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Frequently Asked Questions (FAQs) - Batch 7 Final Screening Assessments

Government of Canada Completes Assessments for 14 Additional Substances under the Chemicals Management Plan

1. How can the Government continue to allow 1,4-dioxane, a substance that is supposed to be banned from use in cosmetics (including some personal care products), in these exact same products that are used by Canadians?

   The health risks associated with a chemical depend on the hazard (its potential to cause health effects) and the dose (the amount of chemical to which you are exposed). 1,4-dioxane was added to the Cosmetic Ingredient Hotlist because such a use was identified as a potential health concern. It is not, however, intentionally added to cosmetics (including personal care products) but may be present in trace amounts, as a by-product of the manufacturing process. After a thorough risk assessment, it was determined that these trace levels do not pose a risk to human health.

   1,4-dioxane was previously added to the Cosmetic Ingredient Hotlist, which is Health Canada's list of ingredients that are intended to be prohibited or restricted for use in cosmetics, including many personal care products. Under Canadian legislation it is illegal to sell cosmetics that contain substances that are harmful to the user.

2. If 1,4-dioxane is already included on the Cosmetic Ingredient Hotlist, why didn't the Government's assessment conclude it poses a risk to human health?

   The Cosmetic Ingredient Hotlist is an administrative list that assists industry in meeting the requirements set out for cosmetics in the Food and Drugs Act. Ingredients on this Hotlist should not be intentionally added to cosmetics that are available on the Canadian market. Under Canadian legislation it is illegal to sell cosmetics that contain substances that are harmful to the user.

   During its assessment, data provided by non-governmental organizations and data published in peer-reviewed literature were reviewed. All data indicated the trace amounts Canadians may be exposed to through inhalation and skin absorption are several thousand times lower than levels at which health effects occur in laboratory animals. Therefore the Government concluded current exposure levels do not pose a risk to human health.

   1,4-dioxane is listed as an ingredient on the Hotlist and therefore should not be intentionally added to cosmetics; however, it may be present in trace amounts, as a by-product of the manufacturing process. These levels do not pose a risk to human health.

3. Can I continue to safely use cosmetics (including personal care products)? What about my children?

   Yes. As part of our assessment the Government determined exposure levels for both adults and children. Our assessment found that adults' exposure to 1,4-dioxane in cosmetics (including personal care products) is several thousand times lower than levels at which effects occur in laboratory animals, and children's exposure was even lower. Over the last several years, industry has introduced upgrades to manufacturing processes to reduce trace levels of 1,4-dioxane in cosmetics

4. How much shampoo would need to be used on a daily basis to reach potential levels of concern for 1,4-dioxane?

   A person would have to apply shampoo to their hair more than 620 times a day, every day in order to reach potential levels of concern for 1,4-dioxane.

5. How do consumers know whether or not Michler's ketone is present in the ink pens they buy?

   A consumer can not tell, based on visual inspection or packaging, if Michler's ketone is present in pen ink. The presence and level of Michler's ketone can only be confirmed by a lab test.

   Some data sources indicate that Michler's ketone may be present, at trace levels, in pen ink sold in Canada. To date, Michler's ketone has not been identified in any children's markers. Health Canada will continue to investigate to what degree Michler's ketone is present in the ink of pens available in Canada. These findings will help refine the risk management strategy.

6. Should parents be concerned about exposure levels if children chew on pens where Michler's ketone is present in the ink?

   Potential exposure to Michler's ketone from the ink in pens is low. As a general precaution, Canadians are reminded to carefully follow safety warnings and direction when using any product. Parents and caregivers are also reminded to encourage young children not to put non-food items in their mouths.

7. Will Canadians using alkyd paints or stains and varnishes containing 2-butanone oxime in their homes experience health effects?

   The gap between the amount of 2-butanone oxime to which Canadians could be exposed from consumer paint and the levels at which health effects are seen in animal studies is small.

   To reduce exposure to the general population, the Government is recommending restricting the concentration limit of 2-butanone oxime in indoor alkyd paints available to consumers. The concentration limit will not affect consumer paints created for outdoor use.

   Canadians are reminded they should carefully follow safety warnings and directions on product labels when using any paint products. You should work in a well-ventilated area and use recommended personal protective equipment noted on the product label.

8. What are the health effects from exposure to 2-butanone oxime?

   The most likely route of exposure to Canadians in inhalation during the use of alkyd paints. Health Canada proposes that for Canadians using products containing 2-butanone oxime on an occasional basis, the primary health effect of concern is reversible damage on the tissue lining the nose.

9. Should any specific safety precautions be taken when using alkyd paints or stains and varnishes containing 2-butanone oxime?

   Canadians are reminded to carefully follow safety warnings and directions on product labels when using any paint products. You should work in a well ventilated area and use recommended personal protective equipment noted on the product label.

10. Does alkyd paint containing 2-butanone oxime pose a risk once it has been applied to walls?

    No. Based on the available information, the most likely route of exposure to 2-butanone oxime for the general population is from inhalation during application and over the course of the following day. 2-butanone oxime is not expected to present a health concern once the painted surface has dried.

11. Should all containers of paint, stains and varnishes containing 2-butanone oxime be removed from my house?

    No. Provided the containers are properly sealed, no health concerns are expected. Canadians are reminded to properly store all of these products and to keep them out of the reach of children.

12. Does removing existing coats of alkyd paint containing 2-butanone oxime pose a risk to health?

    No. Significant exposure to 2-butanone oxime is not expected to occur when removing alkyd paint since the substance would have been dispersed into the air as the original paint dried. As a general reminder, you should follow manufacturers' instructions on the labels and always work in a well ventilated area.

13. Should alkyd paints be disposed of any differently than other paints?

    All paints should be disposed of as per local municipal requirements.

14. What happens next?

    The Government published the final screening assessments and proposed risk management actions for substances assessed in batch 7 online on March 5, 2010 and in Canada Gazette, Part I on March 6. The Government's conclusions are final. However, stakeholders have 60 days to comment on the proposed risk management actions. Stakeholders are encouraged to submit comments on the proposed risk management actions before May 5, 2010.