Regulatory Updates

Distribution date: 16 April 2012

Health Canada has received submissions from industry requesting that the Food and Drug 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 citric acid as a pH adjusting agent in canned peaches; - 18 August 2001, for ascorbic acid as a preservative in canned mandarin oranges; - 10 August 2002, for calcium chloride as a firming agent in canned apricots; - 13 September 2003, for citric acid as a pH adjusting agent in various standardized canned vegetable products (notified as G/SPS/N/CAN/187); - 11 March 2006, for citric acid as a pH adjusting agent in standardized canned apples and various standardized canned vegetable products (notified as G/SPS/N/CAN/258); - 23 December 2006, for calcium disodium EDTA and disodium EDTA as sequestering agents in various standardized canned legumes, with the exception of canned green beans, canned wax beans and canned peas (notified as G/SPS/N/CAN/280); - 13 December 2008, for citric acid as a pH adjusting agent in the production of pickled beets (notified as G/SPS/N/CAN/374); and - 30 July 2011, for citric acid as a pH adjusting agent in the production of canned cut baby corn (notified as G/SPS/N/CAN/555). 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, August 2001 and August 2002 Government Notices, these IMAs were issued prior to 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. The evaluation of the available data supports the safety and efficacy of these food additives in the above specified uses. Therefore, the Food and Drug Regulations have been amended to permit the use of the food additives mentioned above in the specified applications. These Regulations entered into force on 15 March 2012.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 16 April 2012

Health Canada has received submissions from industry requesting that the Food and Drug 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 citric acid as a pH adjusting agent in canned peaches; - 18 August 2001, for ascorbic acid as a preservative in canned mandarin oranges; - 10 August 2002, for calcium chloride as a firming agent in canned apricots; - 13 September 2003, for citric acid as a pH adjusting agent in various standardized canned vegetable products (notified as G/SPS/N/CAN/187); - 11 March 2006, for citric acid as a pH adjusting agent in standardized canned apples and various standardized canned vegetable products (notified as G/SPS/N/CAN/258); - 23 December 2006, for calcium disodium EDTA and disodium EDTA as sequestering agents in various standardized canned legumes, with the exception of canned green beans, canned wax beans and canned peas (notified as G/SPS/N/CAN/280); - 13 December 2008, for citric acid as a pH adjusting agent in the production of pickled beets (notified as G/SPS/N/CAN/374); and - 30 July 2011, for citric acid as a pH adjusting agent in the production of canned cut baby corn (notified as G/SPS/N/CAN/555). 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, August 2001 and August 2002 Government Notices, these IMAs were issued prior to 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. The evaluation of the available data supports the safety and efficacy of these food additives in the above specified uses. Therefore, the Food and Drug Regulations have been amended to permit the use of the food additives mentioned above in the specified applications. These Regulations entered into force on 15 March 2012.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 12 April 2012

On 22 March 2012, the Mexican Ministry of Health published in the Official Journal (Diario Oficial de la Federación) (http://www.dof.gob.mx) Mexican Official Standard NOM-248-SSA1-2011: "Good manufacturing practices for establishments engaged in the manufacture of herbal remedies".The notified Mexican Official Standard sets forth the minimum requirements for the processing of herbal remedies marketed in Mexico to ensure that consumers are supplied with good quality products. The Standard is binding throughout Mexican territory on all establishments engaged in the manufacture, storage and distribution of herbal remedies for human use which are marketed in Mexico.The notified Standard will enter into force 180 calendar days after its publication in the Official Journal.Text available online at:http://www.dof.gob.mx/nota_detalle.php?codigo=5240404&fecha=22/03/2012http://members.wto.org/crnattachments/2012/sps/MEX/12_1266_00_s.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 12 April 2012

On 22 March 2012, the Mexican Ministry of Health published in the Official Journal (Diario Oficial de la Federación) (http://www.dof.gob.mx) Mexican Official Standard NOM-248-SSA1-2011: "Good manufacturing practices for establishments engaged in the manufacture of herbal remedies".The notified Mexican Official Standard sets forth the minimum requirements for the processing of herbal remedies marketed in Mexico to ensure that consumers are supplied with good quality products. The Standard is binding throughout Mexican territory on all establishments engaged in the manufacture, storage and distribution of herbal remedies for human use which are marketed in Mexico.The notified Standard will enter into force 180 calendar days after its publication in the Official Journal.Text available online at:http://www.dof.gob.mx/nota_detalle.php?codigo=5240404&fecha=22/03/2012http://members.wto.org/crnattachments/2012/sps/MEX/12_1266_00_s.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 12 April 2012

Products Covered: Yogurt (HS 0403.10.01)

Regulation Type: Addendum to Regular Notification

Distribution date: 12 April 2012

Products Covered: Yogurt (HS 0403.10.01)

Regulation Type: Addendum to Regular Notification

Distribution date: 12 April 2012 | Final date for Comment: 11 June 2012

Manufacturers and importers of hazardous substances and mixtures must comply with the requirements of the system for hazard classification and communication of hazardous substances relevant to the hazard classification, labelling and safety data sheets.

Products Covered: Dangerous goods (HS: 29, ICS: 13.300)

Regulation Type: Regular notification

Distribution date: 12 April 2012 | Final date for Comment: 11 June 2012

Manufacturers and importers of hazardous substances and mixtures must comply with the requirements of the system for hazard classification and communication of hazardous substances relevant to the hazard classification, labelling and safety data sheets.

Products Covered: Dangerous goods (HS: 29, ICS: 13.300)

Regulation Type: Regular notification

Distribution date: 11 April 2012

The revision of Commission Regulation (EC) No 669/2009 has been adopted as "Commission Implementing Regulation (EU) No 294/2012 of 3 April 2012 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". (OJ L 98, 4 April 2012, pp.7 - 12). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:098:0007:0012:EN:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:098:0007:0012:FR:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:098:0007:0012:ES:PDF or http://members.wto.org/crnattachments/2012/sps/EEC/12_1262_00_e.pdf http://members.wto.org/crnattachments/2012/sps/EEC/12_1262_00_f.pdf http://members.wto.org/crnattachments/2012/sps/EEC/12_1262_00_s.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 11 April 2012

The revision of Commission Regulation (EC) No 669/2009 has been adopted as "Commission Implementing Regulation (EU) No 294/2012 of 3 April 2012 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". (OJ L 98, 4 April 2012, pp.7 - 12). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:098:0007:0012:EN:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:098:0007:0012:FR:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:098:0007:0012:ES:PDF or http://members.wto.org/crnattachments/2012/sps/EEC/12_1262_00_e.pdf http://members.wto.org/crnattachments/2012/sps/EEC/12_1262_00_f.pdf http://members.wto.org/crnattachments/2012/sps/EEC/12_1262_00_s.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification