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Eurofins >> Consumer Product Testing >> Media Centre >> News >> Personal Protective Equipment | Monthly bulletin | May 2020

Personal Protective Equipment | Monthly bulletin | May 2020

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Regulatory news

 


 

​International

 

The use of respirators in response to Covid-19

 

The World Health Organization (WHO) is recommending the use of respirator masks with filtration efficiency at least 95% for particles of 0.3 micron diameter during COVID-19. N95 mask respirators should conform with American NIOSH regulation and FFP2 European regulation.

 

Due to shortages of personal protective equipment (PPE) during the COVID-19 pandemic, health authorities worldwide are looking for solutions to increase the manufacture and import of these types of products with the aim of supplying enough materials to hospital staffs and the general public.

 

Please see the below table summarising recent publications related to respirator masks:

 

Date

Country/region

Tittle

08/04/2020

Canada

Notice – Important Regulatory Considerations for the Reprocessing of Single Use N95 Respirators during the COVID-19 Response

20/03/2020

Europe

Coronavirus: European standards for medical supplies made freely available to facilitate increase of production

27/03/2020

France

Protective Masks: Faced with Coronavirus, Standard Development Bodies Follow Multiple Leads

08/04/2020

France

Info on the AFNOR barrier mask in English-speaking countries

16/04/2020

Germany

Antworten zur Verwendung und zum Inverkehr­bringen von filtrierenden Halb­masken/Atemschutz­masken und weiterer persönlicher Schutz­ausrüstung

30/03/2020

Italy

Mascherine, le norme tecniche per la produzione

26/03/2020

Spain

Marcado CE de las mascarillas filtrantes de protección contra partículas (Equipos de Protección Individual, EPI) V.2

01/04/2020

UK

Research: review of personal protective equipment provided in health care settings to manage risk during the coronavirus outbreak

05/04/2020

US

N95 Respirators and Surgical Masks (Face Masks)

06/04/2020

WHO

Rational use of personal protective equipment for coronavirus disease (COVID-19) and considerations during severe shortages

 

​Europe

 

Standard updates

 

Please see below a table summarising some recent standards updates and upcoming dates of withdrawal (non-exhaustive):

 

(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

 

Reference

Title

Date of Withdrawal (*)

Supersedes

EN 17092-1:2020

Protective garments for motorcycle riders - Part 1: Test methods

2023-03-31

EN 13595-4:2002

EN 13595-3:2002

EN 13595-2:2002

EN 13595-1:2002

EN 17109:2020

Mountaineering equipment - Individual safety systems for rope courses - Safety requirements and test methods

2020-09-30

 

EN ISO 18526-1:202

Eye and face protection - Test methods - Part 1: Geometrical optical properties (ISO 18526-1:2020)

2020-09-30

 

EN ISO 18526-2:2020

Eye and face protection - Test methods - Part 2 : Physical optical properties (ISO 18526-2:2020)

2020-09-30

 

 

Canada

 

Regulatory proposals notified to WTO

 

Please see the below table summarising the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive):

 

Notification number

Countries

Title

G/TBT/N/CAN/609

Canada

Expedited access to disinfectants, hand sanitizers and personal protective equipment to help limit the spread of COVID-19, as well as swabs for testing

 

In light of the unprecedented demand and urgent need for products that can help limit the spread of COVID-19, Health Canada is facilitating access to products that may not fully meet current regulatory requirements, as an interim measure


Product Recalls / Alerts

 

Below you will find a monthly summary of product recalls and alerts in Europe (Source “RAPEX”).

 

Europe

 

RAPEX (European Commission Rapid Alert System for dangerous non-food products – Alerts reported by EU national authorities).

 

The following 4 alerts regarding Personal Protective equipment have been reported, from week 12 to week 15 of 2020.

 

Type of Risk

Countries

Notes

Chemicals

3

Work gloves:

 

  • The leather in the product contains chromium VI
  • The product contains nitrobenzene

The gloves do not comply with the Personal Protective Equipment and REACH Regulations and national legislation

Injuries

1

Sunglasses:

 

The sunglasses have a category 4 protection filter but the labelling indicates category 3

Sunglasses do not comply with the Protective Equipment Regulation and the relevant European standard EN ISO 12312