Proposed Re-evaluation Decision PRVD2022-10, 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin and hydroxymethyl-5,5-dimethylhydantoin and Associated End-use Products

Pest Management Regulatory Agency
30 May 2022
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2022-10E-PDF (PDF version)

Table of contents

• Proposed re-evaluation decision for 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin (DMY) and hydroxymethyl-5,5-dimethylhydantoin (MMY) and associated end-use products
• Proposed re-evaluation decision for DMY and MMY
• Risk mitigation measures
• International context
• Next steps
• Other information
• Additional scientific information

Proposed re-evaluation decision for 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin (DMY) and hydroxymethyl-5,5-dimethylhydantoin (MMY) and associated end-use products

Under the authority of the Pest Control Products Act, all registered pesticides must be re-evaluated by Health Canada's Pest Management Regulatory Agency (PMRA) to ensure that they continue to meet current health and environmental standards and continue to have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports and other regulatory agencies. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin (DMY) and hydroxymethyl-5,5-dimethylhydantoin (MMY) are antimicrobial material preservatives used in a wide variety of products such as liquid detergents, soft soaps, room deodorizers and air fresheners, water-based surfactants, polymer emulsions, protective and decorative coatings, water-based gels for household and industrial products, textiles, water-based adhesives, latex for paper and coatings, and water-based inks. Currently registered products containing DMY and MMY can be found in the Pesticide Product Information Database and in Appendix I of PRVD2022-10, 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin and hydroxymethyl-5,5-dimethylhydantoin and Associated End-use Products. All currently registered products contain both DMY and MMY. Appendix II of PRVD2022-10 lists all uses for which DMY/MMY is currently registered.

This document (PRVD2022-10) presents the proposed re-evaluation decision for DMY and MMY, including the proposed amendments (risk mitigation measures) to protect human health and the environment, as well as the science evaluation on which the proposed decision is based. All products containing DMY and MMY that are registered in Canada are subject to this proposed re-evaluation decision. This document is subject to a 90-day public consultation period^{Footnote 1}, during which the public (including the pesticide manufacturers and stakeholders) may submit written comments and additional information to PMRA Publications. The final re-evaluation decision will be published after taking into consideration the comments and information received during the consultation period.

Proposed re-evaluation decision for DMY and MMY

Under the authority of the Pest Control Products Act and based on an evaluation of available scientific information, Health Canada is proposing continued registration of DMY and MMY, and associated end-use products registered for sale and use in Canada.

DMY and MMY are of value in aiding in the prevention and control of bacterial and fungal contamination of aqueous-based materials. Such contaminations can lead to product failures of function or discolorations/unpleasant odours that will make the product unusable.

Risks to human health and the environment were shown to be acceptable when DMY and MMY are used according to the proposed conditions of registration, which include the mitigation measures identified below.

Risk mitigation measures

Human health

As a result of the re-evaluation of 1,3-bis (hydroxymethyl)-5,5-dimethylhydantoin (DMY) and hydroxymethyl-5,5-dimethylhydantoin (MMY), the PMRA is proposing further risk-reduction measures in addition to those already identified on DMY/MMY product labels. Additional revisions to the DMY/MMY labels are proposed, in order to meet the current labelling standards and for consistency.

To protect workers using end-use products during the manufacturing process:

• A closed transfer system for commercial-class liquid (solution) products.

To protect workers, updated label statements are required to reflect current standards for personal protective equipment (PPE).

To protect consumers, label statements are required to reflect current standards for paper and paperboard use.

Environment

To protect the environment, the following risk mitigation measure is proposed:

• An update to the label statement prohibiting effluent discharge

International context

Hydroxymethyl dimethylhydantoins (DMY and MMY) are currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including the United States, the European Union, and Australia. In the United States, the use pattern for hydroxymethyl hydantoins is more extensive than the Canadian use pattern and includes metalworking fluids, starch solutions, paper and paperboard products. No decision by an OECD member country to prohibit all uses of hydroxymethyl dimethylhydantoins for health or environmental reasons has been identified.

Next steps

Upon publication of this proposed re-evaluation decision the public, including the registrants and stakeholders, are encouraged to submit additional information that could be used to refine risk assessments during the 90-day public consultation period.

All comments received during the 90-day public consultation period will be taken into consideration in preparation of the re-evaluation decision document^{Footnote 2}, which could result in revised risk mitigation measures. The re-evaluation decision document will include the final re-evaluation decision, the reasons for it and a summary of comments received on the proposed re-evaluation decision with Health Canada's responses.

Refer to Appendix I of PRVD2022-10 for details on specific products impacted by this proposed decision.

Other information

The relevant confidential test data on which the proposed decision is based (see the References section of PRVD2022-10) are available for public inspection, upon application, in Health Canada's Reading Room. For more information, please contact Health Canada's Pest Management Information Service.

Additional scientific information

No additional scientific data are required at this time.