Source: https://www.cpsc.gov/Business--Manufacturing/Business-Education/Lead/Total-Lead-Content-Business-Guidance-and-Small-Entity-Compliance-Guide
Timestamp: 2019-12-10 17:27:20
Document Index: 138026371

Matched Legal Cases: ['§ 1261', 'art 1109', '§1500', '§1500', 'art 1512', '§ 1500', '§1500']

Total Lead Content Business Guidance & Small Entity Compliance Guide | CPSC.gov
Total Lead Content Business Guidance & Small Entity Compliance Guide
With a few limited exceptions explained below, all children's products manufactured in or imported into the United States must not contain more than 100 parts per million (ppm) of total lead content in accessible parts.
All children's products, and some furniture, for adults and children, must not contain a concentration of lead greater than 0.009 percent (90 parts per million) in paint or any similar surface coatings. Household paints must also meet this requirement.
You can find the law in section 101 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) (pdf) (Public Law 110-314), as modified by H.R. 2715 (Public Law No. 112-28, August 12, 2011) and in section 2(q)(1) of the Federal Hazardous Substances Act (pdf), 15 U.S.C. § 1261(q)(1) (FHSA).
The total lead content limits do not apply to component parts of a children's product that are not accessible to a child through normal and reasonably foreseeable use and abuse of the product. In addition to passing all applicable use and abuse testing, children’s products or component parts of children’s products which are enclosed, encased, or covered by fabric must measure 5 centimeters or greater in all dimensions to be considered inaccessible. Please see 16 CFR 1500.87 and our section below on Inaccessible Component Parts for more information.
What do I have to do to ensure that my product complies with the total lead content limits?
Manufacturers and importers of children’s products must third party test their product using a CPSC-accepted laboratory.
There are, however, a limited number of exemptions and exceptions to the third party testing requirement discussed further below.
Yes, provided that certain conditions are satisfied. The Commission has issued a rule regarding testing component parts. You can rely upon the test results or a certification from a component part supplier if the requirements in our regulation at 16 CFR part 1109 are met. That rule requires that in order to rely upon test results or a certification from a supplier, you must use “due care” to ensure that the tests results or the certificate is valid, and be given access to the underlying documentation, such as test results and attestations regarding how the testing was conducted and by whom. Generally, certifications of a component part must satisfy the requirement for a children's product certificate, and must be based on the results of testing at a CPSC-accepted laboratory.
Manufacturers and importers must certify, based on the results of the third party testing, that your children's product complies with the requirement limiting the total lead content.
The correct citation to include in the CPC for this total lead content requirement is: 15 U.S.C. 1278a.
The applicable test methods for the ban on total lead content are:
Lead Content in Children's Metal Products: Standard Operating Procedure for Determining Total Lead (Pb) in Metal Children's Products (including Children's Metal Jewelry), Revision November 15, 2012, Test Method CPSC-CH-E1001-08.3 (pdf).
Lead Content in Children's Non-Metal Products: Standard Operating Procedure for Determining Total Lead (Pb) in Non-Metal Children's Products, Revision November 15, 2012, Test Method CPSC-CH-E1002-08.3 (pdf).
Note: Following development of the initial versions of the test methods for measuring lead in metal and nonmetal products, Test Method CPSC-CH-E1001-08.1 (pdf) and Test Method CPSC-CH-E1002-08.1 (pdf), respectively, CPSC staff developed Test Method CPSC-CH-E1001-08.2 (pdf) and Test Method CPSC-CH-E1002-08.2 (pdf) with expanded options for the use of X-ray Fluorescence (XRF). CPSC staff further expanded the options for the use of XRF in the current test methods: Test Method CPSC-CH-E1001-08.3 (pdf) and Test Method CPSC-CH-E1002-08.3 (pdf).
