Health Canada
Health Canada Updating Proposal for Food Allergen Regulatory Amendments Based on Consultation Results
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_156-eng.php
As a result of the over 140 comments received up until early December 2008 following the publication of the proposed regulatory amendment in Canada Gazette, Part I in July 2008, Health Canada has made several decisions and changes to its regulatory proposal to address concerns raised by stakeholders and Canadian consumers. These include:
The development of Canadian criteria for the establishment of new priority food allergens;
The decision to add mustard as a priority allergen in the regulations based on this criteria document;
The decision to not add onions and garlic to the list of priority allergens in the regulations based on this criteria document; and
The decision to remove the proposed exemptions of declaration for fining agents and wax coatings on the labels of pre-packaged food products.
The goal is to have the updated regulations published in the Canada Gazette Part II in the spring of 2010. For information on a consultation session, please visit http://www.hc-sc.gc.ca/fn-an/consultation/_allergen2009/index-eng.php.
Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2009-guidance-directrice_reporting-notification/index-eng.php
For a summary and discussion of this document visit our Press Archives.
Natural Health Products Directorate
Status of Submissions – Quarter 2 (as of September 30th, 2009)
Totals
- 41,872 PLAs received
- 30,464 completed
- 15,790 NHPs licensed (representing 20,674 products and 977 companies)
- Remainder were either refused or withdrawn
- 59% of “backlog” applications have been or are in the process of being completed (82% have been addressed)
- 67% of regular workload applications have been or are in the process of being completed (77% have been addressed)
Quarter 2
- 4,717 PLAs completed (up from Q1’s 3,520)
- 2,647 NHPs licensed
- 1,540 PLAs refused
- 49% refused when applicant did not respond to request for more information
- 42%failed to meet basic application requirements
- 7% refused when the applicant’s response to a request for more information did not meet requirements
- 1% did not meet NHP definition
- 1% refused when significant changes (“unsolicited change”) were made to the product itself in response to a request for more information
- 64% of PLAs completed during Q2 were submitted in 2009
- 10% of PLAs completed during Q2 were submitted in 2008
- 13% of PLAs completed during Q2 were submitted in 2007
- 11% of PLAs completed during Q2 were submitted in 2006
- 1% of PLAs completed during Q2 were submitted in 2005
- 1% of PLAs completed during Q2 were submitted in 2004
New Abbreviated Labeling Standards and Finished Product Specifications Form for NHPs
The NHPD has published its first batch of abbreviated labeling standards for NHPs supporting several ingredients considered to be lower risk medicinal ingredients. View the full notice in our Press Archives.
New Monographs
Soybean Extract and Isolates
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodnatur/applications/licen-prod/monograph/mono_soy_extra_isolate-eng.pdf
German Chamomile
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodnatur/applications/licen-prod/monograph/mono_germ_chamom_allem-eng.pdf
Roman Chamomile
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodnatur/applications/licen-prod/monograph/mono_rom_chamom-eng.pdf
Updated Monographs
Fluoride-Containing Anti-Caries Products
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodnatur/applications/licen-prod/monograph/mono_fluoride_fluorure-eng.pdf
Technical Reports and Notices
Technical Report on the Regulation of Soy Isoflavone Products
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodnatur/legislation/docs/technical-report-soy-isoflavone-eng.pdf
Revised Guidelines for the Use of Stevia in NHPs
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodnatur/legislation/docs/notice-avis-stevia-eng.pdf
Update Regarding 2010 Target for Full Implementation
What is the significance of the 2010 date?
As of January 1st, 2010, all NHPs must comply with the licensing requirements under the Natural Health Product Regulations (NHPR), meaning that all DINs must be transferred to NPNs by that deadline. Health Canada has set a goal of addressing the NHP licensing backlog by March 31st, 2010. The following measures will be taken: streamlining current practices, fast-tracking of lower-risk NHP reviews, adopting new product monographs, grouping applications for similar product types, and introducing electronic tools to support efficient submission and review of applications. The NHPD will be informing applicants of review time targets, to assist applicants in planning the release of new products and in bringing new product formulations to market.
