From: Francesco Masi [mailto:
[email protected]] On Behalf Of PMRA INFOSERV
Sent: July-12-11 4:55 AM
To: Lindalu Forseth
Subject: Re: Aromatherapy Flea Repellent products
Hello Lindalu,
Please read the following information below. If your product contains a new Active Ingredient to Canada, or if this is the first time you are trying to register something, I strongly suggest making use of the Pre-Submission Consultation service.
To determine with certainty if your product does indeed fall under the PCPA, please refer specifically to the Subject To Registration section below:
All products designed to manage, destroy, attract or repel pests that are used, sold or imported into Canada are regulated by Health Canada’s Pest Management Regulatory Agency (PMRA). These products include chemicals, devices, and even organisms, and are referred to collectively as pest control products, or simply 'pesticides.' The federal legislative authority for the regulation of pesticides in Canada is the Pest Control Products Act. The use of pesticides is also subject to regulation under provincial/territorial legislation.
Section 6 of the Pest Control Products Act states that
6. (1) No person shall manufacture, possess, handle, store, transport, import, distribute or use a pest control product that is not registered under this Act, except as otherwise authorized under subsection 21(5) or 41(1), any of sections 53 to 59 or the regulations.
Conditions of registration
(2) No person shall manufacture, import, export or distribute a registered pest control product unless it conforms to the conditions of registration respecting its composition and the person complies with the other conditions of registration.
Packaging of pest control products
(3) No person shall store, import, export or distribute a pest control product that is not packaged in accordance with the regulations and the conditions of registration.
Defence
(4) A person shall not be found to have contravened subsection (3) if it is established that the person reasonably believed that the pest control product was packaged in accordance with the regulations and the conditions of registration.
Misuse of pest control products
(5) No person shall handle, store, transport, use or dispose of a pest control product in a way that is inconsistent with
(a) the regulations; or
(b) if the product is registered, the directions on the label recorded in the Register, subject to the regulations.
Defence
(6) A person shall not be found to have contravened subsection (5) if it is established that the person
(a) reasonably believed that the directions on the label accompanying the pest control product complied with the regulations or, if the product is registered, with the directions on the label recorded in the Register; and
(b) handled, stored, transported, used or disposed of the product in accordance with the directions on the label accompanying it.
Packaging and advertisement of pest control products
(7) No person shall package or advertise a pest control product in a way that is false, misleading or likely to create an erroneous impression regarding its character, value, quantity, composition, safety or registration.
Activities that endanger health, etc.
( 8 ) No person shall manufacture, possess, handle, store, transport, distribute, use or dispose of a pest control product in a way that endangers human health or safety or the environment.
Offence and punishment
(9) A person who contravenes any provision of this section is guilty of an offence and liable
(a) on summary conviction, to a fine of not more than $200,000 or to imprisonment for a term of not more than six months, or to both; or
(b) on conviction on indictment, to a fine of not more than $500,000 or to imprisonment for a term of not more than three years, or to both.
"pest control product" means
(a) a product, an organism or a substance, including a product, an organism or a substance derived through biotechnology, that consists of its active ingredient, formulants and contaminants, and that is manufactured, represented, distributed or used as a means for directly or indirectly controlling, destroying, attracting or repelling a pest or for mitigating or preventing its injurious, noxious or troublesome effects;
(b) an active ingredient that is used to manufacture anything described in paragraph (a); or
(c) any other thing that is prescribed to be a pest control product.
Registering a product in Canada can range from 9-24 months, depending on the category of submission. You can find the relevant documents here:
http://www.hc-sc.gc.ca/cps-spc/pubs/pes ... hp#lps-spe
And our Forms:
http://www.hc-sc.gc.ca/cps-spc/pest/reg ... ex-eng.php
The Pest Control Products Act, and Regulations:
http://laws.justice.gc.ca/en/P-9.01/
http://canadagazette.gc.ca/partII/2006/ ... 124-e.html
====================================================
Pre-Submission Consultation:
A Pre-Submission Consultation Request is a service offered at no cost by the Agency that provides regulatory advice to registrants or applicants prior to the submission of an application to register or amend a pest control product. The pre-submission process may also be utilized as a mechanism for obtaining advice on a study protocol.
Pre-Submission Consultations are recommended for:
- New registrants with limited experience with the Canadian pesticide regulatory system -products that may qualify as Low-Risk Biochemical / Non-Conventional Pesticides (e.g., essential oils, food grade actives)
- Products that contain active ingredients under re-evaluation
Pre-submission consultations are required for:
- Joint Review requests
- Microbial applications
- For an overview of the Joint Review
All information on Pre-Submission Consultatins can be found here:
http://www.hc-sc.gc.ca/cps-spc/pest/reg ... ex-eng.php
As a reminder, the required documentation for the Pre-Submission Consultation Request consists of:
- Cover Letter
- Completed Pre-Submission Consultation Request Form
- Completed Product Specification Form
- 1 Electronic file in PDF Normal of the proposed label text .
Once you have filled everything out, you can simply e-mail it to:
[email protected]
Due to workload and backlog, the Pre-Submission Consultation Coordinator will contact you, within 02 to 04 weeks of the receipt of your documents.
=========================================================
Hope this helps.
Regards,
Francesco Masi
Regulatory Information Officer / Agent d'information sur la réglementation
Pest Management Regulatory Agency/Agence de réglementation de la lutte antiparasitaire
2720 Riverside Drive
Ottawa, ON, K1A 0K9
1-800-267-6315 (Within Canada)
613-736-3799 (Elsewhere)
http://www.hc-sc.gc.ca/cps-spc/pest/index-eng.php