We wish to update you on recent developments on the restriction currently listed in the Natural Health Products Ingredient Database (NHPID) for Titanium dioxide as a Non-Medicinal Ingredient (NMI) in sunscreens and the resolution we have reached with the Natural and Non-Prescription Health Products Directorate (NNHPD) on this file.
Currently the NHPID lists Titanium dioxide for topical use as an opacifying agent and colour additive but is not permitted in sunscreens (primary and secondary).
We have received confirmation from the NNHPD that until this TiO2 restriction has been consulted upon, the NNHPD will maintain a status-quo, with TiO2 being acceptable as an NMI in sunscreen products as an opacifying agent and colour additive. Correspondingly, we understand that this restriction will not be enforced during submission review at this time, and that further stakeholder consultations will be pursued should this status change in the future.
WHAT THIS MEANS:
- For any sunscreen applications for which you have filed and received a rejection because you listed TiO2 as a NMI, you may re-file these applications (please reach out to regulatory@cosmeticsalliance.ca if you fall into this category as our understanding from the NNHPD is no applications have been rejected to-date and we have been asked to confirm this from our members).
- For any sunscreen applications in queue, you should not receive any questions or be rejected if you have listed TiO2 as a NMI on your application.
- For any new application, you may proceed with filing these applications and expect no questions regarding the listing of TiO2 as a NMI in your application.
- For existing products, there is no need to adjust your formulations at this time. If you have become aware of the restriction in the NHPID and have begun re-formulating or re-configuring your products because of this change, please notify us at regulatory@cosmeticsalliance.ca.
Should you have experiences contradictory to the above, please notify Cosmetics Alliance so we can facilitate a follow-up with the NNHPD.
NEXT STEPS
We appreciate that the NNHPD has informed us of this change prior to dropping of the writ of election. They have requested information from Cosmetics Alliance and our membership, which we will be sharing with you in the coming days. We will be managing the consolidation from this input through our Product Compliance & Market Access Committee. This information will assist them in better understanding industry practices, the role of TiO2 as a NMI versus medicinal ingredient in sunscreen products, as well as the scientific rationale for its use for different purposes. This information will facilitate any future revisions to the NHPID entry for TiO2 such that industry may continue to formulate products in a manner that meets the intent of the Food and Drugs Act and its regulations.
The NNHPD remains committed in this fiscal year to publishing the NHPID guidance that was originally consulted on as part of the Management of Applications Policy (MAP) last summer. The NHPID portion of the MAP consultation document was removed due to the complexity of the issue and the need to implement the MAP for the other elements.
