Cosmetics Alliance (CA) Canada has been working with Health Canada officials to allow for the importation of non-special cosmetics into China without the need for animal testing (i.e., animal testing waiver) through the use of a Health Canada-issued certificate. This certificate would be designed to meet what is presently understood to be the specific requirements for the exemption under Article 33 of China’s “Cosmetic Supervision and Administration Regulations” (CSAR), particularly that such a certificate be government issued. At this juncture, it remains unclear as to the actual intent of the Chinese regulator as it is possible that these provisions are intended to ultimately protect domestic production in China as no exporting jurisdiction has yet been able to provide such a certificate that the Chinese authority has accepted as meeting the requirements of their regulation. Consequently, imported cosmetics essentially remain subject to animal testing in China. This proposed Health Canada certificate is being designed to clearly demonstrate products are manufactured to ISO GMP standards for cosmetics, or better, such that it will help to inform Canadian trade officials if a trade compliant is warranted.
Through CA efforts, Health Canada officials have notionally agreed in principle that the best plan of action would be to leverage existing Health Canada licensing activities for drugs and/or NHPs; or third-party auditing practices under applicable manufacturing standards for cosmetics as issued by the International Organization for Standardization (ISO).
CA’s Formal Proposal, along with the proposed draft wording that would likely be reflected in any corresponding certificate issued by Health Canada, was shared with officials this past July/August for final legal and Ministerial review.
Unfortunately, officials have confirmed that they are presently operating under their “caretaker convention due to the upcoming election” [see correspondence below]. This convention puts on hold any formal interactions with stakeholders concerning legislative and regulatory policy considerations under consultation or development. As a result, officials do not anticipate being in the position to discuss next steps until after the election on September 20, 2021.
In the interim, although we are aware that regulators in some jurisdictions have developed certificates or processes to address these provisions, we understand that all such certificates are presently ‘under review’ by the Chinese authority, and to our knowledge, none have yet to be formally approved. We are also aware that certificates issued by third parties with formal, legalized recognition by a reputable regulatory agency in the exporting country are being filed with the Chinese authorities; however, similarly, none of these to date have been considered acceptable at this time.
Note: CA Canada does work with Health Canada to issue GMP Certificates through our Certificates Program. We would be pleased to work with our members (or their clients, in the case of Contract Manufacturers) to issue such certificates; however, these GMP certificates are intended for generic manufacturing considerations, and we would clarify that it is unlikely that this will meet the specific criteria for a ‘regulator-issued certificate’, as per the provisions of Article 33 of the Chinese Regulations. That said, some of our members have elected to try to leverage these GMP Certificates on the off chance that, these would be deemed acceptable at some point. If this possibility is of interest to members, we would encourage you to get in touch with our Certificates Program.
CA Canada will continue to pursue the finalization of a formal process to enable a Health Canada-issued certificate for this specific purpose and will endeavor to drive Health Canada to move forward as quickly as possible with a workable solution immediately following the election.
