Canadian Regulatory Update

Jan 1, 2012 | Contact Author | By: David C. Steinberg, Steinberg & Associates
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Title: Canadian Regulatory Update
Health Canadax EUx FDAx Canadax
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Keywords: Health Canada | EU | FDA | Canada

Abstract: Discussion of regulatory changes, beginning with the most urgent. In addition, highlights comments published by Health Canada, in conjunction with Advertising Standards Canada, on acceptable and unacceptable cosmetic claims.

Canada has had many regulatory changes to its chemicals, drugs and most recently, to its cosmetics. This column will discuss those regulatory changes, beginning with the most urgent. In addition, this column will highlight new comments published by Health Canada, in conjunction with Advertising Standards Canada, on acceptable and unacceptable cosmetic claims.

Urgent Ingredient Issues

In the February 2003 issue of Cosmetics & Toiletries magazine, this author and Kathleen Rowland (now Ljubisic) reviewed the chemical registration plan as part of the Canadian Environmental Protection Act (CEPA),1 which went into effect in 1988. At the time that CEPA was passed, chemicals in Canada were recorded in the Domestic Substances List (DSL) but there were two exemptions—polymers and chemicals regulated by the Food and Drugs Act (F&DA). Between Jan. 1, 1987, and Sep. 13, 2001, ingredients used in cosmetics or drugs and regulated by the F&DA were exempt from CEPA notification. In the late 1990s, when this exemption was overturned by Parliamentary Review, these substances were placed on the In-Commerce List (ICL). In addition, they became subject to CEPA’s New Substance Notification Regulations (NSNR), which were implemented in 1994 for chemicals entering the Canadian market after 1988 and requiring approval before being placed on the DSL. NSNRs are regulated by Health Canada and Environment Canada.

Four lists are on the ICL, including: Substances in Human Pharmaceuticals, Veterinary Drugs and Similar Products In Commerce Between 1987 and 2001—CAS Registry Number Known; Substances in Cosmetics and Personal Care Products In Commerce Between 1987 and 2001—CAS Registry Number Known; Substances in Cosmetics and Personal Care Products In Commerce Between 1987 and 2001—CAS Registry Number Not Found; and Substances in Cosmetics and Personal Care Products In Commerce Between 1987 and 2001—Ingredient or Mixture of Ingredients Unknown.2

CEPA requires the nomination of all chemicals that enter Canada’s environment in quantities over 100 kg/year either via manufacture or import as a chemical or mixture, i.e., cosmetic formulations. The exceptions are naturally occurring substances, which are defined as: natural source materials or an extract/isolate from natural source materials; primary molecular structures that are unaltered from their original forms (regardless of processing method); or a salt or derivative of substances that are natural source materials and primary molecular structures provided that the structural alterations are reversible under environmentally relevant conditions.

While all chemicals on the ICL have been allowed in Canada for cosmetics and OTC drug use, now Environment Canada and Health Canada are reviewing this list. Any ingredient currently on the list or eligible to be considered in commerce during the period cited above must be re-registered by Feb. 14, 2012, or it will be considered a new chemical and subject to an NSNR. Included on the list are many trade names, duplicate entries, mixtures and unusual names such as: cinnamon wood, barley water, purified spring water, essence of kiwi, pina colada, premium whole leaf aloe vera concentrate, actiphyte of Japanese green tea concentrate and BG50A. In order to re-register an ingredient, a CAS number is required and registration forms are available on Health Canada’s website.

Completing an NSNR is a costly process and involves testing requirements and fees, as explained in the 2003 column.1 All ingredient suppliers and cosmetic manufacturers should verify their ingredients on the ICL and ensure they are re-registered. If the ingredients are not on the ICL but the supplier/manufacturer has proof that the ingredient was in Canada in 1987–2001, they can also apply for this status on Health Canada’s ICL Web page.

Other News from Environment Canada

Another important recent announcement is decamethylcyclopentasiloxane’s (D5’s) positive review by the Environment Canada’s Siloxane D5 Board of Review. Its conclusion was that the material “does not pose a danger to the environment or its biological diversity.” This was submitted by the Canadian Cosmetic, Toiletry and Fragrance Association (CCTFA) to the Canadian Minister of Environment on Oct. 20, 2011. Previously, D5 was listed as CEPA Toxic, which could have led to restrictions or even prohibition from use in Canada.

