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US lead and phthalate legislation

SATRA has recently extended its list of CPSC-accredited tests.

by Martin Heels

Across the United States, the Consumer Products Safety Commission (CPSC) is responsible for protecting the public from ‘unreasonable risks of injury’ associated with the use of all consumer products. Footwear and leathergoods that are intended for children must comply with the Consumer Safety Product Improvement Act (CPSIA) 2008, which is under the jurisdiction of the CPSC.

Since 2012, federal law has demanded that all products manufactured in the USA or imported into the country must be certified to demonstrate that they meet with the CPSIA 2008 requirements. These Children’s Product Certificates (CPC) must be supported by test reports from CPSC-accredited, independent third-party laboratories which are accredited to ISO 17025 – the international standard for laboratory competency – and listed on the CPSC website.

In addition to the CPSIA 2008 mandatory toy testing standards (that are generally not applicable to footwear and leathergoods), there are two key parts to this legislation for these types of products. These are Section 101 – the lead paint rule and Section 108, which restricts the amounts of six phthalate plasticisers in children’s products. Both sections are applicable to footwear and leathergoods intended for children.

Sub-section 101(a) of the CPSIA 2008 is often referred to as ‘the lead paint rule’. It restricts the amount of lead in children’s products – that is, products designed or intended primarily for children of 12 years of age and under. It is interesting to note that the European Toy Safety Directive (2009/48/EC) defines children as 14 years old or younger, which is two years older than this US definition. Lead is a highly toxic element, exposure to which can produce a wide range of adverse health effects – such as neurological damage – and children are particularly vulnerable to lead poisoning. Lead also accumulates in the body, so repeated exposure to even low levels of lead can eventually endanger health.


A centrifuge is used during the phthalates testing procedure to precipitate undissolved solids out of the extraction solvent

The Section 101 requirements are in addition to the ‘extractable lead’ restriction in ASTM F963-11, which is applicable to children’s toys and is often relevant to assess the chemical risks with young children’s footwear that might be sucked, chewed or licked. This limits the amount of lead that can be extracted from the item after exposure to simulated stomach acid to replicate digestion. However this is extractable lead, and is different to the total amount of lead that is restricted as part of the lead paint rule.

The current requirements in Section 101 are that children’s products must contain less than 90 parts per million (ppm) of lead in surface coatings such as paints, varnishes or lacquers and 100 ppm in substrates. Analytical methods must be in accordance with CPSC standard CH-E1003-09.1 for paint and other similar surface coatings, CH-E1001-8.1 for metal items and CH-E1002-08.2 for non-metal substrates. However, these methods contain many different testing options, so testing laboratories have generally developed their own standard operating procedures based on these methods. Such procedures must be included in a laboratory’s ISO 17025 list of accredited tests. SATRA has been accredited for testing to the lead paint rule since December 2010.



A sole unit being prepared for testing

The CPSIA 2008 also restricts the amount of six specific phthalates in children’s toys and childcare articles. These phthalates are plasticisers that can be added to plastics, especially polyvinyl chloride (PVC), to increase their softness and flexibility. The relevant phthalate plasticisers are listed in table 1 and are divided into two groups, each containing three phthalates. DEHP, DBP and BBP are restricted in all toys and certain childcare articles, but DINP, DIDP and DnOP are restricted only in toys and childcare articles that can be placed in a child’s mouth. The hazards from these groups of chemicals are as a result of long-term exposure and the young are particularly vulnerable to the carcinogenic, mutagenic and reproductive toxicity (CMR properties) of these chemicals.

Table 1: The six types of phthalates restricted in the CPSIA 2008
Phthalate Abbreviation CAS number Restrictions
Bis (2-ethylhexyl) phthalate DEHP 117-81-7 No greater than 0.1 per cent by mass of
plasticised material in toys and certain childcare articles.
Dibutyl phthalate DBP 84-74-2
Benzyl butyl phthalate BBP 85-68-7
Di-isononyl phthalate DINP 28553-12-0
No greater than 0.1 per cent by mass of
plasticised material in toys and childcare articles which can be placed in a child’s mouth.
Di-isodecyl phthalate DIDP 26761-40-0
Di-n-octyl phthalate DnOP 117-84-0

The definitions of these terms are explained in table 2 and testing must be carried out using an analytical method based on CPSC-CH-1001-09.3. The six phthalates and their maximum permitted levels are identical to those in entry numbers 51 and 52 in the European REACH Regulation (1907/2006) Annex XVII and these are also included in the SATRA footwear restricted substances list which is available free for SATRA members.

Table 2: CMR definitions
Term Definition
Carcinogens Substances and preparations which, if they are inhaled or ingested of if they penetrate the skin, may induce cancer or increase its incidence.
Mutagens Substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce heritable genetic defects or increase their incidence.
Reprotoxins Substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may produce or increase the incidence of non-heritable adverse effects in progeny and/or an impairment of male or female reproductive functions or capacity.

Unlike Section 101 of the CPSIA 2008, footwear is specifically excluded from the phthalate requirements. However, to show due diligence in their risk assessments, US retailers are increasingly including these limits in their footwear specifications. This is because there is a high risk of children under 36 months of age placing such items in their mouths. SATRA has increased its list of CPSC-accredited tests so its reports can be used to support CPCs for both lead and phthalate compliance.

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Publishing Data

This article was originally published on page 6 of the July/August 2015 issue of SATRA Bulletin.

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