FILTER HALF MASKS

Kondrat and Partners
legal aid in the market introduction of protection measures against Covid – 19 – ochronaprzedcovid@kondrat.pl

FILTER HALF MASKS
Category: personal protective equipment

Legal requirements

The legal requirements for this product category are set out in:

  • Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment

 

Conditions of sale in the territory of Poland

  • carrying out the product conformity assessment procedure in accordance with Regulation 2016/425 on personal protective equipment,
  • preparation by the manufacturer of a declaration of conformity for compliance with the requirements of Regulation 2016/425 on personal protective equipment;
  • obtaining a certificate issued by a European Notified Body, which confirms that the product complies with the relevant standard (information on relevant standards can be found below; the list of bodies entitled to certification is available here: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501);
  • CE marking of the product.

Compliance with standards

Half-masks – as personal protective equipment – shall meet the requirements of the standard:

  • PN-EN 140:2001/Ap1:2003 – Respiratory protective devices – Half-masks and quarter masks – Requirements, testing, marking (or EN 140:1998 EN 140:1998/AC:1999 respectively); or
  • PN-EN 149+A1:2010 – Respiratory protective devices – Filtering half-masks to protect against particles – Requirements, testing, marking (or EN 149:2001+A1:2009 respectively).

 

Documents required for sale

  • declaration of conformity of compliance with the requirements of Regulation 2016/425 on personal protective equipment,
  • a product certificate confirming that the product complies with the relevant standard.

 

Labelling

  • CE marking,
  • type name, batch or serial number or other information allowing the identification of the mask (if the size or nature of the mask does not allow it – the required information shall be included on the packaging or in the accompanying document),
  • manufacturer’s data,
  • importer’s data,
  • in accordance with the requirements of the relevant standard (number of the standard, name of the half-mask, protection class, manufacturer’s data).

 

VAT rate

As a rule, medical devices and PPE are subject to 23% or 8% VAT rate. The rate depends on whether the product is assigned to the relevant Polish Classification of Goods and Services (PKWiU) end-group.

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