Revision of Guidelines for the Safety Assessment of Novel Foods

In the Government of Canada's Action Plan, developed to address the recommendations of the Royal Society of Canada's Expert Panel on the Future of Food Biotechnology, Health Canada committed to:

1. Updating its guidelines for novel foods derived from plants and microorganisms.
2. Developing new guidelines for the safety assessment of novel foods derived from livestock animals and fish.

In addition, the promulgation of Division 28 of the Food and Drug Regulations in 1999 required that the guidelines be updated to address Health Canada's new responsibility for pre-market assessment of novel foods.

A public consultation took place from July to September 2003, focussing on the document "Guidelines for the Safety Assessment of Novel Foods derived from Plants and Microorganisms (August 2002 draft)". The document proposed significant revisions to the guidelines published in 1994, including:

• more detailed information about the premarket notification procedure
• more explicit guidance on the safety assessment data requirements for the different types of novel foods
• the latest international guidance

The revisions to the guidelines are also based on the experience gained in Health Canada's evaluation of novel food products, and reflect advances in scientific knowledge and technology. The revised guidelines are consistent with guidance documents developed at the international level with respect to the assessment of genetically modified foods.

Separate safety assessment criteria for novel foods derived from animals are under development.

Report on the Public Consultation

• Report on Stakeholder Comments and Health Canada's Responses

Public Consultation

All three parts of the consultation, plus all three appendices:

• Revision of Health Canada's Guidelines for the Safety Assessment of Novel Foods - Health Canada Public Consultation
  - July to September 2003