Proposed Risk Management Approach for 1,4-Benzenediol (Hydroquinone) Chemical Abstract Service Registry Number (CAS RN) 123-31-9
Environment Canada
Health Canada
July 2008
The Canadian Environmental Protection Act, 1999(CEPA 1999) (Canada 1999) requires the Minister of the Environment and the Minister of Health (the Ministers) to categorize all substances on the Domestic Substances List (DSL). Categorization involves identifying those substances on the DSL that a) are considered to be persistent (P) and/or bioaccumulative (B), based on the criteria set out in the Persistence and Bioaccumulation Regulations, and “inherently toxic” (iT) to humans or other organisms, or b) present, to individuals in Canada, the greatest potential for exposure (GPE). In addition, the Act requires the Ministers to conduct screening assessments of substances that meet the categorization criteria. The assessment further determines whether the substance meets the definition of “toxic” set out in section 64 of CEPA 1999.
In December 2006, the Challenge identified 193 chemical substances through categorization which became high priorities for assessment due to their hazardous properties and their potential to pose risks to human health and the environment. In February 2007, the Ministers began publishing, for industry and stakeholder comment, profiles of batches containing 15 to 30 high-priority substances. New batches are released for comment every three months.
In addition, the mandatory information–gathering provisions under section 71 of CEPA 1999 are being used under the Challenge to gather specific information where it is required. The information that is collected through the Challenge will be used to make informed decisions and appropriately manage any risks that may be associated with these substances.
The substance 1,4-benzenediol, Chemical Abstract Service (CAS) Registry Number 123-31-9, referred to throughout this document by “hydroquinone,” was included in Batch 1 of the Challenge under the Chemicals Management Plan.
A Notice summarizing the scientific considerations of a final screening assessment report was published by Environment Canada and Health Canada in the Canada Gazette, Part I, for hydroquinone on July 5, 2008, under subsection 77(6) ofCEPA 1999. The final screening assessment report concluded that hydroquinone is entering or may be entering the environment in a quantity or a concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
On the basis of the carcinogenicity of hydroquinone, for which there may be a probability of harm at any level of exposure as well as the potential inadequacy of the margin between estimated exposure from products and the critical effect level for non-cancer effects, it is concluded that hydroquinone is a substance that may be 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 2008).
Based on the available information, it is concluded that hydroquinone is 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. It is therefore concluded that hydroquinone does not meet the criteria in paragraph 64a and 64b of CEPA 1999, but that it does meet the criteria in paragraph 64c of CEPA 1999.
The final screening assessment report also concluded that hydroquinone does not meet the criteria for persistence and does not meet the criteria for bioaccumulation, as defined by thePersistence and Bioaccumulation Regulations (Canada 2000) made under CEPA 1999. The presence of hydroquinone in the environment does not result primarily from human activity.
For further information on the final screening assessment report conclusion for hydroquinone, refer to the final screening assessment report, available at http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot_1_e.html.
Following a screening assessment of a substance under section 74 of CEPA 1999, a substance may be found to meet the criteria under section 64 ofCEPA 1999. The Ministers can propose to take no further action with respect to the substance, add the substance to the Priority Substances List (PSL) for further assessment, or recommend the addition of the substance to the List of Toxic Substances in Schedule 1 of CEPA 1999. Under certain circumstances, the Ministers must make a specific proposal either to recommend addition to the List of Toxic Substances or to recommend the implementation of virtual elimination (or both). In this case, the Ministers proposed to recommend the addition of hydroquinone to the List of Toxic Substances in Schedule 1 ofCEPA 1999. As a result, the Ministers will develop a regulation or instrument respecting preventive or control actions to protect the health of Canadians and the environment from the potential effects of exposure to this substance.
The final screening assessment report did not conclude that hydroquinone meets the conditions set out in subsection 77(4) ofCEPA 1999. As a result, hydroquinone will not be subject to the virtual elimination provisions under CEPA 1999 and will be managed using a life-cycle approach, to prevent or minimize its release into the environment.
Hydroquinone is part of the chemical grouping discrete organics and the chemical sub-grouping phenols.
