Chemicals used for treatment of water intended for human consumption: Virgin granular activated carbon (8 pages in Hebrew and 24 pages in English).

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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

Human health

Chemicals used for treatment of water intended for human consumption: Virgin granular activated carbon (8 pages in Hebrew and 24 pages in English).

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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

Human health

Draft Regulation on Compounds of copper hydroxide

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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

Food safety Human health Pesticides Maximum residue limits (MRLs)

Draft Regulation on Compounds of copper hydroxide

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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

Food safety Human health Pesticides Maximum residue limits (MRLs)

Draft resolution on gibberellic acid

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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

Food safety Human health Pesticides Maximum residue limits (MRLs)

Draft resolution on gibberellic acid

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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

Food safety Human health Pesticides Maximum residue limits (MRLs)

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 ;

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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 ;

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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

Draft Supreme Decree amending certain articles of the regulations on the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products (9 pages, in Spanish).

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Distribution date: 14 February 2012

The notified draft Supreme Decree contains four articles, one final supplementary provision and five transitional supplementary provisions which amend certain articles of the regulations on the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products, approved by Supreme Decree No. 0162011SA, with a view to complementing the implementation of Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary products).

Products Covered: Perfumes and toilet waters (excl. aftershave lotions, personal deodorants and hair lotions) (HS code(s): 3303); Beauty or make-up preparations and preparations for the care of the skin, incl. sunscreen or sun tan preparations (excl. medicaments); manicure or pedicure preparations (HS code(s): 3304); Preparations for use on the hair (HS code(s): 3305); Soap; organic surface-active products and preparations for use as soap, in the form of bars, cakes, moulded pieces or shapes, whether or not containing soap; organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap; paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent (HS code(s): 3401); Organic surface-active agents (excl. soap); surface-active preparations, washing preparations, incl. auxiliary washing preparations, and cleaning preparations, whether or not containing soap (excl. those of heading 3401) (HS code(s): 3402); Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up for retail sale or as preparations or articles, e.g. sulphur-treated bands, wicks and candles, and fly-papers (HS code(s): 3808); Finishing agents, dye carriers to accelerate the dyeing or fixing of dyestuffs and other products and preparations such as dressings and mordants of a kind used in the textile, paper, leather or like industries, n.e.s. (HS code(s): 3809); Toilet paper and similar paper, cellulose wadding or webs of cellulose fibres, of a kind used for household or sanitary purposes, in rolls of a width

Regulation Type: Regular notification

Human health

Draft Supreme Decree amending certain articles of the regulations on the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products (9 pages, in Spanish).

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Distribution date: 14 February 2012

The notified draft Supreme Decree contains four articles, one final supplementary provision and five transitional supplementary provisions which amend certain articles of the regulations on the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products, approved by Supreme Decree No. 0162011SA, with a view to complementing the implementation of Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary products).

Products Covered: Perfumes and toilet waters (excl. aftershave lotions, personal deodorants and hair lotions) (HS code(s): 3303); Beauty or make-up preparations and preparations for the care of the skin, incl. sunscreen or sun tan preparations (excl. medicaments); manicure or pedicure preparations (HS code(s): 3304); Preparations for use on the hair (HS code(s): 3305); Soap; organic surface-active products and preparations for use as soap, in the form of bars, cakes, moulded pieces or shapes, whether or not containing soap; organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap; paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent (HS code(s): 3401); Organic surface-active agents (excl. soap); surface-active preparations, washing preparations, incl. auxiliary washing preparations, and cleaning preparations, whether or not containing soap (excl. those of heading 3401) (HS code(s): 3402); Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up for retail sale or as preparations or articles, e.g. sulphur-treated bands, wicks and candles, and fly-papers (HS code(s): 3808); Finishing agents, dye carriers to accelerate the dyeing or fixing of dyestuffs and other products and preparations such as dressings and mordants of a kind used in the textile, paper, leather or like industries, n.e.s. (HS code(s): 3809); Toilet paper and similar paper, cellulose wadding or webs of cellulose fibres, of a kind used for household or sanitary purposes, in rolls of a width

Regulation Type: Regular notification

Human health

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