Administrative Directive on the certification of good manufacturing practices in domestic and foreign laboratories (18 pages, in Spanish).

Distribution date: 11 October 2010 | Final date for Comment: 10 May 2025
The notified Administrative Directive contains nine sections and three annexes. It regulates the operational aspects of good manufacturing practice (GMP) certification audits of laboratories engaged in the manufacture of pharmaceutical products, medical devices and sanitary products, and establishes criteria and procedures for such certification.
Products Covered: Pharmaceutical products: Medicine, herbal medicine, dietary products and sweeteners, biologics and galenic products (classified under Chapter 30 of the Harmonized System or 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
The Draft Resolution n.º 95/2009, notified through G/TBT/N/BRA/362 Food products - was published by Anvisa as Resolution RDC n.º 27/2010, August 6th 2010. ; ; The full text is available only in Portuguese and can be downloaded at: ; ; http://www.in.gov.br/visualiza/index.jsp?data=09/08/2010&jornal=1&pagina=63&totalArquivos=104 ;

Distribution date: 11 October 2010 | Final date for Comment: 10 May 2025
Products Covered: Food products.
Regulation Type: Addendum to Regular Notification
The Draft Resolution n.º 95/2009, notified through G/TBT/N/BRA/362 Food products - was published by Anvisa as Resolution RDC n.º 27/2010, August 6th 2010. ; ; The full text is available only in Portuguese and can be downloaded at: ; ; http://www.in.gov.br/visualiza/index.jsp?data=09/08/2010&jornal=1&pagina=63&totalArquivos=104 ;

Distribution date: 11 October 2010 | Final date for Comment: 10 May 2025
Products Covered: Food products.
Regulation Type: Addendum to Regular Notification
Proposed Revision of Industrial Products subject to Safety and Quality Mark

Distribution date: 18 October 2010 | Final date for Comment: 17 December 2010
: This proposal is for revising the safety criteria for toilet paper, sunglasses and glasses frame subject to Safety and Quality Mark; ; - Safety Criteria for Toilet paper ; Q Creating safety requirements for two types of hazardous chemicals such as formaldehyde and colon bacterium in regards of facial tissue and toilet paper and not using chlorine gas as bleaching agent; ; Q Fluorescent whitening agent shall not be detected in facial tissue and not be used in the process of fabrication of toilet paper. ; ; - Safety Criteria for Sunglasses and Glasses frame ; Q Creating safety requirements for hazardous chemicals, which regulate the releasing amount of nickel in metallic sunglasses and glasses frame under 0.5 £gg/cm2/week. ; ; ; ¡° For industrial products subject to safety and quality mark, manufacturers and importers shall indicate safety and quality mark on their products, according to criteria of safety and quality mark. ;
Products Covered: Toilet paper, Sunglasses and Glasses frame (HS: 480300, 9003, 900410)
Regulation Type: Regular notification
Proposed Revision of Industrial Products subject to Safety and Quality Mark

Distribution date: 18 October 2010 | Final date for Comment: 17 December 2010
: This proposal is for revising the safety criteria for toilet paper, sunglasses and glasses frame subject to Safety and Quality Mark; ; - Safety Criteria for Toilet paper ; Q Creating safety requirements for two types of hazardous chemicals such as formaldehyde and colon bacterium in regards of facial tissue and toilet paper and not using chlorine gas as bleaching agent; ; Q Fluorescent whitening agent shall not be detected in facial tissue and not be used in the process of fabrication of toilet paper. ; ; - Safety Criteria for Sunglasses and Glasses frame ; Q Creating safety requirements for hazardous chemicals, which regulate the releasing amount of nickel in metallic sunglasses and glasses frame under 0.5 £gg/cm2/week. ; ; ; ¡° For industrial products subject to safety and quality mark, manufacturers and importers shall indicate safety and quality mark on their products, according to criteria of safety and quality mark. ;
Products Covered: Toilet paper, Sunglasses and Glasses frame (HS: 480300, 9003, 900410)
Regulation Type: Regular notification
Dried dill

Distribution date: 19 October 2010 | Final date for Comment: 18 December 2010
This draft technical regulation specifies the physical properties, chemical composition, microbiological limits, packing and labeling, sampling and testing and examination method for dried dill.
Products Covered: Dried dill
Regulation Type: Regular notification
Dried dill