Will the current Compliance Policy for Natural Health Products be extended?
The Compliance Policy for NHPs was adopted to provide a reasonable transition period to allow distributors of NHPs to apply for product licences and bring their products into compliance with the requirements of the NHPR. Under this policy, if a product licence application was submitted to the NHPD by its priority deadline date (*final date June 1, 2008), it would be considered a lower priority for enforcement actions unless a risk to health was identified. The NHPD is working collaboratively with the Health Products and Food Branch (HPFB) Inspectorate in the development of a revised risk-based compliance and enforcement approach to be implemented sometime in the fall of 2010.
When will a submission number no longer be considered a "lower risk/lower priority" for compliance and enforcement actions?
While a specific date has not been determined, the HPFB Inspectorate will likely begin to implement the approach in the fall of 2010. An end date to the current practice (i.e. submission numbers considered a lower enforcement priority) will be discussed during the cross-country workshops scheduled for November 2009. Accordingly, Health Canada's compliance approach for NHPs continues to focus primarily on products that pose unacceptable risks to the health of Canadians. Unacceptable risks to health are identified by consumer and industry complaints, adverse reaction reports, alerts from foreign regulators, publications in reputable health journals, etc.
How long will I be able to use labels that include a DIN that was issued for my product?
All NHPs with DINs must obtain a product licence by December 31, 2009. All NHPs advertised, promoted or sold on the market, must comply with the labelling requirements of the NHPR and be in accordance with the terms of the product’s market authorization. When a labelling change is required as a result of a post licensing notification or amendment made to a marketed product, including transitional DINs, this change must comply with the post-licensing requirements and labeling requirements of the NHPR. Modifications to labels are expected to be made within six to twelve months of the issuance or amendment of a product licence, and label stock bearing a DIN can therefore be used during this six to twelve month transition period.
Advertising Standards Canada
ASC 2009 Q3 Complaints Report (July 1-September 30, 2009)
http://www.adstandards.com/en/standards/adComplaintsReports.asp
Health Canada’s Cosmetic Program
Cosmetic Ingredient Hotlist September 2009
http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-critique/prohibited-eng.php
International Cooperation on Cosmetic Regulation - Outcome of the Meeting held September 9 - 11, 2009, Tokyo, Japan
http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/iccr_2009-eng.php
1. Alternative Test Methods
Regulators received and endorsed an updated report on ICATM activities.
Regulatory authorities will continue to cooperate, to coordinate and to endorse ICATM activities.
2. GMP (Good Manufacturing Practice)
Regulators confirmed their previous agreement to implement the International Organization for Standardization (ISO) Standard 22716 in their respective regions, wherever possible.
3. Safety of Ingredients/ Authorized Substances Lists
As follow-up to a request made at ICCR-2, industry submitted a proposal for regulators on oversight of ingredient safety.
In ICCR-3, regulators reviewed the proposal and asked industry to submit more detailed proposals, with specific examples of potential topics and issues for consideration within 2-3 months.
4. Nanotechnology
Regulators and industry discussed the outcomes from the nanotechnology workshop hosted by the European Commission-Joint Research Centre in Ispra, Italy in July 2009 as the basis for direction of future work.
Regulators and industry agreed to establish an ad hoc working group to discuss criteria for nanomaterials to be used in cosmetics.
5. Cosmetics Labeling
Industry submitted a proposal for work items to regulators at ICCR-3.
Regulators requested that the industry proposal should be revised to be more specific for each of the elements for future consideration.
Industry committed to update and expand the proposal in a timely fashion.
6. Sunscreens
Both industry and regulators agreed to support ISO sunscreen activities.
7. Regulators' Liaison to Industry Technical Working Group
Industry and Regulators agreed to explore options to improve communications between Regulators and Industry to ensure the efficiency and productivity of ICCR is maintained.
