Proposed Registration Decision PRD2025-17, Nealta Miticide, containing Cyflumetofen

Pest Management Regulatory Agency
8 December 2025
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2025-17E-PDF (PDF version)

Summary

Table of contents

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

Proposed registration decision for cyflumetofen

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 Nealta Miticide, containing the technical grade active ingredient cyflumetofen, to control spider mites on greenhouse ornamentals. 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 sponsors groups, manufacturers, and both provincial and federal governments.

Nealta Miticide is currently registered to control certain spider mites on a variety of agricultural crops under use-site category numbers 4, 5, 13, 14 and 27. For details, refer to the Proposed Registration Decisions PRD2014-10 Cyflumetofen, PRD2024-07 Nealta Miticide, containing Cyflumetofen and Registration Decisions RD2014-24 Cyflumetofen, and RD2024-13 Nealta Miticide, containing cyflumetofen.

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

This summary describes the key points of the evaluation, while the Science evaluation in the full version of Proposed Registration Decision PRD2025-17, Nealta Miticide, containing Cyflumetofen provides detailed technical information on the human health, environmental and value assessments of Nealta Miticide, containing cyflumetofen.

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 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 Nealta Miticide, containing cyflumetofen, 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 Nealta Miticide, containing cyflumetofen, 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 PRD2025-17.

What is cyflumetofen?

Cyflumetofen is a beta-ketonitrile derivative. It interferes with energy production within cells and acts as an acaricide on contact with spider mites. Foliar application of cyflumetofen formulated as Nealta Miticide provides control of spider mites on greenhouse ornamentals.

Health considerations

Can approved uses of cyflumetofen affect human health?

Nealta Miticide, containing cyflumetofen, is unlikely to affect your health when used according to label directions.

Potential exposure to cyflumetofen may occur when handling and applying the end-use product or when entering an area that has been treated with the product. When assessing health risks, two key factors are considered:

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

The dose levels used to assess risks are selected 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 level at which no effects are observed. The health effects noted in animals occur at dose levels more than 100-times higher (and often much higher) than levels to which humans are normally exposed when pesticide products are used according to label directions.

In laboratory animals, the technical grade active ingredient cyflumetofen was of low acute toxicity by the oral, dermal, and inhalation routes of exposure. It was minimally irritating to the eyes and non-irritating to the skin. Cyflumetofen caused an allergic skin reaction; consequently, the hazard statement “POTENTIAL SKIN SENSITIZER” is required on the label.

The end-use product, Nealta Miticide, containing cyflumetofen, was of low acute toxicity via the oral, dermal and inhalation routes of exposure. Nealta Miticide was non-irritating to the eyes, minimally irritating to the skin and did not cause an allergic skin reaction.

Prior to the initial registration of cyflumetofen, registrant-supplied short- and long-term (lifetime) animal toxicity tests, as well as information from the published scientific literature, were assessed for the potential of cyflumetofen to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The most sensitive endpoints for risk assessment were effects on the adrenal glands. There was no evidence that cyflumetofen damaged genetic material; however, it did cause testicular tumours and thyroid tumours in male rats. There was no evidence of increased sensitivity of the young compared to adult animals, although a serious endpoint (a birth defect) was noted in rabbit fetuses at a dose level that was also toxic to the mothers. The risk assessment protects against the effects noted above and other potential effects by ensuring that the level of exposure to humans is well below the lowest dose level at which these effects occurred in animal tests.

Occupational risks from handling Nealta Miticide

Occupational risks are not of health concern when Nealta Miticideis used according to the proposed label directions, which include protective measures.

Workers mixing, loading or applying Nealta Miticide, and workers entering recently treated fields, nurseries, and greenhouses can be exposed to cyflumetofen residues through direct skin contact or through inhalation. Therefore, the label specifies that anyone mixing, loading and applying Nealta Miticidemust wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes. In addition, the label specifies that for application of Nealta Miticide using handheld airblast/mistblower equipment, workers must wear chemical-resistant coveralls with a chemical-resistant hood over long-sleeved shirt, long pants, chemical-resistant gloves, socks, chemical-resistant footwear and a respirator with a NIOSH-approved organic-vapour-removing cartridge with a prefilter approved for pesticides OR a NIOSH-approved canister approved for pesticides. Eye, head and respiratory protective equipment are required when applying Nealta Miticide above waist height using handheld equipment. The label also requires that workers do not enter or be allowed into treated areas during the restricted-entry interval (REI) of 12 hours. Taking into consideration the label statements, the number of applications and the duration of exposure for handlers and postapplication workers, the risks to these individuals from exposure to Nealta Miticide are not of health concern when the end-use product is used according to the proposed label directions.

Health risks in residential and other non-occupational environments

Non-occupational risks are not of concern when used according to label directions.

There are no risks in residential and other non-occupational environments as Nealta Miticide will only be applied in commercial greenhouses. Furthermore, exposure to treated ornamental plants that are subsequently purchased at retail locations is considered negligible.

Environmental considerations

What happens when cyflumetofen is introduced into the environment?

When used according to label directions, the environmental risks associated with the major new use of cyflumetofen on greenhouse ornamentals is acceptable.

The proposed major new use of cyflumetofen in greenhouse non-food crops (ornamentals) poses a negligible risk to terrestrial or aquatic organisms. When cyflumetofen is used according to the label, the environmental risks are considered acceptable.

Value considerations

What is the value of Nealta Miticide?

Nealta Miticide contains the active ingredient cyflumetofen and controls spider mites on greenhouse ornamentals.

The use of Nealta Miticide to control spider mites on greenhouse ornamentals is new. The product is applied to the foliage of these crops. Nealta Miticide represents a new mode of action against spider mites on greenhouse ornamentals. Therefore, it may aid in resistance management of these pests on these crops.

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 Nealta Miticide to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures - Human health

To reduce the potential exposure of workers to cyflumetofen through direct skin contact or through inhalation, workers mixing, loading and applying Nealta Miticideand performing cleaning and repair activities must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes. In addition, the label specifies that for application of Nealta Miticide using handheld airblast/mistblower equipment, workers must wear chemical-resistant coveralls with a chemical-resistant hood over long-sleeved shirt, long pants, chemical-resistant gloves, socks, chemical-resistant footwear and a respirator with a NIOSH-approved organic-vapour-removing cartridge with a prefilter approved for pesticides OR a NIOSH-approved canister approved for pesticides. The label also requires that workers do not enter or be allowed entry into treated areas during the REI of 12 hours. Furthermore, a standard label statement to prohibit the use of this product in residential areas is present on the label.

Additional mitigation label statements are required on the label of Nealta Miticide. Eye, head and respiratory protective equipment are required when applying Nealta Miticide above waist height using handheld equipment and the statement to prohibit the use of this product in residential areas must be revised.

Key risk-reduction measures - Environment

No additional mitigation label statements are required on the label of Nealta Miticide.

Next steps

Before making a final registration decision on Nealta Miticide, containing cyflumetofen, Health Canada’s PMRA will consider any written comments received from the public that are directly related to this proposed decision PRD2025-17, such as comments directed to the science evaluation, in response to this consultation document up to 45 days from the date of publication of PRD2025-17 (by 22 January 2026). 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 makes its registration decision, it will publish a Registration Decision on Nealta Miticide, containing cyflumetofen (based on the Science evaluation of PRD2025-17). In addition, the test data referenced in this consultation document 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