Suppliers that export chemicals directly into Canada or that supply ingredients for finished products that are sold in Canada and, therefore, regulated under the Food and Drugs Act (F&DA) in Canada need to ensure that these substances are nominated to the revised In-Commerce List (ICL) in Canada.
Health Canada is currently updating and revising their In-Commerce List (ICL) through an open nomination process. The ICL contains more than 9,000 substances that are regulated under the F&DA and were in commerce in Canada between Jan. 1, 1987 and Sep. 13, 2001. These substances are found in pharmaceuticals, veterinary drugs, biologics and generic therapies, cosmetics, medical devices and food additives. Unfortunately, this original list contained duplicate entries, missing entries, ambiguous entries containing generic terms, common names and trade names, making the list difficult to serve as a “definitive” regulatory inventory moving forward. The personal care industry has the chance to correct the list and supply information that would allow for this inventory to be finalized.
Regardless of the previous "in-commerce" status of a supplier's ingredients in Canada, substances that have not been recognized as "in commerce" through this process in Canada by Feb. 14, 2012, will no longer be considered to be "in-commerce" and will be subject to market restrictions as part of the Canadian Environmental Protection Act's (CEPA) new substance provisions.
Members of the Personal Care Products Council and the Canadian Cosmetic, Toiletry and Fragrance Association (CCTFA) have worked together to identify substances on the current ICL to identify the most appropriate substance name, CAS Number and identity of these ingredients as well as to identify those substances that are already inventoried on Health Canada's Domestic Substances List (DSL) and therefore not subject to this nomination process.
Suppliers, distributors, and importers of substances and finished products must engage in the nomination of substances to the revised ICL. Supplier engagement in this process will be key as the information required to support nominations is specific to the raw material being supplied to the personal care industry. As such, downstream users of raw materials need to be reassured that their formulas will not be at risk in the Canadian cosmetics market.
The following steps, if not taken today, will result in potential regulatory hurdles tomorrow (including data intensive new substances requirements).
- Become Familiar with the ICL and the ICL nomination process.
- Review all substances against the current ICL, and notify customers of engagement in the ICL nomination process.
- Nominate any substances on the current ICL with CAS numbers not on the DSL or already listed on the revised ICL.
- Substances not on the ICL (or DSL) with proof of sale in Canada between Jan. 1, 1987 and Sep. 13, 2001 can also be nominated. This may require work with customers to identify ICL eligible substances, as proof of sale has to be in a F&DA-regulated product to protect the existing status of these substances.
- Contact customers, the Personal Care Products Council, or CCTFA with questions.
- Engage now, as Feb. 14, 2012 is the deadline for nominations.
Re-registering raw materials soon on the ICL can help suppliers, distributors and manufacturers avoid time intensive regulatory reviews and pre-market notification requirements and ensure uninterrupted access to the Canadian marketplace. For more information on this nomination process, consult Health Canada's ICL website.