Anyone who makes, produces or assembles a product is considered to be a manufacturer. If what you make is sold or donated, something as simple as adding ribbons to hair clips, knitting hats, or stringing beads into necklaces makes you a manufacturer. Under the law, importers are also considered to be manufacturers and must meet the same requirements.

Yes, the law covers all manufacturers and importers -- large and small, domestic and foreign. All businesses, including handmade toy and apparel makers, crafters, those making charitable donations, and other small business must take appropriate steps to be sure that their products conform to all aspects of the law and safety standards, including the new lead content and phthalates limits (more on phthalates) and mandatory toy standards.

A children’s product is one designed or intended primarily for children 12 years of age or younger. Toys, clothes, furniture, books, jewelry, blankets, games, CDs/DVDs, strollers, and footwear may all be considered children’s products.



In determining whether a consumer product is “intended primarily” for a child 12 years of age or younger, the following factors will be considered:

• A statement by the manufacturer about the intended use of the product, including a label on the product, if such statement is reasonable.
  
  
• Whether the product is represented in its packaging, display, promotion or advertising as appropriate for use by children 12 years of age or younger.
  
  
• Whether the product is commonly recognized by consumers as being intended for use by a child 12 years of age or younger.
  
  
• The Age Determination Guidelines (pdf) issued by Commission staff.

If a product is intended for adults or for general use by consumers of all ages, then it is not intended primarily for children. Products marketed and priced in a manner that would not make them appropriate for use by a child would also not be intended primarily for children. An example would be an expensive telescope -- because it is sold for general use by all ages, it is not a children’s product even though it can be used by a child on occasion.

Yes, you can make and donate children’s products to local charities and hospitals, if they are made of exempted materials or materials that you feel confident do not contain lead (see Table B). Children’s products made of yarn, dyed or undyed fabrics and natural materials such as untreated wood or cotton do not contain lead at levels sufficient to exceed the new lead limits.

If your products are made for children 12 and under, they will need to be third-party tested if you use paint or a similar surface coating (pdf). Products for children under 3 will need to be tested to the small parts standard (pdf) if you create a product (such as a toy, puzzle or doll) that could break into small pieces when used, dropped or otherwise handled by a child.

Avoid making and donating children’s products with soft vinyl or plastic, buttons or zipper pulls, or metal jewelry or embellishment or other pieces that may exceed the lead or phthalates limits.

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 (see Table A). 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.

Table A: Compliance and Testing Timetable

* Testing and certification are not required for products already in inventory that are covered by the new lead and phthalate limits and toy standards.

Note: The enforcement of the requirement for a general certificate of conformity for non-children’s products will resume on February 10, 2010. The Commission will be issuing additional information on this topic prior to that date.

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

It is prudent for manufacturers to develop a quality assurance program to ensure products meet safety standards. This may include screening raw materials and sub-components, so that as final products are produced, there is a greater likelihood of them meeting standards and being certified by a testing lab. For lead paint and lead content, an X-Ray Fluorescence (XRF) machine (used by a trained, qualified person) is a possible method to determine if a component has lead, but note that XRF is not a replacement for a third-party test.

Manufacturers and importers must comply with certificate requirements (pdf), which is the documentation that shows that the product has been tested and meets appropriate standards. The certificate must accompany the product(s) either in paper or electronic form. The Commission intends to initially focus enforcement efforts on compliance with the underlying safety rules, rather than on the certificate or form of the certificate itself.

No. If your products need to be tested (see Table A), and they are materially identical and made in the same fashion with no change in assembly, equipment used, etc., then a single sample may be all that is necessary for testing purposes. A change in materials or design can be enough to alter testing results.

For these standards, no third-party testing or certificate is needed before February 10, 2010; however, manufacturers must still ensure their products meet the requirements of the law. There are several things manufacturers can do to be highly confident that their products are compliant:

• Get to know your product and the laws and regulations that affect you. Know what is and is not required of you and your products. These requirements can change.
  
  
• Develop sound business processes that put safety (and meeting safety standards) first.
  
  
• Although there may be no requirement to test and certify, you may choose to do so in the context of a quality assurance program, which ensures products will meet the requirements of the law. This may include testing raw materials, components and final products. This will also make it easier for you to meet the mandatory third-party testing and certification requirements when they become effective. For lead content testing, one solution would be to hire a qualified, trained person who can quickly screen all of your raw materials and finished products with a handheld device called an X-Ray Fluorescence (XRF) machine.
  
  
• If you choose not to test, ask your suppliers about the chemical/material content of their products. Seek out materials that will enable you to produce products that are in compliance.

CPSC is currently working to determine exemptions to the lead content limits and the requirement to test. In the interim, until the Commission issues final rules in these areas, certain materials can be used in making products or be sold as children’s products without risk of sanction or penalties by the Commission provided the manufacturer, distributor or seller does not have actual knowledge that the products have more than the acceptable lead limit. The Commission generally will not prosecute someone for making, selling or distributing items in these categories (see Table B) even if it turns out that such an item actually contains more than 600 ppm lead.

Sellers will not be immune from prosecution if CPSC’s Office of Compliance finds that someone had actual knowledge that one of these children’s products contained more than 600 ppm lead or continued to make, import, distribute or sell such a product after being put on notice. Agency staff will seek recalls of violative children’s products or other corrective actions, where appropriate.

Table B - These materials or components can be used (separately or
in combination) and sold (provided they have not been treated or altered
or undergone any processing that could result in the addition of lead):

Under section 15(b) of the Consumer Product Safety Act, companies must immediately tell the Commission if they learn of a children’s product that violates the law or has a defect that may present a product hazard.

Phthalates are a group of chemicals (oily, colorless liquids) that are used, among other things, to make vinyl and other plastics soft and flexible. Many types of phthalates are in use today. As of February 10, 2009, three have been prohibited outright in the United States for use in certain products and three more are prohibited pending further action by the Commission.

Three phthalates, DEHP, DBP, and BBP, have been permanently banned in concentrations of more than 0.1% in “children’s toys” or “child care articles.”

• A “children’s toy” is a product intended for a child 12 years of age or younger for use when playing. General use balls, bath toys/bath books, dolls and inflatable pool toys are examples of toys that are covered by the law and might contain phthalates. Bikes, playground equipment, musical instruments, and sporting goods (except for their toy counterparts) are not considered toys and therefore not affected by the ban.
  
  
• A “child care article” is a product that a child 3 years of age and younger would use for sleeping, feeding, sucking or teething. Bibs, child placemats, child utensils, feeding bottles, cribs, booster seats, pacifiers and teethers are child care articles that are covered by the law and might contain phthalates.

Three additional phthalates, DINP, DIDP, and DnOP, have been prohibited in concentrations of more than 0.1% pending further study and review by the Commission and a group of outside experts. This interim prohibition applies to: (a) child care articles, and (b) 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 (for example: squeeze toys, teethers, bathtub toys and uninflated pool toys).

The CPSIA defines children’s toys as consumer products designed or intended for use by children 12 and under when playing. Packaging is generally not intended for use by children when they play, given that most packaging is discarded and is not used or played with as a children’s toy or child care article. However, if the packaging is intended to be reused, or used in conjunction with a child care article or with a children’s toy while playing, such as a heavy-gauge reusable bag used to hold blocks, it would be subject to the phthalates ban.