Risk management scope for low boiling point naphthas group

Official title: Risk management scope for Low boiling point Naphthas Group (LBPNs)

• Subgroup 1 (C₉-C₁₄ Hydrocarbon solvents)
• Subgroup 2 (C₉ Aromatic solvents)
• Subgroup 3 (C₆-C₉ Aliphatic solvents)

Environment and Climate Change Canada

Health Canada

March 2024

Summary of proposed risk management

This document outlines the risk management options under consideration for 17 substances included in the Low Boiling Point Naphthas Group (herein abbreviated as LBPNs), which have been proposed to be harmful to human health in Canada, but not to the environment.

In particular, the Government of Canada is considering:

• Measures to reduce dermal and/or inhalation exposures of the general population to LBPN substances in subgroup 1 (C₉-C₁₄ hydrocarbon solvents, 9 substances) and subgroup 2 (C₉ aromatic hydrocarbon solvents, 1 substance) from certain cosmetic products including hair oil, body lotion, nail polish, nail adhesive and other cosmetic specialty products (that is, for removing post-depilatory residue and hair extensions adhesive) to levels that are protective of human health by describing LBPNs in subgroup 1 and subgroup 2 as prohibited or restricted ingredients on the Health Canada Cosmetic Ingredient Hotlist; and

• Regulatory or non-regulatory measures to reduce dermal and/or inhalation exposures of the general population to the LBPN substances in subgroup 1 (C₉-C₁₄ hydrocarbon solvents, 9 substances), subgroup 2 (C₉ aromatic hydrocarbon solvents, 1 substance), and subgroup 3 (C₆-C₉ aliphatic solvents, 7 substances) from certain products available to consumers, including adhesives, paints, coatings, degreasers, automotive care, shoe care, adhesive remover, and electronics cleaner to levels that are protective of human health.

To inform risk management decision-making, information on the following topics should be provided (ideally on or before May 15, 2024), to the contact details identified in section 8 of this document:

• Current quantities (kilograms) and concentrations (percent weight per weight) of certain LBPNs that are in products available to consumers;
• Changes in the use patterns for products containing LBPNs from previous data collection initiatives (noted in section 4.2 of this document);
• Existing, potential alternative or replacement substances to LBPNs for use in cosmetics and in certain products available to consumers;
• Socio-economic and technical impacts if the import and/or use of LBPNs were prohibited or restricted or substituted by an alternative substance in certain consumer applications in Canada, specifically in cosmetics and consumer products where they have been identified as a concern;
• Purpose/function of the LBPNs in cosmetics and products available to consumers;
• The minimum concentration of LBPNs in certain cosmetics and products available to consumers that will maintain performance function;
• Best practices currently implemented in industry to minimize consumer exposure to LBPNs in end-use products;
• Identification of standard procedures and analytical methods available for the testing of LBPNs in cosmetics or products available to consumers; and
• Information pertaining to the interchangeability of other LBPN substances (including subgroup 4 LBPNs as well as other LBPNs previously addressed under the CMP) as a replacement for subgroup 1-3 LBPNs in cosmetics and products available to consumers.

The risk management options outlined in this Risk Management Scope document may evolve through consideration of assessments and risk management options or actions published for other Chemicals Management Plan (CMP) substances as required to ensure effective, coordinated, and consistent risk management decision-making.

Note: The above summary is an abridged list of options under consideration to manage these substances and to seek information on identified gaps. Refer to section 3 of this document for more complete details in this regard. It should be noted that the proposed risk management options may evolve through consideration of additional information obtained from the public comment period, literature, and other sources.

1. Context

The Canadian Environmental Protection Act (CEPA) (Canada 1999) provides the authority for the Minister of the Environment and the Minister of Health (the Ministers) to conduct assessments to determine if substances are toxic to the environment and/or harmful to human health as set out in section 64 of CEPA^{Footnote 1,Footnote 2} , and if so to manage the associated risks.     

The 27 substances, listed in Annex A are referred to throughout this document as the “LBPNs Group” and are part of the Government of Canada’s Chemicals Management Plan.

