Partial amendment to the Minimum Requirements for Biological Products (1 page, available in English)
Distribution date: 04 April 2012 | Final date for Comment: 27 April 2012
The Minimum Requirements for Biological Products shall be partially amended to add the standard for a vaccine to be newly approved.
Products Covered: Drugs (HS: 30)
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Biological Products (1 page, available in English)
Distribution date: 04 April 2012 | Final date for Comment: 27 April 2012
The Minimum Requirements for Biological Products shall be partially amended to add the standard for a vaccine to be newly approved.
Products Covered: Drugs (HS: 30)
Regulation Type: Regular notification
Draft Amendment of the Official Standards for Ordinary Fertilizers ( 12 pages, in English)
Distribution date: 04 April 2012 | Final date for Comment: 03 June 2012
Official standard to be amended: ; EFused silicate phosphate ; EMixed organic fertilizer ; EComplex fertilizer ; EMixed sludge compound fertilizer ; ; Official standards to be established: ; EFused sludge ash silicate phosphate fertilizer ; EMixed animal waste compound fertilizer ; EMixed compost compound fertilizer ; EMixed fertilizer that contains agricultural chemicals ;
Products Covered: Fertilizer (HS: 3101, ; 3103,3105) ;
Regulation Type: Regular notification
Draft Amendment of the Official Standards for Ordinary Fertilizers ( 12 pages, in English)
Distribution date: 04 April 2012 | Final date for Comment: 03 June 2012
Official standard to be amended: ; EFused silicate phosphate ; EMixed organic fertilizer ; EComplex fertilizer ; EMixed sludge compound fertilizer ; ; Official standards to be established: ; EFused sludge ash silicate phosphate fertilizer ; EMixed animal waste compound fertilizer ; EMixed compost compound fertilizer ; EMixed fertilizer that contains agricultural chemicals ;
Products Covered: Fertilizer (HS: 3101, ; 3103,3105) ;
Regulation Type: Regular notification
This addendum aims to inform that the Conformity Assessment Procedure, issued by Inmetro National Institute of Metrology, Quality, and Technology previously notified under G/TBT/N/BRA/375/Add.1 (school items) as Ministerial Act n º 481, 7 December 2010 was amended by Inmetro Ordinance Ministerial Act n º 90, 23 February 2012, incorporating changes of some items and revoking articles. ; ; Additionally, incorporates the provisions under item 6.2 of the Inmetro Ordinance Ministerial Act n º 491/2010, concerning the registrations renewal documents as part of the conformity assessment procedures and revokes Ministerial Act nº 188, 8 June 2007, to the stated date of 23 December 2012. ; ; ; The full text of this measure is available in Portuguese and can be downloaded at: ; ; http://www.inmetro.gov.br/legislacao/rtac/pdf/RTAC001796.pdf ;
Distribution date: 27 March 2012
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, Quality, and Technology previously notified under G/TBT/N/BRA/375/Add.1 (school items) as Ministerial Act n º 481, 7 December 2010 was amended by Inmetro Ordinance Ministerial Act n º 90, 23 February 2012, incorporating changes of some items and revoking articles. ; ; Additionally, incorporates the provisions under item 6.2 of the Inmetro Ordinance Ministerial Act n º 491/2010, concerning the registrations renewal documents as part of the conformity assessment procedures and revokes Ministerial Act nº 188, 8 June 2007, to the stated date of 23 December 2012. ; ; ; The full text of this measure is available in Portuguese and can be downloaded at: ; ; http://www.inmetro.gov.br/legislacao/rtac/pdf/RTAC001796.pdf ;
Distribution date: 27 March 2012
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
Regulations Amending the Food and Drug Regulations (1611 - Asparaginase)
Distribution date: 23 March 2012
The proposed amendments notified in G/SPS/N/CAN/403 (dated 15 December 2009) were adopted 2 March 2012 as the Regulations Amending the Food and Drug Regulations (1611 - Asparaginase). These Regulations entered into force on 2 March 2012.
Products Covered:
Regulation Type: Addendum to Regular Notification
Regulations Amending the Food and Drug Regulations (1611 - Asparaginase)
Distribution date: 23 March 2012
The proposed amendments notified in G/SPS/N/CAN/403 (dated 15 December 2009) were adopted 2 March 2012 as the Regulations Amending the Food and Drug Regulations (1611 - Asparaginase). These Regulations entered into force on 2 March 2012.
Products Covered:
Regulation Type: Addendum to Regular Notification
Two products subject to Self-regulatory Safety Confirmation (1 standard, in Korean)
Distribution date: 19 March 2012 | Final date for Comment: 18 April 2012
o Change the category and applied item of safety criteria for indoor flooring materials ; Change the category of the indoor flooring material from Safety and Quality Mark to Self-regulatory Safety Confirmation and add woody flooring materials ; o PVC flooring material ; ∙ 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 as follows: ; - In PVC flooring material for Ondol(Korean floor heating system), the total amount of DEHP, DBP and BBP contents of upper part shall be no more than 1.5% and that of lower part shall be no more than 5.0%. ; - In PVC flooring material for things other than Ondol, the total amount of their contents of upper part shall be no more than 3.0% and that of lower part shall be no more than 10.0%. ; ∙ Coating thickness of PVC flooring material shall be over 0.015mm. ; o The maximum emission rate of hazardous substances for wood flooring material ; ∙ Formaldehyde: 0.12, Toluene : 0.08, TVOC : 0.40 (mg/m² ∙h) ;
Products Covered: Indoor flooring materials
Regulation Type: Revision to Regular Notification
Two products subject to Self-regulatory Safety Confirmation (1 standard, in Korean)
Distribution date: 19 March 2012 | Final date for Comment: 18 April 2012
o Change the category and applied item of safety criteria for indoor flooring materials ; Change the category of the indoor flooring material from Safety and Quality Mark to Self-regulatory Safety Confirmation and add woody flooring materials ; o PVC flooring material ; ∙ 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 as follows: ; - In PVC flooring material for Ondol(Korean floor heating system), the total amount of DEHP, DBP and BBP contents of upper part shall be no more than 1.5% and that of lower part shall be no more than 5.0%. ; - In PVC flooring material for things other than Ondol, the total amount of their contents of upper part shall be no more than 3.0% and that of lower part shall be no more than 10.0%. ; ∙ Coating thickness of PVC flooring material shall be over 0.015mm. ; o The maximum emission rate of hazardous substances for wood flooring material ; ∙ Formaldehyde: 0.12, Toluene : 0.08, TVOC : 0.40 (mg/m² ∙h) ;
Products Covered: Indoor flooring materials
Regulation Type: Revision to Regular Notification
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