Recently, with the spread of covid-19 in many eu countries, supplies such as protective masks, protective clothing and goggles have become popular in the market. As the largest producer of protective equipment in the world, Chinese enterprises have also entered a period of business explosion. Both traditional manufacturers and new manufacturers hope to take this opportunity to sell their products to the eu market.
As a necessary document for the legal sale of Chinese products in the eu, CE certification has recently become the focus of the market. CE certificates issued by various certification agencies and intermediary companies dazzle Chinese enterprises. The following is an answer to all the questions about protective mask CE.
Frequently asked questions about the CE certification of protective masks
1. What is the classification of protective masks prescribed by the eu?
A: the grades of protective masks are divided into FFP1, FFP2 and FFP3, as shown in the figure below, which are all typical types of protective masks.
Protective masks are subject to the (EU)2016/425 personal protective equipment (ppe) code, which is a category III product. The test standard is en149:2001 + a1:2009.
2. CE certification mode of protective masks
A: according to the (EU) 2016/425 PPE regulations, protective masks can only be legally sold in the EU after obtaining a Module B (type inspection certification) + Module C2 (internal quality control + product random supervision and sampling inspection) or Module D (production process quality control) certificate. In simple terms, it must be either Module B + Module C2 or Module B + Module D.
3. What kind of certification institution can be engaged in the CE certification of protective masks?
A: only a certification body authorized by the European commission (EU) 2016/425 PPE mask products Module B, Module C2 and/or Module D has the right to engage in CE certification activities for protective masks. No certification body without the authorization of PPE regulations, no certification body without Module B, C2 and/or D qualifications, and no intermediary that is not a certification body shall have the right to conduct CE certification activities for respirators. At present, the domestic is to solve the problems of exposed a lot of no qualification certification organizations and intermediary organizations, take advantage of the enterprise for the eu regulations do not understand, mislead enterprises to carry out the wrong choice, a large amount of invalid CE certificate issued, makes the enterprise in the process of exports to the eu, facing the huge commercial risk and legal risk.
There are four steps to determine whether a certification company is a formal PPE CE certification organization and can conduct CE certification activities for protective masks:
01 the official website of the European Union
https://ec.europa.eu/growth/tools-databases/nando/index.cfm? Fuseaction = notifiedbody. Main
All the certification bodies authorized by the European commission are published on this website. You can check the information and authorization scope of the certification bodies according to the number of the certification bodies.
02 determine whether the certification body has PPE regulatory (EU) authorization 2016/425:
Each accreditation body has a different scope of authorization. Without the authorization of PPE regulation (EU) 2016/425, it is not entitled to conduct CE certification activities for protective masks, and the certificates issued by it are not in accordance with EU laws. If the agency has a mandate under the PPE regulation (EU)2016/425, the scope of its qualifications is shown below:
Determine if the certification body has a respiratory protection subcategory
PPE regulations have nine categories of product authorization, and the authorization scope of each PPE certification announcement body is also different. If there is no small category of respiratory protection, even PPE certification announcement body cannot engage in CE certification activities of protective masks. For the query method, click the "HTML" or "PDF" link on the right side of PPE authorization on the official website to see if there is a small class of respiratory protection authorization, as shown in the red box below:
Confirm whether the certification body can be authorized by Module B, C2 or D:
The certification body has the authority to issue Module B, C2 and/or D certificates only if it is fully qualified for Module B, C2 and/or D. The authorization display is shown in the following red box:
Manufacturers can enter the eu market legally only after they have obtained a Module B + Module C2 certificate or a Module B + Module D certificate. If only part of Module B, C2 or D is authorized by the certification body, then it has no power to issue certificates without recognized qualifications, and the enterprise holds the certificates and cannot legally sell them in the eu market
4. What are the CE certificates of masks in circulation in the market that comply with the regulations of the European Union?
A: there are so many CE certificates circulating in the market that it is difficult for enterprises to judge which are legal and which are in accordance with eu laws.
So far, there are 31 qualified masks. The query method is as follows:
The first step into the's official website: https://ec.europa.eu/growth/tools-databases/nando/index.cfm? Fuseaction = directive. Notifiedbody&dir _id = 155501
Step 2: select the following in the box:
5. Does CE meet the qualification requirements of ASOCIACIoN DE INVESTIGACIoN DE LA INDUSTRIA TEXTIL?
A: search bulletin no. 0161 on the eu bulletin website, and click the "HTML" or "PDF" link on the right side of PPE authorization on the official website, with full Module B, C2 and/or D qualifications, as shown in the red box below. So proclamation 0161 (ASOCIACIoN DE INVESTIGACIoN DE LA INDUSTRIA TEXTIL) is officially accredited and meets the requirements.
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