2. Issue

Health Canada and Environment and Climate Change Canada conducted a joint scientific assessment of the Low Boiling Point Naphthas Group (LBPNs). A notice summarizing the scientific considerations of the draft assessment for these substances was published in the Canada Gazette, Part I, on March 16, 2024. For further information, refer to the draft assessment for Low Boiling Point Naphthas Group (LBPNs).

2.1  Draft assessment conclusion

On the basis of the information available, the draft assessment proposes  that substances in the LBPNs Group described as “C₉-C₁₄ Hydrocarbon solvents”, “C₉ Aromatic solvents”, and “C₆ – C₉ Aliphatic solvents”, respectively subgroup 1 (9 substances), subgroup 2 (1 substance), and subgroup 3 (7 substances)  as listed in Annex A, which include 17 of the 27 substances assessed, are toxic under section 64(c) of CEPA, as they are entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health. However, it is proposed to conclude that these 17 substances are not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity, or that constitute or may constitute a danger to the environment on which life depends under paragraphs 64(a) or 64(b) of CEPA.

10 of the 27 substances in the group described as “LBPNs with no identified uses in products available to consumers” (subgroup 4, listed in Annex A) are not considered to be harmful to human health or the environment at current levels of exposure, as they do not meet any of the criteria set out under paragraphs 64(a), 64(b) or 64(c) of CEPA.

The exposures of concern for the general population identified in the draft assessment are dermal and/or inhalation exposure to LBPNs in certain cosmetics and do-it-yourself (DIY)/home improvement products available to consumers. As such, this document will focus on these exposures and sources (refer to section 5).

2.2  Proposed recommendation under CEPA

CEPA sets out a 2-track approach for managing risks.

Under sub-section 77(3), the Ministers are required to propose recommending the addition of a substance that poses the highest risk, as defined in paragraph (a), (b) or (c), to Part 1^{Footnote 3} of Schedule 1 of the Act and, in developing a proposed regulation or instrument respecting preventive or control actions, to give priority to the total, partial or conditional prohibition of activities in relation to the substance or to the release of the substance into the environment.

For other substances recommended for addition to Part 2 of Schedule 1 of the Act, the Ministers shall give priority to pollution prevention, and this could include regulatory or non-regulatory measures [such as prohibition if warranted].

On the basis of the findings of the draft assessment conducted as per CEPA, the Ministers propose to recommend that 17 of the 27 substances in the LBPNs Group, described as “C₉-C₁₄ Hydrocarbon solvents” (9 substances), “C₉ Aromatic solvents” (1 substance), and “C₆ – C₉ Aliphatic solvents” (7 substances), as listed in Annex A, be added to Part 2 of Schedule 1 of the Act. Addition of a substance to Schedule 1 to CEPA enables the Government to propose certain risk management measures under CEPA to manage potential ecological and human health risks associated with the substance.

Until regulations specifying criteria for the classification of substances that pose the highest risk or that are carcinogenic, mutagenic or toxic to reproduction are available, the 17 LBPNs are proposed to be recommended for addition to Part 2 of Schedule 1. Following the availability of the aforementioned criteria, the substance may be moved to Part 1 of Schedule 1, if applicable.

The Ministers will take into consideration comments made by stakeholders during the 60-day public comment period on the draft assessment for LBPNs and this Risk Management Scope document.

If the Ministers finalize the recommendation to add the 17 LBPNs to Part 2 of Schedule 1, risk management instruments must be proposed within 24 months from the date on which the Ministers recommended that the 17 LBPNs be added to Schedule 1 to CEPA, and finalized within 18 months from the date on which the risk management instruments are proposed, as outlined in sections 91 and 92 of CEPA (refer to section 8 for publication timelines applicable to this group of substances).

3. Proposed risk management

3.1 Proposed human health objectives

Proposed human health objectives are quantitative or qualitative statements of what should be achieved to address human health concerns.

The proposed human health objective is to reduce exposure of the general population to the  substances in subgroups 1, 2 and 3 of the LBPNs (listed in Annex A) to levels that are protective of human health.

