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Proposed Registration Decision PRD2025-03, Tea Tree Oil, Timorex Gold

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Summary

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

To obtain a full copy of Proposed Registration Decision PRD2025-03, Tea Tree Oil, Timorex Gold please contact our publications office.

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

Table of contents

Proposed registration decision for Timorex Gold

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act, is proposing registration for the sale and use of Timorex Gold, containing the technical grade active ingredient tea tree oil for the control of botrytis grey mold on greenhouse and outdoor ornamentals, the control of white rust on greenhouse and outdoor chrysanthemums, and the suppression of fusarium wilt on greenhouse and outdoor carnations. This evaluation was completed under the User Requested Minor Use Label Expansion program, which is a cooperative program between Agriculture and Agri-Food Canada and Health Canada's Pest Management Regulatory Agency and includes participation by sponsor groups, manufacturers, and both provincial and federal governments.

Tea tree oil is currently registered for use on various field and greenhouse food crops (in other words, grapes, peppers, cucumbers, lettuce, eggplant, hops, potato, blueberry, raspberry, strawberry and tomato), as well as outdoor cannabis and cannabis grown in greenhouses or other enclosed growing structures. For details, refer to Evaluation Report ERC2014-01, Tea Tree Oil, Proposed Registration Decision PRD2016-18, Tea Tree Oil and Registration Decision RD2016-30, Tea Tree Oil.

An evaluation of available scientific information found that, under the approved conditions of use, the health and environmental risks and the value of Timorex Gold, containing tea tree oil, are acceptable.

This summary describes the key points of the evaluation, while the Science evaluation of the full version of Proposed Registration Decision PRD2025-03, Tea Tree Oil, Timorex Gold provides detailed technical information on the human health, environmental and value assessments of Timorex Gold, containing tea tree oil on greenhouse and outdoor ornamentals.

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 individuals and the environment from the use of pest control products. Health or environmental risk is considered acceptableFootnote 1 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 valueFootnote 2 when used according to the label directions. Conditions of registration may include 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 (for example, children). They also consider the unique characteristics of organisms in the environment. These methods and policies also consider the nature of the effects observed and the uncertainties when predicting the impact of pesticides. For more information on how the Health Canada regulates pesticides, the assessment process and risk-reduction programs, please visit the Pesticides and pest management portion of the Canada.ca website.

Before making a final registration decision on Timorex Gold, containing tea tree oil, Health Canada's PMRA will consider any written comments received from the public in response to this consultation document.Footnote 3 Health Canada will then publish a Registration DecisionFootnote 4 on Timorex Gold, containing tea tree oil, which will include the decision, the reasons for it, a summary of comments received on the proposed registration decision and Health Canada's response to these comments.

For more details on the information presented in this summary, please refer to the Science Evaluation of PRD2025-03.

What is tea tree oil?

Tea tree oil is an extract from a cultivated tree native to Australia, New Zealand and Southeast Asia. Compounds contained in tea tree oil have anti-fungal properties which affect certain fungal pathogens. Tea tree oil is the active ingredient in Timorex Gold, which is registered to control or suppress certain diseases on various field or greenhouse crops.

Health considerations

Can approved uses of tea tree oil affect human health?

Tea tree oil is unlikely to affect human health when used according to label directions.

Toxicology studies in laboratory animals describe potential health effects from varying levels of exposure to a chemical and identify the dose where no effects are observed. When assessing health risks, two key factors are considered:

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

Potential exposure to tea tree oil may occur through the diet (food and water) or when handling and applying the product. In laboratory animals, tea tree oil was of slight acute toxicity via the oral route, low acute toxicity via the dermal and inhalation routes, severely irritating to the eyes and skin, and considered to be a skin sensitizer. Although tea tree oil has low acute inhalation toxicity, because it is a severe eye and skin irritant, tea tree oil has the potential to cause respiratory irritation if inhaled.

In laboratory animals, the end-use product, Timorex Gold, was of low acute toxicity via the oral, dermal, and inhalation routes, moderately irritating to the eyes and skin, and considered to be a skin sensitizer. Because it is moderately irritating to the eyes and skin, Timorex Gold has the potential to cause respiratory irritation if inhaled.

Residues in drinking water and food

Dietary risks from food and drinking water are acceptable.

Timorex Gold is currently registered for use on indoor and outdoor food crops, outdoor cannabis and cannabis grown in greenhouses or other enclosed growing structures. In addition, the likelihood of residues of tea tree oil in drinking water will be very low. Dietary exposure, including drinking water, is not expected from the proposed expansion of use of tea tree oil to greenhouse non-food crops and outdoor ornamentals. Consequently, health risks from dietary exposure are acceptable for all segments of the population, including infants, children, adults and seniors.

Risks in residential and other non-occupational environments

Estimated risk for residential and other non-occupational exposure is acceptable.

Timorex Gold is registered as a commercial fungicide end-use product. There are no residential uses for Timorex Gold.

