Risk management scope for Parabens group

Official title: Risk management scope for: Parabens group, specifically: Benzoic acid, 4-hydroxy-, methyl ester (Methylparaben), Benzoic acid, 4-hydroxy-, propyl ester (Propylparaben), Benzoic acid, 4-hydroxy-, butyl ester (Butylparaben), Benzoic acid, 4-hydroxy-, 2-methylpropyl ester (Iso-Butylparaben)

Chemical Abstracts Service Registry Numbers (CAS RNs): 99-76-3; 94-13-3; 94-26-8; 4247-02-3

Environment and Climate Change Canada

Health Canada

March 2020

Summary of proposed risk management (RM)

This document outlines the risk management options under consideration for methylparaben, propylparaben, butylparaben and iso-butylparaben, which have been proposed to be harmful to human health.

In particular, the Government of Canada is considering the actions below to address the health concerns:

Cosmetics

Non-prescription drugs

Natural Health Products (NHPs)

The risk management options outlined in this RM 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.

The Parabens Group:

Methylparaben, propylparaben, butylparaben and iso-butylparaben are four of the seven substances referred to collectively as the Parabens Group under the third phase of the Chemicals Management Plan and have been proposed to be harmful to human health (Canada, 2016).

In addition, the three remaining substances in this grouping, ethylparaben, iso-propylparaben, and benzylparaben, are proposed not to meet the criteria under paragraph 64(c) of CEPA as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

All seven substances in this assessment were identified as having low potential to be causing ecological harm, according to information considered under the Ecological Risk Classification of organic substances (ERC) approach (ECCC 2016), it is proposed to conclude that methylparaben, ethylparaben, propylparaben, butylparaben, benzylparaben, iso-propylparaben, and iso-butylparaben do not meet the criteria under paragraphs 64(a) or (b) of CEPA as they 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.

1. Context

The Canadian Environmental Protection Act, 1999 (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 CEPAFootnote 1 Footnote 2, and if so, to manage the associated risks.

As part of the third phase of the Chemicals Management Plan (CMP), the Ministers plan to assess and manage, where appropriate, the potential health and ecological risks associated with approximately 1550 substances (Canada 2016).

2. Issue

Health Canada and Environment and Climate Change Canada conducted a joint scientific assessment relevant to the evaluation of seven parabens including methylparaben, propylparaben, butylparaben and iso-butylparaben, in Canada. A notice summarizing the scientific considerations of the draft screening assessment  for these  substances was published in the Canada Gazette, Part I, on February 29, 2020. (Canada 2019). Refer to the draft screening assessment for parabens for further information.

2.1 Draft screening assessment conclusion

On the basis of the information available, the draft screening assessment proposes that methylparaben, propylparaben, butylparaben and iso-butylparaben meet the criteria under section 64(c) of CEPA because they are entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health (Canada 2019). However, it is proposed to conclude that these substances do not meet the criteria under paragraphs 64(a) or 64(b) of CEPA as they 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.

The draft screening assessment also proposes that methylparaben, propylparaben, butylparaben and iso-butylparaben do not meet the criteria for persistence and/or bioaccumulation, as set out in the Persistence and Bioaccumulation Regulations of CEPA (Canada, 2000).

The exposure sources of concern, identified in the draft screening assessment, are based on the potential absorption of butylparaben and iso-butylparaben from the use of cosmetics; butylparaben and iso-butylparaben from non-prescription drugs; and methylparaben, propylparaben, butylparaben, and iso-butylparaben from NHPs. As such, this document will focus on these exposure sources of concern (refer to section 5).

2.2 Proposed recommendation under CEPA

Based on the findings of the draft screening assessment conducted under CEPA, the Ministers propose to recommend that methylparaben, propylparaben, butylparaben and iso-butylparaben be added to the List of Toxic Substances in Schedule 1 of the ActFootnote 3.

The Ministers will take into consideration comments made by stakeholders during the 60-day public comment period on the draft screening assessment and its associated RM Scope document.

If the Ministers finalize the recommendation to add methylparaben, propylparaben, butylparaben and iso-butylparaben to Schedule 1, risk management instruments must be proposed and finalized within a set period of time 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 objective

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

For methylparaben, propylparaben, butylparaben and iso-butylparaben, the proposed objective is focused on addressing the risks and exposure sources of concern outlined in section 5 of this document. As such, the proposed human health objective for methylparaben, propylparaben, butylparaben and iso-butylparaben is to decrease exposure of the general population to these substances from certain cosmetics, NHPs, and non-prescription drugs, to levels that are protective of human health.