3.2 Proposed risk management objectives

Proposed risk management objectives set quantitative or qualitative targets to be achieved by the implementation of risk management regulations, instruments and/or tools for a given substance or substances. In this case, the proposed risk management objectives for LBPNs are:

• To reduce dermal and/or inhalation exposures of the general population to LBPN substances in subgroup 1 (C₉-C₁₄ hydrocarbon solvents) and subgroup 2 (C₉ aromatic hydrocarbon solvents) from certain cosmetic products to levels that are protective of human health; and
• To reduce dermal and/or inhalation exposures of the general population to the LBPN substances in subgroup 1 (C₉-C₁₄ hydrocarbon solvents), subgroup 2 (C₉ aromatic hydrocarbon solvents), and subgroup 3 (C₆-C₉ aliphatic solvents) from certain products available to consumers, to levels that are protective of human health. A more detailed listing of subgroups of concern in particular product types can be found in Tables 1, 2, and 3 in section 5.

These objectives may be refined on the basis of stakeholder consultation and new information, the proposed risk management, the outcome of the draft assessment, and socio-economic and technical considerations (refer to section 6). Revised human health and risk management objectives will be presented in the Risk Management Approach document that will be published concurrently with the final assessment for these substances.

3.3 Proposed risk management options under consideration

To achieve the proposed risk management objectives and to work towards achieving the proposed human health objective, the risk management options under consideration for the LBPNs Group are:

• Measures to reduce exposures of the general population to LBPNs in subgroup 1 (C₉-C₁₄ hydrocarbon solvents) and subgroup 2 (C₉ aromatic hydrocarbon solvents) from dermally applied cosmetic products, including hair oil, body lotion, nail polish, nail adhesive and other cosmetic specialty products (that is, for removing post-depilatory residue and hair extensions adhesive), by describing LBPNs in subgroup 1 (C₉-C₁₄ hydrocarbon solvents) and subgroup 2 (C₉ aromatic hydrocarbon solvents) as prohibited or restricted ingredients on the Health Canada Cosmetic Ingredient Hotlist. The Hotlist is used to communicate that certain substances may not be compliant with requirements of the Food and Drugs Act or provisions of the Cosmetic Regulations.
• Regulatory or non-regulatory measures to help reduce dermal and/or inhalation exposures to LBPNs in subgroup 1 (C₉-C₁₄ hydrocarbon solvents), subgroup 2 (C₉ aromatic hydrocarbon solvents) and subgroup 3 (C₆-C₉ aliphatic solvents) from certain products available to consumers including adhesives, paints, coatings, degreasers, automotive care, shoe care, adhesive remover, and electronics cleaner to levels that are protective of human health.

Note that these proposed risk management options, are preliminary and subject to change. Following the publication of this document, additional information obtained from the public comment period and from other sources will also be considered in the instrument selection and development process^{Footnote 4} . The risk management options may also evolve through consideration of assessments and risk management options or actions published for other CMP substances to ensure effective, coordinated, and consistent risk management decision-making.

3.4 Performance measurement and evaluation

Performance measurement evaluates the ongoing effectiveness and relevance of the actions taken to manage risks from toxic substances^{Footnote 5} . The aim is to determine whether human health and/or environmental objectives have been met and whether there is a need to revisit the risk management approach for that substance, to ensure that risks are managed effectively over time. To achieve this, the Government of Canada will evaluate the effectiveness of the risk management actions for LBPNs.

The Government of Canada plans to measure the effectiveness of the risk management actions by collecting and analyzing data to measure progress towards meeting the risk management objectives.

The results of the performance measurement evaluation will be used to inform whether further risk management action is warranted and will be made available to Canadians along with recommendations for further action, if applicable.

