• CPSC: The U.S. Consumer Product Safety Commission is the government agency charged with protecting the public from unreasonable risks of serious injury or death from thousands of types of consumer products under the agency's jurisdiction. 
• CPSIA: The CPSIA stands for the Consumer Product Safety Improvement Act which is a law that was enacted in August of 2008. The stated purpose of this bill is to “establish consumer product safety standards and other safety requirements for children’s products and to reauthorize and modernize the Consumer Product Safety Commission.”

There is no easy way to tell at this point, but the CPSC is developing a voluntary certification program where you would be able to label a product as “meets CPSC requirements.” This must be backed up by a reasonable test program and results.

The CPSIA defines a children’s product as designed and intended primarily for a child age 12 years of age and younger. Recent clarifications stress not just the word “primarily” but  also “for use.” Manufacturers should refer to CPSC’s Four Pillars, 10 Questions, Final Interpretative Rule on the definition of a children's product and PPAI’s webinar on this topic.

Products that are regulated by the CPSC include adult wearing apparel, matchbooks, lighters and more. A full list of regulated items is available at www.CPSC.gov. Third-party testing for these non-children’s product may not be mandatory, but compliance with the applicable safety standards  is mandatory. Currently, compliance and general certifications of conformity are required for many of these regulated items. The general conformity certification must be based on a test of each product or a reasonable testing program.

If any part of the supply chain recognizes the potential use of a product by children 12 years of age and younger, children’s product testing should be performed. One should consider the Final Interpretative Rule on the definition of a children's product and additional CPSC guidance to confirm if item would be classified as a children’s product, but the supply chain should be open about expected uses of a product as well.

Collectibles that are intended for adults may be interesting or appealing to children 12 years of age and younger. If a product is an adult collectible, it is intended solely for use by adults as a display item and is often labeled accordingly. Adult collectibles may be distinguished from collectibles intended for children by their theme, high cost, limited production or display features (like hooks or pedestals). For example, collectible die-cast items may be highly detailed, have a display case or platform and may cost a lot of money. If the die-cast collectible was intended for children, it would most likely be a simple design and be more affordable. Along with the factors mentioned above, the method of distribution should also be considered.

Generally, yes the criteria for California Proposition 65 is the same or higher than that of the CPSIA, but it is best to check to make sure that there is nothing out there that is lower than what the CPSIA levels are.

Bathrobes fall under regulations for children’s apparel regulations, particularly flammability; therefore, one would primarily consider the weight and the material of the garment.

Without knowing more about the product and its intended use, the supplier is unable to know whether a label is required. It is required, however, that a warning label is present at the point of distribution.

Being a product intended for children, it must meet all CPSIA requirements as well as state regulations for children’s jewelry. There is also an upcoming ASTM standard for children’s jewelry that will most likely take place in the beginning of 2012.

With the upcoming regulation changes that will take effect on December 31 requiring third-party testing, it is important that manufacturers begin to certify that their products meet set standards. Any children’s product produced after August 14, 2009, must have a tracking label.

There is a blanket testing flammability standard that must be followed by producers as well as the regulations set by the CPSIA.

It alleviates the required testing, which can make for a major cut in cost for producers.

The supplier must ensure compliance of the “blank” with the applicable standards. The supplier needs at least a reasonable testing program for a non-children’s blank if it is subject to a standard and third-party testing if the blank is a children’s product. The decorator must ensure compliance of the products used to decorate the product, and of the finished product if any changes were made that could affect the previous compliance of the “blank." Both parties are required to provide tracking labels if the item is a children’s product.

The distributor is not responsible for manufacturing or compliance but certainly doesn’t want to put non-compliant products on the market. The distributor should ask for compliance certification and documentation from the supplier.

When a distributor knows that a product is intended for use by children 12 years of age and younger and the supplier has not and will not perform testing, it is not entirely clear how the legal liabilities will fall, but the law is based on the premise that a non-compliant product cannot be placed on the market. 

The law is based on the premise that a non-compliant product cannot be placed on the market. If a distributor knows that a product is intended for use by children 12 years of age and younger and the supplier has not or will not perform testing, it is recommended that distributors have their own tests conducted. Anticipation of these situations may require budget additions or thoughtful examination of who you choose to do business with. There are no set rules for handling or anticipating these situations.

In order to ensure the safety of various products and campaigns, it is in a distributor's best interest to communicate the nature and distribution of the products being manufactured to the supplier.

PPAI or individual testing labs cannot comment on the legal protection of such an arrangement; this is would be the responsibility of a company’s legal counsel.

CPSIA requires that the Importer certify compliance of a children’s product. Assuming the supplier is the importer and the item is a children’s product, it is a Federal regulation that a children's product certification is provided with the product. You have the option of refusing to represent suppliers if they cannot provide the required certificate. It is important that only compliant product be placed on the market.

Your choice is whether to do business with a manufacturer and their decision is whether they want your business. If a manufacturer's products are covered by a federal safety standard, compliance with CPSIA is required by law and significant fines are associated with non-compliance. These fines were significantly increased with the passage of the Consumer Product Safety Improvement Act of 2008.

Typically, most buyers won't pay for third-party testing. If no tests are required for a product, but an end buyer would like testing done, then who pays the testing costs would be part of a dialogue with your buyer.

When a consumer product does not require compliance to any current rule or standard, the distributor should communicate this to the customer. If the customer continues to ask for some proof of compliance, the distributor could have the product tested for something that is currently required for children’s products, for example, lead. The cost of this test is relatively low and the customer and consumer could be reassured about the safety of the product if they knew it did not pose a lead exposure risk. The distributor should consider this solution only after educating the customer about consumer product safety standards. If testing is performed and a general conformity certificate produced, the customer could question the section of the certificate that lists the applicable safety regulations, which for the unregulated product, would be left blank or “N/A.”

No, the CPSC fines the manufacturer of record or the importer of record if produced overseas. The CPSC would fine whoever issues the general conformity certificate. This does not account for potential civil action. 

As an educational tool, PPAI has developed TurboTest to help in determining which rules and regulations might apply to your product. Click here to access TurboTest. Additionally, the CPSC website also has lists of regulated products, under the Business tab. Also, services like this are provided by testing labs.

A general conformity certificate is all you need if you trust the person or group producing it. The certificate is based on testing and the reasonable test program.

Go the CPSC’s list of accredited testing laboratories to find a testing lab.

The ASTM standards are available for purchase online.

The CPSC's guidance on age-grading is available online.

The FDA maintains a list of Generally Recognized As Safe (GRAS) ingredients and a list of color additives.

No.

Specialized Technology Resources (UL-STR) provides 15% off for PPAI members. Testing costs in China are much cheaper and are offered by UL-STR in China as well.

Yes. It is best to have the product tested in the country of manufacture–you will know the test results before shipping and testing costs tend to be lowest. There are many CPSC accredited testing laboratories overseas.

It’s hard to estimate costs when there is so much variability in the products, however, a standard children’s product would need to comply with the tests noted below. Note that these standard prices are per analysis and, in particular, the lead content is performed on all accessible substrate materials unless they are exempted. The testing costs are based on laboratory location—testing is significantly less expensive in Asia than in the US. Toys would require additional testing for phthalates and for full heavy metals in surface coatings (not just total lead).

UL-STR and PPAI recommend that a product regulated by the CPSIA be tested annually. If the production volume is less than 10,000, then testing should be performed at the production of every 10,000 items. Additionally, whenever there is a material change to the item, testing should be performed.

Specialized Technology Resources (UL-STR) provides 15% off for PPAI members. Testing costs in China are much cheaper and are offered by UL-STR in China as well.

The ASTM standards are available for purchase online.

The ASTM standards catalogs are available online.

• Flammable Fabrics Act
• Fiber Identification Act
• Care Labeling Regulations

Component testing can reduce redundant testing. For example, if the identical button is used on five styles of children’s sweaters, the button can be tested once as a component rather than test it with each of the five styles of sweaters. Component testing can also identify test failures early on, by testing a component before it is applied to the finished product and tested at that stage. Component testing may offer a marketing advantage to many component suppliers who will promote the sale of pre-certified CPSIA compliant products. With component testing, though, it is critical that there be good traceability to the finished product and that the manufacturing process does not contaminate the component.

Yes. If a diaper bag, for example, includes components that are used by children, phthalate, FDA or CPSIA regulations could apply.

Yes, if all of the individual, accessible parts of a product are tested, those test results can stand-in for a test of the entire product. Note that a Certificate must be issued for the finished product based on the component testing.

If it is a children’s product or toy, the entire product must meet all applicable requirements. The elastic band would be treated as a component part and would need to be tested.

If you have a means in place to track the product and you know that the manufacturing process remained the same throughout different orders (same factory, same equipment, same lot, and same inks) then batch testing could be acceptable. You wouldn’t have to test each order as long as you are confident that the manufacturing and materials are the same for each order.

What are the testing requirements for toys?

• Mechanical safety testing (use and abuse), with specific criteria dependent on appropriate or labeled age of the product. This testing applies to toys and other articles intended for use by children.
• Lead content (applicable to toys and children’s products)—accessible substrate materials only.
• Total lead in surface coatings.
• Heavy metals in surface coatings—this test is specific to toys per ASTM F963.
• Phthalate content of surface coatings and high-risk substrate materials—this test is specific to toys per CPSIA.
• Tracking label required for all children’s products per CPSIA. 

Products need to be recertified annually. If suppliers change factories or a raw material used in the making of a product, however, the product will need to be recertified immediately.

Yes, they will need to be tested separately.

