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
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 | Final date for Comment: 12 May 2025
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Addendum to Regular Notification
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 | Final date for Comment: 12 May 2025
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Addendum to Regular Notification
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 | Final date for Comment: 12 May 2025
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Addendum to Regular Notification
TITLE: Psychoactive Substances Bill: Introduction to Parliament of new legislation to control currently unregulated psychoactive substances. ; AGENCY: Ministry of Health ; ACTION: Introduction of legislation to Parliament ; SUMMARY: The Ministry of Health has previously notified the TBT Committee of policy decisions about the development of legislation to control unregulated psychoactive substances in New Zealand, in G/TBT/N/NZL/63. Legislation has been drafted and a bill was introduced to Parliament on 26 February 2013. ; The Bill seeks to address the problem with the increasing number of unknown, untested and potentially dangerous psychoactive substances. Currently, psychoactive substances (other than alcohol and tobacco) are controlled in the Misuse of Drugs Act 1975, but it takes time to assess new substances and schedule them. The Government is unable to keep up with the rapid development of new substances, and as soon as one substance is controlled another appears. ; Under the new legislation, all psychoactive substances will be controlled unless a manufacturer can prove they pose no more than a low risk of harm. Manufacturers will be required to provide evidence of clinical trials and demonstrate good manufacturing practice. Any substances that do meet the threshold for approval will then be subject to retail requirements including purchase age, place of sale, advertising and labelling restrictions. ; The Bill provides for a licensing regime for the importation and manufacture of psychoactive substances; establishes a regulator and an expert committee; establishes regulation-making powers for retail restrictions, approval criteria and fees; and provides for offences and penalties for non-compliance. ; DATES: The Psychoactive Substances Bill was introduced to Parliament on 26 February 2013. The Bill will receive its first reading in early April and will then be sent to the Health Select Committee for consideration. It is expected to be enacted by mid-August 2013. ; COMMENTS: Comments can be sent to [email protected] or [email protected] and will be accepted for 60 days from the date of this notification. ; URLs: ; http://www.legislation.govt.nz/bill/government/2013/0100/latest/DLM5042921.html?src=qs ; http://www.health.govt.nz/about-ministry/legislation-and-regulation/regulatory-impact-statements/new-regulatory-regime-psychoactive-substances ; ;
Distribution date: 10 April 2013 | Final date for Comment: 12 May 2025
Products Covered: 3824.90.99 39L 2921.19.00 39B
Regulation Type: Addendum to Regular Notification
TITLE: Psychoactive Substances Bill: Introduction to Parliament of new legislation to control currently unregulated psychoactive substances. ; AGENCY: Ministry of Health ; ACTION: Introduction of legislation to Parliament ; SUMMARY: The Ministry of Health has previously notified the TBT Committee of policy decisions about the development of legislation to control unregulated psychoactive substances in New Zealand, in G/TBT/N/NZL/63. Legislation has been drafted and a bill was introduced to Parliament on 26 February 2013. ; The Bill seeks to address the problem with the increasing number of unknown, untested and potentially dangerous psychoactive substances. Currently, psychoactive substances (other than alcohol and tobacco) are controlled in the Misuse of Drugs Act 1975, but it takes time to assess new substances and schedule them. The Government is unable to keep up with the rapid development of new substances, and as soon as one substance is controlled another appears. ; Under the new legislation, all psychoactive substances will be controlled unless a manufacturer can prove they pose no more than a low risk of harm. Manufacturers will be required to provide evidence of clinical trials and demonstrate good manufacturing practice. Any substances that do meet the threshold for approval will then be subject to retail requirements including purchase age, place of sale, advertising and labelling restrictions. ; The Bill provides for a licensing regime for the importation and manufacture of psychoactive substances; establishes a regulator and an expert committee; establishes regulation-making powers for retail restrictions, approval criteria and fees; and provides for offences and penalties for non-compliance. ; DATES: The Psychoactive Substances Bill was introduced to Parliament on 26 February 2013. The Bill will receive its first reading in early April and will then be sent to the Health Select Committee for consideration. It is expected to be enacted by mid-August 2013. ; COMMENTS: Comments can be sent to [email protected] or [email protected] and will be accepted for 60 days from the date of this notification. ; URLs: ; http://www.legislation.govt.nz/bill/government/2013/0100/latest/DLM5042921.html?src=qs ; http://www.health.govt.nz/about-ministry/legislation-and-regulation/regulatory-impact-statements/new-regulatory-regime-psychoactive-substances ; ;
Distribution date: 10 April 2013 | Final date for Comment: 12 May 2025
Products Covered: 3824.90.99 39L 2921.19.00 39B
Regulation Type: Addendum to Regular Notification
Draft Resolution nº 10, April 2nd 2013 Anvisa proposal for the implementation of the Brazilian System of Medicines control mechanisms and procedures for traceability of production, commercialization, dispensation and prescription of medicines. (6 pages, Portuguese)
Distribution date: 12 April 2013 | Final date for Comment: 09 May 2013
