Agri-food Regulatory Compliance


Our unique approach


As with all our work, we pursue a holistic approach to all regulatory audits, striking a balance that is compliant with the pertinent legislation while supporting the desired marketplace position of the product.

Our toolkit


1. Health Canada Submissions:  Novel Food, Novel Dietary Fibre, Health Claims on Food, Food Additive, Infant Formula


Novel Food Pre-market Notifications:

We prepare, write and submit Novel Food Pre-market Notifications to Health Canada on behalf of several clients. Health Canada approved Novel Foods are listed here; applications for some have been prepared by us:
http://www.hc-sc.gc.ca/fn-an/gmf-agm/appro/index_e.html

Novel Food Applications are comprehensive scientific documents, which must adhere to the following Health Canada Guidelines, available for viewing at:
http://www.hc-sc.gc.ca/fn-an/gmf-agm/pol/index_e.html

Novel Dietary Fibre Applications:

We have 15 years' experience in submitting Novel Fibre applications to Health Canada. Our comprehensive approach includes securing the clinical and scientific data outlined in Health Canada's Guidelines
 http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/novel_fibre_nouvelle_app-ann2_e.html, and preparing a high-calibre submission that meets Health Canada's requirements. Some Novel Dietary Fibres approved following submissions prepared by us are listed within CFIA Novel Dietary Fibre Table 6-12 at the following link:
http://www.inspection.gc.ca/english/fssa/labeti/guide/ch6ae.shtml#6.8

Health Claims on Foods

is one of Health Canada's newest guidance documents, which we were engaged to implement and submit to Health Canada in support of a health claim on a bioactive ingredient, the month following its March 2009 publication:
http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/health-claims_guidance-orientation
_allegations-sante-eng.php

Natural Health Products PLA's (Product License Applications) and NPN (Natural Product Numbers)

Our pre-market submissions to the NHP Directorate are thorough, accurate and well-written, leading to faster response times and earlier launch dates.

2. FDA GRAS Notifications:

Thoroughly researched, drawing expertise from a select team of professionals, well-written to expedite FDA review.

3.  CFIA and FDA Animal Feed Supplement Registration:

Our growing expertise in acquiring regulatory compliance for several marketplace applications of bioactives now includes pre-market notifications pertaining to animal feed supplements and veterinary drugs.

4. Label Creation, Audit & Remedial Services:

- Food Labels - Websites - Advertising

Our Seal of Approval covers:
    * Label audits and reviews sales sheets, advertising and websites
    * Compliance in defined geographical markets (e.g. USA, Canada, the EU)
    * Compliance of proposed claims and statements
    * Identification of overlooked claims
    * Nutrition Facts Table (Cda), Nutrition Facts Panel(USA) and Nutrition Labelling (EU) creation and review
    * Accurate provision of mandatory and voluntary information
    * Reviews of educational, research-based promotional material
    * Accurate and speedy French Translation 

5. Regulatory Impact Studies:

Several organizations -- both private and public -- call on us to understand and assess the effect of regulations on specific market place activity, some of which include:
- Canadian International Trade Tribunal

- Canadian Agricultural Policy Institute

- Agriculture and Agri-Food Canada

Release of final report pending AAFC approval

6. Participation in Government-agency led Consultations in Canada and the US :

Since the inception of our company 24 years ago, we have participated in several Government-agency consultations, the more recent of which are highlighted below.

(1) Canada:
- Health Claims Consultation
- Health Canada:  Proposed Policy:  Definition and Energy Value for Dietary Fibre
- Health Canada:  Dietary Sodium Reduction Strategy
- Health Canada: New Nutrition Facts and List of Ingredients Coming into force December 2021
- Canada's Food Guide Revision
- Whole Wheat and Whole Grain Discussion

(2) USA:
- Gluten-free Labelling of Foods

7. Courses and Seminars

Want to acquire hands-on learning? Attend one of our bi-annual full-day courses, sponsored by the Guelph Food Technology Centre: click here for course details.

Regulatory Services