Problems relating to Trade and Investment on Mexico

19. Industrial standards, approval of safety standards
Issue	Issue details	Requests	Reference

(1) Unspecified Measurement Standard on the Label Marking Rules

- Most of the products out of the 186 items selected are meaningless as goods subject to the energy saving control. Moreover, due to the absence of public disclosure concerning the test method, and the usage mode per day, the numerical valuation basis varies by manufacturer concerning the energy consumption marked on the label. It will drive consumers into confusion, as they are unable to compare numerical values when purchasing products. Another energy efficiency regulation NOM-032 for consumer technology products with standby power feature is due for enforcement. Regardless of the duplication, both regulations apply.
- GOM has introduced, since September 2011, Regulation for Power Consumption Marking (RPCM) on as many as 186-items of product categories. However, to this date, GOM has not identified the measurement method for power consumption, so that the fussy stituation continues without uniformity in the marked numerical values and their reliabilities.
It has created confusions upon customers' product purchase, with a possibility of disruption in fair competition.
- This regulation has been enforced since 19 September 2014 with fulfillment of the marking requirement by 17 December 2014, while measurement of standby power is necessary by domestic test laboratories in Mexico. There has been no written statement from GOM explaining the relationship of this regulation with the other existing energy marking regulations.

- It is requested that GOM:
-- reduces the products subject to this regulation.
-- maintains compatibility of the text method and power consumption calculation method to those of EU/the U.S.
-- exempts application of this regulation on the products to which NOM-032 applies.
- It is requested that GOM narrows the products categories subject to the RPCM marking requirements.
- It is requested that GOM makes compatible with the existing International Specifications in its legislation concerning the Test Method, and Computation of Electricity Consumption. Procedures are complex for the Temporary Import Incentive Measures.
- It is requested that GOM:
-- authorises measurements and accreditation by external test laboratories outside Mexico, and
-- clarifies its relation to the other existing energy marking regulations.

- Article 23 of "Ley para el Aprovechamiento Sustentable de la Energia" (Law on Exploitation of Sustainable Energy)
- Articles Nos. 25-28 of Regulations on Use of Sustainable Energy
- List of Machinery and Equipment on which Energy Consumption Information Marking is required by Ministry of Commerce on Manufacturers, Importers, Distributors
- Mexican Official Compulsory Standard NOM-032-ENER-2013: "Maximum electrical power limits for equipment and appliances requiring standby power. Test methods and labelling"

(2) Vexatiously Complex Labeling Requirement

- Products sold in Mexico must be labeled with product information (Country of Origin, Importer Information, etc.). Products not packed in individual box must be labeled one by one by hand with added cost and time, by hiring part-time workers.

- NOM (Norma Oficial Mexicana)

(3) Control on Higher Efficiency of Low Voltage Motors (LVMs)

- LVMs, including those assembled into machinery, are subject to higher efficiency control in each country, including the U.S., Canada, Brazil and Mexico. The accreditation standards, which vary by country, form de facto trade barriers due to the complexity of the application process that requires not only the efficiency requirements but the local accreditation as well.

- It is requested that GOU dispenses with the accreditation requirement on LVMs, assembled into machinery that satisfies the regulated efficiency level to remove the trade barriers.

(4) Nebulous Legal Examination Period (LEP) for Registration (Registro Sanitario) under the Pharmaceutical Affairs Law

- The problems applicants face at The Federal Commission for the Protection against Sanitary Risk (COFEPRIS) in regard to the legal examination period include the following:
(1) Timely response is not received within LEP ('Legal Examination Period' for Registro Sanitario varies by risk classification, the longest being 60-business days for Class III. Nevertheless, it takes currently 1-2 years for approval, in effect.) It deprives entering enterprises of the ability to establish sales projection, materially inconveniencing their business activity in the Mexican domestic market.
(2) Absence of clear and firm reply from COFERPRIS to the issues pointed out and queried by the applicants.
(3) Absence of clear and firm reply from COFERPRIS when the response can be made.
(4) Disclosure of information is extremely limited in many respects.

- It is requested that GOM:
(1) strictly adheres to the legal examination period,
(2) gives clear-cut response to the enquires from applying enterprises,
(3) gives information back to the applicant when the examination is completed, should GOM fail to complete examination within the LEP.
(4) positively discloses information.

- Articles 204,376, General Health Law (Ley General De Salud)
- Article 82, Regulation of Health Supplies (Reglamento De Insumos Para La Salud).

(5) Complex Pharmaceutical Affairs Registration Procedures	- Product registration procedures (Registro Sanitario ) are complicated in importing and exporting medical equipment.	- It is requested that GOM repeals the renewal requirement on product registration procedures. Namely, no renewal is necessary once the Product is registered. Please refer to Japan's system.
	(Action) - In January 2012, GOU promulgated Ministerial Decree on Accreditation, providing confidence in the Equivalence of Certification on the Sanitary Registration Scheme for the Pharmaceutical Equipment under Ministry of Health, Labour and Welfare. - In April 2012, COFEPRIS introduced Prior Technical Examination Scheme by a Third Party Test Laboratory, without COFEPRIS technical examination.

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