We have incorporated new details into the revised Monograph Consultation Update Schedule created by Cosmetics Alliance which can be found here.
The following 8 monographs were published on March 28, 2025.
Batch 4b
- Calendula – Buccal, Goldenseal – Buccal, Sage – Buccal, Thyme _ Buccal
Monographs not in batches
- Spirulina, Echinacea angustifolia, Garlic, Lecithin
This load also includes revisions to the 4 multi-ingredients monographs listing the medicinal ingredient Cannabis sativa as a result of Regulations Amending Certain Regulations Concerning Cannabis (Streamlining of Requirements) published in the Canada Gazette, Part II, on March 12th, 2025.
It should be noted that the NNHPD’s monographs only include Hemp seed and Hemp seed preparations; however, the Specifications section was adjusted in the following monographs to align with the above-mentioned updates. Note that its source material ‘seed’ was also revised to ‘non-viable seed’.
- Antioxidants, Workout Supplements, Fixed oil products, Traditional Chinese Medicine Ingredients (TCMI)
In fact, the derivatives made by processing a non-viable seed, a stalk (mature without any leaf, flower, seed or branch) or its derived fiber, and the root of any of its parts (or a product made by those derivatives) are no longer excluded NHP substances. However, the original requirement that Cannabis sativa does not contain more than 10 μg/g THC, an isolated or concentrated phytocannabinoid or a synthetic duplicate of that phytocannabinoid remains in place.
In addition to adjusting the Specifications section, the following minor revisions were also conducted:
Antioxidants:
- Revision of the genus of spirulina as per the current taxonomy and addition of 3 spirulina species
- Addition of the combination rule for blueberry to match the single ingredient monograph
- Addition of a combination rule for Spirulina species
Workout Supplements:
- Adjustments of the rules for caffeine to match the ones listed in the caffeine and cognitive functions products monographs
- Addition of a footnote for Table 12 specifying that the placeholder variables (X and Y) for the Creatine direction of use statements should be defined on the PLA form as an additional direction of use statement.
- Two duration of use statements revised to list the duration in weeks rather than months to resolve a validation issue.
Fixed oil products:
- Some information in Table 2 was revised to ‘As per the XX monograph’ as inconsistencies between the information on the Fixed oil products monograph and on the respective single ingredient monographs were identified.
- Additional claims were added to Table 3 to ensure consistency between fatty acids.
- Claims related to EPA + DHA were combined under one section and quantities were clarified to ensure consistency with the single ingredient monographs.
- Two footnotes were added for Table 3.
- Additional note indicating that the quantity (XX% or mg) of total omega-3 (or omega-6) fatty acids can be added on the label if desired.
- Under combination rule, the statement, ‘The combined maximum daily dose of EPA + DHA or EPA + DHA + DPA in a single product must not exceed 5,000 mg for 18 years and older per day’ was revised to remove ‘EPA + DHA + DPA’ since this would only apply to EPA and DHA.
TCMI:
- Additional introductory notes to clarify the expectations in terms of preparation according to pharmacopoeial standards and restrictions at Class II and III.
- Additional notes included under the quantity section to clarify the expectations for topical products.
- Small adjustments of the risk statement section to match revisions made in other monographs and current approach for TCM products.
- 11 medicinal ingredients were moved from Table 3 to Table 1 as the NHPID comments for these ingredients are in fact not linked to any specific requirements.
- Minor revisions to monographs previously updated:
- In addition, we have made minor revisions to the following 3 monographs:
Amla:
- One of the common names was missing in the French version.
- Typo in one of the common names.
Aloe-oral:
• Source material part revised from ‘Leaf latex’ to ‘Latex’ to match NHPID.
Aloe leaf gel:
- Source material part and methods of preparation revised in French to match NHPID.
- Risk statement revised in French from ‘Consulter’ to ‘Consultez’ and ‘si vous souffrez de diabète’ to ‘si vous avez le diabète’ to match the wording used in other monographs.
