NMP and NEP - information sheet

2-Pyrrolidinone, 1-methyl- (N-Methylpyrrolidone) (NMP)
CAS Registry Number (RN) 872-50-4

2-Pyrrolidinone, 1-ethyl- (N-Ethylpyrrolidone) (NEP)
CAS RN 2687-91-4

Publications summarized:

• Updated Draft Assessment for NMP and NEP (published on January 27, 2024 for a 60-day public comment period ending on March 27, 2024). Public comments received on the first draft screening assessment were considered and a summary of the comment with Government responses was published.
• Risk Management Scope for NMP (published on January 27, 2024 for a 60-day public comment period ending on March 27, 2024). Risk management is proposed.
• Associated notice: Canada Gazette, Part I: Vol. 158, No. 4 – January 27, 2024

On this page

• Overview
• About these substances
• Human and ecological exposures
• Key health and ecological effects (hazard)
• Consideration of subpopulations who may be more susceptible or highly exposed
• Risk assessment outcomes
• Proposed assessment conclusions
• Preventive actions and risk reduction
• Additional considerations
• Where to find updates on risk management actions
• Related resources

Overview

• The Government of Canada conducts risk assessments of substances under the Canadian Environmental Protection Act, 1999 (CEPA) to determine whether they present or may present a risk to human health or to the environment.
  • The risks posed by a substance are determined by both its hazardous properties (potential to cause adverse human health or ecological effects) and the amount or extent of exposure to people or the environment.
  • When needed, the Government implements risk management measures under CEPA and other federal acts to help prevent or reduce potential harm.
• The ecological hazard and exposure potentials of NMP and NEP were classified using the Ecological Risk Classification of Organic Substances (ERC) Approach.
• A draft screening assessment for NMP and NEP was originally published in February 2017. Since then, new information became available regarding exposure to products available to consumers containing NMP and NEP that had the potential to alter assessment conclusions. As a result, the screening assessment was updated.
• The Government is proposing that NMP may be harmful to human health, but not the environment, at levels of exposure for the use of certain deck construction adhesive considered in the assessment. NMP is associated with reproductive and developmental effects.
  • To help reduce potential human exposures to NMP, the Government is proposing regulatory or non-regulatory actions.
• NEP is associated with reproductive effects; however, it is not proposed to be harmful to human health or to the environment at levels of exposure considered in the assessment.

About these substances

• The assessment focuses on 2 substances, referred to as N-methylpyrrolidone (NMP) and N-ethylpyrrolidone (NEP) under the third phase of the Chemicals Management Plan (CMP).
• NEP was added as a priority for assessment based on the results of the identification of risk assessment priorities process. Given the similarity in structures, NEP could be used as a substitute for NMP in commercial products.
• NMP and NEP are human-made substances that do not occur naturally in the environment.
• According to information gathered by the Government, NMP is used in Canada primarily as a solvent in industrial and consumer products, such as agricultural products, electrical and electronic products, metal and mining products, paper products, mixtures or manufactured items, and plastic and rubber materials.
• Additional products in Canada containing NMP that may be available to the general population include adhesives and sealants, auto interior cleaners, cleaning and degreasing products, paints and coatings, and paint removers. NMP may be present in certain personal care products including pharmaceuticals as a non-medicinal ingredient, and in a limited number of nail care, synthetic nail or eyelash adhesives and adhesive removers, and hair products. NMP is also present as a formulant (not an active ingredient) in certain pest control products.
• Businesses in Canada reported using NEP in chemical manufacturing, and to manufacture adhesives and sealants, paints and coatings, and plastic and rubber materials. NEP was not identified in any products available to consumers in Canada.

Human and ecological exposures

• The assessment indicates that people living in Canada may be exposed to NMP from environmental sources (air) and the use of products available to consumers, as described above. Dermal (skin) and inhalation routes of exposure may both contribute to potential NMP exposure.
• Exposure of people living in Canada to NEP is not expected.
• According to the information considered under the ERC Approach, NMP and NEP were identified as having low ecological exposure potential.

Key health and ecological effects (hazard)

• International data reports on these substances were considered to inform the health effects characterization in the assessment, among other sources of information. This included assessments by the United States Environmental Protection Agency and the European Chemicals Agency (ECHA).
• Both NMP and NEP have been classified by ECHA as suspected reproductive toxicants.
• Based on laboratory studies, NMP was identified as a reproductive and developmental toxicant. Critical effects identified for characterizing the risk to human health for NMP were reproductive effects and effects on the male reproductive system.
• According to information considered under the ERC Approach, NMP and NEP were identified as having a low ecological hazard potential.

