US restricted substances legislation
Considering how important it is to consider local laws when selling products into the USA.
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Most consumer products – including footwear – are subject to legislation before they can be sold in the United States of America, and this requirement can be both federal (nationwide) and/or state specific. While federal legislation affects all the states, state legislation sometimes has more stringent requirements. Consequently, it is imperative to know into which states you are selling your product. This is particularly important if you are selling products via the internet.
The Consumer Product Safety Commission (CPSC) was established in 1972 with the mandate to ‘protect the public from unreasonable risks of serious injury or death associated with the use of thousands of types of consumer products under the agency’s jurisdiction’. This includes products that pose fire, electrical, chemical, or mechanical hazards or can injure children. As part of this responsibility, the Consumer Product Safety Improvement Act (CPSIA) was implemented in 2008. This is federal law and, therefore, compliance is required across the whole of the USA. The CPSIA legislation affects all products designed or intended primarily for children 12 years of age or younger and contains eight sections, two of which are particularly applicable to footwear.
Section 101 is concerned with children’s products containing lead, and is also known as the ‘lead paint rule’. Section 101 restricts the amount of lead in accessible parts of children’s products manufactured in or imported into the USA, with the exception of certain products which, by their nature, cannot contain lead in excess of the legal limits. A component part is considered to be inaccessible if either it is not physically exposed by reason of a sealed covering or casing or it does not become physically exposed through reasonably foreseeable use and abuse of the product.
The requirements were implemented in stages, and since 14th August 2011, restrict the total amount of lead to no more than 100 parts per million (ppm) of lead in substrates, 90ppm in paints and similar surface coatings (which would include polymeric coatings applied to leather) and 300ppm in jewellery. To enable you to prove conformance with this requirement, SATRA has developed microwave digestion methods in line with US regulations for three different categories – surface coatings, non-metal items and metal products.
Manufacturers and importers of children’s products are required to produce a written children’s product certificate (CPC) stating that their product complies with all applicable children’s product safety legislation. These CPCs must be based on test results from independent CPSC accredited laboratories, such as SATRA.
The final stage of this legislation was introduced in February 2013 as a requirement for random sampling, in addition to the existing requirements for CPCs. Failure to meet these requirements could lead to fines and, for products being imported, at best it could lead to samples being held while the paperwork is obtained. At worst, products could be seized at US ports.
Section 108 relates to the prohibition on sale of certain products containing specified phthalates. Concerns have been raised about one specific group of plasticisers – phthalates – which could be included in polyvinyl chloride (PVC). While phthalates are most associated with PVC, they can also be present in other flexible synthetic polymers, such as polyurethane, although typically at much lower concentrations.
Among other health concerns, some phthalates have been linked with concerns regarding hormonal effects on people exposed to them over a period of time. This is particularly relevant to products used by children. It should be noted that the CPSC has stated that children’s shoes are not considered as either toys or childcare articles, and so therefore are outside the scope of section 108. However, many US retailers are still asking for evidence that footwear complies with these requirements. Only accessible components require testing. Parts are considered as accessible if they are able to be placed in the mouth and have at least one dimension of less than 50mm.
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During use, it is foreseeable that toys and childcare articles may be sucked, chewed or swallowed, with the possible consequence that the plasticisers could leach out or be extracted out of the polymer into the child’s digestive system. Once in the body, some phthalates can behave as endocrine disruptors, meaning they can have an effect the balance of hormones in the body. This US legislation mirrors the current EU legislation covering childcare articles and toys. It places restrictions on the six same phthalates, insofar as di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP) have been permanently prohibited by Congress in concentration of more than 0.1 per cent in children’s toys or childcare articles. A child’s toy is defined as ‘a product intended for a child 12 years of age or younger for use when playing’, and a childcare article means ‘a product that a child aged three years and younger would use for sleeping, feeding, sucking or teething’.
Three additional phthalates: diisononyl phthalate (DINP), diisodecyl phthalate (DIDP) and di-n-octyl phthalate (DnOP) were also prohibited pending further study. The interim prohibition of DINP, DIDP and DnOP applies to childcare articles or toys that can be placed in a child’s mouth or brought to the mouth and kept in the mouth so that it can be sucked or chewed, and that contains a concentration of more than 0.1 per cent of the above phthalates. In 2014, the Chronic Hazard Advisory Panel (CHAP) report was published and recommended that DIDP and DnOP need not be prohibited. It did, however, recommend a permanent ban on Di-isobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP), and an interim ban on diisooctyl phthalate (DIOP), although this action has not yet been ratified.
