19 March 2010
HC Pub: 100131
ISBN: 978-1-100-15354-4 (print version)
ISBN: 978-1-100-15355-1 (PDF version)
Catalogue number: H113-9/2010-7E (print version)
Catalogue number: H113-9/2010-7E-PDF (PDF version)

This page is a summary of the consultation document. If you would like to comment, please request the full consultation document.

To obtain an electronic copy of the document, Proposed Registration Decision PRD2010-07, Garlic Oil, please contact our publications office.

Should you require further information, please contact the Pest Management Information Service.

Table of Contents

• Proposed Registration Decision for Garlic Oil
• What Does Health Canada Consider When Making a Registration Decision?
• What Is Garlic Oil?
• Health Considerations
• Environmental Considerations
• Value Considerations
• Measures to Minimize Risk
• Next Steps
• Other Information

Proposed Registration Decision for Garlic Oil

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the  Pest Control Products Act and  Regulations, is proposing full registration for the sale and use of Garlic Oil FCC 8170 and Comfort Zone, containing the technical grade active ingredient garlic oil, to repel mosquitoes outdoors.

An evaluation of available scientific information found that, under the approved conditions of use, the product has value and does not present an unacceptable risk to human health or the environment.

This summary describes the key points of the evaluation, while the Science Evaluation section of Proposed Registration Decision PRD2010-07, Garlic Oil, provides detailed technical information on the human health, environmental and value assessments of Garlic Oil FC 8170 and Comfort Zone.

What Does Health Canada Consider When Making a Registration Decision?

The key objective of the Pest Control Products Act is to prevent unacceptable risks to people and the environment from the use of pest control products. Health or environmental risk is considered acceptable if there is reasonable certainty that no harm to human health, future generations or the environment will result from use or exposure to the product under its proposed conditions of registration. The Act also requires that products have value when used according to the label directions. Conditions of registration may include special precautionary measures on the product label to further reduce risk.

To reach its decisions, the PMRA applies modern, rigorous risk-assessment methods and policies. These methods consider the unique characteristics of sensitive subpopulations in humans (such as children) as well as organisms in the environment (for example, those most sensitive to environmental contaminants). These methods and policies also consider the nature of the effects observed and the uncertainties when predicting the impact of pesticides. For more information, please refer to the following:

• Protecting Your Health and the Environment
• Pesticide Registration Process
• Pesticide Risk Reduction Program

Before making a final registration decision on garlic oil, the PMRA will consider all comments received from the public in response to this consultation document. The PMRA will then publish a Registration Decision on garlic oil, which will include the decision, the reasons for it, a summary of comments received on the proposed final registration decision and the PMRA's response to these comments.

For more details on the information presented in this summary, please refer to the Science Evaluation section of Proposed Registration Decision PRD2010-07, Garlic Oil.

What Is Garlic Oil?

Garlic oil is an extract of garlic (Allium sativum). In the end-use product, Comfort Zone, it is formulated to be water-soluble. Garlic contains a high concentration of sulphur compounds, only some of which contribute to its characteristic odour. Garlic is known to be repellent to various insects, however the exact mode of action of this repellency is unknown.

Health Considerations

Can Approved Uses of Garlic Oil Affect Human Health?

Garlic oil is unlikely to affect your health when used according to label directions.

Exposure to garlic oil may occur when handling and applying the end-use product, Comfort Zone, as well as during typical residential activities following application. When assessing health risks, two key factors are considered:

• the levels where no health effects occur; and
• the levels to which people may be exposed.

The dose levels used to assess risks are established to protect the most sensitive human population (for example, children and nursing mothers). Only uses for which the exposure is well below levels that cause no effects in animal testing are considered acceptable for registration.

The technical grade active ingredient, garlic oil, is of slight acute toxicity by the oral route, low acute toxicity by the dermal route, a severe skin irritant, a moderate eye irritant, and a dermal sensitizer. Because garlic is a known mucosal irritant, inhalation of garlic oil mist or vapour may result in throat and respiratory tract irritation. The end-use product, Comfort Zone, is of low acute toxicity by both the oral and dermal route, may be a skin and eye irritant, and a possible dermal sensitizer. Cautionary statements alerting the user to garlic oil's acute toxicity, skin and eye irritation, and dermal sensitization are required on the technical grade active ingredient product label, as well as Comfort Zone being a possible skin and eye irritant, and a dermal sensitizer.

