Regulatory Updates

Distribution date: 03 August 2007

Health Canada has received submissions to amend the Food and Drug Regulations to permit new uses of the following food additives that are already listed in the Tables to Division 16 of Part B of these Regulations: - sunset yellow FCF as a colouring agent in cheese-flavoured corn snacks at a maximum level of use of 600 parts per million (p.p.m.) if used singly; if used in combination with other synthetic food colours, the maximum level of use is 300 p.p.m. in accordance with paragraph B.06.002(c) of the Regulations; - propylene glycol mono fatty acid esters (propylene glycol monostearate) as an emulsifying agent in ice cream at a maximum level of use of 0.35%; sorbitan tristearate as an emulsifying agent in unstandardized frozen desserts and ice cream at a maximum level of use of 0.035%; - sorbitan monostearate as an emulsifying agent in puddings at a maximum level of use of 0.5%; - powdered cellulose as a bulking agent in the following foods at the respective maximum levels of use: (1) Batter and breading - 1%, (2) Canapé toast - 2%, (3) Confectionery (calorie-reduced) - 25%, (4) Unstandardized edible ices - 3%, (5) Fillings - 0.5%, (6) Foods sold in tablet form - 50%, (7) Icings - 1%, (8) Seasonings - 3%, (9) Sweet baked goods - 8%; and - sodium bisulphate as a pH adjusting agent in unstandardized bakery products at a maximum level of use consistent with good manufacturing practice. 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. They were published in the "Government Notices" section of the Canada Gazette, Part I, as follows: - on 29 November 1997 for sunset yellow FCF; - on 28 August 1999 and November 3, 2001 for powdered cellulose; - on 17 November 2001 for sorbitan monostearate; - on 5 January 2002 for propylene glycol monostearate and sorbitan tristearate; and - on 30 March 2002 for sodium bisulphate. These IMAs were issued prior to June 2002, the date when Canada began to notify its IMAs. At the time that these IMAs were issued, it was anticipated that 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. Accordingly, these regulatory amendments were considered to be of low significance and were permitted to proceed directly to the Canada Gazette, Part II. 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 2 May 2007, the date on which these amendments came into force.

Products Covered: Food additives (ICS: 67.220)

Regulation Type: Regular notification

Distribution date: 02 August 2007

The Animal Health Law is enforceable throughout Mexican territory. Its aim is to establish the basis for the diagnosis, prevention, control and eradication of diseases and pests which affect animals; ensure animal welfare; regulate good livestock practices applicable in primary production and in "Federal Inspection Type" establishments which are dedicated to the slaughter of animals and the processing of products of animal origin for human consumption, in the case of the latter in coordination with the Ministry of Health, in accordance with each Ministry's sphere of competence; regulate establishments, products and the development of activities relating to animal health and the provision of veterinary services; and regulate chemical, pharmaceutical, biological and food products for animal use or consumption. The provisions of this Law are public policy and of social interest.

Products Covered: Animals

Regulation Type: Regular notification

Distribution date: 31 July 2007

Following the notification G/SPS/N/EEC/103/Add.15 (dated 6 July 2006), the regulation announced has been published as "Commission Regulation (EC) No 829/2007 of 28 June 2007 amending Annexes I, II, VII, VIII, X and XI to Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the placing on the market of certain animal by-products " (Official Journal L191, 21 July 2007, pp.1-99). The full text can be downloaded from the internet address indicated below: English: http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/l_191/l_19120070721en00010099.pdf French: http://eur-lex.europa.eu/LexUriServ/site/fr/oj/2007/l_191/l_19120070721fr00010099.pdf Spanish: http://eur-lex.europa.eu/LexUriServ/site/es/oj/2007/l_191/l_19120070721es00010099.pdf The notified document can be obtained from the EC Enquiry Point: sps@ec.europa.eu

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 31 July 2007

The Maine Department of Environmental Protection is proposing to adopt amendments to Ch. 152 intended to address volatile organic compound (VOC) emissions from consumer products. The proposed amendments will add approximately 18 categories of regulated consumer products and will place limits on certain toxic compounds in some consumer product categories. The amendments also modify the date-coding requirements.

Products Covered: HS:  Chapter 29;   ICS:  13.020

Regulation Type: Regular notification

Distribution date: 30 July 2007 | Final date for Comment: 28 September 2007

Establishment of maximum residue limits (MRLs) for veterinary drug, ceftiofur, in foods.

Products Covered: Cattle (other edible offal*), Pig (other edible offal), other terrestrial mammals (muscle, fat, liver, kidney and other edible offal) * "Other edible offal" refers to all edible parts, except muscle, fat, liver, and kidney

Regulation Type: Regular notification

Distribution date: 26 July 2007

Proposed maximum residue limits (MRLs) for Cumyluron.

Products Covered: ・ Fish and crustaceans (HS: 03.02, 03.03, 03.04, 03.06, 03.07) ・ Edible vegetables and certain roots and tubers (HS: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.13, 07.14) ・ Edible fruits and nuts, peel of citrus/melons (HS: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.14) ・ Coffee, mate and spices (HS: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09, 09.10)　 ・ Cereals (HS: 10.01, 10.02, 10.03, 10.04, 10.05, 10.07, 10.08) ・ Oil seeds and oleaginous fruits; miscellaneous grains, seeds and fruits (HS: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10, 12.11, 12.12, 12.14)

Regulation Type: Emergency notifications (SPS)

Distribution date: 20 July 2007

Products Covered: Pharmaceutical Products (HS 300000)

Regulation Type: Regular notification

Distribution date: 20 July 2007

The notified Technical Regulation establishes the analytical tests which must be carried out by the regulatory authority to verify the quality of medicines. The provisions of this Regulation apply to all medicines imported into or manufactured in Central American countries.

Products Covered: Medicines for human use (International Classification for Standards (ICS) code 11.120.01;  HS tariff heading 30)

Regulation Type: Regular notification

Distribution date: 20 July 2007

The purpose of this Regulation is to establish the general specifications that must be met by vegetable, animal and marine oils and fats and their edible by-products, which are pre-packaged and processed so as to be suitable for human consumption and which are marketed within the Central American area. The specifications and parameters contained in this Regulation apply to the above-mentioned pre-packaged refined oils and fats. When an oil or fat has been subjected to some process of chemical change or to geographical or climatic variations, supplementary or reference criteria may, for those reasons, be used, in order to confirm that they comply with the Regulation.

Products Covered: Fats and oils. International Classification for Standards (ICS) code 67.020. HS heading 15

Regulation Type: Regular notification

Distribution date: 20 July 2007

This Regulation establishes the physico-chemical specifications that must be met by anhydrous fuel ethanol and denatured anhydrous fuel ethanol to be used or marketed as fuel in the Central American States Parties. It applies to anhydrous fuel ethanol and denatured anhydrous fuel ethanol obtained by means of alcoholic fermentation, if the two products are to be used or marketed as fuel for spark-ignition engines either in their pure form in engines designed or adapted for such use or blended with gasoline in spark-ignition engines.

Products Covered: Etanol carburante anhidro y etanol carburante anhidro desnaturalizado y sus mezclas con gasolina (Anhydrous fuel ethanol and denatured anhydrous fuel ethanol and its mixtures with gasoline) (International Classification for Standards) (ICS) code 75.160.20) HS headings 2207.10 and 2207.20

Regulation Type: Regular notification