No, it cannot. Instead, it can be used to ensure that each production batch is consistent with the third-party tested sample.

First, labs in China are frequently a favorite of producers because of their low cost. Every major laboratory company, such as STS and Solid Citizen People, has dozens of laboratories throughout China; therefore, there should not weariness based solely on location of the laboratory. It is best to know and build a relationship with your supplier and rely on them to find a reputable testing facility.

Yes. Astute staff members in the compliance departments of distributors will know to look for complete test reports to ensure that no important information was redacted (crossed-out, whited-out, or deleted by software programs) or altered in any way.  All test reports from the lab should have “Page 1 of 10” or a similar notation to indicate the total number of pages in the complete report.  Any noticeable alterations to or omissions from a test report should instantly cause the reader to suspect it as being an unreliable document, which, in turn, will cause the distributor to doubt the supplier’s integrity.

All Children’s Products, as defined by the CPSIA, must have a Tracking Label permanently affixed to it and its packaging.  A Children’s Product is “a consumer product designed or intended primarily for children twelve years of age or younger”.  Most suppliers and apparel makers of children’s garments are affixing the Tracking Label directly on the sewn-in-label (“SIL”) of the garment.  The SIL usually contains the garment size, country of origin, the RN number, fiber identification information, and care instructions.  These SILs are usually printed from rolls of tape, so there should be room to print one more line on it to include the Tracking Label.  Decorators who buy pre-sewn blanks can simply sew-in an additional SIL with its Tracking Label information.  Most end-users and brands will not want a Tracking Label to be included in the art because it detracts from the marketing or promotional message of the decoration.

The Tracking Label must be on the item and on the packaging if any.  Packaging would include hang-tags, display boxes, and similar methods used to inform consumers and end-users of the benefits of using the product and use/care instructions.  Plain polybags used during shipping are excluded.

Although both the supplier and the distributor should be made fully aware of the intended age-group of the end-users, it is ultimately the distributor who has a relationship with the client who is ordering the products.  The distributor’s account people should be asking the client questions such as:

• “How will this product be used?”
• “How old will the end-users of this product be?”
• “If children are the end-users, what is their age range?”
• “How will the product be distributed or given out?”
• “Who is the client? Is it a company like Disney, Coca-Cola or other brands that have exceedingly high compliance and labeling requirements?”

Once the distributor has the answers to the above questions, then he/she is better informed to work effectively with the supplier to choose the most appropriate product for the client and its end-users and to jointly work on any labeling and packaging issues that may arise.

Most suppliers who have been burned by receiving and paying for imported non-compliant or shoddy products have learned the hard way to test the products before the goods are shipped.  This avoids pre-payment for bad goods and the need to figure out what to do with bad goods in the U.S. warehouse. It is now illegal to reship non-conforming goods to another country unless:  (1) the goods comply with the safety regulations of the destination country; and (2) the officials in the destination country agree to accept those goods;  in some cases, the CPSC must be notified and their approval must be granted before shipping.  Testing costs outside the U.S. are typically one-half to two-thirds less expensive than having the same tests done in the U.S.  Excellent economies of scale, lower wages, and intense competition allow certified labs in Asia to charge considerably less than their U.S. counterparts.  Remember, use only CPSC-certified labs. Click here to access a list of CPSC-certified labs.

There are many excellent test labs from which to choose.  It is highly advisable to look for a lab partner that can provide more than the lowest price.  The old adage “you get what you pay for” rings very true in the product testing and certification business too.  Select a test lab based on some of the following criteria:

Capabilities:  If your business is mostly in the soft lines area, such as apparel, towels, fabric tote bags and similar textile items, then look for a lab that specializes in testing these articles.  The same principle applies to hardline items, such as electrical products, electronics, writing instruments, drinkware, key chains, carabiners, and the like.  You will want a lab that is skilled and knowledgeable about all the regulations that apply to these types of products.

Locations: Check to see if the lab has locations in or very near to the cities where your factories or vendors are located.  The closer the lab is to the factory, the faster and cheaper it will be to get samples to the lab for testing.

Customer Service: This is the weakest area with most of the major lab companies.  Many labs will not have a specially-assigned Customer Service Manager in the U.S. to take care of your every need and question.  This criterion is especially critical for a small supplier or distributor that does not have a compliance staff to handle all the daily fires that pop up in managing this area.  A quality test lab should be a valued partner in your business.  Ensure that your lab will provide you with a skilled, patient and knowledgeable Customer Service Manager.

Integrity: Check various online publications such as www.prnewswire or www.chinalaborwatch.com,  or Google “test lab and bribes”, to see if your current or potential new lab partner has been named in various actions or claims for corruption overseas.  Factories offering bribes to auditors and inspectors, and even lab representatives, is an all-too-common problem in Asia.  Not only has the integrity of the factory broken down by bribery, but the integrity of the inspection, auditing and testing processes has been destroyed, and we, who are suppliers, distributors and end-users, are victims of this corruption.  Choose a lab, inspection or auditing partner that has a low or no incidence rate of bribery.

Price: This is often the first criterion on most companies’ priorities list.  It’s an important one, of course, but the key is to simply shop around.  The testing business is a very competitive one.  U.S.-based labs are faced with many competitors from Europe and Asia (especially with China Government-subsidized labs).  One effective trick is to do an “RFQ”, which is short-hand for “Request for Quotes”.  Take ten (10) of your most popular items and send one sample of each item to the main U.S. office of each of the labs on your short-list of candidates.  Tell them to quote you for each item, using ONLY mandatory tests that are required by applicable U.S. federal and state (and/or Canada, if you do business in Canada) regulations. Tell them if they include “recommended, but not required tests” in the quotes, they will be disqualified.  Have the labs quote you for testing done in the U.S. as well as in Hong Kong/China/India, etc. (where your factories or vendors are located).  Give them three weeks to complete the RFQ, and they must provide you with not only their best pricing, but also their best turnaround time, and their promise to assign one dedicated Customer Service Manager to your company who is based in the U.S.  All labs work on volume, and their discount structure is based on the potential annual volume of testing revenues they will make from each client.  They will most certainly ask for this projected annual volume number, so be ready to provide an accurate and honest projection to get a discount rate from the lab.  One last near-secret tip on this subject:  most labs have at least three (3) price structures:  (1).  U.S. Client Pricing for clients who pay their testing bills in the U.S.; (2).  U.S. Client Pricing for clients who pay their bills directly to the Asia lab; and (3). Local Asia Pricing for local clients who pay their bills directly to the Asia lab.  Door #(1) is the most expensive, and Door #(3) is the least expensive.  Scenario #(2) is the most reliable one because it does not involve the factory or vendor in the lab relationship (other than sending in samples to the lab).  Scenario #(3) is the riskiest because most U.S. companies do not have Asia offices that will qualify as a “local” customer, so the factory or local vendor will need to play a role in the contractual and payment structure with the lab.  This is not ideal.

Remember, the definition of a Children’s Product is “a consumer product designed or intended primarily for children 12 years of age or younger”.  Therefore, if the product is truly a “general use” item and does not have any childlike or child-appealing artwork, logos, cartoons or other features on it, and the item has little or no play value, then the product should not need a CPSIA Tracking Label or need to be compliant with CPSIA-required testing for Children’s Products.  However, a general use item can easily be transformed into a Children’s Product by simply applying a cartoon decoration, adding a toy item such as a small plush animal keychain to it, or even by the method and location in how it is sold or given away.  This is one of the most difficult areas of the CPSIA involving products that may be given to children.  The key is learning how to determine if the product is “intended primarily” for kids 12 years and younger.  

A tracking label can be located anywhere on the product, so long as it is reasonably conspicuous and a reasonable consumer can locate and read it on the product.  It must be permanent so it cannot be easily washed or peeled off.  Therefore, stickers and labels are not allowed by law.  Decorators can certainly add the Tracking Label to the client’s design, but one supplier that did this on some key-fobs in 2011 received a very strong client complaint and widespread industry criticism for combining the client’s art and the Tracking Label on the primary surface of the item.  As to the payment for any Tracking Label, the supplier and distributor will have to work out the added cost for the label.  The client will most likely not pay for it so the cost must be included in the client’s final price.

Generally speaking, the “Final Manufacturer” is the company or person that made the last improvement, modification or addition to the product before it is shipped to the retailer or consumer.  If you added a screen-print, embroidered art (or other decoration), or even a pack of crayons or chalk to an art kit, you would be deemed to be the Final Manufacturer, and you would need to add at Children’s Product Tracking Label to the final product.  In the world of children’s clothing, if a supplier purchased kids’ tee-shirt blanks from Hanes, Fruit-of-the-Loom, or any of the other blank tee makers, and you added a screen-print to the front of the tee, you would be considered to be the Final Manufacturer, and you would be required to add your Tracking Label to the garment.

Technically speaking, only Children’s Products require third-party testing at this time.  However, there are many federal and state regulations that apply to other consumer products that also ban or regulate hazardous chemicals in consumer products but third-party testing is not mandatory for those items.  Compliance with these laws and regulations is still mandatory, but third-party testing is not required for such products.  But, for the purposes of this discussion, if a screen-printer is going to apply any inks to any Children’s Product, then those inks must be tested by a third-party lab that is accredited by the CPSC.  Included with the basic inks for testing, should be the hardeners, thinners, solvents, flatteners, and all other chemicals that might be added to the inks during the screen-printing process.  However, the screens, the screen frames, emulsion and other components, supplies and equipment used during the screening process that do not become a part of the final product, do not need to be tested unless there is a potential for leaching of harmful chemicals from those components into the ink.

