What is DOC? The Relationship Between CE Certification and DOC Declaration of Conformity

 What is DOC? The Relationship Between CE Certification and DOC Declaration of Conformity

What is CE Certification?

A professional explanation can be found through search engines, so I won't elaborate here. In simple terms: Products exported to the EU require CE certification, and the CE marking is recognized in all 27 EU member states. Products without CE certification cannot be exported to EU countries; even if they manage to enter those countries, the lack of CE certification will lead to legal risks.

What is the CE Mark?

The "CE mark" is not a product standard, but rather a conformity mark indicating compliance with all applicable EC directives. Specific directives and technical standards vary depending on the product type.

For example, electronic devices with specific input voltages must comply with the Low Voltage Directive, while finger paint must comply with EN 71 Substance Restrictions. Although these products are very different, they must all bear the CE mark to indicate compliance with all mandatory regulations.

Because each EC directive specifies a particular product, their regulatory scope varies. Some EC directives regulate the substances in materials, while others regulate energy efficiency or electrical safety. In addition to the CE marking itself, some directives also cover product and packaging labeling (such as the Packaging Act, Battery Act, and WEEE).

Product compliance requirements go beyond just a printed CE marking. You must ensure that these items comply with all technical standards and requirements listed in the applicable EN and EC directives.

Importing and selling non-compliant items in the EU is illegal, and even if the goods have passed customs inspection, they may still be subject to forced recall and fines.

Do non-EU companies and exporters need to comply with the CE marking rules?

The CE marking is only required when products are imported into or exported to EU member states. It is not required when sold in the US, Australia, or any other market.

Previously, enforcement only targeted importers within the EU. That said, the situation has changed as the EU has been overwhelmed by non-compliant and unsafe products from cross-border e-commerce companies.

As a countermeasure, the EU has now implemented legislation mandating that third-party cross-border operators and service providers in the supply chain (such as freight forwarders and fulfillment centers) check whether importers or exporters possess the relevant CE documentation.

Therefore, CE compliance is crucial for both traditional B2B exporters and B2C cross-border e-commerce sellers, both for EU companies importing goods and exporters exporting to the EU.

Which products must be CE marked?

Some EC and EN directives regulate only specific products, but most apply to a wider range of products. We will explore the regulatory scope of each directive further in this article, but let's first look at the product categories that require CE marking.

A. Electronic Products

Battery-powered devices

Cables

Power sockets

Power banks

Laptops

Tablets

Mobile phones

Video game consoles

TV and computer screens

Home appliances (fans, refrigerators, beauty devices)

Audio-visual equipment (headphones, speakers, monitors)

Battery products (e.g., mobile phone batteries, laptop batteries, power storage devices)

Lighting products (e.g., Christmas lights)

B. Toys

Soft toys

Nail polish

Electronic toys

Wooden toys

Plastic toys

Other children's products

C. Machinery

Machinery (general)

Non-automatic weighing instruments

Measuring instruments

Helmet systems for carrying passengers

Elevators

Personal protective equipment

Pressure equipment

Pyrotechnics

D. Medical Devices

Active implantable medical devices

In vitro diagnostic medical devices

Medical laser equipment

E. Vehicles

Leisure crafts

Bicycles

Electric bicycles

F. Protective equipment

Helmet

Sunglasses

G. Other Products

Helmet systems for carrying passengers

Equipment and protective systems for potentially explosive atmospheres

Civil explosives

Hot water boilers

Noise emissions to the environment

Simple pressure vessels

Do all products sold in the EU have to bear the CE marking? Only products covered by one or more “CE Directives” should bear the CE marking. All other products should not bear the CE marking.

The following are some products to which the CE marking does not apply:

Clothing

Home textiles

Non-electric kitchen appliances

What problems might arise if I sell products that do not meet CE standards?

Importing and selling products that do not meet CE standards into the EU is illegal and can result in fines, mandatory recalls, or even prosecution. Here are some examples:

Customs inspections: If an importer cannot provide the required documentation or if imported goods are not properly marked, customs authorities have the right to seize and destroy the goods. In recent years, customs authorities have also worked closely with consumer safety agencies to track certain high-risk product categories.

EU consumer safety agencies: Each EU member state has its own government organization responsible for implementing and enforcing EU directives. Here are some of the measures they take to check for violations:

Requirement of DOC documents and test reports

On-site inspections

Shopping from e-commerce stores to test product samples

Investigating consumer reports of non-compliance

Personal injury or property damage: While CE compliance may seem overly bureaucratic, these directives and standards are in place for a reason. Products not manufactured to safety standards, such as mobile phone chargers or toys, can be extremely unsafe. Importers and cross-border e-commerce sellers need to assume financial responsibility in case of injury or property damage due to non-compliant and unsafe products.

