Guidance on safety requirements for biocides: Overview, application requirements

Purpose

This guidance document outlines the tools and approaches you can use to meet the requirements in the Biocides Regulations (regulations) on safety. These tools and approaches may reduce the number of requests for clarification that we send, thus allowing the Minister to make a decision on your biocide in a timely manner.

You're responsible for ensuring that you:

have scientific evidence to support the safety of your biocide
label and package your biocide to mitigate risks in accordance with the regulations

Your application should include:

sufficient information on the benefits and risks associated with your biocide (including safety information) and any uncertainties relating to those benefits and risks
a summary of this information (including safety information) and any uncertainties relating to those benefits and risks

General

If you wish to deviate from this guidance, you should contact us at nnhpd-dpsnso@hc-sc.gc.ca before filing your application.

If the Minister does not have sufficient information to conclude that the benefits outweigh the risks of your biocide, taking into consideration any related uncertainties, we will either:

request additional information to support your biocide or
refuse to issue a market authorization for your biocide

Examples of situations where we may request additional information include:

when we are aware of a safety concern related to the biocide
when the proposed risk information on the label text is inconsistent with the hazard profile of your biocide
- for example, your biocide is labelled as an irritant when it's known to be corrosive
when there are known impurities
- for example, carcinogenic impurities
if you have submitted the minimum application requirements, but there is insufficient information in your application for the Minister to make a decision
when information in your safety summary shows there is a specific concern that should be investigated

Examples of additional safety information that could be requested to better characterize the benefits and risks of your biocide include:

data
literature
safety data sheets (SDS)
written scientific rationale

Good laboratory practice

You should conduct safety testing according to good laboratory practice (GLP) to ensure your data is of high quality and is reliable. You're responsible for choosing a testing laboratory that complies with our GLP compliance requirements. There are many test laboratories in North America that are able to conduct testing compliant with GLP.

Other types of GLP compliance standards include those published by the:

If you choose to use non-GLP compliant safety data (for example, non-GLP studies or GLP studies with outages):

make sure the alternate standard you choose to assess your facility's compliance is equivalent to GLP certification
- an example of an alternate standard would be certain International Organization for Standardization certification standards
- this scenario is more common for testing done by European laboratories
we will assess whether the deviations from GLP or alternate standards are acceptable

You should include rationales to demonstrate:

how they differ from GLP standards
how they meet alternative standards
your use of non-GLP compliant testing

Take note that including rationales for non-GLP data does not guarantee we will accept the submitted data to support the safety of your biocide.

Application requirements

Full review and full review - novel biocide applications

You must provide in your application:

safety information
a safety summary

Applications based on comparison and use of foreign decisions

You do not need to provide safety data or a safety summary in your initial application if you're relying on identical safety information from an application of another biocide that received authorization. This applies to applications filed through the following pathways:

use of foreign decisions (UFD)
comparison - labelling only
comparison - administrative

However, we recommend that you include a summary of differences between the foreign biocide or comparison product and your biocide (for example, packaging). This will reduce the need for clarification requests for applications filed through the following pathways:

UFD
comparison - labelling only

Visit the summary section for more information.

Monograph applications

Safety information for monograph applications is required, as the monograph only elaborates on efficacy information.

To help the Minister determine that the benefits of your biocide outweigh the risks taking into account any related uncertainties, you should submit the following safety information:

a copy of the SDS, if available
- for example, products with commercial uses
an explanation of the biocide's hazard profile
safety rationales to support the proposed risk information and directions for use

The SDS, if available, should include:

end-point toxicities and how they relate to the Hazardous Products Regulations (HPR) classification
information on the biocide's safety profile

You must also provide a safety summary, though it can be abbreviated when using the monograph application pathway. The Minister may request additional safety information in order to assess the biocide's benefits, risks and uncertainties.