Personal Protective Equipment

When buying an anti-smog mask, it is worth knowing what terms such as CE mark, EU-Type Examination Certificate (EU-Type Examination Certificate) or Declaration of Conformity (Declaration of Conformity) mean. Such documents are obligated to be made available by each manufacturer of anti-smog masks.

See below for basic information on the EU Type Examination Certificate and CE Mark.

The CE marking/marking (Conformité Européenne) affixed to a product is the manufacturer's declaration that the marked product complies with the requirements of the so-called "New Approach" directives of the European Union. These directives concern issues relating to safety of use, health protection and environmental protection, and define the risks which the manufacturer should detect and eliminate. By marking his product with the CE mark, the manufacturer declares that the product complies with the requirements of all relevant directives

One such document is Regulation 2016/425 of the European Parliament and of the Council (EU) number 2016/425, which came into force on 9 March 2016.
This is a regulation concerning so-called individual protective equipment describing in particular the formal and technical requirements they must meet. In particular, so-called Category III measures are subject to special supervision.

This group also includes filtration respirators for industrial use as well as those referred to as anti-fog masks.
Regulation 2016/425 replaced the previous regulation which was Council Directive 89/686/EEC and its rules are mandatory from April 2019.  
This document in particular formalises the rules of CE marking and the procedures for obtaining the relevant certificates as well as the supervision of such products. 

Anti-smog masks, like other category III personal protective equipment, must first undergo the appropriate technical tests and then pass the so-called EU type test.  In the case of a positive scenario, the result is an EU Type Test Certificate. Both stages must be performed by accredited institutions with notified body status. In Poland, at the time of publication of this material, to the best of our knowledge, there are only 2 such centres:

- Central Institute for Labour Protection in Łódź,
- and the Polish Register of Shipping (PRS) SA.

In the course of carrying out tests, accredited centres use the Norm EN 149 (at present, this is the version EN 149:2001 + A1:2009 also designated as PN-EN 149+A1:2010), which specifies in detail the list of tests, the manner in which they are to be carried out and the specification of so-called classes of protection.

After obtaining the certificate, the manufacturer of the tested product issues a so-called Declaration of Conformity. In the case of anti-smog masks, this is a short document presenting the details of the manufacturer, the products that have been certified, the version of the EN 149 standard used for technical tests, the notified body that carried out the EU type tests and performs the supervision, as well as how the supervision was carried out.

It is worth noting here that anti-smog masks must then be supervised for a further 5 years from the date of receipt of the test certificate.

More on Regulation 2016/425 can be found at: https://eur-lex.europa.eu/legal-content/PL/TXT/HTML/?uri=CELEX:32016R0425&from=EN

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