Component Part Testing

It depends on the specific safety rule.

For safety rules that require testing of the finished product in order to determine compliance (such as functional or mechanical testing, or the accessibility of component parts), the finished product must always be tested.

For safety rules that do not have such requirements (such as total lead content testing), third party testing the individual components may be acceptable provided that no further changes occur after the testing.

For example, a manufacturer of a children’s toy intended for ages under 3 may rely on testing of total lead content of the color varieties of plastic pellets that will be used in its plastic injection molding process instead of the finished products, even if the same pellets were used to produce a wide variety of plastic products, but testing would still be needed for the small parts requirement.

It depends. When there is a material change to a component part of a product that does not affect other component parts and does not affect the finished product's ability to comply with other applicable children's product safety regulations, then a manufacturer may issue a new CPC based upon the combination of the earlier initial certification test and the new test for the materially changed component part.

For example, if you manufacture a painted wooden toy car, and you change paint supplier(s), you need to test only the paint for compliance in order to issue a new CPC. In other words, because parts like the metal axles did not change, you do not have to retest them. If, however, the suppliers of the metal axles changed, then the whole finished product may need to be retested for compliance with requirements such as the small parts ban.

Yes, provided that certain conditions are satisfied. Firms can rely upon the test results or a certification from a component part supplier if the requirements at 16 CFR part 1109 are met. Firms must use due care to ensure that the test result and/or the certificate is valid and be given access to the underlying documentation, such as test results and attestations regarding how the testing was conducted and by whom. Generally, certifications of a component part must satisfy the requirement for a CPC and must be based on the results of testing from a third-party, CPSC-accepted laboratory.

Yes, component part testing may not be sufficient for a children's product that is being tested for its structural integrity (e.g., small parts) because that testing needs to be conducted on the finished product.

Under 16 CFR part 1109 a party "exercising due care" must use the degree of care that a prudent and competent person engaged in the same line of business or endeavor would exercise under similar circumstances. Due care does not permit willful ignorance. The concept of due care is flexible and will vary depending on the circumstances and the industry in question. At a minimum, due care requires taking some affirmative step to ensure the validity of the test report or certification being relied upon.

Actions taken by a certifier to ensure the reliability of test reports from a supplier may differ depending on the nature of the component part supplied, the risk of noncompliance, the industry involved, and the nature of the relationship with the supplier. A long term relationship with a trusted supplier that receives a large portion of its profits from one manufacturer may not require the same level of inquiry or monitoring as that of a new supplier that provides parts to many different manufacturers infrequently. Depending on the industry and the specific situation, a certifier may take various actions in order to know something about the validity of the test reports or certifications being relied upon, such as:

• receiving and reviewing the required documentation, and making inquiry regarding any discrepancies;
• asking questions about testing and sampling procedures;
• requesting written test procedures;
• ensuring the supplier's third party conformity assessment body is CPSC accepted;
• spot checking a supplier's test results; or
• visiting a supplier's factory or third party laboratory.

There are several approaches that may serve as evidence of due care by an importer to ensure that a foreign manufacturer, that has provided a certification, conducts periodic testing. Simply reviewing the foreign manufacturer's periodic testing plan or production testing plan may not satisfy the requirement, without further evidence that the plans were actually implemented. An importer may need to conduct occasional onsite visits to the supplier's manufacturing facility to examine evidence that the required periodic testing has been properly performed or may need to verify the authenticity of the supplier's test reports by contacting the testing laboratory for verification. An importer may also wish to occasionally submit samples from a product received from the supplier for testing, to compare the test results to those conducted by the foreign manufacturer.

Composite testing (combining various samples in a single test) may be acceptable for chemical requirements (e.g., total lead content in substrate) as long as certain requirements are met.

It is important to note that composite testing only provides the total amount the target chemical in the combined composite, not how much of the target chemical is in each individual sample; therefore, to determine whether each individual sample is compliant or needs retesting, the test result is attributed to each sample. For example, assume that the doll uses three different colored plastics (A, B, and C). The composite is comprised of 50% A, 30% B, and 20% C. The lead content of the composite is 40 ppm. When the resulting lead content is applied to each color of plastic, the potential concentration of lead in each plastic is the measured lead content of the composite divided by the percentage of that plastic in the composite, or:

• Potential lead content of plastic A = 40 ppm/50% or 80 ppm
• Potential lead content of plastic B = 40 ppm/30% or 133 ppm
• Potential lead content of plastic C = 40 ppm/20% or 200 ppm

Because both plastics B and C potentially could contain more than 100 ppm lead, additional testing is needed to support compliance with the requirement and issue a certificate.

