legal aid in the market introduction of protection measures against Covid – 19 – firstname.lastname@example.org
ategory: personal protective equipment
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
- carrying out the conformity assessment procedure in accordance with Regulation 2016/425 on personal protective equipment,
- preparation by the manufacturer of a declaration of conformity with the requirements of Regulation 2016/425 on personal protective equipment; a model declaration is available below:
EU DECLARATION OF CONFORMITY
- PPE (product number, type, batch or serial number):
- Name and address of the manufacturer and, where applicable, of his authorized representative:
- This declaration of conformity shall be issued under the sole responsibility of the manufacturer:
- Subject of the declaration (identification of PPE enabling traceability; a sufficiently clear colour illustration may be included where this is necessary for the identification of PPE):
- The subject matter of this declaration described in point 4 shall comply with the relevant requirements of Union harmonisation legislation: …
- References to the relevant harmonised standards which have been applied, together with the date of the standard, or to other technical specifications, together with the date of the specifications for which conformity is declared:
- Where applicable, the notified body … (name, number) … carried out an EU type-examination (Module B) and issued an EU type-examination certificate … (reference to this certificate).
- Where appropriate, PPE shall be subject to a conformity assessment procedure … (either type compliance based on internal production control and supervised product inspections at random intervals (module C 2) or type conformity based on production process quality assurance (module D)) … under the supervision of the notifier … (name, number).
- Additional information:
Signed on behalf of: …
(place and date of issue):
(name, position) (signature):
- obtaining a certificate issued by a European notified body which confirms that the product complies with the relevant standard (information on the relevant standards can be found below; a list of certification bodies is available here: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501);
Note! Many products with incorrect certificates have appeared on the market, for example, the certificate was issued by an unauthorized entity; it is therefore important to check that you have the correct certificate,
- ce marking of the product.
Half masks – as means of individual protection – should 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 – Filter half masks for protection against particles – Requirements, testing, marking (or EN 149:2001+A1:2009, respectively).
- declaration of conformity for compliance with the requirements of Regulation 2016/425 on personal protective equipment,
- a certificate for the product confirming that the product complies with the relevant standard.
- CE marking,
- type name, lot or batch number or other information enabling the mask to be identified (where 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),
- the manufacturer's details, i.e. the name, registered trade name or registered trade mark and the postal address at which it can be contacted (if it is not possible to appear on the mask — the manufacturer's details shall be indicated on the packaging or in the accompanying document)
- the importer's particulars , in the case of imported masks, i.e. the name, registered trade name or registered trade mark and the postal address at which it can be contacted (if it is not possible to appear on the mask – the importer's data shall be indicated on the packaging or in the accompanying document),
- according to the requirements of the relevant standard (standard number, half mask name, protection class, manufacturer's data).
Due to the prevailing pandemic, specific arrangements have been provided for the supply of personal protective equipment and medical devices. The Ministry of Health has introduced a special purchasing procedure under which products can be purchased in accordance with the guidelines of the national consultant in the field of infectious diseases.
In accordance with this procedure:
- half masks may only be used for staff providing health care services, including sanitation, services and other persons involved in action against the coronavirus epidemic,
- half masks must comply with the above standards or NIOSH-42C FR84 (US) or GB2626-2006 (China) or AS/NZ 1716:2012 (Australia) or JMHLW – Notification 2014-2018 (Japan) – in the range of:
1) filtration efficiency against solid and/or liquid aerosols not less than 94 % ,
2) breathing resistance – not more than 300 Pa,
(3) a CO2 content in inhaled air, if applicable, of less than 1 % of the
- whereas it is necessary to have a declaration of conformity of the product with the requirements of EU Regulation 2016/425,
- product must be CE marked.
- no later than 36 hours before the intention to export or dispose of the FFP2/FFP3 masks outside Polish territory, the governor responsible for the trader's registered office or place of residence must be informed,
- the governor may or may not submit an application to the Prime Minister to prohibit the export or disposal of these products outside the territory of Polish.
As a general rule, medical devices and PPE are subject to a 23% or 8% VAT rate. The amount of the rate depends on the assignment of the product to the correct final grouping of the PKWiU.
In accordance with the provisions of the Regulation of the Minister of Finance of 25 March 2020. on goods and services for which the rate of tax on goods and services is reduced and the conditions for the application of reduced rates, it is possible to apply a reduced rate of 0% of the tax in the case of the free transfer by a taxable person of goods belonging to his undertaking, in particular any donations of personal protective equipment – only masks, face guards/windows, goggles, safety goggles, overalls, shoe protectors, caps and gloves.
However, certain conditions must be met for the application of the reduced VAT rate (the donation must be made in writing, between the donor and one of the entities enumerated in the legislation, it must be clear from the contract that the goods delivered will be used by the rightholders).
The reduced rate of VAT can therefore be applied to donations made under the above conditions between 1 February 2020 and 31 August 2020.