The CE Marker--Understand and Avoid Importing Risks
Think of this label as an umbrella. Various European Union (EU) directives dictating product standards--materials and methods--eventually find their way under this label bound for the EU market. Since its inception in 1985, it has become an iconic symbol for high quality standards and uncompromising compliance enforcement.
Related Reading: European Union’s CE Marking vs. the Chinese Export Logo
If your product does not have this marking, it will be denied entry into the EU market. And even if this market is not your target, the "Conformité Européene" is well on its way to becoming a global symbol of quality, and without it, your product might be viewed with suspicion and potentially passed over for one which bears the CE label.
The CE label certifies that designated products manufactured or imported into EU Member States are in compliance with an array of quality standards meant to protect consumer health, supply chain safety, and the environment.
Some industries requiring the CE marking include:
- Electrical Equipment and Electronics (EEE) -- (measured against) -- Low Voltage Directive (LVD); EMC Directive; R&TTE Directive; RoHS
- Children’s toys -- Toy Safety Directive
- Machinery -- Machinery Directive
There are also standards for vehicles, medical equipment, Personal Protection Equipment (PPE) -- overall around 23 different industries are targeted.
And therein lies the strength of the CE label: it is comprehensive in its overall product coverage, yet each industry’s particular rules are detailed and specific.
Your technical file: What is required for CE compliance?
It is the responsibility of the EU manufacturer or importer to establish across-the-board compliance for all products entering the market. These companies are required to maintain what’s known as a technical file, subject to periodic authoritorial review. Individual directives specify exactly what is required in each technical file, but in general it should include:
- Declaration of Conformity – Technical description and specification
- All test reports
- Design drawings and diagrams of your product
- Material information of all substances used in your product
- A list of applied standards (RoHS, Toy Safety, etc.)
- Appropriate labeling
- Product instructions
- Risk assessment information
- Description of the conformity assessment procedure
- Addresses of manufacture and storage locations
- Copies of the documents that manufacturer submitted to a notified body, if involved
- A copy of the EC-type examination certificate, if involved
Technical documents can be made available in any format (i.e. paper or electronic) and must be held for a period of up to 10 years after the manufacture date of the last unit.
Importing Risks
Demand the Data Behind the Label
As an importer, you are responsible for making sure your factories are manufacturing your product to EU standards. It is not wise to assume your overseas factory in, say, China, is aware of all EU-required directives, and a CE label is not difficult to forge.
The best practice is to look for factories with a solid history of compliance. A way to do that is to do as an authoritorial body would and ask to see documents resembling a technical file. The results of this request should quickly make clear whether or not the factory in question is serious about quality standards.
QIMA's Initial Production CheckOnce your factory has been chosen, an Initial Production Check (IPC) is the first step in ensuring the quality of your product will be consistent throughout production. An IPC is an early-warning system that safeguards your product against costly import risks.
Once Compliant, Maintain Your Production Quality
Back on the subject of risk assessment: suppose that your imported product does achieve initial compliance certification and is CE-marked for market. Your product is successful and has spread across the continent; however, after a few years you are subjected to a follow up review. This is not uncommon for EEE products and children’s toys, as they face a high level of scrutiny.
What you, based on your initial certification, thought was a compliant product fell out of spec without your realization, and you are exposed. Not only are you responsible for an expensive buyback of your product, but the cost to your brand reputation might be too high to recover from.
QIMA's Production Monitoring ServiceWith a dedicated production monitoring inspector, you can keep eyes on the factory floor from the start to finish of your product, and receive daily reports so that any deviation from your requirements can be targeted and corrected early in the process, and well before it leaves the factory.
Full compliance with complex EU standards is a complete investment in high-quality manufacturing. No half-hearted measures will sustain themselves. Factories must be “all in” with their commitment; otherwise, as these EU directives continue to change the course of global manufacturing, they will be uprooted from service quicker than ever.
A note concerning the UK: UKCA (UK Conformity Assessed) marking is a new UK product marking that is used for goods being placed on the market in Great Britain (England, Wales and Scotland). It covers most goods which requied the CE marking in EU. The UKCA marking came into effect on 1 January 2021. However, to allow businesses time to adjust to the new requiremetns, you will still be able to use the CE marking until 1 January 2022 in most cases. From 1 January 2023, the UKCA marking must, in most cases, be affixed directly to the product.
QIMA will help you stay connected with this new market with top-tier Product inspections.
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