Table 1 presents other names, trade names, chemical groupings, the chemical formula, the chemical structure and the molecular mass for hydroquinone.
Table 1 Identity of Hydroquinone
| CAS Registry Number | 123-31-9 |
|---|---|
| DSL name | 1,4-Benzenediol |
| Inventory names1 | 1,4-Benzenediol (TSCA, DSL, ENCS,AICS,ECL, SWISS, PICCS,ASIA-PAC,NZIoC) Hydroquinone (DSL, EINECS,PICCS) Hydrochinon (EINECS, SWISS, PICCS) Benzene, 1,4-dihydroxy- (PICCS) P-dihydroxybenzene (PICCS) P-hydroxyphenol (PICCS) |
| Other names | Hydroquinone; 1,4-Benzoquinol; 1,4-Dihydroxybenzene; 4-Hydroxyphenol; Aida; Arctuvin; Benzohydroquinone; Benzoquinol; Black & White Bleaching Cream; BQ(H); Diak 5; Dihydroquinone; Eldopacque; Eldopaque; Eldopaque Forte; Eldoquin; Eldoquin Forte; HE 5; Hydroquinol; NSC 9247; p-Benzenediol; p-Dihydroquinone; p-Dioxybenzene; p-Hydroquinone; p-Phenylenediol; p-Quinol; Phiaquin; Quinol; Solaquin Forte; Tecquinol; Tenox HQ; UN 2662; UN 2662 (DOT) |
| Chemical group | Discrete organics |
| Chemical sub-group | Phenols |
| Chemical formula | C6H6O2 |
| Chemical structure |  |
| SMILES | Oc(ccc(O)c1)c1 |
| Molecular mass | 110.11 g/mol |
Based principally on the assessment of the European Commission, a critical effect for characterization of risk to human health is carcinogenicity, for which a mode of induction involving direct interaction with genetic material cannot be precluded.
With respect to non-cancer effects, the lowest oral no-observed-effect level (NOEL) (15 mg/kg-bw/day) is from the rat 2-generation reproduction study, based on parental toxicity. However, given that the predominant source of exposure to the general population is through the naturally occurring presence of hydroquinone in foods and beverages, derivation of a margin of exposure between effect levels in dietary studies with experimental animals and upper-bounding estimates of exposure would not be meaningful. For non-cancer effects, the incremental exposure and risk associated with hydroquinone in environmental media resulting from its manufacturing and industrial uses are considered to be negligible.
Dermal exposure to hydroquinone from use of consumer products can occur. The consumer product scenario with the highest potential dermal exposure is contact with oxidative hair dye containing hydroquinone (7.5 x 10-3 µg/kg-bw/day). There is a margin of exposure of well over 1 000 000 between this value and the dermal no-observed-adverse-effects level (NOAEL) of 73.9 mg/kg-bw/day in the 90-day rat study. With respect to non-cancer effects via the dermal route, this margin is considered adequate to account for uncertainty in the database on exposure and effects (Canada 2008).
Risks associated with skin-lightening preparations containing hydroquinone, regulated under the Food and Drugs Act, need to be considered together with the clinical benefits of the preparations, a task which is beyond the scope of this screening assessment. However, Health Canada has received 10 reports (between January 1, 1965 and November 30, 2007) of adverse reactions suspected to be associated with the use of over-the-counter skin-lightening creams (Personal communication from Jenna Griffiths, Marketed Health Products Directorate, Health Products and Food Branch, Health Canada, January 8, 2008; unreferenced).
According to the submissions made under section 71 ofCEPA 1999, the known current uses of hydroquinone in Canada include the following: as a polymerization inhibitor in unsaturated polyester and methylmethacrylate resin monomers; as a stabilizer in colorants and various types of industrial and consumer adhesives, thread lockers and thread sealants; as an additive to heat shrink tubing, restorative paste, bonding tape, film tape, liquid bandages, etc; as a performance additive in sheetfed printing and heatset inks; and as a reducing agent in photographic developing solutions (Canada 2007).