3.2 Proposed risk management objective

Proposed risk management objectives (RMO) 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 methylparaben, propylparaben, butylparaben and iso-butylparaben for the protection of human health, are to:

The proposed risk management objectives may be revised in the RM Approach document that will be published concurrently with the screening assessment for these substances, or in subsequent risk management documents (e.g. consultation document on proposed instrument), as the case may be.

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 methylparaben, propylparaben, butylparaben and iso-butylparaben are:

Following the publication of this RM Scope document, additional information obtained from the public comment period and from other sources will be considered, along with the information presented in this document, in the instrument selection and development processFootnote 4. The risk management options outlined in this document may evolve through consideration of assessments and risk management options published for other CMP substances to ensure effective, coordinated, and consistent risk management decision-making.

3.4 Risk management information gaps

At this time, the following additional information is being requested from interested stakeholders to help fill any information gaps and to inform risk management decision-making regarding methylparaben, propylparaben, butylparaben and iso-butylparaben use in Canada:

Should stakeholders have such further information, they should provide it ideally on or before April 29, 2020, within the timelines (and to the contact) identified in section 8 of this document.

3.5 Performance measurement and evaluation

Performance measurement evaluates the ongoing effectiveness and relevance of the actions taken to manage risks from toxic substancesFootnote 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 review, on a regular basis, the effectiveness of the risk management actions for methylparaben, propylparaben, butylparaben and iso-butylparaben.

To this end, over time, the Government of Canada plans to collect and analyze data, such as biomonitoring data from the Canadian Health Measures Survey (CHMS) on the presence of methylparaben, propylparaben, butylparaben and iso-butylparaben due to exposures to these substances from cosmetic products, non-prescription drugs, and NHPs.

The results of performance measurement and 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.

4. Background

4.1 General information on the Parabens Group

Parabens are a family of alkyl esters of para-hydroxybenzoic acid, the word paraben being a contraction of “para-hydroxybenzoic acid”.  Different parabens differ in the chemical substitutions in the para position of the benzene ring.

All seven parabens in the parabens group are synthetically produced. However, some also occur naturally in certain fruits such as blueberries, strawberries, grapes, olives, yeast and barley.

4.2 Current uses and identified sectors

According to information submitted in response to surveys under section 71 of CEPA (Canada 2012), methylparaben was reported to be manufactured in Canada in 2011 at a volume of 981 kg, and reported to be imported into Canada at a volume of 563,000 kg.  Butyl-, propyl-, and iso-butylparaben were not reported to be manufactured in Canada.

In response to CEPA Section 71 survey (Canada, 2017), propylparaben was reported to be imported, in 2016, at a volume of 8,526 kg, butylparaben at a volume of 100-1000 kg, and iso-butylparaben at a volume of 232 kg.

In Canada, as per the draft screening assessment (Canada 2019) parabens are widely used as preservatives or antimicrobials against yeast, moulds and bacteria, in various cosmetic products, prescription and non-prescription drugs, NHPs, as well as in products available to consumers. They are also used in pest control products.  Methyl- and propylparaben are approved food additives, which may be used as preservatives in certain foods and beverages sold in Canada.

The results from the 2014 and 2015 Canadian Health Measures Survey (CHMS) showed that 93% of Canadians aged 3 to 79 had at least one detectable paraben in their urine (methylparaben, ethylparaben, propylparaben or butylparaben).  Detectable paraben levels reflect recent exposure only and do not necessarily indicate the possibility of an adverse event occurring (Statistics Canada 2016).

Cosmetic products

Based on notifications submitted under the Cosmetic Regulations to Health Canada from 2014 to 2017, methyl-, propyl-, butyl-, iso-propyl and iso-butylparabens are used in a wide range of cosmetic products in Canada.

As per the draft screening assessment (Canada, 2019), methylparaben and propylparaben were not identified as concerns in cosmetic products. Levels of butylparaben and iso-butylparaben were identified as a concern in some cosmetics products.

Prescription drugs

Methyl-, and propylparaben are reported as non-medicinal ingredients in some prescription drug products. Propylparaben was not identified as a concern in prescription drug productsFootnote 6.  As per the draft screening assessment (Canada 2019), oral and dermal exposures to methylparaben in prescription drugs were not addressed in the assessment as the level of methylparaben in Canadian-approved pharmaceutical products is within standard use.