Cyclotetrasiloxane (D4) has already been declared CEPA Toxic and will probably be prohibited from use in cosmetics and drugs in the future. With the D5 decision reversal, trace amounts of D4 will be allowed as contaminants of D5. However, if the generic term cyclomethicone is included in an ingredient list or cosmetic notification, no level of D4 will likely be permitted. Therefore, those who have not yet changed their ingredient disclosure from cyclomethicone to the correct INCI name, i.e., Cyclopentasiloxane or Cyclohexasiloxane, should do so immediately.

The second issue is Environment Canada’s proposal to declare Red 17 (CI 26100) (non-certified batches are called Solvent Red 23) as CEPA Toxic. Use of Red 17 in the United States is low, but those who export or manufacture products containing the ingredient in Canada should reformulate. This oil-soluble dye is found in nail polish, nail polish remover, lipsticks and bath oils. It will probably be added to the Health Canada’s Cosmetic Ingredient Hotlist, which would ban it from Canada. Another cosmetic ingredient, diethylhexyl adipate, is being proposed for the CEPA Toxic designation. While this has less use than Red 17 according to the U.S. Food and Drug Administration’s (FDA) Voluntary Cosmetic Registration Program database, it is an emollient used in perfumes/colognes, bath products, aftershave lotions, skin fresheners, skin cleansers, makeup foundations, lipsticks and other skin care products. Finally, triclosan has been moved up to a “pilot substance” for review, meaning it has been given a higher priority. This review has been affected by the pressure by nongovermental organizations, which are constantly attacking this ingredient.

Drugs vs. Cosmetics vs. Natural Health Products

In 2009, Health Canada started organizing product regulation under its F&DA through its Classification of Products at the Drug/Cosmetic Interface, which regulates products under one of three types of regulations: drug regulations, cosmetic regulations or natural health product (NHP) regulations.3

The first and only product that has been reclassified is antiperspirant, which is now regulated as a cosmetic instead of as a natural health product. This aligns Canada’s regulations with that of the European Union (EU), but it will prevent dual-labeled products between Canada and the United States, as the United States still regulates antiperspirants as OTC drugs. There are other products under consideration such as skin protectants, medicated cosmetics, dandruff shampoos, etc., but it is encouraging that sunscreens will probably be the next on the list.

Health Canada and Cosmetics

Health Canada have been working for several years to have the required Cosmetic Notification Form available as an electronic format. The current file format can be filled in electronically but it must be printed and mailed to Health Canada. Notification currently is required no later than 10 days after the cosmetic enters Canada. A guidance document is available to answer questions on filing.4

In addition, Health Canada has created a new system for notifications called the Cosmetic Online System (CosmOS), which will allow for improved management of information and forms. The launch of the system has been delayed so that problems including incident reporting can be worked through but it is expected to be available in 2012. The system will create an online database of cosmetic products in Canada and will allow for label submissions. There are five fields in the system: type of notification and submission; product brand and name; use (human-animal); form (from a list); and function (from a list). All lists will include “other” as an option and space to clarify; contact information for the registrant, including name, address, phone, fax, e-mail address and website; contact information for the product distributor; and product composition including a supplier contact, which had not been required under the current notification system.

Health Canada is also working on changes to its Cosmetic Program, which encompasses strengthening Cosmetic Notification requirements. Included may be the pre-market notification of 60 days or more before a product can be sold on the Canadian market. In addition, exact concentrations of ingredients would need to be provided rather than codes for ranges, which are currently used (see Table 1). Health Canada may require manufacturers to submit a draft of the text on their product labels, including any contact allergens found in fragrances that are listed in the EU’s Annex III List of Substances Which Cosmetic Products Must Not Contain Except Subject to Restrictions and Conditions Laid Down. Finally, Health Canada is seeking a better definition for “coal tar dyes.” It is important to note that these are proposed changes that are under discussion; the industry will need to wait until the final version is adopted.

