Personal Protective Equipment | Summer Recap 2020

Eurofins newsflash Chemical

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:

Production of protective masks
Sale of protective masks in mass retail chains
French Customs publishes guide to facilitate the import of masks
Protective masks: the answers to your questions
JORF No. 0107 of May 2, 2020
Text No. 52 Notice of April 30, 2020 to operators concerning the export of personal protective equipment as described in Annex I to Commission Implementing Regulation (EU) 2020/568 April 23, 2020.
JORF n ° 0110 of May 5, 2020
Text n ° 62 Notice to importers of “general public” masks reserved for non-sanitary uses.
JORF n ° 0113 of May 8, 2020.
Text n ° 25 Order of May 7, 2020 relating to the application of the reduced rate of value added tax to protective masks and products intended for personal hygiene suitable for combating the spread of the covid-19 virus.

Safe PPE for Sport

On 5^th 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:

Presentation-Summary CE marking of EPI and PS products

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(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.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 6^th 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 11^th 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

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

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
Chemical, Fire, Health risk / other	4	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