Consideration of subpopulations who may be more susceptible or highly exposed

• There are groups of individuals within the Canadian population who, due to greater susceptibility or greater exposure, may be more vulnerable to experiencing adverse health effects from exposure to substances.
• Certain subpopulations are routinely considered throughout the assessment process, such as infants, children, and people of reproductive age. For instance, age-specific exposures are routinely estimated and developmental and reproductive toxicity studies are evaluated for potential adverse health effects. For NMP, these subpopulations were taken into account in the risk assessment outcomes.

Risk assessment outcomes

• Assessments focus on information critical to determining whether substances are harmful to human health or the environment under CEPA. This is done by considering scientific information, including information, if available, on subpopulations who may have greater susceptibility or greater exposure vulnerable environments and cumulative effects and by incorporating a weight of evidence approach and precaution.
• Based upon a comparison of levels to which people living in Canada may be exposed to NMP from the occasional use of certain deck construction adhesives, and levels associated with critical health effects, it was determined that this substance may pose a risk to human health.
• Exposure of people living in Canada to NEP is not expected; therefore, the risk to human health is considered to be low.
• Based upon the outcome of the ERC Approach, both substances are considered unlikely to be causing ecological harm.

Proposed assessment conclusions

• The Government is proposing that NMP may be harmful to human health, at levels of exposure considered in the assessment. It is also proposing that NEP is not harmful to human health since exposure is not expected.
• The Government is also proposing that NMP and NEP are not entering the environment at levels that are harmful.
• It is proposed that NMP does not meet the persistence or the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.

Preventive actions and risk reduction

• If the proposed conclusion is confirmed in the final assessment, the Government will consider proposing to add NMP to Part 2 of Schedule 1 to CEPA. Adding a substance to Schedule 1 enables the Government to take enforceable risk management actions under CEPA, using a 2-track approach to manage risks.
  • Toxic substances that pose the highest risk (that is, meet certain criteria) are added to Part 1 of Schedule 1. These are prioritized for total, partial or conditional prohibition.
  • Other toxic substances are added to Part 2 of Schedule 1 and are prioritized for pollution prevention.
  • Regulations specifying criteria for the classification of substances that pose the highest risk or that are carcinogenic, mutagenic or toxic to reproduction may be developed. When criteria are available, some substances considered for addition to Part 2 of Schedule 1 may instead be considered for addition to Part 1 of Schedule 1.
• Publication of the risk management scope aims to inform stakeholders of proposed risk management options and initiate discussion about their development. The Government will consider the following actions to address human health concerns:
  • Regulatory or non-regulatory actions to help reduce inhalation and dermal exposure of people living in Canada, including persons of childbearing age to NMP from the use of products that are available to consumers, including deck construction adhesives.
• Information is being sought by the Government to inform risk management decision-making. Details can be found in the risk management scope, including where to send information during the public comment period, ending March 27, 2024.
• Risk management actions may evolve through consideration of assessments and risk management actions published for other substances. This is to ensure effective, coordinated, and consistent risk management decision-making.

Additional considerations

• Although NEP is not considered to be harmful to human health or to the environment at current levels of exposure, this substance is associated with health effects of concern, namely its reproductive toxicity. Therefore, there may be a concern if exposure were to increase. For this reason, this substance may be considered in future initiatives to track its commercial status or identify new uses or exposures.
• Stakeholders are encouraged to provide any information pertaining to NEP that may help inform the choice of follow-up activity, during the 60-day public comment period on the assessment. This could include information on new or planned import, manufacture or use of the substance.

Where to find updates on risk management actions

• Additional information on the risk management of substances addressed under the CMP is available.
• Use the Substances Search tool to find substances that are referenced in certain legislative or regulatory instruments or on Government of Canada websites. 

Related resources

• NMP may be found in products available to consumers. People living in Canada should follow any safety warnings and directions related to the product and dispose of products responsibly according to municipal or local guidelines.
• Visit Healthy home for information on chemical safety in and around the home, including on NMP (for consumers).
• Assessments conducted under CEPA focus on risks of exposure of the general population. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System (WHMIS). If a substance is harmful to the general population, it could also be of concern for individuals in situations where a higher volume of the substance is used or where the substance is used for a longer duration (for example, the workplace). The Government of Canada recognizes that it is the responsibility of the federal, provincial and territorial occupational health and safety organizations to coordinate legislation for the safe use of chemicals in the workplace. We are working to support this role by integrating the information, tools, and technical expertise of the CMP and Health Canada’s Workplace Hazardous Products Program.