3.5 Risk management information gaps

Interested stakeholders can provide further information to inform risk management decision-making regarding the LBPNs Group, as identified in the draft assessment, including:

• Current quantities (kilograms) and concentrations of certain LBPNs that are in products available to consumers;
• Changes in the use patterns for products containing LBPNs from previous data collection initiatives (noted in section 4.2 of this document);
• Potential alternative or replacement substances to LBPNs for use in cosmetics and in certain products available to consumers, and the socioeconomic implications associated with the substitution of these alternatives;
• Socio-economic and technical impacts if the import and/or use of LBPNs were prohibited or restricted in certain consumer applications in Canada, specifically in the cosmetics and consumer products where they have been identified as a concern;
• Purpose/function of the LBPNs in cosmetics and products available to consumers;
• The minimum concentration of LBPNs in certain cosmetics and products available to consumers that will maintain performance function;
• Best practices currently implemented in industry to minimize consumer exposure to LBPNs in end-use products;
• Identification of standard procedures and analytical methods available for the testing of LBPNs in cosmetics or products available to consumers; and
• Information pertaining to the interchangeability of other LBPN substances (including subgroup 4 LBPNs as well as other LBPNs previously addressed under the CMP) as replacements for subgroup 1-3 LBPNs in cosmetics and products available to consumers.

Stakeholders that have information to help address these gaps should provide it on or before May 15, 2024 to the address identified in section 8.

4. Background

4.1 General information on the Low Boiling Point Naphthas Group

LBPNs are complex and highly variable combinations of hydrocarbons produced by the distillation of crude oil, followed by the fractionation of the resultant hydrocarbon streams by boiling point range. These petroleum fractions are commonly used as blending streams for gasoline, solvents and other industrial / residential use products. They contain straight and branched chain alkanes (that is, paraffins and isoparaffins), cycloalkanes (also known as cycloparaffins), alkenes (also known as olefins), and aromatic hydrocarbons, predominantly in the carbon range of C4 to C₁₄. As such, LBPNs are considered to be of Unknown or Variable composition, Complex reaction products or Biological materials (UVCBs). These materials are derived from natural sources or complex reactions. A UVCB is not an intentional mixture of discrete substances and is considered a single substance. The complexity and variability of their compositions can make them difficult to fully and consistently characterize.

For the human health risk assessment, the 27 substances in the LBPNs Group are separated into subgroups on the basis of differences in health effects, presence or absence in products available to consumers containing the substance, and aromatic content (see also Annex A). These subgroups are:

• C₉-C₁₄ Hydrocarbon solvents (subgroup 1, 9 substances);
• C₉ Aromatic hydrocarbon solvents (subgroup 2, 1 substance);
• C₆-C₉ Aliphatic hydrocarbon solvents (subgroup 3, 7 substances); and
• LBPNs with no identified uses in products available to consumers (subgroup 4, 10 substances).

 (ECCC, HC 2024).

4.2 Current use(s) and identified sector(s)

LBPNs are used in a variety of industrial and commercial processes and products. According to information submitted in response to CEPA section 71 surveys and voluntary submissions (Environment Canada 2012; ECCC 2016a,b), LBPNs in Canada are mainly used as solvents that become part of the formulation or mixture to which they are added, as viscosity adjustors, and as fuels or fuel additives. Products containing LBPNs are used as processing aids in petroleum production and other industrial processes, as lubricants and lubricant additives, in paint and coating additives, as solvents for cleaning and degreasing, in adhesives and sealants, as corrosion inhibitors and anti-scaling agents, and as demulsifiers (that is, specialty chemicals used to separate emulsions) in paraffin control and dewaxing. LBPNs may also be used in automotive care products, plastics and rubber, printing inks, pulp and paper processing aids, household cleaners, personal care products, and as formulants in pest control products. Some LBPNs have specialty applications in products such as in anti-adhesive agents, plating and surface treatment agents, and some pigments. Some of the LBPN substances may be used as components in the manufacture of food packaging materials (for example, formulation of inks, coatings and adhesives) which have no direct contact with food. They may also be used as components in the manufacture of coatings, plastics- and paper/paperboard-based food packaging materials, which are in direct contact with food. They may also be used as components of incidental additives (for example, lubricants and/or cleaners) used in food processing establishments with negligible or no food contact.

