Playpens Regulations: SOR/2018-186

Canada Gazette, Part II, Volume 152, Number 20

Registration

September 26, 2018

CANADA CONSUMER PRODUCT SAFETY ACT

P.C. 2018-1187 September 24, 2018

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 37 footnote a of the Canada Consumer Product Safety Act footnote b, makes the annexed Playpens Regulations.

Playpens Regulations

Interpretation

Definitions

1 The following definitions apply in these Regulations.

accessory means a product, including a change table accessory and a sleep accessory, that is designed or advertised to be used with a playpen and that has the following characteristics:

fastener includes all of the following items:

good laboratory practices means practices that are in accordance with the principles set out in the Organisation for Economic Co-operation and Development document entitled OECD Principles of Good Laboratory Practice, Number 1 of the OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, ENV/MC/CHEM(98)17, the English version of which is dated January 21, 1998 and the French version of which is dated March 6, 1998. (bonnes pratiques de laboratoire)

occupant retention area means

playpen means a product that has the following characteristics:

structural cover means a structural component of a playpen or sleep accessory that has the following characteristics:

supplied with, in respect of an accessory, means designed to be used and sold together with a specific playpen or accessory that is made by the same manufacturer. (fourni)

Specifications

Requirements for Playpens and Accessories

Toxicity

2 Every playpen or accessory that contains a toxic substance must comply with section 25 of the Toys Regulations in relation to that substance.

Coatings

3 Every playpen and accessory must be free from any surface coating material that contains any of the following substances:

Stitching

4 All stitching that forms part of a playpen or accessory must be lock-stitching.

Shearing and pinching

5 A playpen or accessory must not have any part that is accessible to the child and that may cause injury to the child due to shearing or pinching.

Parts — textile or other pliable material

6 Any part of a playpen or accessory that is made of a textile or other pliable material and that is permanently affixed to a rigid structural component of the product must not, when the playpen or accessory is tested in accordance with Schedule 1, tear or become detached from the component.

Mesh — strength and integrity

7 (1) Any mesh that is made of a textile or other pliable material and that forms part of a playpen or accessory must not, when tested in accordance with Schedule 2, tear or become detached.

Mesh — size of openings

(2) The openings in mesh that is made of a textile or other pliable material and that forms part of a playpen or accessory must be of such a size that the hemispherical tip of a probe described in Schedule 3 is unable to pass through the openings when tested in accordance with that schedule.

Flammability

8 Any part of a playpen or accessory that is made of a textile or other pliable material must have a flame spread time greater than seven seconds, when tested in accordance with the Canadian General Standards Board standard CAN/CGSB-4.2 No. 27.5, entitled Textile Test Methods: Flame Resistance — 45° Angle Test — One-Second Flame Impingement, as amended from time to time, in either of the following circumstances:

Posts

9 A post of a playpen or sleep accessory must not extend more than 1.5 mm — measured within 76 mm from the outermost surface of the post — above the lowest point on the upper surface of the higher of the sides that adjoin the post.

Openings — entrapment

10 When a playpen or sleep accessory is tested in accordance with Schedule 4, there must not be any completely bounded opening in the surfaces that define the occupant retention area through which a solid rectangular block that measures 60 mm × 100 mm × 100 mm is capable of passing in any orientation.

Parts — wood, plastic or similar hard material

11 (1) Every exposed part of a playpen or accessory that is made of wood, plastic or a similar hard material must be smoothly finished to eliminate sharp edges and points and be free from cracks, burrs and other defects.

Parts — metal

(2) Every exposed part of a playpen or accessory that is made of metal must be smoothly finished to eliminate sharp edges and points and be free from burrs.

Metal tubing

(3) Every cut edge of any metal tubing that is part of a playpen or accessory must meet one of the following requirements if the cut edge is accessible to the child:

Bolts

(4) The threaded end of every bolt of a playpen or accessory must, if the end is accessible to the child, be covered by an acorn nut or a device that offers equivalent protection.

Small parts

12 Every part of a playpen or accessory that is accessible to the child and that is small enough to be totally enclosed in the small parts cylinder illustrated in Schedule 5 must be affixed to the product so that the part does not become detached when it is subjected to a force of 90 N applied in any direction.

Parts — openings

13 Every slot, notch, groove or other opening in a wooden, plastic or metal part of a playpen or accessory — or in a part of one made of a similar hard material — that is accessible to the child must meet one of the following requirements:

Cords and straps — length — general

14 (1) A cord, strap or other similar item that is attached by only one of its ends to a playpen or sleep accessory must not measure more than 188 mm in length when it is stretched by the gradual application of a force of 22 N.

Cords and straps — length — change table accessory

(2) In the case of a cord, strap or other similar item that is attached by only one of its ends to a change table accessory that is placed on or fixed to a playpen, the portion of the cord, strap or item that extends into the playpen’s occupant retention area must not measure more than 188 mm in length when it is stretched by the gradual application of a force of 22 N.

Cords and straps — loops — general

15 (1) When tested in accordance with section 1 of Schedule 6, a cord, strap or other similar item that is attached to a playpen or sleep accessory must not be capable of forming either of the following loops:

Cords and straps — loops — change table accessories

(2) When tested in accordance with section 2 of Schedule 6, a cord, strap or other similar item that is designed to restrain a child in a change table accessory that is placed on or fixed to a playpen must not be capable of forming a loop that can be pulled into the occupant retention area of the playpen and that permits the passage of the small head probe illustrated in the figure to that schedule.

Pads

16 A floor pad or mattress pad that is supplied with, or that is designed or advertised to be used with, a playpen or sleep accessory respectively must, when it is installed according to the manufacturer’s instructions, meet the following requirements:

Additional Requirements for Playpens

Stability

17 When a playpen is tested in accordance with Schedule 7, at least three support points, each of which is found below or as close as possible to a post and one of which is not in a straight line with the other two, must remain in contact with the inclined plywood sheet.

Height of sides

18 When the top rails of the sides of a playpen are placed in the manufacturer’s recommended use position and no load is applied to its playing surface, the upper surface of the top rail of every side must be at least 508 mm higher than the playing surface.

Side deflection

19 The upper surface of the top rail of every side of a playpen must

Strength of sides

20 The top rail of every side of a playpen that has a hinge and the latching or locking mechanisms of the rail must not, when the playpen is tested in accordance with section 2 of Schedule 8, break or disengage.

Rigid top rails — folding playpen

21 A rigid top rail of a folding playpen that has at least two hinges that latch or lock when the playpen is placed in the manufacturer’s recommended use position and that permits the top rail to fold vertically downwards from that position when unlatched or unlocked must meet the following requirements:

Non-rigid top rails

22 A non-rigid top rail of a playpen must not, when tested in accordance with section 3 of Schedule 9, deform so that the surfaces or points that are identified on the template that is illustrated in the figure to that section and that are set out in columns 1 and 2 of the table to that section are in simultaneous contact with the top rail.

Top rails affixed to brackets

23 A playpen that has brackets that are affixed to its top rails and that are located above its posts must, when the playpen is tested in accordance with Schedule 10, meet the following requirements:

Latching or locking mechanisms — folding playpens

24 (1) A folding playpen must have a latching or locking mechanism that prevents the playpen from spontaneously folding up or collapsing when the playpen is placed in the manufacturer’s recommended use position.

Latching or locking mechanisms — top rails that fold down

(2) A latching or locking mechanism that is on the top rail of a folding playpen that has a hinge permitting the rail to fold downwards must latch or lock automatically when the rail is placed in the manufacturer’s recommended use position.