A number of other uses of hydroquinone in Canada have also been identified. Although prohibited for use in cosmetic products applied to the skin and mucous membranes, including skin-lightening products (Health Canada 2007a), there were 110 notifications of cosmetic products containing hydroquinone filed with Health Canada under the Cosmetic Regulations of the Food and Drugs Act, primarily in manicure preparations and hair dyes, at concentrations ranging up to 3% (Health Canada 2007b). Health Canada's Drug Product Database lists 34 marketed products. This does not included products that are not marketed, discontinued or have been inactivated. Hydroquinone is also found in 3 licensed natural health products (NHPs), which were all previously DIN-assigned products (now discontinued DINs).
Provincially, the National Association of Pharmacy Regulatory Authorities (NAPRA) lists hydroquinone topical preparations as Schedule II drugs, which are less strictly regulated and do not require a prescription but do require professional intervention from the pharmacist at the point of sale and possibly referral to a practitioner. They are available only from the pharmacist and must be kept within an area of the pharmacy where there is no public access and no opportunity for patient self-selection (www.napra.ca) (Personal communication from Robin Marles, Natural Health Products Directorate, Health Products and Food Branch, Health Canada, November 22, 2007; unreferenced).
Hydroquinone is also present at 0.3% concentration as a stabilizer in two pest control products registered under thePest Control Products Act. One product is a restricted-class herbicide for use in irrigation canals to control vegetation and the second product is a commercial-class microbiocide used in oil field water injection recovery systems (PMRA2007).
Hydroquinone may also be used as a chemical intermediate in the synthesis of the following types of chemicals: antioxidants and antiozonants used in rubber processing; antioxidants used in industrial fats, oils and foods; and stabilizers for paints, varnishes, motor oils and fuels. It is used in the photographic industry for the development of black-and-white film and hospital X-rays and also in lithography. It has also been reported as a component of casting compounds, and may be used as a corrosion inhibitor in boilers and cooling towers (OECD SIDS 2002).
Anthropogenic releases of hydroquinone may occur during its production and use in photographic applications, antioxidants, monomer inhibitors, dyes and pigments, agricultural chemicals and as a stabilizer in paints and varnishes, motor fuels and oils. It may also be released to the environment in the effluent of photographic processes (HSDB 2006). Table 2 summarizes on-site releases and off-site disposal of hydroquinone (and its salts) to unspecified media from industrial facilities in Canada from 2001 to 2006, as reported in the National Pollutant Release Inventory (NPRI 2007).
Table 2. Releases of hydroquinone for 2001-2006
| Year | On-site releases | Off-site disposal | Release units |
|---|---|---|---|
| 2006 | 2 | 0 | kg |
| 2005 | 2 | 1 | kg |
| 2004 | 2 | 49 | kg |
| 2003 | 2 | 1 | kg |
| 2002 | 0 | 1 | kg |
| 2001 | 1 | 1 | kg |
Hydroquinone occurs naturally as a conjugate with beta-D-glucopyranoside in the leaves, bark and fruit of a number of plants, especially the ericaceous shrubs such as cranberry, cowberry, bearberry and blueberry (Varagnat 1982; Harbison and Belly 1982; Hudnall 1987). It has been detected at low levels in coffee, tea, red wine, beer, cola soft drinks, 2% milk, orange juice, corn, wheat and rice cereals, wheat germ, and various fruits, including pears, oranges, cantaloupes, cherries, asparagus, apples, blueberries and cranberries (Deisinger et al. 1996). Hydroquinone is known to play a role in the defence mechanisms of certain classes of beetles (Aneshansley et al. 1969). It is also known to be present in the particulate fraction of cigarette smoke (IARC1985).
Hydroquinone is manufactured by the oxidation of aniline to quinone and the subsequent reduction of quinone to hydroquinone. Other routes of synthesis include the oxidative cleavage of diisopropyl benzene and the hydroxylation of phenol (OECD SIDS 2002). According to current information reported pursuant to theCEPA 1999 section 71 notice with respect to hydroquinone, 17 Canadian companies and 2 foreign companies reported importing hydroquinone (whether alone, in a product, in a mixture or in a manufactured item) in 2006 in a quantity greater than or equal to 100 kg, while another 10 Canadian companies reported importing hydroquinone (whether alone, in a product, in a mixture or in a manufactured item) in 2006 in a quantity less than 100 kg. No Canadian companies manufactured hydroquinone in Canada in 2006 (Canada 2007b). The total quantity imported was between 100 000 kg and 1 000 000 kg (Canada 2007b).