In the draft assessment, C₉-C₁₄ Hydrocarbon solvents (subgroup 1), C₉ Aromatic hydrocarbon solvents (subgroup 2) and C₆-C₉ Aliphatic hydrocarbon solvents (subgroup 3) were identified as ingredients in a number of cosmetics in Canada. Types of products that were reported to contain these substances include nail polishes, nail adhesives, waterproof mascaras, non-permanent eye makeup, hair adhesive removers, depilatory lotions, hair wax removers, hair colours, and cleansers (personal communication, email from HC Consumer and Hazardous Products Safety Directorate (CHPSD) to HC ESRAB, dated Dec 10, 2019, to May 14, 2020).

However, given the chemical and structural similarities of individual LBPNs, it is possible for other CAS RNs in subgroup 1, subgroup 2, or subgroup 3, to be interchangeably used within each subgroup if they meet product specifications. Therefore, consideration should be given to whether any of the LBPNs in subgroup 1, subgroup 2, or subgroup 3 could be used in the products described above.

5. Exposure sources and identified risks

5.1 C₉-C₁₄ Hydrocarbon solvents (subgroup 1, 9 substances)

The draft assessment identified general population exposures of concern to subgroup 1 LBPNs from the use of certain cosmetics. 5 substances in subgroup 1 (C₉-C₁₄ hydrocarbon solvents) had dermal exposures of concern identified for certain cosmetics (see section 4.2); however, as described in section 4.2, consideration is being given to the possibility that any LBPN substances that could fall under subgroup 1 could be used in cosmetics. Other exposures of concern from products available to consumers (that is, DIY/home improvement products) are described below. The critical health effects associated with LBPNs identified in the draft assessment (ECCC, HC 2024) are based on developmental and nervous system effects.

Estimated dermal and/or inhalation exposure from cosmetics containing concentrations of subgroup 1 LBPNs that range from 2% to 60% as well as from products available to consumers containing concentrations of subgroup 1 LBPNs  that range from 14% to 100% result in margins of exposure that are considered inadequate to address uncertainties in the health effects and exposure databases.

No other sources of exposure of concern were identified for subgroup 1 LBPNs.

5.2 C₉ Aromatic hydrocarbon solvents (subgroup 2, 1 substance)

The draft assessment identified general population exposures of concern to subgroup 2 LBPNs (one substance) from the use of certain cosmetics and other products available to consumers (that is, DIY/home improvement products) as described below. The critical health effects associated with LBPNs identified in the draft assessment (ECCC, HC 2024) are based on maternal toxicity, developmental and nervous system effects.

Estimated combined dermal and inhalation exposure from cosmetics containing concentrations of subgroup 2 LBPNs that range from 15% to 57% as well as from products available to consumers containing concentrations of subgroup 2 LBPNs that range from 10% to 40% resulted in margins of exposure that are considered inadequate to address uncertainties in the health effects and exposure databases.

No other sources of exposure of concern were identified for subgroup 2 LBPNs.

5.3 C₆-C₉ Aliphatic hydrocarbon solvents (subgroup 3, 7 substances)

The draft assessment identified general population exposures of concern to subgroup 3 LBPNs (7 substances) from the use of certain products available to consumers (that is, DIY/home improvement products) as described below. The critical health effects associated with LBPNs identified in the draft assessment (ECCC, HC 2024) are based on developmental and nervous system effects.

Estimated combined dermal and inhalation exposure from products available to consumers that range from 5% to 100% subgroup 3 LBPNs resulted in margins of exposure that are considered inadequate to address uncertainties in the health effects and exposure databases.

No other sources of exposure of concern were identified for subgroup 3 LBPNs.

6. Risk management considerations

6.1 Alternatives and alternate technologies

Compositional variability within and between LBPNs can lead to the interchangeable use of CAS RNs in products if they meet product use specifications. While the draft assessment is on the 27 substances, it is acknowledged that other LBPNs with similar composition to these 27 substances are sometimes substituted for similar uses or in products. Efforts are being made to gain insight into the likelihood of substitution of other LBPNs in cosmetics and products available to consumers. The Government of Canada would take actions as needed to protect human health, if evidence of regrettable substitution is identified.

