G/TBT/N/MEX/307  
29 April 2016  
(16-2411)  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 governme nt involved (Articles 3.2 and 7.2):  
2. Agency responsible: Secretaría de Salud  (Ministry of Health) 
Name and address (including telephon e 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:  
Comité Consultivo Nacional de Normalización de Regulación y Fomento Sanitario  (National 
Advisory Committee on Standardization for the Regulation and Promotion of Health) 
Oklahoma número 14, planta baja, Colonia Nápoles 03810, México, D.F. 
Tel.: 5080 5200, Ext. 1333 
Email: rfs@cofepris.gob.mx   
3. Notified under Article 2.9.2 [X], 2. 10.1 [ ], 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): Denatured 
ethyl alcohol (tariff heading: 22072001) 
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
norma oficial mexicana PROY-NOM-138-SSA1-2015, que establece las especificaciones 
sanitarias del alcohol etílico desnaturalizado, utilizado como material de curación, así como 
para el alcohol etílico de 96ºg.l. sin desnaturalizar, utilizado como materia prima para la elaboración y/o envasado de alcohol etílico desnaturalizado como material de curación  
(Draft Mexican Official Standard PROY-NOM -138-SSA1-2015 establishing the sanitary 
specifications for denatured ethyl alcohol, used as a wound dressing material, for 
undenatured 96° G.L. ethyl alcohol, used as a raw material in the production of denatured ethyl alcohol as a wound dressing material, and for packaging establishments) (11 pages, 
in Spanish) 
6. Description of content: Ethyl alcohol, or ethanol, is one of the most widely used wound 
dressing materials, due to its antiseptic properties. However, given that ethyl alcohol can 
be easily obtained by the general population an d is an addictive substance, it may be used 
inappropriately (ingested), and its consumption may lead to public health problems. 
Denaturing substances are therefore added to ethyl alcohol, such as denatonium benzoate, 
sucrose octaacetate and acetone, which give it an unpleasant taste. Nevertheless, it is necessary to issue provisions on the control and processing of this wound dressing 
material, in order to prevent it from being used for purposes other than those for which it 
is marketed, namely, to dress wounds. G/TBT/N/MEX/307 
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable: The notified draft Standard establishes the sanitary specifications for 
denatured alcohol, used as a wound dressing material, for denatured 96° G.L. ethyl alcohol 
used as raw material in the production of denatured ethyl alcohol as a wound dressing material, and for packaging establishments. 
8. Relevant documents:  
 Norma Oficial Mexicana NOM-241-SSA1-2012, Buenas prácticas de fabricación para 
establecimientos dedicados a la fabricación de dispositivos médicos  (Mexican Official 
Standard NOM-241-SSA1-2012: Good manufacturing practices for establishments engaged in the manufacture of medical devices) 
 Norma Oficial Mexicana NOM-008-SCFI-2002, Sistema General de Unidades de 
Medida (Mexican Official Standard NOM-008-SC FI-2002: General system of units of 
measurement) 
 Norma Oficial Mexicana NOM-002-SCFI-2011, Productos preenvasados - Contenido 
neto - Tolerancias y métodos de verificación  (Mexican Official Standard NOM-002-
SCFI-2011: Pre-packaged products - Net content - Tolerances and verification methods) 
 Norma Oficial Mexicana NOM-030-SCFI-2006, Información comercial - Declaración 
de cantidad en la etiqueta.- Especificaciones (Mexican Official Standard NOM-030-
SCFI-2006: Trade information - Quantity de clarations on labels - Specifications) 
 Norma Oficial Mexicana NOM-137- SSA1-2008, Etiquetado de dispositivos médicos 
(Mexican Official Standard NOM-137- SSA1-2008: Labelling of medical devices) 
 Norma Oficial Mexicana NOM-005-STPS-1998, Relativa a las condiciones de 
seguridad e higiene en los centros de trabajo para el manejo, transporte y 
almacenamiento de sustancias químicas peligrosas  (Mexican Official Standard NOM-
005-STPS-1998 on occupational health an d safety requirements governing the 
handling, transport and storage of hazardous chemical substances) 
 Norma Oficial Mexicana NOM-002-STPS-2010, Condiciones de seguridad - 
Prevención y protección contra incendios en los centros de trabajo (Mexican Official 
Standard NOM-002-STPS-2010: Safety requir ements - Prevention of and protection 
against fire in the workplace) 
 Norma Oficial Mexicana NOM-018-STPS-2015, Sistema armonizado para la 
identificación y comunicación de peligros y riesgos por sustancias químicas peligrosas en los centros de trabajo (Mexican Official Standard NOM-018-STPS-
2015: Harmonized system for the identifica tion and communication of dangers and 
risks associated with hazardous chemical substances in the workplace) 
9. Proposed date of adoption: The notified draft Mexican Official Standard will be adopted 
upon its publication in the Official Journal as a final standard. 
Proposed date of entry into force: This Standard will enter into force, on a mandatory 
basis, 60 calendar days after its publication in the Official Journal.  
10. Final date for comments: 60 days after its notification to the WTO. 
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresse s, if available, of other body: 
Secretaría de Economía 
Subsecretaría de Competitividad y Normatividad Dirección General de Normas 
Tel.: (+52) 55 52 29 61 00, Ext. 43244 
Fax: (+52) 55 5520 9715 Website: http://www.economia-noms.gob.mx/?P=144  
Email: normasomc@economia.gob.mx  and/or sofia.pacheco@economia.gob.mx  
Text available online at: 
http://www.dof.gob.mx/nota_detalle.p hp?codigo=5434785&fecha=27/04/2016  
https://members.wto.org/crnattachments/2016/TBT/MEX/16_1719_00_s.pdf