US chemical legislation and children’s footwear

Exploring the chemical restrictions that are applicable to suppliers of children’s footwear into the US market.

by Rebecca Shaw

The safety of children’s products – including footwear – is of paramount importance to consumers. In the USA, as in many other countries, there is strict legislation regarding the chemical safety of children’s products, which has been enacted at both federal and state levels. State legislation can be more stringent than federal legislation, although federal legislation applies in all of the United States. When selling products into the US market, it is important to know in which states the product will be sold, to ensure that you are meeting all the applicable legislation.

CPSC lead restrictions in children’s products

The Consumer Products Safety Commission (CPSC) is responsible for protecting the public from unreasonable risks of injury or death associated with the use of consumer products under its jurisdiction. As part of this responsibility, the CPSC introduced the Consumer Product Safety Improvement Act (CPSIA) in 2008. Section 101 of the act is often referred to as ‘the lead paint rule’ and restricts the amount of lead in products intended for children 12 years of age and under. The requirements have become increasingly more stringent since the introduction of the act. The current requirements for lead are 100 parts per million (ppm) for substrates, 90ppm for coatings and 300ppm for jewellery. The CPSIA affects all products intended for use by children 12 years old and younger, not just toys. As such, footwear for children up to and including 12 years of age must meet with the requirements. It is a piece of federal legislation, so compliance is required across the entire USA.

Lead is a highly toxic substance, exposure to which can produce a wide range of adverse health effects, including neurological damage. As lead accumulates in the body, repeated exposure to even low levels of this substance can endanger health. Children are particularly vulnerable to the toxicity of lead.

Since January 2012, federal law has demanded that all products manufactured in the USA or imported into the country must be certified that they meet with the requirements. These Children’s Product Certificates (CPC) must be based on test results from CPSC-accredited third-party laboratories. Failure to meet with these requirements could result in delay or seizure of products at US ports, and possible fines. SATRA is an accredited third-party laboratory for lead testing as outlined in the CPSIA requirements, and can provide test reports in line with US regulations.

SATRA has developed three test methods – using Microwave Digestion followed by Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES) – to assess footwear and children’s products in accordance with the CPSC standard operating procedures E1001-08.2, E1002-08.2 and E1003-09.1, as follows:

• SATRA TM428:2012 – the quantitative determination of total lead in paint and other similar surface coatings
• SATRA TM442:2012 – the quantitative determination of total lead in children’s non-metal products
• SATRA TM443:2012 – The quantitative determination of total lead in children’s metal products.

Each of these methods has been developed specifically for testing different types of materials in accordance with the regulations. For typical children’s footwear, any leathers, textiles and polymers would be tested in accordance with SATRA TM442:2012 for children’s non-metal products. Any metal items (such as eyelets) would be tested in accordance with SATRA TM443:2012 for children’s metal products. Finally, if there were any paints or surface coatings – such as painted metal eyelets – the paints would be tested separately in accordance with SATRA TM428:2012.

CPSC phthalate restrictions in toys and childcare articles

In addition to the CPSC restrictions on lead, the CPSIA 2008 also restricts certain phthalates in toys and childcare articles under section 108 for children 12 years old and under. There are six restricted phthalates: Bis (2-ethylhexyl) phthalate (DEHP), Dibutyl phthalate (DBP) and benzyl butyl phthalate (BBP), which are restricted to less than 0.1 per cent in children’s toys or childcare articles, and Di-isononyl phthalate (DINP), Di-isodecyl phthalate (DIDP) and Di-n-octyl phthalate (DnOP), which are restricted to less than 0.1 per cent in children’s toys which can be placed in the mouth, or childcare articles.

The requirements under section 108 are specifically for children’s toy and childcare articles. Therefore, footwear is not specifically covered by the legislation. However, these section 108 requirements can be used to show due diligence testing for young children’s footwear which may be placed in the mouth. Some of these phthalates are also included in specific state legislation, such as Washington State CHCC and California Proposition 65. The restricted phthalates are suspected to be potential carcinogens and endocrine disruptors. As such, they may affect hormones and the physical and mental development of children. Phthalates are commonly used as plasticisers in certain polymers, such as polyvinyl chloride (PVC or vinyl), where they may be added in the order of 30-50 per cent by weight to increase the polymer’s flexibility.

Washington State’s ‘Chemicals of High Concern to Children’ list

In April 2008, Washington State introduced the ‘Children’s Safe Product Act (CSPA). The aim of the legislation is to reduce the risk of dangerous chemicals being used in products intended for children under 12 years of age. This includes footwear, although exempts athletic footwear with cleats or spikes.

This law consists of two parts. The first part limits the amount of lead, cadmium and phthalates in children’s products. This was pre-empted when the US Congress passed the CPSIA in July 2008. The second part of the act requires manufacturers of children’s products to notify the Washington State Department of Ecology when a Chemical of High Concern to Children (CHCC) is present in any of their products. If the product contains more than one component (for example, footwear may contain textiles and polymers), notification for the relevant component is required. The CHCC reporting list currently contains 66 substances, many of which are also included on the European REACH Substances of Very High Concern (SVHC) list and the California Proposition 65 list. If a product contains a substance from the list, this does not necessarily mean the product is harmful to health. However, notification to the Washington State Department of Ecology is required.

Notification is to take place on an annual basis. It is required for chemicals on the CHCC list which are intentionally added to a product during manufacture, or a contaminant in the product with a concentration greater than 100ppm. Notification must include the name of the chemical from the CHCC list, the CAS number of the substance, the product component in which it is present and a description of the CHCC’s function, if any. For instance, if a listed plasticiser is present, this may have been used to aid flexibility. The name and address information of the reporting manufacturer or importer is also required, as well as the concentration of the CHCC.