This is an excellent question to explain “component testing”.  The CPSC permits component testing to allow manufacturers to save money in testing.  If a supplier uses the same materials and components in a multitude of products, the supplier may be able to test those common materials and components only once per year, provided there are no changes in the formulation, raw materials, design, manufacturing method, or supplier of any of the materials or components.  If at any time, there is a change in any one of these factors, then the company must have the affected material or component retested.  All components and materials must be tested at least once every 12 months pursuant to the CPSIA, whether or not there has been any change to the material or component factors.

As for the question relating to award medals for children’s running races, the supplier here does not need to produce General Certificates of Conformity (“GCC”) (soon to become a Children’s Product Certificate for all Children’s Products) for each and every award made by this supplier.  A blanket GCC/CPC will suffice so long as the awards all use the same materials, manufacturing method and design, and come from the same factory, vendor or supplier.  The testing is done by component testing as described above, and a separate GCC should be issued for each style of the award, listing the regulations, standards, and bans that the product has been tested for (and passed). Click here for a sample GCC form.

The best practice is to actual units from the production run in order to avoid the common problem of the factory substituting in “Golden Samples” (samples that the factory knows will pass testing, and probably made with safer materials and better construction methods).  The challenge is making sure that the factory uses actual production units to send to the lab for testing.  Many labs can send a local representative to the factory to randomly select samples off the production line but there is a cost for these services.  Tests should be run on the same item at least once per year if the item is a frequently sold item, depending on the volume, frequency of production lots, and complexity of the product.  The CPSC has stated that products must be tested at least every 12 months in order to comply with the CPSIA.  If, at any time, there is a change in the factory, material/components or their suppliers, design, manufacturing process or other factors that would alter the product or its materials or its function, then the product must be tested again to ensure that the modified item meets all applicable regulatory and safety requirements.

But the recipient might give the stress reliever to one of their kids even if the client never intended it to be used by a child. Items such as stress balls, plastic tangles, squeeze toys, Slinkys, Magic Rings, etc., all have potential “play value” for adults and children, even if the item does not have child-appealing artwork or logos on it.  It should be automatically conceivable that certain stress reliever products will be given to children, depending on the shape, size and intended function of the item. Always look for play value in the item.  Ask yourself:  “Can a child entertain him/herself with this item?  Would a reasonable child want to play with this item?”  Unfortunately, most of these items are not designed or intended for children, so there are some potential safety hazards that many of these “adult” items may pose to small children, including, but limited to, small parts, sharp points and edges, finger entrapment, strangulation, throat impaction, and suffocation hazards.  One way to avoid potential liability is to ensure that the item has a warning sticker or label such as:  “This item is not a toy.  Keep away from small children.  Contains small parts (or whatever hazard the item may pose).”

Both suppliers and distributors should play active roles in determining whether an item is suitable for the intended end-user.  Distributors are in the best place to ask their clients the pertinent questions about the intended use, environment, age-group, and method of distribution for the products.  The distributor should then work with the supplier to determine whether the item has been designed, manufactured and tested for the appropriate age group.  Adding artwork and certain child-appealing features to the product will certainly cause a General Use item to be transformed into a Children’s Product.  A cartoon like South Park is generally intended for older, mature audiences because of the nature of the content, the time the show is aired on television, and other factors.  However, an animated show like The Simpsons may have a younger demographic than South Park, so products with The Simpsons artwork, characters and logos, would require greater caution and efforts to ensure safety and compliance for a younger age group.

At this time, there are no public databases with this type of information.  There are many legal and practical issues that arise with this type of sourcing/compliance database.  Some trade associations have been considering such a database for their members, but legal concerns, competition and protecting trade secrets have, to date, prevented any successful launch of any database of this nature.  One word of caution:  be careful if selecting vendors and suppliers from online vendor listings such as  Alibaba.com.  The Latin phrase “Caveat Emptor” (“Let the buyer beware”) has never been truer.

So long as there has not been any change in the materials, components, suppliers, design (other than artwork), manufacturing methods, and ink formulations, the re-order should not need to be re-tested.  For screen prints, no re-testing would be needed unless there has been a change in the ink formulations, the ink supplier(s), any solvents, thinners, flatteners, hardeners and other chemicals that are used in the screening process that become part of the finished product, then no re-testing should be needed for the re-order.  Inks (with all the chemical components included) should be tested at least once per year to comply with CPSIA requirements.  Testing base colors will be sufficient;  a supplier does not need to test every PMS color in the book to comply.  If the screen-printer buys 26 base colors from its ink manufacturer, then each of the 26 base colors should be tested.

Unfortunately, there is no legal relief or defense available by law to the distributor in this case.  For every product that is put into commerce, every party that has played a role in the chain-of-distribution (factory >> supplier >> distributor >> client) has “joint and several” liability for injuries and death caused by any defect in the product.  Of course, the distributor may sue or countersue its supplier for indemnity (whether by contract—per the purchase order terms and conditions—or by law under the doctrine of implied indemnity), but this is a costly and time-consuming way to seek legal redress.  A better way for distributors to protect themselves is to insist that each and every supplier provides a policy of insurance to the distributor, BUT, the supplier must specifically name the distributor as a Policy Holder or as an Additional Insured to ensure that the distributor will have first-level protection under that policy.  The policy, typically a Commercial General Liability (CGL) Policy, should also include products liability coverage, with a single-limit of at least $1,000,000 per occurrence.  If a supplier provides riskier products or products in large quantities and infrequent orders, then the coverage limit should be greater (e.g., $2,000,000 per occurrence).  The distributor should obtain a Certificate of Insurance from the supplier to evidence this insurance coverage, and the certificate should include a clause that requires the insurance carrier to notify the distributor at any time the supplier should cancel or modify the coverage described in the certificate.

There will always be a risk for potential liability whenever a product is put into the stream of commerce.  However, certain defenses can be made by a sharp lawyer to reduce or even eliminate the potential liability.  Most courts in the U.S. will consider liability for all foreseeable hazards with a product, regardless of the amount of time that has elapsed since the original date of manufacture or distribution.  Changes in regulations since the date of manufacture may also impact the legal outcome.  But, the bottom line is that a supplier’s and distributor’s risk will remain in place if the product has any defects in design, materials or manufacturing, and these are factors that are within the supplier’s control.  Factors such as unintended use, misuse, or abuse of the product will provide both the supplier and distributor with arguments to defend against such actions.

If the supplier or distributor has less than 10 employees (part-time or full-time), it is exempt from Cal Prop 65.  However, if a product is indirectly shipped to California and a bounty hunter, the State Attorney General or other authorized enforcer files a Notice of Violation because the item has, for example, high concentrations of lead, then the supplier or distributor can raise the defense that the item was not originally sold or distributed in California.  The regulation applies only to products sold or distributed in the State of California.  If the product is originally distributed and sold outside of CA and a consumer or end-user subsequently brings the product into CA, the regulation would not be applicable to such item, but manufacturer/distributor/retailer may need to prove that the item was not sold in California.  Written proof such as purchase orders, shipping documents and other documents can prove this.

The Illinois Lead Labeling Law (under the Illinois Lead Poisoning Prevention Act) requires that a warning label must be applied to any children’s jewelry, child care article, toy,  or children’s product if it has more than 40ppm of total lead content.  The regulation, in relevant part, is as follows:

(b) Children's products.  Effective January 1, 2010, no person, firm, or corporation shall sell, have, offer for sale, or transfer the items listed in this Section [Emphasis Added] that contain a total lead content in any component part of the item that is more than 0.004% (40 parts per million) but less than 0.06% (600 parts per million) by total weight or a lower standard for lead content as may be established by federal or State law or regulation unless that item bears a warning statement that indicates that at least one component part of the item contains lead.

The warning statement for items covered under this subsection (b) shall contain at least the following: "WARNING:  CONTAINS LEAD.  MAY BE HARMFUL IF EATEN OR CHEWED.  MAY GENERATE DUST CONTAINING LEAD."

A strict reading of the underlined language above should indicate the intent of the regulation.  If any company sells, offers for sale or transfers the items to the State of Illinois, then liability will fall on them.  In this case, if the distributor, unbeknownst to the supplier, “transfers” the product to Illinois, then the distributor should be liable if the products violate the statute for having high lead (more than 40 ppm but less than 600 ppm of total lead content) and do not have the requisite warning label.  The supplier in this case would not be liable.

In most cases, due to contractual and regulatory obligations, the supplier or its overseas vendors will be responsible for the testing.  Practically speaking, distributors in our industry do or should require that the suppliers provide the appropriate testing reports and GCCs for the products being sold to the distributors.  Thus, the best person or company to ensure that these documents are acquired for the distributors would be the supplier.  The supplier, in this case, is the “cheapest cost avoider” because the supplier has the most control over the design, production, testing and shipping of the goods, and can use the same test reports and GCCs for the same item being sold to other distributors.

• Lead-containing paint ban: this regulation, which has been law since 1977, bans the use of lead-containing paint on toys as well as wet paint and furniture coated with such paint. The current limit for lead in paint is 90 parts per million (ppm). 
• Lead content limit: as of August 14, 2009, products designed or intended primarily for children 12 years and younger may not contain more than 300 ppm of lead content by weight for any accessible part of the product. Note that there are some material exemptions. Beginning August 14, 2011, the level will be lowered to 100 ppm. This is proactively applicable, meaning it only applies to children's products manufactured after that date. 

The CPSIA requires that products designed or intended primarily for children 12 years old and younger cannot contain more than 100 ppm of lead in any accessible part. Note that there are some material exemptions to the CPSIA's Lead requirements.

