Children's Product Certification and Third-Party Testing
Two certificates exist and they are not interchangeable. A general certificate rests on a reasonable testing program; a children's product certificate rests on testing by a laboratory the Commission has accepted for that specific rule.
The rule in short
Every children's product subject to a children's product safety rule requires a Children's Product Certificate based on testing by a third party conformity assessment body accepted by the Commission for that rule. Certification is followed by periodic testing at intervals that depend on whether the manufacturer runs a production testing plan or uses an accredited laboratory, and by retesting after any material change.
Certification is where product safety compliance becomes a documentary system. The physical product may be perfect, but the obligation is to hold a certificate supported by testing of a specified kind, kept current through a plan, and reissued when the product changes. A firm that cannot produce the supporting record is treated as if the testing did not happen.
Two certificates and which applies
A General Certificate of Conformity covers a product that is not a children's product but is subject to a rule enforced by the Commission. It certifies compliance based on a test of each product or on a reasonable testing program, and the testing need not be done by an accredited laboratory.
A Children's Product Certificate covers a children's product subject to a children's product safety rule. It must be based on testing by a third party conformity assessment body that the Commission has accepted for the specific rule or test method involved. Acceptance is rule-specific: a laboratory accepted for lead content is not thereby accepted for a mechanical standard.
A children's product is one designed or intended primarily for children twelve years of age or younger, determined by the manufacturer's statement of intent, the packaging and labeling, whether the product is commonly recognized as intended for that age group, and the published age determination guidelines.
What the certification testing has to establish
The certification rule sets a substantive standard rather than a procedural one. The testing must support certification with a high degree of assurance that the product complies with each applicable children's product safety rule.
That phrase carries weight. It means the sample selected must be representative of production, the number of samples must be sufficient for the variability of the process, and the test method must be the one the rule prescribes. A single passing sample from a pilot run is not a high degree of assurance about a production batch, and the certifier is expected to be able to explain the sampling rationale.
Where a manufacturer relies on component part testing, or on another party's finished product testing, that reliance is permitted on stated conditions including the exercise of due care and the retention of the underlying records. Reliance does not transfer responsibility; the certifier remains answerable for the certificate.
| Route | What the manufacturer does | Periodic third party testing interval |
|---|---|---|
| Periodic testing plan only | Documents a plan setting tests, intervals and sample numbers | At least once a year |
| Production testing plan | Runs recurring tests or process controls that include actual testing | At least once every two years |
| Accredited testing laboratory route | Tests continued compliance at a laboratory accredited to the international competence standard | At least once every three years |
| After a material change | Retests to the affected rules before distribution | Immediately, and a new certificate issues |
Keeping the certificate alive
Certification is a point-in-time statement about a production run, and the rules require testing to continue afterwards. All manufacturers of children's products must conduct periodic testing through a third party conformity assessment body.
The interval depends on what else the manufacturer does. Without a production testing plan or accredited laboratory testing, periodic third party testing must occur at least once a year. With a production testing plan providing a high degree of assurance of continued compliance, the interval extends to at least once every two years. Where continued compliance is checked at a laboratory accredited to the international competence standard, using the same test methods used for certification, the interval extends to at least once every three years.
The interval may be expressed as a fixed production interval, a set number of units, or another method the manufacturer chooses, provided the applicable maximum is not exceeded. The plan must be specific to each children's product at each manufacturing site, and the factors to consider in setting the interval include test result variability, results close to a numerical limit, known process factors, consumer complaints, the introduction of new component parts, and the potential for serious injury.
A change in design, materials or manufacturing process that could affect compliance is a material change, and it requires retesting to the affected rules and a new certificate before the changed product is distributed. Firms tend to catch design changes and miss supplier substitutions, which are the most common material change in practice. A resin change made by a component supplier for its own reasons is a material change to the finished product, whether or not anyone at the certifier was told.
What has to be on the certificate
The content requirements are precise. A finished product certificate must identify the product covered, using at least one unique identifier such as a global trade item number, model number, serial number, stock keeping unit or universal product code, along with enough description to match the product to the certificate.