This draft Technical Regulation establishes the implementation of the Brazilian System of Medicines control mechanisms and procedures for traceability of production, commercialization, dispensation and prescription of medicines. ; It is established, within the Brazilian System of Medicines Control, mechanisms and procedures for traceability of drugs though capture technology, electronic storage and transmission of data through all the chain that involves production, commercialization, import, dispensation and prescription and other types of movement provided by health controls. ; The provisions contained in this draft Technical Regulation applies to all medicines that must be registered at Anvisa to be commercialized in Brazil. ; This draft Technical Regulation revokes Resolution RDC 59, November 24th, 2009. ; According to article 23, it will be granted periods of 180 and 360 days from the date of entry into force of this Resolution for companies to promote the necessary adjustments to comply with this Technical Regulation. ;
Products Covered: Medicines. HS: 30.0000
Regulation Type: Regular notification
Draft Resolution nº 10, April 2nd 2013 Anvisa proposal for the implementation of the Brazilian System of Medicines control mechanisms and procedures for traceability of production, commercialization, dispensation and prescription of medicines. (6 pages, Portuguese)
Distribution date: 12 April 2013 | Final date for Comment: 09 May 2013
This draft Technical Regulation establishes the implementation of the Brazilian System of Medicines control mechanisms and procedures for traceability of production, commercialization, dispensation and prescription of medicines. ; It is established, within the Brazilian System of Medicines Control, mechanisms and procedures for traceability of drugs though capture technology, electronic storage and transmission of data through all the chain that involves production, commercialization, import, dispensation and prescription and other types of movement provided by health controls. ; The provisions contained in this draft Technical Regulation applies to all medicines that must be registered at Anvisa to be commercialized in Brazil. ; This draft Technical Regulation revokes Resolution RDC 59, November 24th, 2009. ; According to article 23, it will be granted periods of 180 and 360 days from the date of entry into force of this Resolution for companies to promote the necessary adjustments to comply with this Technical Regulation. ;
Products Covered: Medicines. HS: 30.0000
Regulation Type: Regular notification
TITLE: Safer Consumer Products ; ; AGENCY: California Department of Toxic Substances Control ; ; ACTION: 15 Day Public Notice and Comment Period - Notice of Public Availability of Additional Post Hearing Changes ; ; SUMMARY: Pursuant to Government Code section 11346.8(c), notice is hereby given that the Department of Toxic Substances Control (DTSC) has revised the text of the proposed regulations which establish the process for identifying and prioritizing consumer products and their chemicals of concern, evaluating their alternatives, and imposing regulatory responses, by adding chapter 55 to division 4.5 of Title 22, California Code of Regulations, and amending the Table of Contents. A written comment period for these LATEST REVISIONS to the proposed regulations text has been established to commence on April 10, 2013, and close at 5:00p.m. on April 25, 2013. ; ; DTSC mailed the original text and made it available for public review and comment on July 27, 2012. A public hearing was held on September 10, 2012, during which DTSC accepted written and oral testimony. In addition, written comments were accepted during the 45-day public comment period, which was extended by 30 days, and ended October 11, 2012. DTSC made post-hearing changes to the proposed regulations, which were mailed and made available for public review and comment on January 29, 2013. Written comments were accepted on these post-hearing changes through February 28, 2013. DTSC has now made additional post-hearing changes to the proposed text. It considers these new changes to the rulemaking to be sufficiently related changes, as defined in Title 1, California Code of Regulations, section 42. ; ; A copy of the revised text is provided in the attachment called Text of Proposed Regulations Additional Post-Hearing Changes. The January 29, 2013 additions to the originally proposed text are indicated by single underline, and deletions are indicated by single strikeout. The April 10, 2013 additions are indicated by double underline, and deletions are indicated by double strikeout. ; ; DTSC will be accepting, through April 25, 2013, written comments solely on the April 10, 2013 revisions. ; ; The information upon which DTSC relied on is available for public inspection between 8:00 a.m. and 5:00 p.m. on the 22nd Floor, 1001 I Street, Sacramento, California. Requests and inquiries concerning this matter may be directed to Jackie Buttle at the address indicated below; or by telephone at (916) 322-3900. ; ; Copies of the revised text of the proposed regulations are also posted to DTSCs internet site at: http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/index.cfm and http://www.dtsc.ca.gov/SCPRegulations.cfm, or may be obtained from Ms. Jackie Buttle. ; ; Notice is given that any interested persons may submit comments regarding the ; April 10, 2013 REVISIONS to the proposed text to DTSC by email at [email protected], fax (916) 324-1808, or by mail to: ; ; Jackie Buttle ; Acting Regulations Coordinator ; Department of Toxic Substances Control ; P.O. Box 806 ; Sacramento, CA 95812-0806 ; ; PLEASE NOTE: All comments must be received by DTSC no later than 5:00 P.M. PDT on April 25, 2013, regardless of the form of transmission. ; ; URLs: ; http://dtsc.ca.gov/LawsRegsPolicies/Regs/upload/2-SCP-REVISED-Proposed-Regulations_APA-MARKUP-April-2013.pdf ; ; ; ; ; ; ; ; ;
Distribution date: 19 April 2013 | Final date for Comment: 12 May 2025
Products Covered: Chemicals (HS Chapter 38; ICS 71.100)
Regulation Type: Addendum to Regular Notification
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