Regulatory Updates
Regulations Amending the Food and Drug Regulations (1558 - Food Additives)
Distribution date: 10 August 2010
Health Canada has received submissions from industry requesting that the Regulations be amended to enable the use of the following food additives. As a means to improve the responsiveness of the regulatory system, Interim Marketing Authorizations (IMAs) were issued to permit the immediate use of these food additives, while the regulatory process was undertaken to formally amend the Regulations. They were published in the "Government Notices" section of the Canada Gazette, Part I, as follows: - 3 February 2001, for glycerol ester of wood rosin in beverages containing citrus or spruce oils; - 3 November 2001, for hydrogen peroxide in the production of oat hull fibre; - 1 February 2003, for sodium hydroxide in whey cheese (Ricotta cheese) (notified as G/SPS/N/CAN/160); - 15 March 2003, for microcrystalline cellulose in whipping cream that has been heat-treated below 100°C (notified as G/SPS/N/CAN/164); - 14 February 2004, for sucrose esters of fatty acids in unstandardized confectionery products (notified as G/SPS/N/CAN/197); and - 17 July 2004, for microcrystalline cellulose in breath freshening strips (notified as G/SPS/N/CAN/209). Members were informed that a revision to the notifications would be published at the start of the amendment process at which time a comment period would be provided. (In the case of the February 2001 and November 2001 Government Notices, these IMAs were issued prior to June 2002, the date Canada began to notify its IMAs. At the time that these IMAs were issued, it was anticipated that the WTO notification would occur later when the appropriate regulatory amendments were published in the Canada Gazette, Part I.) However, in July 2006, the Canadian regulatory process was modified to permit regulatory amendments having low significance when assessed against a triage framework to proceed directly to final approval and publication in Canada Gazette, Part II. The IMAs noted above are enabling measures as they allow the sale of additional foods containing the food additive, or the sale of food containing the food additive at higher levels than previously permitted. No concerns or issues have been identified by Canada's trading partners since the IMAs were issued. Therefore, the Food and Drug Regulations have been amended to permit the use of the food additives mentioned above in the specified applications. These IMAs were revoked on 7 July 2010, the date on which these amendments came into force.
Products Covered:
Regulation Type: Addendum to Regular Notification
Regulations Amending the Food and Drug Regulations (1558 - Food Additives)
Distribution date: 10 August 2010
Health Canada has received submissions from industry requesting that the Regulations be amended to enable the use of the following food additives. As a means to improve the responsiveness of the regulatory system, Interim Marketing Authorizations (IMAs) were issued to permit the immediate use of these food additives, while the regulatory process was undertaken to formally amend the Regulations. They were published in the "Government Notices" section of the Canada Gazette, Part I, as follows: - 3 February 2001, for glycerol ester of wood rosin in beverages containing citrus or spruce oils; - 3 November 2001, for hydrogen peroxide in the production of oat hull fibre; - 1 February 2003, for sodium hydroxide in whey cheese (Ricotta cheese) (notified as G/SPS/N/CAN/160); - 15 March 2003, for microcrystalline cellulose in whipping cream that has been heat-treated below 100°C (notified as G/SPS/N/CAN/164); - 14 February 2004, for sucrose esters of fatty acids in unstandardized confectionery products (notified as G/SPS/N/CAN/197); and - 17 July 2004, for microcrystalline cellulose in breath freshening strips (notified as G/SPS/N/CAN/209). Members were informed that a revision to the notifications would be published at the start of the amendment process at which time a comment period would be provided. (In the case of the February 2001 and November 2001 Government Notices, these IMAs were issued prior to June 2002, the date Canada began to notify its IMAs. At the time that these IMAs were issued, it was anticipated that the WTO notification would occur later when the appropriate regulatory amendments were published in the Canada Gazette, Part I.) However, in July 2006, the Canadian regulatory process was modified to permit regulatory amendments having low significance when assessed against a triage framework to proceed directly to final approval and publication in Canada Gazette, Part II. The IMAs noted above are enabling measures as they allow the sale of additional foods containing the food additive, or the sale of food containing the food additive at higher levels than previously permitted. No concerns or issues have been identified by Canada's trading partners since the IMAs were issued. Therefore, the Food and Drug Regulations have been amended to permit the use of the food additives mentioned above in the specified applications. These IMAs were revoked on 7 July 2010, the date on which these amendments came into force.
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: 09 August 2010 | Final date for Comment: 08 October 2010
Proposed maximum residue limits (MRLs) for agricultural chemicals (Bifenthrin, Chlorfenapyr and Propoxycarbazone).
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); - Fish and crustaceans (HS Codes: 03.02, 03.03, 03.04, 03.06 and 03.07); - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07, 04.08, 0409); - 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, 08.13 and 08.14); - Coffee, tea, mate and spices (HS Codes: 09.02, 09.03, 09.05, 09.04, 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); - Products of the milling industry; malt; starches; inulin; wheat gluten (HS Codes: 11.01); - 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 fats (HS Codes: 15.02); and - Residues and waste from the food industries; prepared animal fodder (HS Codes: 23.02).
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: 09 August 2010 | Final date for Comment: 08 October 2010
Proposed maximum residue limits (MRLs) for agricultural chemicals (Bifenthrin, Chlorfenapyr and Propoxycarbazone).
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); - Fish and crustaceans (HS Codes: 03.02, 03.03, 03.04, 03.06 and 03.07); - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07, 04.08, 0409); - 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, 08.13 and 08.14); - Coffee, tea, mate and spices (HS Codes: 09.02, 09.03, 09.05, 09.04, 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); - Products of the milling industry; malt; starches; inulin; wheat gluten (HS Codes: 11.01); - 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 fats (HS Codes: 15.02); and - Residues and waste from the food industries; prepared animal fodder (HS Codes: 23.02).
