Regulatory Updates
Amendment to Enforcement Order of Industrial Safety and Health Law and related ordinances (1 page, in English)
Distribution date: 30 January 2017 | Final date for Comment: 28 February 2017
<p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-GB;mso-bidi-language:AR-SA;">The Enforcement Order of Industrial Safety and Health Law and related ordinances are to be partially amended to place obligations on the business operators relating to </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">Antimony trioxide (Sb<sub>2</sub>O<sub>3</sub>)</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-GB;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">.</span></span></span></span></p>
Products Covered: Antimony trioxide (Sb2O3) and preparations containing them, etc. (HS: 2825.80)
Regulation Type: Regular notification
AFDC 10 (4087) P3 Fertilizers Mono-Ammonium Phosphate and Di-Ammonium Phosphate (MAP & DAP) Specification (4 pages, in English) ;
Distribution date: 27 January 2017 | Final date for Comment: 28 March 2017
<p style="margin:6pt 0cm;"><span lang="EN-GB">AFDC 10 (4087) P3 Fertilizers Mono-Ammonium Phosphate and Di-Ammonium Phosphate (MAP & DAP) Specification</span><span> (4 pages, in English)<strong></strong></span></p>
Products Covered: Fertilizers Mono-Ammonium Phosphate and Di-Ammonium Phosphate (MAP & DAP) (ICS: 29.220.20)
Regulation Type: Regular notification
AFDC 10 (4468) P3 Fertilizer - Potassium chloride (muriate of potash) Specification (6 pages, in English) ;
Distribution date: 27 January 2017 | Final date for Comment: 28 March 2017
This Standard prescribes the requirements and methods of sampling and test for potassium chloride (muriate of potash) fertilizer. The standards also prescribe the packaging and labelling requirements.
Products Covered: Fertilizer - Potassium chloride (muriate of potash) (ICS: 29.220.20)
Regulation Type: Regular notification
AFDC 10 (4585) P 3 Fertilizers Determination of Nitrate Nitrogen (2 pages, In English) ;
Distribution date: 27 January 2017 | Final date for Comment: 28 March 2017
<span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-bidi-font-family:Arial;mso-bidi-language:AR-SA;mso-ansi-language:EN-GB;mso-fareast-language:EN-US;">This Standard prescribes a method for the determination of nitrate nitrogen in fertilizers.</span>
Products Covered: Fertilizers (ICS: 29.220.20)
Regulation Type: Regular notification
AFDC 10 (4470) P3 Fertilizer - Potassium sulphate (sulphate of potash) - Specification (6 pages, in English)
Distribution date: 27 January 2017 | Final date for Comment: 28 March 2017
This Standard prescribes the requirements and methods of sampling and test for potassium sulphate (sulphate of potash) fertilizer. The standards also prescribe the packaging and labelling requirements.
Products Covered: Fertilizer - Potassium sulphate (sulphate of potash) (ICS: 29.220.20)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 27 January 2017 | Final date for Comment: 28 March 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Chlorpropham.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02 and 02.06) - Dairy produce (HS Code: 04.01) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03 and 10.05) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01 and 12.12) - Animal or vegetable fats and oils (HS Code: 15.02)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 27 January 2017 | Final date for Comment: 28 March 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemicals: Pesticides: Dazomet, Metam and Methyl isothiocyanate. Dazomet, Metam and Metyl isothiocyanate are used as pesticide respectively. Dazomet and Metyl isothiocyanate can be readily metabolized to Metyl isothiocyanate in plants. Therefore, Japan is considering the MRL as a group of these substances.
Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01 and 10.03) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.04, 12.05, 12.06, 12.07 and 12.12)
Regulation Type: Regular notification
By means of this Addendum No. 1, the Republic of Ecuador advises that the "Substitute Technical and Sanitary Regulation on the sanitary registration and control of processed natural products for medicinal use and of establishments that manufacture, store, distribute or market such products", notified in document G/TBT/N/ECU/326 of 3 May 2016, was issued pursuant to Resolution No. 23 of 7 October 2016 of the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA), published in Official Journal No. 891 of 28 November 2016. Text available from: Ministerio de Industrias y Productividad (Ministry of Industry and Productivity) Subsecretaría de la Calidad (Under-Secretariat for Quality) Organismo Nacional encargado de la Notificación (National Notification Authority) Contact person: Marlon Martínez B. Yánez Pinzón N26-12, entre Av. Colón y La Niña Quito, Ecuador Tel.: (+593-2) 394-8760, Ext. 2358 / 2255 Email: PuntocontactoOTCECU@mipro.gob.ec / mmartinez@mipro.gob.ec
Distribution date: 23 January 2017
Products Covered: 3006700000 ;
Regulation Type: Addendum to Regular Notification
<p>TITLE: Current Good Manufacturing Practice Requirements for Combination Products; Guidance for Industry and Food and Drug Administration Staff; Availability</p><p>AGENCY: Food and Drug Administration, HHS</p><p>ACTION: Notice of availability</p><p>SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry and FDA staff entitled "Current Good Manufacturing Practice Requirements for Combination Products." The guidance describes and explains the document on current good manufacturing practice (CGMP) requirements for combination products, which published in the Federal Register of 22 January 2013, and includes general considerations for CGMP compliance as well as analysis of hypothetical scenarios.</p><p>DATES: Submit either electronic or written comments on this guidance at any time.</p><p></p>
Distribution date: 19 January 2017
Products Covered: Combination products (HS: 3004, 9018.11-90) (ICS: 71.100, 13.020)
Regulation Type: Addendum to Regular Notification
PROY-NOM-080-SCFI-2015, "Arroz del estado de morelos" (Draft Mexican Official Standard PROY-NOM-080-SCFI-2015, Rice from the State of Morelos) (21 pages, in Spanish)
Distribution date: 19 January 2017
The notified draft Mexican Official Standard establishes the technical requirements governing the appellation of origin "Arroz del Estado de Morelos" (rice from the State of Morelos), which is owned by the Mexican State under the Industrial Property Law. This draft Standard has been issued pursuant to the requirements of Article 2 of the General Declaration of Protection of the Appellation of Origin "Rice from the State of Morelos", published in the Mexican Official Journal on 16 February 2012, and the provisions of sub-paragraph XV of Article 40 of the Federal Law on Metrology and Standardization. The municipalities in the State of Morelos that are covered by the appellation of origin are listed in the Standard.
Products Covered: Rice (HS tariff subheading 1006.10)
Regulation Type: Regular notification
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