6.2 Socio-economic and technical considerations

Socio-economic factors will be considered in the selection process for a regulation or instrument respecting preventive or control actions, and in the development of the risk management objective(s) as per the guidance provided in the Treasury Board document Assessing, Selecting, and Implementing Instruments for Government Action [PDF] (TBS 2007). In addition, socio-economic factors will be considered in the development of regulations, instrument(s) or tool(s), to address risk management objective(s), as identified in the Cabinet Directive on Regulation (TBS 2018) and Red Tape Reduction Action Plan (TBS 2012) and the Red Tape Reduction Act (Canada 2015).

7. Overview of existing risk management

7.1 Related Canadian risk management context

Domestically, the existing risk management actions are as follows:

Cosmetics: None of the 27 LBPNs in the draft assessment are on the Cosmetic Ingredient Hotlist. The Hotlist is used to communicate that certain substances may not be compliant with requirements of the Food and Drugs Act or provisions of the Cosmetic Regulations.

Food additives and food flavouring agents: The 27 LBPNs from this assessment are not found on the List of Permitted Food Additives. As described in the draft assessment, LBPNs are not allowed as food additives in Canada. The safety of food flavouring agents is subject to the provisions of section 4(1)(a) of the Food and Drugs Act.

Food packaging and incidental additives: LBPNs may be used as a component in the manufacture of food packaging materials and as components of incidental additives (for example, lubricants and/or cleaners) used in food processing establishments with negligible or no food contact (ECCC, HC 2024). The safety of chemicals used in food packaging materials is subject to the provisions of Division 23 of the Food and Drug Regulations and section 4(1)(a) of the Food and Drugs Act.

Pest Control Products: Of the LBPNs found in currently registered pest control products, 7 LBPNs from this draft assessment are on List 2 of Health Canada’s Pest Management Regulatory Agency (PMRA) List of Formulants. These formulants are potentially toxic, based on either structural similarity to List 1 (that is, toxic) formulants or data suggestive of toxicity. They are also considered high priority for testing. Registrants with List 2 formulants in their products are strongly encouraged to consider amending formulations by substituting more acceptable alternatives, such as those on Lists 3, 4A and 4B. One LBPN is found on List 3 of the PMRA List of Formulants. Substances on this list do not meet the criteria of Lists 1, 2, 4A and 4B.

Products available to consumers: Paint products, cleaners, automotive care and other DIY/home improvement products are subject to classification and labelling requirements set out in the Consumer Chemicals and Containers Regulations, 2001 (CCCR 2001) under the Canada Consumer Product Safety Act. None of the 17 LBPNs proposed to be toxic in this draft assessment are listed as substances of special concern in the CCCR (2001). However, all hazardous ingredients, as defined in the CCCR (2001), must be considered when classifying a product. A consumer product that meets any of the acute hazard classification criteria set out in the CCCR, 2001 must display labelling in the form of hazard symbols, warning statements, instructions for safe use and first-aid treatments in both official languages. The label must also correctly disclose all hazardous ingredients. Packaging requirements such as child-resistant containers may also apply.

Certain products would also be subject to the Volatile Organic Compound Concentration Limits for Certain Products Regulations. The regulations establish maximum VOC concentration limits and emission potentials for the manufacture and import of over 130 categories and subcategories of products.

Environment: LBPNs are subject to the Regulations Respecting Reduction in the Release of Volatile Organic Compounds (Petroleum Sector). These regulations require the implementation of comprehensive leak detection and repair programs at Canadian petroleum refineries, upgraders and certain petrochemical facilities.

