TITLE: Labeling of Pesticide Products and Devices for Export; Clarification of Requirements ; ; AGENCY: Environmental Protection Agency (EPA) ; ; ACTION: Final rule ; ; SUMMARY: EPA is revising the regulations on the labeling of pesticide products and devices intended solely for export. Specifically, EPA is restructuring the current regulations to clarify which provisions apply under various circumstances. EPA is also increasing specificity in the regulations by requiring that people who transfer unregistered pesticide products between registered establishments operated by the same producer within the United States must also comply with the requirements of this part if those products are intended solely for export at the time of such transfer. EPA believes that this requirement is necessary to ensure appropriate handling of such products as they move in commerce before they actually leave the United States. ; ; DATES: This final rule is effective 19 March 2013. The compliance date for the requirement to label unregistered pesticide products intended solely for export that are being shipped between registered establishments operated by the same producer is 21 January 2014. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2013-01-18/html/2013-01055.htm ; http://www.gpo.gov/fdsys/pkg/FR-2013-01-18/pdf/2013-01055.pdf ;
Distribution date: 31 January 2013
Products Covered: Pesticides (HS 3808; ICS 13.020, 13.300, 65.100.01)
Regulation Type: Addendum to Regular Notification
TITLE: Labeling of Pesticide Products and Devices for Export; Clarification of Requirements ; ; AGENCY: Environmental Protection Agency (EPA) ; ; ACTION: Final rule ; ; SUMMARY: EPA is revising the regulations on the labeling of pesticide products and devices intended solely for export. Specifically, EPA is restructuring the current regulations to clarify which provisions apply under various circumstances. EPA is also increasing specificity in the regulations by requiring that people who transfer unregistered pesticide products between registered establishments operated by the same producer within the United States must also comply with the requirements of this part if those products are intended solely for export at the time of such transfer. EPA believes that this requirement is necessary to ensure appropriate handling of such products as they move in commerce before they actually leave the United States. ; ; DATES: This final rule is effective 19 March 2013. The compliance date for the requirement to label unregistered pesticide products intended solely for export that are being shipped between registered establishments operated by the same producer is 21 January 2014. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2013-01-18/html/2013-01055.htm ; http://www.gpo.gov/fdsys/pkg/FR-2013-01-18/pdf/2013-01055.pdf ;
Distribution date: 31 January 2013
Products Covered: Pesticides (HS 3808; ICS 13.020, 13.300, 65.100.01)
Regulation Type: Addendum to Regular Notification
Draft Ministry of Public Health (MOPH) Measure on entitled "Food Additives (No. 4): Steviol glycoside"
Distribution date: 31 January 2013 | Final date for Comment: 11 February 2013
In response to international requests regarding the Draft Ministry of Public Health Notification, entitled "Food Additives (No. 4): Steviol glycoside", notification G/SPS/N/THA/211, an extension period is provided until 11 February 2013.
Products Covered:
Regulation Type: Addendum to Regular Notification
Draft Ministry of Public Health (MOPH) Measure on entitled "Food Additives (No. 4): Steviol glycoside"
Distribution date: 31 January 2013 | Final date for Comment: 11 February 2013
In response to international requests regarding the Draft Ministry of Public Health Notification, entitled "Food Additives (No. 4): Steviol glycoside", notification G/SPS/N/THA/211, an extension period is provided until 11 February 2013.
Products Covered:
Regulation Type: Addendum to Regular Notification
TITLE: Current Good Manufacturing Practice Requirements for Combination Products ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Final rule ; ; SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the 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. ; ; DATES: This rule is effective 22 July 2013. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2013-01-22/html/2013-01068.htm ; http://www.gpo.gov/fdsys/pkg/FR-2013-01-22/pdf/2013-01068.pdf ; ;
Distribution date: 31 January 2013
Products Covered: Combination products (HS: 3004, 9018.11-90) (ICS: 71.100, 13.020)
Regulation Type: Addendum to Regular Notification
TITLE: Current Good Manufacturing Practice Requirements for Combination Products ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Final rule ; ; SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the 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. ; ; DATES: This rule is effective 22 July 2013. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2013-01-22/html/2013-01068.htm ; http://www.gpo.gov/fdsys/pkg/FR-2013-01-22/pdf/2013-01068.pdf ; ;
Distribution date: 31 January 2013
Products Covered: Combination products (HS: 3004, 9018.11-90) (ICS: 71.100, 13.020)
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: 28 January 2013 | Final date for Comment: 29 March 2013
Proposed maximum residue limits (MRLs) for the following agricultural chemicals. Pesticides: Phenthoate and Spirodiclofen
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06 and 02.08) - Dairy produce, birds' eggs and natural honey (HS Code: 04.01) - Products of animal origin, not elsewhere specified or included (HS Code: 05.04) - 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, 07.13 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: 09.01, 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 and 12.10) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
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: 28 January 2013 | Final date for Comment: 29 March 2013
Proposed maximum residue limits (MRLs) for the following agricultural chemicals. Pesticides: Phenthoate and Spirodiclofen
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06 and 02.08) - Dairy produce, birds' eggs and natural honey (HS Code: 04.01) - Products of animal origin, not elsewhere specified or included (HS Code: 05.04) - 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, 07.13 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: 09.01, 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 and 12.10) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Communiqué No: 2013/1 Conformity Assessment to Standards in Importing (30 pages, available in Turkish).
Distribution date: 23 January 2013
<a name="sps6a"><span style="color:#000000;font-face:Verdana;font-size:x-small;"><span style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;">The purpose of this Communiqué is to regulate the ; principles and procedures for the import controls of the products which are ; listed in Annex-1, to ensure<span style="mso-spacerun:yes;"> </span>conformity ; to standards or technical regulations</span></span></a>
Products Covered: Communiqué on some industrial products which are subject to control to check conformity with mandatory standards (HS Code; Listed in Annex-1).
Regulation Type: Regular notification
Communiqué No: 2013/1 Conformity Assessment to Standards in Importing (30 pages, available in Turkish).
Distribution date: 23 January 2013
<a name="sps6a"><span style="color:#000000;font-face:Verdana;font-size:x-small;"><span style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;">The purpose of this Communiqué is to regulate the ; principles and procedures for the import controls of the products which are ; listed in Annex-1, to ensure<span style="mso-spacerun:yes;"> </span>conformity ; to standards or technical regulations</span></span></a>
Products Covered: Communiqué on some industrial products which are subject to control to check conformity with mandatory standards (HS Code; Listed in Annex-1).
Regulation Type: Regular notification
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