The component part rule requires two attestations:

• 16 CFR § 1109.5(g)(7) requires an attestation by the component part supplier that the testing meets any applicable testing requirements (such as periodic testing); and
• 16 CFR § 1109.5(g)(10) requires an attestation by the finished product manufacturer (or importer) that they exercised due care to ensure compliance with 16 CFR § 1109.5(b).

16 CFR § 1109.5(g)(7) requires “an attestation by the party conducting the testing that all testing of a component part or finished product by that party was performed in compliance with applicable provisions of section 14 of the CPSA, part 1107 of this chapter, or any more specific rules, bans, standards, or regulations.” The “party conducting testing” means the manufacturer or the laboratory that actually performed the testing on the product samples, not the “testing party,” which is defined in the rule as a party who procures or requests that testing be conducted. In the case of non-children’s products (aka general-use products), it is possible that the testing party can also be the party who actually conducted the testing.

Test reports from laboratories accredited to ISO/IEC 17025 (see 16 CFR § 1107.21(g)(1)(ii) for the most recent accepted version) automatically fulfill this attestation requirement with regard to the test(s) performed.

No particular format is required, although the attestation must be in writing and signed by an authorized representative attesting party.

The attestation should reflect the services provided by the party conducting the testing. For example, a laboratory that only tests samples that were provided for compliance with the applicable consumer product safety regulation would need to attest that the lab followed the correct/acceptable test method(s). A laboratory that conducts testing and has additionally contracted with the customer to provide another service (such as selecting samples for certification, material change, or periodic testing) would need to attest to performing any additional functions pursuant to any applicable requirements in section 14 of the CPSA and 16 CFR part 1107.

ISO/IEC 17025:2005 Accredited Laboratories

Test reports from laboratories accredited to ISO/IEC 17025 (see 16 CFR § 1107.21(g)(1)(ii) for the most recent accepted version) automatically fulfill the attestation requirement in 16 CFR § 1109.5(g)(7) with regard to the test procedures followed by providing a signed test report as long as the test report complies with ISO/IEC 17025, is in writing, and is signed by an authorized person.

All children’s products must be tested by third-party, CPSC-accepted laboratories which are, by definition, accredited to ISO/IEC 17025. Accordingly, all test reports issued by a third-party, CPSC-accepted laboratory meet the attestation requirement in 16 CFR § 1109.5(g)(7). For testing of general-use component parts and finished products, test reports from laboratories accredited to ISO/IEC 17025, regardless of whether they are CPSC-accepted, also meet the attestation requirement in 16 CFR § 1109.5(g)(7).

If an ISO/IEC 17025 laboratory performs an additional service (such as sample selection), the attestation to the additional service must state that the service followed the appropriate sampling protocols, if any, in the applicable underlying rule. This additional attestation may be included with the test report, attached to the test report, or provided as a separate document.

All others that provide testing services

Attestations (meaning a written, signed statement) for testing performed by any party other than an ISO/IEC 17025 laboratory should contain the information:

• a title (e.g., “Test Report,” “Component Part Test Report,” “Attestation”);
• the name and address of the party conducting the testing and the location where the tests were carried out, if different from the address of the party conducting the testing;
• if the information is on a test report, unique identification of the test report (such as the serial number), and on each page an identification in order to ensure that the page is recognized as a part of the test report, and a clear identification of the end of the test report;
• identification of the test method(s) used;
• a description, the condition, and unambiguous identification of the item(s) tested;
• the test results with, where appropriate, the units of measurement; and
• the name(s), function(s), and signature(s) or equivalent identification of person(s) authorizing the test report.

No specific format is required, and this attestation can be provided in the test report, attached to the test report, or provided as a separate document.

If the party performed a service in addition to testing product samples (such as sample selection), the party conducting such service must attest to following the appropriate sampling protocols, if any.

The certifier or testing party must make this attestation. A certifier is the entity that issues a finished product or component part certificate of compliance pursuant to 16 CFR part 1110. A testing party is the entity who procures or requests that testing be conducted.

Each attestation must state that due care was exercised while the component part or finished product (as applicable) was in the testing party or certifier’s custody to ensure:

• Proper management and control of all raw materials, component parts, subassemblies, and finished products is established and maintained for any factor that could affect the finished product’s compliance with all applicable rules;
• The manufacturing process does not add or result in a prohibited level of a chemical from any source, such as the material hopper, regrind equipment, or other equipment used in the assembly of the finished product; and
• (3) No action or inaction subsequent to testing and before distribution in commerce has occurred that would affect compliance, including contamination or degradation.

In addition to the actual attestation provided above and the signature of an authorized person, the following information must also be on the document:

• the name(s), function(s), and signature(s) of the person(s) making the attestation;
• the address of the person(s) making the attestation; and
• an identification of the lot or batch of component parts or finished products.