Regulatory Updates
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 wto@standards.co.nz or Sara_mcfall@moh.govt.nz 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
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 wto@standards.co.nz or Sara_mcfall@moh.govt.nz 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
Products Covered: 3824.90.99 39L 2921.19.00 39B
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
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
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
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
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