8. Expansion of ICCR
Regulators and Industry felt that it was too soon for expansion of membership and an impact assessment should be developed beforehand.
Preliminary discussion of criteria for new members was discussed.
Therapeutic Products Directorate
Guidance Document on Post-Drug Identification Number (DIN) Changes
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/change_din-eng.php
Consultation on Good Manufacturing Practices - Program Review
http://www.hc-sc.gc.ca/dhp-mps/consultation/compli-conform/2009gmp-bpf-index-eng.php
Health Canada is conducting a review of its Good Manufacturing Practices (GMP) inspection program for drug establishments in an effort to make the program more risk-based. A number of factors highlighted the need for a review at this time, including the growing complexity of health products now available on the Canadian market and international trends related to GMP inspections. The review involves a detailed evaluation of all aspects of the GMP program including such things as inspection scheduling and the conduct of inspections.
Environment Canada
Chemicals Management Plan Moves into New Phase with Release of Draft Screening Assessments for Batch 7 Substances
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2009/2009_152-eng.php
Of the 14 substances assessed in this batch, three may pose a risk to human health (Michler’s ketone, n-BGE and 2-butanone oxime). Michler’s ketone is primarily found in Canada as a residue in paper colourants; n-BGE is used as a diluent in epoxy resins, which are then used to make coatings, adhesives, binders, sealants, fillers, electrical insulation and resins; and, 2-butanone oxime is used primarily to prevent film from forming in alkyd paints, primers, varnishes and stains.
Five of the remaining 11 substances, which are no longer in commerce in Canada, have hazardous properties that could affect the environment if commercial activity resumes. Therefore it is being proposed that the Significant New Activity (SNAc) provisions of the Canadian Environmental Protection Act 1999 be applied, which require new and future uses to be notified and assessed.
Canadian Health Food Association
New Lobby Campaign Revealed at Expo East – Save Our Natural Health Products
www.saveournaturalhealthproducts.ca
GE Seeds Originating in Canada Pose Major Concern for Canadian Organics
The European Commission’s Rapid Alert System for Food and Feed has discovered an illegal genetically engineered (GE) trait in German food products, which originated from Canada. Although no organic products have been implicated at this time, the discovery of this unauthorized GE trait in food products is a major concern for the Canadian organic sector, and for consumers around the world. The GE flax in question, called ‘Triffid,’ was designed specifically to withstand applications of synthetic chemical pesticides.
Government Funds Branding Campaign
The Canadian government has announced a $32 million investment into a branding initiative to enhance the competitiveness of the country’s food sector. The Canada Brand Advocacy Initiative (CBAI) will put the country's maple leaf brand on products grown by Canadian farmers in a bid to increase global sales. The initiative will help farmers promote their products by funding market analysis, advertising campaigns and public opinion research. The media release did not mention anything about organic agriculture.
Program Advisory Committee
CHFA identified a number of industry representatives to participate as potential members on the NHPD-established Program Advisory Committee (PAC) Working Groups (WG). Three Working Groups will or have been formed to provide recommendations to the PAC. These include:
- Standards of Evidence – formed with target completion date December 2009
- Testing Requirements – formed with target completion date January 2010
- Compliance and Enforcement – to meet after NHPD compliance & enforcement consultations
NHPD workshops
NHPD is undertaking cross Canada workshops in November to discuss key developments and help formulate an appropriate compliance and enforcement strategy. CHFA received an invitation and will participate in the workshops to provide comments in relation to compliance and enforcement activities for NHPs for sale in Canada, including compliance communication, timelines for NHPs on market not holding a license and NHPs carrying a Drug Identification Number (DIN) on the label. Workshop dates and locations have been finalized and include:
- Vancouver, British Columbia November 16-17, 2009
- Toronto, Ontario November 19-20, 2009
- Montreal, Quebec November 24-25, 2009
Recent Developments in Stewardship Ontario programs
All brand owners and/or first importers of natural health products (NHPs) that have permanent establishment in Ontario should be aware of Stewardship Ontario’s Consolidated Municipal Hazardous or Special Waste (MHSW) Program Plan.
