TITLE: Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers ; ; AGENCY: Food and Drug Administration (FDA), Health and Human Services (HHS) ; ; ACTION: Final rule ; ; SUMMARY: The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) and copolymers of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) as color additives in contact lenses. This action is in response to two color additive petitions (CAPs) filed by CooperVision, Inc. ; ; DATES: This rule is effective 2 May 2013; except as to any provisions that may be stayed by the filing of proper objections. See section VII for related information on the filing of objections. Submit either electronic or written objections and requests for a hearing by 1 May 2013. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2013-04-01/html/2013-07294.htm ; http://www.gpo.gov/fdsys/pkg/FR-2013-04-01/pdf/2013-07294.pdf ; ; ;
Distribution date: 08 April 2013
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Addendum to Regular Notification
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of the Enzyme Asparaginase, obtained from Aspergillus oryzae (pCaHj621/BECh2#10), in Green Coffee - Reference Number: NOM/ADM-0007
Distribution date: 02 April 2013 | Final date for Comment: 07 June 2013
This document provides information on Health Canada's modification to the List of Permitted Food Enzymes to enable the use of the enzyme asparaginase, in green coffee. Health Canada's Food Directorate has completed a detailed safety assessment of a food additive submission seeking to enable the use of the enzyme asparaginase, obtained from Aspergillus oryzae (pCaHj621/BECh2#10), in green coffee. Health Canada previously approved the use of this food additive in other food applications described in the List of Permitted Food Enzymes. As no safety concerns were raised through this assessment, and since this food additive is already approved for use in other foods in Canada, the Department is enabling its use as described in the information document below. The purpose of this communication is to publically announce the Department's decision in this regard and to provide the appropriate contact information for any inquiries or for those wishing to submit any new scientific information relevant to the safety of this additive.
Products Covered: Asparaginase in green coffee (ICS Codes: 67.140, 67.220)
Regulation Type: Regular notification
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of the Enzyme Asparaginase, obtained from Aspergillus oryzae (pCaHj621/BECh2#10), in Green Coffee - Reference Number: NOM/ADM-0007
Distribution date: 02 April 2013 | Final date for Comment: 07 June 2013
This document provides information on Health Canada's modification to the List of Permitted Food Enzymes to enable the use of the enzyme asparaginase, in green coffee. Health Canada's Food Directorate has completed a detailed safety assessment of a food additive submission seeking to enable the use of the enzyme asparaginase, obtained from Aspergillus oryzae (pCaHj621/BECh2#10), in green coffee. Health Canada previously approved the use of this food additive in other food applications described in the List of Permitted Food Enzymes. As no safety concerns were raised through this assessment, and since this food additive is already approved for use in other foods in Canada, the Department is enabling its use as described in the information document below. The purpose of this communication is to publically announce the Department's decision in this regard and to provide the appropriate contact information for any inquiries or for those wishing to submit any new scientific information relevant to the safety of this additive.
Products Covered: Asparaginase in green coffee (ICS Codes: 67.140, 67.220)
Regulation Type: Regular notification
Feed and food of non-animal origin
Distribution date: 27 March 2013
The revision of Commission Regulation (EC) No 669/2009 has been adopted as "Commission Implementing Regulation (EU) No 270/2013 of 21 March 2013 amending Annex I to Regulation (EC) No 669/2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin" (L 82, 22 March 2013, pp.47-48). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:082:0047:0048:EN:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:082:0047:0048:ES:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:082:0047:0048:FR:PDF
Products Covered:
Regulation Type: Addendum to Regular Notification
Turkish Food Codex Communiqué on Lokum (Turkish Delight) (4 pages, in English).
Distribution date: 02 April 2013 | Final date for Comment: 01 June 2013
Communiqué concerning Turkish Food Codex-Communiqué on Lokum (Turkish Delight) (Communiqué No: 2004/24 Official Journal: 22.05.2004-25469) has been published in order to regulate the national legislation and to put a certain standard for these products. This Communiqué identifies the characteristics of Lokum for production, preparation, processing, storing and handling and putting into markets in compliance with the relevant technical and hygienic conditions. The decision has been given on the purpose of revising the present Communiqué due to the necessity of extending the scope of the above mentioned legislation, overcoming the current issues and, at the same time, enabling the compliance with the international legislation. ; This Communiqué covers all varieties of Lokum (Turkish Delight) produced in Turkey and the physical and chemical characteristics of the products are determined. In addition, specific rules have been added for sampling and methods of analysis, transportation and sale. ; Note: This document has also been notified under the SPS Agreement. ;
Products Covered: Lokum (Turkish Delight) (HS Code: 1704,1705) (ICS: 67.040).
Regulation Type: Regular notification
Feed and food of non-animal origin
Distribution date: 27 March 2013
The revision of Commission Regulation (EC) No 669/2009 has been adopted as "Commission Implementing Regulation (EU) No 270/2013 of 21 March 2013 amending Annex I to Regulation (EC) No 669/2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin" (L 82, 22 March 2013, pp.47-48). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:082:0047:0048:EN:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:082:0047:0048:ES:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:082:0047:0048:FR:PDF
Products Covered:
Regulation Type: Addendum to Regular Notification
Fertilizing Materials (4 pages, in English)
Distribution date: 22 March 2013 | Final date for Comment: 22 April 2013
Establishes conditions when a fertilizing material is considered an organic input material requiring labeling and registration, mandates a laboratory analysis to be included with a product label during registration under specified circumstances, and clarifies sampling and recordkeeping requirements.
