Inflatable PVC products
Guidance on applicability of the phthalates directive
1.
Introduction:
The phthalates directive (2005/84/EC) restricts the use of DINP, DIDP and DNOP in any toy that can be
placed in the mouth.
1
The EU commission have issued a guidance document which offers help on the meaning of “can be
placed in the mouth” but in the view of many in the toy industry, it is unclear, most notably in its
treatment of inflatable toys.
For inflatable toys additional guidance was considered necessary and this document was drawn up by
a group of UK toy manufacturers, retailers and importers. The primary aim was to provide improved
guidance on what types of inflatable toys are within the scope of the restrictions on the use of DINP,
DIDP and DNOP. .
2.
The meaning of the phrase “can be placed in the mouth”
For the purposes of this document, “can be placed in the mouth” has the following meaning:
The toy or component is able to enter the child’s mouth cavity in such a way that a substantive area of
plasticised material may be chewed and sucked with a high degree of comfort and ease giving rise to
prolonged periods of mouthing.
The rationale for this definition is explained in appendix 1
Valves that are designed to allow inflation of the toy by mouth, are deemed to meet the definition of
placed in the mouth. This therefore precludes the use of any of the 6 restricted phthalates specified in
the directive.
3. Factors that determine whether a product can be placed in the mouth and
sucked and chewed:
The duration for which a child will suck and chew on a toy in a 24 hour period will depend upon several
factors, the most relevant of which are highlighted below, in an approximate priority order:
3.1 Age of child (age grade of toy)
A common finding of all scientific studies into mouthing of objects by children, is that in general terms
mouthing activity decreases as the age of the child increases. It is widely accepted that by the age of 3
years the mouthing of toys has diminished to negligible levels for the vast majority of toys. Mouth
actuated toys are an obvious exception as are the valves of certain types of inflatable toys.
3.2 Carer supervision
Many toys are used under the supervision of an adult. The degree of supervision varies from active to
passive, constant to sporadic. The biting and chewing of certain inflatable toys is likely to be stopped
by supervisors because of the fear of puncturing the PVC sheeting. Importantly large outdoor products
and products containing accessible water are likely to be regarded as a hygiene risk and so prolonged
sucking and chewing will be discouraged by supervisors.
3.3 Normal and foreseeable play patterns
Some products are played with in a manner that minimises the chance of any prolonged mouthing e.g.
the child is mobile over certain areas (slides, run outs etc)
Toys with a small volume that are easy to inflate and deflate, are considered to meet definition of “can
be placed in the mouth”. See also 3.5 and 3.6 below.
1
http://ec.europa.eu/enterprise/newsroom/cf/itemlongdetail.cfm?item_id=167
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3.4 Accessibility
Parts that are inaccessible according to the definitions in EN71-1 manifestly can not be placed in the
mouth. Detachable components should be considered as available to the child for potential mouthing.
Large inflatable toys especially outdoor toys are not stored within easy access of the child when
deflated. They are not stored in a toy box along with smaller toys but typically in a garden shed or
garage.
3.5 Size
Components or items that exceed 5cm in all three dimensions are deemed not able to be placed in the
mouth, subject to point 3.7 below. Components that do not fulfil this dimensional requirement could be
argued to physically fit into the mouth but whether they are likely to be sucked and chewed, requires
consideration of other factors as set out in this section.
3.6 Weight
Heavy toys or fixed toys are unlikely or impossible for a child to bring to the mouth. It must be
recognised that portable, lightweight toys are easier to carry around and bring to the mouth.
3.7 Resistance to compression or flexing
Inflatable PVC products are particularly prone to compression and flexure and the ease of this depends
upon the inflation pressure. Some shapes can be compressed so that they fit into the mouth cavity
where sucking and chewing might occur. Some products can be used just as well if poorly inflated
(eg.roll n see), whereas others can not (eg inflatable slide). Large inflatable toys lose most of their play
value if punctured and so will be taken from the child for repair or disposal.
3.8 Shape
Some shapes are uncomfortable in the mouth cavity and/or occupy so much of the mouth that sucking
and chewing is severely impeded.
3.9 Texture,
PVC sheeting as used in inflatable toys usually has a smooth texture and is slippery when wetted with
saliva or water. Such textures are considered to have a comfortable feel in the mouth.
3.10 Smell
PVC sheeting typically does have an odour due to low levels of solvent residues but this odour would
not influence a child’s mouthing behaviour.
3.11 Taste,
Plasticised PVC has no particular taste incentive for a child.
4.
Illustrative Examples
Using the criteria and information set out in this document, a selection of illustrative examples of the
classification of inflatable products are provided below:
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Large Outdoor Inflatable Toys
Large above ground pools:
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Firstly determine if these items are classified as toys using the definition set out in the toy
safety directive. These types of products are not normally sold as toys and contain relatively
deep water.
