CE certification As a necessary document for the legal sale of Chinese products in the EU, it has recently become the focus of the market. Chinese enterprises are dazzled by the CE certificates issued by various certification bodies and intermediary companies.
At present, there is a huge demand for the export of epidemic prevention materials. Many unqualified intermediaries use their ignorance of EU regulations to mislead enterprises to choose the wrong CE certificate, which makes enterprises face huge commercial risks in the process of exporting to the EU.
EU for protection Mask Classification of
Protective masks are classified into FFP1, FFP2 and FFP3, as shown in the figure below, which are typical styles of protective masks.
The applicable regulations for protective masks are (EU) 2016/425 Personal Protective Equipment Regulations, which belong to Class III products.
The test standard is EN149:2001+A1:2009.
CE certification mode of respirator
According to the provisions of (EU) 2016/425 PPE regulations, protective masks can be legally sold in the EU only after they have obtained the certificate of Module B (type inspection certification)+Module C2 (internal quality control+random supervision and random inspection of products) or Module D (quality control of production process).
In short,
Module B+Module C2
Or Module B+Module D.
What institutions can be engaged in CE certification of respirators?
Only the certification notified bodies authorized by the European Commission (EU) 2016/425 PPE regulations for respirator products Module B, Module C2 and/or Module D are authorized to engage in the CE certification of respirators.
Any certification notified body without the authorization of PPE regulations, certification notified body without Module B, C2 and/or D qualifications, and intermediary agencies that are not certification notified bodies have no right to carry out CE certification activities for respirators.
At present, the prominent problem exposed in China is that a large number of unqualified certification agencies and intermediaries mislead enterprises to make wrong choices by taking advantage of their ignorance of EU regulations, and issued a large number of invalid CE certificates, which makes enterprises face huge commercial and legal risks in the process of exporting to the EU.
Confirm whether a certification company is a formal PPE CE certification body,
Methods for conducting CE certification activities for respirators,
There are four steps.
step
Step 1: Query the official website of the European Union to query the information of the notified body
website:
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main
All certification notified bodies authorized by the European Commission are publicized on this website. You can query the information and scope of authorization of the certification notified body according to its number.
Step 2: Determine whether the certification notified body has the authorization of PPE Regulation (EU) 2016/425
Each certification notified body has a different scope of authorization. Without the authorization of the PPE Regulation (EU) 2016/425, it has no right to carry out CE certification activities for respirators, and the certificate issued by it does not comply with the provisions of EU laws.
Step 3: Determine whether the certification notified body has a subcategory of respiratory protection
There are nine categories of product authorization in the PPE regulations, and the authorization scope of each PPE certification announcement body is also different. If there is no small category of respiratory protection, even the PPE certification announcement body cannot engage in the CE certification of respirators.
Step 4: Confirm whether the certification announcement body can have the authorization of Module B, C2 or D
The certification announcement body is only authorized to issue Module B, C2 and/or D certificates if it has complete Module B, C2 and/or D qualifications.
Manufacturing+ Only after obtaining the Module B+Module C2 certificate or the Module B+Module D certificate can the dealer enter the EU market for legal sales.
If only part of Module B, C2 or D is authorized by the certification body, then it has no right to issue certificates without recognition qualification. Enterprises hold their certificates and cannot legally sell them in the EU market.
