The Canadian Health Minister Allan Rock announced on September 4 the government's intention to proceed with the development of environmental assessment regulations for substances in products regulated under the "Food and Drugs Act" (F&DA).
These regulations would require substances in products such as pharmaceuticals, biologics, food additives, novel foods, personal care products and cosmetics to meet environmental assessment standards in addition to current requirements to comply with health and safety criteria.
International monitoring has established that certain substances contained in products regulated under the "Food and Drugs" Act are present at detectable levels in the environment.
While further research is required to understand their direct impact on ecosystems and indirect impact on human health, Health Canada recognises the need to implement regulations to manage any risk these substances may pose.
Health Canada wants to develop, in consultation with Environment Canada and all stakeholders, effective and efficient regulatory requirements that would permit adequate and diligent environmental assessment of these products based on the most up to date scientific information.
Health Canada and Environment Canada will create a scientific expert panel to provide a technical foundation for the development of the regulatory framework, that will assist in the development of a research agenda to allow for a better understanding of the potential effects of the release of pharmaceutical and personal care products into the environment and to look at appropriate disposal methods.
Health Canada will set up an Environmental Assessment Unit, in consultation with Environment Canada, to undertake assessments of substances in products covered by the F&DA.
After September 13, 2001, companies seeking approval to import and manufacture new products regulated under the Food and Drugs Act will have to notify the Minister of the Environment under the New Substances Notification Regulations of the new Canadian Environmental Protection Act (CEPA).
F&DA products that were on the market before September 14, 2001 will be assessed under the new Environmental Assessment Regulations for F&DA products, once they are developed. However, immediate and appropriate action will be taken if, at any time during this parallel process of research and developing new regulations, products are deemed to be hazardous to human health or to the environment.