Main points of attention

PPE (incl. RPE) is the last element in risk control hierarchy --> In practice often the only or primary mitigation of the risk (mainly small and medium enterprises and healthcare sector).

• Based on 89/656/EC PPE (incl. RPE) must fit the wearer correctly --> Not implemented in all Member States by obligatory face-fit testing.
• CE marked “Ear loops” masks will not provide the expected protection for wearers --> Need to strengthen the enforcement of fit assessment (mandatory face-fitting tests are the solution, this for all types of tight fitting respiratory protection).
• Some European countries are consciously reacting --> Widespread implementation of the approach based on experience from countries and ESF local organizations (UK, Italy, and partially France, the Netherlands, Sweden, Finland and Spain). Also outside Europe several countries (e.g. USA, Canada, Australia, New Zealand, South Africa) made face-fit testing mandatory while others (e.g. India, China) made it a recommended practice.
• A revision of the standard EN 149 should include a better definition for ‘adjustable head harness’ in order to make sure that the fit of the mask on humans can be achieved.

Background

Due to the current situation with the Omicron variant of the virus, in more and more situations the use of FFP2 masks by the general public is required. This is not always a government decision, but also specific organisations/facilities require this for the public visiting (e.g. healthcare facilities, universities/schools, …).

Therefore, the European Safety Federation considers it necessary to repeat some concerns we already made a year ago, and also add a few following recent evolutions.

First of all, we want to refer to our paper dated 04/02/2021 (see attached as annex) as the vast majority of the points made at that moment are still valid. 

The UK Office for Product Safety & Standards publishes Guidance for PPE being supplied in or into Great Britain as well as for PPE being supplied in or into Northern Ireland. For the latest version of the guidance, see : Guidance for businesses on Regulation 2016/425 and the Personal Protective Equipment (Enforcement) Regulations 2018 

Link to the official list of Approved Bodies for PPE 

Our effective member in the UK, BSIF, published a some Q&A concerning Brexit on their website (News section) - see www.bsif.co.uk/newsarticles 

202112 : ESF organises on 16/02/2022 a webinar on UKCA for its members - see https://www.eu-esf.org/services/workshops/ukca-workshop-16th-of-februari-2022 

202108 : The UK Government has extended the deadline by one year, through until the 1st of January 2023, for the placing on the market of CE marked product to still be acceptable in GB (England, Wales and Scotland). This means UKCA certification is necessary latest 1/1/2023 instead of 1/1/2022. See https://www.gov.uk/guidance/using-the-ukca-marking#check-whether-you-need-to-use-the-new-ukca-marking 

20201118 : find here the ESF note concerning UKCA mark

20190611 : find here the paper ESF prepared on the consequences for certificates in case of a no deal Brexit

ESF would like to bring to your attention that the obligation (or recommendation) to wear FFP2 masks for the general public might not result in the intended protection and could even be a step back, due to the created false sense of protection. We urge all involved authorities to carefully consider all aspects and make sure that a potential obligation (or recommendation) is accompanied by the necessary supporting measures. 

Some types of Personal Protective Equipment (PPE), mainly protective garments, require a finish (with possible reapplication after the cleaning process) to maintain the protective characteristics. This is typically a fluorocarbon finish.

ESF Proposal for guidance on how to deal with certficates in the transition from Directive to Regulation.

ESF Proposal for guidance on how to deal with certficates in the transition from Directive to Regulation.

ESF Proposal for guidance on how to deal with certficates in the transition from Directive to Regulation.

20170427: ESF Proposal for guidance on how to deal with certficates in the transition from Directive to Regulation.

20190507: An updated version is available 

ESF Proposal for guidance on how to deal with certficates in the transition from Directive to Regulation.

ESF flowchart: Who am I (FR) [cliquez download]

ESF flowchart Who am I (EN) [click on download]