ARCHIVED - Memorandum to Registrants, Applicants and their Representatives for Capsaicin Products - Capsaicin Statement of Guarantee and Labelling Allowances

August 10, 2010

Purpose

The purpose of this memo is to communicate Health Canada's Pest Management Regulatory Agency's (PMRA) policy with respect to standardizing the guarantee statement for capsaicin on the Statement of Product Specification Form (SPSF) and the labels of pest control products containing this active ingredient.

Background

Capsaicin produces a burning sensation when it comes in contact with skin or mucous membranes. It is commonly used to repel animals such as bears, dogs and squirrels. It is derived from fruits of plants in the Capsicum genus. Also present in these fruits are other capsaicinoid chemicals that produce a similar burning sensation (dihydrocapsaicin and nordihydrocapsaicin). Therefore the label should list both the capsaicin and related capsaicinoids to accurately reflect the true strength of the pest control product.

Capsaicin Guarantee Declaration Requirement

The guarantee declaration on the SPSF and label for products containing capsaicin must include the capsaicin and the related capsaicinoids. This information must be presented as follows:

Technical Grade Active Ingredients (TGAIs)

(see Appendix I)

SPSF

Capsaicin: 12.06% ^*

Dihydrocapsaicin: 8.64%

Nordihydrocapsaicin: 1.44%

Label

Capsaicin: 12.06%

Related Capsaicinoids: 10.08%

^*values listed are for demonstration purposes only

End-use Products (EPs) and Manufacturing Concentrates (MAs)

(see Appendix II)

SPSF

Capsaicin: 0.44% ^*

Related Capsaicinoids: 0.37%

Label

Capsaicin: 0.44%

Related Capsaicinoids: 0.37%

^*values listed are for demonstration purposes only

Implementation

The PMRA will implement this requirement as follows:

For registrations of existing TGAIs

No action is required since all currently registered TGAIs meet this requirement.

For registrations of existing EPs and MAs

Registrants are required to update the SPSF and label with this requirement either when the next application is filed to amend the product register or at registration renewal, whichever occurs first. (The registered TGAI or MA used to formulate the product must already meet this requirement.)

For applications to register new products

SPSF and label must be consistent with this requirement. (The registered TGAI or MA used to formulate the product must already meet this requirement.)

Appendices

Appendix 1 - Sample Technical Grade Active Ingredient SPSF

Row 1:

1. Trade Name:
2. Common Name: Capsaicin
3. Chemical Name: 6-Nonenamide, N-((4-hydroxy-3-methoxyphenyl)methyl-8-methyl-,(E)-
4. Name:
   Address:
   Multiple Suppliers? Yes: □
5. Reg #:
6. Purity:
7. CAS #: 404-86-4
8. List #:
9. % w/w: 12.06
10. Purpose: Active Ingredient
11. % LCL: 11.46
12. % Nominal: 12.06
13. % UCL: 12.66
14.  
    1. Label Guarantee: Capsaicin
    2. Value: 12.06
    3. Units: %
    4. LCL: 11.46
    5. UCL: 12.66
15. Other Info:

Row 2:

1. Trade Name:
2. Common Name: Dihydrocapsaicin
3. Chemical Name: Nonenamide, N-((4-hydroxy-3-methoxyphenyl)methyl-8-methyl-,(E)-
4. Name:
   Address:
   Multiple Suppliers? Yes: □
5. Reg #:
6. Purity:
7. CAS #: 19408-84-5
8. List #:
9. % w/w: 8.64
10. Purpose: Active Ingredient
11. % LCL: 8.21
12. % Nominal: 12.06
13. % UCL: 12.66
14.  
    1. Label Guarantee
    2. Value:
    3. Units:
    4. LCL:
    5. UCL:
15. Other Info:

Row 3:

1. Trade Name:
2. Common Name: Nordihydrocapsaicin
3. Chemical Name: Octanamide, N-((4-hydroxy-3-methoxyphenyl)methyl-7-methyl-,(E)-
4. Name:
   Address:
   Multiple Suppliers? Yes: □
5. Reg #:
6. Purity:
7. CAS #: 28789-35-7
8. List #:
9. % w/w: 8.64
10. Purpose: Active Ingredient
11. % LCL: 1.37
12. % Nominal: 1.44
13. % UCL: 1.516
14.  
    1. Label Guarantee
    2. Value:
    3. Units:
    4. LCL:
    5. UCL:
15. Other Info:

Row 4:

1. Trade Name:
2. Common Name:
3. Chemical Name:
4. Name:
   Address:
   Multiple Suppliers? Yes: □
5. Reg #:
6. Purity:
7. CAS #:
8. List #:
9. % w/w: 8.64
10. Purpose: Active Ingredient
11. % LCL:
12. % Nominal:
13. % UCL:
14.  
    1. Related Capsaicinoids
    2. Value: 10.08
    3. Units: %
    4. LCL: 9.58
    5. UCL: 10.58
15. Other Info:

Appendix II - Sample End-Use Product SPSF

Row 1:

1. Trade Name: TGAI Trade Name
2. Common Name: Capsaicin
3. Chemical Name: 6-Nonenamide, N-((4-hydroxy-3-methoxyphenyl)methyl-8-methyl-,(E)-
4. Name:
   Address:
   Multiple Suppliers? Yes: □
5. Reg #:
6. Purity: 12.06
7. CAS #: 404-86-7
8. List #:
9. % w/w: 3.65
10. Purpose: Active Ingredient
11. % LCL: 0.40
12. % Nominal: 0.44
13. % UCL: 0.48
14.  
    1. Label Guarantee: Capsaicin
    2. Value: 0.44
    3. Units: %
    4. LCL: 0.40
    5. UCL: 0.48
15. Other Info:

Row 2:

1. Trade Name: TGAI Trade Name
2. Common Name: Capsaicinoids
3. Chemical Name: Nonanamide, N-((4-hydroxy-3-methoxyphenyl)methyl-8-methyl-
   and
   Octanamide, N-((4-hydroxy-3-methoxyphenyl)methyl-7-methyl-
4. Name:
   Address:
   Multiple Suppliers? Yes: □
5. Reg #: XXXX
6. Purity: 10.08
7. CAS #:
8. List #:
9. % w/w:
10. Purpose: Active Ingredient
11. % LCL: 0.33
12. % Nominal: 0.37
13. % UCL: 0.41
14.  
    1. Label Guarantee: Related Capsaicinoids
    2. Value: 0.37
    3. Units: %
    4. LCL: 0.33
    5. UCL: 0.41
15. Other Info: CAS Numbers: 19408-84-5 and 28789-35-

For More Information

Inquiries regarding the capsaicin statement of guarantee and labelling allowances or the implementation of these requirements should be directed to the PMRA's Pest Management Information Service.