72 Notificaciones OMC de productos naturales procesados de uso medicinal, vigi-lancia y control y sanciones de la Normativa Técnica Sani-taria Ecuatoriana “sustitutiva para la obtención del registro sanitario y control de productos naturales procesados de uso medicinal, y de los establecimientos en donde se fabrican, almacenan, distribuyen y comercializan”. Objeto y razón de ser: La presente Normativa Técnica Sanitaria tiene por objeto establecer los parámetros de calidad, segu-ridad y eficacia, bajo los cuales se otorgará el Registro Sani-tario a los Productos Naturales Procesados de Uso Medicinal. De la misma forma establecer los criterios para la realización de la promoción, control y vigilancia de dichos productos. Además, establecer los parámetros para la operación, con-trol, vigilancia y sanción de los establecimientos donde se fabrican, almacenan, distribuyen y comercializan los Produc-tos Naturales Procesados de Uso Medicinal. El ámbito regulatorio de la Normativa Técnica Sanitaria es de aplicación obligatoria para las personas naturales o jurídicas, nacionales o extranjeras, responsables de la fabricación, im-portación, almacenamiento, distribución y comercialización de los Productos Naturales Procesados de Uso Medicinal en todo el territorio nacional. ESTADOS UNIDOS Notificación: G/TBT/N/USA/1106 Temporary Standard for Ultra-Filtered Milk Products (6 pa-ges, in English). Adopts temporary standards for Ultra-Filtered Milk Products that will allow for the production and sale of these products in California. The Department demonstrated due diligence in completing the regular rulemaking process and submitted the Certificate of Compliance to OAL in accordance with Go-vernment Code section 11346.1(e), prior to the expiration of the 180-day period required for emergency filings. However, on March 18, 2016, the Department withdrew the regular ru-lemaking file from the Office of Administrative Law (OAL) in order to publish a 15 day notice of a document added to the rulemaking file and amended regulatory text. Therefore, the 180-day time period for emergency filings has now expired. The Department is now seeking to readopt the emergency regulations, with amendments that are substantially equi-valent to the original emergency text, in accordance with section 36637 of the Food and Agricultural Code and Go-vernment Code section 11346.1, which pertain to emergen-cy filings. This readoption of the emergency filing would be effective for 90 days in accordance with Government Code section 11346.1(h). The Department must complete the regu-lar rulemaking process within that time period and resubmit the file to OAL. Objeto y razón de ser: Prevention of deceptive practices and consumer protection. Notificación: G/TBT/N/USA/1119 Hazardous Materials: Incorporation by Reference Edition Up-date for the American Society of Mechanical Engineers Boiler and Pressure Vessel Code and Transportation Systems for Li-quids and Slurries: Pressure Piping Code (6 pages, in English). This direct final rule incorporates by reference the most recent editions of the ASME Boiler and Pressure Vessel Code. The purpose of this update is to enable non-specification (nur-se tank) manufacturers and other DOT and UN specification packaging manufacturers to utilize current technology, ma-terials, and practices to help maintain a high level of safety. PHMSA is replacing the ASME referenced standard (1998 Edition) with the new, current ASME standard (2015 Edition) for boiler and pressure vessels. PHMSA is also replacing the ASME 1998 Edition referenced standard of ASME’s Transpor-tation Systems for Liquids and Slurries: Pressure Piping to the current 2012 Edition. Objeto y razón de ser: Protection of the environment. ISRAEL Notificación: G/TBT/N/ISR/924 SI 1295 – Dried or semi-dried fruits (10 pages, in Hebrew) Revision of the Mandatory Standards SI 1075, SI 1130, SI 1295 and SI 1312, to be replaced with SI 1295, dealing with dried or semi-dried fruits, such as raisins, plums, figs and other dried fruits in general but excludes dates. The major differences between the old version and this new revised draft standard are as follow: • Adds references to Israel’s Public Health Regulations (Food) (Food additives) and does not provide the detailed list in the standard (paragraph 2.2.2) • Adds a requirement that the maximum heavy metals con-tent will comply with the Israel’s MOH relevant document (paragraph 2.3.1) and that the pesticide residues will com-ply with MOH relevant regulations (paragraph 2.3.2) • Adds a new requirement to mark the water content in hy-drated fruits (paragraph 2.6) • Adds new marking requirements for water content and for the maximum free water activity allowed (paragraph 3.1) • Provides a list of defects allowed in raisins, dried figs and dried plums (paragraph 3.3) • Changes the microbiological requirements (paragraph 3.4) Both the old standards and this new revised standard will apply for a period of 1 year from publication in Israel Official Gazette. During this time products may be tested according to the old or the new revised standards. Objeto y razón de ser: Protection of human health or safety. Notificación: G/TBT/N/ISR/927 SI 431 – Mayonnaise (6 pages, in English; 8 pages, in Hebrew). Revision of the Mandatory Standard SI 431, dealing with ma-yonnaise. This draft standard revision adopts the European rules collection FIC Europe – Code of practice – Mayonnai-se – September 2006, and therefore is significantly different from the old standard. The major differences between the old version and this new revised draft standard are as follow: • Narrows the standard’s scope to include only mayonnaise and excludes any other type of water in oil emulsion spreads • Allows using other optional food ingredients • Adds to paragraph 3 dealing with food additives a refe-rence to Israel’s Public Health Regulations (Food) (Food Additives) • Adds a new paragraph 5 dealing with food contaminants • Adds a new paragraph 6 dealing with hygiene and changes the microbiological requirements
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