Regulations on the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products (162 pages, in Spanish)
Distribution date: 10 January 2011 | Final date for Comment: 11 March 2011
The notified text contains 283 articles, eight supplementary, transitional and final provisions and 6 annexes, and establishes the regulatory provisions of Law No. 29459 on pharmaceutical products, medical devices and sanitary products, which govern the registration, control and surveillance of these products, in accordance with the National Medicinal Drug Policy.
Products Covered: Pharmaceutical products: Medicine, herbal medicine, dietary products and sweeteners, and biological and galenic products (classified under Chapter 30 of the Harmonized System or in the Customs Tariff); Medical devices (falling within tariff headings 9018, 9019, 9021, 9022 and 9402 of the Harmonized System or Customs Tariff); Sanitary products: Cosmetics, domestic hygiene products and absorbent personal hygiene products (falling within the following tariff headings of the Harmonized System or Customs Tariff: 3303, 3304, 3305, 3401, 3402, 4818, 5601, subheading 3808.91.3401, 3402, 3809.91.00, 4818 and 5601)
Regulation Type: Regular notification
Implementation Rules for Compulsory Certification of Fire Fighting Apparatus - Fire Extinguishing Agents (24pages, in Chinese)
Distribution date: 10 January 2011 | Final date for Comment: 11 March 2011
The implementation rules specify the scope, certification model, major processes of certification, general requirements for certification, use of certificates and certification marks, fee-charging, etc.
Products Covered: Fire extinguishing agents ; ICS: HS: 3813.0010 ;
Regulation Type: Regular notification
Implementation Rules for Compulsory Certification of Fire Fighting Apparatus - Fire Extinguishing Agents (24pages, in Chinese)
Distribution date: 10 January 2011 | Final date for Comment: 11 March 2011
The implementation rules specify the scope, certification model, major processes of certification, general requirements for certification, use of certificates and certification marks, fee-charging, etc.
Products Covered: Fire extinguishing agents ; ICS: HS: 3813.0010 ;
Regulation Type: Regular notification
; This addendum aims to inform that the Conformity Assessment Procedure, issued by Inmetro National Institute of Metrology, Standardization and Industrial Quality, and notified under G/TBT/N/BRA/375 (school items), was now adopted as a final text, published on 9 December 2010, as Ministerial Act n º 481, 7 December 2011 (Portaria n º 481, de 7 de Dezembro de 2010), which revokes the Ministerial Act Nº188, 8 June 2007 (Portaria Inmetro Nº 188, de 08 de junho de 2007) to the stated date of 9 June 2012. ; ; ; The full text of this measure is available in Portuguese and can be downloaded at: ; ; http://www.inmetro.gov.br/legislacao/rtac/pdf/RTAC001637.pdf ;
Distribution date: 10 January 2011 | Final date for Comment: 10 May 2025
Products Covered: ): pencil sharpeners (HS 8214.10); backpacks and briefcases (HS 4202); drawing sets (HS 9017); Ball point pens; felt tipped and other porous -tipped pens and markers; fountain pens, stylograph pens and other pens; duplicating stylos; propelling or sliding pencils (HS 9608); student rubber (HS 4016); child scissors (HS 8214); student glue (HS 3505) and others school items.
Regulation Type: Addendum to Regular Notification
; This addendum aims to inform that the Conformity Assessment Procedure, issued by Inmetro National Institute of Metrology, Standardization and Industrial Quality, and notified under G/TBT/N/BRA/375 (school items), was now adopted as a final text, published on 9 December 2010, as Ministerial Act n º 481, 7 December 2011 (Portaria n º 481, de 7 de Dezembro de 2010), which revokes the Ministerial Act Nº188, 8 June 2007 (Portaria Inmetro Nº 188, de 08 de junho de 2007) to the stated date of 9 June 2012. ; ; ; The full text of this measure is available in Portuguese and can be downloaded at: ; ; http://www.inmetro.gov.br/legislacao/rtac/pdf/RTAC001637.pdf ;
Distribution date: 10 January 2011 | Final date for Comment: 10 May 2025
Products Covered: ): pencil sharpeners (HS 8214.10); backpacks and briefcases (HS 4202); drawing sets (HS 9017); Ball point pens; felt tipped and other porous -tipped pens and markers; fountain pens, stylograph pens and other pens; duplicating stylos; propelling or sliding pencils (HS 9608); student rubber (HS 4016); child scissors (HS 8214); student glue (HS 3505) and others school items.
Regulation Type: Addendum to Regular Notification
Food Grade Salt , Arabic (17 pages) English (12 pages).
Distribution date: 12 January 2011 | Final date for Comment: 13 March 2011
This draft technical regulation specifies the requirements stated in the Gulf standard GSO 1843 "Food Grade Salt" under clauses 10 & 11 (packaging & labeling) as mandatory requirements. It specifies that: ; Iodised salt should be packed in air tight bags of either high density polyethylene (HDPE) or polypropylene (PP) (laminated or non-laminated) or LDPE-lined jute bags (Grade 1803 DW jute bags lined with 150 gauge polyethylene sheet). ; Bulk packing units should not exceed 50 kg. ; Bags that have already been used for packing other articles such as fertilizers, cement, chemicals, etc. Should not be reused for packing iodised salt. ; ; It describes label requirements such as : ; ; The name of the product, as declared on the label shall be "salt". ; The name "salt" shall have in its close proximity a declaration of either "Food Grade" or "Cooking Salt" or "Table Salt". ; Only when salt contains one or more ferrocyanide salts, added to the brine during the crystallization step, the term "dendritic" could be included accompanying the name. ; Where salt is used as a carrier for one or more nutrients, and sold as such for public health reasons, the name of the product shall be declared properly on the label, for example "salt fluoridated", "salt iodated", "salt iodized", "salt fortified with iron", "salt fortified with vitamins" and so on, as appropriate. ;
Products Covered: Food Grade Salt , HS 25 01 00 10
Regulation Type: Regular notification
Food Grade Salt , Arabic (17 pages) English (12 pages).
