There is a strategy used by financial institutions to train personnel to identify counterfeit money. They teach people to be very familiar with the traits and properties of real money. Therefore their ability to spot fakes is not based on understanding the latest trick of the criminal but on understanding what makes a currency note legitimate.
This is the purpose of this article – to teach you how to recognize a valid and legal disinfectant chemical efficacy claim for products sold for use in Canada. This article does not apply for jurisdictions outside of Canada. In the past, people went to experts in the field to find out information and solve problems. There was a relationship between “seeker” and “teacher” that resulted in mutual benefit and the establishment of trust.
In the internet age, people with relative ease can access information on the internet from around the world. In a few hours people can perceive themselves as “self-sufficient” in information on many topics. This self-education may occur without any potential understanding of the actual trustworthiness of the information.
The problems associated with Antibiotic Resistant Organisms (AROs) have created a demand for easier-to-use, more effective and green/sustainable solutions. Companies around the world have harnessed the power of the Internet to take their message directly to the customer and by-passing the traditional experts in the field – the Chemical Distributors.
This flood of information makes it impossible for anyone to keep up with and comment on the latest proclamation of product performance. This new concept I would like to call “Claims-Washing” of disinfectants. Claims-Washing for a liquid, solid or aerosol disinfectant product occurs when companies do not openly express their efficacy claims on their labels or Canadian marketing literature or do not obtain a DIN registration for their product while making these claims to potential Canadian customers.
In Canada any liquid, solid or aerosol product which claims to disinfect surfaces is regulated under the Food and Drugs Act and requires a Drug Identification Number (DIN). The registration process which results in the issuing of a DIN ensures that the label claims are based on truth using methods recognized by Health Canada. The registration also ensures that ingredients used are suitable for the product’s intended use. The registration also ensures there is a manufacturer, distributor or agent residing in Canada which can be held responsible for the claims made about the product. The sale of any liquid, solid or aerosol product in Canada which makes a disinfectant claim when used as directed on the label without a DIN is against the Law. There is no such thing as a partial DIN, or a DIN is pending so you can buy it now… – No DIN, No Legal Sale.
Foreign registrations are not equivalent to a DIN registration. An International Disinfectant registration doesn’t mean it is as good as a DIN registration or that it will meet Canadian regulatory requirements. Many other countries do not have the same review process as Health Canada and vendors can make claims without any verification of performance or ingredients. Anyone relying on information about product performance on a non-DIN registered product has no way to know if the claims are true. Without a DIN there is no one to ensure the ingredients are acceptable for use – you have no way to know what you are buying. Without a DIN you don’t necessarily have anyone held accountable for the claims being made on the product.
1. Specific Organism Efficacy Claims on the Label – When registering a disinfectant in Canada, Health Canada will review the claims the company will make on the package label. The only way to make an organism claim on the label is to submit efficacy data to support the claim. A potential buyer of a disinfectant can completely trust any specific organism claim on a label with a DIN.
2. No Specific Organism Claims on the Label – There are only 4 reasons why any specific organism may not be listed on the label:
A. The product may have been registered as a Category IV Registration
B. Organisms may be listed on Secondary Registration Claims
C. There is no evidence of efficacy
D. The organism has never been tested
A. Category IV Registration – Certain listed active ingredients (such as quaternary ammonium chlorides – quats, chlorine bleach, etc) have a very long history of efficacy and performance as environmental hard surface disinfectants. Health Canada has recognized a pattern of performance and created a list of requirements or monograph that describes a way to fast track the registration of a hard surface disinfectant. As long as a registrant doesn’t make specific organism claims, follows certain contact time requirements and other elements specifically listed in the Category IV monograph they can receive this basic DIN without automatic efficacy information review by Health Canada. If you use a Category IV DIN registered product you are using a product with a general low level claim and for environmental surfaces and for many uses this is appropriate. However, if there are problem pathogens such as ARO’s and you want the assurance of performance against the ARO then a Category IV DIN registered product is probably not what you need.
B. Secondary Registration Claims – The efficacy information for an organism of interest may be similar to other organisms already on the label or it may have been generated after the initial registration. If the DIN registrant states the disinfectant’s identity and efficacy claim in writing and distributes this information in Canada, it is considered to be a Product Insert and therefore an extension of the product label. Health Canada can therefore hold the DIN registrant responsible for the claim and may require the registrant to submit the information for efficacy review. DIN registered product claims in writing freely available in the public domain inside Canada are as reliable as the DIN registrant.
C. No Evidence of Efficacy – This is the most obvious reason why a product claim is not available in writing on the label or on a secondary public document in Canada. If the DIN product identity and efficacy are not linked together in writing there is no Health Canada reviewable claim which the user can rely upon for accuracy. There is also no way to hold the vendor accountable for the claim.
D. The Organism has Never Been Tested – Pathogens of concern are continually being discovered by medical research. In many cases there has not been enough time or demand for specific organism testing with hard surface disinfectants. A DIN product vendor cannot make an inductive efficacy claim – Product A uses ingredient B, ingredient B is effective on organism C, therefore Product A is effective on organism C. The purchaser of the DIN product can make this inductive assumption but they take responsibility for assuming the disinfectant will meet their needs.
Advertising in Canada
How does advertising of DIN registered disinfectants such as magazine ads or internet web pages fit into efficacy claims? If the advertising of DIN products is distributed in Canada then it is considered to be a Product Insert – just like a Secondary Efficacy claim. But remember – no written efficacy claim in Canada specifically regarding the DIN product, no efficacy claim to hold the DIN owner accountable before Health Canada.
Advertising from Different Countries
What if the web site(s) or advertising states it is not intended for Canada? What if the advertising information does not specifically state it is for use in Canada? The Food and Drugs Act in Canada only applies to market activity and product use in Canada. The vendor is not accountable to Health Canada for the quality or truthfulness of these international efficacy claims.
An easy to follow flow chart is available to help you ask the questions necessary to clarify the claims and help you determine the quality of the claims. Download a copy of the document here and refer to page 4 of the document.