G/TBT/N/MEX/494  
7 April 2021 
(21-2869) 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 : MEXICO  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2.  
Agency responsible : Secretaría de Economía  (Ministry of the Economy),  Comisión 
Federal para la Protección contra Riesgos Sanitarios (Federal Commission for Protection 
against Health Risks)  
 
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 above:  
Calle Pachuca número 189, pisos 7 y 12, Colonia Condesa, Demarcación Territorial 
Cuauhtémoc, Código Postal 06140, Ciudad de México  
Tel.: (+52) 55 5729 9100, Ext. 13217/13264  
Email:  
César Osvaldo Orozco Arce: cesar.orozco@economia.gob.mx  
Tania Daniela Fosado Soriano: tania.fos ado@economia.gob.mx  
José César Ramos:  jose.ramosr@economia.gob.mx  
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) : Topical 
ethyl or isopropyl alcohol -based antiseptics  
5. Title, number of pages and language(s) of the notified document : NORMA Oficial 
Mexicana de Emergencia NOM -EM-022-SE/SSA1 -2021, Especificaciones generales para 
antisépticos tópicos a base de alcohol etílico o isopropílico -Información comercial y 
sanitaria  (Emergency Mexican Official Standard NOM -EM-022-SE/SSA1 -2021, General 
specificat ions for topical ethyl or isopropyl alcohol -based antiseptics - Commercial and 
health information) (21 pages, in Spanish)  
6. Description of content : The notified Emergency Mexican Official Standard establishes 
the requirements and health and commercial sp ecifications to be met by the preparation, 
mixing, production and distribution processes for topical antiseptics, in gel or solution 
form, based on ethyl or isopropyl alcohol or mixtures thereof, and set s out the test 
methods for the verification of these specifications.  
The notified Emergency Mexican Official Standard is binding on all establishments 
engaged in the manufacture, importation and distribution of topical antiseptics, in gel or 
solution form, based on ethyl or isopropyl alcohol or mixtures ther eof, which are to be 
marketed in Mexico.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Alcohol -based hand sanitizers must meet certain technical specifications to 
ensure that they are effective against the SARS -CoV2 (COVID -19) virus, without posing G/TBT/N/MEX/494  
- 2 - 
  a risk to the health of users ; Consumer information, labelling ; Protection of human health 
or safety  
8. Relevant documents:  
• NOM-002-SCFI-2011 Productos preenvasados -Contenido neto -Tolerancias y 
métodos de verificación , published in the Official Journal on 1 0 August 2 012. 
• NOM-008-SCFI-2002 Sistema General de Unidades de Medida, published in the 
Official Journal on 2 7 November 2 002. 
• NOM-030-SCFI-2006 Información comercial -Declaración de cantidad en la 
etiqueta -Especifica ciones , published in the Official Journal on 6 November 2 006. 
• NOM-073-SSA1 -2015 Estabilidad de fármacos y medicamentos, así como de 
remedios herbolarios , published in the Official Journal on 7 June 2 016. 
• NOM-076-SSA1 -2002 Salud ambiental -Que establece los requisitos sanitarios 
del proceso de etanol (alcohol etílico) , published in the Official Journal on 9 
February 2 004. 
• NOM-137-SSA1 -2008 Etiquetado de dispositivos médicos , published in the 
Official Journal on 1 2 December 2 008. 
• NOM-138-SSA1 -2016 Que establece las especificaciones sanitarias del alcohol 
etílico desnaturalizado, utilizado como material de curación, así como para el 
alcohol etílico de 96° G.L. sin desnaturalizar, utilizado como materia prima para 
la elaboración y/o envasado de alco hol etílico desnaturalizado como material de 
curación , published in the Official Journal on 2 5 April 2 017. 
• NOM-240-SSA1 -2012 Instalación y operación de la tecnovigilancia , published in 
the Official Journal on 3 0 October 2 012. 
• NOM-241-SSA1 -2012 Buenas práct icas de fabricación para establecimientos 
dedicados a la fabricación de dispositivos médicos , published in the Official 
Journal on 1 1 October 2 012. 
9. Proposed date of adoption 6 April 2 021 
Proposed date of entry into force : 6 April 2 021 
10. Final date for comments : Not applicable  
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Secretaría de Economía  
Dirección General de Normas (Directorate -General of Standards)  
Calle Pachuca número 189, pisos 7 y 12, Colonia Condesa, Demarcación Territorial 
Cuauhtémoc, Código Postal 06140, Ciudad de México  
Tel.: (+52) 55 5729 9100, Ext. 13217/13264  
Email:  
César Osvaldo Orozco Arce: cesar.orozco@economia.gob.mx  
Tania Daniela Fosado Soriano: tania.fosado@economia.gob.mx  
José César Ramos:  jose.ramosr@economia.gob.mx  
Website : http://www.economia.gob.mx/comunidad -negocios/normalizacion/catalogo -
mexicano -de-normas  
https://www. dof.gob.mx/nota_detalle.php?codigo=5615147&fecha=05/04/2021