Distribution date: 12 January 2011 | Final date for Comment: 13 March 2011
This draft technical regulation specifies the requirements stated in the Gulf standard GSO 1843 "Food Grade Salt" under clauses 10 & 11 (packaging & labeling) as mandatory requirements. It specifies that: ; Iodised salt should be packed in air tight bags of either high density polyethylene (HDPE) or polypropylene (PP) (laminated or non-laminated) or LDPE-lined jute bags (Grade 1803 DW jute bags lined with 150 gauge polyethylene sheet). ; Bulk packing units should not exceed 50 kg. ; Bags that have already been used for packing other articles such as fertilizers, cement, chemicals, etc. Should not be reused for packing iodised salt. ; ; It describes label requirements such as : ; ; The name of the product, as declared on the label shall be "salt". ; The name "salt" shall have in its close proximity a declaration of either "Food Grade" or "Cooking Salt" or "Table Salt". ; Only when salt contains one or more ferrocyanide salts, added to the brine during the crystallization step, the term "dendritic" could be included accompanying the name. ; Where salt is used as a carrier for one or more nutrients, and sold as such for public health reasons, the name of the product shall be declared properly on the label, for example "salt fluoridated", "salt iodated", "salt iodized", "salt fortified with iron", "salt fortified with vitamins" and so on, as appropriate. ;
Products Covered: Food Grade Salt , HS 25 01 00 10
Regulation Type: Regular notification
Reviewing Aspects of the Engine Fuel Specifications Regulations 2008: Discussion Paper
Distribution date: 26 January 2011 | Final date for Comment: 27 March 2011
A consultation document outlining various proposals to amend existing fuel specifications as delineated under the Engine Fuel Specifications Regulations 2008. ; Specific proposals that have TBT implications include those that are designed to: ; Relax existing specifications: ; X Minimum E70 for petrol for summer season reduced from 22% to 20% ; X Minimum MON for regular grade petrol reduced from 82 to 81 ; X Vapour pressure waiver of 7 kPa for petrol/ethanol blends extended to winter season ; X Density waiver for diesel/biodiesel blends up to 5% biodiesel of 0.002 kg/m3 (giving a maximum density of 0.852 kg/m3) ; Align with international specifications: ; X Inorganic chloride content limit for ethanol reduced from 32 mg/kg to 10 mg/kg ; X Maximum PAH content for diesel reduced from 11% mass to 8% mass ; X Maximum phosphorus content for biodiesel reduced from 10 mg/kg to 4 mg/kg ; Future proof the regulations: ; X Definitions of petrol and diesel amended to explicitly cover all fuels regardless of the feedstock or production process ;
Products Covered: 2710.19.13; 2710.19.15; 2710.19.21: 2710.19.23: 2710.19.25: 2710.19.27: 2710.19.39: 2710.19.62: 2710.19.66: 2710.19.68: 2710.19.72: 3824.90.87: 3824.90.93: 3824.90.96: 3824.90.98
Regulation Type: Regular notification
Reviewing Aspects of the Engine Fuel Specifications Regulations 2008: Discussion Paper
Distribution date: 26 January 2011 | Final date for Comment: 27 March 2011
A consultation document outlining various proposals to amend existing fuel specifications as delineated under the Engine Fuel Specifications Regulations 2008. ; Specific proposals that have TBT implications include those that are designed to: ; Relax existing specifications: ; X Minimum E70 for petrol for summer season reduced from 22% to 20% ; X Minimum MON for regular grade petrol reduced from 82 to 81 ; X Vapour pressure waiver of 7 kPa for petrol/ethanol blends extended to winter season ; X Density waiver for diesel/biodiesel blends up to 5% biodiesel of 0.002 kg/m3 (giving a maximum density of 0.852 kg/m3) ; Align with international specifications: ; X Inorganic chloride content limit for ethanol reduced from 32 mg/kg to 10 mg/kg ; X Maximum PAH content for diesel reduced from 11% mass to 8% mass ; X Maximum phosphorus content for biodiesel reduced from 10 mg/kg to 4 mg/kg ; Future proof the regulations: ; X Definitions of petrol and diesel amended to explicitly cover all fuels regardless of the feedstock or production process ;
Products Covered: 2710.19.13; 2710.19.15; 2710.19.21: 2710.19.23: 2710.19.25: 2710.19.27: 2710.19.39: 2710.19.62: 2710.19.66: 2710.19.68: 2710.19.72: 3824.90.87: 3824.90.93: 3824.90.96: 3824.90.98
Regulation Type: Regular notification
Proposed enactment of safety criteria for Industrial Product subject to Safety and Quality Mark
Distribution date: 27 January 2011 | Final date for Comment: 28 March 2011
This proposal is for enacting the safety criteria for PVC flooring material subject to Safety and Quality Mark; ; - Safety Criteria for PVC flooring material ; Q Creating safety requirements for hazardous chemicals such as DEHP(Di-Ethyl Hexyl Phthalate), DBP(Di-butyl Phthalate) and BBP(Butyl benzyl Phthalate), which regulate the total amount of their contents in PVC flooring material less than or equal to 0.1%; ; Q Coating thickness of PVC flooring material shall be over 0.015mm.
Products Covered: PVC flooring material (HS: 3918)
Regulation Type: Regular notification
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