Public Notice under the Commodity Inspection Act (14 pages, in English; 25 pages, in Chinese).
Distribution date: 06 October 2016 | Final date for Comment: 05 December 2016
<p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="font-size:9pt;"><span>In order to encourage industries to reduce the use of restricted chemical substances in electrical and electronic equipments and to control the restricted chemical substances at each stage of the supply chain and life cycle of electrical and electronic equipments, also to promote the awareness of consumers on effective utilization of resources and reduction of environmental burden, the BSMI proposes that manufacturers or importers shall follow the requirements stipulated in Section 5 "Marking of presence" of CNS 15663(2013.7) and clearly mark "the presence conditions of the restricted substance" (i.e. Marking of </span></span></span><span lang="EN-US">p</span><span lang="EN-US">resence) on the body, packages, stickers, or the instruction books <span style="letter-spacing:-0.1pt;">of</span> 92 items of electrical and electronic products (please refer to the attachment for a detailed list). </span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="font-size:9pt;"><span>The conformity assessment procedures remain the same, i.e. Registration of Product Certification (RPC), Type-approved Batch Inspection (TABI) or Declaration of Conformity (DoC) .</span></span></span></p>
Products Covered: 92 items of electrical and electronic products (HS: Chapters 84 & 85 & 90)
Regulation Type: Regular notification
; ; ;By means of this Addendum No. 3, the Republic of Ecuador advises that Amendment No. 1 to the first revision (1R) of Technical Regulation of the Ecuadorian Standardization Institute (RTE INEN) No. 093 "Cosmetics", notified in document G/TBT/N/ECU/111/Add.2 of 8 December 2015, has been issued pursuant to Resolution No. 16 357 of 1 September 2016 of the Under-Secretariat for the Quality System of the Ministry of Industry and Productivity, published in Official Journal No. 847 of 23 September 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) 3948760, Ext. 2358/2255 ;Enquiry point: [email protected]/[email protected] ; ;
Distribution date: 28 September 2016
Products Covered: 3303.00.00.00, 3304.10.00.00, 3304.20.00.00, 3304.30.00.00, 3304.91.00.00, 3305.10.00.00, 3305.20.00.00, 3305.30.00.00, 3305.90.00.00, 3306.10.00.00, 3306.90.00.00, 3307.10.00.00, 3307.20.00.00, 3307.30.00.00, and 3307.90.90.00. ;Perfumes and toilet waters (HS 330300); Lip make-up preparations (HS 330410); Eye make-up preparations (HS 330420); Manicure or pedicure preparations (HS 330430); Powders, whether or not compressed (HS 330491); Shampoos (HS 330510); Preparations for permanent waving or straightening (HS 330520); Hair lacquers (HS 330530); Other (HS 330590); Dentifrices (HS 330610); Other (HS 330690); Pre-shave, shaving or after-shave preparations (HS 330710); Personal deodorants and antiperspirants (HS 330720); Perfumed bath salts and other bath preparations (HS 330730); Other (HS 330790). ;
Regulation Type: Addendum to Regular Notification
Public Notice under the Commodity Inspection Act (6 pages, in English; 4 pages, in Chinese)
Distribution date: 27 September 2016 | Final date for Comment: 26 November 2016
<p style="text-align:justify;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>In accordance with the Commodity Inspection Act, plugs and socket-outlet for fixed wiring, adapters and cord sets are currently subject to mandatory inspection. To enhance consumer protection, the BSMI intends to revise the inspection standards for the products by adopting the up-to-date version.</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span>In addition to the safety requirements for the commodities above, the BSMI proposes to require marking of presence conditions of restricted substances. Such m</span></span></span><span lang="EN-GB">arkings shall be made in accordance with Section 5 of CNS 15663(2013-07) on the body, packages, stickers or the instruction books of the product. For those who utilize website as a means to announce "the presence conditions of the restricted substances," the website address shall be clearly stated on the body, packages, stickers or the instruction books of the product. </span></p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;">The conformity assessment procedures remain the same, i.e. Registration of Product Certification (RPC) or Type-approved Batch Inspection (TABI).</span></span><p style="text-align:justify;-ms-layout-grid-mode:char;-ms-text-justify:inter-ideograph;"><span lang="EN-US" style="font-size:11pt;"></span></p><p style="text-indent:22pt;-ms-layout-grid-mode:char;"><span lang="EN-US" style="font-size:11pt;"></span></p><p><span lang="EN-US" style="letter-spacing:-0.1pt;font-family:'Times New Roman','serif';font-size:11pt;"></span></p>
Products Covered: (1) Plugs and Socket-outlets for fixed wiring and Adapters : ; a. Plugs and socket-outlets for fixed wiring (CCCN 8536.69.90.00.6A) ; b. Adapters (CCCN 8536.69.90.00.6C) ; (2) Cord sets: ; a. Cord extension sets (CCCN 8544.42.90.90.9A) ; b. Non-detachable cord sets(CCCN 8544.42.90.90.9B) ; c. Detachable cord sets (CCCN 8544.42.90.90.9C) ; d. Cord sets (CCCN 8544.42.90.90.9D) ; e. Cable reels (CCCN 8544.42.90.90.9E) ;
Regulation Type: Regular notification
<pre><p>TITLE: Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs</p><p>AGENCY: Food and Drug Administration, HHS</p><p>ACTION: Final rule</p><p>SUMMARY: The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine.</p><p>DATES: This rule is effective on 29 November 2016. See section IV for compliance dates.</p></pre>
Distribution date: 26 September 2016
Products Covered: Human and animal drugs (HS Chapter 3004; ICS: 11.120, 11.220)
Regulation Type: Addendum to Regular Notification
PROY-NOM-010-ASEA-2016, Gas Natural Comprimido (GNC). Requisitos mínimos de seguridad para Terminales de carga y Terminales de descarga de módulos de almacenamiento transportables y Estaciones de suministro de vehículos automotores (57 páginas, en español)