This revised program, if approved, would replace the current Phase 1 MHSW Program Plan. While the current Phase 1 MHSW Program may not impact our members that make and/or import NHPs for distribution in Ontario, the consolidated program plan will have an impact at some point, as some types of NHPs are included in the definition of pharmaceuticals (one of the MHSW materials). Therefore, companies will be required to pay a steward fee to Stewardship Ontario to operate the MHSW program, regardless of their gross Ontario revenues.
The program plan (volumes 1 and II), overview, and industry’s consultation document are posted for comment at Environmental Registry.
Canada Talking to Europe about Organic Equivalencies
The Canada Organic Office (COO) is in the process of equivalency determination with the European Union (EU). They have been working with industry to review the technical variances list, in preparation for the Canada Food Inspection Agency’s discussion with the EU in mid-September.
Equivalency is determined by assessing and comparing two regulatory systems, including the standards, to determine whether the principles and outcomes achieved are equivalent. Variations are identified and advice and input are sought from industry on the significance of variations found in the respective standards. Each government takes this input into consideration while determining if the foreign organic regime can be deemed equivalent.
If Canada and EU accept each other variances, an agreement can be reached, but the content of the agreement will depend on Department of Foreign Affairs and International Trade (DFAIT) and Agriculture Canada policies. The intent of an import-export agreement is to allow organic producers to certify only once to their domestic regulations and simultaneously meet domestic requirements and the import requirements of the importing country. Therefore, producers can access both markets while only being certified to the domestic system.
Organic Standards
One of the important components of the Canada Organic Regime is the Canada Organic Standards, which are being referenced in Organic Products Regulations, 2009, to address the technical requirements for organic producers. It is the industry’s goal to clarify the requirements of mandatory Organic standards. The voting process on the latest amendment (referred as “4th ballot”) just ended in early July. While the industry is waiting for the “4th ballot” results on the amendment of the Organic Standards, it is our understanding that the Canada Organic Office (COO) is currently negotiating with the Canadian General Standards Board (CGSB) to have a “5th ballot” this fall to further amend the Canadian Organic Standards.
CHFA Defends Folic Acid Fortification in Letter to the Editor
On August 18, 2009 The Globe and Mail published an article that outlined the latest study that found folic acid fortification to our food supply may elevate predisposed individuals to certain diseases such as cancer. CHFA President and CEO Penny Marrett responded:
It may be considered a dilemma whether or not to have mandatory folic-acid fortification in our food supply. On one hand, the number of babies born in Canada with spina bifida and other neural-tube defects has decreased significantly since its introduction in 1998. On the other, increased exposure to the vitamin 'may' cause certain diseases in predisposed individuals. Until we have the research to show higher levels of this B vitamin are doing more harm than good, the price of foregoing the benefits of this program is just too costly.
Penelope (Penny) Marrett
President & CEO
Canadian Health Food Association
The original article, Fortifying foods with folic acid may present health risk, can be found here www.theglobeandmail.com/life/health/fortifying-foods-with-folic-acid-may-present-health-risk/article1255355.
CCTFA
2009 CIR Compendium Now Available for Purchase
https://www.lulu.com/commerce/index.php?fBuyContent=7463563
The 2009 CIR Compendium is the most complete collection of cosmetic ingredient safety reviews available. The 2009 CIR Compendium contains concise information on each ingredient reviewed by CIR and its Expert Panel over the past 33 years. Professionals in the cosmetic industry, as well as dermatologists and toxicologists, who need concise information about safety assessments, will find the 2009 CIR Compendium an indispensable, easy-to-use resource. It contains summaries of the most essential information on more than 1,400 safety assessments by the CIR Expert Panel.
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