The CPSIA provided that lead content in paint and similar surface-coating materials must be reduced from 600 ppm to 90 ppm. 16 CFR 1303 contains more information regarding the lead in paint ban.

Yes. There are inks already in commerce that meet the 90 ppm limit.

Yes, with wet chemistry (as opposed to XRF), it is possible to test for very low levels of lead.

Section 212 of the Consumer Product Safety Improvement Act (CPSIA) states that the Consumer Product Safety Commission (CPSC) shall "establish and maintain a database on the safety of consumer products and other products or substances" regulated by the Commission. The database must be publicly available, searchable and accessible through the Commission's website.

The online public database, which is located at www.saferproducts.gov, serves as the single intake point for all consumer reports of harm. Consumers can also use the site to search for product recalls.

It is essential that manufacturers (in our case both suppliers and distributors) register with the database to ensure they receive all compliant notifications in a timely manner.

All suppliers and distributors should go to the business portal on www.saferproducts.gov and register to receive electronic notifications. Conduct periodic searches of www.saferproducts.gov for your product line (brand or company) as well as product category.

When consumers report an incident, they are required to enter information into the following eight fields:

• Description of product
• Identify the manufacturer
• Describe risk or harm
• Incident date
• Category of submitter
• Contact information
• Verification of accuracy of the report
• Consent of submitter to transmit the report to the manufacturer

All consumers must verify the accuracy and truthfulness of their statements by checking a box. Criminal penalties could be assessed for false statements. Once verified, the consumer cannot delete or edit the content. Consumers cannot post duplicate reports on the same incident and cannot post anonymously.

Once the complaints are registered, the CPSC will:

Identify the complaint; investigate and analyze the complaint—the CPSC will triage the complaint by collecting facts, verifying the complaint, considering the risk of injury and the significance or risk of future injury; and enforce standards

Reports are then transmitted to the manufacturer. Reports will not be transmitted to the manufacturer without the consent of the consumer. During a test run of the database, more than 95 percent of the reports were transmitted to the manufacturer. The manufacturer has 10 days to respond before that complaint is made public.

The decision to respond can only be made by the manufacturer. The CPSC may remove the consumer report if the manufacturer can prove that:

• The complaint is factually inaccurate
• The complaint makes confidential data public

The manufacturer does not have to respond on the public database to a consumer complaint, but should do internal research to determine if the manufacturer has a Section 15 reporting obligation.

If you are unsure, either report or call the CPSC for guidance at 800-638-2772 (TTY 301-595-7054).

If the product has been recalled, direct the consumer to the CPSC recall link. If the item has not been recalled, industry experts suggest that you limit statements to: "Thank you for bringing this matter to our attention. Please contact our customer service team at..." Once the consumer contacts the manufacturer directly, you can work to resolve the issue by refund or return. For even more information, you can access the CPSC's Recall handbook.

In the promotional products industry, the supplier is typically the "manufacturer" for the purposes of federal consumer protection laws. Importers are considered manufacturers as well. There may be times when, depending on what a distributor does to a product, that a distributor may also be the manufacturer.

The CPSC's guidance on age grading is available online.

New regulations regarding cadmium are expected to be enacted very soon. Some states have already passed laws regarding the use of cadmium, primarily in children’s jewelry. If the product is not covered by a current regulation but an end buyer insists on tests for cadmium, a supplier or distributer could test the product according to the European standard which limits total cadmium to 100 ppm.

Polyvinyl chloride (PVC), soft plastics and coatings on soft plastics are some examples of materials that could contain phthalates.

The CPSC is working to establish phthalate test guidelines. Third-party testing to that guidance was expected to be mandatory on February 10, 2011 but another stay has extended that date. The CPSIA limits the types of phthalates permitted to be used in toys and child-care articles. A toy is defined as a product intended for use by a child 12 years of age or younger for use when the child plays. A child-care article is a product that a child three years of age or younger would use when sleeping, feeding, sucking, or teething. The CPSC has provided some guidance on the definition of child-care article.

Phthalate testing is required for toys and child-care articles. Child-care articles facilitate sleep and feeding and would include sleepwear and bibs. If an apparel item is a child-care article, phthalate testing would be required on materials that the CPSC has identified as possibly containing phthalates, such as the grips on the feet of sleepwear, surface coatings, elastics and any other soft plastic materials. It is very unlikely that the fabric itself would contain phthalates and testing of the fabric itself is not required.

Phthalate testing applies only to toys and child-care articles such as infant sleepwear or bibs. If the garment qualifies as a child-care article, phthalate testing would be required. Phthalates are rarely found in screen printed materials, however, they are sometimes found in the inks used to create puffy images or logos as well as pliable printed material. The CPSC has identified all surface coatings as materials that may contain phthalates and should be tested.

No, there are no guidelines that solely address melamine. There is, however, an FDA extraction for food contact items made of melamine-formaldehyde resin.

Chromium levels are not regulated by the Federal government. The ASTM F963 standard does include chromium as a regulated heavy metal in surface coatings of toys, and the CPSIA made ASTM F963 mandatory.

There are a couple of flammability tests that might apply. If the film is being used as clothing, there are flammability testing requirements. If the vinyl plastic film is being used in a toy, then the flammable solid test may be required.

Mechanical safety testing (use and abuse) applies to toys and other articles intended for use by children. ASTM F963 includes additional mechanical hazards tests for specific toys.

Choking hazard risks are covered by 16 CFR 1501, the small parts regulation for products intended for use by children three years of age and younger. An item is considered a small part if it fits completely within the small parts cylinder, which has a diameter of 1.25 inches. These regulations apply to products “as received” and after applicable use and abuse testing.

Any toy or other article intended for use by children three years of age and younger that presents a choking, aspiration, or ingestion hazard because of small parts is a banned hazardous substance. The CPSC lists examples of toys or articles intended for use by children under three and exemptions to the rule and the size requirements and test procedure.

The 16 CFR 1500.48,49 regulates testing for sharp edges and sharp points of toys and other articles intended for use by children eight years of age and younger.

Also known as Use and Abuse Testing, the 16 CFR Ch. 11 §1500.53 regulates specific test requirements.

• General Conformity Certificate (GCC): this is a supplier’s declaration of conformity based on either a test of each item or a reasonable testing program and is required for CPSC regulated products.
• Children's Product Certification (CPC): these certificates should be produced for all children’s products and reflect the results of third-party testing. Note that GCC and CPC are sometimes used interchangeably.
• CPSIA: Congress signed into law the Consumer Product Safety Improvement Act of 2008 (CPSIA) as Public Law 110-314. This act makes significant changes to consumer product safety laws and gives the Consumer Product Safety Commission (CPSC) significant new responsibilities for ensuring the safety of consumer products. Find out more about the CPSC and other regulations that could apply to promotional products here.

They must be issued by the domestic manufacturer or importer of record based on the test of each product or a reasonable testing program (which may include third-party tests). They must be made available to the person putting the product on the market (the distributor) and available both to Customs and the CPSC.

No. Although they are not required to be part of every shipment, GCC’s should be kept readily available. 

The CPSC makes sample GCCs and CPCs available online.

For CPSC-regulated product, you should expect a GCC that details the product’s compliance. A test report reflecting that the product meets requirements may also be requested. If it is a children’s product, certification of third-party testing should be provided. For a product that is not regulated by the CPSC, a certificate and test report indicating compliance to applicable regulations (such as FDA for food contact items) should be requested.

As an importer, it is your responsibility to issue the general certificates of conformity. You will need to be confident that the product is in compliance since you are issuing the certificates.

Yes. Since component testing is allowed, ink manufacturers can have inks third-party tested for lead in paint and issue the appropriate documentation. Decorators may simply pass that documentation to the buyer as compliance certification.

If there are no applicable CPSC regulations for the product, then a GCC would not be required. A GCC is required for any item covered by CPSC regulations but if nothing applies, there should be no certificate. There are times when testing is not needed but certification to a CPSC regulation is still required, such as the 16 CFR 1610 flammability for wearing apparel. Actual flame testing is not required when fabric weight is 2.6 oz/square yard or more, or when certain fabrics are used. But one still must certify that the garment conforms to 16 CFR 1610 (even though testing was not required). The CPSC makes sample GCCs and CPCs available online.

All apparel falls under CPSC regulations as a result of the Flammable Fabrics Act, therefore GCC’s are required for adult apparel. Third-party testing and certification for flammability of clothing textiles is required for products manufactured after 11/17/2010.

When importing undecorated shirts, it is important that you get confirmation that the garments meet flammability standards as well as fiber ID and care labeling regulations. All inks must also be compliant. If the fabric is very thin or is a suspect fabric, you may want to test it yourself.

All children’s products manufactured after August 14, 2009.

No.

At a minimum, the tracking label must identify the factory and date of production, as well as contact information to find out if the item was subject to a recall. You can find more guidance in the CPSC's Statement of Policy on the Tracking Label mandate.

Yes.

Even with a web URL, the manufacturer should include a contact name and contact information for those consumers who may not have web access. However, the company name does not need to be the supplier's. The end consumer must have access to a company name so they know who to go back to if there are any issues.

Yes, a factory can be identified by code on the product’s tracking label. This is recommended for distributors so that a product’s source could be determined quickly.

The requirement is that the consumer must have someone’s name and contact information, whether it is the distributor, supplier, private labeler or retailer. The company noted on the tracking label must be able to determine, based on the tracking number, when and where product was made. The law doesn’t specify whose name must be on the product, as long as someone’s is. You can find more guidance in the CPSC's Statement of Policy on the Tracking Label mandate.

