Draft Decision establishing the Andean Technical Regulation laying down the operating requirements for establishments engaged in the manufacture of domestic hygiene products and absorbent personal hygiene products (28 pages, in Spanish).
Distribution date: 28 May 2009 | Final date for Comment: 27 July 2009
The notified draft Technical Regulation is comprised of fourteen (14) paragraphs of requirements (personnel, organization, sanitation and hygiene, buildings and facilities, equipment, accessories and tools, maintenance and services, storage and distribution, handling of raw materials and inputs, production, packing and packaging, quality assurance, documentation and records, references, complaints and claims and grounds for product withdrawal) and an annex containing a guide to conducting inspections of establishments which manufacture domestic hygiene products and absorbent personal hygiene products, which sets out the assessment and grading criteria for control and monitoring inspections.
Products Covered: Domestic hygiene products and absorbent personal hygiene products: 3804.00 Residual lyes from the manufacture of wood pulp, whether or not concentrated, desugared or chemically treated, including lignin sulphonates, but excluding tall oil of heading 38.03; 1520.00.00 Glycerol, crude; glycerol waters and glycerol lyes; 28.15 Sodium hydroxide (caustic soda); potassium hydroxide (caustic potash); peroxides of sodium or potassium; Sodium hydroxide (caustic soda): 2815.11.00 Solid; 2815.12.00 In aqueous solution (soda lye or liquid soda); 2815.20.00 Potassium hydroxide (caustic potash); 2815.30.00 Peroxides of sodium or potassium; 3808.94 Disinfectants; Put up in forms or packings for retail sale or as articles: 3808.94.11 Containing bromomethane (methyl bromide) or bromochloromethane; 3808.94.19 Other; Other: 3808.94.91 Containing bromomethane (methyl bromide) or bromochloromethane; 3808.94.99 Other; 3808.10.11 Based on permethrin or cypermethrin or other synthetic substitutes for pyrethrum; 3402.20.00 Preparations put up for retail sale; 4818.40.10 Napkin liners for babies; 4818.40.20 Sanitary towels and tampons; 4818.20.00 Handkerchiefs, cleansing or facial tissues and towels
Regulation Type: Regular notification
TITLE: Control of Volatile Organic Compounds (VOC) from Adhesives and Sealants; ; RI 3721 2009 ; ; AGENCY: State of Rhode Island, Department of Environmental Management, Office of Air Resources ; ; ACTION: Rule adoption ; ; SUMMARY: Establishes rules pertaining to the control of VOC from adhesives and sealants. Limits the VOC content of 40 categories of adhesive and sealant products. ; ; EFFECTIVE DATE: 4 June 2009 ; ; FOR FURTHER INFORMATION CONTACT: ; Barbara Morin ; State of Rhode Island ; Department of Environmental Management ; Office of Air Resources ; 235 Promenade Street ; Providence, RI 02908-5767 USA ; Tel: 401-222-2808, ext. 7012 ; Email: [email protected] ; Website : http://www.dem.ri.gov/ ; ; The full text of USA/455/Add.1 is at: ; http://www.dem.ri.gov/pubs/regs/regs/air/air44_09.pdf ;
Distribution date: 26 May 2009
Products Covered: Adhesives, sealants (HS 3506) (ICS 91.100, 13.040, 13.020)
Regulation Type: Addendum to Regular Notification