Some XRF technology is approved to test certain types of homogenous materials, with limitations, such as certain metal materials, polymers and plastics, and crystal, ceramic, and other siliceous materials, in CPSC-accepted laboratories. Approval of XRF technology has reduced the price of third party testing for lead content. (Additionally, there is a specific XRF technology that is approved for use in testing to the separate lead-in-paint requirements).
The applicable test methods for the ban on total lead content are listed above.
International and State Level Lead Content Requirements
Yes. All testing for lead content and other requirements must be performed by a CPSC-accepted laboratory using the methods approved by the Commission. Other countries have requirements and testing methods that differ from those of the CPSC.
Yes, the Commission has determined that certain classes of products do not exceed the lead content limits under section 101 of the CPSIA. The regulation includes determinations that certain 100 percent untreated, unadulterated products do not need to be tested by a third party laboratory.
Some determinations relied upon are those exempting products such as pure wood (not plywood or other composites); paper and other similar products made from cellulosic fiber; CMYK ink printing processes, certain precious and semi-precious gemstones and other minerals (provided that the mineral or material is not based on lead or lead compounds); natural or cultured pearls; certain natural and manufactured fibers, such as cotton, wool, and polyester, among others; certain plant-derived and animal-derived materials, such as animal glue, bee's wax, seeds, nut shells, flowers, sea shells, leather; and finally certain stainless steel and precious metals, as listed. The list above is a sampling of the determinations that the Commission has made. You can find the complete regulation, including the list of determinations, at 16 C.F.R. §1500.91.
Yes. If you are issuing a Children's Product Certificate certifying to another children's product safety rule (such as the lead in paint limit), you will need to ensure that all applicable children’s product safety rules are certified to in Section 2 of the CPC.
I understand the determination that certain fabrics do not contain lead can be affected by printing or dyeing those fabrics. What do I need to do to ensure that my dyed fabrics fall under these determinations and do not require third party testing?
As discussed above, certain natural fiber and manufactured fiber textiles have been determined to not contain levels of lead in excess of the limits and do not need to be third party tested. Those fabrics are:
Natural fibers (dyed or undyed) including, but not limited to: cotton, kapok, flax, linen, jute, ramie, hemp, kenaf, bamboo, coir, sisal, silk, wool (sheep), alpaca, llama, goat (mohair, cashmere), rabbit (angora), camel, horse, yak, vicuna, qiviut, guanaco; and
Manufactured fibers (dyed or undyed) including, but not limited to: rayon, azlon, lyocell, acetate, triacetate, rubber, polyester, olefin, nylon, acrylic, modacrylic, aramid, and spandex.
To use this determination, you must ensure that the textiles are not treated or adulterated in any way with materials that could introduce lead into the material. (Dyes are not considered to be a material that may introduce lead into a material.)
This means that if you choose to print on your textile with after-treatment applications, including screen prints, transfers, decals, or other prints, you can no longer rely on the determination. You must have your inks or your final products tested by a CPSC-accepted laboratory or have the ink manufacturer provide you with a Children's Product Certificate certifying that the inks passed testing by a CPSC-accepted laboratory.
Certain types of printing on textiles use inks that effectively act like dyes. Those inks are absorbed into the fabric, and they become part of the fabric. If you are printing with a "dye-like ink," then, instead of ensuring compliance with the "lead in paint" requirements (a 90ppm limit), your garment is likely to be exempt from testing. See 16 CFR 1500.91. If you intend to rely on this materials determination, you must conduct reasonable due diligence with your supplier or manufacturer to ensure the nature of the ink being used is in fact dye-like ink.
Generally, CPSC staff differentiates inks, paints, or pigments that effectively act like a dye by applying a scraping test. If the ink, paint, or pigment scrapes off then it is considered to be a surface coating (subject to the lead in paint limit of 90ppm); if it does not scrape off, then it is considered to be part of the textile itself (subject to the total lead content limit of 100ppm). For more information on the lead in paint requirements, please visit www.cpsc.gov/leadinpaint.
