Recently, with the spread of the new crown epidemic situation in many EU countries, protective masks, protective clothing, goggles and other anti-epidemic materials have become popular in the market. As the world's largest producer of protective equipment, Chinese companies have also ushered in a period of business outbreaks. Both traditional production enterprises and new enterprises that have switched to production hope to take this opportunity to sell their products to the EU market.
CE certification, as a necessary document for the legal sale of Chinese products in the EU, has recently become the focus of the market. CE certificates issued by various certification bodies and intermediary companies dazzled Chinese enterprises. The following are ZRLK's answers to the problems encountered by everyone in protective masks CE.
Common problems of CE certification for protective masks
1. What is the EU's classification for protective masks?
Answer: The grades of protective masks are divided into FFP1, FFP2 and FFP3. As shown in the figure below, they are the typical styles of protective masks.
The applicable regulations for protective masks are (EU) 2016/425 Personal Protective Equipment Regulations, which belong to category III products. The test standard is EN149:2001+A1:2009.
2. The mode of CE certification for protective masks
Answer: According to (EU) 2016/425 PPE regulations, protective masks must obtain Module B (type inspection certification) + Module C2 (internal quality control + product randomness supervision and random inspection) or Module D (production process quality control) certificate After that, it can only be legally sold in the EU. To put it simply, you must choose Module B + Module C2 or Module B + Module D.
3. What kind of certification body can engage in CE certification of protective masks?
Answer: Only the certification bodies authorized by the European Commission (EU) 2016/425 PPE regulatory mask products Module B, Module C2 and/or Module D are authorized to carry out CE certification activities for protective masks. Any certification announcement agency that is not authorized by the PPE regulations, certification announcement agency that does not have Module B, C2, and/or D qualifications, or an intermediary agency that is not a certification announcement agency, has no right to carry out CE certification activities for protective masks. At present, the most prominent problems exposed in China are a large number of unqualified certification bodies and intermediary agencies. Taking advantage of the companies' lack of understanding of EU regulations, misleading companies to make wrong choices, issuing a large number of invalid CE certificates, making companies export to the EU process China is facing huge business risks and legal risks.
There are four steps to confirm whether a certification company is a formal PPE CE certification body and can carry out CE certification activities for protective masks:
01 Check the official website of the European Union for the information of the notified body:
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main
All certification and announcement agencies that are authorized by the European Commission are publicized on this website. You can query the information and authorization scope of the agency according to the number of the certification and announcement agency.
02Determine whether the certification body has the PPE Regulation (EU) 2016/425 authorization:
The authorization scope of each certification announcement body is different. Without the authorization of the PPE Regulation (EU) 2016/425, it is not authorized to carry out CE certification activities for protective masks, and the certificates issued by it are not in compliance with EU law. If the institution is authorized by PPE Regulation (EU) 2016/425, the scope of its qualifications is displayed as follows:
03 Determine if the certification body has a sub-category of respiratory protection
There are nine categories of product authorization in PPE regulations, and the scope of authorization of each PPE certification announcement body is also different. If there is no sub-category of respiratory protection, even the PPE certification announcement body cannot engage in CE certification activities for protective masks. For the query method, click on the "HTML" or "PDF" link on the right side of the PPE authorization on the official website to see if there is a subclass authorization for respiratory protection, as shown in the red box below:
04 Confirm whether the certification body can have the authorization of Module B, C2 or D:
The certification body only has the complete Module B, C2 and/or D qualifications to issue Module B, C2 and/or D certificates. The authorized display is shown in the red box below:
Only after obtaining the Module B + Module C2 certificate or Module B + Module D certificate can the manufacturer enter the EU market for legal sale. If the certification and certification body has only part of the authorization of Module B, C2 or D, then he has no right to issue a certificate without recognized qualifications, and the company holds its certificate and cannot be legally sold in the EU market.
4. Which CE certificates of masks in the market are in compliance with EU regulations?
A: There are many kinds of CE certificates in circulation on the market. It is difficult for enterprises to judge which ones are legal and which are in compliance with EU laws.
So far, there are 31 mask protection qualifications. The query method is as follows:
The first step is to enter the official website: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501
Step 2: Select as follows in the box:
5. Announcement No. 0161 (ASOCIACIóN DE INVESTIGACIóN DE LA INDUSTRIA TEXTIL) of ZRLK agency application does CE meet the qualification requirements?
Answer: Check the bulletin number 0161 on the EU bulletin website, click on the "HTML" or "PDF" link on the right side of the PPE authorization on the official website, and have the complete Module B, C2 and/or D qualifications, see the red box below. Therefore, the qualification of the announcement number 0161 (ASOCIACIóN DE INVESTIGACIóN DE LA INDUSTRIA TEXTIL) is officially recognized and meets the requirements.
