Product Documentation and Certification Guide

August 07, 2023
Table of Contents

Product certificates and other compliance documents are mandatory for a wide range of products. In this guide, we cover the basic concepts of product certification in the United States and the European Union.

What is product certification?

Product certificates are, generally speaking, documents ‘certifying’ or ‘declaring’ that a certain product is compliant with specific product regulations and standards. Product certificates can, in some cases, be issued by an external party. However, in most cases, product certificates are created by domestic manufacturers or importers.

Examples include:

  • Declaration of Conformity
  • Declaration of Compliance (DoC)
  • Children’s Product Certificate (CPC)
  • General Certificate of Conformity (GCC)

Why do I need a product certificate?

For certain products it’s mandatory to issue or obtain product certification. For example, you need to self-issue a Children’s Product Certificate (CPC) if you’re importing toys or other children’s products to the United States. Without a CPC, your products can be refused entry, subject to a recall - or rejected by Amazon.com.

How do I get a product certificate?

That depends on the specific regulation. That said, most product certificates are actually issued by the importer or domestic manufacturer - not by a third party.

How much does it cost?

Product certificates generally don’t cost anything to issue. But, it’s important to note that product certificates are often based on lab test results - which you do need to pay for.

What is the difference between a test report and a product certificate?

A test report is a list of tests, methods, and results. Basically, the test confirms if a product is compliant with one or more regulations or standards. Product certificates, on the other hand, are ‘declarations’ that that confirm if a product is compliant with certain regulations. But, that declaration is not proof of compliance.

Keep in mind that you often need some sort of test result to base your product certificate on. As such, it’s not acceptable to make a declaration based on the assumption that the product is compliant.

European Union Examples

Product declarations and other documents are mandatory when importing a wide range of products in the EU. Here are a few examples:

Declaration of Conformity (DoC)

The Declaration of Conformity (DoC) is mandatory for all products that must be CE marked. Here are a few examples:

  • Toys
  • Electronics
  • Sunglasses
  • Personal protective equipment
  • Machinery
  • Medical devices

Here’s some information you need to include the DoC:

  • Importer/Manufacturer
  • Declaration statement
  • Applicable regulations/directives
  • Applied EN/ISO/other standards
  • Product model number/SKU
  • Product description

You generally need a test report in order to issue a DoC. Further, for some products, it’s mandatory to get the product tested by an accredited company (notified body).

Technical File

The technical file is not a “certificate” or “declaration”, but still part of the mandatory set of product documents for all products covered by one or more “CE marking” directive. Here are a few examples:

  • Low Voltage Directive (LVD)
  • Electromagnetic Compatibility (EMC) Directive
  • Radio Equipment Directive (RED)
  • RoHS Directive
  • Personal Protective Equipment (PPE) Directive
  • Machinery Directive
  • Medical Devices Directive

 

Required Documents

Here are some documents you may need to include in the technical file:

  • Product design drawings
  • Product photos
  • Bill of materials
  • Source code
  • Label files
  • Packaging files
  • User manual copy
  • List of applicable directives/regulations/standards
  • Test reports
  • Risk assessment

User Manuals

User manuals are also mandatory for most products covered by the CE mark. Here are some things you need to include in the user manual:

  • Installation instructions
  • Product overview
  • Safety instructions
  • How to use the product
  • How to replace batteries/charge (if any)
  • How to dispose of the product

Declaration of Compliance (DoC)

The Declaration of Compliance (DoC) is mandatory for certain types of plastic food contact materials. Here are some product examples:

  • Stainless steel water bottles (with plastic lids)
  • Bamboo melamine composite
  • Plastic food packaging
  • Plastic cups
  • Plastic cutlery

The Declaration of Compliance (DoC) must be issued based on test results.

United States Examples

CPSC product certificates are mandatory for children’s products, helmets, and other products imported and sold in the USA.

Children’s Product Certificate (CPC)

The Children’s Product Certificate (CPC) is mandatory for all products covered by the CPSIA. In other words, the CPC is mandatory for all products for children aged 12 years or younger. Notice that this is not only valid for toys, but also children’s clothing, furniture, and baby products.

CPC Information

1. Product name and description

2. List of applied and mandatory ASTM and CPSC standards (e.g ASTM F963)

3. Importer information (US company name, US address, e-mail, phone)

4. Contact information of the person with access to the test report (name, address, e-mail, phone)

5. Manufacturing location (city, province, country) and date (month, year)

6. Testing date (month, year) and location (city, province, country)

7. CPSC accepted third-party lab testing company (company, contact person, address, phone, e-mail)

Lab Test

Third-party lab testing (CPSC accepted testing companies) is mandatory for all children’s products. The CPC is also based on the lab test result, and cannot be issued without one.

CPC Template

You can find a CPC template on the official CPSC website.

General Certificate of Conformity (GCC)

The General Certificate of Conformity (GCC) is very similar to the CPC. However, the GCC applies to a different product range:

  • Apparel
  • Bicycle Helmets
  • ATVs
  • Paints
  • Bunk Beds
  • Lighters
  • Mattresses
  • Bikes
  • Pool drain covers

GCC Information

1. Product name and description

2. List of applicable CPSC safety rules and ASTM standards

3. Your company name

4. Contact details: Mailing address, e-mail address, phone number

5. Name of the person holding the test report

6. Date (month, year) and place (city, country) of production

7. Date (month, year) and place (city, country) of product testing

8. Third-party testing company, contact person, e-mail, phone number and address

 

CPC Template

You can find a GCCC template on the official CPSC website.

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