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Eurofins >> Consumer Product Testing >> Media Centre >> News >> Personal Protective Equipment | Summer Recap 2020

Personal Protective Equipment | Summer Recap 2020

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Regulatory news


 

France

 

Measures related to the fight against the spread of COVID-19

 

Recently, the French authorities have published several articles relating to the production, sale, pricing, importation and usage of masks during the COVID-19 pandemic. Publications include:

 

 

Safe PPE for Sport

 

On 5th May 2020, The Direction Générel de la concurrence, de la consummation et de la repression des frauds (DGCCRF) published an article with guidance on appropriate PPE for sport.

 

To see the official publication: Personal protective equipment (PPE): choose a safe product!, please click here.

 

Spain

 

Guidelines for masks and protective clothing manufacturing

 

The Ministry of Industry, Commerce and Tourism has published new documents related to masks and protective clothing. See below a list of recent publications:

 

Overview:

  • Clarification of the different types of PPE and Health Products
  • What mask do I need depending on my situation
  • List of all standards applicable to PPE and Medical Devices

 

PPE-type masks:

  • Regular manufacturing process for PPE masks
  • How to legalize EPI type masks

 

Marketplace Spain Chamber:

 

Europe

 

Standards updates

 

Please see the below table summarising the most recent standard 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 (*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

 

CENELEC / CEN

Reference

Title

Date of Withdrawal (*)

Supersedes

EN 407:2020

Protective gloves and other hand protective equipments against thermal risks (heat and/or fire).

2021-04-30

EN 407:2004

EN ISO 20320:2020

Protective clothing for use in Snowboarding - Wrist Protectors - Requirements and test methods (ISO 20320:2020).

2020-10-31

 

EN ISO 15384:2020

Protective clothing for firefighters - Laboratory test methods and performance requirements for wildland firefighting clothing (ISO 15384:2018).

2020-10-31

EN 15614:2007 

EN 469:2020

Protective clothing for firefighters - Performance requirements for protective clothing for firefighting activities

2021-01-31

EN 469:2005/AC:2006
EN 469:2005/A1:2006
EN 469:2005

 

Publications in relation to PPE published by European Commission

 

Below you will find a table summarising some recent publications in the Official Journal of the European Union relating to PPE Regulation (EU) 2016/425.

 

Drafts supplementing Regulation (EU) No 305/2011

Dat72020e

Reference

Title

19-05-2020

C/2020/3257

Commission Implementing Decision (EU) 2020/668 of 18 May 2020 on the harmonised standards for personal protective equipment drafted in support of Regulation (EU) 2016/425 of the European Parliament and of the Council

 

​China

 

China releases GB standards relevant to medical health and PPE

 

Recently, the State Administration for Market Regulation (SAMR) and the Standardization Administration of the People’s Republic of China (SAC) published the Announcement No.7 of 2020 and Announcement No. 10 of 2020 (in Chinese) to approve and release a batch of GB standards, related to medical health and PPE.

 

The below table outlines some of these standards (non-exhaustive list):

 

Standard No.

Standard Name

Superseded Standard

Implementation date

GB 27948-2020

General requirements for air disinfectant

GB 27948-2011

Nov. 01,2020

GB 27949-2020

General requirements for medical instrument disinfectant

GB/T 27949-2011

Nov. 01,2020

GB 27950-2020

General requirements for hand disinfectant

GB 27950-2011

Nov. 01,2020

GB 27952-2020

General requirements for ordinary objects surface disinfectant

GB 27952-2011

Nov. 01,2020

GB 27953-2020

General requirements for disinfectant to prevent infection

GB 27953-2011

Nov. 01,2020

GB 27954-2020

General requirements for disinfectant for mucous membrane

GB 27954-2011

Nov. 01,2020

GB 38850-2020

List of materials and substances restricted from use in disinfectant

Initial

Nov. 01,2020

GB/T 38880-2020

Technical specifications for children’s masks

Initial

May 06, 2020

 

New national standard for children’s masks

 

On 6th May 2020, the new national standard GB/T 38880-2020 (technical specification) for children’s masks came into effect. This recommendation applies to children’s masks (for those between 6 and 14 years old) that can filter particulate matter in the air, and can block microorganisms, pollen and spray, etc.

