Regulatory Updates
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
Direktif Mengenai Syarat Pendaftaran Produk Farmaseutikal Dari Luar Negara Berkaitan Keperluan Amalan Perkilangan Baik (APB) (3 pages, in Malay).
Distribution date: 05 March 2012 | Final date for Comment: 04 May 2012
The directive describes that all registration application of pharmaceutical product(s) which are manufactured in overseas countries will only be considered if the manufacturer of the product(s) is in a *PIC/S Participating Authority country or *ICH member country or the manufacturer has been inspected by a PIC/S Participating Authority or ICH member country National Drug Regulatory Agency (NDRA). ; *PIC/S: Pharmaceutical Inspection Co-operation Scheme ; *ICH: International Conference on Harmonization ;
Products Covered: Pharmaceutical products that are manufactured in overseas countries (ICS: 11.120.01; HS: 30.06).
Regulation Type: Regular notification
Direktif Mengenai Syarat Pendaftaran Produk Farmaseutikal Dari Luar Negara Berkaitan Keperluan Amalan Perkilangan Baik (APB) (3 pages, in Malay).
Distribution date: 05 March 2012 | Final date for Comment: 04 May 2012
The directive describes that all registration application of pharmaceutical product(s) which are manufactured in overseas countries will only be considered if the manufacturer of the product(s) is in a *PIC/S Participating Authority country or *ICH member country or the manufacturer has been inspected by a PIC/S Participating Authority or ICH member country National Drug Regulatory Agency (NDRA). ; *PIC/S: Pharmaceutical Inspection Co-operation Scheme ; *ICH: International Conference on Harmonization ;
Products Covered: Pharmaceutical products that are manufactured in overseas countries (ICS: 11.120.01; HS: 30.06).
Regulation Type: Regular notification
1. Feed Act 2009 (25 pages, in English) ; 2. Feed (Licence to Import Feed and/or Feed Additive) Regulations 2011 (27 pages, in English and Malay). ; 3. Feed (Labelling of Feed and Feed Additive) Regulations 2011 (7 pages, in English and Malay). ; 4. Feed (Prohibited Use of Antibiotics, Hormones or Other Chemicals) Regulations 2011 (13 pages, in English and Malay). ; 5. Feed (Manufacture and Sale of Feed and Feed Additive) Regulations 2011 (29 pages, in English and Malay). ; 6. Feed (Methods of Analysis of Feed and the Form of Certificate of Analysis) Regulations 2011 (17 pages, in English and Malay). ;
Distribution date: 05 March 2012 | Final date for Comment: 04 May 2012
Feed Act 2009 and Feed Regulations 2011 were developed to provide information and explanations to regulate feed quality by controlling the importation, manufacture, sale and use of feed and feed additive, to ensure that feed satisfies nutritional requirement of animals, is not harmful to animals and is not contaminated so that animals and animal products are safe for human consumption and other usage, and for other matters incidental thereto.
Products Covered: Feed and feed additives (ICS: 65.120).
Regulation Type: Regular notification
1. Feed Act 2009 (25 pages, in English) ; 2. Feed (Licence to Import Feed and/or Feed Additive) Regulations 2011 (27 pages, in English and Malay). ; 3. Feed (Labelling of Feed and Feed Additive) Regulations 2011 (7 pages, in English and Malay). ; 4. Feed (Prohibited Use of Antibiotics, Hormones or Other Chemicals) Regulations 2011 (13 pages, in English and Malay). ; 5. Feed (Manufacture and Sale of Feed and Feed Additive) Regulations 2011 (29 pages, in English and Malay). ; 6. Feed (Methods of Analysis of Feed and the Form of Certificate of Analysis) Regulations 2011 (17 pages, in English and Malay). ;
Distribution date: 05 March 2012 | Final date for Comment: 04 May 2012
Feed Act 2009 and Feed Regulations 2011 were developed to provide information and explanations to regulate feed quality by controlling the importation, manufacture, sale and use of feed and feed additive, to ensure that feed satisfies nutritional requirement of animals, is not harmful to animals and is not contaminated so that animals and animal products are safe for human consumption and other usage, and for other matters incidental thereto.
Products Covered: Feed and feed additives (ICS: 65.120).
Regulation Type: Regular notification
RESPONSE to comments received regarding draft Mexican Official Standard PROY-NOM-248-SSA1-2006: "Good manufacturing practices for establishments engaged in the manufacture of herbal remedies"
Distribution date: 28 February 2012
On 24 February 2012, the Mexican Ministry of the Economy published in the Official Journal (Diario Oficial de la Federación) (http://www.dof.gob.mx) the RESPONSE to the comments received regarding draft Mexican Official Standard PROY-NOM-248-SSA1-2006, published on 28 April 2009.Text available at:http://www.dof.gob.mx/nota_detalle.php?codigo=5235264&fecha=24/02/2012http://members.wto.org/crnattachments/2012/sps/MEX/12_0788_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
RESPONSE to comments received regarding draft Mexican Official Standard PROY-NOM-248-SSA1-2006: "Good manufacturing practices for establishments engaged in the manufacture of herbal remedies"
Distribution date: 28 February 2012
On 24 February 2012, the Mexican Ministry of the Economy published in the Official Journal (Diario Oficial de la Federación) (http://www.dof.gob.mx) the RESPONSE to the comments received regarding draft Mexican Official Standard PROY-NOM-248-SSA1-2006, published on 28 April 2009.Text available at:http://www.dof.gob.mx/nota_detalle.php?codigo=5235264&fecha=24/02/2012http://members.wto.org/crnattachments/2012/sps/MEX/12_0788_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
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