Inhalation, dermal, and ocular exposures are possible when applying the product, particularly to the applicator and bystanders located near the treatment area. Also, entry into a recently sprayed area may result in dermal exposure. Therefore, spray advisory and restricted entry statements are required on the end-use product label to minimize applicator and bystander exposures.

The data requirements for short-term toxicity, prenatal developmental toxicity, and genotoxicity were waived by the PMRA based on the long history of safe consumption of garlic as a whole foodstuff and garlic oil in natural health products.

Residues in Water and Food

Dietary risks from food and water are not of concern.

The proposed use pattern for Comfort Zone is for non-food situations. Garlic oil readily degrades in the environment, so any inadvertent exposure of garlic oil to food, feed, or water from drift or direct contact is not expected to result in any dietary risk.

Risks From Handling Garlic Oil

Risks are not of concern when Comfort Zone is used according to label directions, which include protective measures.

Domestic users handling and applying Comfort Zone to areas that attract mosquitoes, such as plants, shrubs, turf, and under decks, can come in direct contact with garlic oil on the skin and in the eyes. Following the precautionary label statements aimed at minimizing exposure to the product will ensure domestic users are appropriately protected. Potential for inhalation of garlic oil while handling and applying the end-use product is anticipated to be negligible if users observe the precautionary label statements.

Accidental bystander exposure is possible from spray drift, but exposure is expected to be negligible if the precautionary label statements are observed by the applicator.

Post-application exposure is possible in individuals who immediately enter freshly treated areas. The transfer of garlic oil from turf or foliar application to an individual who is not sensitive to garlic will not pose a health concern.

Environmental Considerations

What Happens When Garlic Oil, as part of the End-Use Product Comfort Zone, Is Introduced Into the Environment?

Garlic oil is not expected to pose significant environmental risk when used according to label directions.

Garlic oil is expected to degrade rapidly in the environment. Garlic oil is a naturally occurring compound, and is considered non-toxic from an environmental perspective because it acts as a repellent. Environmental exposure is expected to be minimal when used according to the label directions.

Value Considerations

What Is the Value of Comfort Zone?

Comfort Zone is an insect repellent for mosquitoes.

Comfort Zone is a product for domestic use containing 4% Garlic oil for application on grass, plants, shrubs and under decks and porches. The product repels mosquitoes from these areas for up to five days.

Measures to Minimize Risk

Labels of registered pesticide products include specific instructions for use. Directions include risk-reduction measures to protect human and environmental health. These directions must be followed by law.

The key risk-reduction measures being proposed on the label of Comfort Zone to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

The statements, "MAY BE A SKIN AND EYE IRRITANT" and "POTENTIAL SKIN SENSITIZER" have been included on the principal display panel of the label and "Do not swallow", "Avoid getting on skin and in eyes", "May cause skin and eye irritation", "Avoid inhaling/breathing mist or vapours, and "Potential skin sensitizer" have been included in the "PRECAUTIONS" section of the secondary display panel of the end-use product label.

Because some individuals may be sensitive or allergic to garlic, the statements, "Apply only when the potential for drift is minimal", "Individuals who are sensitive or allergic to garlic should avoid handling Comfort Zone" and "Individuals who are sensitive or allergic to garlic should avoid treated areas until dry or until after a heavy rain" have also been included in the "PRECAUTIONS" section of the secondary display panel of the label.

Next Steps

Before making a final registration decision on garlic oil, the PMRA will consider all comments received from the public in response to Proposed Registration Decision PRD2010-07, Garlic Oil. The PMRA will accept written comments on this proposal up to 45 days from the date of publication.  Please forward all comments to Publications. The PMRA will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed final decision and the Agency's response to these comments.

Other Information

When the PMRA makes its registration decision, it will publish a Registration Decision on garlic oil (based on the Science Evaluation of Proposed Registration Decision PRD2010-07, Garlic Oil). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).