Health Canada's objective in distributing this consultation document is to provide stakeholders with an opportunity to comment on proposed new lead content restrictions under the Lead Risk Reduction Strategy for Consumer Products (LRRS) before the formal regulatory process is initiated. Identifying and resolving stakeholder concerns through early consultation is expected to facilitate the development of effective and workable lead content regulations for affected products.
Lead is an inexpensive heavy metal which has many potential uses in children's products, but the substance is very toxic, especially to children, even at low doses. Lead builds up in the body so ongoing exposure, even to relatively low levels of lead, can eventually result in accumulation of harmful levels in the body. Lead has been shown to have subtle effects on children's development even at very low blood lead levels. No safe level of lead in the blood has been identified by the international scientific community. However, since lead occurs naturally in the earth, and has been used industrially for centuries, it is found in trace amounts everywhere. It would be impractical for regulators to set limits of zero lead in products, since testing will always show detectable amounts of lead.
Children are especially at risk of exposure to lead in consumer products, since exposure occurs mainly when lead-containing products are chewed, sucked, or swallowed. Lead is a soft metal and some exposure can also occur when objects with surfaces containing high amounts of lead, such as lead figurines, are handled and the hands are then put to the mouth.
The Canada Consumer Product Safety Act (CCPSA), which replaced Part I and Schedule I of the Hazardous Products Act, came into force on June 20, 2011. The Act includes prohibitions on the manufacture, import, advertisement or sale in Canada of consumer products which pose an unreasonable hazard to human health or safety. The CCPSA also prohibits the supply of products that do not meet the requirements set out in the regulations. There are various regulatory limits on the lead content of children's products under the CCPSA. However, current regulations do not address all children's products or product components which may create a risk of chronic exposure to lead.
The LRRS proposes lead content limits for four categories of consumer products to which children are most likely to be exposed. Group 1 Regulations have been enacted as the Consumer Products Containing Lead (Contact with Mouth) Regulations. These Regulations, which are under the CCPSA, can be viewed at the Justice Canada site.
This regulatory proposal would extend the scope of the Consumer Products Containing Lead (Contact with Mouth) Regulations to additional product groups. The proposed changes are indicated below. This is not an official regulatory draft.
The definition of "consumer product containing lead" would be expanded to include:
The following definition would be added:
"child care article" means a product that is intended to facilitate the carrying, transport, relaxation, sleep, or hygiene of a child under four years of age
To align with the provisions of the Canada Consumer Product Safety Act, the scope of the regulations will be adjusted to include the manufacture of affected products, as well as the import, advertisement or sale.
Some questions which stakeholders may wish to comment on are outlined below. However, Health Canada welcomes stakeholder input on all areas which directly relate to the above regulatory proposal.
If you are unsure whether specific types of products would be affected by this proposed regulatory initiative, please identify these product types.
Unless otherwise specified, federal regulations come into force on the date they are registered. To allow for a transition period, the regulations may indicate that they come into force a specified period of time after the day on which they are registered.
The Consumer Products Containing Lead (Contact with Mouth) Regulations do not require the use of any specific test methodology for determining total lead content. However, parts exempted from the total lead limit of 90 mg/kg must be tested for compliance with the 90 mg/kg migratable lead limit using the EN71-3 methodology specified in the Regulations.
While companies are advised to test products they market in Canada to ensure that they are compliant with all applicable health and safety requirements, this regulatory proposal does not include mandatory requirements for testing and certification of affected products and product parts.
Please identify any issues of concern which do not fall into the areas listed above.
Health Canada will review and respond to stakeholder comments received on this consultation document by providing a written summary of the comments and Health Canada's responses. Further consultation activities may be undertaken, if appropriate, between completion of this consultation and initiation of the formal regulatory process. The formal regulatory process includes an additional opportunity for stakeholder to provide input, generally in the form of a 75-day comment period following pre-publication in Canada Gazette, Part I.
Stakeholders may submit comments in any written form, by regular mail to the address below or by e-mail to CPS-SPC@hc-sc.gc.ca. Respondents may wish to respond directly to the questions above.
The closing date for submission of comments on this proposal is February 17, 2012.
Consultation on proposed Group 2 Regulations under the Lead Risk Reduction Strategy for Consumer Products
Risk Management Bureau
Consumer Product Safety Directorate
123 Slater Street, 4th floor, Address locator 3504D