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Mexico - Official Standard PROY-NOM-138-SSA1-2015 establishing the sanitary specifications for denatured ethyl alcohol, used as a wound dressing material

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Mexico - Official Standard PROY-NOM-138-SSA1-2015 establishing the sanitary specifications for denatured ethyl alcohol, used as a wound dressing material

Ministry of Health has issued notification on 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.

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 and 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.

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.

Final date for comments:  60 days after its notification to the WTO.

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures, so that these can be taken up suitably.

 

 


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