Latching or locking mechanisms — operation

25 Every latching or locking mechanism on a playpen must meet one of the following requirements:

Appearance of latching or locking — top rails

26 When a playpen is tested in accordance with Schedule 11, a top rail of a playpen that has a latching or locking mechanism must fold when the mechanism is unlatched or unlocked.

Entanglement

27 When a playpen is tested in accordance with Schedule 12, the load illustrated in Figure 2 to that schedule must not remain caught on any mechanism, fastener or projection of the playpen that is accessible to the child.

Structural integrity

28 The playing surface of a playpen, any component of the playpen that is located below the playing surface as well as the playpen’s rigid structural components must not exhibit any damage when the playpen is tested in accordance with Schedule 13.

Vertical displacement — removable floor pad with panel

29 (1) A removable floor pad of a playpen that is composed of a rigid panel or a series of rigid panels must not, when the playpen is tested in accordance with section 1 of Schedule 14, be displaced upwards more than 133 mm.

Vertical displacement — removable and foldable component

(2) A removable and foldable component of a playpen that is composed of a rigid panel or a series of rigid panels and on which a removable floor pad rests must not, when the playpen is tested in accordance with section 2 of Schedule 14, be displaced upwards more than 133 mm.

Additional Requirements for Accessories

Entrapment — accessory placed on or fixed to playpen

30 (1) When tested in accordance with section 1 of Schedule 15, any opening that is created when an accessory is placed on or fixed to a playpen must not permit the passage of the small head probe illustrated in Figure 1 to that section unless the opening also permits the passage of the large head probe illustrated in Figure 2 to that section.

Entrapment — accessory detached or displaced

(2) When tested in accordance with section 2 of Schedule 15, any opening that is created when an accessory detaches or is displaced from a playpen must not permit the passage of the small head probe illustrated in Figure 1 to section 1 of that schedule.

Exception

(3) Subsections (1) and (2) do not apply in respect of a manufacturer’s recommended use position for an accessory if, in that position, the playpen’s floor pad cannot be used with the playpen.

Structural integrity — sleep and change table accessories

31 Every sleep accessory and change table accessory must be capable of supporting one of the following loads at the following locations for 60 seconds without any damage to the accessory:

Sleep accessories — angle

32 (1) The angle of the sleeping surface of a sleep accessory must not exceed 7° from the horizontal.

Sleep accessories — angle of foldable mattress pad

(2) The angle of the surfaces adjacent to a fold in a foldable mattress pad that is supplied with, or that is designed or advertised to be used with, a sleep accessory must not, when the sleep accessory is tested in accordance with Schedule 16, exceed 7° from the horizontal.

Sleep accessories that rock or swing — angle

33 Every sleep accessory that rocks or swings must meet the following requirements:

Sleep accessories — height of sides

34 The upper surface of every side of a sleep accessory must be at least 191 mm higher than the sleeping surface when no load is applied to the sleeping surface.

Sleep accessories — restraint systems

35 A sleep accessory must not have a child restraint system.

Information and Advertising

General Provisions

Reference to Canada Consumer Product Safety Act or Regulations

36 Information that appears on a playpen or accessory, that accompanies one or that is in any advertisement for one must not make any direct or indirect reference to the Canada Consumer Product Safety Act or these Regulations.

Advertising

37 An advertisement must not show a playpen or accessory in any way that is contrary to the warnings set out in sections 44 to 49.

Presentation of Information

Presentation — general

38 The information required by these Regulations must meet all of the following requirements:

Print

39 (1) The required information must be printed in a standard sans-serif type that

Height of type

(2) The height of the type is determined by measuring an upper case letter or a lower case letter that has an ascender or a descender, such as “b” or “p”.

Signal words

40 (1) The signal words “WARNING” and “MISE EN GARDE” must be displayed in boldfaced, upper case type that is not less than 5 mm in height.

Other information — height of type

(2) All other required information must be displayed in type that is not less than 2.5 mm in height.

Requirements for Playpens and Accessories

Required information

41 The following information must appear on every playpen and on every accessory that is sold separately, as well as on any packaging in which one of those products is displayed to the consumer:

Assembly and use — playpens

42 (1) The following information must appear on every playpen in text, drawings or photographs, or in any combination of them:

Assembly and use — accessories

(2) The following information must appear on every accessory in text, drawings or photographs, or in any combination of them:

Exception — accessories supplied with playpens

(3) Despite subsection (2), if the accessory is supplied with a playpen, the information required by that subsection may appear on the playpen.

Exception — Pouches

43 Despite paragraph 38(b), the information that is required by section 42 may be contained in or on a pouch that is permanently affixed to the playpen or accessory if the relevant warnings set out in sections 44 to 49 are provided with that information.

Additional Requirements for Playpens

Warning — all playpens

44 The following warning or its equivalent must appear on every playpen:

WARNING

MISE EN GARDE

Warning — folding playpens

45 The following warning or its equivalent must appear on every folding playpen, immediately after the warning required by section 44:

WARNING

MISE EN GARDE

Additional Requirements for Accessories

General

Warning — accessories

46 The following warning or its equivalent must appear on every accessory:

WARNING

MISE EN GARDE

Warning — accessories — occupant retention area

47 The following warning or its equivalent must appear on every accessory that extends over or into the occupant retention area, immediately after the warning required by section 46:

WARNING

MISE EN GARDE

Warning — accessories other than sleep accessories

48 The following warning or its equivalent must appear on every accessory other than a sleep accessory, immediately after the warnings required by sections 46 and 47:

WARNING

MISE EN GARDE

Sleep Accessories

Warning — sleep accessories

49 The following warning or its equivalent must appear on every sleep accessory immediately after the warnings required by sections 46 and 47:

WARNING

MISE EN GARDE

Repeal

50 The Playpens Regulations footnote 1 are repealed.

Coming into Force

Six months after publication

51 These Regulations come into force on the day that, in the sixth month after the month in which they are published in the Canada Gazette, Part II, has the same calendar number as the day on which they are published or, if that sixth month has no day with that number, the last day of that sixth month.

SCHEDULE 1

(Section 6)

Test for Strength of Parts Made of a Textile or Other Pliable Material that are Permanently Affixed to a Rigid Structural Component

1 The following method is to be used for testing the strength of playpen or accessory parts that are made of a textile or other pliable material and that are permanently affixed to a rigid structural component of the product:

SCHEDULE 2

(Subsection 7(1))

Test for Strength of Mesh and Integrity of Attachment

1 The following method is to be used for testing the strength of mesh on a playpen or accessory and the integrity of its attachment to that product:

SCHEDULE 3

(Subsection 7(2))

Test for Determination of Mesh Size

1 The following method is to be used for testing the size of openings in mesh on a playpen or accessory:

SCHEDULE 4

(Section 10)

Test for Openings

1 The following method is to be used for testing completely bounded openings that are formed or exposed in the surfaces that define the occupant retention area of a playpen or sleep accessory:

SCHEDULE 5

(Section 12)

Small Parts Cylinder

Small Parts Cylinder - Description below

SCHEDULE 6

(Section 15)

Tests for Loops

Playpens and Sleep Accessories

1 The following method is to be used for testing a loop that is formed by a cord, strap or other similar item of a playpen or sleep accessory:

Change Table Accessories

2 The following method is to be used for testing a cord, strap or other similar item of a change table accessory that is designed to restrain a child:

Figure — Small head probe

Figure — Small head probe - Description below

SCHEDULE 7

(Section 17)

