Regulatory Updates
Proposal for a Directive of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles (COM(2011) 764) ( 96 pages, in English, French and Spanish).
Distribution date: 27 February 2012 | Final date for Comment: 27 April 2012
This proposed Directive is a recast of Directive 2007/23/EC to align it to the New Legislative Framework and in particular to Decision No 768/2008/EC. ; The changes made to the provisions of Directive 2007/23/EC concern: the definitions, the obligations of economic operators, the presumption of conformity provided by harmonised standards, the declaration of conformity, CE marking, notified bodies, the safeguard clause procedure and the conformity assessment procedures. ; The proposal does not change the scope of the Directive and the essential safety requirements, except for the essential safety requirements relating to the use of commercial blasting agents and military explosives, which some pyrotechnic articles, notably automotive pyrotechnic articles such as air bag gas generators, contain in small amounts. ;
Products Covered: Fireworks and other pyrotechnic articles (HS 3604).
Regulation Type: Regular notification
Proposal for a Directive of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles (COM(2011) 764) ( 96 pages, in English, French and Spanish).
Distribution date: 27 February 2012 | Final date for Comment: 27 April 2012
This proposed Directive is a recast of Directive 2007/23/EC to align it to the New Legislative Framework and in particular to Decision No 768/2008/EC. ; The changes made to the provisions of Directive 2007/23/EC concern: the definitions, the obligations of economic operators, the presumption of conformity provided by harmonised standards, the declaration of conformity, CE marking, notified bodies, the safeguard clause procedure and the conformity assessment procedures. ; The proposal does not change the scope of the Directive and the essential safety requirements, except for the essential safety requirements relating to the use of commercial blasting agents and military explosives, which some pyrotechnic articles, notably automotive pyrotechnic articles such as air bag gas generators, contain in small amounts. ;
Products Covered: Fireworks and other pyrotechnic articles (HS 3604).
Regulation Type: Regular notification
Chemicals used for treatment of water intended for human consumption: Virgin granular activated carbon (8 pages in Hebrew and 24 pages in English).
Distribution date: 24 February 2012 | Final date for Comment: 24 April 2012
Revision of the Mandatory Standard SI 5438 part 13. This draft standard revision adopts the European Standard EN 12915-1: March 2009. ; The major differences included in the Hebrew section are as follows: ;  Adds to paragraph 5.2 dealing with particle size distribution, a new requirement for test certificate for particle size distribution performed during production, instead of the sample required in the old version. ;  Adds to paragraph 6.2.3 dealing with water-extractable substances, a maximum limit of 0.05 µg/l for benzo (a) pyrene, instead of the requirement for polycyclic aromatic hydrocarbons (PAH) that appeared in the old version. ;  Adds new advanced test methods to paragraph 8. ;  Adds to paragraph 9, dealing with labelling, transportation and storage, a requirement to comply also with Israel Mandatory Standard SI 2302 parts 1 and 2. ;  Adds to paragraph 9.4 a new requirement for Hebrew marking. ;  Adds to Annex A a new reference and a new requirement to provide a safety sheet (MSDS). ;
Products Covered: Chemicals used for treatment of water intended for human consumption (ICS: 71.100.80; HS: 3802.10).
Regulation Type: Regular notification
Chemicals used for treatment of water intended for human consumption: Virgin granular activated carbon (8 pages in Hebrew and 24 pages in English).
Distribution date: 24 February 2012 | Final date for Comment: 24 April 2012
Revision of the Mandatory Standard SI 5438 part 13. This draft standard revision adopts the European Standard EN 12915-1: March 2009. ; The major differences included in the Hebrew section are as follows: ;  Adds to paragraph 5.2 dealing with particle size distribution, a new requirement for test certificate for particle size distribution performed during production, instead of the sample required in the old version. ;  Adds to paragraph 6.2.3 dealing with water-extractable substances, a maximum limit of 0.05 µg/l for benzo (a) pyrene, instead of the requirement for polycyclic aromatic hydrocarbons (PAH) that appeared in the old version. ;  Adds new advanced test methods to paragraph 8. ;  Adds to paragraph 9, dealing with labelling, transportation and storage, a requirement to comply also with Israel Mandatory Standard SI 2302 parts 1 and 2. ;  Adds to paragraph 9.4 a new requirement for Hebrew marking. ;  Adds to Annex A a new reference and a new requirement to provide a safety sheet (MSDS). ;
Products Covered: Chemicals used for treatment of water intended for human consumption (ICS: 71.100.80; HS: 3802.10).
Regulation Type: Regular notification
Draft Regulation on Compounds of copper hydroxide
Distribution date: 17 February 2012 | Final date for Comment: 10 March 2012
This draft sanitary regulation modifies Resolution RE nº165, 29 August 2003, by including in it the use of copper hydroxide in the culture of soy (Leaf application).
Products Covered: Copper hydroxide
Regulation Type: Regular notification
Draft Regulation on Compounds of copper hydroxide
Distribution date: 17 February 2012 | Final date for Comment: 10 March 2012
This draft sanitary regulation modifies Resolution RE nº165, 29 August 2003, by including in it the use of copper hydroxide in the culture of soy (Leaf application).
Products Covered: Copper hydroxide
Regulation Type: Regular notification
Draft resolution on gibberellic acid
Distribution date: 17 February 2012 | Final date for Comment: 10 March 2012
This draft sanitary regulation modifies Resolution RE nº165, 29 August 2003, by changing in it the use of gibberellic acid in the cultures of banana (Brushing or immersion, MRL and safety period not determined due type of application).
Products Covered: Gibberellic acid
Regulation Type: Regular notification
Draft resolution on gibberellic acid
Distribution date: 17 February 2012 | Final date for Comment: 10 March 2012
This draft sanitary regulation modifies Resolution RE nº165, 29 August 2003, by changing in it the use of gibberellic acid in the cultures of banana (Brushing or immersion, MRL and safety period not determined due type of application).
Products Covered: Gibberellic acid
Regulation Type: Regular notification
AGENCY: Department of Health and Human Services (HHS), Food and Drug Administration (FDA) ; ; TITLE: Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma; correction ; ; ACTION: Final rule; correction ; ; SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of 3 January 2012. In the Federal Register of 3 January 2012, FDA published a final rule entitled Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma, which provided incorrect publication information regarding a 60-day notice that announced the availability of an opportunity for public comment on the proposed collection of certain information by FDA pertaining to the final rule. This document corrects this error. ; ; DATES: This rule is effective 2 July 2012. ; ; URL: ; http://www.gpo.gov/fdsys/pkg/FR-2012-02-08/html/2012-2828.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-02-08/pdf/2012-2828.pdf ;
Distribution date: 16 February 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: Department of Health and Human Services (HHS), Food and Drug Administration (FDA) ; ; TITLE: Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma; correction ; ; ACTION: Final rule; correction ; ; SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of 3 January 2012. In the Federal Register of 3 January 2012, FDA published a final rule entitled Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma, which provided incorrect publication information regarding a 60-day notice that announced the availability of an opportunity for public comment on the proposed collection of certain information by FDA pertaining to the final rule. This document corrects this error. ; ; DATES: This rule is effective 2 July 2012. ; ; URL: ; http://www.gpo.gov/fdsys/pkg/FR-2012-02-08/html/2012-2828.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-02-08/pdf/2012-2828.pdf ;
Distribution date: 16 February 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
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