 

The mask, is categorised based on performance as aprotective mask (F) or hygiene mask(W) and can come in three sizes (small, medium and large).

 

The main requirements are as follows:

  • Basic requirements:raw materials, personalised/tailored fit, nose clips, etc..
  • Migratable optical brightener (FZ/T 01137)
  • Residue of ethylene oxide (GB/T 14233.1-2008)
  • Breaking strength of mask strap, and the connection between mask strap and body (GB/T 32610-2016)
  • Inhalation resistance (GB/T 32610-2016)
  • Particle protective performance (GB/T 32610-2016).

 

Extending the transition period of standard GB 2626-2019 for respirators

 

On 11th June 2020, the Standardization Administration of China (SAC) published notice nº 29 in relation to extending the transition period of the national standard GB 2626-2019 (Respiratory Protection with self-priming and Anti-Particulate filter Respirator), because of the COVID-19 pandemic, by one year to July 1, 2021.

 

International

 

Regulatory proposals notified to the WTO

 

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

 

Notification number / Link

Country

Title

G/TBT/N/PER/120

Peru

Technical specifications for the manufacture of cloth face-masks for use by the community

The purpose of the document is to establish technical specifications in order to outline the design and manufacturing requirements for cloth face-masks for use by the community

G/TBT/N/USA/1602

US

Approval Tests and Standards for Air-Purifying Particulate Respirators

With this rulemaking, parallel performance standards are added to existing regulatory requirements for PAPRs to allow for the approval of respirators in a new class, PAPR100, that may be better suited to the needs of workers in the healthcare and public safety sectors currently experiencing a shortage of air-purifying particulate respirators due to Coronavirus Disease 2019 (COVID-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) . This rulemaking also consolidates the technical standards for all types of air-purifying particulate respirators into one subpart, and standards pertaining to obsolete respirators designed for dust, fume, mist, pesticide and paint spray are removed from the regulation entirely. This rulemaking will have no substantive impact on the continued certification testing and approval by the NIOSH National Personal Protective Technology Laboratory of existing PAPR class HE (high-efficiency series) respirators or non-powered air-purifying particulate respirators, including N95 filtering facepiece respirators, currently in significant demand by healthcare workers and emergency responders. NIOSH expects that the addition of PAPR100 devices to the marketplace will help to relieve the current high demand for possibly hundreds of thousands of additional particulate filtering facepiece respirators needed specifically in healthcare and emergency medical response settings

G/TBT/N/MAR/31

Morocco

Order of the Minister of Industry, Trade and the Green and Digital Economy on reusable protective fabric masks for non-medical use

 

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 16 alerts regarding Personal Protective Equipment have been reported, from week 16 to week 20 of 2020.

 

Type of Risk

Number of alerts

Notes

Chemicals

1

Work gloves:

 

  • The leather in the product contains chromium VI
  • The gloves do not comply with Personal Protective Equipment and REACH regulations and national legislation

Health risk / other

15

Particle filter mask:

 

  • The particle/filter retention of the material is insufficient
  • The product bears a CE marking but is not certified as protective equipment by the relevant body

Does not comply with EN 149

 

The following 46 alerts regarding Personal Protective Equipment have been reported, from week 21 to week 26 of 2020.

 

Type of Risk

Number of alerts

Notes

Chemical, Fire, Health risk / other

4

Hand disinfectant:

- The product contains an insufficient amount of ethanol and propan-2-ol

- The presence of methanol is not accompanied by required corresponding hazard pictograms and warnings

- The product contains an insufficient amount of ethanol

- Users have no information on the toxicity and flammability of the product, which, in the presence of an ignition source, could lead to a fire. The product does not comply with the Biocidal Products and Classification, Labelling and Packaging (CLP) Regulations

Biocidal particle filter mask:

- The product advertises a biocidal and protective potential against viral particles and other microorganisms but neither its filtering capacity has been certified nor its use as a biocidal product has been authorised, by the relevant European bodies and legislations

Health risk / other

40

Particle filter mask: The particle/filter retention of the material is insufficient

Injuries

2

Motorcycle helmet: The impact absorption capacity of the helmet is insufficient. It does not comply with the Regulation ECE 22-05