This concentration is reported in ranges:

• 1 Equal to or more than the practical quantification limit (PQL), but less than 100ppm
• 2 Equal to or more than 100ppm but less than 500ppm
• 3 Equal to or more than 500ppm, but less than 1,000ppm
• 4 Equal to or more than 1,000ppm, but less than 5,000ppm
• 5 Equal to or more than 5,000ppm but less than 10,000ppm
• 6 Equal to or more than 10,000ppm.

If the manufacturer determines during the annual notification that there is no change from the previous notification, a written statement may be submitted to indicate that the previously reported data is still valid. If the CHCC has been removed from the children’s product since the previous notification, the manufacturer may inform the Washington State Department of Ecology, which will update the records accordingly. All notifications are required annually on the anniversary of the first notice.

Children’s products have been split into four tiers:

• Tier 1 – Children’s products intended to be put into a child’s mouth (such as children’s products for feeding) or applied to a child’s body (for example, children’s lotions and creams), or any mouthable children’s products intended for children three years of age or younger. Pram shoes would be considered as mouthable.
• Tier 2 – Children’s products intended to be in prolonged direct contact with a child’s skin (that is, for more than one hour). Most footwear and clothing would be classified in this tier.
• Tier 3 – Children’s products intended for short periods of direct contact with a child’s skin – for less than one hour – for instance, many types of toys.
• Tier 4 – Inaccessible components in children’s products that during reasonably foreseeable use and abuse would not come into direct contact with the child’s skin or mouth.

Notification for Tier 4 is not required unless there is an amendment to the regulation. The notification dates are being phased based on the size of the manufacturer (measured by gross sales) and Tier group. The notification date for the largest manufacturers/ importers of Tier 1 products ended in August 2012, and Tier 2 notification dates ended in February 2013. Organisations failing to report or which report values below those later found by the regulators are liable for fines of up to $5,000 for the first breach, and a maximum of $10,000 for subsequent offenses.

Notification dates for the largest footwear manufactures/importers have already ended for Tier 1 and Tier 2 products. The majority of the notifications made so far have been for antimony and cobalt compounds, with further notifications being made for phthalates and some organic solvents such as toluene, that can be found in footwear or footwear materials.

California Proposition 65

The State of California has specific requirements to limit the exposure of its citizens to potentially harmful chemicals. California Proposition 65 is also known as the ‘Safe Drinking Water and Toxic Enforcement Act of 1986’. It is intended to improve consumer health protection by requiring suppliers of articles to clearly label their products if they contain chemicals which have been identified by the state as being carcinogenic or having an adverse effect on development or reproductive health. Such chemicals have been included in the California Proposition 65 list. The statute requires that ‘no person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state (California) to cause cancer or reproductive toxicity without first giving a clear and reasonable warning…’ Therefore, any product sold in California which contains a chemical from the Proposition 65 list at a level that could be judged to pose a risk to the user, should be labelled with a clear warning at the point of sale.
 

Exemptions

Businesses with less than ten employees and government agencies are exempt from Proposition 65’s warning requirements. The Proposition 65 list should not be seen as a ban on specific chemicals. Instead, it should be viewed as a requirement to inform consumers about the potential risk involved, so that they can take whatever action they deem appropriate to protect themselves from exposures to these harmful chemicals. There are currently over 850 chemicals on the Proposition 65 list. Chemicals of specific concern for footwear include phthalate plasticisers used in flexible PVC and the use of lead and cadmium pigments. In addition, the Proposition 65 list also contains certain solvents. Therefore, care should be taken with the use of solvent-based adhesives and cleaners, to ensure that these solvents dissipate fully and traces do not remain.

In order to determine if the level of the Proposition 65 chemical is sufficiently high to pose a risk to the consumer, the California Office of Environmental Health Hazard Assessment (OEHHA) has published the ‘safe harbour’ levels for approximately 300 of the listed chemicals. These are exposure levels quantified in micrograms per day (µg/day). These are expressed as ‘No Significant Risk Levels’ (NSRLs) for carcinogenic chemicals and ‘Maximum Allowable Dose Levels’ (MADLs) for substances that cause birth defects or other reproductive harm.

Enforcement

The California Attorney General’s Office enforces Proposition 65, as can any district attorney or city attorney. In addition, any individual acting in the public interest may enforce Proposition 65 by filing a lawsuit against a business alleged to be in violation of this law. Such enforcement has often been linked to campaigns by members of the public and pressure groups who search out products which contain Proposition 65 chemicals, but are not correctly labelled. These individuals can issue a 60-day Notice of Violation – a legal document alleging violations of California Proposition 65 warning requirements. During this time period, the California attorney general's office can review the allegations and take over the proceedings. If the attorney’s office did not take any action at the end of the 60 days, a private party can take legal action against the supplier and/or retailer. Plaintiffs are entitled to part of the compensation payment from the courts.

Over 45 of these 60-day notices were issued for violations of California Proposition 65 warning requirements for footwear during 2012. The majority of these notices have been issued for lead and phthalate plasticiser violations. A business found in violation of Proposition 65 is subject to civil penalties of up to $2,500 per day for each violation. In addition, the business may be ordered by a court of law to stop committing the violation.

Publishing Data

This article was originally published on page 36 of the March 2013 issue of SATRA Bulletin.

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