A distinguishing code that would allow your distributors to trace the product back to you, and then you could determine when and where the product was produced, should be acceptable. However, by law, a company name must be included, whether it is the customer, distributor or supplier. The end consumer must have access to a company name so they know who to go back to if there are any issues

By law, tracking labels must be affixed to all children’s products. However, these tracking labels do not need to be incorporated into the logo, but may be imprinted on the bottom or inside of the item.

If items are only sold in bulk, then the tracking label may be affixed to the bulk packaging as well as the item itself if that is practicable. As a general rule, tracking labels should be affixed to both the product and the packaging. You can find more guidance in the CPSC's Statement of Policy on the Tracking Label mandate.

Yes. There are no regulatory issues regarding loop labels.

The law requires that markings with the specified information be permanent and placed on the item where practicable and on the packaging.

Section 103 of the CPSIA provides that the tracking label must contain information that will enable the manufacturer to ascertain the location and date of production of the product and cohort information (including the batch, run number, or other identifying characteristic) and any other information determined by the manufacturer to facilitate ascertaining the specific source of the product by reference to those marks. You can find more guidance in the CPSC's Statement of Policy on the Tracking Label mandate.

Adhesive labels are not considered ‘permanent’ so would not be a suitable method of applying the tracking label information. Stamping would be acceptable, as long as the stamp was permanent and not able to be rubbed off or otherwise easily removed. You can find more guidance in the CPSC's Statement of Policy on the Tracking Label mandate.

One party is not more legally obligated than the other. It would be prudent to request a tracking label from the manufacturer in China so that you can track the product back to an individual factory. The decorator should also imprint a tracking label in case of problems with the ink(s).

If the product is too small to include the tracking label code, it is acceptable to label only the packaging. The tracking label info should be on the individual product packaging and not just the shipping carton, though, unless the product is sold in bulk and does not have individual packaging. If a keychain, for example, comes on a blister card or has header card, the tracking label information could be included there. Ideally, the tracking label should be with the product even if it cannot be on the product.

No. The reasonableness of attaching a label to hosiery has already been thoroughly considered in the application of the federal Care Labeling rules. Those rules can be a guide to what is practicable in this case.

It would be ideal if each component were to include the tracking number since they come from different suppliers. It is recommended that both the packaging and the shipping container include tracking label information as well to ascertain date of pack out—that is the date that the ‘finished product’ was made—and where it was packed out. If each component could not be marked, the traceability of the packed out product should enable you to de

It seems that they are missing the location of production (factory), although if this information is known based on the date of production (perhaps only one factory producing the foam letters at any given time), the current labeling should be considered acceptable. If the location of production cannot be determined from the date of production or any of the other wording, then they would need to add some type of code indicating actual production factory. You can find more guidance in the CPSC's Statement of Policy on the Tracking Label mandate.

The tracking label provision applies only to children’s products. The first step is determining if you have a children’s product. With promotional items, this is especially challenging because the theme (including the logo) and the distribution method (to whom and where product is distributed) are often not known when the product is first made. But if the product could reasonably be expected to be used by children—small water bottles, plush items and puzzles are a few examples of promotional items that are also children’s products—it must comply with CPSIA requirements for children’s products. If you are supplying unprinted items and the packaging would not stay with the finished product after printing, the unprinted product—the blank—should include appropriate tracking label information. The printer should also include some type of tracking label for the printing inks.  It’s important that the product be able to be traced back to manufacturing facility should there be a problem with product, and it should be possible to trace back to the printer should there be a problem with the inks.

Yes. In case there are problems with the ink, the supplier, distributor and consumer need to be able to contact the printing facility. We suggest including the tracking information at the lower corner of the design itself or at the bottom hem of the shirt.

Based on current CPSC requirements, tracking label information is required both for the t-shirt and the imprint. The intent of the tracking label provision is to assist with a product recall so it is important to be able to identify the date and place of manufacture of the t-shirt as well as date and place of the decoration, in case there is an issue with the ink. There are no specific requirements on where and how to apply the tracking label information. Some decorators are including it on inside bottom seam, some with the logo. The tracking label must be permanent so a hangtag or removable sticker is not an acceptable means of including the tracking label information.  

Wearing apparel already has standards and regulations for tracking labels—consider the care label. Labeling laws already require an RN number. The manufacturer may just need to add the date to be compliant. 

Yes. The ink must meet any applicable lead regulations. 

Although regulations state that tracking labels must be affixed to product and packaging, if no packaging exists, none needs to be created to comply with the regulation. Tracking labels affixed to the product will be sufficient.

It would seem that traceability is needed for both the blank t-shirt as well as the decoration. Given the reason for the tracking label requirement, which is to assist with identification of product involved in a recall, being able to trace back to the manufacturer does not help if the problem is with lead in paint used to decorate the product. The promotional products industry is rather unique in that it is not the finished product that is initially purchased. If one were buying a printed t-shirt, only one tracking label would be able to provide sufficient information.  But with the two touches, traceability information for both seems to be needed.  

If the product is too small to include the tracking label code, it is acceptable to label only the packaging. The tracking label information should be on the individual product packaging and not just the shipping carton, though, unless the product is sold in bulk and does not have individual packaging. If the balloons come in a bag, the tracking label information could be included there.

It applies to anyone distributing in Pennsylvania; therefore, it is their responsibility to make sure that the product is properly labeled.

Depending on the size of the bag, it may or may not be required. Various states also have different regulations regarding these bags.

Yes, the ASTM F963 has become mandatory by CPSIA.

Yes, most of them are. The majority of companies that produce plush are strictly plush producers so they are well aware of the regulations in place for the products.

No there is not a standard form, but there are required fields that must be present on the label. More information can be found on product safety labels on the product safety site.

CPSC recommends testing every two years.

The label is specific to Europe. It is important to remember that even though a product meets European standards, it may not meet United States standards.

• Flammable Fabrics Act
• Fiber Identification Act
• Care Labeling Regulations

You can ask a testing lab. It’s almost impossible for the average company to keep track of this information because there is no one place that lists all international regulations for all products.

Yes. All apparel requires an RN number, which is really a factory code.

Phthalate testing is required for toys and child-care articles. Child-care articles facilitate sleep and feeding and would include sleepwear and bibs. If apparel item is a child-care article, phthalate testing would be required on materials that the CPSC has identified as possibly containing phthalates, such as the grips on the feet of sleepwear, surface coatings, elastics, and any other soft plastic materials. It is very unlikely that the fabric itself would contain phthalates and testing of the fabric itself is not required.

Children’s sleepwear has specific testing requirements (i.e. every 5000 yards of material), but no specific requirements have been established for standard apparel. For other children’s apparel, you should look to the reasonable test program set by the CPSC for guidance. At a minimum, annual testing is recommended.

Medium to heavy weight tee-shirts typically weigh more than 2.6 ounces per square yard and are exempt from flammability testing. The exemption is based on the weight of the garment. If under that weight, flammability testing applies as well as compliance to the Fiber Identification Act and Care Labeling Regulations.

All apparel falls under CPSC regulations as a result of the Flammable Fabrics Act, therefore GCC’s are required for adult apparel. Third-party testing and certification for flammability of clothing textiles is required for products manufactured after 11/17/2010.

No, all apparel will require GCCs. Third-party testing is specific to children’s products. However, GCC’s do require self-testing, so a reasonable test program will need to be in place.

The life of a garment is considered 50 washes, which basically represents one wash per week for a year. A commercial garment might be washed more often than that, but still would be expected to withstand 50 washes for its life.

No. It is acceptable to have the shirt tested to applicable flammability standards and have the ink tested separately before printing on the shirt. If the shirt and the ink meet the applicable regulations separately, and there is traceability of inks to the final product, and the process of printing on the shirt does not chemically alter the product, final product testing would not be required. Certificate indicating compliance of the final product is required, though, but can be based on the individual shirt and ink testing.

On the apparel products, we sell into the industry that are NOT for children what are the minimum requirements for labeling or identification? We typically put the PO#, our ASI # and PPAI # and usually the item number in addition to the required country of origin on the product or sewn on the tag. Is that enough for standard promotional products?

If it is apparel, you need to include on the care label the fiber content, RN# and COO.

It is acceptable to place this information on the tracking label. Adding additional information is fine as long as the required information is present.

None. Hats are exempt from the Flammable Fabrics Act.

None. Socks are exempt from the Flammable Fabrics Act.

Yes, so long as they are also labeled in English.

No. If it is a gift, as opposed to putting it on the market in that country, it would not have to meet European standards. If it was going on the market in Europe, then, of course, stricter standards would apply, but as a gift, no additional testing or labeling is required.

The care labeling, country of origin and tracking label do not have to be on the actual socks. However, they must be on the packaging. For care labeling, the following is required:

1. Full care instructions
2. Ensure care labeling instructions, if followed, cause no harm to the product
3. Warn about certain procedures that may harm the product

Under the Fiber Identification Act, the law requires the fiber content, country of origin and manufacturer or dealer identification (RN) to be present.

We are planning to give socks away. Do we need to create packaging in order to display the care labeling and country of origin information?

Products are granted exemption from the Care Labeling requirement if they are completely washable and sold for less than $3.

You are not required to create packaging for the labeling; however, because you cannot put the labeling on the product, it is recommended that you include some sort of packing with the information.

There are no requirements for cellulose backing on embroidered products.

Embroidery backing is not typically subjected to the flammability of textiles testing because:

1. It is typically not large enough to test (need 2" x 6" piece)
2. It is typically not exposed during normal wear
3. The weight exemption may also apply

The law requires third-part testing on decoration of youth-sized garments only. If the apparel is an adult-sized garment, then in most cases it wouldn't need to be tested. In some cases, the end buyer may choose to take on the additional costs to have the testing done and protect their brand.

