Regulatory Updates

Proposed Revision of Safety Criteria for Industrial Products subject to Safety and Quality Mark. (pages, in Korean)

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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

Human health

Proposed Revision of Safety Criteria for Industrial Products subject to Safety and Quality Mark. (pages, in Korean)

Product Image

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

Human health

Dried dill

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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

Food standards

Dried dill

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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

Food standards

Proposed Revision of Industrial Products subject to Safety and Quality Mark

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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

Human health

Proposed Revision of Industrial Products subject to Safety and Quality Mark

Product Image

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

Human health

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 ;

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Distribution date: 11 October 2010

Products Covered: Food products.

Regulation Type: Addendum to Regular Notification

Human health

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 ;

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Distribution date: 11 October 2010

Products Covered: Food products.

Regulation Type: Addendum to Regular Notification

Human health

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

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Distribution date: 11 October 2010

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

Human health

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

Product Image

Distribution date: 11 October 2010

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

Human health

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