G/TBT/W/434  
19 January 2016  
(16-0378)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: Spanish  
 
  ECUADOR - COSMETICS 
STATEMENT BY MEXICO TO THE COMMITT EE ON TECHNICAL BARRIERS TO TRADE 
4-6 NOVEMBER 2015 
The following communication, dated 15 January 2016, is being circulated at the request of the 
delegation of Mexico. 
 
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  1.  Mexico wishes to submit once again the following trade concern with respect to Draft Technical 
Regulation of the Ecuadorian Standardizatio n Institute (RTE INEN) No. 093, "Cosmetics" 
(G/TBT/N/ECU/111 and its addendum), and Emerge ncy Technical Regulation of the Ecuadorian 
Standardization Institute (RTE INEN) No. 093, "Cosmetic products" (G/TBT/N/ECU/116 and its 
addenda), issued by Ecuador. 
2.  In addition to submitting concerns to this Committee, Mexico has expressed its concerns to 
Ecuador bilaterally and through formal comments, bu t no replies have yet been received. For this 
reason, this specific trade concern is being submitted on the basis of the following points: 
a. First of all, Mr Chairman, Mexico did not find in the original notification of the technical 
regulation any reference concerning unexpected events of an urgent nature that might have justified it first being issued on an emergency basis. 
b. RTE INEN No. 093 stipulates, in respect of cosmetics covered by the technical regulation, 
that the "marketing, retailing and/or import thereof are subject to submission to the National Health Authority of the mandatory sanitary notification (NSO), along with, 
inter alia , technical information (product information file, which must include the 
cosmetic product safety report); and the obta ining of the NSO identification code for 
cosmetic products issued by the National Health Authority". 
c. As regards the requirement to produce a "cosmetic product safety report", Mexico 
considers that Ecuador may be infringing Article 2.2 of the TBT Agreement, because, on the basis of available scientific and technical information, it does not believe that there is any need to request a safety assessment report for such products. 
d. The technical regulation also stipulates that cosmetics are to be manufactured in 
accordance with the good manufacturing practice requirements established in Ecuadorian Technical Standard NTE INEN-ISO 22716 in force. This could involve further violation of 
Article 2.2 of the TBT Agreement, because good manufacturing practice certification 
tends to be voluntary all over the world. We therefore need to know why Ecuador has decided to require compliance with good manufacturing practice guidelines such as the 
ISO 22716 standard. 
e. The regulation requires labelling and any instructions for use and disposal, as well as any 
other manufacturer's information, to be in Spanish. This requirement could be inconsistent with Article 2.2 of the TBT Agr eement, as individual product names and the 
International Nomenclature of Cosmetic Ingredients (INCI) cannot be translated into 
Spanish, since these are proper names. G/TBT/W/434 
- 2 - 
  f. The regulation also stipulates that evidence of compliance with the technical regulation, 
in the form of a "certificate of conformity  of products and systems" issued by an 
accredited product certification body designated in the country, must be produced prior to the marketing of domestic or imported products covered by the regulation. This 
measure may infringe Article 5.1.1 of the TBT Agreement as regards access to Ecuador 
for Mexican products, since, according to information from the Mexican cosmetics industry, there is no cosmetics certifying body in Ecuador that can issue the "certificate 
of conformity of products and systems". 
3.  Mexico formally submitted comments to Ecuador on 29 January 2014, along with the following 
requests: 
a. To give consideration and respond to the comments submitted by Mexico with respect to 
compliance with the principle of proportionality set forth in the TBT Agreement. 
b. Mexico would like to know what analyses, or  research, have been conducted by Ecuador 
on available alternatives in support of th e decision to enforce the ISO 22716 guidelines. 
c. Mexico requests information as regards compliance by the bodies accredited to issue the 
"certificate of conformity of products and sy stems" with the provisions of Article 5.2 of 
the TBT Agreement. 
d. To justify the urgent problems which arose or threatened to arise for Ecuador that led it 
to adopt this "emergency" technical regulation in the first place, and in the light of the risk posed by not immediately applying RTE INEN No. 093. 
4.  Lastly, in the bilateral dialogue that was held with Ecuador, we were told that a more recent 
version of this technical regulation would be published around the middle of this year. We cannot, 
however identify any notification of this measure. Could Ecuador give us any information in that regard? 
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