Upper-bounding estimates of hydroquinone intake for each age group in the general population of Canada are based upon maximum identified concentrations in environmental media and food items (Canada 2008). The upper-bounding estimate of exposure to hydroquinone for the general population ranges from 91.32 µg/kg-bw (kilogram of body weight) per day for the 60+ age group to 393.45 µg/kg-bw per day in the 0–6 month (not formula-fed) age group. Based on these estimates, intake from food and beverages represents the predominant source of exposure to hydroquinone for the general population of Canada, comprising over 99% of total exposure for all age groups. As indicated earlier, hydroquinone and its glucose conjugate, 4-hydroxyphenyl-β-D-glucopyranoside (arbutin), are naturally present in many foods and beverages. Since arbutin is reported to hydrolyze readily in dilute acidic solutions to yield D-glucose and hydroquinone, ingested arbutin is expected to be converted to free hydroquinone in the stomach (Deisinger et al. 1996). As such, both measured concentrations of hydroquinone and arbutin in food and beverages were considered in deriving estimates of intake from food and beverages. Contributions to total intake from other media (ambient and indoor air, water and soil) were considered to be negligible in comparison to intake from food and beverages.
Dermal exposure during the use of consumer products containing hydroquinone can also contribute to total exposure for the general population. A number of upper-bounding exposure scenarios for different products containing hydroquinone have been generated (Canada 2008). These include intake from the use of black-and-white photographic developing solutions (7.9 x 10-4µg/kg-bw/day), household adhesives (7.2 x 10-5µg/kg-bw/day), manicure preparations (3.0 x 10-4µg/kg-bw/day) and oxidative hair dyes (7.5 x 10-2µg/kg-bw/day). Because of the low vapour pressure of hydroquinone, it is considered unlikely that there will be any significant inhalation exposure associated with any of these uses. With regard to exposure resulting from the use of photographic developing solutions, the results from a recent study involving the biological monitoring of professional darkroom workers in the United Kingdom indicated no increase in the urinary excretion of hydroquinone for exposed workers, indicating that even for this potentially highly exposed population, intake of hydroquinone from use of developing solutions is unlikely to be a concern (UKHSE 1993).
Exposure estimates were not derived for skin-lightening preparations containing hydroquinone, regulated under the Food and Drugs Act, due to the wide range of potential clinical uses. Additionally, access to these products is controlled through provisions established by the National Association of Pharmacy Regulatory Authorities.
Hydroquinone is known to be present in the particulate fraction of cigarette smoke (IARC 1985) and this may also contribute to overall exposure.
Confidence in the upper-bounding estimate of intake of hydroquinone in environmental media is considered to be moderate, as limited measured concentrations were available. Confidence in the estimates of exposure estimates from use of consumer products containing hydroquinone is considered to be low, as the estimates are based on assumptions; the estimates of exposure resulting from these uses, however, are considered to be overestimates of actual exposure.
Hydroquinone is subject to:
- reporting under the National Pollutant Release Inventory;
- the Food and Drug Regulations or the Natural Health Products Regulations under the Food and Drugs Act, when used in drugs or natural health products, respectively;
- the Drug Product Database, in which it is registered as an active ingredient;
- the Controlled Products Regulations established under the Hazardous Products Act, requiring any ingredient on the Ingredient Disclosure List to be disclosed on the Material Safety Data Sheet;
- the Consumer Chemicals and Containers Regulations, 2001 established under the Hazardous Products Act, requiring products to be classified against criteria based on short-term exposure situations, with the results determining the appropriate product labelling and packaging requirements;
- the Cosmetic Ingredient Hotlist established under the Food and Drugs Act;
- the Tobacco Reporting Regulations and the Determination of Phenolic Compounds in Tobacco Smoke; and
- the Pest Management Regulatory Agency (PMRA) List of Formulants (List 1).