Distribution date: 26 September 2016
Este Proyecto de Norma Oficial Mexicana es de cumplimiento obligatorio para todas las instalaciones de Terminales y Estaciones de GNC en la República Mexicana y aplica a los sistemas, componentes, equipos y materiales utilizados en las:<br />1.2.1. Las Terminales de Carga y Estaciones de Servicio desde la válvula de entrada de gas natural al Sistema de Compresión hasta el punto de transferencia del GNC a los sistemas de almacenamiento transportables o a los sistemas vehiculares<br />1.2.2. Las Terminales de Descarga desde el punto de recepción de GNC hasta la válvula de entrega de gas natural del usuario<br />1.2.3. Estaciones de suministro satélite desde el punto de recepción de GNC hasta el punto de transferencia del GNC a los sistemas vehiculares.<br />1.2.4. No incluye:<br />a) Las Estaciones de Regulación y Medición de recepción de gas natural de las Terminales de Carga y Estaciones de Suministro, ni de entrega de gas natural de las Terminales de Descarga.<br />b) Los vehículos para el transporte de recipientes de GNC<br />1.2.5. No aplica a:<br />a) Aparatos para Recargar Vehículos (ARV)<br />b) Equipos integrados de compresión y despacho de GNC
Products Covered: Aluminium containers for compressed or liquefied gas (HS code(s): 7613); Petroleum products and natural gas handling equipment (ICS code(s): 75.200)
Regulation Type: Regular notification
PROY-NOM-003-SAG/GAN-2016, Propóleos, producción y especificaciones para su procesamiento (10 páginas, en español)
Distribution date: 26 September 2016 | Final date for Comment: 25 November 2016
Esta Norma es aplicable a las unidades económicas pecuarias dedicadas a la producción, importación, acondicionamiento y almacenamiento con fines de distribución y comercialización de propóleos y sus extractos en el territorio nacional. La aplicación de las disposiciones contenidas en esta Norma compete a la Secretaría de Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (SAGARPA), a través de la Coordinación General de Ganadería así como a las Delegaciones de la SAGARPA en el ámbito de sus respectivas atribuciones y circunscripciones territoriales.
Products Covered: Other sugars, incl. chemically pure lactose, maltose, glucose and fructose, in solid form; sugar syrups not containing added flavouring or colouring matter; artificial honey, whether or not mixed with natural honey; caramel (HS code(s): 1702)
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Radiopharmaceuticals (1 page, in English)
Distribution date: 22 September 2016 | Final date for Comment: 20 October 2016
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">The Minimum Requirements for </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Radiopharmaceuticals </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">are to</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">be partially amended to add the standard</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">s</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">for </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">a radiopharmaceutical </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">to be newly approved.</span></span></span></span></span></span></span></span></span></span>
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Regular notification
DUS 1575:2016, Occupational safety - Onshore oil and gas production operations - Requirements (38 pages, in English)
Distribution date: 22 September 2016 | Final date for Comment: 21 November 2016
<p><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;"></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">This Draft Uganda standard </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">covers occupational safety practices that apply to production operations, drilling, well servicing and work over operations to ensure occupational safety of personnel within the oil and gas sector and or industry. </span></span></span><span style="line-height:107%;font-family:'Calibri','sans-serif';font-size:11pt;">The requirements in this Draft Uganda Standards are intended to ensure that the oil and gas industry implements occupational safety practices concentrating on personal protection and safe workplace, to include: owners, operators, contractors, and service providers during oil and gas operations and production.</span></p>
Products Covered: Occupational safety, onshore oil and gas production operations
Regulation Type: Regular notification
Textiles - High Density Polyethylene and Polypropylene Woven Sacks for Packaging or Filling (Quality Control) Order, 2016 (4 pages, in English)
Distribution date: 22 September 2016 | Final date for Comment: 21 November 2016
<p>This Order seeks to ensure conformity to High Density Polyethylene (HDPE) / Polypropylene (PP) Woven Sacks for Packaging / Filling listed in the Schedule to the specified Indian Standards.</p>
Products Covered: IS 14887: Textiles - High Density Polyethylene (HDPE) / Polypropylene (PP) Woven Sacks for packaging of 50 kg Foodgrains (HS Code 39232100/39232990) ; ; IS 16208: Textiles - High Density Polyethylene (HDPE) / Polypropylene (PP) Woven Sacks for packaging 10 kg, 15 kg, 20 kg, 25 kg and 30 kg Foodgrains (HS Code 39232100/39232990) ; ; IS 14968: Textiles - High Density Polyethylene (HDPE) / Polypropylene (PP) Woven Sacks for packaging 50 kg / 25 kg Sugar (HS Code 39232100/39232990) ; ; IS 14252: Textiles - High Density Polyethylene (HDPE) / Polypropylene (PP) Woven Sacks for filling Sand (HS Code 39232100/39232990)
Regulation Type: Regular notification
Proposed Amendments to the Regulation on the Safety and Efficacy Evaluation for Veterinary Pharmaceutical Products
Distribution date: 20 September 2016 | Final date for Comment: 19 November 2016
The proposed amendments mainly focus on the following: Adding the list of veterinary pharmaceutical products to exempt the data on residue from the required documents, etc.
Products Covered: Veterinary pharmaceutical products
Regulation Type: Regular notification
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