EC certification, often referred to in the context of the CE marking, is the process by which a product is deemed to comply with the essential health, safety, and environmental protection requirements of the European Union (EU). It is not a quality mark but rather a mandatory conformity mark for many products sold within the European Economic Area (EEA).
At its core, the EC certification process involves ensuring a product meets relevant EU directives and regulations before it can be legally placed on the market. A critical outcome and component of this process is the creation of specific documentation, notably the EC declaration of conformity.
Understanding the EC Declaration of Conformity
According to the reference provided:
The EC declaration of conformity is the written statement and the a single declaration drawn up to demonstrate the fulfilment of the EU requirements relating to a product bearing the CE marking.
This declaration is a legal document issued by the manufacturer (or their authorized representative) taking full responsibility for the product's compliance. It lists the specific EU directives and regulations the product conforms to and often references harmonized standards used to demonstrate compliance.
Why is EC Certification (CE Marking) Important?
Obtaining CE marking through the EC certification process is crucial for several reasons:
- Market Access: It is a legal requirement for many products to be sold or put into service in the EEA.
- Free Movement: It allows products to move freely within the single market without facing additional national requirements related to the covered risks.
- Consumer Confidence: The CE mark indicates that a product meets high safety standards, potentially increasing consumer trust.
The EC Certification Process in Brief
The path to EC certification typically involves several steps:
- Identify Applicable Directives and Regulations: Determine which EU requirements apply to your product based on its nature and intended use.
- Identify Harmonized Standards: Find the relevant European harmonized standards that offer a presumption of conformity with the essential requirements.
- Perform Conformity Assessment: Test the product to ensure it meets the requirements. This may involve internal testing or assessment by a notified body (a third-party conformity assessment body).
- Compile Technical Documentation: Create a technical file containing information about the product, its design, manufacture, and operation, along with test reports and assessment results.
- Draw up the EC Declaration of Conformity: Create the legal document stating the product's compliance, using the information from the technical documentation.
- Affix the CE Marking: Once all steps are completed and compliance is assured, the CE mark is affixed to the product or its packaging.
- Example: A manufacturer of small electrical appliances follows this process. They identify the Low Voltage Directive and EMC Directive as applicable, test their toaster against the relevant harmonized standards, compile a technical file with schematics and test reports, sign an EC declaration of conformity, and then affix the CE mark to the toaster's base and packaging.
In summary, EC certification is the necessary process, leading to the CE marking, which demonstrates a product's conformity with EU health, safety, and environmental requirements, with the EC declaration of conformity serving as the formal statement of this compliance by the manufacturer.
