Services Regulatory Compliance
Strategies
A. 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.
B. Our toolkit
1. Food Law Expertise in the following countries:
Canada |
United States of America |
United Kingdom |
European Union |
2. Health Canada Novel Food Submissions, Novel Dietary Fibre Submissions and Health Claims on Food Submissions:
Novel Food Applications:We prepare, write and submit Novel Food Applications 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
3. Audit & Remedial Services:
| - Food Labels | - Websites | - Advertising |
Our Seal of Approval covers:
* Label audits
* Compliance in defined geographical markets (e.g. USA, Canada)
* Compliance of proposed claims and statements
* Identification of overlooked claims
* Nutrition Facts Table scrutiny
* Accurate provision of mandatory and voluntary information
* Reviews of educational, research-based promotional material
4. 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
- Canadian Agricultural Policy Institute
- Agriculture and Agri-Food Canada
Release of final report pending AAFC approval
5. Participation in Government-agency led Consultations in
Canada and the
US :
Since the inception of our company 15 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
- Pre-market Notification Submissions
- Canada's Food Guide Revision
- Whole Wheat and Whole Grain Discussion
(2) USA:
- Gluten-free Labelling of Foods
- Health Claims Consultation
- Health Canada: Proposed Policy: Definition and Energy Value for Dietary Fibre
- Health Canada: Dietary Sodium Reduction Strategy
- Pre-market Notification Submissions
- Canada's Food Guide Revision
- Whole Wheat and Whole Grain Discussion
(2) USA:
- Gluten-free Labelling of Foods
6. 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.
United Kingdom
European Union