Test for Stability

1 The following method is to be used for testing the stability of a playpen:

Figure — Stability test device

Figure — Stability test device - Description below

SCHEDULE 8

(Sections 19 and 20)

Tests for Deflection and Strength of Sides

1 The following method is to be used for testing the deflection of a playpen’s sides:

2 The following method is to be used for testing the strength of a side of a playpen that has a hinge:

SCHEDULE 9

(Sections 21 and 22)

Tests for Top Rail Configuration

1 The following method is to be used for testing the space created when a rigid top rail of a folding playpen is folded:

2 The following method is to be used for testing the V-shaped space created by the unlatching or unlocking of only one of the hinges of a rigid top rail of a playpen:

3 The following method is to be used for testing the space created when a non-rigid top rail of a playpen is folded:

Figure — Test Template B

Figure — Test Template B - Description below

TABLE

Combinations of Surfaces and Points

Item

Column 1

Surface or point
of template

Column 2

Surface or point
of template

1

B1

B2

2

C1

C2

3

C1

D

4

C2

D

5

B1C1

B2C2

6

C1D

C2D

SCHEDULE 10

(Section 23)

Test for Top Rails Affixed to Brackets

1 The following method is to be used for testing the top rail of a playpen that is affixed to brackets that are located above a post:

SCHEDULE 11

(Section 26)

Test for Latching or Locking Mechanisms

1 The following method is to be used for testing the latching or locking mechanism of a top rail of a playpen:

SCHEDULE 12

(Section 27)

Test for Entanglement

1 The following method is to be used for determining whether a mechanism, fastener or projection of a playpen that is accessible to the child poses an entanglement hazard:

Figure 1 — Ring gauge

Figure 1 — Ring gauge - Description below

Figure 2 — Load

Figure 2 — Load - Description below

SCHEDULE 13

(Section 28)

Tests for Structural Integrity

1 The following method is to be used for testing the structural integrity of the playing surface of a playpen, of any component of the playpen that is located below the playing surface and of the playpen’s rigid structural components under static conditions:

2 The following method is to be used for testing the structural integrity of the playing surface of a playpen, of any component of the playpen that is located below the playing surface and of the playpen’s rigid structural components under dynamic conditions:

SCHEDULE 14

(Section 29)

Tests for Vertical Displacement of Removable Floor Pad and Removable and Foldable Component

1 The following method is to be used for testing the vertical displacement of a removable floor pad of a playpen that is composed of a rigid panel or a series of rigid panels:

2 The following method is to be used for testing the vertical displacement of a removable and foldable component of a playpen that is composed of a rigid panel or a series of rigid panels and on which a removable floor pad rests:

SCHEDULE 15

(Subsections 30(1) and (2))

Tests for Entrapment in Accessories

1 The following method is to be used for testing openings that are created when an accessory is placed on or fixed to a playpen:

Figure 1 — Small head probe

Figure 1 — Small head probe - Description below

Figure 2 — Large head probe

Figure 2 — Large head probe - Description below

2 The following method is to be used for testing openings that are created by the detachment or displacement of an accessory from a playpen:

SCHEDULE 16

(Subsection 32(2))

Test for Angle of Foldable Mattress Pad of Sleep Accessories

1 The following method is to be used for testing the angle of the surfaces adjacent to a fold in a foldable mattress pad that is supplied with, or that is designed or advertised to be used with, a sleep accessory:

SCHEDULE 17

(Paragraph 39(1)(b))

Standard Sans-serif Type

Standard Sans-serif Type - Description below

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues: Playpen designs have evolved since the last major amendment to the Playpens Regulations in 1991. Health Canada has identified safety concerns with certain playpen product designs, including playpen accessories such as sleep accessories and change table accessories. Incidents with these products have resulted in injuries and deaths.

Description: Under the Canada Consumer Product Safety Act (CCPSA), the new Playpens Regulations (the Regulations) are being introduced to address identified hazards by Health Canada, including additional performance requirements and test methods to address unintentional folding or collapse of the playpen’s top rails, and the introduction of performance requirements and test methods for playpen accessories, including accessories intended for infant sleep.

The Regulations are intended to help improve the safety of these products and to further safeguard against injuries and deaths by aligning the majority of the Canadian requirements with American mandatory rules, and aligning some others with the current Cribs, Cradles and Bassinets Regulations (CCBR).

Cost-benefit statement: The costs of the changes are associated with the few regulatory requirements that are not in alignment with those in the American mandatory rules, relating to angles of sleep surfaces. Industry members may choose to re-engineer, rebrand, or pull non-compliant products to meet the new requirements. Total costs are estimated at $6.5 million over 20 years when discounted at 7%. The benefit is a reduction in the risk of airway obstruction in sleeping infants associated with uneven or angled sleeping surfaces. A break-even analysis indicates that the benefits would outweigh the costs if one death was avoided over 20 years.

“One-for-One” Rule and small business lens: The “One-for-One” Rule does not apply, since the Regulations do not impose any administrative costs on industry. The small business lens does not apply because the estimated nationwide cost impact is less than $1 million per year.

Domestic and international coordination and cooperation: The Regulations align the majority of the Canadian requirements with the American mandatory rules while also aligning some other requirements with the current CCBR. Greater alignment helps facilitate industry compliance and trade between the two countries. Those few areas where the Regulations do not align with American requirements are necessary to enhance the level of safety of infants and young children.

Gender-based analysis plus: The Regulations take into consideration the amount of strength that children and the elderly can apply, and have specified requirements to allow for the operation of products while still providing safety. No difference was noted between the different gender of occupants and caregivers. There is no additional cost associated with this issue.

Background

The Playpens Regulations came into force on September 1, 1976, and were developed to help reduce injuries and deaths from occurring in products designed to provide a safe playing environment for infants and young children. Over the years, playpen designs have evolved and Health Canada has identified safety hazards with certain playpen designs, including playpens with accessories such as change table accessories and sleep accessories. The hazards include strangulation in collapsed top rails, entrapment between accessories and the playpen, entrapment in openings in the textile sides of the playpen, and angles of sleeping surfaces of sleep accessories. Health Canada has responded to these issues by negotiating voluntary recalls with industry.

Health Canada’s Consumer Product Safety Directorate (CPSD) has received reports of incidents, including injuries, deaths, and safety concerns, related to the use of playpens and playpen accessories from consumers, physicians, medical officers, and industry.

Between 1990 and December 31, 2017, CPSD received 162 reports of incidents associated with playpens and playpen accessories. Of these, there were 11 deaths, one serious injury, 33 minor injuries, and 117 incidents without injury.

Of the 11 reported deaths, 4 involved a playpen accessory. In 2005, a child died as a result of head entrapment between the playpen top rail and a change table accessory that was left attached to the playpen. In 2009, a child died in a sleep accessory with a sloped sleeping surface. Two children died when they were placed to sleep on change table accessories, in 2008 and 2013. The children were placed to sleep on their stomach and their side respectively, which could have contributed to their deaths.

Another death occurred in 2010 when a child in a playpen at the foot of the parents’ bed suffocated on soft bedding that had fallen into the playpen during the night.

Of the remaining six deaths, two, in 1998 and 2007, involve children strangling in collapsed top rails. In 1991 and 1995, two children were strangled when their clothing became caught on projections on the top rail of playpens. In 1999, a child died as a result of strangulation by a strap that the child pulled into the playpen. In 2017, a child died as a result of asphyxiation possibly due to mattress pad displacement.