La República de Ecuador comunica con relación al proyecto de Reglamento Técnico Ecuatoriano RTE INEN 031 para “Líquido de frenos hidráulicos, sean de fabricación nacional o importados, que se comercialicen en la República del Ecuador”, del Instituto Ecuatoriano de Normalización, notificado mediante el documento identificado con la signatura G/TBT/N/ECU/29 del 21 de mayo de 2007, que éste ha sido expedido mediante la Resolución N° 012-2008 del 19 de mayo de 2008, publicado en el Registro Oficial Nº 460 del 05 de noviembre de 2008. ; ; Texto disponible en el Ministerio de Industrias y Productividad, Subsecretaría de Comercio e Inversiones, Organismo Nacional encargado de la Notificación: ; Responsable: Arturo Barbosa G. ; Avdas. Eloy Alfaro y Amazinas, 2º Piso, Edif. MAGAP ; Quito - Ecuador ; Tel:(+593-2) 2566041, Ext.284 ; Fax:(+593-2) 2504922 ; Punto de Contacto:[email protected], [email protected] ;
Distribution date: 26 May 2009
Products Covered: HS tariff subheading 3819.00.00
Regulation Type: Addendum to Regular Notification
Reglamento Técnico Centroamericano RTCA 65.05.54:09, Fertilizantes y Enmiendas de Uso Agrícola. Requisitos para el Registro (Central American Technical Regulation (RTCA) No. 65.05.54:09: Fertilizers and soil conditioners for agricultural use. Registration requirements).Text available online at:http://members.wto.org/crnattachments/2009/sps/CRI/09_1825_00_s.pdf
Distribution date: 26 May 2009 | Final date for Comment: 25 July 2009
The notified Technical Regulation lays down the requirements for the registration of fertilizers and soil conditioners for agricultural use. It applies to the registration of agricultural fertilizers and soil conditioners which are manufactured, formulated, extracted from natural sources, packaged, repacked/repackaged, imported, exported, distributed and marketed in countries of the Central American region.
Products Covered: International Classification for Standards (ICS) code 65.080
Regulation Type: Regular notification
Proyecto de Resolución del Ministerio de la Protección Social "Por la cual se establece el reglamento técnico sobre los requisitos sanitarios que debe cumplir el chocolate y productos de chocolate para consumo humano, que se procese, envase, transporte, comercialice, expenda, importe o exporte en el territorio nacional" (Draft Ministry of Social Welfare Resolution "Establishing technical regulations on the health requirements to be met by chocolate and chocolate products for human consumption which are processed, packaged, transported, marketed or sold in, imported into or exported from Colombian national territory").
Distribution date: 25 May 2009 | Final date for Comment: 19 August 2009
The notified Resolution covers the following: Purpose; Scope; Definitions; Basic hygiene requirements; Classification; Raw materials; General requirements for table chocolate, chocolate and chocolate substitutes for direct consumption; Physico-chemical and microbiological requirements; Maximum pesticide limits for table chocolate, chocolate and chocolate substitutes; Prohibitions; Packaging and labelling; Requirements for the importation of chocolate and chocolate products; Inspection, monitoring and control, safety measures, penalties, notification and period of validity.
Products Covered: Chocolate and chocolate products
Regulation Type: Regular notification
Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (Revision of Agricultural Chemical Residue Standards)
Distribution date: 13 May 2009 | Final date for Comment: 12 July 2009
Proposed maximum residue limits (MRLs) for imicyafos, pyrasulfotole, destomycin A and terdecamycin.
Products Covered: Meat and edible meat offal (HS Codes 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09); Dairy and eggs (HS Codes 04.01, 04.07 and 04.08); Edible vegetables and certain roots and tubers (HS Codes 07.01, 07.02, 07.07, 07.06, 07.09, 07.10, 07.12 and 07.14); Edible fruits (HS Codes 08.07, 08.10, 08.11 and 08.13); and Cereals (HS Codes 10.01, 10.02, 10.03, 10.04, 10.07 and 10.08).