Products Covered: Fertilizing materials (HS Chapter 31; ICS: 65.080)
Regulation Type: Regular notification
Fertilizing Materials (4 pages, in English)
Distribution date: 22 March 2013 | Final date for Comment: 22 April 2013
Establishes conditions when a fertilizing material is considered an organic input material requiring labeling and registration, mandates a laboratory analysis to be included with a product label during registration under specified circumstances, and clarifies sampling and recordkeeping requirements.
Products Covered: Fertilizing materials (HS Chapter 31; ICS: 65.080)
Regulation Type: Regular notification
TITLE: Safer Consumer Products ; ; AGENCY: California Department of Toxic Substances Control ; ; ACTION: Notice of Public Availability of Documents Added to the Rulemaking File and Extension of Comment ; ; SUMMARY: Notice is hereby given, pursuant to Government Code section 11347.1, subdivision (b), that the Department of Toxic Substances Control (DTSC) has added the following documents to the Safer Consumer Products rulemaking file, which was published in the California Regulatory Notice Register (Z-2012-0717-04) on July 27, 2012: ; ; (1) External Scientific Peer Review Reports ; DTSC has added nine external scientific peer review reports to the rulemaking file. DTSC has complied with Health and Safety Code section 57004, regarding submission of the scientific portions of the January 29, 2013, post-hearing changes to the proposed safer consumer product regulations to an external scientific peer review. The documents were submitted to scientific peer reviewers through the University of California. Their written reports, which contain an evaluation of the scientific basis of the post-hearing changes to the proposed regulations, have been added to the rulemaking file. ; ; (2) California Environmental Policy Council Resolution ; DTSC has also added to the rulemaking file the California Environmental Policy Council (Council) resolution adopted on February 28, 2013. Health and Safety Code section 25252.5, subject to a specified exception, requires DTSC to prepare, and submit to the Council for review, a multimedia life cycle evaluation prior to adopting these regulations. However, the law provides an exception to this requirement if the Council conclusively determines that the regulations will not have any significant adverse impacts on public health or the environment. During the February 28, 2013, meeting of the Council written and oral testimony was accepted on the issue described herein. The Council unanimously made a conclusive determination that the adoption of these regulations would not have a significant adverse impact on public health or the environment. Thus, DTSC is not required to prepare a multimedia life cycle evaluation for these regulations. ; ; A public comment period for the documents added to the rulemaking file, as described above, will commence on 13 March 2013, and close at 5 p.m. on 28 March 2013. ; ; Interested persons may submit comments by e-mail to [email protected], by fax to ; (916) 324-1808, or by mail to: ; ; Ms. Jackie Buttle ; Acting Regulations Coordinator ; Department of Toxic Substances Control ; P.O. Box 806 ; Sacramento, CA 95812-0806 ; ; URLs: ; http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/index.cfm ; http://www.dtsc.ca.gov/SCPRegulations.cfm ;
Distribution date: 22 March 2013
Products Covered: Chemicals (HS Chapter 38; ICS 71.100)
Regulation Type: Addendum to Regular Notification
TITLE: Safer Consumer Products ; ; AGENCY: California Department of Toxic Substances Control ; ; ACTION: Notice of Public Availability of Documents Added to the Rulemaking File and Extension of Comment ; ; SUMMARY: Notice is hereby given, pursuant to Government Code section 11347.1, subdivision (b), that the Department of Toxic Substances Control (DTSC) has added the following documents to the Safer Consumer Products rulemaking file, which was published in the California Regulatory Notice Register (Z-2012-0717-04) on July 27, 2012: ; ; (1) External Scientific Peer Review Reports ; DTSC has added nine external scientific peer review reports to the rulemaking file. DTSC has complied with Health and Safety Code section 57004, regarding submission of the scientific portions of the January 29, 2013, post-hearing changes to the proposed safer consumer product regulations to an external scientific peer review. The documents were submitted to scientific peer reviewers through the University of California. Their written reports, which contain an evaluation of the scientific basis of the post-hearing changes to the proposed regulations, have been added to the rulemaking file. ; ; (2) California Environmental Policy Council Resolution ; DTSC has also added to the rulemaking file the California Environmental Policy Council (Council) resolution adopted on February 28, 2013. Health and Safety Code section 25252.5, subject to a specified exception, requires DTSC to prepare, and submit to the Council for review, a multimedia life cycle evaluation prior to adopting these regulations. However, the law provides an exception to this requirement if the Council conclusively determines that the regulations will not have any significant adverse impacts on public health or the environment. During the February 28, 2013, meeting of the Council written and oral testimony was accepted on the issue described herein. The Council unanimously made a conclusive determination that the adoption of these regulations would not have a significant adverse impact on public health or the environment. Thus, DTSC is not required to prepare a multimedia life cycle evaluation for these regulations. ; ; A public comment period for the documents added to the rulemaking file, as described above, will commence on 13 March 2013, and close at 5 p.m. on 28 March 2013. ; ; Interested persons may submit comments by e-mail to [email protected], by fax to ; (916) 324-1808, or by mail to: ; ; Ms. Jackie Buttle ; Acting Regulations Coordinator ; Department of Toxic Substances Control ; P.O. Box 806 ; Sacramento, CA 95812-0806 ; ; URLs: ; http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/index.cfm ; http://www.dtsc.ca.gov/SCPRegulations.cfm ;
Distribution date: 22 March 2013
Products Covered: Chemicals (HS Chapter 38; ICS 71.100)
Regulation Type: Addendum to Regular Notification
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