Examples of minor injuries include: bruising; lacerations; threads from stitching becoming wrapped around a finger, toe, or neck; and small parts such as foam and hard plastic pieces that came off the playpen and were found in children’s mouths. The serious injury involved the partial severing of a child’s finger as the playpen was being set up.

Between 1995 and December 31, 2017, Health Canada negotiated 19 voluntary recalls with industry, of which 8 were related to entanglement, 6 to top rail collapse and 5 to accessories. In an effort to address incidents, Health Canada has issued public education materials and warnings concerning playpens and playpen accessories including: a playpen public education bulletin in 2009 about the safe use of playpens; a booklet entitled “Is Your Child Safe” in 2006 which includes recommendations concerning playpens; and a warning to parents and caregivers in 1998 about the potential strangulation hazard posed by projections on some playpens.

Issues

Playpen designs have evolved since the last major amendment to the Playpens Regulations in 1991. Health Canada has identified safety concerns with certain playpen product designs, including playpen accessories such as sleep accessories and change table accessories. Incidents with these products have resulted in injuries and deaths.

Despite outreach activities, continued incidents highlight the need for regulatory changes to improve the safety of playpens and playpen accessories to, for example: limit the size of openings between playpen rails and playpen accessories; limit the angles of sleep surfaces; include requirements for latching and locking of top rails and for the strength and integrity of top rails; limit projections on playpens; limit the length of accessible straps; and mandate that warnings be present specifying to never put a child to sleep on a change table accessory or place soft bedding in the playpen.

Health Canada has also received requests from playpen manufacturers for greater alignment of the Canadian requirements with American requirements.

Objectives

The objective of the Regulations is to help increase playpen safety by aligning the majority of the Canadian requirements with the American mandatory rules, and aligning some others with the CCBR. American mandatory rules for playpens and their accessories are in the Code of Federal Regulations (CFR) and consist of 16 CFR Part 1221 – Safety Standard for Play Yards and 16 CFR Part 1218 – Safety Standard for Bassinets and Cradles.

Description

The Playpens Regulations were originally promulgated under Part I of the Hazardous Products Act, and were transferred to the CCPSA when Part I of the Hazardous Products Act was repealed in June 2011. The Regulations repeal and replace the Playpens Regulations (SOR/2016-189). The Regulations enhance safety and better align Canada’s safety requirements with American mandatory rules. This approach allows for the use of consistent terminology within the Regulations and terminology which is also consistent with other similar regulations made under the CCPSA, such as the CCBR.

The Regulations will strengthen construction and performance requirements in the following areas:

  1. Entrapment in openings in the textile sides of playpens and sleep accessories
  2. Floor pad spacing and mattress pad spacing
  3. Angles of sleep surfaces
  4. Warnings
  5. Stability
  6. Latching and locking of top rails
  7. Side deflection and strength
  8. False latch
  9. Top rail configuration
  10. Top rail to corner post attachment
  11. Entanglement on projections
  12. Corner post height
  13. Floor pad thickness
  14. Height of playpen sides
  15. Openings — finger entrapment
  16. Floor pad vertical displacement
  17. Strength of playing surfaces
  18. Mesh opening sizes
  19. Mesh and fabric attachment strength
  20. Accessories — entrapment
  21. Number of wheels
  22. Side height of sleep accessories
  23. Mattress pad thickness of sleep accessories
  24. Integrity of playpen accessories
  25. Angle of sleep accessories that rock or swing
  26. Allowance for the use of a pouch to store assembly and use instructions

Items 1 to 3 align with the CCBR, while items 4 to 25 align with American mandatory rules, with one exception regarding entrapment hazards associated with playpen accessories (item 20). Item 26 was added to address stakeholders’ feedback. A more detailed description of the new requirements can be found below.

1. Entrapment in openings in the textile sides of playpens and sleep accessories

Some playpens and sleep accessories have fasteners, such as zippers or snaps, to fasten the textile sides to the product’s frame. The potential exists for the textile cover to become unfastened, which could result in a child becoming entrapped between, or falling through, a resulting opening. The Regulations specify requirements for openings which can pose an entrapment hazard. The Regulations include a performance requirement and test method — aligned with that of the CCBR — to assess and limit the size of openings in playpens and sleep accessories.

Health Canada is aware of one product that had been sold in Canada but not in the United States that exhibited an opening through which the torso probe passed, and which required a very low force to undo the zippers which held the sleep accessory onto the playpen. Health Canada is therefore including this test to address playpen and sleep accessory designs for which the textile cover can be unfastened to create a potential entrapment hazard.

2. Floor pad spacing and mattress pad spacing

Floor pads and mattress pads that do not fit snugly against the sides of the playpen or sleep accessory may create gaps between the pad’s edge and the product’s sides. A child could become wedged in such gaps or exposed to hazards underneath the pad. The CCBR include a requirement limiting any gap between the mattress and any part of the crib, cradle, or bassinet side to 30 mm. Similarly, the Regulations include a 30 mm limit for between the floor pad and the playpen’s sides or between the mattress pad and sleep accessory’s sides.

The intent of this requirement is to help further reduce the risk of entrapment between the mattress pad’s edge and the product’s sides. The American mandatory rules do not have a floor pad spacing limit for playpens, but they have a mattress pad spacing limit of one inch (25.4 mm) for playpen sleep accessories. Both the 25.4 mm limit and the 30 mm limit effectively afford the same degree of protection to young children given the extremely small difference. There is no evidence indicating that 30 mm is not adequately protective; the limit has been present in the CCBR since 1986. Sleep accessories that comply with the American limit would also comply with the Canadian limit.

3. Angles of sleep surfaces

The potential for serious injury or death is present when infants and young children are not placed to sleep on a firm and flat sleeping surface. To limit the potential for suffocation or asphyxia, a maximum angle is introduced for the sleeping surface of sleep accessories. Based on the current available science and a Health Canada risk assessment, the Regulations include a maximum angle of seven degrees for the incline of the sleep surface. Please also see item 25 for the angles of products that rock or swing.

Health Canada’s risk assessment included an examination of known incidents and deaths and the results of a 1995 Australian study — the only known scientific study on infant sleep surface angles. The study’s infant test subjects were assessed at angles of 5, 7 and 10 degrees to determine what angle was the most protective in minimizing the risk of an infant rolling and getting trapped in a corner or other entrapment/asphyxiation scenario. All of the infants who were subjected to the five- and seven-degree angles were able to keep their airway open, since at those angles, the infants still had the ability to pivot their head in order to maintain a free airway. Conversely, the infants tested at an angle of 10 degrees were unable to pivot their head, and their airway remained obstructed. This risk applies to any sleep surface. Health Canada, therefore, is adopting a seven degrees maximum flatness angle in keeping with the view that all surfaces for sleep should provide the same level of safety.

4. Warnings

There is the potential for serious injury or death as a result of improper use of a playpen or accessory to a playpen. The Regulations include bilingual warning statements relating to issues such as blind and curtain cord proximity to playpens to reduce the risk of strangulation; the assembly and use of playpens and accessories, including the age and abilities range of children for whom the products are designed; supervision while a child is in the playpen; and keeping the playpen free of soft bedding to reduce the risk of suffocation.

5. Stability

Over the years, the design of playpens has evolved from rigid structures to the playpen models now available, which have more flexible sides, and are typically collapsible or foldable. The test for stability in the Regulations does not require all support points to remain in contact with the test plane. Given the flexible playpen designs available today and in alignment with the American mandatory rules, the Regulations require that the playpen must have at least three perimeter support points that remain in contact with the test plane. Additionally, one of the support points must not be in a straight line with the other two and must be of a sufficient distance from one another.