Each of the 50 states in the Union has the legal right to legislate and govern itself, provided it does not contradict federal law. These states can, however, require more than the federal law does. As a result, different states can place a different emphasis on chemicals of concern. As a result, it is imperative to know where you intend to sell your products, to ensure that you have met all the requirements for those states. It may not be as simple as picking one state as a worst-case scenario and then assuming that it covers everywhere. For example, if a chemical is not included in the California Proposition 65 list, it cannot be assumed that no other state has legislation for that chemical.
Often referred to as ‘Proposition 65’ or ‘Prop 65’, this legislation is actually entitled the ‘Safe Drinking Water and Toxic Enforcement Act of 1986’. This act requires the state of California to publish and maintain a list of chemicals which are known to cause cancer, birth defects or other reproductive harm. The list is updated annually and now contains over 900 entries. 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…’ Consequently, any product being 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 at the point of sale with wording similar to the following:
WARNING: This product contains chemicals known to the State of California to cause cancer or birth defects or other reproductive harm.
Government agencies and companies with less than ten employees are exempt from these requirements. It is important to appreciate that the inclusion of a chemical on the list does not mean that it is banned from use. Indeed, The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is in the process of producing ‘safe harbor’ limits which are based on either No Significant Risk Levels (NSRLs) for carcinogens or Maximum Allowable Dose Levels (MADLs) for chemicals that cause reproductive toxicity. Approximately one-third of the chemicals listed currently have safe harbour limits. It is intended that any new chemicals added to the list should be assigned limits within one year of first appearing on the list, but that the outstanding chemicals will not all be evaluated within the first five years of their inclusion.
Chemicals contained on the list which could be present in footwear include breakdown products from restricted azo dyes, phthalates and solvents. Failure to comply with these requirements can lead to fines of up to $2,500 per day per product, and possible restrictions on sale until the labelling is resolved.
In addition, in October 2013, the Safer Consumer Products programme was launched in California. This is further intended to reduce the presence of toxic chemicals in products that consumers buy and use. It identifies specific products that contain potentially harmful chemicals and requires manufacturers to answer two questions concerning chemicals they have added: i) is this ingredient necessary? and ii) is there a safer alternative?
The list of candidate chemicals initially contained approximately 1,200 entries, but has now increased to over 2,500 entries. While not included in the initial priority products, clothing is one of the categories included in the three-year work plan.
In April 2008, Washington State enacted the Children’s Safe Product Act (CPSA). This legislation requires manufacturers to notify the Washington State Department of Ecology if products intended for children contain any substances listed as being ‘chemicals of high concern to children’. The list currently contains 66 entries, and notification is required if any of the chemicals are present – either due to intentional addition or inadvertent contamination at a concentration greater than 100 parts per million.
The notification must include, among other details, the name of the chemical which is present, the ‘Chemical Abstract Service’ registration number (CAS number), details of which component or components the chemical can be found in, a brief description of the chemical’s function in the product, the total amount of the chemicals of high concern in each component and the name and address of the manufacturer or importer. The notification must be renewed annually as long as the chemical is used. Among the chemicals listed are phthalates, solvents and heavy metals and their salts, which could be present in dyestuffs. Failure to notify the correct authorities can result in a fine of up to $5,000 per violation.
Vermont uses Act 188, which relates to the regulation of toxic substances. From 1st July 2016, this requires a report to be made to the Vermont Department of Health if children’s products contain any chemicals of high concern to children. This list is currently the same list of 66 chemicals that Washington State uses, but also authorises fees for each reported chemical.
In the state of Maine, the ‘safer chemicals in children’s product’ rules, colloquially known as the ‘Kids Safe Products Act’, lists over 1,400 chemicals. These are divided into three bands – ‘chemicals of concern’, ‘chemicals of high concern’ and ‘priority chemicals’. The chemicals of high concern are arsenic, Bis phenol A (BPA), cadmium, mercury, nonylphenol and nonylphenol ethoxylates.
As briefly outlined in this article, care must be taken when selling products in the USA. Research needs to be done regarding individual states’ legislation in order to avoid the risk of costly ramifications.
How can we help?
As part of our comprehensive chemical services for SATRA members, SATRA’s chemistry team can give further details on laboratory testing packages and procedures to assess footwear in accordance with the CPSIA 2008, the Washington State CHCC list and California Proposition 65. This is in addition to our full range of restricted substances and REACH testing capabilities. Please email firstname.lastname@example.org for further information.
This article was originally published on page 10 of the November 2015 issue of SATRA Bulletin.