Chemical Regulatory Updates – Latest Global Changes

Regulations Amending the Food and Drug Regulations (1558 - Food Additives)

Distribution date: 11 August 2010 | Final date for Comment: 10 May 2025

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

Adoption/publication/entry into force of reg.

Fertilizers, Soil Correctives, Inoculants and Biofertilizers

Distribution date: 12 August 2010 | Final date for Comment: 19 November 2010

This is to notify that the Secretariat of Animal and Plant Health (SDA) of the Ministry of Agriculture, Livestock and Food Supply (MAPA) issued "Portaria" nº 402 on 22 July 2010, published in the "Diário Oficial da União" Nº 140 (Federal Official Journal) from 23 July 2010, section 1, page 3, to open a public consultation on a draft that establishes Annexes I, II, II, IV, V, regarding the revision of the levels mentioned in Article 5 of Normative Instruction SDA n° 27, 5 June 2006, previously notified under document G/SPS/N/BRA/111/Add.1 on 18 July 2006. http://members.wto.org/crnattachments/2010/sps/BRA/10_3130_00_x.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification

Contaminants Plant health Heavy metals

Fertilizers, Soil Correctives, Inoculants and Biofertilizers

Distribution date: 12 August 2010 | Final date for Comment: 19 November 2010

Products Covered:

Regulation Type: Addendum to Regular Notification

Contaminants Plant health Heavy metals

United States Pharmacopeial Convention; Filing of Food Additive Petition

Distribution date: 13 August 2010 | Final date for Comment: 10 May 2025

The Food and Drug Administration (FDA) is announcing that the United States Pharmacopeial Convention has filed a petition proposing that the food additive regulations that incorporate by reference food-grade specifications from prior editions of the Food Chemicals Codex (FCC) be amended to incorporate by reference food-grade specifications from the FCC, 7th Edition.

Products Covered: The following food additives are covered in this filing notice: Hydrogen peroxide (HS Code: 2847), amino acids (HS Code: 2922.49.40), folic acid (HS Code: 2936.29.10), vitamin D3 (HS Code: 2936.29.50), vitamin D2 (HS Code: 2936.29.50), gellan gum, 1,3-butylene glycol (HS Code: 2905.39.10), epoxidized soybean oil (HS Code: 1518.00), glycerides and polyglycerides of hydrogenated vegetable oils, acacia gum (HS Code: 1301.20.00), acesulfame potassium, aspartame (HS Code: 29.24.29.10), dioctyl sodium sulfosuccinate, glycine (HS Code: 2922.49.40), sucralose, sucrose acetate isobutyrate, polydextrose, sodium stearoyl lactylate, propylene glycol alginate, oleic acid derived from tall oil fatty acids (HS Code: 2916.15.10), olestra, sucrose oligoesters, a-acetolactate decarboxylase enzyme preparation, Candida guilliermondii, Candida lipolytica, ethyl acetate (HS Code: 2915.31.00), solvent extraction process for citric acid (HS Code: 2918.14.00), boiler water additives: sodium carboxymethyl cellulose and sorbitol anhydride esters, ozone, hydrogen peroxide solution (HS Code: 2847), mannitol (HS Code: 2905.43.00), brominated vegetable oil (HS Code: 1518.00), saccharin (HS Code: 2925.11.00)