6. Latching and locking of top rails

To further safeguard playpens against unintentional collapse, the Regulations include requirements relating to playpens’ top rail latching and locking mechanisms. The Regulations require that any latching or locking mechanism must engage automatically and have either a single-action mechanism that requires the application of a specified force to unlatch or unlock it, or a dual-action mechanism that requires separate deliberate and simultaneous actions to unlatch or unlock it.

7. Side deflection and strength

The Regulations include requirements to prevent playpen sides from breaking or folding when subjected to static weights. Reports of incidents received by Health Canada, as well as voluntary playpen recalls that it has requested, have highlighted the importance of strengthening the requirements relating to side deflection and strength. The potential for serious injury or death is created when a playpen side unexpectedly disengages, folds, or deflects, reducing the playpen’s side height when a child is in the playpen.

8. False latch

In order to further safeguard against unintentional folding or collapse of the top rail, the Regulations include requirements that no top rail must give the appearance of being in the manufacturer’s recommended use position unless the locking device is fully engaged.

9. Top rail configuration

Health Canada has worked with companies to voluntarily recall playpens with top rails that can unexpectedly collapse while the child is in the playpen. The resulting “V” shape created by the playpen’s collapsed top rails presents a neck entrapment hazard to the child. The Regulations include a test to eliminate playpen designs incorporating a hinge or latch that is capable of creating a “V” or diamond shape when folded.

10. Top rail to corner post attachment

Health Canada has received reports of incidents involving top rail to corner post attachment, and is proposing a requirement to prevent fatigue failures, such as broken corner brackets and loosened fasteners, in the corner post attachment joints. The Regulations include a test assessing whether corner brackets can withstand a single significant twisting action applied at a specific location near the midpoint of the top rails.

11. Entanglement on projections

A child’s clothing can become entangled on projections on a playpen. To safeguard against entanglement, the Regulations include a requirement that a playpen must not have any projection, fastener, or mechanism that can entangle an occupant’s clothing or other object worn by the occupant.

12. Corner post height

Corner posts may present a strangulation hazard to the occupant. An occupant’s clothing may become caught on a corner post. Therefore, the Regulations include a requirement to limit the height of corner posts to 1.5 mm above the lowest point on the upper surface of the higher of the sides that adjoin the post. The measurement is taken from within 76 mm from the outermost surface of the post.

13. Floor pad thickness

A maximum thickness of 38 mm for floor pads is included in the Regulations. This requirement helps to safeguard against hazards associated with thick, bulky floor pads. These hazards are: (a) entrapment between the sides of the playpen and the floor pad, and (b) airway obstruction that can result from the surface of the floor pad conforming to the contours of a sleeping child’s face. Please note that hazard (a) is also addressed by other requirements in the Regulations (Floor pad vertical displacement and Mattress pad spacing). Hazard (b) is also addressed in part by warnings to not put children to sleep in playpens.

14. Height of playpen sides

The minimum side height requirement for playpens is increased from 480 mm to 508 mm (measured from the top of the playing surface to the top of the upper surface of the lowest side) to safeguard against falls out of playpens.

15. Openings — finger entrapment

Health Canada has received requests from industry to update the dimensions specified in the open holes requirement for playpens such that they are consistent with American mandatory rules. This requirement is intended to prevent the possibility of children’s fingers being caught in open holes in the product. The Regulations specify that if a hole admits a 5.33 mm diameter probe, it must also admit a 9.53 mm diameter probe. This requirement is in line with the probe used currently as an industry standard, which helps to safeguard against entrapment of fingers or toes in holes in the product.

16. Floor pad vertical displacement

Health Canada has received reports of incidents regarding playpen floor pads that are capable of being detached from the playpen’s base by the child. This exposes the occupant to a potential entrapment hazard. A child’s head could become entrapped between the floor pad and the side of the playpen or under the floor pad. The Regulations include a test which involves applying an upwards force to the floor pad to limit the amount of upwards displacement of the floor pad.

17 Strength of playing surface

As Health Canada has received reports of floor boards breaking, the Regulations include an improved static load test, requiring the application of two simultaneous forces, as well as a dynamic load test.

18. Mesh opening sizes

Further to requests from industry, the mesh probe specifications are changed. Therefore, Canadian requirements will use the probe currently considered as an industry standard, which helps to safeguard against entrapment of fingers or toes in holes in the product. Furthermore, the test specified in the Regulations does not involve cutting a sample of mesh from the product.

19. Mesh and fabric attachment strength

In order to address reported incidents related to the attachment strength of textiles or other pliable materials to a rigid structural component of a playpen, the Regulations include a test which involves applying a force to a textile side to determine if it can become detached from the frame.

20. Accessories — entrapment

Many playpens are now marketed as multi-use products with various accessories, such as playpen change table and sleep accessories, which attach to the playpen’s frame. Typically, these accessories attach to the top of a playpen and are not intended to be installed in the use position when a child is in the main body of the playpen. The Regulations include requirements relating to entrapment, strangulation, and warnings concerning the correct use of accessories.

These requirements align with the American mandatory rule, with the exception of testing requirements for cantilevered accessories. The American mandatory rules include additional parameters which limit the area to be tested when the accessory is cantilevered. The Regulations do not make such a distinction for cantilevered accessories, as the same level of protection is required for all designs of accessories and it is possible to design a cantilevered accessory that presents an entrapment hazard which would not be tested under the current American mandatory rules. As such, to help protect against entrapment hazards, the test to be performed is not to be limited to a specific area.

21. Number of wheels

Health Canada has received requests from industry to remove the requirement restricting the number of wheels a playpen can have. Health Canada has performed testing to examine whether playpen models with more than two wheels were more likely to shift or move than models with two wheels or less. It was determined that playpens with four wheels were not more likely to move. Furthermore, the United States Consumer Product Safety Commission (U.S. CPSC) has indicated to Health Canada staff that playpen models with more than two wheels or casters are not prevalent on the American market, and that they were unaware of incidents related to wheels. The Regulations remove the restriction on the number of playpen wheels or casters.

22. Side height of sleep accessories

Similar to stand-alone bassinets under the CCBR, sleep accessories are typically intended to be used until the child is capable of rolling over. The Regulations include a side height requirement of 191 mm (measured from the top of the mattress pad to the top of the upper surface of the lowest side, with no compression on the mattress pad) for sleep accessories to reduce the risk of the child falling out.

23. Mattress pad thickness of sleep accessories

A maximum thickness of 38 mm for mattress pads of sleep accessories is included in the Regulations. This also aligns with the maximum thickness of the mattress pad of sleep accessories in the CCBR. This requirement helps to safeguard against hazards associated with thick, bulky mattress pads. These hazards are the following: (a) entrapment between the sides of the sleep accessory and the mattress pad; and (b) airway obstruction that can result from the surface of the mattress pad conforming to the contours of a sleeping child’s face. Note that, as mentioned above, the side height of the sleep accessory is measured from the top of the mattress pad to the top of the lowest side of the sleep accessory, with no compression on the mattress pad. Therefore, the thickness of the mattress pad also helps to safeguard against reducing the effective side height of the sleep accessory.

24. Integrity of playpen accessories

The Regulations require a sleep accessory to withstand a static load of 24 kg, placed in succession in the centre of the sleep accessory and at all of its corners. The load approximates three times the weight of an infant that would be placed in the sleep accessory. The Regulations require that change table accessories withstand a static load of 45 kg applied to the centre of the surface that supports the child.

