G/TBT/N/ESP/44  
5 February  2021 
(21-0943) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : SPAIN 
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible : Ministerio de Consumo  (Ministry of Consumer Affairs)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from ab ove: 
Dirección General de Consumo (Directorate -General of Consumer Affairs)  
Tel.: (+34) 918 224 505  
Address : Príncipe de Vergara, 54 28006 Madrid  
Email: dgconsumo@mscbs.es  
3. Notified under Article 2.9.2 [ ], 2.10.1 [X], 5.6.2 [ ], 5.7.1 [ ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : Hygiene 
masks (or community face co verings), the intended use of which is to minimize the 
projection of the user's respiratory droplets containing saliva, sputum or respiratory 
secretions when talking, coughing or sneezing, and to limit penetration into the user's 
nose and mouth area of res piratory droplets of external origin, provided that such masks 
are not considered as medical products or personal protective equipment (PPE).  
5. Title, number of pages and language(s) of the notified document : Proyecto de 
Orden Ministerial por la que se establecen los requisitos de información y comercialización 
de mascarillas higiénicas  (Draft Ministerial Order establishing information and marketing 
requirements for hygiene masks) (17 pages, in Spanish)  
6. Description of content:  
• Definition of the conce pts of hygiene mask (or community face covering), 
accessory, filter and responsible economic operator;  
• establishment of the information and marketing requirements for hygiene masks 
or community face coverings and their accessories;  
• establishment of of capa city and equipment requirements for laboratories 
certifying the quality of these products.  G/TBT/N/ESP/44  
- 2 - 
  7. Objective and rationale, including the nature of urgent problems where 
applicable : The main purpose of the notified Order is to expand on the establishment of 
a specific regulatory framework for hygiene masks and community face coverings and 
their accessories, in order to offer greater levels of safety and trust to the public, market 
surveillance authorities and enterprises in the sector . The ex perience gained since the 
entry into force of Order SND/345/2020 of 1 9 April  has demonstrated the need to expand 
the scope of this Order and to identify specific aspects of this product category . Another 
reason for drafting this Order was the publication o f the CEN Workshop Agreement CWA 
17553 :2020 on community face coverings, which covers the requirements of the various 
standards and/or technical specifications drawn up by the various member States of the 
European Union, and which provides new information regarding Spanish UNE technical 
specifications ; Protection of human health or safety ; Consumer protection.  
8. Relevant documents:  
9. Proposed date of adoption 15 February 2 021 
Proposed date of entry into force : 16 February 2 021 
10. Final date for comments : Immediate publication on grounds of emergency (Covid -19) 
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Website : 
Proyecto_requisitos_de_informacion_y_comercializacion_de_mascarillas_higienicas.pdf 
(Draft information and marketing requirements for hygiene masks) 
(www.mscbs.gob.es ) 
 
The draft text that was published has subsequently been amended.  
The final draft is the one provided under point 8.  
 
Ministerio de Consumo  
Dirección General de Consumo  
Príncipe de Vergara, 54  
28006 Madrid  
Spain  
Tel.: 918 224 505  
dgconsumo@mscbs.es  
 
https://members.wto.org/crnattachments/2021/TBT/ESP/21_0863_00_s.pdf