Non-prescription drugs

Methyl-, propyl-, butyl-, and iso-butylparaben are reported as non-medicinal ingredients in some over-the-counter (non-prescription) drug products.

As per the draft screening assessment (Canada, 2019), levels of methyl-, and propylparaben were not identified as a concern in non-prescription drug products, whereas levels of butyl-, and iso-butylparaben were identified as a concern in certain non-prescription drug products.

NHPs

Methyl-, propyl-, butyl-, and iso-butylparaben are also reported as non-medicinal ingredients in several NHPs.  They are of concern in certain NHPs.

5. Exposure sources and identified risks

The purpose of the RM Scope is to present Environment and Climate Change Canada’s (ECCC) and Health Canada’s (HC) early proposal to manage the risks identified in the screening assessment. As such, the exposure sources of concern are further discussed in this document.

Methylparaben

According to the draft screening assessment (Canada 2019), the critical effect for methylparaben includes clinical signs of ill-health, stomach erosion, and spleen and thyroid atrophy.  The margins of exposure for oral exposure to some NHPs: (anti-diarrheal medication, heartburn medication, radiological contrast media); were considered potentially inadequate to address uncertainties in the health effects and exposure databases.

Propylparaben

In the draft screening assessment (Canada 2019), the critical effect level was based on an NOAEL (no observed adverse effect level) at the highest dose tested in a study of reproduction, reproductive development, or prenatal development. However, the possibility of adverse effects at high doses could not be excluded. The margins of exposure for oral exposure to a NHP (heartburn medication) were considered potentially inadequate to address uncertainties in the health effects and exposure databases.

Butylparaben

The draft screening assessment (Canada 2019) indicated that the critical effect for butylparaben is reduced anogenital distance in both sexes, reproductive organ weight, sperm count and motility. The calculated margins of exposure to some cosmetics (hair dye); some NHPs (herbal cough medicine, sunscreen); and some non-prescription drugs (children’s analgesic suspension, antacid) are considered potentially inadequate to address uncertainties in the health effects and exposure databases.

Iso-butylparaben

As per the draft screening assessment (Canada 2019), the critical effect is reduced sperm count and motility. The calculated margins for exposure to the following cosmetic products: body lotion, body oil, body scrub, face make-up face lotion, eye lotion, sunless tanning product, shampoo, hair conditioner, body cleanser, as well as NHP (analgesic cream) and non-prescription drug (sunscreen) are considered potentially inadequate to address uncertainties in the health effects and exposure databases.

6. Risk management considerations

6.1 Alternatives and alternate technologies

There are several alternatives to the parabens being used in cosmetics, prescription and non-prescription drugs and NHPs in Canada.

6.2 Socio-economic and technical considerations

No information on socio-economic or technical considerations was identified.  We ask that stakeholders submit information on these considerations, if known.

Socio-economic factors will be considered in the selection process for a regulation and/or instrument respecting preventive or control actions, and in the development of the risk management objectives. Socio-economic factors will also be considered in the development of regulations, instrument(s) and/or tool(s) as identified in the Cabinet Directive on Regulatory Management (TBS 2012a) and the guidance provided in the Treasury Board document Assessing, Selecting, and Implementing Instruments for Government Action (TBS 2007).

7. Overview of existing risk management

7.1 Related Canadian risk management context

There are no specific restrictions for the use of parabens in cosmetic products in Canada.  Parabens are restricted in Canada in NHPs to an oral upper limit of 10 mg/ kg bw/day exposure of the sum of methyl-, ethyl-, and propylparaben.

Methyl- and propylparaben are on the List of Permitted Preservatives (Lists of Permitted Food Additives) for use at up to 1000 ppm (0.1%) in certain foods and beverages. Butylparaben and iso-butylparaben are not permitted for use as  food additives

7.2 Pertinent international risk management context

The EU has set the maximum concentration in cosmetics of 0.4% (w/w) for methylparaben as single ester and a total maximum concentration of 0.8% for mixtures of esters (w/w).  It has also set the maximum concentration for butylparaben and propylparaben (and their salts) in cosmetics as: 0.14% (as acid) for the sum of the individual concentrations; and 0.8% (as acid) for mixtures of methyl-, butyl-, propyl-, and ethylparaben, and their salts (including maximum 0.14% for the mixture of butyl- and propylparaben). Iso-butylparaben is prohibited in cosmetics in the EU. (EU, 2009, 2014).

