Regulations on pharmaceutical establishments (72 pages, in Spanish).

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Distribution date: 06 December 2010 | Final date for Comment: 04 February 2011

The notified text contains 149 articles, eight supplementary, transitional and final provisions and 2 annexes. It sets forth the technical and sanitary requirements for establishments engaged in the manufacture, import, export, storage, marketing, distribution, dispensation and sale of pharmaceutical products, medical devices and sanitary products.

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

Human health

Zehnte Verordnung zur Durchführung des Bundes-Immissionsschutzgesetzes (Verordnung über die Beschaffenheit und die Auszeichnung der Qualitäten von Kraft- und Brennstoffen – 10. BImSchV) (10th Ordinance on the Implementation of the Federal Immission Control Act (Ordinance on the Quality and Labelling of Fuels, 10th BImSchV)), 10 pages, German

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Distribution date: 03 December 2010 | Final date for Comment: 01 February 2011

Implementing the European Fuel Quality Directive 98/70/EC this ordinance sets - in respect of road vehicles, non-road mobile machinery (including inland waterway vessels when not at sea), agricultural and forestry tractors, and recreational craft when not at sea - technical specifications for fuels to be used with positive ignition and compression-ignition engines and labelling requirements for fuels. The ordinance applies especially to petrol, diesel fuels, gas oil, biodiesel, ethanol fuel, liquid petroleum gas, natural or bio gas as fuel, vegetable oil fuel and fuel oil. ; ; The ordinance increases in particular the maximum permissible percentage of ethanol in petrol fuel from the current 5 per cent by volume of ethanol to 10 per cent by volume. The quality requirements for transport fuels are standardized in DIN or CEN standards and have been incorporated into the Ordinance on the Quality and Labelling of Fuels. ; ; Implementing the European limit for the maximum permissible sulphur content of gas oils intended for use by non-road mobile machinery (including inland waterway vessels), agricultural and forestry tractors, and recreational craft will be reduced to 10 mg/kg from 1 January 2011. ;

Products Covered: KN-Code: 2710 11 41, KN-Code: 2710 11 45, KN-Code: 2710 11 49, KN-Code: 2710 11 51, KN-Code: 2710 11 59, KN-Code: 2710 19 41, KN-Code: 2710 19 45, KN-Code: 2710 19 49, KN-Code: 3824 90 91, KN-Code: 3824 90 97, KN-Code 22 07, KN-Code 38 24, KN-Codes: 2711 12 11 – 2711 19 00, KN-Code: 2711 21 00, HS: 1507 – 1518, KN-Codes: 2710 19 61 – 2710 19 69

Regulation Type: Regular notification

Zehnte Verordnung zur Durchführung des Bundes-Immissionsschutzgesetzes (Verordnung über die Beschaffenheit und die Auszeichnung der Qualitäten von Kraft- und Brennstoffen – 10. BImSchV) (10th Ordinance on the Implementation of the Federal Immission Control Act (Ordinance on the Quality and Labelling of Fuels, 10th BImSchV)), 10 pages, German

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Distribution date: 03 December 2010 | Final date for Comment: 01 February 2011

Implementing the European Fuel Quality Directive 98/70/EC this ordinance sets - in respect of road vehicles, non-road mobile machinery (including inland waterway vessels when not at sea), agricultural and forestry tractors, and recreational craft when not at sea - technical specifications for fuels to be used with positive ignition and compression-ignition engines and labelling requirements for fuels. The ordinance applies especially to petrol, diesel fuels, gas oil, biodiesel, ethanol fuel, liquid petroleum gas, natural or bio gas as fuel, vegetable oil fuel and fuel oil. ; ; The ordinance increases in particular the maximum permissible percentage of ethanol in petrol fuel from the current 5 per cent by volume of ethanol to 10 per cent by volume. The quality requirements for transport fuels are standardized in DIN or CEN standards and have been incorporated into the Ordinance on the Quality and Labelling of Fuels. ; ; Implementing the European limit for the maximum permissible sulphur content of gas oils intended for use by non-road mobile machinery (including inland waterway vessels), agricultural and forestry tractors, and recreational craft will be reduced to 10 mg/kg from 1 January 2011. ;

Products Covered: KN-Code: 2710 11 41, KN-Code: 2710 11 45, KN-Code: 2710 11 49, KN-Code: 2710 11 51, KN-Code: 2710 11 59, KN-Code: 2710 19 41, KN-Code: 2710 19 45, KN-Code: 2710 19 49, KN-Code: 3824 90 91, KN-Code: 3824 90 97, KN-Code 22 07, KN-Code 38 24, KN-Codes: 2711 12 11 – 2711 19 00, KN-Code: 2711 21 00, HS: 1507 – 1518, KN-Codes: 2710 19 61 – 2710 19 69

Regulation Type: Regular notification

National Food Safety Standard for Detergents

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Distribution date: 29 November 2010 | Final date for Comment: 28 January 2011

This standard establishes requirements for detergents for cleaning food utensils, devices, vegetables and fruits.

Products Covered: Detergents in contact with food

Regulation Type: Regular notification

Food safety Human health Contaminants

National Food Safety Standard for Detergents

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Distribution date: 29 November 2010 | Final date for Comment: 28 January 2011

This standard establishes requirements for detergents for cleaning food utensils, devices, vegetables and fruits.

Products Covered: Detergents in contact with food

Regulation Type: Regular notification

Food safety Human health Contaminants

National Food Safety Standard for Disinfectant

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Distribution date: 29 November 2010 | Final date for Comment: 28 January 2011

This standard establishes requirements for disinfectants for cleaning food utensils, devices, vegetables and fruits.

Products Covered: Disinfectants in contact with food

Regulation Type: Regular notification

Food safety Human health Contaminants

National Food Safety Standard for Disinfectant

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Distribution date: 29 November 2010 | Final date for Comment: 28 January 2011

This standard establishes requirements for disinfectants for cleaning food utensils, devices, vegetables and fruits.

Products Covered: Disinfectants in contact with food

Regulation Type: Regular notification

Food safety Human health Contaminants

National Food Safety Standard for Disinfection of Tableware

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Distribution date: 29 November 2010 | Final date for Comment: 28 January 2011

This standard establishes requirements for the disinfection of tableware.

Products Covered: Disinfectants

Regulation Type: Regular notification

Food safety Human health Contaminants

National Food Safety Standard for Disinfection of Tableware

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Distribution date: 29 November 2010 | Final date for Comment: 28 January 2011

This standard establishes requirements for the disinfection of tableware.

Products Covered: Disinfectants

Regulation Type: Regular notification

Food safety Human health Contaminants

Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 648/2004 as regards the use of phosphates and other phosphorous compounds in household laundry detergents (COM(2010) 597) (14 pages, in English).

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Distribution date: 26 November 2010 | Final date for Comment: 25 January 2011

The draft Regulation proposes to restrict the content of phosphates and other phosphorous compounds in household laundry detergents in the EU by setting an upper limit of 0.5% by weight of total phosphorus (P) content. ; The draft Regulation does not affect detergents for automatic dishwashers or those used by professionals (Institutional & Industrial detergents) as technically and economically feasible alternatives are not yet available throughout the EU but the proposal includes a review clause of the situation concerning automatic dishwashers detergents by end of 2014. ;

Products Covered: Detergents (CN Code 3402)

Regulation Type: Regular notification

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