25. Angle of sleep accessories that rock or swing

In recent years, Health Canada has requested the voluntary recall of playpen models that included a rocking function for the playpen’s sleep accessory. Depending on the maximum rock angle and the angle of the product at rest, the accessory can tilt, causing an infant to roll to one side. An infant can become wedged in a corner or pressed against the side of the accessory, posing a risk of suffocation or positional asphyxia. Both the proposed maximum rock or swing angle and the maximum angle at rest are in line with the American mandatory rules and the CCBR, at 20 degrees and 7 degrees respectively.

26. Allowance for the use of a pouch to store assembly and use instructions

The Regulations allow the use of a pouch to store the assembly and use instructions, as long as it is accompanied by the relevant warnings.

Coming into force

The Regulations will come into force six months after they are published in the Canada Gazette, Part II (CGII), during which time the current Regulations would continue to apply to all playpens sold, advertised, imported, or manufactured in Canada. This provision allows industry the opportunity to modify or redesign their products to meet regulatory requirements, and verify the regulatory compliance of their products through product testing.

Regulatory and non-regulatory options considered

Status quo

Maintaining the current Playpens Regulations was rejected because it was determined that regulatory changes are required in order to provide a necessary level of safety with respect to the use of playpens and playpen accessories. The Regulations address safety concerns such as those specifically associated with accessories and unintentional collapse that have been identified as causing serious injuries or deaths.

Incorporate by reference American mandatory rules

This option was rejected because Health Canada has identified three requirements to supplement the current American mandatory rules. These are intended to further help protect against hazards relating to: (1) entrapment in completely bounded openings; (2) suffocation in gaps between the floor pad and the playpen’s side; and (3) asphyxia caused by angled sleep surfaces. The adoption of these Canadian requirements in the Regulations is necessary to further safeguard against playpen-related injuries and deaths. In addition, this option was rejected to allow for the use of consistent terminology within the Regulations and with other similar regulations made under the CCPSA, such as the CCBR. This option was also rejected to allow the use of drafting conventions that exist at the level of Canadian federal legislation.

Adopt the Regulations

Adopting the Regulations was determined to be the preferred method of helping to further protect the health and safety of infants and young children using playpens and playpen accessories. This option increases regulatory alignment with the American requirements and addresses important safety issues, such as those associated with playpen accessories. It also allows Health Canada to establish requirements and test methods to address specific hazards that are not currently addressed in the American mandatory rules.

Benefits and costs

A cost-benefit analysis (CBA) was prepared to quantify the expected costs and benefits of the proposed regulatory changes. footnote 2 Based on discussions with the U.S. CPSC and the Juvenile Products Manufacturers Association, the CBA assumed that most playpens currently sold in Canada are compliant with the American mandatory rules, with a relatively small chance of some minor exceptions (the baseline scenario). Therefore, the introduction of parallel regulations in Canada does not impose any additional costs on manufacturers, importers, wholesalers, retailers, or consumers. The only costs the regulations impose are those associated with the regulatory requirements identified as incremental changes to the baseline.

There are four differences between the American mandatory rules and these Regulations. Only one of these differences represents an actual additional requirement, which is related to the angles of sleep accessories (item 3 in the “Description” section). This item is further divided into two areas: (a) the incline of the sleep surface, and (b) the angles of foldable mattress pads.

With respect to the three other requirements that deviate from the American mandatory rules (items 1, 2, and 20 in the “Description” section), the CBA assumes that the introduction of these requirements would not result in any additional costs. This is because most playpen models on the market already comply with the requirements set out in items 1 and 2, and Health Canada is not aware of any products that would be affected by the difference set out in item 20. However, Health Canada is aware of one exception: in 2011, Health Canada sampled and tested a playpen model that had openings in the textile sides that did not meet the proposed performance requirements. In addition, the playpen had a sleep accessory that presented a sleeping surface that did not meet the seven-degree limit. This model was subsequently voluntarily recalled in Canada. The product had not been sold in the United States.

Costs

The CBA identified three actions that playpen suppliers may take to comply with the regulatory requirements: rebrand, re-engineer, or pull non-compliant products.

For analytical purposes, the CBA first assumed universal adoption of each of these strategies and separately estimated the cost of complying with the proposed regulations under each approach. footnote 3 In practice, however, manufacturers will likely pursue a combination of these strategies, depending on a variety of company-specific considerations (e.g. number of affected products and the importance of the Canadian market to their overall business). For estimating the costs of these Regulations, the CBA therefore assumes an equal three-way split across the three strategies.

Rebrand

Companies may attempt to rebrand their accessories so they are not considered sleep accessories in Canada. After the rebranding of the accessory, Health Canada may still classify the accessory as a sleep accessory.

Under this scenario, the CBA estimated that the total present value (PV) costs of the Regulations are $1.38 million over 20 years.

The qualitative impacts of this scenario include a positive impact on consumers, as there is no change in product availability. There could be a potential negative impact on consumers if they ignore the branding indicating that the product is not for sleep, as this would reduce the likelihood of avoided risks. A quantified but not monetized negative impact on industry is an increase in barriers to trade due to different branding requirements in Canada.

Re-engineer

Alternatively, companies could re-engineer their sleep accessories to meet the seven-degree angle requirement and seven-degree foldable mattress pad angle requirement, and the related side height requirement footnote 4 for products in Canada.

Under this scenario, the CBA estimated that the total PV costs of the Regulations are $1.64 million over 20 years.

Qualitative impacts of this scenario include a negative impact on consumers of the possibility that some may purchase playpens with sleep accessories with angles greater than seven degrees directly from the United States, if specific models are highly desired, reducing the likelihood of avoided risks. However, the introduction by individuals or companies of such sleep accessories into Canada would constitute an illegal importation pursuant to section 6 of the CCPSA.

Pull products

Finally, companies could discontinue the sale of sleep accessories with angle limits greater than seven degrees, for products in Canada.

To determine the costs of such an approach, the CBA estimated the loss of consumer surplus that would be attributable to discontinuation of the sale of affected accessories. Consumer surplus is the difference between the maximum amount that consumers would be willing to pay for an item (in this case, a sleep accessory) and the price they actually pay.

Under this scenario, the CBA estimated that the total PV costs of the Regulations are $16.42 million over 20 years.

The analyzed cost only includes the loss of consumer surplus described above, and does not include producer surplus that importers, retailers, and wholesalers would incur if they chose this compliance strategy, which was assessed qualitatively. Another potential impact that was not quantified is the possibility that some may purchase playpens with sleep accessories with angles greater than seven degrees directly from the United States, if specific models are highly desired. However, as mentioned above, the introduction by individuals or companies of such sleep accessories into Canada would constitute an illegal importation pursuant to section 6 of the CCPSA.

Average across strategies

Assuming that manufacturers would choose a combination of all three strategies, the CBA estimated that the total PV costs of the Regulations are approximately $6.5 million over 20 years. The qualitative impacts to industry and consumers vary across the three strategies and are identified in the respective sections above.

The costliest scenario (pulling products) was analyzed using lost consumer surplus, which increased the cost of this option significantly compared to the other two scenarios. Therefore, while the CBA assumed an average of the three strategies in determining costs of the Regulations, the lost consumer surplus of the third option generates the high average cost.