Regulation Type: Regular notification
El Gobierno de Costa Rica, informa que el RTCA 11.01.04:09 Productos Farmacéuticos. Estudios de estabilidad de medicamentos de uso humano, notificado bajo la signatura G/TBT/N/CRI/23, del 7 de diciembre del 2004, ha sufrido modificaciones en su forma y su fondo. Por tal razón se concede un plazo de 60 días a partir de la fecha de notificación para que los países miembros realicen comentarios. ; ; ; El documento puede ser accesado en la siguiente dirección electrónica: http://www.reglatec.go.cr/consulta/rtc-11-01-04-2009.pdf ; ; Centro de Obstáculos Técnicos al Comercio ; Sitio en Internet: http://www.reglatec.go.cr ; Punto de Contacto OMC: [email protected] ; Teléfono: (506) 2235-2700, ext. 265 ; Fax: (506) 2297-1439 ; San José, Costa Rica ; http://members.wto.org/crnattachments/2009/tbt/cri/09_1715_00_s.pdf
Distribution date: 12 May 2009
Products Covered: Pharmaceutical products. Stability of medicines for human use (HS tariff headings 3003 and 3004)
Regulation Type: Addendum to Regular Notification
Cleaning paste based on synthetic surface active agents
Distribution date: 12 May 2009 | Final date for Comment: 05 June 2009
3rd amendment to SI 733. This amendment changes the normative reference mentioned in paragraph 104 dealing with packaging. This paragraph is the only mandatory part of the standard. According to the amendment, the cleaning paste containers should now comply with the Mandatory Standard SI 2302 part 1, instead of SI 743.
Products Covered: Cleaning paste (ICS: 71.100.40; HS: 3402).
Regulation Type: Regular notification
Title: Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph ; AGENCY: Food and Drug Administration (FDA), HHS ; ACTION: Final rule ; ; SUMMARY: The Food and Drug Administration (FDA) has issued this final rule to require important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDS). The new labeling is required for all OTC IAAA drug products whether marketed under an OTC drug monograph or an approved new drug application (NDA). The full text includes responses to comments from interested parties. ; ; DATES: Effective date 29 April 2010. Compliance date 29 April 2010. ; ; For further information contact: ; Arlene Solbeck ; Center for Drug Evaluation and Research (CDER) ; Food and Drug Administration ; 10903 New Hampshire Ave., Bldg. 22, MS 5411 ; Silver Spring, MD 20993 USA ; Tel: 301-796-2090 ; Email: [email protected] ; ; Full text at: ; http://edocket.access.gpo.gov/2009/E9-9684.htm ; http://edocket.access.gpo.gov/2009/pdf/E9-9684.pdf ;
Distribution date: 11 May 2009
Products Covered: Over-the-counter human drugs, Internal analgesic, antipyretic, and anti-rheumatic drug products (HS: Chapter 3004; ICS: 11)
Regulation Type: Addendum to Regular Notification
Draft Decision establishing the Andean Technical Regulation laying down the operating requirements for establishments engaged in the manufacture of domestic hygiene products and absorbent personal hygiene products (28 pages, in Spanish).
Distribution date: 08 May 2009 | Final date for Comment: 07 July 2009
El presente proyecto de reglamento técnico contiene catorce (13) numerales de requisitos (personal, organización, saneamiento e higiene, edificaciones e instalaciones, equipos accesorios y utensilios, mantenimiento y servicios, almacenamiento y distribución, manejo de materias primas e insumos, producción, envase y empaque, aseguramiento de la calidad, documentación y archivo, biblioteca, quejas y reclamos y causales de retiro de productos) y un anexo con una guía para realizar la inspección de establecimientos fabricantes de productos de higiene domestica y productos absorbentes de higiene persona con los criterios de evaluación y calificación para las inspecciones de control y vigilancia.
Products Covered: Domestic hygiene products and absorbent personal hygiene products: 3804.00 – Residual lyes from the manufacture of wood pulp, whether or not concentrated, desugared or chemically treated, including lignin sulphonates, but excluding tall oil of heading 38.03; 1520.00.00 – Glycerol, crude; glycerol waters and glycerol lyes; 28.15 – Sodium hydroxide (caustic soda); potassium hydroxide (caustic potash); peroxides of sodium or potassium; Sodium hydroxide (caustic soda); 281
Regulation Type: Regular notification
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