Advertising Claims

Health Canada, in conjunction with Advertising Standards of Canada, also has published Guidelines for Cosmetic Advertising and Labeling Claims in 2006, which has recently been updated with additional claims. All claims are listed either as acceptable or unacceptable and are divided by categories of: substrate (hair, nails and skin); product (oral care, cosmetic sun care products, makeup, etc.); and claim type (anti-aging, nourish, therapy, etc.), with further sub-categories such as the ones listed in parentheses above.5 The latest additions are nails, exfoliants (under skin) and skin moisturizers (under skin).

Comments

It is critical for ingredient suppliers and marketers with ingredients on the ICL to re-register these ingredients before the deadline. The cost of an NSNR along with the disruption of business will be significant. Changing the CEPA Toxic designation for D-5 is a true triumph of good science. Cosmetic regulation needs more decisions such as this, and the individuals from the CCTFA who worked on this issue deserve the industry’s gratitude.

Health Canada’s movement of topical drugs without dose restrictions to instead be regulated as cosmetics resolves many issues that arose with the creation of NHPs. If NHPs were written like the United States’ dietary supplement laws, they would have included the critical phrase “for ingestion.” One approach would have been to add this phrase but when that seemed unlikely, Health Canada moved NHPs toward cosmetic regulation. The products still contain actives that are pre-approved and tested, etc., but they will be labeled and aligned more like they are in the EU. This is good news for Canadian manufacturers and at the end of this movement, the United States will be the only country that regulates OTC drugs without dose restrictions as drugs. Maybe this will trigger some action by the FDA.

Finally, total electronic registration of cosmetics will allow Health Canada to obtain more information for quicker action if there are safety concerns. The critical issue will be if Health Canada moves to a pre-approval mode instead of notification. As this is not official yet, the industry will need to follow where this leads. The advertising claims guidelines benefit the cosmetics industry since there is no question as to what is acceptable and what is not. As Canada closely follows U.S. rules, although the United States does not have such a list of acceptable and unacceptable claims, U.S. manufacturers and regulatory personnel could perhaps use the Canadian list to help decide what to claim. Reproduction of the article without expressed consent is strictly prohibited.

References

Send e-mail to davidpreserve@comcast.net.

  1. K Rowland, Canadian Environmental Protection Act and Its Personal Care Implications, Cosm Toil 118(2) 26–31 (2003)
  2. In-Commerce List of Food and Drugs Act Substances, Health Canada, www.hc-sc.gc.ca/ewh-semt/contaminants/person/impact/list/index-eng.php (Accessed Nov 11, 2011)
  3. Guidance Document: Classification of Products at the Cosmetic-Drug Interface, Health Canada, www.hc-sc.gc.ca/cps-spc/pubs/indust/cosmet_drug_guide-drogue-ref/index-eng.php (Accessed Nov 11, 2011)
  4. Guide for Completing Cosmetic Notification Forms, Health Canada, www.hc-sc.gc.ca/cps-spc/cosmet-person/indust/require-exige/guide-eng.php (Accessed Nov 11, 2011)
  5. Guide for Cosmetic Advertising and Labelling Claims, Health Canada, www.hc-sc.gc.ca/cps-spc/pubs/indust/cosmet/index-eng.php#a23 (Accessed Nov 11, 2011)
 

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Table 1. Codes for ingredient concentration ranges

 Table 1. Codes for ingredient concentration ranges

Range of Ingredient Code
30–100% 1
10–30% 2
3–10% 3
1–3% 4
0.3–1% 5
0.1%–0.3% 6
0.1% or less 7

 

Biography: David C. Steinberg, Steinberg & Associates

David C. Steinberg founded Steinberg & Associates, a consulting firm based in Plainsboro, NJ, USA, in 1995. Co-founder of the graduate program in cosmetic sciences at Fairleigh Dickinson University, where he lectured for 18 years on cosmetic chemistry, Steinberg has more than 35 years of experience in marketing, technical service and regulatory affairs in the personal care industry. In addition, he was president of the Society of Cosmetic Chemists in 1991. Steinberg is a frequent speaker worldwide on cosmetic regulations and preservation as well as sunscreen and cosmetic ingredient chemistry. In 2009, he was honored as the first regulatory expert in personal care to be granted fellow status by the Regulatory Affairs Professional Society. He wrote the Alluredbook, Preservatives for Cosmetics, Third Edition. 

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