Other costs

In addition to the costs to industry and consumers identified above, another area of potential costs associated with the Regulations relates to implications associated with some provincial or territorial legislation that requires child-care operations to use playpens (and cribs) in their facilities that meet the federal requirements for these products. It is important to note that it is these provincial and territorial requirements that directly impose the requirement on child-care facilities and not the federal regulations themselves. The Regulations and the supporting CCPSA cover the manufacture, import, advertisement, or sale of products, but do not apply to their use. Enforcement of products within licenced child-care facilities is solely at the discretion of the provinces and territories. Therefore, any cost to child-care facilities due to the replacement of playpens that may be imposed by provincial and territorial legislation is not within Health Canada’s jurisdiction. Health Canada will continue to work with and support its provincial and territorial counterparts during the implementation of the Regulations.

Benefits

The CBA found that available incident data did not present an instance of infant mortality or serious injury that was clearly attributable solely to product features that are addressed by the incremental differences between the Regulations and the American mandatory rules (items 1, 2, 3, and 20 in the “Description” section).

Nonetheless, there is evidence that these elements of the Regulations could have a beneficial effect. This evidence is provided by the study conducted in Australia in 1995 discussed earlier which studied the movements and reactions of 11 infants in various positions in tilting cradles at rocking angles of 5, 7, and 10 degrees to determine what angle was the most protective in minimizing the risk of an infant rolling and getting trapped in a corner or getting into another entrapment or asphyxiation scenario. All of the infants who were subjected to the five- and seven-degree angles were able to keep their airway open since at those angles the infants still had the ability to pivot their head in order to maintain a free airway. Conversely, the infants tested at an angle of 10 degrees were unable to pivot their head, and their airway remained obstructed. Therefore, in the absence of robust data on mortalities or serious injuries attributable to factors that would be mitigated by the Regulations, the CBA could not estimate their benefits on an expected-value basis. As an alternative, a break-even approach was used — i.e. characterizing and quantifying the number of such incident(s) that the Regulations would need to prevent in order for their benefits to be equal to their costs.

Assuming that manufacturers would adopt a mix of all three compliance strategies, the CBA estimated that the benefits would outweigh the costs of the Regulations if one death was avoided over 20 years.

Accounting statement
 

2016

2017

2018

2019

2020

20-YEARtable 1 note a

TOTAL PVtable 1 note b

ANNUALIZED AVERAGE

Table 1 Notes

Note a

Values presented for 2016–2020 as well as the 20-year total are undiscounted.

Return to note a referrer

Note b

PV calculated using a discount rate of 7%.

Return to note b referrer

Note c

Assumed playpens-to-births ratio is 70%

Return to note c referrer

Note d

Because of data limitations, it is not possible to estimate benefits on an expected value basis. A break-even approach is employed — i.e. characterizing and quantifying the number of such incident(s) that the Regulations would need to prevent in order for their benefits to be equal to their cost, and is reported in Section B.

Return to note d referrer

A. Quantified impacts (2016 Canadian dollars)table 1 note c

Benefits to consumerstable 1 note d

(see Section B)

Costs to consumers

$972,799

$976,475

$470,704

$473,266

$475,382

$11,005,699

$6,483,640

$612,010

Net benefits

n/a

B. Quantified impacts not monetized

Positive impacts

Required number of risks avoided over 20 years for break-even with total PV costs = 648 minor injuries OR 12.5 major injuries OR 0.9 fatalities.

Negative impacts

Industry (pull products): Lost producer surplus for importers, wholesalers, and retailers of playpens with affected accessories.

C. Qualitative impacts

Positive impacts

Consumers (rebrand): No change in product availability.

Negative impacts

Consumers (rebrand): Consumers might ignore change in branding and related images and use “not for sleep” accessories for sleep regardless, reducing likelihood of avoided risks.

Consumers (rebrand, re-engineer, and pull products): Consumers might cross the American border to purchase playpens with sleep accessories, thereby mitigating some of the impact (i.e. it would lower consumer surplus loss), but would also defeat the purpose of the Regulations and increase risk.

Industry (rebrand): Negative impact on trade due to different requirements in Canada.

“One-for-One” Rule

The “One-for-One” Rule does not apply, since the Regulations do not impose any administrative costs on industry.

Small business lens

The small business lens does not apply because the estimated nationwide cost impact is less than $1 million per year and small business costs have been determined not to be disproportionately large for the following reasons:

  1. According to available information, there are no playpens currently manufactured in Canada and large manufacturing firms in the United States constitute the majority of the playpens sold in Canada. Although some playpens are also imported from other countries, the percentage is currently unknown, and is believed to be very small in comparison.
  2. While information is lacking on the number of small businesses that sell playpens in Canada, import information was analyzed to estimate the number of importers of playpens to Canada. Based on import data for a 3-year period (October 2013 to August 2016 inclusive), and taking into consideration the quantities and total values of playpen imports per company, Health Canada has estimated that 37 companies that import playpens may be considered small businesses. These include distributors, online retailers, and “on-the-ground” retailers. However, the CBA indicated that the costs of the Regulations will likely ultimately be passed on to consumers in the form of higher retail prices, and will therefore not likely be incurred by small businesses.

Gender-based analysis plus

The Regulations take into consideration the amount of strength that children and the elderly can apply and have specified requirements to allow for the operation of products while still providing safety.

The Regulations take into consideration the incident characteristics associated with playpens and their accessories. The injury pathways are the same for all children. The Regulations help to protect infants and young children when using playpens and their accessories irrespective of their height, weight, age, or gender. There is no additional costs associated with gender-based considerations.

Consultation

Preconsultation to the publication in the Canada Gazette, Part I (CGI)

On April 16, 2013, Health Canada released a consultation document regarding the proposed changes to the Regulations. Specifically, the proposal was to introduce additional requirements for playpens in Canada; some of these new requirements would align with applicable requirements in the CCBR, and the majority of the new requirements would align with the American mandatory rules.

This consultation involved the publication of a news release by Health Canada, as well as the posting of the consultation document on its website. Health Canada also directly mailed the consultation document to a targeted group of 257 stakeholders, which was comprised of public health organizations, provincial/territorial public health authorities, retailers, manufacturers, importers, and product testing laboratories. Notification of this consultation was also sent via email to approximately 18 000 subscribers through Health Canada’s Consumer Product Safety listserv, which is a database of industry and consumer stakeholders who have signed up to receive an electronic newsletter on the latest news and information about Health Canada’s work in the area of consumer product safety. Interested parties were invited to provide comments on the proposal within 75 days.

A total of seven submissions were received. Responses were received from two provincial governments (Quebec and Manitoba), an industry group, a national injury prevention organization, a consumer group, a test laboratory and an industry member. None of the respondents indicated that they were opposed to Health Canada’s proposed approach. The industry group and industry member were supportive of harmonization with the American mandatory rules. The consumer group, the national injury prevention organization and the Quebec government were in support of the proposed changes and the increased level of safety. The Manitoba government did not express a position, but asked to stay informed of the regulatory changes. The test laboratory provided comments regarding clarification on the proposed test methods.

Since the 2013 consultation, Health Canada made changes to the CCBR which were published in the CGII on June 29, 2016. Among the changes is a limit on the angle of the sleep surface support. For a necessary level of safety, the Regulations incorporate the same angle limit.

Consultation with provincial and territorial governments regarding child care facilities

Legislation in some provinces and territories requires that licensed child-care operations use playpens that meet federal requirements. This means that if changes were introduced into federal regulations, the provincial and territorial legislation would require the use of playpens that meet the new federal requirements. Therefore, in addition to the 2013 consultation, all provinces and territories were contacted to solicit input through a letter to Assistant Deputy Ministers of health ministries on November 23, 2016. Two provinces and one territory (Newfoundland, Nova Scotia and Yukon) responded and did not have concerns. It is important to note that it is the provincial and territorial requirements that directly impose the requirement on child-care facilities to use playpens that are compliant with the federal regulations, and not the federal regulations themselves. The Regulations and the supporting CCPSA cover the manufacture, import, advertisement, or sale of playpens, but do not apply to the use of these products.

