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Fredrik Gronkvist

Product Compliance Basics

Product compliance can mean many things, depending on the product, market and age group. For some products, it’s a simple matter that only involves a basic country of origin label. For other products, product compliance is a complicated procedure that starts at the design stage of the product. 

a. Product Standards

Product standards, such as ASTM F963, define technical specifications, chemical restrictions (e.g. lead and mercury) and physical properties (e.g. sharp edges and loose parts). Certain regulations, for example CPSIA, require compliance with applicable ASTM standards.

However, most product standards are not mandatory in the sense that compliance is a legal requirement. That said, they still serve as a good reference point when developing new products. 

As an importer, you’re ultimately responsible for ensuring that your products are safe. Using an ASTM or UL standards is therefore the best way to ensure that’s the case – regardless of whether it’s mandatory or not.

How to ensure compliance: Confirm all applicable product standards and assess if your product design is compliant. Make the necessary changes if not.

b. Substance Regulations

Regulations such as FHSA (USA), CA Prop 65 (California, USA) and REACH (EU) sets restrictions on chemicals and heavy metals in consumer products. A product containing excessive amounts of regulated substances is not legal to import and sell.

Here are some commonly restricted substances:

  • Formaldehyde
  • Lead
  • Cadmium
  • Mercury
  • Phthalates

How to ensure compliance: Assess applicable substance regulations and book a product or material sample and submit for third party lab testing.

c. Labeling Requirements

Country of origin (e.g. Made in China or Made in Vietnam) is mandatory for almost every product imported and sold in the United States. Additional labeling requirements also apply to certain product categories and states:

  • Children’s Products: CPSIA Tracking Label
  • Electronics: FCC Mark
  • Products sold in or to California: CA Prop 65 Warning Label

How to ensure compliance: Assess all applicable labeling requirements and create label files that you later submit to your supplier.

d. Documentation Requirements

Self-issued compliance declarations are generally a formality, but still a critical part of the process. For example, CPSIA (Children’s Products) require that the importer can provide a Children’s Product Certificate upon request. 

Here’s an overview of documentation for certain products:

  • Children’s Products: Children’s Product Certificate (CPC)
  • Various Products: General Certificate of Conformity (GCC)
  • Electronics: FCC Declaration of Conformity

How to ensure compliance: Confirm all mandatory documents/certificates for your product and create a PDF version that you print and sign. This document may be requested by the US customs, retailers, Amazon or market surveillance authorities.

e. Laboratory Testing Requirements

While lab testing is not always mandatory, it’s the only way to ensure that your products are compliant with all relevant product standards (e.g. ASTM F963) and substance regulations (e.g. CA Prop 65).

While the lab test doesn’t necessarily have to be done within the borders of the United States, the lab testing company must generally be accredited the relevant authority, such as the CPSC.

Here’s an overview of established testing companies:

  • QIMA
  • Bureau Veritas
  • Intertek
  • TUV
  • SGS
  • CMA Testing and Certification

How to ensure compliance: Order a product sample and submit it to a third party testing company.

Product Overview

Children’s Products

Consumer Product Safety Improvement Act (CPSIA) is applicable to all children’s products sold in the United States. The compliance process involves the following parts:

  • Compliance with all relevant ASTM standards
  • CPSIA tracking label
  • Children’s Product Certificate (CPC)
  • Testing Plan
  • Third party lab testing

Note that CPSIA is applicable to not only toys, but also children’s apparel and furniture. As such, 

Apparel & Textiles

Here’s an overview of regulations for clothing and other textiles sold in the United States:

Labeling

  • Fiber composition (e.g. 100% cotton)
  • ASTM Standard D5489-07 care symbols
  • Manufacturer or importer identity
  • Language: English
  • Country of Origin (e.g. Made in China)

Other

  • California Proposition 65 (California only)
  • CPSC substance bans and FHSA (e.g. formaldehyde)
  • Flammable Fabrics Act

Electronics

Electronics are more tricky than other products. While electronics are generally more high risk than other product categories, the path to ensure compliance is not always clear cut.

Many small businesses are familiar with FCC regulations. However, these regulations only cover radio communication, not electrical safety – which should be the main concern for every electronics importer.

Instead, US electronics importers can decide whether to ensure compliance with voluntary standards or certification schemes developed by Underwriters Laboratories (UL), Intertek (ETL) or other standards organizations.

Examples

  • UL 1642: Standard for Lithium Batteries
  • UL 13: Standard for Power-Limited Circuit Cables
  • UL 9540: Standard for Energy Storage Systems and Equipment

While compliance with UL and other standards is voluntary, you are still liable in case a customer is injured or property is damaged. Given the risk nature of electronics, it’s therefore essential to ensure that the product, including its battery and power supply (if any), is compliant with relevant safety standards – mandatory or not.

In 2015, the importers flooded the market with unsafe hoverboards. Amazon pulled 95% of all product listings after multiple accidents, and required all sellers to provide UL 1642 test reports to prove that their hoverboards were in fact safe.

The same goes for retailers, as they would never touch an electronics product that comes without test reports and other compliance documentation.

FAQ

Is the importer or supplier responsible for ensuring compliance?

A common misunderstanding among startups and other small businesses importing products, is that compliance is not really their business – but the responsibility of the manufacturer. 

This is absolutely not the case. At best, a manufacturer has a vague understanding of US product regulations. From their perspective, they receive label files, a list of restricted substances and technical requirements.

That said, manufacturers are not compliance experts and should not be expected to act as one. They don’t have the expertise to guide or support the buyer to ensure compliance.

Nor should they. The manufacturers role is to make your product. That’s it.

What can happen if my imported products are not compliant?

There are a few different scenarios that can play out if you import non-compliant products:

  • Shipment seized by the US customs (e.g. due to incorrect labels)
  • Forced product recall (e.g. due to technical nonconformity or injury)
  • Amazon product listing rejected or removed

Keep in mind that the objective is not merely a matter of “getting through the customs check”. The real risk lies in consumer injury or property damage that may occur weeks, months or even years after you’ve sold the product.

About the Author

Fredrik Gronkvist is a Swedish Entrepreneur currently based in Hong Kong. His company Asiaimportal (HK) Limited operates ComplianceGate.com, a portal providing free guides and tools helping US, EU and Australian importers comply with mandatory product regulations.

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