The epidemic of New Coronary Pneumonia has spread raging. Although the domestic situation has slowed down, the situation in Europe and the United States is still unclear. The demand for related epidemic prevention materials has surged. Among them, personal protective glasses and face masks are one of the important anti-epidemic materials. The risk of viruses protects personal health and safety.
For the EU market, CE certification is essential. According to the log issued by the European Commission on March 13th, export of goggles masks (including virus protection functions) to the EU must comply with PPE regulations (EU) 2016/425, and recommendations for compliance evaluation and market monitoring procedures ( commission recommendation (EU) 2020/403).
1. How to identify the true and false certificates at a glance
The CE certificate needs to be issued by the notified body (Notified Body, NB) authorized by the EU to be qualified and valid. Each bulletin board has its own unique number (4 Arabic numerals), and the scope of the authorized certification is different. The application and issuance of the CE certificate shall be executed by the notified body authorized by the corresponding regulations and directives.
A qualified CE certificate must have the following three conditions:
EU Type Examination Certificate
Announcement organization number
For example NB 0196
EU Authorized Notified Body
PPE Eye Protection Appendix V
Second, the focus of the interpretation of regulations
● If the emergency approval product does not adopt the PPE regulations harmonized standard as the product technical requirements and other technical requirements, such as the WHO recommended requirements, it is necessary to ensure that the adopted technical requirements are equivalent to the basic health and safety requirements of the PPE regulations. When issuing a certificate to such a PPE product that adopts other technical requirements, the notified body needs to immediately notify the competent authority and the notified body of other PPE regulations.
● If the market supervision agency determines that the product complies with the basic health and safety requirements of the PPE regulations, even if the compliance evaluation has not been completed, the market supervision agency may allow it to sell within a certain period of time, and the product must continue to complete its compliance evaluation process.
● The competent authorities of member countries can also evaluate and organize the purchase of PPE products without CE mark during the epidemic. The products can only be provided to medical workers for use and cannot be circulated in the market. At the same time, market spot checks will focus on spot-checking PPE products related to epidemic prevention to prevent serious risks caused by substandard products.
In short, export manufacturers still need to obtain CE certification, but only in some cases allowed by the authorities to delay completion. Products without the CE mark have to face regulatory risks such as notification, recall, and punishment when they enter the market.
3. Types of protective glasses
There are currently three types of personal protective glasses on the market, namely spectacles, googles, and face-shields.
According to EU PPE regulations, there are three types of protective eyewear. The protective glasses and masks mentioned above are all 2 types of products, and a few are 3 types. The certification requirements for category 2 eye protectors are as follows:
● EU type inspection certificate and EN 166: 2001 test report
● Manufacturer self-declaration of conformity statement
● Product CE Mark
4. How to deal with the global market for protective glasses and face shields
● EU: EN 166-Personal Eye Protection Device / CE Certificate
● United States: ANSI Z87.1-glasses and face protection
● Canada: CSA Z94.3-glasses and face protection
● Australia: AS / NZS 1337.1 professional eye and face protectors
● China: GB 14866 personal eye protection technical requirements