Yes, there is defined language and size requirements for children's products that pose a choking hazard to children less than three: WARNING! Choking Hazard: Small parts. Not for children under 3 years.

Undecorated textiles made with natural fabrics are exempt from lead testing.

Standards and required testing for undecorated textiles include fiber content rules, care labeling instructions and flammability testing, which are exempt in some cases based on weight. Proof of testing should be made available by your supplier. Refer to PPAI webinar on product safety and apparel for more information.

If you partner with a third-party lab to test up to three ink colors, you can combine these and test them once under the Composite Testing Rule. Instead of testing three inks three separate times, you can combine them and reduce the cost of testing. We work closely with UL-STR, a third-party lab accredited by the Consumer Product Safety Commission (CPSC). They offer a discount on testing services to PPAI members. Click here to learn more about this member benefit.

CPCs should be produced by the supplier when the product enters the stream of commerce and made available upon request. If a distributor imports the blank product, the distributor is considered the supplier and must make a CPC available for each children's product. Click here to view a sample of a CPC.

Panelists reported that yes, they were aware of suppliers charging extra for the application of a secondary tracking label.

Suppliers are required to create a CPC for any children's product before it enters the stream of commerce. Suppliers do not need to ship the document with every order, but it must be available. Click here to view a sample of a CPC.

The secondary tracking label for the decoration of children's apparel, which constitutes a material change to the product, can be incorporated into the imprint design, printed on the inside back neck, on the bottom hemline or sewn in as a label behind the original care/tracking label. The varied location options for this label may ease its burden. PPAI's Tracking Label Solution has satisfied some of the items required to print, which should reduce the total size of the label. It also serves as a repository for all your labels.

The CPSC has stated that there is not a "one size fits all" solution, but the tracking labels are a requirement for all children's products.

Yes, with some exemptions, flammability testing is required for all fabrics/textiles.

To conduct the flame test, you need a 2-inch by 6-inch piece of fabric. If you can’t get a piece that large, you either don’t test, or you combine it with another part of the garment and test it.

No, they are not exempt. Blankets are not covered by 1610, because they are not apparel. Blankets have a separate ASTM standard for flammability (ASTM D4151). This is not a federal requirement, but an industry standard. T-shirts and sweatshirts are subject to 16 CFR 1610.

Right now, customs is not looking at every item coming into the U.S. UL-STR’s guidance is that if the manufacturer can’t supply required testing documentation, you should make sure it is done yourself. It is a Federal requirement that you comply, and you don’t want to discover that your product is not in compliance after it has been placed on the market.

Regulations must be met despite the size of the order. Custom screen printers should get all inks certified for the lead in paint regulation and have a system in place to track products with those types of inks. Screen printers can also rely on certificates provided by the manufacturer of the ink that it meets the lead in paint standards provided certificates are based on CPSC-accredited third-party lab testing. They must also be confident that the manufacturing process will not introduce lead into the product.

Phthalate testing applies only to toys and child-care articles such as infant sleepwear or bibs. If the garment qualifies as a child-care article, phthalate testing would be required. Phthalates are rarely found in screen printed materials, however, they are sometimes found in the inks used to create puffy images or logos as well as pliable printed material. The CPSC has identified all surface coatings as materials that may contain phthalates and should be tested.

H.R. 4040, which became the CPSIA, applies to all CPSC standards including adult apparel because adult apparel needs to comply with the Flammable Fabrics Act. Regarding the tee-shirt, it must be phthalate free only if it considered a child-care article such as sleepwear.

Lead in paint testing applies to surface coatings such as “puffy” inks, as well as phthalate testing if item is a toy or child-care article. When screen printed, some inks becomes part of the fabric, so are not accessible for lead in paint testing but would be tested for lead content as part of the substrate material. Some paints that remain on the surface of the garment (i.e. puffy paints) are accessible and would need to be tested for lead in paint.

When importing undecorated shirts, it is important that you get confirmation that the garments meet flammability standards as well as fiber ID and care labeling regulations.  All inks must also be compliant. If the fabric is very thin or is a suspect fabric, you may want to test it yourself.

Test results for all inks along with traceability documentation linking the tested inks to your product and confirmation that the screen printing process does not contaminate the inks.

Yes, the CPSIA requires that infant garments be tested for lead, phthalates and other chemicals. The law requires that this testing for lead be done by a third-party lab. Third-party testing is subject to a stay on phthalates.

The CPSC doesn’t have strict regulations as to how to include tracking label on garments. You can include a sewn-in label or stamp the inside lower seam of the shirt. It is important to remember that the label must be legible and permanent.

Yes. Various regulations would apply to this type of product and require testing. The flammability requirement for all wearing apparel could apply to this product barring any weight or material exemptions. If the item is decorated with screen printing, the ink used in the process would need to meet the lead standard of the CPSC.

If inks can be removed from the fabric, they must be tested for lead in paint which requires third-party testing now. In most cases, the inks are not able to be scraped off the garment and so are subjected to substrate testing. Third-party testing for lead in substrate is not yet mandatory; however, compliance to lead content is required now and most companies are testing to confirm compliance.

In this case, the specific shirt does not need to be tested. It is acceptable to get the testing certificate from the shirt manufacturer and the paint/ink certificate from the silk screener, provided certain parameters are met:

Certificates must directly relate to your specific product, whether by lot code, style number, PMS color, etc. A general certificate stating that “all xxx inks meet CPSIA requirements” is not acceptable as it does not directly relate to the inks used on your product.

There must be nothing in the manufacturing process that could contaminate the final product. We have seen, for example, inks that meet CPSIA lead limits but the inks on the final product were high in lead. The manufacturing process itself added lead contamination as the screens were cleaned using leaded gasoline. This is just one example of how a manufacturing process could introduce lead and the final product may therefore not comply. Certificates from the component suppliers (shirt, ink) can be used only if the manufacturing process would not affect the components.

Certificates should be based on laboratory testing. In the case of the screen print inks, testing must be performed by a CPSC-recognized third-party testing laboratory, and we recommend obtaining a copy of that actual test report for your files. For the shirt itself, third-party testing is not mandatory but any compliance is based on some type of testing, whether by supplier, factory, or otherwise. For a children’s shirt, there is minimal testing required, i.e. flammability per 16 CFR 1610 (unless material or weight exempts it).

These shirts should already have tracking label information affixed to the product when purchased as a blank, indicating when and where they were produced, along with manufacturer’s name. With textiles, the company information is often in the form of an RN number. There also needs to be the indication of factory name and date code (when and where produced). In addition, there needs to be traceability to the screen printer and date of printing. 

Testing for phthalates is not required because a tee-shirt is not a toy or a child-care article.

Children’s sleepwear goes up to size 6x by regulation. There have been many discussions regarding sleepwear and loungewear. If the tee-shirt has decorations that indicate it is likely to be worn as sleepwear, then it could be considered sleepwear and you’d be best to be sure that it meets phthalate requirements. Whether or not it is sleepwear, it must comply with 16 CFR 1610 flammability requirements as well as Fiber ID and Care Labeling Regulations.

Only if it is intended for sleepwear. This would be a judgment call, but we advise on the side of prudence. If marketed or decorated in a way that indicates it is likely to be worn as sleepwear, it should be tested as sleepwear.

No. Toys are children’s products that have play value. All toys are children’s products but not all children’s products are toys.

Yes. The t-shirt manufacturer must include tracking info on the t-shirts themselves. In addition, the imprinter must supply tracking info for the imprint.

No. This is not a federal, mandatory standard yet. It is a guideline from the CPSC, and banned in several states. Drawstrings are a constant cause for recalls due to the potential for strangulation. It is best to exclude drawstrings on children’s apparel.

Even though the item is not a garment yet, it will need to meet any Flammable Fabric standards. As the importer of record, you will also need to be able to provide the GCC on those fabrics.

While this may be beneficial to business relationships, this type of education is not required by law. Producers of woven labels should also note that they are exempt from the lead rules in children’s products as fabric/textile is an exempt material.

Not for the CPSIA lead content standards as the textile itself is exempt. A t-shirt would need to meet flammability requirements (unless exempt based on weight or material). There are also Fiber ID and Care Labeling regulations to which the t-shirt must comply.

In 2009, the CPSC’s general counsel issued a statement in response to the Writing Instrument Manufacturers of America (WIMA), the National Association of Manufacturers (NAM) and PPAI regarding pens, stating that most pens are general use items, as likely to be used by an adult as a child. The statement went on to say that even if the name of an elementary school is imprinted on the side of the pen, it does not change the inherent nature of that pen from an adult item to a children’s product, thus exempting most pens from CPSIA regulations. If however, the pen is goofy or playful or if an adult would be embarrassed to use it in a business setting, it could be considered a children’s product.

While pens are normally considered a general use item, if there is play value and the pen is marketed directly to children, then it could be considered a children’s product. The “mortification rule” might be useful in this case: is the pen something you would feel uncomfortable using in a business meeting? If so, it might be a children’s item.

In accordance with guidance from the CPSC's general counsel, a pen with a decal of a cartoon character would probably be considered a general use item. The more play value one adds to the pen, the more likely it will be considered a children’s product.

On the sole basis of it being handed out to children, no. In accordance with guidance from the CPSC's general counsel, the targeted audience of a writing instrument does not determine its use. To determine whether or not an item is a children’s product, consider these factors.

