Eurofins Personal Protective Equipment Bimonthly Bulletin (September-October 2021)
EUROPE
New European recommendations for PPE’s market surveillance
On 2 September 2021, European Commission published the following recommendation related to personal protective equipment (PPE):
COMMISSION RECOMMENDATION (EU) 2021/1433 of 1 September 2021 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat.
It adopts new points which the authorities must follow and comply with in market surveillance procedures of this type of goods.
Below is a summary table with the recommended points:
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Market surveillance procedures |
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Point |
Procedure |
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1 |
From 1 October 2021, Market surveillance authorities should no longer authorise PPE which are is not in accordance with Article 19 of Regulation (EU) 2016/425. |
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After 1 October 2021, PPE in accordance with points 7 or 8 of Commission Recommendation (EU) 2020/403 cannot be placed on the Union market |
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2 |
Medical devices, which are not in accordance with Article 52 of Regulation (EU) 2017/745, will only be authorised for the Union Market by following the procedure for derogations from the conformity assessment procedures laid down in Article 59 of Regulation (EU) 2017/745. |
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3 |
PPE or medical devices, which have been authorised in accordance with the mechanisms described in point 7 or 8 of Commission Recommendation (EU) 2020/403, shall only be made available until 31 May 2022. |
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By means of exception, any such PPE or medical device, which is part of existing stocks may be made available until such stocks are fully exhausted but, in any event, no later than 31 July 2022. |
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4 |
From 1 August 2022, PPE or medical devices have to be in according with Article 19 of Regulation (EU) 2016/425 or Article 52 of Regulation (EU) 2017/745 and bear a CE marking, in accordance with Article 17 of Regulation (EU) 2016/425 or Article 20 of Regulation (EU) 2017/745, unless, in the case of medical devices, specific derogations from the conformity assessment procedure have been authorised by Member States according to Article 59 of Regulation (EU) 2017/745. |
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5 |
A non-compliant PPE product or medical device has to be reported immediately to the Commission and the other Member States. |
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6 |
A non-compliant PPE product or medical device |
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For more information, consult the official publication here.
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.
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CEN |
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Reference |
Title |
Date of withdrawal (*) |
Supersedes |
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Eye and face protection for occupational use - Part 2: Additional requirements for protectors used during welding and related techniques (ISO 16321-2:2021) |
30-09-2024 |
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Protective clothing - General requirements - Amendment 1 (ISO 13688:2013/Amd 1:2021) |
31-03-2022 |
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Eye and face protection for sports use - Part 2: Requirements for eye protectors for squash and eye protectors for racquetball and squash 57 (ISO 18527-2:2021) |
31-03-2022 |
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SPAIN
Guidance for the manufacturing and selection of masks
The Ministry of Industry, Commerce and Tourism has issued updated UNE specifications for hygienic masks. The following is a list of recent publications (in Spanish only):
- Summary of new specifications UNE 0064-1, 0064-2, 0065 (updated versions of 2021) for hygienic masks
- Download UNE 0064-1. Non-reusable hygienic masks. Part 1: For use in adults
- Download UNE 0064-2. Non-reusable hygienic masks. Part 2: For use in children
- Download UNE 0065. Reusable hygienic masks for adults and children
- Download UNE-CWA 17553: 2020 Community facial covers
U.S.
New requirements for recycling claims
On 5 October 2021, Californian Governor Gavin Newsom signed Senate Bill 343 - Environmental advertising: recycling symbol: recyclability: products and packaging. The aim is to provide accurate and useful information about the environmental impact of plastic products.
This bill will prohibit a person from offering, selling, distributing, or importing into the state any product or packaging for which a deceptive or misleading claim is made about the recyclability of the product or packaging and will also provide the requirements for information and documentation for the use of the term “recyclable,” the use of a chasing arrows recycling symbol, or other representation that advises consumers to recycle a consumer good.
The table below summarises some recent ASTM standards updates:
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Reference |
Title |
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Standard Guide for Conformity Assessment of Personal Protective Clothing and Equipment |
Below you will find a monthly summary of product recalls and alerts in Europe (Source “RAPEX”) and in the U.S. (Source “CPSC).
Europe
RAPEX (European Commission Rapid Alert System for dangerous non-food products – Alerts reported by EU national authorities).
The following 8 alerts regarding Personal Protective equipment were reported between week 34 and week 41 of 2021.
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Type of Risk |
Number of alerts |
Notes |
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Health risk/ other |
7 |
Particle filter mask |
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1 |
Particle filter mask |
US
Between 21 August and 20 September 2021, the CPSC (Consumer Product Safety Commission) published the following recalls: 0 recall in PPE products.