Manufacturers and Importers of Consumer Products

Children’s product safety is not a new concern. But it has become a more complicated challenge for manufacturers large and small. Today’s toys and other children’s products are made with a wider variety of materials, including new polymers and chemicals. Regulatory bodies are imposing tougher standards, including the Consumer Product Safety Improvement Act (CPSIA) in the US. The number of materials and products subject to regulation is expanding, while regulatory scrutiny itself is increasing.

Manufacturers must be aware of all the standards and testing requirements of the law and take appropriate steps to ensure that they meet not only the current requirements, but also are preparing themselves and their products to meet future requirements. As an example, children’s products that are painted are subject to both lead paint and lead content limits, though at this time, testing is not required for lead content but it is for lead paint. It should be noted that manufacturers must already be testing and certifying for lead in paint, as well as standards for small parts, cribs and pacifiers.

Where testing is required, manufacturers and importers of children’s products must test their products using a third‐party accredited testing lab.

US Regulations of Interest

  • August 2008 – The U.S. Congress enacted the Consumer Product Safety Improvement Act (CPSIA 2008), establishing new limits for lead for products marketed to children 12 years and younger and adding the regulation of six phthalates in toys and certain child-care articles that can be placed in the mouth.

  • February 10, 2009 – Lead limit of 600 ppm in paint and substrates and six phthalates limit set to 0.1% (chart).

  • August 14, 2009 – Lead limit lowered to 90 ppm in paint and mandatory levels of ASTM F963 of seven other metals and 300 ppm in substrate with 100 ppm if technologically feasible by August 2011.

  • February 10, 2010 – Mandatory testing by a certified third-party testing lab or fire-walled manufacturer’s lab.

European Regulations

  • Toys sold in Europe must meet the regulated levels under EN 71. EN 71 Part 3 sets required levels for inorganics. EN 71 Parts 9, 10, 11 set levels for organics. This part of this European Standard specifies requirements and test methods for the migration of the elements antimony, arsenic, barium, cadmium, chromium, lead, mercury and selenium from toy materials and from parts of toys except materials not accessible (see part 1 of this standard).

  • ASTM F963 - specification relates to possible hazards that may not be recognized readily by the public and that may be encountered in the normal use for which a toy is intended or after reasonably foreseeable abuse. It does not purport to cover every conceivable hazard of a particular toy.

  • In December 2008, a new EU Directive was signed setting new limits and adding new compounds to both the lists of metals and organics. The new legislation will go into effect in 2011, but the chemical testing will not be required until 2013.

Rulings & Updates

New Flexibility Granted on Component Parts Testing Policy for Lead December 18, 2009
- CPSC Extends the Stay of Enforcement on Testing and Certification Requirements for Many Children's Products
Accreditation of 7 Laboratories as "Firewalled" 3rd-Party Conformity Assessment Bodies, July, 2009
- The staff recommended that the following laboratories be accredited for the requirements and test methods indicated.
CPSC: SOP for Determination of Phthalates February 09, 2009
- CPSC staff has concluded that these test methods are sufficient to determine the concentration of the 6 regulated phthalates in most consumer products.
Phthalates Ruling: Memorandum Opinion & Order: National Resources Defense Council v. CPSC
- Section 108 of the CPSIA, entitled “Prohibition on sale of certain products containing specified phthalates,” establishes a framework for the federal regulation of children’s toys and child care products containing phthalates.
Proposed Revision of ASTM F963-07, May 2009
- On February 17, 2009, ASTM officially proposed replacing the current consumer product safety rule, F 963-07e1 with F 963-08.
Statement of Commission Enforcement Policy on Section 101 Lead Limits February 6, 2009
- In section 101, Congress made clear that the lead limits apply not only to products manufactured after the effective date, but also to products manufactured earlier. In August, these limits will drop to 300 ppm.