Amazon and CE Marking

Selling products on Amazon Europe (Germany, France, Italy, Spain, and the UK) requires compliance with all applicable EU regulations. For the relevant product categories, this includes the CE marking.

In addition to product and packaging images, Amazon primarily requires a Declaration of Conformity (DoC) and laboratory test reports.

Failure to provide this information may result in the product being refused sale.

Required Documents

A. Declaration of Conformity (DoC)

The Declaration of Conformity is a document issued by the importer or manufacturer that includes the following information:

Product Identification/SKU

Product Function

Manufacturer/Importer's Name and Address

EN Standards or Directives List

Location

EU Representative

The DoC is the primary document used to demonstrate compliance with government agencies, retailers, and even end consumers.

B. Technical Documentation (Test Reports, etc.)

In addition to the DoC, importers also need to prepare technical documentation. This document covers the technical aspects of the product, combining testing and quality control procedures and documentation. The following is an overview of the minimum information that technical documentation should include:

Project Description

Conceptual design, drawings, wiring and circuit diagrams, component plans, sub-components, parts list, etc.

List of applicable standards (in-house or by a third party) and quality control procedures

Test reports and quality control records

Markings and copies of markings

Risk assessment

C. User Manual (Instructions, etc.)

You must create a user manual that includes the following information:

1. Instructions on how to install the product

2. Overview of product-related accessories

3. Safety instructions

4. Instructions on how to use the product

5. Instructions on charging the product

6. Instructions on how to dispose of the product in an environmentally friendly manner

D. Test Report

While test reports are part of technical documentation, I must emphasize that you cannot rely on test reports issued by the buyer. Although not mandatory for most products

CE Certification Models

There are three types:

CE certification is a conformity assessment, generally in two forms: Self-Declaration (DOC) and Certificate of Conformity (CE). A self-declaration can be understood as: the company only needs to conduct its own testing, sign and issue a CE declaration, and assume all responsibility.

DOC – Declaration of Conformity: Issued by the manufacturer according to EU requirements, theoretically free.

CE – Certificate of Conformity: Issued by a third-party testing organization. It involves rigorous testing according to EMC (electromagnetic compatibility) and LVD (safety regulations) standards and directives stipulated for CE certification. A CE certificate is issued for products that pass the tests. The cost ranges from several thousand to tens of thousands of yuan. This is a declaration of conformity issued by a third-party testing organization and must be accompanied by test reports and other technical documents. The company must also sign a Declaration of Conformity.

CE-NB – Notified Body: Issued by over 1200 organizations in EU member states. Samples must be sent to an Notified Body laboratory for testing. A CE certificate is issued after passing the tests. The cost ranges from several thousand to hundreds of thousands of yuan.

Why are my DOCs not accepted by Amazon?

Recently, many Amazon users have complained to me that their own DOCs, as well as those prepared by service providers and certification companies, have been submitted multiple times but have not been approved by Amazon. So far, all my DOC (Declaration of Conformity) applications have successfully passed Amazon's review. Here's my experience to share:

Compliance with Amazon's DOC Requirements: A DOC is similar to a product warranty, aiming to declare that a product complies with EU regulations, making a compliance declaration regarding product quality, documentation, systems, etc.

First, let's look at Amazon's requirements (using toys as an example):

Key Points:

1. CE Marking Required

2. Name and address of EU-based manufacturer or registered trademark (EU representative)

3. CE Certification Required

CE is a mandatory European certification. All products within the catalog must have the CE marking and certification; otherwise, they are not allowed to be sold in Europe. All certification standards must be comprehensive, using the latest standards, and the certificate must be valid.

4. Correct DOC Template and Standard Specifications

A DOC declaration of conformity cannot be filled out arbitrarily; it has a fixed template and product standard categories.

5. EC Declaration of Conformity - This document can be obtained from the brand owner, EU/UK importer, or EU/UK authorized representative.

The DOC (Declaration of Conformity) must be signed and stamped by the EU representative or importer.

EC Declaration of Conformity

Why is my DOC still failing Amazon's review even though it was prepared according to requirements?

This involves details and other additional requirements.

Details: What we consider certification compliance and correct standards may differ from Amazon's requirements. We need guidance from professionals with Amazon compliance experience regarding standards. This is why Amazon does not recognize some companies' DOCs.

PS: In addition to the requirements mentioned above by Amazon, the DOC must also include information about the system, and the signature must comply with European regulations.