NNHPD has updated the following monographs:
- the Primary and Secondary Sunscreen Monographs,
- the Acne Therapy Monograph and
- various other monographs
The sunscreen and acne monographs were published on December 19 in the NHP Ingredient Database; however, we understand there have been technical issues with posting these at Health Canada.
Below are the updated monographs in the meantime.
It is our understanding that, under the Monograph Update Project, no modifications are anticipated that would necessitate mandatory product licence amendments or labelling revisions. We kindly request your confirmation of this understanding. Should you identify any such changes, please advise us by responding to this email.
IN SUMMARY (Full details in the monographs)
Main changes to the Primary Sunscreen and Secondary Sunscreen monographs
- Added information to include nano titanium dioxide and nano zinc oxide under the monographs (i.e. Acceptable quantity, dosage forms, specifications)
- Added Bemotrizinol and Bisoctrizole to the Secondary Sunscreen monograph
- Added the list of acceptable dosage forms for all NHPs and NPDs
- Added in vitro methods for SPF and broad-spectrum testing (i.e. ISO 23675, ISO 23698)
- Added a note on PA rating for NHPs and NPDs allowing PA ratings as additional information on the label for NHPs only at this time and only for zinc oxide or a combination of zinc oxide and titanium dioxide.
PA rating (Protection grade of UVA)
- The PA rating system was developed in Japan and is currently used by most Asian countries.
- This system addresses UVA protection based on the Persistent Pigment Darkening method (e.g., ISO 24442).
- For NPD ingredients, data must be provided to NNHPD through the labelling only submission pathway to support any additional information regarding the PA rating.
- For NHP products containing zinc oxide or a combination of zinc oxide and titanium dioxide, the PA rating is acceptable as additional information on the label, as long as it is truthful and not misleading. Valid data using a standardized and reproducible method must be available upon request. This does not apply to titanium dioxide alone which is less effective at blocking long-wave UVA (UVA I) rays.
- Added a Product Facts table for NHPs
Main changes to the Acne monograph
- Added claims/terms to the recommended uses (e.g. Penetrates pores to eliminate/clear most acne pimples; For the treatment/management of acne breakouts).
- Added the following note to claims:
- The term “acne pimples” above can be replaced by any of the following: “acne zits” “acne blemishes”, “acne spots”, “blackheads”, “whiteheads” and “comedones”.
- Added a Product Facts Table for NHPs
- Other minor revisions:
- Added the following quantity information:
- Quantity can be expressed as percentage weight by weight (% w/w) or percentage weight by volume (% w/v), depending on the product formulation.
- Revised/Added references
- Source information column removed for NPD ingredient