Because pens and writing instruments are typically considered general use items, age grading is unnecessary.

There are no regulations for ink in general use pens. If it were to be considered an art material, then the pen would need to be tested and labeled according to LHAMA.

If the pen is not considered a children’s product, then it does not need to be tested according to the standards of the CPSIA. Prop 65 is primarily a warning label program, not a testing program, however, if the pen will be distributed within the state of California it should comply with California safe harbor levels or have a warning label affixed.

Crayons are regulated by the Federal Hazardous Substances Act (FHSA) and the Labeling of Hazardous Art Materials Act (LHAMA). These laws require that all art materials be reviewed to determine the potential for causing a chronic hazard and that appropriate warning labels be put on those art materials found to pose a chronic hazard. The term "art material" includes "any substance marketed or represented by the producer or repackager as suitable for use in any phase of the creation of any work of visual or graphic art of any medium." The designated regulation for this law is ASTM D-4236.

The ASTM D4236 needs to be printed on the box, and the product must have LHAMA certification in order to place this on the box. Once all this is in place, the actual printing on the box would state "Conforms to ASTM D4236."

Generally, not for retail items are exempt from nutritional labeling. They still, however, must have the basic labeling, such as the statement of identity, net contents, and ingredients. Depending on the size of the packaging and how the item is distributed, labeling requirements will vary. For example, some smaller packaged food items are allowed to provide a phone number or website where the ingredients can be given because there is not proper spacing on the item's package.  

No, it is not required. The master case for the items, however, should be coded.

Probably not, but it is safest and recommended to include it.

There is a section in the regulations, 21 CFR, dealing with this topic regarding nutritional labeling only.

No, they do not. Food is not covered by the CPS. Most food regulations are created for those who are two years of age or older. 

The FDA has jurisdiction. There are specific pet food regulations that were not covered, but the FDA oversees them because people may have a tendency to eat them if need be.

There may be additional allergens added to the list, such as sesame seeds. Most of what they do regarding changes in regulations, however, will depend on the funding that they get. They will be looking to the borders and tightening up on the import process. They will also be working on bettering the traceability of food in order to isolate where problems are coming from if one should occur and how to stop it from spreading.

It could. Watch PPAI's webinar on the definition of children's products to learn more.

Not at the present time, although we do expect regulations to toughen.

Yes. If an aluminum bottle is coated on the inside with a non-stick or plastic coating, FDA extraction requirements per 21 CFR 175.300 would apply.

While various regulations could apply to this type of product depending upon its contact with food (FDA) and its targeted consumer (children—CPSIA), drinking containers with lids are not automatically non-compliant.  There are many that are compliant.

All glassware regulations apply to shot glasses. According to an exception on the lip and rim rule, shot glasses might be exempt as the standard does not apply to ceramic or glassware that has less than 60 mm of the decorating area below the rim.

The U.S. tension testing limit of the Toy Safety Standards is 15 pounds while the European standard is 20.2 pounds. We recommend that drinkware with pop-up tops or other removable parts that could be a choking hazard be tested to one of those standards.

No. EN71 is the European toy safety standard.  US has different children’s product rules as well as FDA extraction requirements for drinkware.

Yes.

Children’s backpacks are covered by the CPSIA. All children’s products subject to CPSC regulations are subject to reasonable test programs and will require periodic testing by third-party labs.

Backpacks can be used by adults and children. The size of the backpack would need to be considered, as well as the logo or theme in order to determine if the product is a children's product.

Backpacks do not need to be tested for phthalates, because they are not child-care items nor toys.

If it’s a small size, it could be considered a children’s product, particularly if it has a child-friendly logo. Size, method of distribution and type of decoration will help determine if the product is for adults or children.

No. A tote bag that does not fulfill any of the other definitions of a children’s product according to the CPSC would not be considered a children’s products simply because the logo refers to a children’s hospital.

No. Regardless of the intended audience of the comb, it would be considered a general use item. If it meets any of the CPSC’s definitions of a children’s product, then it could be considered a children’s product and would require testing and a tracking label.

Most awards and trophies would not be considered children’s products. Children’s products are items designed or intended primarily for use by children 12 years of age or younger. Even awards given to children are not really used by children. Most often, they are put on a shelf as a room decoration. Unless there is play value or function to the award, the CPSC would not consider these to be children’s products requiring CPSIA compliance. For example, if an award was shaped like a car and had moving wheels designed for play, it could be a children’s product. Without non-functioning wheels, the award would be considered a general use product.

California Proposition 65 is a list of 800+ chemicals known by the State of California to be harmful. If these chemicals are present in unacceptable amounts, labeling is required of the product will be distributed in California.

Pioneer labels each package with the month and year in which it was produced. From there, the producer has a system in place which can use these numbers to look at the exact date of production.

Either a general certificate of conformity (GCC) or a children's product certificate (CPC) should be requested. TurboTest, a tool provided free of charge to PPAI members, can also be useful in guiding distributors to find what is needed to properly comply with regulations, helping vendors to find a reliable distributor that follows such regulations.

The balloon itself is not tested but all of the material that is used in the packaging is. Testing on balloons is used instead for informational purposes rather than in search of hazards presented by the product.

Chemical testing became mandatory in 2008, but third-party testing is not required until December 31st. Other various tests became mandatory at different times.

Matchbooks are regulated in 16 CFR 1202. A GCC is required for all matches manufactured after 2/10/10.

A crocking test is done by rubbing the product back and forth. It is generally done by a handheld machine. It has a small disk on the end of it and a white cotton fiber is attached that is rubbed against the product to check for staining. The test is usually first done in a dry state and then it is done in a wet state.

Yes, they are. Many clients have begun testing toys intended for pets as if they were children’s toys.

No, they are not. A toy, however, must be clearly marked that it is intended for pets only. If not, it will need to follow the regulations in place for children’s toys.

No there is not and because the CPSC does not regulate they pet toys, they would not be a helpful resource when looking for suggestions. Instead, third-party test labs should be used to check the safety of these products.

The CPSIA could be mentioned in order to make sure that the products meet the standards of products intended for children. It is suggested that all pet toys follow the regulations in place for children’s items because it is highly likely that a child will come into contact with them.

There are currently no regulations in place when dealing with pet food, and its production is not regulated by the FDA.

Lapel pins are often appealing to children. You need to consider both the design and how are they distributed. A Mickey Mouse character distributed at Disney World could be considered a children’s product while an item designed for adults, distributed only to adults at an adult only setting, would be considered an adult product.

If these are standard children’s watches, they do not require phthalate compliance as they are neither children’s toys nor child-care articles.  If these are ‘play’ watches and thus toys, then phthalate compliance is mandatory. In some cases, a customer will require phthalate compliance, regardless of whether it is a US regulatory requirement.

With regards to phthalate content, PVC is a plastic in which phthalates are often used. There is, of course, phthalate-free PVC which the factory would have to specifically request and purchase. An alternative would be to use a different material, perhaps even fabric or silicone rubber or other plastic that would not use phthalates.

Depending on how the product will be used, the guidelines vary. For the most part, however, the products cannot contain any colors that are not to be used on a certain body part. For example, there are many colors that are not meant to be used around the eyes. There are also a number of chemicals that are banned from these products such as methylene chloride. In addition, all labeling must be appropriate for sale. All of the necessary guidelines can be found on the FDA website.

It is important to look for microbiological results, and specifically check to make sure that there are no heavy metals or formaldehyde. Also, look for some sort of finished product specification in order to ensure that the finished product has met all regulations.

The typical ruler or calculator would be considered a general use item. However if a maze or puzzle is added, the items could be reclassified as toys. Note that there are rulers and calculators that are specifically designed for children that would be considered children’s products, such as those with large buttons, bright primary colors, in animal or other child-appealing shapes. This is a conservative approach but child appeal and play value are important factors in determining if an item is considered a toy versus a children’s product versus a general use item.

As a toy, the following testing would apply:

• Mechanical safety testing (use and abuse), with specific criteria dependent on appropriate or labeled age of product. This testing applies to toys and other articles intended for use by children.
• Lead content (applicable to toys and children’s products)—accessible substrate materials only.
• Total lead in surface coatings.
• Heavy metals in surface coatings—this test is specific to toys per ASTM F963.
• Phthalate content of surface coatings and high-risk substrate materials – this test is specific to toys per CPSIA.
• Tracking label required for all children’s products per CPSIA.

If the product is targeted for use by children, then yes. If it is a flag of an NFL team that could attract adults, then this product could be considered a general-use product.

Congress recognized that it might not be practicable to mark every part of a child’s game that has a board and small game pieces, and allows for primary component labeling alone. Apply this idea to your product and it may be unnecessary to mark all twenty of the blocks in each of your sets. Depending on the nature of your blocks it might also be reasonable to mark one side of one block. If the blocks come with a storage box or bag, these would also be areas to place a mark.

Typically, they are considered a general use consumer product and are not regulated; however, if the product is involved in a campaign aimed primarily at children 12 years of age and younger, it could be considered a children’s product and CPSC regulations would apply.

A stressball is not necessarily intended for children, but many are in cute shapes that appeal to children and do have play value. Err on the side of caution; if the stressball has play value and/or appeals to children, it could be considered a children’s product and therefore should comply with CPSIA regulations.

If considered a toy or children’s products, they must undergo lead tests, lead in paint and phthalate testing. While silicone items are generally considered to be low risk products, be advised that risk doesn’t determine the need for testing under CPSIA. If it is a children’s product it must undergo testing regardless of the level of risk associated with the product.

What are my testing and labeling obligations for a lenticular bookmark/ruler? The ruler is made of cardboard with a plastic lenticular coating and is intended for children.

