Chemicals used for treatment of water intended for human consumption: Sodium chlorite (9 pages in Hebrew and 38 pages in English and French).
Distribution date: 11 August 2011 | Final date for Comment: 10 October 2011
Revision of the Mandatory Standard SI 5438 part 8. This draft standard revision adopts the European Standard EN 938: January 2009. The major differences between the old version and this new revised draft standard are detailed in page 3 of the European Standard (Foreword). In addition, here are the major changes that appear in the standard's Hebrew section: ; -Deletes from table 6 of paragraph 4.4 the requirements for type 2 sodium chlorite, leaving only one type. ; -Adds new sampling methods to paragraph 5.1.3 dealing with sampling from tanks and tankers. ; -Adds references to other international analysis methods in addition to the European method described in paragraph 5.2, as well as amending its formulas. ; -Adds to paragraph 6 dealing with labelling-transportation-storage a requirement to comply also with Israel Mandatory Standards SI 2032 parts 1 and 2. ; -Changes paragraph 6.4 dealing with marking by adding a requirement to mark in Hebrew and by adding a requirement to mark the concentration of sodium chlorite. ; ;
Products Covered: Chemicals used for treatment of water intended for human consumption (ICS: 71.100.80; HS: 2829.1011).
Regulation Type: Regular notification
Chemicals used for treatment of water intended for human consumption: Sodium chlorite (9 pages in Hebrew and 38 pages in English and French).
Distribution date: 11 August 2011 | Final date for Comment: 10 October 2011
Revision of the Mandatory Standard SI 5438 part 8. This draft standard revision adopts the European Standard EN 938: January 2009. The major differences between the old version and this new revised draft standard are detailed in page 3 of the European Standard (Foreword). In addition, here are the major changes that appear in the standard's Hebrew section: ; -Deletes from table 6 of paragraph 4.4 the requirements for type 2 sodium chlorite, leaving only one type. ; -Adds new sampling methods to paragraph 5.1.3 dealing with sampling from tanks and tankers. ; -Adds references to other international analysis methods in addition to the European method described in paragraph 5.2, as well as amending its formulas. ; -Adds to paragraph 6 dealing with labelling-transportation-storage a requirement to comply also with Israel Mandatory Standards SI 2032 parts 1 and 2. ; -Changes paragraph 6.4 dealing with marking by adding a requirement to mark in Hebrew and by adding a requirement to mark the concentration of sodium chlorite. ; ;
Products Covered: Chemicals used for treatment of water intended for human consumption (ICS: 71.100.80; HS: 2829.1011).
Regulation Type: Regular notification
TITLE: Labeling for Bronchodilators To Treat Asthma; Cold, Cough, ; Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the- ; Counter Human Use ; ; AGENCY: Food and Drug Administration, HHS. ; ; ACTION: Final rule. ; ; SUMMARY: The Food and Drug Administration (FDA) is amending the final ; monograph (FM) for over-the-counter (OTC) bronchodilator drug products ; to add additional warnings (e.g., an ``Asthma alert'') and to revise ; the indications, warnings, and directions in the labeling of products ; containing the ingredients ephedrine, ephedrine hydrochloride, ; ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine ; hydrochloride, and racepinephrine hydrochloride. FDA is issuing this ; final rule after considering data and information submitted in response ; to the Agency's proposed labeling revisions for these products. This ; final rule is part of FDA's ongoing review of OTC drug products. ; ; DATES: ; ; Effective Date: This regulation is effective 23 January 2012. ; ; Compliance Date: The compliance date for all products, regardless ; of annual sales, is 23 January 2012. ; ; FULL TEXT URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18347.htm ; http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/pdf/2011-18347.pdf ;
Distribution date: 04 August 2011
Products Covered: Human Drug Products (HS Chapter 30; ICS 11.120)
Regulation Type: Addendum to Regular Notification
TITLE: Labeling for Bronchodilators To Treat Asthma; Cold, Cough, ; Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the- ; Counter Human Use ; ; AGENCY: Food and Drug Administration, HHS. ; ; ACTION: Final rule. ; ; SUMMARY: The Food and Drug Administration (FDA) is amending the final ; monograph (FM) for over-the-counter (OTC) bronchodilator drug products ; to add additional warnings (e.g., an ``Asthma alert'') and to revise ; the indications, warnings, and directions in the labeling of products ; containing the ingredients ephedrine, ephedrine hydrochloride, ; ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine ; hydrochloride, and racepinephrine hydrochloride. FDA is issuing this ; final rule after considering data and information submitted in response ; to the Agency's proposed labeling revisions for these products. This ; final rule is part of FDA's ongoing review of OTC drug products. ; ; DATES: ; ; Effective Date: This regulation is effective 23 January 2012. ; ; Compliance Date: The compliance date for all products, regardless ; of annual sales, is 23 January 2012. ; ; FULL TEXT URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18347.htm ; http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/pdf/2011-18347.pdf ;
