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Media Centre >> Knowledge e-news >> Eurofins PPE Bimonthly Bulletin (July-August 2021)

Eurofins Personal Protective Equipment Bimonthly Bulletin (July-August 2021)

EUROPE

Harmonised standards for hearing protectors

On 21 July 2021, The European Commission published the following decision related to Personal Protective equipment:

Commission Implementing Decision (EU) 2021/1201 of 16 July 2021 amending Implementing Decision (EU) 2020/668 as regards harmonised standards on hearing protectors.

The main point to note is the addition of harmonised standards for hearing protectors in annex I, II of Regulation (EU) 2016/425 and listed in Annex III of this decision.

For more details, consult the official publication on the European Commission’s website here.

Perfluorinated carboxylic acids restricted under REACH Annex XVII Entry 68

On 5 August 2021, the European Union (EU) published Regulation (EU) No 2021/1297, which updated Annex XVII of REACH. Certain perfluorocarboxylic acids (C9-C14 PFCAs), their salts and C9-C14 PFCA-related substances will be banned from being placed on the market or used in most applications from 25 February 2023 onwards.

Read more about the main updates on the restricted substances here.

Standards updates

The below table summarises the most recent standard updates and upcoming dates of withdrawal (non-exhaustive):

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Date of withdrawal: the latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

CEN
Reference	Title	*Date of withdrawal ()**	Supersedes
EN ISO 19818-1:2021	Eyes and face protection - Protection against laser radiation - Part 1: Requirements and test methods (ISO 19818-1:2021)	2024-06-30

FRANCE

Surgical masks claiming a biocidal activity

The ANSM (Agence nationale de sécutiré du medicament et ds produits de santé) and the DGCCRF (Direction générale de la concurrence, de la consommation et de la répression des frauds) have published several notices related to surgical masks , due to the emergence of masks claiming to have biocidal activity, as a reminder of the main considerations for placing these devices on the market:

Any claim must be duly proven in the environment of the intended use of the mask.
The benefit associated with the use of a substance or a biocidal material must be demonstrated by comparison with untreated masks.
The risks associated with the presence of a biocidal substance or material should be assessed.

For more information, consult the ANSM’s website here (in French) and here (in English), and DGCCRF’s website here (in French).

UK Government extends UKCA marking deadline

On 24 August 2021, the UK government announced that businesses have been given an additional year to apply the UKCA marking to their products, businesses now have until 1 January 2023 to apply the UKCA marking to their products.

After receiving feedback from the industry, the UK government has extended the date to give businesses more time to implement the changes necessary to comply with the UK marking requirements.

For more information, consult the UK government website here.

Consultation to change the PPER legislation

During summer 2021, the UK Health and Safety Executive opened a public consultation about Amendments to the Personal Protective Equipment at Work Regulations 1992 (PPER) with the aim of understanding and extending the scope under the PPER.

Employers will have a duty to provide the same health and safety protections in respect of PPE as they do currently for employees.

In order to use respiratory protective equipment (RPE) safely and effectively, it must be able to fit the wearer's face to provide adequate protection for individual wearers. Fit testing will ensure that the equipment selected is suitable for the wearer and is a control measure to comply with health and safety laws. HSE has made the following information available on its website:

Respiratory protective equipment at work.

Guidance on respiratory protective equipment (RPE) fit testing.

Fit testing basics.

For more information about the PPER consultation, visit the HSE's website here.

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 36 alerts regarding Personal Protective equipment were reported between week 25 and week 33 of 2021.

Type of Risk	Number of alerts	Notes
Health risk/ other	32	Particle filter mask The particle/filter retention of the material is insufficient and the total filtration capacity of the mask is insufficient. It does not comply with the Personal Protective Equipment Regulation and with EN 149.
	1	Particle filter mask The product bears a CE marking but its filtering capacity has not been tested by a relevant competent European conformity assessment body. It does not comply with the Personal Protective Equipment Regulation and with EN 149.
	1	Gloves The rubber of the glove is too permeable. Consequently, contaminated fluids could pass through the gloves, increasing the risk of infection. It does not comply with the Personal Protective Equipment (PPE) Regulation.
Injuries	2	Helmet The impact absorption capacity is insufficient. It does not comply with the Regulation ECE 22-05.

Between 21 June and 20 August 2021, the CPSC (Consumer Product Safety Commission) published the following recalls: 0 recall in PPE products.