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TOYS

CHILDREN'S PRODUCTS

CHEMICAL

ELECTRICAL AND ELECTRONIC

HARDLINES

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REGULATIONS OF DIFFERENT

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Directive on the restriction of Phthalates – 2005/84/EC – EU Directive relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and childcare articles)

 

Phthalates are industrial chemicals produced in large quantities. Up to 90 percent of the production are used as plasticizers. Plasticizers make plastics soft, flexible and durable. For example, PVC may contain up to 40 percent phthalates. Further applications are as stabilizers and carrier substances.

 

Phthalates with short ester chains (< C9) have been suspected of negative health effects. Therefore, the Directive restricts the use of 6 types of phthalates (as listed below) in toys and personal care products for children.

 

See “Plasticizers for Plastics’ at the bottom of page for the details of plasticizer types and the substitutes for the banned phthalates.

 

The plasticized parts of the toys or child products under concern should comply with the requirements of the Phthalate Directive.

 

 

Requirements of the Directive

 

DEHP, DBP and BBP shall not be used as substances or constituents of preparations, at concentrations of greater than 0.1% by mass of the plasticized material, in toys and childcare articles.

 

DINP, DIDP and DNOP shall not be used as substances or as constituents of preparations, at concentrations of greater than 0.1% by mass of the plasticized material, in toys and childcare which can be placed in the mouth by them.

 

The following Table summarizes the types of Phthalates to be determined and the corresponding limits.

 

Type of Phthalate

Limits as specified in 2005/84/EC

Bis-(2-ethylhexyl) Phthalate (DEHP) Content

0.1%

Dibutyl Phthalate (DBP) Content

0.1%

Benzylbutyl Phthalate (BBP) Content

0.1%

Diisononyl Phthalate (DINP) Content

0.1%

Diisodecyl Phthalate (DIDP) Content

0.1%

Di-n-octyl Phthalate (DNOP) Content

0.1%

 

 

 

Guidance on the interpretation of “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 plasticized material may be chewed and sucked with a high degree of comfort and ease giving rise to prolonged periods of mouthing.

 

Size

Components or items that exceed 5 cm in all three dimensions are deemed not able to be placed in the mouth.  Components that do not fulfil this dimensional requirement could be argued to physically fit into the mouth.

Whether they are likely to be sucked and chewed, consideration of other factors as set out in the document is required.

 

Remark: valves that are designed to allow inflation of the toy by mouth, are deemed to meet the definition of placed in the mouth.

 

Illustrative Examples

Using the criteria and information set out in the document, a selection of illustrative examples of the classification of inflatable products are provided below:

 

(I) Roll n See (infant inflatables)

  • 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 products will fit in the mouth especially as it will be compressible.

           PTH 2.jpg

Recommendation: toy can be placed in the mouth.

 

(II) 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.

PTH 1.jpg 

Recommendation: toy can be placed in the mouth.

 

(III) 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”.

 

(IV) 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.

 

 

 

Plasticizers for Plastics

 

Plasticizers for plastics are additive, most commonly phthalates, that give hard plastics like PVC the desired flexibility and durability. They are often based on esters of polycarboxylic acids with linear or branched aliphatic alcohols of moderate chain length. Plasticizers work by embedding themselves between the chains of polymers, spacing them apart (increasing of the "free volume"), and thus significantly lowering the glass transition temperature for the plastic and making it softer. For plastics such as PVC, the more plasticiser added, the lower its cold flex temperature will be. This means that it will be more flexible, though its strength and hardness will decrease as a result of it. Some plasticizers evaporate and tend to concentrate in an enclosed space; the "new car smell" is caused mostly by plasticizers evaporating from the car interior.