The label for Timorex Gold includes measures to prevent bystander and residential exposure, such as reducing spray drift, restricting access to the treated areas for 4 hours or until sprays have dried and precautionary statements to keep bystanders out of the treatment areas (field or greenhouse) during application.

Residential and non-occupational exposure to Timorex Gold is expected to be low when label directions are observed. Consequently, the health risk to residents and the general public is acceptable.

Occupational risks from handling Timorex Gold

Occupational risks are acceptable when Timorex Gold is used according to the label directions, which include protective measures.

Workers handling Timorex Gold can come into direct contact with tea tree oil through inhalation and contact with the eyes and skin. To protect workers from exposure to Timorex Gold, the label will require workers to wear personal protective equipment (PPE) during mixing, loading, application, clean-up and repair. In addition, the Timorex Gold label requires a restricted-entry interval (REI) of 4 hours, or until sprays have dried, and includes a spray advisory statement to minimize spray drift.

For greenhouse uses, thorough ventilation must occur during the restricted-entry interval, such that the spray mist or fog has cleared before workers may enter. If early entry is necessary during the restricted-entry interval, workers must wear the appropriate PPE.

The occupational risks are acceptable when the precautionary statements on the labels are observed.

Environmental considerations

What happens when tea tree oil is introduced into the environment?

When used according to label directions, the environmental risks associated with the major new uses of tea tree oil and its associated end-use product, Timorex Gold, on greenhouse non-food crops and outdoor ornamentals are acceptable.

The environmental impact of the use of tea tree as a biofungicide on greenhouse food crops and field crops was assessed in ERC2014-01, Tea Tree Oil, PRD2016-18, Tea Tree Oil and RD2016-30, Tea Tree Oil. Tea tree oil is toxic to aquatic organisms and beneficial insects. Risk mitigation measures for these organisms are present on the registered label of Timorex Gold.

The proposed major new uses of tea tree oil on greenhouse non-food crops and outdoor ornamentals have the same application rates and methods as the registered use pattern on greenhouse and field crops. As such, the proposed major new uses of tea tree oil are not expected to increase the environmental exposure of non-target organisms compared to the registered use when label directions are followed.

After a scientific review of the available information, the PMRA has concluded that the environmental risks associated with the major new uses of tea tree oil on outdoor ornamentals and greenhouse non-food crops are acceptable when used according to label directions.

Value considerations

What is the value of Timorex Gold?

Timorex Gold provides control of botrytis grey mould on greenhouse and outdoor ornamentals, suppression of fusarium wilt on greenhouse and outdoor carnations, and control of white rust on greenhouse and outdoor chrysanthemums.

Botrytis grey mould, fusarium wilt and white rust are major concerns for producers of ornamental plants, carnations and chrysanthemums, respectively, under field or greenhouse conditions, as they can result in unmarketable plants, or even plant death. When applied as a foliar application according to the labelled use directions, Timorex Gold will manage these diseases on the associated greenhouse and outdoor ornamental crops. The registration of Timorex Gold for these uses will provide producers of greenhouse and outdoor ornamentals with an additional product option to manage these important diseases.

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 Timorex Gold to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures - Human health

The signal words "WARNING - EYE AND SKIN IRRITANT" and "POTENTIAL SKIN SENSITIZER" are on the principal display panel of the Timorex Gold label.

No additional mitigating measures are required for the proposed use expansion. However precautionary statements have been updated to meet current standards.

Workers are required to wear personal protective equipment (PPE) during mixing, loading, application, clean-up and repair. The degree of PPE depends on the activity and method of application.

For Timorex Gold, there is a restricted-entry interval of 4 hours, or until sprays have dried. If early entry is necessary during the restricted-entry interval, workers must wear the appropriate PPE (long-sleeved shirt, long pants, chemical-resistant gloves, protective eyewear (goggles or face shield), sock and shoes, and a NIOSH-approved R95 or P95 (minimum) filtering facepiece respirator (dust mask) that is properly fit tested). Entry or re-entry to greenhouses is only permitted after a thorough ventilation and spray mist or fog has cleared and the treated surface has dried.To limit bystander exposure, the label for Timorex Gold includes a drift statement and precautionary statements to not apply the end-use product when bystanders are near the treatment areas (field or greenhouse).

Key risk-reduction measures - Environment

The following new risk mitigation measures are required:

Next steps

Before making a final registration decision on Timorex Gold, containing tea tree oil, Health Canada's PMRA will consider any written comments received from the public in response to this consultation document up to 45 days from the date of publication (11 June 2025) of PRD2025­03. Please forward all comments to Publications or through the Public Engagement Portal (Public Engagement Forms – Consultation Comment). Health Canada will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed decision and Health Canada's response to these comments.

Other information

When the Health Canada makes its registration decision, it will publish a Registration Decision on Timorex Gold, containing tea tree oil (based on the Science Evaluation of PRD2025-03). In addition, the test data referenced in PRD2025-03 will be available for public inspection, upon application, in the PMRA's Reading Room. For more information, please contact the PMRA's Pest Management Information Service.

Page details

2025-07-31