Carer supervision / Normal foreseeable play patterns: Sucking and chewing likely to be
actively discouraged
Not regularly deflated and inflated
Not normally inflated by mouth
Accessibility / Weight / Size: When deflated large heavy items which are not normally available
to a child
Size: When inflated, will not fit into the mouth.
Recommendation: Many items are not classified or sold as toys and so are
outside the scope of the phthalates directive. Those that are sold as toys can
not be placed in the mouth.
Inflatable goal posts, basketball rings etc
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Age of child: these toys are likely to be for children over 3 years of age
Normal foreseeable play patterns: outdoor activity toys which do not encourage static use of
the product, children are unlikely to stand and mouth a goal post.
Size: they are unlikely to fit in the mouth
Weight: they are often weighted / anchored to stop the toy from moving so are not very portable
and difficult to bring to the mouth
Resistance to compression: Product will not function properly if not fully inflated
Recommendation:
Can not be placed in the
mouth.
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Bouncy castle type toy
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Age: normally 3 years +
Normal & foreseeable play patterns: Active, outdoor play
Accessibility: when not in use the product will not be stored in the toy box but in other less
accessible places.
Size: unlikely to fit in the mouth when inflated
Weight: Product are not portable and are normally anchored to the ground
Resistance to compression: Product will not function correctly if partially deflated.
Recommendation: Can not be placed in the mouth.
Paddling pools
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Age: 9 months + (especially if pool can be used as a ball pit - see also following section on ball
pits).
Carer supervision: Constantly supervised activity especially with younger children.
Normal & foreseeable play patterns: Mainly active play. Outdoor toys – mouthing discouraged
due to hygiene reasons and risk of puncturing
Accessibility: Not easy to inflate and deflate so product typically not normally accessible to the
child in a deflated state.
Size: Mouthing on rounded walls not possible due to size.
Resistance to compression: Rounded wall sections do not compress into the mouth because
they deform, bend and slip away from the mouth, even when not fully inflated.
Shape: Some shapes and profiles can physically fit into the mouth although some are located
in a position that is not comfortable for a child to mouth.
Recommendation: Pool can not be placed in the mouth but certain shapes can.
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Ball pit inflatable toy
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Age: In the region of 9 months +.
Carer supervision: Frequent supervision can be expected but no real discouragement from
mouthing behaviour.
Normal & foreseeable play patterns: Limited degree of activity. Indoor toys
Accessibility: Usually small enough when deflated to be stored amongst other toys to which the
child may have access.
Size/ resistance to compression: There are may be areas that might fit into the mouth if
compressed especially because high pressure inflation is not necessary for play.
Recommendation: parts of the toy can be placed in the mouth.
Inflatable Slides
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Smaller designs are indoor or outdoor toys.
Age: Typically 3 years+ Larger designs or those including water are outdoor toys and for older
children
Carer supervision: Low age graded slides will have high carer supervision whereas those for
older children will have limited carer supervision.
Normal & foreseeable play patterns: Outdoor toys – mainly active play, mouthing discouraged
due to hygiene reasons and risk of puncturing. Indoor toys also predominantly active play.
Accessibility: Not easy to inflate and deflate. Product typically stored away from child when
deflated.
Size: Mouthing is normally not possible due to size and shape.
Resistance to compression: Products do not work well if partly inflated, so highly likely to be
difficult to compress into the mouth.
Recommendation: Can not be placed in the mouth.
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Large Indoor Inflatable Toys
Inflatable furniture
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Some designs are functional and may be classed as non-toys and outside the scope of the
phthalates directive
Age: Most unlikely to fall below 3 years of age. Products typically span a wide age range.
Carer supervision: little or no supervision can be expected. Most products unlikely to be
perceived as hazardous for children under 3 years
Normal & foreseeable play patterns: likely to sedentary so care needed if shapes can fit into the
mouth if child is lying down for example. Indoor toys that could be used outdoors.
Accessibility: Usually small enough when deflated to be stored amongst other toys to which the
child may have access.
Size: Most profiles are not capable of fitting into the mouth.
Resistance to compression: Products may be used part deflated and so compressibility must
be taken into consideration.
Recommendation: Case by case evaluation required due to variation in the
designs and intended use of these products
Small Indoor Inflatable Toys
Roll n See (infant inflatables)
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Age: Under 3 years, typically much lower, child could be teething
Carer supervision: Periodic and passive. Sucking and chewing will not be discouraged.
Normal & foreseeable play patterns: Longer periods of play. Sucking and chewing will occur.
Accessibility: When deflated the toy is likely to remain accessible to the child and young age
group will still find interest in the deflated toy.
Weight: Light, portable product.
Resistance to compression: Unlikely to be rigidly inflated and toy will deflate with time
Shape: When inflated, parts of the product will fit in the mouth especially as it will be
compressible.
Recommendation: toy can be placed in the mouth.
