EU PPE Regulation 2016/425
About this article:
Since the onset of COVID-19 we have had a number of questions related to the EU PPE regulations and how to tell if a product meets European safety standards. In this article we summaries 8 key questions about the EU's PPE Regulation 2016/425.
Respiratory face masks (FFP) and personal protective equipment (PPE) are covered by the EU Regulation 2016/425 on PPE (the 'PPE Regulation') which came into force on 21 April 2018. The regulation covers the use of PPE in domestic, leisure and sports, as well as professional use. It excludes some specific police and military uses.
The PPE regulation covers the design, manufacture and sale of personal protective equipment within the EU single market ensuring the the PPE (i) provides the necessary health and safety protection against the relevant risks and (ii) a CE marking is fixed to the PPE as evidence of compliance of the product with applicable standards.
1. What is Personal Protective Equipment under the PPE Regulation?
The PPE regulation defines it as "equipment designed and manufactured to be worn for protection against one or more risks to that persons health and safety."
2. Who is affected by the Legislation?
The PPE regulation affects manufacturers, importers, distributors and even online e-commerce retailers who are all classified as 'economic operators'. The regulation applies to products manufactured in the EU as well as imported goods.
3. What obligations are place on manufacturers of PPE?
- The most significant obligation is for the manufacturer to carry out a conformity assessment procedure (usually with an approved third party laboratory called a 'Notified Body') including but not limited to design and manufacture in accordance with Annex II and technical information in accordance with Annex III.
- To make an EU declaration of conformity: The EU declaration of conformity shall state that the fulfilment of the applicable essential health and safety requirements set out in Annex II has been demonstrated.
- Manufacturers from outside the EU are also required to undertake the same procedure for PPE manufactured outside the EU.
- PPE is accompanied by instructions and information in a language understood by end consumers.
- All items shall bear a batch number, type or serial number either on the product itself or on the packaging.
It is forbidden to place PPE products on the European market without conformity assessment.
4. What obligations are place of Importers and Distributor's of PPE?
Importers and Distributors assume legal responsibility under Article 10 of the PPE Regulation 'when making available PPE' to ensure:
(i) the manufacturer has undertaken the conformity assessment and provided an EU declaration of conformity (recitals 24 and 25 of the regulation) and has been issued an EU type examination certificate for a period of 5 years;
(ii) all relevant documentation such as user instructions, are up to date and in the language of the market and included with the smallest available package sold
(iii) ensure traceability of the products through the supply chain
It is forbidden for Importers and Distributors to place PPE products on the European market without conformity assessment.
5. Which assessment criteria are Face Filtering Pieces described in the Regulation?
The Regulations Annex V: EU Type-examination (Module B) specify the conformity assessment procedures for FFP respiratory face masks.
6. Who is authorised to carry out a Conformity Assessment under Annex V of the regulation?
Conformity assessment is undertaken by a notified body. This is an independent standards and testing firm accredited by each country in the EU to undertake the assessments. Annex V: EU type examination certificates can only be issued by an EU notified body. An updated list of European notified bodies is available on the EU's Nando database here.
The PPE Guidelines confirm "Notified bodies provide the professional and independent judgements, which consequently enable manufacturers ...to presume [product] conformity to the PPE Regulation."
7. Which category do FFP respiratory face masks fall under?
FFP respiratory face masks fall under category III (a) and (c) of the EU PPE regulation. Category III includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health.
8. What are the responsibilities of importers to verify the above?
The bottom line is that responsibility for product safety also rests with importers and distributors. Rigorous due diligence must be undertaken to ensure the manufacturer has complied with all aspects of the PPE regulation. The importer and or distributor assumes legal liability for defective or unregulated products in the European market.