Regulation Type: Regular notification
AGENCY: Environmental Protection Agency (EPA) ; ; TITLE: Proposed Significant New Use Rule for Multi-walled Carbon Nanotubes; Reopening of Comment Period ; ; ACTION: Proposed rule; reopening of comment period ; ; SUMMARY: EPA issued a proposed rule in the Federal Register of 3 February 2010, concerning a proposed significant new use rule (SNUR) for the chemical substance identified generically as multi-walled carbon nanotubes (P-08-199). In order to address public comments, EPA is adding information to the docket and reopening the comment period. This document reopens the comment period for 30 days. ; ; DATES: Comments, identified by docket identification (ID) number EPA-HQ-OPPT-2009-0686, must be received on or before 27 August 2010. ; ; URL: ; http://edocket.access.gpo.gov/2010/2010-18543.htm ; http://edocket.access.gpo.gov/2010/pdf/2010-18543.pdf ;
Distribution date: 04 August 2010
Products Covered: Carbon nanotubes (HS: 2803 ICS: 13.020, 71.100)
Regulation Type: Addendum to Regular Notification
AGENCY: Environmental Protection Agency (EPA) ; ; TITLE: Proposed Significant New Use Rule for Multi-walled Carbon Nanotubes; Reopening of Comment Period ; ; ACTION: Proposed rule; reopening of comment period ; ; SUMMARY: EPA issued a proposed rule in the Federal Register of 3 February 2010, concerning a proposed significant new use rule (SNUR) for the chemical substance identified generically as multi-walled carbon nanotubes (P-08-199). In order to address public comments, EPA is adding information to the docket and reopening the comment period. This document reopens the comment period for 30 days. ; ; DATES: Comments, identified by docket identification (ID) number EPA-HQ-OPPT-2009-0686, must be received on or before 27 August 2010. ; ; URL: ; http://edocket.access.gpo.gov/2010/2010-18543.htm ; http://edocket.access.gpo.gov/2010/pdf/2010-18543.pdf ;
Distribution date: 04 August 2010
Products Covered: Carbon nanotubes (HS: 2803 ICS: 13.020, 71.100)
Regulation Type: Addendum to 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 (16 pages, in English).
Distribution date: 30 July 2010 | Final date for Comment: 28 September 2010
The main elements of the legislative proposal are: ; to allow the placing on the market of three new fertiliser types namely calcium formate, fluid zinc fertiliser and IDHA (a chelating agent) in order to make them more easily available for farmers across the EU; ; to harmonise the rules for micro-nutrient solutions and micro-nutrient chelates i.e. to allow the use of more than one chelating agent, to adopt common values for the minimum content of water-soluble micro-nutrient and to introduce labelling obligations for chelating agents chelating at least 1% of the water-soluble micro-nutrient; ; to introduce fertiliser type designations allowing micro-nutrients blends to be in compliance with the requirements of Article 3 of Regulation (EC) No 2003/2003; ; to introduce references 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 (16 pages, in English).
Distribution date: 30 July 2010 | Final date for Comment: 28 September 2010
The main elements of the legislative proposal are: ; to allow the placing on the market of three new fertiliser types namely calcium formate, fluid zinc fertiliser and IDHA (a chelating agent) in order to make them more easily available for farmers across the EU; ; to harmonise the rules for micro-nutrient solutions and micro-nutrient chelates i.e. to allow the use of more than one chelating agent, to adopt common values for the minimum content of water-soluble micro-nutrient and to introduce labelling obligations for chelating agents chelating at least 1% of the water-soluble micro-nutrient; ; to introduce fertiliser type designations allowing micro-nutrients blends to be in compliance with the requirements of Article 3 of Regulation (EC) No 2003/2003; ; to introduce references to EN standards to simplify legislation. ;
Products Covered: Fertilisers (HS: 31)
Regulation Type: Regular notification
"Commission Regulation (EU) No 595/2010 of 2 July 2010 amending Annexes VIII, X and XI to Regulation (EC) No 1774/2002 of the European Parliament and of the Council laying down health rules concerning animal by-products not intended for human consumption"
Distribution date: 29 July 2010
Certain member States, trading partners and economic operators have indicated their interest in the use of blood and a wider range of blood products from equidae, both of the European Union and third country origin, for technical purposes in the European Union. The same interest was indicated in the use of horn and horn products and hoof and hoof products intended for the production of organic fertilizers or soil improvers. In order to facilitate the use of such blood and of such blood products or horn and horn products and hoof and hoof products intended for the production of organic fertilizers or soil improvers, it is necessary to lay down animal health requirements for their use for technical purposes.
Products Covered: Animal by-products and products derived thereof not intended for human consumption
Regulation Type: Regular notification
"Commission Regulation (EU) No 595/2010 of 2 July 2010 amending Annexes VIII, X and XI to Regulation (EC) No 1774/2002 of the European Parliament and of the Council laying down health rules concerning animal by-products not intended for human consumption"
Distribution date: 29 July 2010
Certain member States, trading partners and economic operators have indicated their interest in the use of blood and a wider range of blood products from equidae, both of the European Union and third country origin, for technical purposes in the European Union. The same interest was indicated in the use of horn and horn products and hoof and hoof products intended for the production of organic fertilizers or soil improvers. In order to facilitate the use of such blood and of such blood products or horn and horn products and hoof and hoof products intended for the production of organic fertilizers or soil improvers, it is necessary to lay down animal health requirements for their use for technical purposes.
Products Covered: Animal by-products and products derived thereof not intended for human consumption
Regulation Type: Regular notification
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