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Bath toys and other small sized inflatables
Inflatable Bath toy
• Age: Likely to be under 3 years.
• Carer supervision: Very limited, expectation that the product is safe to be left alone with the
child. Bath time is always supervised for young children but supervisor unlikely to be concerned
about mouthing and risk of puncturing the product. Easy to deflate and inflate so greater
chance of mouthing the deflated product
• Normal & foreseeable play patterns: hand held, likely to be sucked and chewed. Played with
outside of the bath.
• Accessibility: easily accessible when inflated or deflated.
• Size and Weight: Small light weight easy to bring to mouth, place in mouth and keep there.
Recommendation: toy can be placed in the mouth.
Other Inflatable products
Armbands
Armbands are not considered to be toys and are items of personal protective equipment (PPE) and fall
within the scope of the PPE directive. They are not within the scope of the phthalates directive.
The same comments apply to swim rings that are tested and sold as PPE. Swim rings sold as toys do
fall within the scope of the phthalates directive and so must be assessed to determine if they can be
placed in the mouth. As these products are lightweight and portable, they may be played with outside
of the swimming pool and in a partially deflated state. The item is deemed to meet the definition of “can
be placed in the mouth”.
Beach balls and other PVC balls
Depends on size and compressibility…
Small sized inflatable balls made from PVC sheeting (beach ball type) should be assumed to meet
definition of placed in the mouth. Football type products can not be placed in the mouth if over 5 cm
diameter, especially if difficult to compress.
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Appendix 1
Background Information and rationale
Although the phthalates directive restricts 6 phthalates, DINP is the only plasticiser of interest for
inflatable toys. The new restriction on DINP (which effectively amounts to a ban) only applies to toys
that “can be placed in the mouth”. It is therefore necessary to have some clear criteria to assist in the
determination of which toys can be placed in the mouth and hence fall with the scope of the ban on
DINP.
In order to appropriately interpret the phrase “can be placed in the mouth” in the context of the
phthalates directive, it necessary to understand the background the directive’s development.
The phthalates directive is intended to provide a high level of protection for children against any
possible risk related to exposure to certain phthalates. For DINP in particular, there is some scientific
uncertainty as to whether exposure gives rise to a health risk in children, so the phthalates directive
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was issued by the EU Commission, on the basis of the precautionary principle .
In the Parliamentary process the Council of Ministers and the European Parliament added additional
layers of precaution when they expanded the Commission’s original proposal so that it covered all toys
that “can be placed in the mouth” (not just those intended to be mouthed) by any child (not just children
under 3 years).
With this in mind it is important to not to keep on adding further layers of precaution when determining
which toys meet the spirit of the phrase “can be placed in the mouth” For this reason it is considered
appropriate that large inflatable toys are assessed in their inflated state, not deflated as suggested in
the EU commission guide. Further justification for this approach can be found in the later sections of
this document.
There is wide acceptance that simply being able to lick a toy, does not mean that it “can be placed in
the mouth”.
Short duration sucking and chewing will not lead to a measurable level of migration of DINP. This is
3
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been proven by independent work conducted in the EU and the USA . In fact to obtain measurable
levels of migration the PVC material has to be put through simulated chewing, typically for at least 3
hours.
There is a wealth of information that shows young children do not place objects (not just toys) in their
mouth for more than a few minutes per day. As for actually chewing on the objects in the mouth, it is
clear that this action will be much shorter duration than time spent in the mouth. Sucking is an action
that will typically occur for longer durations but sucking is less aggressive than chewing and is primarily
associated with babies and young infants.
The argument that young children will have unrestricted and unsupervised access to toys of any type is
not accepted by the toy industry and in the context of phthalates and DINP, would represent a wholly
unacceptable level of unjustified precaution.
The EU Commission’s guidance document clearly acknowledges that it does not address the likelihood
that a toy or childcare article will be mouthed, it simply provides some criteria that help in deciding if an
item can fit in to the mouth. This is a major flaw with the commission’s guide because the task facing
toy producers is to determine which toys are likely to be placed in the mouth and sucked and/or chewed
2
Commission communication on the precautionary principle (COM (2000) 1
http://ec.europa.eu/dgs/health_consumer/library/pub/pub07_en.pdf
3
http://www.dti.gov.uk/files/file21800.pdf
4
http://www.cpsc.gov/library/foia/foia02/brief/fiveyearpt1.PDF?bcsi_scan_2A7082C2B1213BAA=0&bcsi_scan_
filename=fiveyearpt1.PDF
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for prolonged periods. It would be disproportionate and illogical to argue that an item is with the scope
of the directive simply because part of it is physically able to enter in to the mouth cavity.
The EU Commission’s guidance document introduces a size criterion for placing in the mouth of 5cm in
all three dimensions. This dimensional constraint is not based upon anthropometric data and has not
been scientifically established.
END
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