Health Canada intends to work with its provincial and territorial counterparts during the implementation of the Regulations in the same way that it is currently working with them with respect to the CCBR, which is similarly referenced in provincial and territorial legislation. Activities include clarifying that the use of existing products currently in child-care facilities is not enforced by Health Canada, and that the provinces and territories are responsible for enforcement strategies regarding existing products.

CGI publication

On April 22, 2017, the proposed Playpens Regulations were published in the CGI. A link to the CGI publication was posted on the Health Canada website. Direct emails were sent to approximately 18 000 subscribers through Health Canada’s Consumer Product Safety listserv. Health Canada also directly mailed a letter with a link to the consultation document to a targeted group of approximately 80 stakeholders, which included public health organizations, provincial/territorial public health authorities, retailers, manufacturers, importers, and product-testing laboratories. Interested parties were invited to provide comments on the proposal within 75 days.

Feedback from stakeholders

Submissions were received from 12 stakeholders. Comments were received from five manufacturers, two industry associations (one Canadian association and one American association), three provincial governments, and one consumer. One Canadian industry association was supportive of efforts to align requirements with the American mandatory rules. Several comments were questions about specific requirements and did not mention if they were supportive or not of the proposed Regulations. Three stakeholders questioned the rationale for the angle of sleep surface, one of which did not support the proposed changes. A consolidation of key comments and responses from Health Canada was sent to these stakeholders in February 2018.

The comments fell under the following themes:

Sleep surface angle

Comments were received from two manufacturers and one American industry association concerning the proposed maximum angle requirement of sleep surface. Questions were raised as to how the requirement would be applied to foldable mattress pads and the rationale behind the difference between the Canadian Regulations and the American mandatory rules. Further information regarding Health Canada’s rationale for the requirement was provided to stakeholders who commented on the proposal. One American industry association did not support this change and wanted this requirement to align with the 10-degree requirement in the United States. Health Canada maintains that any angle over seven degrees is not protective of sleeping infants.

Coming-into-force date

One American industry association and one manufacturer requested that the coming-into-force date be based on the importation or manufacturing date, rather than the sale date, so that remaining products on store shelves may be sold off if they have not been sold by the coming-into-force date. The CCPSA applies to the following activities related to consumer products: manufacturing, importation, advertising or sale. The coming-into-force date applies to all activities, six months after its publication in the CGII. This information was communicated to stakeholders.

Required information

One American industry association and one manufacturer commented that due to the small size of some products, it would be difficult to display all of the required instructions. The Regulations have been modified to allow a pouch for assembly and use instructions, as long as it is accompanied by the required warnings.

Precision on differences between two sections addressing entrapment

One American industry association and two manufacturers requested explanations on the differences between Sections 10 and 30 of the Regulations. Section 10 addresses completely bounded openings that are formed or exposed in the surfaces that define the occupant retention area of a playpen or sleep accessory. Section 10 does not include openings between the playpen and the accessory. Section 30 deals with the openings created by the addition of an accessory attached to a playpen, and these are assessed through the test prescribed in Schedule 15. Section 30 applies to all types of accessories when placed or affixed on the playpen.

Angles of foldable mattress pads

One American industry association commented that a foldable mattress pad that is less than 38 cm in length could not be tested as per the test method proposed in the CGI. The Regulations now include further instructions on how to test the smaller foldable mattress pad.

Cantilevered accessory

One manufacturer asked for clarification about the test area for cantilevered accessories as per the test method in Schedule 15. The American mandatory rules define cantilevered accessories and limit the area to be tested for entrapment when the accessory is cantilevered. The Regulations do not define cantilevered accessories, as they are captured within the definition of “accessory.” The Regulations do not limit the area to be tested for entrapment. With accessory designs currently available, the application of the requirement in the Regulations is consistent with the American mandatory rules. However, if accessory designs evolve in a way that removes them from the current definition of cantilevered accessories, then the American mandatory rules may not be adequate to prevent entrapment hazards. The test method in Schedule 15 applies to any accessory as per the definition in the Regulations and therefore is not to be limited to a specific area.

Differences between the Regulations and the proposed Playpens Regulations that were published in the CGI

Regulatory cooperation

The majority of the changes align the Canadian requirements with those adopted for playpens and playpen accessories in the United States.

Health Canada has actively collaborated with the U.S. CPSC through its participation on the American Society for Testing and Materials (ASTM) playpen standard, bassinet and cradle standard, and change table standard subcommittees, and through discussions with U.S. CPSC staff.

Differences remain between the Canadian requirements and the American mandatory rules. For two of the differences (items 1 and 2 in the Description section) there is expected to be very little or no impact on the movement or trade of products between the two countries because it is expected that most, if not all, playpen models on the market already comply, as shown during playpen sampling and testing projects. The third difference (item 3 in the Description section) is a more protective requirement because evidence has demonstrated the potential for increased safety benefits. The CBA identified a range of compliance strategies that industry may choose with regard to the angles of sleep surfaces, with a range of impacts. The fourth difference (item 20 in the Description section) will have no impact on current models as there is currently no known model that would be affected by the difference, but may help prevent against entrapment risks posed by future designs.

Rationale

Between 1990 and December 31, 2017, CPSD received 162 reports of incidents associated with playpens and playpen accessories. Of these, there were 11 deaths, one serious injury, 33 minor injuries, and 117 incidents without injury.

Of the 11 deaths, 4 were related to accessories, 2 to top rail collapse, 2 to entanglement, one to unsafe environment around the playpen, one to unsafe environment in the playpen, and one asphyxiation possibly due to mattress pad displacement.

In order to respond to these incidents, Health Canada has been actively participating in discussions with Canadian and American manufacturers and safety advocates regarding the overall safety of playpens and accessories. Health Canada has worked in collaboration with a number of companies to voluntarily recall various models of playpens after incidents occurred or testing found safety issues with the products.

In addition, manufacturers of playpens have requested greater alignment of the Regulations with other recognized international standards, particularly those of the United States, as alignment simplifies compliance for their industry.

In response to these issues, the Regulations address the request for better alignment with the American mandatory rules and would help address identified hazards associated with playpens in order to help protect the health and safety of young children.

Implementation, enforcement and service standards

The Regulations do not result in any major changes to Health Canada’s enforcement activities. Compliance and enforcement is facilitated by more clearly worded requirements laid out in the Regulations, as well as greater alignment between Canadian and American requirements.

Compliance and enforcement of the Regulations will follow established departmental approaches and procedures, including sampling and testing of products, inspection at retail, and follow-up on complaints made by the Canadian public, public health organizations, and industry. Non-compliant products will be subject to the actions available to Health Canada inspectors and other officials. Actions selected will depend on the seriousness of the circumstances. These actions may include a voluntary commitment to product correction by industry, negotiation with industry for the voluntary removal of non-compliant products from the market, seizure, orders for recall or other measures, administrative monetary penalties, or prosecution under the CCPSA. Health Canada will also seek to maximize proactive compliance with the Regulations through ongoing industry and retailer education, and maximize safe use of playpens through consumer outreach and education.

Contact

Safya Ratnani
Consumer Product Safety Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Address Locator: 4908B
269 Laurier Avenue West
Ottawa, Ontario
K1A 0K9
Fax: 613-954-1133
Email: safya.ratnani@canada.ca