Record of Decision from Meeting with the Canadian Cosmetic Toiletry and Fragrance Association

Oct 20th list of ingredients for classification

October 20, 2004

Attendees

Documents : Oct 20th list of ingredients for classification

Opening
Welcome and roundtable introduction

1. Status Update

CCTFA requested an update on the number of product licence issued and personal care product submissions received to date.

• So far NHPD has issued one NPN for personal care product, but many more for other natural health products. As there is no distinct category to capture these products from other submissions, NHPD currently does not have data on the number of submission solely for personal care products.

2. Category IV Monographs

CCTFA inquired on the status of compendial applications received prior to July 1, 2004 , and monograph development for personal care products.

• S. 6 of the Natural Health Products Regulations came into force on July 1, 2004 . NHPD is not legally bound to review compendial applications received prior to that date within the 60 days requirement. However operationally, NHPD will review them in the same manner.
  
  
• For those referencing the Category IV monographs, NHPD will treat them as compendial applications, and make every effort to review them within 60 days. More staff has also been hired to handle compendial monograph applications.
  
  
• NHPD will post on-line the criteria for development of monographs, and the list of ingredients for which NHPD may develop monographs for, along with the associated time line. A statement to the effect on the use of the monographs, and liability clauses will be included.
  
  
• CCTFA will prioritize the ingredients for which NHPD is currently examining with TPD on their classifications, will identify any that may be missing, and will advise NHPD of key ingredients for the personal care sector which should be addressed on a high priority basis
  
  
• NHPD is currently examining ways to improve the submission management system. This will include the quality of the application data and the process flow.

3. Product Classification

CCTFA inquired on whether products not yet classified can be deemed as drugs (since natural health products fall under the definition of a drug at the level of the Food and Drugs Act) until classified otherwise.

• Legal has indicated to NHPD that this is not feasible, but NHPD will reconfirm again.

4. INCI Labelling

CCTFA requested a written statement to confirm that INCI nomenclature is acceptable for non-medicinal ingredients (NMI), and for NHPD to examine whether it is acceptable for medicinal/active ingredients (MI) also.

• NHPD will provide a statement to the effect that INCI nomenclature is acceptable for NMIs.
• NHPD will examine the feasibility for accepting INCI nomenclature for MIs.

5. Positive NMI Listing

CCTFA inquired on the feasibility to use cosmetic ingredients (i.e. those set out in the Cosmetic Dictionary) beyond the 500 NMIs currently listed on the NHPD NMI list.

• NHPD accepts NMIs currently not listed on the NHPD NMI list so long as the purpose, use and safety information are provided.
• NHPD and CCTFA will work together to consider a process for adding INCI names to NHPD's positive NMI list.

6. Animal Tissue Form

CCTFA inquired on the difference between the animal tissue form used by NHPD to that by TPD.

• NHPD clarified that the information is being uniformly collected throughout other directorates in the Branch. One of the key difference is that there is no longer a "BSE-free country" , hence the need to track the origin of the animal.
• NHPD will examine whether there is duplication in data collection. That is, whether the information is already provided in the product licence application form. If so, will examine the need to amend the animal tissue form accordingly.

7. Security Packaging

CCTFA requested that no security packaging be required for cosmetic-like NHPs, and indicated that such requirement is too onerous for these low risk products. CCTFA indicated that security packaging is not required for similar cosmetic-like drugs.

• NHPD will examine this based on risk.

8. Advertising

CCTFA inquired on the hold up of advertising pre-clearance by the Advertising Standards Canada (ASC).

• NHPD clarified that so long as a valid market authorization is issued, pre-clearance can be done based on such terms of market authorization. Without such authorization, pre-clearance will not be possible.
• NHPD provided an update on the progress of the advertising guideline.

9. Compliance and Enforcement

CCTFA inquired about the role of the HPFB Inspectorate with NHP inspections

• The NHP Regulations do not require pre-market site inspections.
• NHPD may request inspectors to conduct random site inspections as part of the post market surveillance to see whether companies are in compliance with their Good Manufacturing Practices.
• NHPD confirmed that inspections are the responsibility of the HPFB Inspectorate.

10. Export Certificate

CCTFA inquired on whether NHPD will issue an export certificate for NHPs.

• The text for this certificate is currently being finalized, and will soon be issued by NHPD.
• Information on this will be posted on-line.

11. Communications and Training

CCTFA requested NHPD participation at the December 2004 regulatory workshops in Toronto and Montreal , and inquired the feasability to conduct a sector specific workshop for CCTFA members.

• NHPD representatives were invited to attend the December 2004 CCTFA Regulatory workshops to learn more about the personal care industry.
• NHPD will further examine the feasibility to conduct a sector-specific workshop in the near future. This will replace the need to attend the December 04 regulatory workshops.

Next Meeting

To be confirmed