alloys can only claim to fight the six specified bacteria that may cause infections, not the infections themselves.
5. EPA registration claims taken out of context and misstated. The press release does not accurately state the EPA-approved claims for Antimicrobial Copper alloys and fails to include required disclaimer language. The claims also fail to mention that efficacy has been demonstrated only against: Vancomycin-Resistant Enterococcus faecalis (VRE), Staphylococcus aureus, Enterobacter aerogenes, Escherichia coli O157:H7, Pseudomonas aeruginosa, and Methicillin-resistant Staphylococcus aureus ("MRSA"). Marketing materials for Antimicrobial Copper products must also inform the user that the use of a registered Antimicrobial Copper alloy is a supplement to and not a substitute for standard infection control practices; users must continue to follow all current infection control practices, including those practices related to cleaning and disinfection of environmental surfaces. Finally, the press release fails to note that that registered Antimicrobial Copper alloys cannot be oiled, lacquered, waxed, painted, or otherwise coated in any way.
6. Reference to copper being proven to "effectively kill bacteria and prevent the re-growth of bacteria on a variety of surfaces and substrates." Antimicrobial Copper can only claim to inhibit the buildup and growth of the five mentioned bacteria within two hours of exposure between routine cleaning and sanitizing steps.
7. Use of Antimicrobial Copper for "instruments and hardware" and image of surgical instruments. Surgical instruments and other medical devices are not EPA-approved uses for Antimicrobial Copper alloys. These applications are regulated by the U.S. Food and Drug Administration (FDA) and therefore public health claims for these uses cannot be expressed or implied without an FDA clearance.

 

Copper Sinks and Tubs

A manufacturer of copper sinks and tubs made the following claims about some of their products:

"Since copper is a natural antibacterial, antimicrobial surface, it is not necessary to disinfect or scrub the sink or tub. To help keep the copper product looking its best, apply a thin coat of wax occasionally."

CLARIFICATION:

The above statements are not approved by the U.S. EPA. Antimicrobial Copper is a supplement to and not a substitute for standard infection control practices. Users must continue to follow all current infection control and cleaning practices. Routine cleaning to remove dirt and grime is necessary for good sanitation and to assure the effective performance of the Antimicrobial Copper surface.

Also, Antimicrobial Copper surfaces must not be coated in any way (i.e. with waxes, paints, lacquers, etc.) in order to be effective. The natural tarnishing of copper alloys does not compromise their antimicrobial property.

 

Copper Imbedded Socks and Clothing

An article reported that a manufacturer of socks woven with copper imbedded fibers made several claims about the socks which are not approved by the U.S. EPA. The article stated as follows (the company name has been removed):

1. "The U.S. Environmental Protection Agency this year allowed manufacturers to make the claim that copper and copper alloys used in clothing can kill germs. So [Company] started using copper fiber to make socks. The claim says put on a pair of copper socks and 99.9 percent of the germs on your feet will be dead in two hours."
2. "Eliminates 99.9% of bacteria and fungi."

These statements are erroneous and misleading for several reasons:

1. The U.S. EPA has not approved Antimicrobial Copper surfaces for use in clothing or fabrics as the antimicrobial efficacy of the materials has not been demonstrated under these use conditions.
2. Some products using copper impregnated fibers are allowed to be marketed under the "treated article exemption," which allows the products to make claims regarding protection of the article itself (but not human health) against bacteria or germs that may cause deterioration, odors or discoloration. This is not to be confused with the registrations granted to Antimicrobial Copper alloys which are permitted to make public health claims.
3. The claim that Antimicrobial Copper alloys kill 99.9% of bacteria within two hours is only valid against six specific bacteria: Vancomycin-ResistantEnterococcus faecalis (VRE), Methicillin-resistant Staphylococcus aureus(MRSA), E.coli O157:H7, Enterobacter aerogenes , Pseudomonas aeruginosa , and Staphylococcus aureus . Claims concerning Antimicrobial Copper's effectiveness against any organism other than these five bacteria have not been approved by the U.S. EPA.
4. The claim that copper kills the germs "on your feet" has not been - and, in fact, cannot be - approved by the U.S. EPA because claims against germs in or on human beings fall under FDA jurisdiction.