General conformity certificates or certificates of compliance from component suppliers can be used to confirm compliance to the CPSIA lead requirement if available. Otherwise testing must be performed to confirm lead compliance. In addition, use and abuse testing per 16 CFR 1500.50 and flammability per 16 CFR 1500.3/1500.44 must be performed on the finished product. Unless there is play value, this item would be considered a children’s product but not necessarily a toy. The tracking label should include information indicating when and where they were produced, along with manufacturer’s name.   

I have a customer looking for scan radios for a children's program. I would consider a radio an item that is “general use,” that is not intended specifically for children 12 years of age and younger (much like a pen) and therefore not subject to CPSIA. Is that a correct interpretation?

Prior to the February 9, 2010 CPSC webinar, the consensus was that this could be considered a general use item.  However, in that webinar the CPSC staff did comment that if the item is specifically targeting children, then it should be treated as a children’s product and comply with appropriate requirements. Since this item is specifically being used for a children's program, it could be considered a children’s product and should be tested accordingly. See the CPSC’s final interpretative rule on the definition of children's products.

No mandatory flame testing exists for blankets of any type or for any certain age. There is an industry flame standard for blankets, ASTM D4151, which is recommended.

Fleece blankets with PVC backing, though, could be regulated by the CPSIA’s phthalates guidelines as it could help children fall asleep.

The flammability of solids testing is only required for children's products; however, it is recommended for the golf towel. It would not be required to meet the Flammability for wearing apparel (16 CFR 1610) requirement.

No, there are not any regulations for that product when targeted for general use.

Generally, umbrellas are not toys and do not require compliance to CPSIA toy safety requirements. However, an umbrella could be considered a children’s product if it is marketed specifically as a children’s umbrella and is smaller in size that adult umbrellas (32” vs. 40-42”). If it is a children’s product it would need to be tested for lead in paint compliance, lead content in all accessible substrate materials is required to comply with the CPSIA limit of 100 ppm and the product must include tracking label information. Phthalates and toy safety requirements do not apply.

The first step is to determine what regulations apply to your product. For adult coins and tokens, there really are not any applicable CPSC regulations although if they could be considered jewelry, there are some lead restrictions.

Those items intended primarily for use by children would need to meet the lead content limit of 100 ppm, along with lead in paint requirement for any painted decorations.

Unless the product is considered a toy or child-care item, phthalate compliance would not be applicable.

In addition to above testing, certain use and abuse tests may be applicable to evaluate for sharp points/sharp edges in toys and other articles intended for use by children (16 CFR 1500.48,.49).

If the item is a toy, the ASTM F963 standard would apply.

Children’s products also require tracking label information per CPSIA. 

In this case, if the item being created is a children’s product, the metal manufacturer should have the items tested for lead compliance by a CPSC-accredited third-party lab. They can then provide you with the third-party testing report. As the importer, you will have to issue the Children's Product Certification but you can rely on the manufacturer’s test report.

It is important that the production of the finished product do nothing that will change the test results from that raw material supplier.

We manufacture calendars for the promotional products industry and in general, consider our products to be general use items. However, in rare cases, we produce planners/journals for school-age children which may fall within the CPSIA guidelines. These items are composed of paper (which is exempt) and wire (which is used in the binding process). We have received Material Safety Data Sheets and letters of compliance from our supplier for our wire.  As part of the 2/10/10 testing requirements, do we also have to test the wire through a third-party or are we allowed to simply have their compliance information on file?

Once the stay of enforcement of testing and certification is lifted (expected on 2/10/2011 but since stayed), all children’s products will require third-party testing. In addition, a Children's Product Certificate must also be issued by the manufacturer (for domestic manufacturing) or the importer of record (for overseas production) certifying that product meets all CPSC requirements based on third-party testing.

The CPSIA does not state who must have the third-party testing performed, but if you are the company issuing the certificate, you will certainly want proof of compliance via third-party testing.

MSDS and a letter do not typically detail third-party testing and, if you are not having the testing done yourself, we recommend that you at least obtain a copy of the full test report for your product.  

Testing must be performed by a CPSC-approved third-party lab. Test reports should specify your particular product rather than a generic “all our wire meets CPSIA requirements.”

Testing should reference applicable CPSC test methods.

While there are no current regulatory requirements for pet toys, we are getting more and more inquiries about pet toy testing. One of the major pet product distributors has very stringent requirements for pet toys. Most companies essentially adopt the children’s toy requirements, some with enhanced bite load and/or seam strength tests (these are tests included in mechanical/physical safety testing). In addition to standard child safety requirements, some companies also include below:

• FDA Extraction—since pet toys are meant to be mouthed, some companies test to FDA requirements for indirect food contact, to help ensure that there are not a lot of chemicals leaching out of the material that is being mouthed.
• Colorfastness to Saliva is also performed by some companies, usually only on colored textile materials, again due to pet mouthing behavior.
• If a pet toy includes a long cord, some companies restrict the length and/or require a warning regarding the potential for entanglement.
• Breaking Strength: Grab method to determine breaking strength and elongation of textile fabrics.
• There may be additional tests performed depending on the product – salt spray for metal items, open/close cycling, static load, moisture content for wood products, etc.

It is more likely that a throw rug would be considered a general use item, which would still need to meet the regulations of the Flammable Fabrics Act.

UL-STR's labs in China can test book components. Any non-paper components would require testing for total lead in substrates. The inks would be tests for total lead in surface coating (if they are not CMYK in process). As a children's product, UL-STR would conduct mechanical and flammability testing on the book if it was not entirely made from paper.

The cords, straps and elastic requirement only applies to toys intended for children under 18 months of age. So, there is no requirement for the lanyards to have a breakaway feature, assuming they are intended for a child above 18 months (they are not toys).

We would recommend testing the lanyards as children's products and the tracking label would be required.

A magnet printed with a Disney character would not necessarily be considered a children's product. Both children and adults are interested in Disney characters. The size of the magnet, the method of distribution and the manufacturer's intended use of the magnet should be considered. For example, a smaller Disney magnet intended to be used a fridge magnet distributed to adults is likely to be considered a general use item. A larger magnet intended for use by a child in play or learning would probably be considered a children's product.

With an item that is used for children ages, infant to preteen, compliance to the most stringent requirements would apply. So as an infant item, there must be no small parts and it must comply with applicable dimensional requirements, along with use and abuse tests using the most stringent criteria (typically rated for the older child).

The item should include a small parts warning for all toys and games intended for children between three and six years that have small parts (which an infant item could not have). An additional warning may be required based on the type of product being distributed. Please confer with a product safety lab.

There are many. They are considered children’s products and are considered to be cosmetics. In addition to children’s product requirements for lead and heavy metals in paint, they also need to meet FDA requirements as a cosmetic with appropriate labeling, all ingredients must be FDA approved for cosmetics, they must be non-toxic (there’s a toxicological risk assessment that must be performed), and tattoos must be clean from a microbial contamination standpoint and have effective preservatives.

Promotional food items that are not intended for resale or retail are required to list contents and ingredients. These items are generally exempt from nutrition facts labeling.

The FDA regulates all foods and health-related products. If the food item is intended for children younger than 12 and contains a toy or playful element (e.g. ring pop), then CPSIA regulations would apply to that element.

The FDA has a list of approved indirect food additives that can be present in food-contact substances, which are defined as "any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting or holding food if such use is not intended to have a technical effect on such food." Assuming that the food container includes only approved materials, the FDA limits the amount of each material that can be present in the container and requires that the container pass the extractives test.

Medicine droppers would be considered Medical devices and so regulated by the FDA.

While they may be regulated by more than one standard, they are most certainly regulated by the FDA as a food contact item.

Yes, there are many. According to the FDA, provision 2-301-16 is intended to ensure that an antimicrobial product applied to the hands is both, 1) safe and effective when applied to human skin, and 2) a safe food additive when applied to bare hands that will come into direct contact with food.

Since hand sanitizing products are intended and labeled for topical antimicrobial use by food employees in the prevention of disease in humans, these products are "drugs" under the Federal Food, Drug, and Cosmetic Act § 201(g). As drugs, hand sanitizers and dips must be manufactured by an establishment that is duly registered with the FDA as a drug manufacturer; their manufacturing, processing, packaging, and labeling must be performed in conformance with drug Good Manufacturing Practices (GMP's); and the product must be listed with FDA as a drug product.

The FDA provides guidance on drug development and approval online.

Food is regulated by the FDA. Find guidance on food regulation and compliance.

The only regulatory requirement for this item would be that the material must be food grade stainless steel per FDA requirements for food contact items. This can be confirmed through XRF testing.

Yes. The law requires labeling for toys with >40 ppm lead and for adult items with >600 ppm lead.

The Illinois Lead Law applies to both adult items and children’s products. A warning statement is required for the following:

1. Toy containing paint (a painted toy designed for or intended for use by children under the age of 12 at play) if lead in surface coating is >40 ppm and < or =90 ppm.
2. Children’s jewelry (marketed for use by, or marketed to children under the age of 12) if lead in surface coating is >40 ppm and < or =90 ppm, or if lead in substrate is >40 ppm and < or =300 ppm.
3. Child-care articles (designed or intended by the manufacturer to facilitate the sleep, relaxation, or feeding of children under the age of six or to help with children six years of age and younger who are sucking or teething) if lead in surface coating is >40 ppm and < or =90 ppm, or if lead in substrate is >40 ppm and < or =100 ppm.
4. Adult items if lead in surface coating or lead in substrate is >600 ppm.