Current Good Manufacturing Practice Requirements for Combination Products; proposed Rule (9 pages, English)
Distribution date: 02 October 2009 | Final date for Comment: 01 December 2009
The Food and Drug Administration (FDA or agency) proposes to codify the current good manufacturing practice (cGMP) requirements applicable to combination products. This proposed rule is intended to promote the public health by clarifying which cGMP requirements apply when drugs, devices, and biological products are combined to create a combination product. In addition, the proposed rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with cGMP requirements for single-entity and co-packaged combination products.
Products Covered: Combination products (HS: 3004, 9018.11-90) (ICS: 71.100, 13.020)
Regulation Type: Regular notification
Equipos y sustancias germicidas para tratamiento doméstico de agua - Requisitos sanitarios
Distribution date: 05 October 2009 | Final date for Comment: 26 April 2025
Domestic water treatment
Products Covered:
Regulation Type: Addendum to Regular Notification
TITLE: Hazard Communication; Proposed Rule ; ; AGENCY: Occupational Safety and Health Administration (OSHA), Department of Labor ; ; ACTION: Proposed Rule ; ; SUMMARY: OSHA is proposing to modify its existing Hazard Communication ; Standard (HCS) to conform with the United Nations' (UN) Globally Harmonized System of Classification and Labelling of Chemicals (GHS). OSHA has made a preliminary determination that the proposed modifications will improve the quality and consistency of information provided to employers and employees regarding chemical hazards and associated protective measures. The Agency anticipates this improved information will enhance the effectiveness of the HCS in ensuring that employees are apprised of the chemical hazards to which they may be exposed, and in reducing the incidence of chemical-related occupational illnesses and injuries. The proposed modifications to the standard include revised criteria for classification of chemical hazards; revised labeling provisions that include requirements for use of standardized signal words, pictograms, hazard statements, and precautionary statements; a specified format for safety data sheets; and related revisions to definitions of terms used in the standard, requirements for employee training on labels and safety data sheets. OSHA is also proposing to modify provisions of a number of other standards, including standards for flammable and combustible liquids, process safety management, and most substance-specific health standards, to ensure consistency with the modified HCS requirements. ; ; COMMENT DEADLINE: 29 December 2009 ; ; FOR FURTHER INFORMATION CONTACT: ; Maureen O'Donnell ; Directorate of Standards and Guidance ; OSHA ; U.S. Department of Labor ; 200 Constitution Avenue, NW, Room N-3718 ; Washington DC 20210 USA ; T: (202) 693-1950 ; ; Full text: ; http://edocket.access.gpo.gov/2009/E9-22483.htm ; http://edocket.access.gpo.gov/2009/pdf/E9-22483.pdf ;
Distribution date: 07 October 2009 | Final date for Comment: 26 April 2025
Products Covered: Chemicals (HS: Chapter 29 ) (ICS: 13, 71)
Regulation Type: Addendum to Regular Notification
Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (Revision of Agricultural Chemical residue standards)
Distribution date: 07 October 2009 | Final date for Comment: 06 December 2009
Proposed maximum residue limits (MRLs) for isotianil, fentrazamide and boscalid.
Products Covered: ・ Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) ・ Fish and crustaceans (HS Codes: 03.02, 03.03, 03.04, 03.06 and 03.07) ・ Dairy and eggs (HS: 04.01, 04.07 and 04.08) ・ Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.12, 07.13 and 07.14) ・ Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11, 08.13 and 08.14) ・ Coffee, mate and spices (HS Codes: 09.01, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) ・ Cereals (HS Codes: 10.03 and 10.06) ・ Oleaginous fruits; miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02 12.05, 12.06 and 12.10) ・ Vegetable oil (HS Codes: 15.08 and 15.14)
Regulation Type: Regular notification
"Portaria" n° 325, issued on 14 September 2009, published in the "Diário Oficial da União" Nº 178 (Federal Official Journal) from 17 September 2009, section 1, pages 4 to 9
Distribution date: 07 October 2009 | Final date for Comment: 15 November 2009
The notified document opens a 60-day public consultation on the draft proposal that establishes the rules regarding specifications, guarantees, registry, packaging and labelling of inoculants for use in agriculture.
Products Covered: Inoculants for use in agriculture
Regulation Type: Regular notification
Medida de carácter sanitario, requisitos fisicoquímicos y microbiológicos que deben cumplir los productos de la pesca
Distribution date: 08 October 2009 | Final date for Comment: 06 January 2010
Fish, molluscs and crustaceans
Products Covered:
Regulation Type: Addendum to Regular Notification
Proposed amendments to Standards & Specifications for Food-Contact Surface Sanitizing Solution
Distribution date: 16 October 2009 | Final date for Comment: 15 December 2009
To strengthen the safety management system for food-contact surface sanitizing solution, the proposed regulation removes 11 chemical agents from the list of ingredients for sanitizing solution formulation, integrates three analogues into one compound, and allows one additional substance for use. To clarify the scope of application of chemical compounds allowed for use in manufacturing sanitizing solution, chemical names of "silver" and "α-Alkyl(C11-C15)-ω-hydroxypoly(oxyethylene)with ethylene oxide content 9 to 13moles" are revised. The regulation also revises general standards for permitted the use of sanitizing solution.