Other related risk management actions:

Various provincial occupational health and safety/exposure standards are also found and listed below:

• Ontario:
  • Occupational exposure limit for Stoddard solvent (no CAS RN identified) under Control of Exposure to Biological or Chemical Agents, RRO 1990, Reg 833

• Quebec:
  • Regulation respecting the quality of the work environment, CQLR c S-2.1, r 11. Air Contaminants limits for “Rubber solvent (Naphtha)” [CAS 8030-30-6], Ligroine, listed as “Naphtha” [CAS 8032-32-4]
  • Regulation respecting occupational health and safety, CQLR c S-2.1, r 13, Air Contaminants limits for “Rubber solvent (Naphtha)” [CAS 8030-30-6], Ligroine, listed as “Naphtha” [CAS 8032-32-4]

• Yukon:
  • Occupational Health Regulations, YOIC 1986/164. Limits for “Rubber solvent (Naphtha)”, “Stoddard Solvent” (no CAS RNs listed)

• Nunavut:
  • Occupational Health and Safety Regulations, Nu Reg 003-2016. Limits for “Rubber solvent (Naphtha) [CAS 8030-30-6]”, “Stoddard Solvent [CAS 8052-41-3]”, “Naphtha [8032-32-4]

• Northwest Territories:
  • Occupational Health and Safety Regulations, NWT Reg 039-2015. Air Contaminants limits for “Rubber solvent (Naphtha]” [CAS 8030-30-6], Ligroine, listed as “Naphtha” [CAS 8032-32-4], and Stoddard Solvent [8052-41-3].

• Alberta:
  • Occupational Health and Safety Code 2009 Order, Alta Reg 87/2009. Air Contaminants limits for “Rubber solvent (Naphtha)” [CAS 8030-30-6], Ligroine, listed as “Naphtha” [CAS 8032-32-4], Stoddard Solvent [8052-41-3].

• Saskatchewan:
  • Occupational Health and Safety Regulations, RRS c O-1.1 Reg 1, RRS c S-15.1 Reg 10. Air Contaminants limits for “Rubber solvent (Naphtha)” [CAS 8030-30-6], Ligroine, listed as “Naphtha” [CAS 8032-32-4].

7.2 Pertinent international risk management context

United States

Cosmetics: No risk management actions were identified for LBPN use in cosmetics in the United States.

Food additives and food flavouring agents: In the United States, one LBPN (Naphtha, CAS RN 8030-30-6) is permitted under the following uses as a food additive, such as:

a) As coatings on fresh citrus fruit - the minimum is to be applied for safe consumption.

b) Petroleum naphtha may be safely used if it meets physical and chemical specifications (for example, has a specific boiling point range, non-volatile residue and UV-VIS absorption characterization).

c) As defoaming agents used in the manufacture of paper and paperboard - permitted under prescribed conditions.

d) As defoaming agents used in coatings - permitted under prescribed conditions.

e) As components of adhesives - permitted under prescribed conditions.

f) As diluents in color additive mixtures for coloring shell eggs, provided no colour penetrates the egg.

One LBPN (Petroleum spirits, CAS RN 64475-85-0) shall not exceed 1ppm and have a specific boiling point range (as outlined above in “b”) as residue solvent for hop extraction.

No other risk management actions were identified for other LBPNs (that is, they are not approved for use unless notified).

Food packaging and incidental additives: In the United States, one LBPN (Ligroine, CAS RN 8032-32-4) is a listed preservative that may be safely used on wooden articles used or intended for use in packaging, transporting, or holding raw agricultural products. No risk management actions were identified for other LBPNs.

Pest control products: In the United States, 3 LBPNs are permitted as a conventional chemical for use. One of these LBPNs (Solvent naphtha (petroleum), light arom. CAS RN 64742-95-6) is exempted from the following:

a) tolerance requirement as a solvent in inert ingredients applied to animals. and, 

b) tolerance requirement as an inert (or occasionally active) ingredients used pre- and post-harvest of crops or raw agricultural commodities.

No other risk management actions were identified for the other LBPNs in pest control products.

Products available to consumers: In the United States, consumer paint and coating products are subject to applicable labelling and information requirements under the Fair Packaging and Labeling Act (FPLA), the Federal Hazardous Substances Act (FHSA), and the Consumer Product Safety Act (CPSA).

Environment: In the United States, 6 LBPNs are listed for reporting requirements under National Emissions Standards for Hazardous Air Pollutants.

Europe

Cosmetics:  Most LBPNs are prohibited in cosmetics if they contain greater than 0.1% benzene, due to hazard classifications as carcinogenic and mutagenic (CMR) (see Regulation (EC) No 1223/2009 Annex II- prohibited substances). Since the LBPNs in this assessment contain less than 0.1% benzene according to available data, the EU cosmetics restrictions are not considered applicable.