Distribution date: 19 October 2010 | Final date for Comment: 18 December 2010
This draft technical regulation specifies the physical properties, chemical composition, microbiological limits, packing and labeling, sampling and testing and examination method for dried dill.
Products Covered: Dried dill
Regulation Type: Regular notification
Proposed Revision of Safety Criteria for Industrial Products subject to Safety and Quality Mark. (pages, in Korean)

Distribution date: 19 October 2010 | Final date for Comment: 18 December 2010
This proposal is for revising the safety criteria for flexible polyvinyl chloride hose, an industrial product subject to safety and quality mark; ; - Safety Criteria for flexible polyvinyl chloride hose ; Q Adding polyvinyl chloride pipe to the scope of application of the safety criteria by changing the item into vinyl chloride hose (pipe) ; ; Q In regards of vinyl chloride hose, creating safety requirements for harmful chemical substance such as lead, cadmium, vinyl chloride monomer, dibutyltin compound, cresol phosphate ester and phthalate plasticizer ; ; Q In regards of polyvinyl chloride pipe, creating safety and quality requirements for lead, plasticizer, tensile strength, yield strength and VICAT softening temperature. ; ; ¡° For industrial products subject to safety and quality mark, manufacturers and importers shall indicate safety and quality mark on their products, according to criteria of safety and quality mark. ;
Products Covered: Flexible polyvinyl chloride hose(HS: 3917)
Regulation Type: Regular notification
Proposed Revision of Safety Criteria for Industrial Products subject to Safety and Quality Mark. (pages, in Korean)

Distribution date: 19 October 2010 | Final date for Comment: 18 December 2010
This proposal is for revising the safety criteria for flexible polyvinyl chloride hose, an industrial product subject to safety and quality mark; ; - Safety Criteria for flexible polyvinyl chloride hose ; Q Adding polyvinyl chloride pipe to the scope of application of the safety criteria by changing the item into vinyl chloride hose (pipe) ; ; Q In regards of vinyl chloride hose, creating safety requirements for harmful chemical substance such as lead, cadmium, vinyl chloride monomer, dibutyltin compound, cresol phosphate ester and phthalate plasticizer ; ; Q In regards of polyvinyl chloride pipe, creating safety and quality requirements for lead, plasticizer, tensile strength, yield strength and VICAT softening temperature. ; ; ¡° For industrial products subject to safety and quality mark, manufacturers and importers shall indicate safety and quality mark on their products, according to criteria of safety and quality mark. ;
Products Covered: Flexible polyvinyl chloride hose(HS: 3917)
Regulation Type: Regular notification
Consumer Protection (Certificate of Conformance and Conformity Mark of Safety Standards) Regulations 2010 (5 pages, in English) and Consumer Protection (Safety Standards for Toys) (Amendment) Regulations 2010 (1 page, in English).

Distribution date: 19 October 2010 | Final date for Comment: 10 May 2025
This notification is the 1st revision of G/TBT/N/MYS/15 which was notified on 6 November 2008. This is due to changes that occurred in the policy direction whereby, the implementation of type approval approach has been replaced with self declaration approach in order to minimise unnecessary obstacle to the toy industry players and also to facilitate trade locally and internationally. ; ; 1. Consumer Protection (Certificate of Conformance and Conformity Mark of Safety Standards) Regulations 2010 ; The regulations is replacing the Consumer Protection (Certificate of Approval and Conformity Mark of Safety Standards) Regulations 2009, which is now repealed. ; The regulations specify the general procedural requirements for self declaration approach with regard to safety standards of consumer goods. These requirements include the registration of business activities, preparation of certificate of conformance, declaration of conformance, safety and marking requirements, offences, penalties and maintenance of records for goods which are marketed in Malaysia. In this context, the consumer goods is referred to toys as specified in the First Schedule under the regulations. ; ; 2. Consumer Protection (Safety Standards For Toys) (Amendment) Regulations 2010 ; This is the amended regulation for the Consumer Protection (Safety Standards For Toys) Regulations 2009. ; The regulations state toys (as defined in the regulations) that are supplied or offered or advertised for supply, or import any goods in Malaysia shall comply with the specified safety standards. ; The amendment has been made to the regulation in which MS 1725:2004, Safety of electric toys is replaced with MS 62115:2008, Electric Toys Safety. ;
Products Covered: Toys (HS: 95,87,36; ICS: 97.200.50) ; Toys and any goods designed or intended for use in play by children less than fourteen years of age but does not include the goods listed in Second Schedule of Consumer Protection (Safety Standards for Toys) Regulations 2009. ;
Regulation Type: Revision to Regular Notification
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