For food additives, methylparaben and its sodium salt is included in the parabens group ADI (Acceptable Daily Intake) of 0-10 mg/kg body weight per day (applicable to the sum of methyl and ethylparaben) established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Propylparaben was originally included in the group ADI but was withdrawn in 2006 due to new information of adverse effects. Methylparaben is permitted in the European Union as a food additive. (JECFA, 2017).

In the U.S., methylparaben and propylparaben are recognized as direct food substances affirmed as “Generally Recognized as Safe” (GRAS) when either of them is used as an antimicrobial agent in food at levels not to exceed a maximum level of 0.1 percent (1000 ppm) in food.  Methylparaben and propylparaben are also approved for use as synthetic flavouring substances and adjuvants. (USA, 2018).

8. Next steps

8.1 Public comment period

Industry and other interested stakeholders are invited to submit comments on the content of this RM Scope or other information that would help to inform decision-making. Please submit additional information and comments prior to April 29, 2020.  

The Risk Management Approach document, which will outline and seek input on the proposed risk management instrument(s), will be published at the same time as the final Screening Assessment Report. At that time, there will be further opportunity for consultation.

Comments and information submissions on the RM Scope should be submitted to the address 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: eccc.substances.eccc@canada.ca

Companies who have a business interest in methylparaben, propylparaben, butylparaben and iso-butylparaben are encouraged to identify themselves as stakeholders. The stakeholders will be informed of future decisions regarding methylparaben, propylparaben, butylparaben and iso-butylparaben and may be contacted for further information.

8.2 Timing of actions

Electronic consultation on the draft Screening Assessment Report and Risk Management Scope: February 29, 2020 to April 29, 2020

Submission of public comments, additional studies and information on methylparaben, propylparaben, butylparaben and iso-butylparaben: On or before April 29, 2020

Publication of responses to public comments on the draft Screening Assessment Report and Risk Management Scope: On or before February 2021

Publication of the final Screening Assessment Report and, if required, the Risk Management Approach document: On or before February 2021

Publication of responses to public comments on the Risk Management Approach, if applicable and if required, the proposed instruments: At the latest, 24-month from the publication of the final Screening Assessment Report

Consultation on the proposed instruments, if required: 60-day public comment period starting upon publication of each proposed instruments

Publication of the final instruments, if required: At the latest, 18-month from the publication of each proposed instruments

9. References

Canada Gazette Part I, vol. 140, no. 9, p. 435-459 (2006). Canadian Environmental Protection Act, 1999: Notice with respect to selected substances identified as priority for action.

Canada. 1999. Canada Gazette. Part III. vol. 22, no. 3. (1999). Canadian Environmental Protection Act, 1999. S.C., 1999, c. 33.

Canada. 2000. Canadian Environmental Protection Act, 1999: Persistence and Bioaccumulation Regulations [PDF], P.C. 2000-348, 23 March 2000, SOR/2000-107. 

Canada. 2015. Treasury Board of Canada Secretariat. Red Tape Reduction Act. S.C. 2015, c.12.

Canada. 2016. Third phase of the Chemicals Management Plan.  

Canada. 2018. List of Permitted Preservatives (Lists of Permitted Food Additives)

Canada. 2019. Dept. of the Environment, Dept. of Health. Draft Screening Assessment, Parabens Group

Environment and Climate Change Canada (ECCC 2016) Ecological Risk Classification of Organic Substances (ERC)

EU (European Union). 2009. Official Journal of the European Union L 342/59

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products

EU (European Union). 2014. Official Journal of the European Union L 107/5 

Commission Regulation (EU) No 358/2014 f 9 April 2014 amending Annexes II and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products

JECFA  (Joint FAO/WHO Expert Committee on Food Additives). 2017. Evaluations of the Joint FAO/WHO Expert Committee on Food Additives (JECFA)

Statistics Canada 2018. Paraben concentrations in Canadians, 2014 and 2015

[TBS] Treasury Board of Canada Secretariat. 2007. Assessing, Selecting, and Implementing Instruments for Government Action

[TBS] Treasury Board of Canada Secretariat. 2012a. Cabinet Directive on Regulatory Management

[TBS] Treasury Board of Canada Secretariat. 2012b. Red Tape Reduction Action Plan

USA (United Sates of America). 2018. FDA, CFR-Title 21, Part 184- Direct food substances affirmed as Generally Recognised  As Safe (GRAS)

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