Food additives and flavouring agents: LBPNs are not permitted as food additives and/or food flavouring agents. They are not found in the EU additive database.

Food packaging and incidental additives: Most LBPNs are not allowed for use in components of active and intelligent materials and articles regarding food packaging due to the carcinogenic and mutagenic hazard classifications.

Pest control products: 4 LBPNs are not permitted for use in plant protection products if they contain greater than 0.1% benzene due to the carcinogenic and mutagenic hazard classifications. No risk management actions for the other LBPNs were identified. Since the LBPNs in this assessment contain less than 0.1% benzene according to available data, the EU plant protection products restrictions are not considered applicable.

Products available to consumers: Most LBPNs cannot be used in substances and preparations placed on the market for sale to the general public in individual concentrations greater than 0.1%, if they contain greater than 0.1% benzene. Since the LBPNs in this assessment contain less than 0.1% benzene according to available data, the EU restrictions for products available to consumers are not considered applicable.

Other related Risk Management actions:

In Europe, LBPNs have worker exposure directives and, particularly for protection of more vulnerable workers (that is, youth, pregnant and nursing women), directives due to hazard classifications.

8. Next steps

8.1 Public comment period

Industry and other interested stakeholders are invited to submit comments on the content of this Risk Management Scope or other information that would help to inform decision-making (such as outlined in section 3.2, 3.3 and/or 3.5). Please submit additional information and comments prior to May 15, 2024.

The Risk Management Approach document, which will outline and seek input on the proposed risk management instruments, will be published at the same time as the final assessment. At that time, there will be further opportunity for consultation.

Comments and information submissions on the Risk Management Scope should be submitted via the address, telephone/fax number or email provided below:

Environment and Climate Change Canada
Gatineau, Quebec K1A 0H3
Telephone: 1-800-567-1999 (in Canada) or 819-938-3232
Fax: 819-938-5212
Email: substances@ec.gc.ca

Companies who have a business interest in LBPNs considered in the draft assessment report are encouraged to identify themselves as stakeholders. The stakeholders will be informed of future decisions regarding LBPNs and may be contacted for further information.

When the first regulation or instrument respecting preventive or control actions is published in relation to the 17 LBPNs, a statement outlining the estimated timeframe for the development of subsequent proposed regulations or instruments will be made available.

8.2 Timing of actions

Electronic consultation on the draft assessment report and Risk Management Scope: March 16, 2024 to May 15, 2024. This should include the submission of public comments, additional studies and/or information on LBPNs.

Publication of responses to public comments on the draft assessment  and Risk Management Scope:  concurrent to the publication of the final assessment and, if required, the Risk Management Approach document.

Publication of responses to public comments on the Risk Management Approach, if applicable and if required, and the proposed instruments: At the latest, 24-month from the date on which the Ministers recommended that LBPNs subgroups described as “C₉-C₁₄ Hydrocarbon solvents”, “C₉ Aromatic solvents”, and “C₆ – C₉ Aliphatic solvents”, as listed in Annex A be added to Schedule 1 of CEPA.

Consultation on the proposed instrument(s), if required: 60-day public comment period starting upon publication of each proposed instrument.

Publication of the final instrument(s), if required: At the latest, 18-month from the publication of each proposed instrument.

These are planned timelines and are subject to change. Please consult the schedule of risk management activities and consultations for updated information on timelines.

References

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Annex A.  Substances in the low boiling point naphthas group by subgroup

Subgroups 1, 2 and 3 are proposed toxic under section 64(c) of CEPA.

*The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
^a This substance represents a UVCB. UVCB is an acronym for Unknown or Variable composition Complex reaction products and Biological material. These materials are derived from natural sources or complex reactions.  A UVCB is not an intentional mixture of discrete substances, and is considered a single substance. The complexity and variability of their compositions can make them difficult to fully and consistently characterize.
^b This substance was included in this assessment as it was considered a priority through other mechanisms.