Proposed Registration Decision PRD2025-13, Rectified clove leaf oil and DECCO 070 EC

• Pest Management Regulatory Agency
• 28 October 2025
• ISSN: 1925-0886 (PDF version)
• Catalogue number: H113-9/2025-13E-PDF (PDF version)

Summary

Table of contents

• Proposed registration decision for rectified clove leaf oil
• What does Health Canada consider when making a registration decision?
• What is rectified clove leaf oil?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Next steps
• Other information

Proposed registration decision for rectified clove leaf oil

Health Canada's Pest Management Regulatory Agency (PMRA), pursuant to subsection 28(1) of the Pest Control Products Act, is proposing registration for the sale and use of Clove Leaf Oil Technical and DECCO 070 EC, belonging to DECCO U.S. Post-Harvest, Inc., containing the technical grade active ingredient rectified clove leaf oil, to control potato sprouting.

An evaluation of available scientific information found that, under the approved conditions of use, the health risks and the value of the pest control products are acceptable.

This summary describes the key points of the evaluation, while the Science evaluation in the full version of Proposed Registration Decision PRD2025-13, Rectified Clove Leaf Oil and DECCO 070 EC provides detailed technical information on the human health and value assessments of rectified clove leaf oil and DECCO 070 EC.

What does Health Canada consider when making a registration decision?

The primary 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 acceptable^{Footnote 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 value^{Footnote 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, Health Canada's 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 Health Canada's PMRA regulates pesticides, the assessment process and risk-reduction programs, please visit the Pesticides and pest management portion of Canada.ca.

Before making a final registration decision on rectified clove leaf oil and DECCO 070 EC, Health Canada's PMRA will consider any written comments received from the public directly related to the proposed decision in this consultation document.^{Footnote 3}

Health Canada will then publish a Registration Decision^{Footnote 4} on rectified clove leaf oil and DECCO 070 EC, 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 PRD2025-13.

What is rectified clove leaf oil?

Rectified clove leaf oil is an essential oil derived from the clove plant that can act as a plant growth regulator and can be used to control potato sprouts prior to shipping. Rectified clove leaf oil destroys the growing points of any sprouts present prior to packing and shipping potatoes.

Health considerations

Can approved uses of rectified clove leaf oil affect human health?

Rectified clove leaf oil is unlikely to affect human health when it is used according to label directions.

Potential exposure to rectified clove leaf oil may occur through the diet, or when handling the end-use product. 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 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.

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.

Based on publicly available information, rectified clove leaf oil is considered to be of slight acute toxicity by the oral and dermal routes of exposure, of low acute toxicity by the inhalation route of exposure, severely irritating to the eyes, moderately irritating to the skin, irritating to the respiratory tract, and a potential skin sensitizer. It is not expected to be mutagenic or genotoxic.

Animals given repeated high doses of eugenol (the main component of clove leaf oil) in the diet showed decreased body weight or body weight gain. Exposure to eugenol in pregnant animals resulted in decreases in maternal food consumption and fetal weights, and developmental effects. Fetal and maternal effects occurred at the same dose. Consequently, there is no sensitivity of the young.

In laboratory animals, DECCO 070 EC is of low acute toxicity by the oral and inhalation routes of exposure, extremely irritating or corrosive to the eyes, moderately irritating to the skin, and is a skin sensitizer.

Residues in food and drinking water

Dietary risks from food are acceptable.

Dietary exposure to rectified clove leaf oil may occur through consumption of treated potatoes; however, rectified clove leaf oil, present in DECCO 070 EC, is not expected to pose a health risk when the end-use product is applied as directed by the label. Based on the indoor use, rectified clove leaf oil residues in drinking water are not expected.

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.

DECCO 070 EC is a commercial class end-use product that is an anti-sprouting agent for potatoes prior to grading and packaging. It is applied in commercial storage facilities where bystanders are not expected to be present. Therefore, risk due to residential and bystander exposure is acceptable.

Occupational risks from handling DECCO 070 EC

Occupational risks are acceptable when DECCO 070 EC is used according to the label directions, which include protective measures.

Workers handling DECCO 070 EC can come into direct contact with rectified clove leaf oil through inhalation and contact with skin during mixing, loading, clean-up, and maintenance. Due to the automated nature of application, occupational exposure during application is not expected. To protect workers from exposure to DECCO 070 EC, the label requires workers to wear a long-sleeved shirt, long pants, chemical-resistant gloves, protective eyewear (goggles or face shield), socks and shoes during mixing, loading, handling, clean-up, and maintenance activities. Postapplication workers involved in handling or packing treated potatoes must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes.

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

Environmental considerations

An environmental risk assessment was not required due to the nature of the proposed use pattern, which would not result in significant environmental exposure.

Value considerations

What is the value of DECCO 070 EC?

The registration of DECCO 070 EC will provide the potato industry with a new option for the management of sprouting in potatoes and a new product for the organic potato sector specifically.

Sprouting in potatoes can lead to substantial losses in quality and marketability. DECCO 070 EC is applied to damp-dried potatoes on a roller prior to packing and shipping, which is consistent with current industry practices. DECCO 070 EC is effective at controlling potato sprouts when applied as directed.

Measures to minimize risk

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

The key risk-reduction measures being proposed on the labels of Clove Leaf Oil Technical and DECCO 070 EC to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures - Human health

The following signal words and hazard statements are required on the principal display panel of the Clove Leaf Oil Technical label: "DANGER", "POISON", "Eye and Skin Irritant", and "Potential Skin Sensitizer". Additionally, the standard precautionary statement "Irritating to Respiratory Tract" is required on the label, to notify users of the irritation potential.

The following signal words and hazard statements are required on the DECCO 070 EC label: "DANGER – Corrosive to Eyes", "Skin Irritant", "Potential Skin Sensitizer", and "Warning: Contains the allergen soy."

Personal protective equipment (PPE) and standard precautionary statements are required on the labels to inform users that products are corrosive to the eyes and moderately irritating to skin, and to warn of the potential for sensitization.

For DECCO 070 EC, workers are required to wear a long-sleeved shirt, long pants, chemical-resistant gloves, protective eyewear (goggles or face shield), socks and shoes during mixing, loading, handling, clean-up and maintenance activities. Postapplication workers involved in handling or packing treated potatoes must also wear appropriate PPE.

Next steps

Before making a final registration decision on rectified clove leaf oil and DECCO 070 EC, Health Canada's PMRA will consider any written comments received from the public that are directly related to proposed decision PRD2025-13, such as comments directed to the science evaluation, in response to this consultation document up to 30 days from the date of publication of PRD2025-13 (by 27 November 2025). If more time is required to provide comments, a request for an extension of an additional 15 days can be made. Your request must be submitted in writing to the PMRA's Publications Section within the 30-day consultation period.

Please forward all comments to PMRA Publications, through the Public Engagement Portal (Public Engagement Portal 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 Health Canada's PMRA makes its registration decision, it will publish a Registration Decision on rectified clove leaf oil and DECCO 070 EC (based on the Science evaluation of PRD2025-13). In addition, the test data referenced in PRD2025-13 will be available for public inspection, upon application, in the PMRA's Reading Room. For more information or if you have questions, please contact the PMRA's Pest Management Information Service.