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Bill C-307

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C-307
Second Session, Thirty-ninth Parliament,
56 Elizabeth II, 2007
HOUSE OF COMMONS OF CANADA
BILL C-307
An Act respecting bis(2-ethylhexyl)phthalate, benzyl butyl phthalate and dibutyl phthalate

AS PASSED
BY THE HOUSE OF COMMONS
NOVEMBER 28, 2007

391284

SUMMARY
This enactment requires that, within 12 months after it comes into force, regulations respecting cosmetics that contain bis(2-ethylhexyl)phthalate be made under subsection 30(1) of the Food and Drugs Act.
The enactment also requires that, within 12 months after it comes into force, an order be made under section 6 of the Hazardous Products Act to add certain products to Part I of Schedule I to that Act.
The enactment further requires the Minister of Health to take steps to regulate the use and labelling of medical devices that contain bis(2-ethylhexyl)phthalate.
Finally, the enactment requires the Minister of the Environment and the Minister of Health to complete a reassessment of benzyl butyl phthalate and dibutyl phthalate under the Canadian Environmental Protection Act, 1999 within 24 months after the enactment comes into force.

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2nd Session, 39th Parliament,
56 Elizabeth II, 2007
house of commons of canada
BILL C-307
An Act respecting bis(2-ethylhexyl)phthalate, benzyl butyl phthalate and dibutyl phthalate
Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:
SHORT TITLE
Short title
1. This Act may be cited as the Phthalate Control Act.
INTERPRETATION
Minimum amount
2. For the purpose of this Act, a product or device shall not be considered to contain bis(2-ethylhexyl)phthalate, benzyl butyl phthalate or dibutyl phthalate if the amount of that phthalate in the product or device is less than 0.1% of the product’s or device’s mass.
Precautionary principle
2.1 In the administration of this Act, the Government of Canada shall apply the precautionary principle that, where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent adverse health impacts or environmental degradation.
REGULATIONS
Regulations —Food and Drugs Act
3. Within 12 months after the coming into force of this Act, the Minister of Health shall, taking into account the precautionary principle set out in section 2.1, recommend to the Governor in Council that regulations be made under subsection 30(1) of the Food and Drugs Act respecting cosmetics that contain bis(2-ethylhexyl)phthalate, and the Governor in Council shall, within that period, make the regulations.
Order — Hazardous Products Act
3.1 Within 12 months after the coming into force of this Act, the Minister of Health shall, taking into account the precautionary principle set out in section 2.1, recommend to the Governor in Council that an order be made under section 6 of the Hazardous Products Act to add to Part I of Schedule I to that Act products whose use involves the product being brought into contact with the mouth of a child of less than three years of age and that contain bis(2-ethylhexyl)phthalate, and the Governor in Council shall, within that period, make the order.
Obligations in relation to medical devices
3.2 The Minister of Health shall
(a) within three months after the coming into force of this Act, finalize the Department of Health’s position paper on bis(2-ethylhexyl)phthalate in medical devices;
(b) within 12 months after the coming into force of this Act, publish a document concerning the labelling that is necessary to comply with the requirements of the Medical Devices Regulations in relation to the risks inherent in medical devices that contain bis(2-ethylhexyl)phthalate;
(c) within 24 months after the coming into force of this Act, require the labelling of medical devices that contain bis(2-ethylhexyl)phthalate;
(d) facilitate the drafting by health professionals associations and hospital associations of clinical practice guidelines respecting the use of medical devices that contain bis(2-ethylhexyl)phthalate and to have the drafting of those guidelines completed within 33 months after the coming into force of this Act;
(e) within 18 months after the coming into force of this Act, prepare a list of medical devices that do not contain bis(2-ethylhexyl)phthalate that are sold in or imported into Canada; and
(f) consider for priority review, applications for medical devices licences where information obtained during the application process discloses that the medical devices do not contain bis(2-ethylhexyl)phthalate.
Risk assessment
4. The Minister of the Environment and the Minister of Health shall, within 24 months after the coming into force of this Act, have completed a reassessment, under the Canadian Environmental Protection Act, 1999, of benzyl butyl phthalate and dibutyl phthalate. The re-assessment shall include a consideration of their exposure through the use of consumer products, including cosmetics, and a consideration of the cumulative effects of those phthalates on humans.
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