France – New Face Mask Decree n° 2021-76 Published in Response to New COVID-19 Variants

Vol. 1227 | 23 Feb 2021

French authorities published a new decree in response to the challenges faced due to new variants of the COVID-19 virus that have been identified as being in Europe. Decree n° 2021-76 was published on 27th, Jan. 2021 and also updated in the Cross Ministries Note on 28th, Jan. 2021.

The Decree is to ensure that consumers are informed about masks that are suitable for protection against the COVID-19 pandemic. All protective masks (meeting or not meeting the characteristics defined by the law) distributed in retail outlets, or offered, should inform the consumer in a clear, visible, legible and easily accessible manner whether those masks meet or do not meet the prescriptions of health authorities.

The Decree states and requires the following:

• Face masks are mandatory in any public area
• At point of sale, compliant masks must be separated from non-compliant masks
  • Distributors must inform when masks comply or not with sanitary authorities' recommendations

The requirements for suitable masks are covered by the following categories:

1. Medical Masks complying to EN 14683 + AC: 2019
2. Imported surgical-shaped masks made available on the domestic market, excluding masks in textile fabric, the performance of which is recognized to be at least equal to that of the masks answering to previous UNS 1 level (see point 4)
3. FFP2 an FFP3 masks complying to EN 149 + A1: 2009
4. Masks reserved for non-sanitary uses meeting the following characteristics:
   • The masks should have the following performance levels:
     • "(I) The outward filtration efficiency of the 3 micron particles is greater than 90%;
     • “(Ii) Breathability allows for four-hour wear;
     • "(Iii) The air permeability is greater than 96 liters per square meter per second, for a depression of 100 pascal;
   • The shape allows a fit on the face with a covering of the nose and chin and does not include sagittal (or vertical) seam;
   • If reusable, the performance levels mentioned should be  maintained after at least five washes

Following the inter ministerial note of the 28th of Jan. 2021 concerning point 4, for a non-sanitary mask:

Importer, manufacturer who claims a filtration performance equal or greater than 90% should:

• Perform testing in a third-party laboratory validated by DGE (DGA method)
• Affix a new logo on the product or the packaging (see Annex V)
  
• Or indicate in a visible, legible and easily accessible manner the filtration performance of the mask on packaging
• Registered until the 31st of March 2021 the publication of the results on DGE website https://www.entreprises.gouv.fr/fr/covid-19/covid-19-informations-relatives-aux-masques-grand-public
• A notice should be added to the mask in the packaging

As previously outlined, masks that do not meet the specifications, can be placed on the market but should not use the official logo and use a non-sanitary mask claim (masque grand Public ou masque à usage non sanitaire)

The decree is available in French only and can be accessed via the link: https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000043070201

The Cross Ministries Note can be found via the link: https://www.entreprises.gouv.fr/files/files/enjeux/covid-19/masques_reservees_a_des_usages_non_sanitaires.pdf

For more information please contact:

Marie-Claire LEROI
labo.softlines@intertek.com
+33 (0)2 32 63 79 35