It must state each rule, ban, standard or regulation to which the product is being certified, listing them separately. It must identify the certifier with a full address and contact details, and identify with contact details the individual maintaining the supporting records, which may be a position title provided the position is always staffed.
It must give the place and period of manufacture, and the most recent place and period of testing, identifying each third party conformity assessment body or other party whose testing the certificate depends on. And it must carry the certifier's attestation, which includes an acknowledgment that knowingly making a materially false statement on the certificate is a federal crime.
Availability, filing and the records behind it
The certificate must accompany the product or shipment and be furnished to distributors and retailers, and must be available to the Commission on request. For imports the rules provide for electronic filing of the certificate data into the customs system, which changes the mechanics of availability without changing what has to be true.
Behind the certificate sits the record file: the testing plan, the test results, the records of any material change and subsequent testing, and the component or third party certificates relied on. Those records must be maintained and produced on request, and their absence is itself a violation independent of whether the product complies.
The practical exposure is that a certificate is easy to issue and hard to support. A firm that certifies against a rule it did not test to, or that cannot produce the laboratory report behind a certificate, has supplied a false certificate, and that is a prohibited act reaching the penalty framework described under civil penalties and the factors that set them. The substantive limits the testing addresses are set out under lead limits, small parts and age grading, and the marking that lets a certified unit be traced afterwards is covered under tracking labels on children's products.
Points to carry away
- A Children's Product Certificate depends on testing by a laboratory accepted by the Commission for the specific rule.
- A General Certificate of Conformity covers other products and rests on a test or a reasonable testing program.
- Periodic testing follows certification, at least annually unless a production testing plan or accredited laboratory route is used.
- A material change to design, materials or manufacturing requires retesting and a new certificate before distribution.
- The certifier must be the importer, or the domestic manufacturer or private labeler, and it carries legal responsibility for the certificate.
Questions readers ask
Who has to issue the certificate, the factory or the importer?
For imported products the importer of record issues it. For domestically manufactured products the manufacturer or the private labeler does. The factory can supply test reports and can prepare the document, but it cannot be the certifier for an imported product, and a certificate naming an overseas factory as the certifying party does not satisfy the rule. That allocation is deliberate: it places responsibility on a party within reach of enforcement, which is also the party that will have to answer for the certificate's accuracy.
Can component testing be used instead of finished product testing?
In defined circumstances, yes. The rules permit reliance on component part testing or certification, or on another party's finished product testing, where the stated conditions are met. The party relying on it must exercise due care, must be able to show that the component tested is the component used, and must keep the underlying records. Component testing is most useful for chemical requirements such as lead content, and least useful for requirements that depend on how the finished product behaves, which cannot be assessed from a part.
How long do the supporting records have to be kept?
The certification recordkeeping rule requires the manufacturer to maintain records including the certificate itself, the testing plan, test results, records of material changes and the certificates or reports relied on, and to make them available on request. Records must be kept for a defined period after production ceases and must be in the English language. Because the certificate travels with the product and the records stay with the certifier, a firm that has changed suppliers or systems is frequently unable to support a certificate it issued.
Sources
- 15 U.S.C. § 2063 — Product certification and labelingRequires general and children's product certificates and third party testing.
- 16 CFR § 1107.20 — General requirementsSets the certification testing obligation and the high degree of assurance standard.
- 16 CFR § 1107.21 — Periodic testingSets the annual, two-year and three-year periodic testing intervals and their conditions.
- 16 CFR § 1107.23 — Material changeRequires retesting and recertification when a material change occurs.
- 16 CFR § 1110.11 — Certificate contentLists the data elements a finished product certificate must carry.
- 16 CFR § 1110.7 — Who must certify finished productsAllocates the certification duty between importer, manufacturer and private labeler.
- 16 CFR § 1112.15 — Acceptance of third party conformity assessment bodiesGoverns when a laboratory may be accepted for a particular rule or test method.
Metro Law Advisors is a publication, not a law firm. This article states general rules and cites its sources; it is not advice about any particular case, and the law differs by state and changes over time.
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