Personal protective equipment (PPE) are products that the user can wear or hold, to be protected against risks either at work, at home or whilst engaging in leisure activities. Statistics on fatal and major work accidents underline the importance of protection and prevention, for which personal protective equipment plays an important role.
Coronavirus response in relation to personal protective equipment
Producing new protective equipment for the EU market
Economic operators across the EU are working relentlessly to increase their respective manufacturing and distribution capacity. To mitigate the effects of disruptive factors, they are redesigning their supply chains by launching new manufacturing lines and/or diversifying their supplier base.
We are considering all means to increase the production and supply of protective equipment in the EU. These include
- identifying and deploying support measures to increase the capacity of existing EU manufacturing facilities
- reaching out to companies that are not active in the EU market
- converting production lines from other industrial sectors, such as the textile sector, to produce protective equipment
We published guidance for manufacturers to help economic operators to assess whether they can convert their existing facilities to produce protective equipment. It details applicable EU legal frameworks and steps that manufacturers need to take to place their products on the EU market.
Increasing production capacity and accelerating approval of protective equipment
On 20 March, the European Committee for Standardisation CEN and the Commission agreed to make all relevant European harmonised standards freely and fully available to increase European production capacity for these essential products.
European harmonised standards are technical specifications used by industry to ensure compliance with the legislative safety requirements, enabling unhindered market access. Normally, companies purchase harmonised standards from national members of the European standardisation organisations and their use is restricted by IPR rules.
Also, on 13 March 2020, we issued a recommendation to speed up the uptake of new products not based on harmonised standards, without compromising on our health and safety standards and without undue delays.
On 24 April, the Directorate-General for Trade introduced temporary measures adjusting the PPE export authorisation scheme for 30 days.
Notified bodies should prioritise and swiftly make conformity assessments for all new requests by economic operators.
For protective equipment products not following harmonised standards, bodies should take WHO recommendations as reference for their technical assessment.
Market surveillance authorities may authorise products for the EU market without finalised conformity assessment procedures if the equipment ensures an adequate level of health and safety in line with EU law requirements.
In exceptional cases, purchases organised by EU countries for healthcare workers may skip necessary conformity assessment procedures for equipment, provided that the EU countries’ authorities have ensured adequate safety levels.
PPE and COVID-19 from September 2021 onward
Since the beginning of the pandemic, we've monitored the supply chain of key PPE products used for COVID-19. Initially, the Directorate-General for Industry focused on securing a stable supply and increasing essential PPE availability. Commission Recommendation (EU) 2020/403 on COVID-related conformity assessment and market surveillance procedures helped increase the availability of PPE products in the short term, benefitting healthcare workers and other first-line responders.
Based on information from EU country authorities and economic operators, the supply of PPE to the EU currently appears stable without shortages such as the ones in the first half of 2020.
The Commission will continue to monitor the supply of critical PPE in the EU. However, in this stable situation, only CE-marked products that have gone through the standard conformity assessment procedures should circulate in the internal market. To ensure legal certainty, the Commission adopted Recommendation (EU) 2021/1433 on conformity assessment and market surveillance procedures related to COVID-19. It sets out deadlines for putting products on the market, their use, and authorisation under derogatory procedures.
EU legislation and PPE
Regulation (EU) 2016/425 of 9 March 2016 on personal protective equipment (the PPE regulation) covers the design, manufacture and marketing of personal protective equipment. It defines legal obligations to ensure that PPE on the EU internal market provides the highest level of protection against risks. The CE marking affixed to PPE provides evidence of compliance of the product with the applicable EU legislation.
As legislation based on the 'new approach' aligned to the new legislative framework policy, manufacturers or their authorised representative in the EU must comply with the essential health and safety requirements of the PPE regulation, directly or by using harmonised European standards. The latter confer presumption of conformity to legal requirements.
The PPE regulation guidelines (1st edition - April 2018) (6 MB) aim to facilitate a common understanding and implementation of the PPE regulation.
The PPE regulation is applicable from 21 April 2018, replacing the previous Directive 89/686/EEC. Guidance documents on transitional provisions are available as a common approach of the PPE committee working group, mainly based on the 'blue guide' on the implementation of EU product rules:
- Guidance document on the PPE transition from Directive 89/686/EEC to Regulation (EU) 2016/425 (FAQ document) (393 KB)
- Implementation of article 47 (101 KB)
- Approval decisions based on EC type-examination certificates (102 KB)
- Validity of an EC-type examination certificate and revision of harmonised standards (100 KB)
- Placing on the market and products in stocks (126 KB)
- Minutes of the PPE working group meetings (4 MB) from 2002 onwards
- Standardisation for PPE: consolidated lists of references of harmonised European standards under the PPE regulation
- Notified bodies for PPE
- List of bodies notified under Regulation (EU) 2016/425 on personal protective equipment (NANDO information system)
- European coordination of notified bodies - Horizontal Committee of Notified Bodies (HCNB) for PPE
Technical secretariat: Ms. Wiene Fokkinga, email: Wiene.Fokkinga@nen.nl
'Recommendation for use' (RfU) sheets
These 'technical sheets for coordination' report the common position of the notified bodies for PPE endorsed by the PPE committee working group
- Horizontal recommendation for use sheets (RfUs) (2 MB) – status in April 2019
- Vertical recommendation for use sheets (RfUs) (1 MB) – status in September2021