Chemical Regulatory Updates – Latest Global Changes

AGENCY: Food and Drug Administration, Department of Health and Human Services (HHS) ; ; TITLE: Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma ; ; ACTION: Final rule ; ; SUMMARY: The Food and Drug Administration (FDA) is revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the ABC Codabar system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components. This final rule is intended to help ensure the continued safety of the blood supply and facilitate consistency in labeling. ; ; DATES: This rule is effective 2 July 2012 ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-01-03/html/2011-33554.htm http://www.gpo.gov/fdsys/pkg/FR-2012-01-03/pdf/2011-33554.pdf ;

Distribution date: 18 January 2012

Products Covered: Blood and blood components, including source plasma, labeling and storage requirements (HS Chapter 3002) (ICS 11)

Regulation Type: Addendum to Regular Notification

AGENCY: Food and Drug Administration, Department of Health and Human Services (HHS) ; ; TITLE: Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma ; ; ACTION: Final rule ; ; SUMMARY: The Food and Drug Administration (FDA) is revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the ABC Codabar system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components. This final rule is intended to help ensure the continued safety of the blood supply and facilitate consistency in labeling. ; ; DATES: This rule is effective 2 July 2012 ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-01-03/html/2011-33554.htm http://www.gpo.gov/fdsys/pkg/FR-2012-01-03/pdf/2011-33554.pdf ;

Distribution date: 18 January 2012

Products Covered: Blood and blood components, including source plasma, labeling and storage requirements (HS Chapter 3002) (ICS 11)

Regulation Type: Addendum to Regular Notification

Firelighters for igniting charcoal or wood for use in barbecue and grill appliances - Safety requirements and test methods (7 pages in Hebrew and 24 pages in English).

Distribution date: 17 January 2012 | Final date for Comment: 17 March 2012

Revision of the Mandatory Standard SI 5201. This draft standard revision adopts the European Standard EN 1860-3: August 2003 and A1: February 2006. ; The major differences between the old version and this new revised draft standard are as follows: ; { Adds a requirement to paragraph 4.1.1.1 dealing with the safety requirements of the firelighter composition, to provide a new manufacturer declaration. ; { Adds new test methods to paragraph 4.1.1.2. ; { Adds to Annex A.3 a reference to the charcoal used in Israel and a requirement that the charcoal used in the test should be the commercial type used in Israel. The type of charcoal should be mentioned in the test certificate. ; { Removes from Annexes B.3.1 and B.3.2 the requirement to measure the ignition time. ;

Products Covered: Firelighters for igniting charcoal or wood (ICS: 97.040.20 and 75.160.10; HS: 2710, 2933.90 and 3606.90).