Drugs, Canadian regulations

In Canada, the current edition of the Food Chemicals Codex, including its supplements, is officially recognized in the Canadian Food and Drug Regulations under Section B.01.045(b) as the reference for specifications for food additives. The new Australia New Zealand Food Authority recognizes the Food Chemicals Codex as a primary source of identity and purity specifications in its Food Standards Code, Chapter 1 General Food Standards, Part 1.3 Substances Added to Food, Standard 1.3.4 Identity and Purity. 

Awareness of the problem developed in the mid 1970s when it was found that mineral waters sold in polyvinyl chloride (PVC) bottles contained measurable amounts of vinyl chloride monomer. Vinyl chloride is a known carcinogen. The Codex Alimentarius Committee on Food Additives and Contaminants has set a guideline of 1 ppm for vinyl chloride monomer in PVC packaging and 0.01 ppm of the monomer in food (Institute of Food Technologists 1988). Another additive found in some PVC plastics is octyl tin mer-captoacetate or octyl tin maleate. Specific regulations for these chemicals exist in the Canadian Food and Drugs Act. 

Regulations for colorant use in Canada have many similarities to the U.S. regulations however, differences do exist. Some colors approved in Canada are not approved in the United States and vice versa. Canada s color regulations for drug color generally list most colors acceptable for use in Europe as well as those listed for use in the United States. However, some differences do exist. See Table 5 for colorants that can be used in Canadian drug applications. ... 

Food and Drug Regulations—Coloring Agents, Part C.Ol.040.2, Canadian Department of Health, August 30, 1995. 

Post-registration clinical studies must be carried out in accordance with the Canadian Food and Drugs Act and Regulations, other applicable federal and provincial legislation, and guidelines issued by Health Canada. 

Division 24 of the Canadian Food and Drug Regulations (food for specialty dietary purposes) have defined gluten-free products (B24.018). The requirements for a... 

In May 1975, amendment B.09.022 was made to Canadian Food and Drug Regulations which limited the amount of C22 monoenoic fatty acids in cooking oils, margarines, shortenings, or other oil products to not more than 5% of the total fatty acids (Statute Revision Commission, 1978). 

Traditional margarines contain 80% fat phase and 20% aqueous phase. Diet margarines consist of 40% fat and 60% aqueous phase. Canadian Food and Drug Regulations, which are similar to those of the Codex Alimentarius, control the composition of margarine in Canada. Different regulations will prevail in other jurisdictions. 

Food and Drug Act and Regulations, Canadian Government Publishing Centre, Supply and Services Canada, Ottawa, Ontario, Canada KIA 0S9. 

Food and Drug Act and regulations of Health and Welfare Canada and the color code outlined in Canadian General Standards Board (CGSB) Standard 24.2-M86, Identification of Medical Gas Containers, Pipelines and Valves [3]. 

Drivers who are subject to the commercial driver s license requirements of the Canadian National Safety Code, or the Licencia Federal de Conductor (Mexico) requirements and operate a commercial motor vehicle in the United States are also subject to the alcohol and drug regulations in Part 382. 

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