Distribution date: 04 August 2011
Products Covered: Human Drug Products (HS Chapter 30; ICS 11.120)
Regulation Type: Addendum to Regular Notification
Nisso America, Inc.; Food Additive Permitted for Direct Addition to Food for Human Consumption; Hydroxypropyl Cellulose; FAP 0A4780
Distribution date: 26 July 2011 | Final date for Comment: 15 August 2011
The Food and Drug Administration (FDA) is amending the food additive regulations for hydroxypropyl cellulose by lowering the minimum permitted viscosity from 145 centipoises (cPs) to 10 cPs and to permit its use as a binder in dietary supplements. This action is in response to a petition filed by Nisso America, Inc. This addendum concerns a notification of adoption, publication or entry into force of regulation. This final rule can be found in the Federal Register of 15 July 2011 at Federal Register: 15 July 2011 (Volume 76, Number 136) Rules and Regulations; Page 41687-41689 or online at http://www.gpo.gov/fdsys/pkg/FR-2011-07-15/pdf/2011-17928.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Nisso America, Inc.; Food Additive Permitted for Direct Addition to Food for Human Consumption; Hydroxypropyl Cellulose; FAP 0A4780
Distribution date: 26 July 2011 | Final date for Comment: 15 August 2011
The Food and Drug Administration (FDA) is amending the food additive regulations for hydroxypropyl cellulose by lowering the minimum permitted viscosity from 145 centipoises (cPs) to 10 cPs and to permit its use as a binder in dietary supplements. This action is in response to a petition filed by Nisso America, Inc. This addendum concerns a notification of adoption, publication or entry into force of regulation. This final rule can be found in the Federal Register of 15 July 2011 at Federal Register: 15 July 2011 (Volume 76, Number 136) Rules and Regulations; Page 41687-41689 or online at http://www.gpo.gov/fdsys/pkg/FR-2011-07-15/pdf/2011-17928.pdf
Products Covered:
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: 26 July 2011 | Final date for Comment: 24 September 2011
: Proposed maximum residue limits (MRLs) for agricultural chemicals pesticides: Ethychlozate, Oxyfluorfen, and Pymetrozine; veterinary drugs: Clavulanic acid and Prifinium.
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) Dairy produce, bird's eggs and natural honey (HS Codes: 04.01,04.07, 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 and 08.14) Coffee, tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.08 and 12.12 Animal or vegetable fats and oils (HS Codes: 15.01 and 15.02)
Regulation Type: 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: 26 July 2011 | Final date for Comment: 24 September 2011
: Proposed maximum residue limits (MRLs) for agricultural chemicals pesticides: Ethychlozate, Oxyfluorfen, and Pymetrozine; veterinary drugs: Clavulanic acid and Prifinium.
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) Dairy produce, bird's eggs and natural honey (HS Codes: 04.01,04.07, 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 and 08.14) Coffee, tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.08 and 12.12 Animal or vegetable fats and oils (HS Codes: 15.01 and 15.02)
Regulation Type: Regular notification
Draft Commission Regulation amending Regulation (EC) No 2003/2003 of the European Parliament and of the Council relating to fertilisers for the purposes of adapting Annexes I and IV thereto to technical progress
Distribution date: 25 July 2011 | Final date for Comment: 23 September 2011
The purposes of the legislative proposal are: ; o To allow the use of calcium borate, copper oxide and manganese oxide as ingredients for the manufacture of fertiliser suspensions. One chelating agent, one complexing agent, two nitrification inhibitors and one urease inhibitor are also proposed for inclusion in the respective lists of authorised substances. ; o To revise the rules for mixture of micro-nutrient fertilisers. ; o To introduce type designations to allow the use of authorised complexing agents listed in Section E.3.2. ; o To modify the rules for micronutrient solutions to allow the use of one complexing agent in such fertilisers. ; o To introduce reference to EN Standards to simplify legislation. ;
Products Covered: Fertilisers (HS:31)
Regulation Type: Regular notification
Draft Commission Regulation amending Regulation (EC) No 2003/2003 of the European Parliament and of the Council relating to fertilisers for the purposes of adapting Annexes I and IV thereto to technical progress
Distribution date: 25 July 2011 | Final date for Comment: 23 September 2011
The purposes of the legislative proposal are: ; o To allow the use of calcium borate, copper oxide and manganese oxide as ingredients for the manufacture of fertiliser suspensions. One chelating agent, one complexing agent, two nitrification inhibitors and one urease inhibitor are also proposed for inclusion in the respective lists of authorised substances. ; o To revise the rules for mixture of micro-nutrient fertilisers. ; o To introduce type designations to allow the use of authorised complexing agents listed in Section E.3.2. ; o To modify the rules for micronutrient solutions to allow the use of one complexing agent in such fertilisers. ; o To introduce reference to EN Standards to simplify legislation. ;
Products Covered: Fertilisers (HS:31)
Regulation Type: Regular notification
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