“Claims- Washing” Understanding Disinfectant Evaluations in Canada

Subsidiary of Sani Marc GroupThe Experts in Sanitation Solutions

“Claims- Washing”Understanding Disinfectant Evaluations in Canada

The Experts in Sanitation Solutions

Use of cream could lead to a reduction of up to 3 centimetres on targeted body parts such as thighs, hips waist and stomach…


"contains a highly effective natural Bio-Slim Complex for a slimmer looking and more defined silhouette" and "combines high performance active ingredients for a dual effect of slimming & reshaping."


Claims

The difference – Nivea = the consumer suffers from a loss of money and dashed hopes

Healthcare – the wrong choice of disinfectant= could mean the difference between life and death!


Why are we here?

How the disinfectant registration process works in Canada

How to determine if a disinfectant will do what you need it to do

What information should you trust

What information should you question

Louis was originally scheduled to be the speaker but his wife decided to have a baby!


Information & Experts

internet age = ease of access to information

allows by-passing the traditional experts

Led to new phenomena, a concept called “Claims- Washing” of disinfectants.


Claims Washing

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, web site or do not obtain a DIN registration for their product while making these claims to potential Canadian customers


Registration Process

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.



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…



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.

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

No DIN = No Assurance


US vs Canadian Registration

US PRODUCT

carries bacterial kill times as quick as 30 seconds24 hour residual protection1 minute certification pending

CANADIAN PRODUCT

Pre-clean all surfaces24 hour protection- Do not touch treated surface after application if residual protection is to be maintained10 minute contact time for disinfection of all organisms on the label


Disinfectant Labels in Canada

2 types of Disinfectant Labels exist:

Specific Organism Efficacy Claims on the Label

No Specific Organism Claims on the Label


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.

DIN on Label = Trust Claims


No Specific Organism Claims on the Label

4 possible Reasons for not having organisms listed on label:

Category IV Registration

Secondary Registration Claims

No Evidence of Efficacy

Organism has never been tested



Often referred to as “General DIN claims”

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.



Category IV monographs have specific rules based on historical data and tests and allow for FASTRACKING the DIN process for basic claims

Low level disinfectant claim for:

Salmonella Chloleraesuis, Staphyloccus aureus, pseudomonas aeroginosa, some easy to kill viruses

Bleach requires a PRE-CLEANED surface

10 minute contact time required


“General DIN Claims”

Cannot claim non-toxic, non-irritant, harmless, etc

The monograph does not allow for:

Use on critical or semi-critical medical devices

Claims against spores (c-diff)

Claims for pathogens (high level)

Mycobacterium species (TB)

HIV

Hep B or C viruses



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



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 that are available in writing and are freely available in the public domain inside Canada are as reliable as the DIN registrant


No Evidence of Efficacy

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.


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.


The Organism Has Never Been Tested

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.

Fact: B = effective on CA + B ≠

effective on C

The purchaser of the DIN product can make this

inductive assumption but they take responsibility for assuming the disinfectant will meet their needs.


Test method is typically AOAC use dilution test in the presence of soil

No soil in test, then pre-cleaning will be required to ensure disinfection!

If not tested using an AOAC test, then there is a high probability that it is marketing and not acceptable evidence for efficacy (exception is Virox)

SCIENCE= Replicable Data

Testing


Advertising in Canada

Canadian distributed advertising - considered “product inserts” and are extensions to the labels

No written efficacy claim in Canada specifically regarding the DIN product, no efficacy claim to hold the DIN owner accountable before Health Canada

Only applies to products intended for sale in Canada

This product is EPA Registered!


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


Don’t fall Victim to Claims Washing!

Read the LABEL! Look for DIN#, Claims on Label

Ask for product specific testing that shows the product name, test method and comparative outcome

Be strong in asking for specific test results for disinfectant products sold in Canada. Be wary of marketing material that only reference independent testing results



Conclusion

Knowledge is Power ~Francis Bacon

A prudent question is one-half of wisdom ~ Francis Bacon

We're drowning in information and starving for knowledge

~Rutherford D. Rogers

Documents

“Claims- Washing” Understanding Disinfectant Evaluations in Canada