 

Dicarboxylic/Tricarboxylic Ester-based Plasticizers

 

(I) Phthalate-based plasticizers are used in situations where good resistance to water and oils is required. Some common phthalate plasticizers are:

 

-         Bis(2-ethylhexyl) phthalate (DEHP), used in construction materials, food packaging, children toys, medical devices, and cling wrap

-         Diisononyl phthalate (DINP), found in garden hoses, shoes, toys, and building materials

-         Bis(n-butyl)phthalate (DnBP, DBP), used for cellulose plastics, food wraps, adhesives, perfumes and also in cosmetics - about a third of nail polishes, glosses, enamels and hardeners contain it, together with some shampoos, sunscreens, skin emollients, and insect repellents

-         Butyl benzyl phthalate (BBzP) is found in vinyl tiles, traffic cones, food conveyor belts, artificial leather and plastic foams

-         Diisodecyl phthalate (DIDP), used for insulation of wires and cables, car undercoating, shoes, carpets, pool liners

-         Di-n-octyl phthalate (DOP or DnOP), used in flooring materials, carpets, notebook covers, and high explosives, such as Semtex. Together with DEHP it was the most common plasticizers, but now is suspected of causing cancer

-         Diisooctyl phthalate (DIOP), all-purpose plasticizer for polyvinyl chloride, polyvinyl acetate, rubbers, cellulose plastics and polyurethane.

-         Diethyl phthalate (DEP)

-         Diisobutyl phthalate (DIBP)

-         Di-n-hexyl phthalate, used in flooring materials, tool handles and automobile parts

 

(II) Trimellitates are used in automobile interiors and other applications where resistance to high temperature is required. They have extremely low volatility.

 

-         Trimethyl trimellitate (TMTM)

-         Tri-(2-ethylhexyl) trimellitate (TEHTM-MG)

-         Tri-(n-octyl,n-decyl) trimellitate (ATM)

-         Tri-(heptyl,nonyl) trimellitate (LTM)

-         n-octyl trimellitate (OTM)

 

(III) Adipate-based plasticizers are used for low-temperature or resistance to ultraviolet light. Some examples are:

 

-         Bis(2-ethylhexyl)adipate (DEHA)

-         Dimethyl adipate (DMAD)

-         Monomethyl adipate (MMAD)

-         Dioctyl adipate (DOA)

 

(IV) Sebacate-based plasticiser

 

-         Dibutyl sebacate (DBS)

 

(V) Maleates

 

-         Dibutyl maleate (DBM)

-         Diisobutyl maleate (DIBM)

 

Other Plasticisers

(I) Benzoates

 

(II) Epoxidized vegetable oils

 

(III) Sulfonamides

-         N-ethyl toluene sulfonamide (o/p ETSA), ortho and para isomers

-         N-(2-hydroxypropyl) benzene sulfonamide (HP BSA)

-         N-(n-butyl) benzene sulfonamide (BBSA-NBBS)

 

(IV) Organophosphates

-         Tricresyl phosphate (TCP)

-         Tributyl phosphate (TBP)

 

(V) Glycols/polyethers

-         Triethylene glycol dihexanoate (3G6, 3GH)

-         Tetraethylene glycol diheptanoate (4G7)

 

(VI) Polymeric plasticizers

Some other chemicals working as plasticizers are nitrobenzene, carbon disulfide and β-naphthyl salicylate. Plasticizers, such as DEHP and DOA, were found to be carcinogens and endocrine disruptors.

 

Safer Plasticizers

 

(I) 1,2-Cyclohexanedicarboxylic acid diisononyl ester (DINCH)

 

Safer plasticizers with better biodegradability and less biochemical effects are being developed. Some such plasticizers are:

 

(I) Acetylated monoglycerides; these can be used as food additives

 

(II) Alkyl citrates, used in food packagings, medical products, cosmetics and children toys

-         Triethyl citrate (TEC)

-         Acetyl triethyl citrate (ATEC), higher boiling point and lower volatility than TEC

-         Tributyl citrate (TBC)

-         Acetyl tributyl citrate (ATBC), compatible with PVC and vinyl chloride copolymers

-         Trioctyl citrate (TOC), also used for gums and controlled release medicines

-         Acetyl trioctyl citrate (ATOC), also used for printing ink

-         Trihexyl citrate (THC), compatible with PVC, also used for controlled release medicines

-         Acetyl trihexyl citrate (ATHC), compatible with PVC

-         Butyryl trihexyl citrate (BTHC, trihexyl o-butyryl citrate), compatible with PVC

-         Trimethyl citrate (TMC), compatible with PVC

 

(III) Alkyl sulphonic acid phenyl ester (ASE), compatible with PVC, vinyl chloride copolymers, TPU, NBR etc.

 

 

 

 

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