If a component part is covered or sealed is it inaccessible?
Yes. A component part of a children's product is inaccessible to a child if the part is not physically exposed by reason of a sealed covering or casing, and it does not become physically exposed through reasonably foreseeable use and abuse of the product including swallowing, mouthing, breaking, or other children's activities, and the aging of the product, as determined by the Commission.
In addition to passing all applicable use and abuse testing, children’s products or component parts of children’s products which are enclosed, encased, or covered by fabric must measure 5 centimeters or greater in all dimensions to be considered inaccessible.
Yes. To the extent lead is used for the technological feasibility of certain electronic devices for children, such products may be allowed to have a higher lead content in certain component parts. Specific lead limits for such products may be found in our regulation 16 C.F.R. §1500.88.
Yes. Off-highway vehicles are not subject to the total lead limits. An "off-highway vehicle" is any motorized vehicle that is manufactured primarily for use off of public streets, roads, and highways, is designed to travel on two, three, or four wheels, and has either a seat designed to be straddled by the operator and handlebars for steering control, or has a non-straddle seat, steering wheel, seat belts, and roll-over protective structure. The definition also includes snowmobiles.
Yes. The metal components of bicycles and related products are permitted to contain up to 300 parts per million of lead. The list of metal component parts to which this exception applies is found in the Commission's Notice of Stay of Enforcement Pertaining to Bicycles and Related Products (pdf) published on June 30, 2009 (74 FR 31254).
Children's bicycles and related products must still be third party tested and certified as compliant with 16 CFR part 1512. Please see our Bicycle Requirements Business Guidance page for additional information.
The term "ordinary book" means a book printed on paper or cardboard, printed with inks or toners, bound and finished using a conventional method, and that is intended to be read or has educational value. The term "ordinary paper-based printed materials" means materials printed on paper or cardboard, such as magazines, posters, greeting cards, and similar products, that are printed with inks or toners and bound and finished using a conventional method.
Neither term includes books or printed materials that contain components that are printed on material other than paper or cardboard or contain non-paper-based components, such as metal or plastic parts, or accessories that are not part of the binding and finishing materials used in a conventional method.
Packaging is generally not intended for use by children, given that most packaging is discarded and is not used or played with as a children's product. Also, disposable packaging is not subject to third party testing and certification requirements.
However, if the packaging is intended to be reused, or used in conjunction with the children's product, such as a heavy gauge reusable bag to hold blocks, the bag becomes a component or part of the product and would be subject to the lead requirements of CPSIA.
Are chemistry sets, science education sets, and other educational materials excluded from the lead content limits for paint and surface coatings if they bear adequate labeling?
Certain articles that are intended for children for educational purposes are exempt for classification as a banned hazardous substance under the Federal Hazardous Substances Act (FHSA) (16 C.F.R. § 1500.85) and the lead limits under CPSIA if: (1) the functional purpose of the particular educational item requires inclusion of the hazardous substance (commonly referred to as the functional purpose exemption); (2) it bears labeling giving adequate directions and warnings for safe use; and (3) is intended for use by children who have attained sufficient maturity, and may reasonably be expected, to read and heed such directions and warnings.
Yes, provided that the outdoor playground equipment is designed or intended primarily for use by children 12 years of age or younger.
Yes. Ordinary printing on paper is subject to compliance with the total lead content requirement of 100 parts per million. However, the Commission, in 16 CFR §1500.91, has determined that paper and other similar materials and CMYK process printing inks commonly used in printing on paper do not require third party testing for compliance with the lead requirement.
In addition, Congress specifically exempted ordinary books and ordinary printed materials from third party testing for compliance with the total lead content requirement.
Are textile printing inks (screen-printing inks) considered to be part of the product’s substrate or a surface coating?
First, please try our Regulatory Robot available online at https://business.cpsc.gov to find out the applicable requirements for your product.