Biochemical New Substance Notifications: Schedule 2
10 May 2022
What Does it Mean for You?
Did You Know?
If you use a living organism (i.e., microorganisms - yeast, fungi, bacteria) in the production process for your chemical or polymer, it is considered a biochemical or biopolymer and additional data requirements apply to your New Substance Notification (NSN) package. This excludes botanical and animal sources unless the substance is a nucleic acid (DNA or RNA) or has enzymatic activity.
It is important to remember that the Schedule 2 notification is not a stand-alone notification; it is meant to provide additional information. Parts 1 and 2 of the New Substance Notification Regulations (Chemicals and Polymers) [NSNR] outline the Schedule 2 requirements that will be required for biochemical and biopolymer NSNs. For biochemical substances that are not DNA, RNA, or an enzyme, items 1 to 4 of Schedule 2 are required; when these substances are imported/manufactured in quantities less than 1,000 kg their NSNs require items 1 to 3. This is the case for the majority of biochemicals and biopolymers. Items 1 to 4 will be further explained below.
What Do Items 1 to 4 of Schedule 2 Mean?
Schedule 2 of the NSNR contains the requirement for information respecting biochemicals and biopolymers. Items 1 to 4 include:
- The identification of the production organism: The organism used to produce the substance must be disclosed to at least the species level. In many cases, it is advisable to provide strain information to ensure the accuracy of the identification. The production organism's identification should be substantiated, and any known aliases disclosed. The strain source and history must also be disclosed. This should include a description of the source from which the strain was isolated, and any subsequent processes of selection, genetic modification, or other engineering.
- A description of any known adverse environmental or human health effects associated with exposure to the production organism: For many microorganisms, the notifier may not know of any adverse effects. It is important to contextualize the relationship or non-relationship of the organism to harmful organisms and provide evidence that a thorough scientific literature search was performed to look for evidence of adverse effects; the absence of known effects cannot be attributed to ignorance of the effects.
- The concentration of the viable production organism in the substance and in end-use products: If there is a chance that a residual living organism is present in the notifiable substance, then microbiological data should be presented to characterize the concentration of the living organism. A sound scientific rationale supporting a concentration of 0 may be sufficient if the processing of the substance includes steps known to sterilize substances (e.g., high pressures and temperatures). A description of the method used to quantify the residual production organism should also be included.
- A description of the method used to separate the production organism for the substance: A detailed description of the process used to separate the microorganism from the notifiable biochemical or biopolymer. This information can be helpful to inform item 3 as well.
To ensure the success of your biochemical or biopolymer NSN submission, the information listed in Schedule 2 and other schedules must be presented in the NSN thoroughly and with scientific rigor. The experts at Intertek Assuris can provide science-based assurance to meet these needs and submit high-quality NSNs for biochemicals and biopolymers.
To learn more about how we can support your business, visit: https://www.intertek.com/assuris/chemicals/.
New Substance Notification Regulations (Chemicals and Polymers) SOR/2005-247 New Substances Notification Regulations (Chemicals and Polymers) (justice.gc.ca)