Products Covered: Food-contact surface sanitizing solution
Regulation Type: Regular notification
Interim Marketing Authorization regarding the use of the phospholipase A2 enzyme derived from Aspergillus niger (PLA-54) in the production of bread, flour, whole wheat flour, unstandardized bakery products, unstandardized whole egg, unstandardized egg yolk and modified lecithin
Distribution date: 21 October 2009 | Final date for Comment: 24 December 2009
Health Canada has received a submission to permit the use of the phospholipase A2 enzyme derived from a genetically modified Aspergillus niger strain, Aspergillus niger (PLA-54), that carries the gene from a porcine pancreas coding for this enzyme. Phospholipase enzymes are classified under the broad class of lipase enzymes. This phospholipase A2 enzyme will be used in the production of bread, flour, whole wheat flour, unstandardized bakery products, unstandardized whole egg, unstandardized egg yolk and modified lecithin, at levels consistent with good manufacturing practice. Evaluation of the available data supports the safety and effectiveness of this phospholipase A2 derived from the genetically modified Aspergillus niger (PLA-54). Therefore, it is the intention of Health Canada to recommend that the Food and Drug Regulations be amended to permit the use of this phospholipase A2 enzyme derived from Aspergillus niger (PLA-54) in the production of bread, flour, whole wheat flour, unstandardized bakery products, unstandardized whole egg, unstandardized egg yolk and modified lecithin, at levels consistent with good manufacturing practice. As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization is being issued to permit the immediate use of this phospholipase A2 enzyme, as indicated above, while the regulatory process is undertaken to amend the Regulations. The proposed regulatory amendments would be enabling measures to allow the sale of the foods mentioned above that have been manufactured through the use of the phospholipase A2 enzyme derived from Aspergillus niger (PLA-54). The amendments are supported by the safety assessment and would have low impact on the economy and on the environment. Consequently, the regulatory amendments may proceed directly to final approval and publication in the Canada Gazette, Part II.
Products Covered: Bread, flour, whole wheat flour, unstandardized bakery products, unstandardized whole egg, unstandardized egg yolk and modified lecithin (ICS Codes: 67.060, 67.120)
Regulation Type: Regular notification
TITLE: Current Good Manufacturing Practice Requirements for Combination Products ; ; AGENCY: Food and Drug Administration (FDA) ; ; ACTION: Correction ; ; SUMMARY: The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of September 23, 2009 (74 FR 48423). The document proposed to codify the current good manufacturing practice requirements applicable to combination products. The document published with an incorrect docket number. This document corrects that error. ; ; The correct Docket number is: [Docket No. FDA-2009-N-0435]. ; ; FOR FURTHER INFORMATION CONTACT: ; Joyce Strong ; Office of Policy (HF-27) ; Food and Drug Administration ; 5600 Fishers Lane ; Rockville, MD 20857 ; Telephone: 301-827-7010 ; ; Full texts: ; http://edocket.access.gpo.gov/2009/E9-23899.htm ; http://edocket.access.gpo.gov/2009/pdf/E9-23899.pdf ;
Distribution date: 28 October 2009 | Final date for Comment: 26 April 2025
Products Covered: Combination products (HS: 3004, 9018.11-90) (ICS: 71.100, 13.020)
Regulation Type: Corrigendum to Regular Notification
Proposed amendment of Safety Criterion for consumer products subject to the self-regulatory safety confirmation (Korean)
Distribution date: 28 October 2009 | Final date for Comment: 27 December 2009
KATS will: ; The safety standard of 'Adhesives' subject to Self-regulatory Safety Confirmation has been revised. ; - 'Adhesives for Wigs' to the category of adhesives which are the item for Self-regulatory Safety Confirmation applied additionally. ; - As to the safety standards for harmful material of adhesives for wigs - Newly prescribed the regulation to prohibit the use of Triphenyltin (TPT) compounds, Tributyltin (TBT) ; compounds, and organomercury compounds, and to limit the use of toluene and formaldehyde to 20 mg/kg or less. ; - Lowered the allowable standard for the content of toluene in adhesives for general consumers from 10% to 0.1%, but 10% for adhesives for professionals maintained at the current level. ; - It is newly prescribed that the allowable standard for the content of formaldehyde in adhesives should be smaller than 1.0%. ;
Products Covered: Adhesives (HS: 3506)
Regulation Type: Regular notification
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