Legislation and Regulations

The law specifies that the employer must carry out a risk inventory and evaluation (RI&E) to map possible dangers and take measures if necessary.

CE marking & technical standards
Personal Protective Equipment in Europe must have CE marking.
To award it to a product, a technical inspection by an independent authority is required as well
as a prescribed quality control by the supplier.

European Standard (EN)
These products meet the requirements of EC Directive 89/686/EEC (Personal Protective Equipment Directive) and are therefore CE marked.
RX masks have been tested and CE approved in accordance with EN 149:2001+A1:2009.
European standards masks

CMR substances - Carcinogenic Mutagenic Reprotoxic substances
CMR substances are carcinogenic mutagenic repro-toxic substances. More specifically, substances which on their own (carcinogenic substances) or in combination with other substances (mutagenic substances) can cause cancer. Repro-toxic substances can have a negative effect on fertility, but also cause damage during the development of the unborn child and result in congenital disorders.

NPF - Nominal Protection Factor
The theoretical protection level of a respirator is based on the performance measured during tests in laboratories. The NPF is calculated by the Total Inward Leakage (TIL), as specified in the EN in question, divided by 100. The maximum concentration of a substance in the air, against which a respirator offers protection, is calculated by multiplying this NPF with the limit (the limits are specified in the lists published by the European authorities).
The Nominal Protection Factor is a number denoting the level of minimal protection of the relevant type of mask. The higher the number, the better the protection.

APF - Assigned Protection Factor
Determined following practical tests in the workplace. Unsatisfactory maintenance, instruction, incorrect use, movement,etc. are taken into account. As specified in BS4275, APF is the level of protection, which can be realistically achieved for 95% of trained and supervised users.
For more information on workplace exposure limits, and to view the list of substances currently listed visit
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