Hydroquinone is listed on the U.S. Toxic Substances Control Act (TSCA) inventory. Hydroquinone is designated as a hazardous air pollutant (HAP) by the U.S. Environmental Protection Agency (EPA). It is listed under the U.S. Superfund Amendments and Reauthorization Act (SARA) as well as the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA). It is listed on the U.S.Federal Insecticide, Fungicide, and Rodenticide Act(FIFRA) as a List 1 inert ingredient. Hydroquinone is also listed under the U.S. Food and Drug Administration (FDA) Federal Food, Drug, and Cosmetic Act (FD&C Act) as an indirect food additive. There are currently no international risk management measures in place for hydroquinone. The Organisation for Economic Co-operation and Development (OECD) has stated that hydroquinone has a low priority for further work. It is listed by the International Agency for Research on Cancer (IARC) as a Group 3 carcinogen (inadequate evidence of carcinogenicity in humans and inadequate or limited evidence in experimental animals).
The U.S. FDA is currently proposing a ban on over-the-counter sales of skin-lightening products containing hydroquinone. The intention is to restrict them only to prescription use under medical supervision. The rule has been put out for public comments through Dec. 26, 2006 (Federal Register 2006).
There are alternative chemicals to the use of hydroquinone for black-and-white photographic development. However these alternatives may not provide the same desired artistic effects as the hydroquinone-based developing solutions for particular uses. As this specialized discretionary market is artistic in nature and highly technical, it is uncertain as to what impact control measures would have on this community.
There are alternative chemistries for hair dyes which do not require hydroquinone.
For certain industrial uses, a major alternative replacement chemical for hydroquinone is catechol. As catechol is also being managed under the Chemicals Management Plan, it would not be considered a suitable replacement. Due to the complex nature of some of the industrial uses for hydroquinone, it is unknown whether there are suitable replacements for all applications.
It is important to note that these substitutes have not undergone an assessment to determine whether they meet the criteria under section 64 of CEPA 1999.
The rise of digital photography, Web publishing and home printing is quickly replacing the home darkroom for photographers wishing to do custom black-and-white photography in Canada. However there is a very small segment of the artistic photographic community which occasionally desires certain effects for black-and-white photographs. These effects are not yet possible with digital technology and require photodeveloping solution containing hydroquinone.
Where information was available, socio-economic factors have been considered, at least in a qualitative manner, in the selection process for an instrument respecting preventive or control actions, and in the development of the risk management objective(s). Socio-economic factors will also be considered in the development of regulations, instrument(s) and/or tool(s) as identified in theCabinet Directive on Streamlining Regulation (Treasury Board of Canada Secretariat 2007) and the guidance provided in the Treasury Board document Assessing, Selecting, and Implementing Instruments for Government Action.
As no additional risk management actions are proposed underCEPA, socio-economic considerations are considered to be negligible.
In screening assessments, potential exposure of the general population, including infants and children, is estimated. To the extent possible, based on available data, exposure to hydroquinone from multiple routes (i.e. inhalation, ingestion and contact on the skin) and possible sources (ambient air, indoor air, drinking water, food, beverages--including breast milk and formula for infants)--soil, and in some instances consumer products) is estimated. Infants and children's exposure is characterized by their unique physiology (e.g. intake of air, food, and water relative to body size) and generally known behaviour characteristics (e.g. crawling versus walking, mouthing activity).
As part of the Challenge, the Government asked industry and interested stakeholders to submit any information on the substance that may be used to inform risk assessment, risk management and product stewardship. In particular, stakeholders were asked through a questionnaire if any of the products containing the substance were intended for use by children. Given the information received, and other data considered, it is proposed that no additional risk management actions to specifically protect children are required for this substance at this time.
An environmental or human health objective is a quantitative or qualitative statement of what should be achieved to address environmental or human health concerns identified during a risk assessment.
As the primary source of exposure for the general public would be from consuming naturally occurring hydroquinone in food and beverages, the proposed human health objective for hydroquinone is to minimize exposure to, and hence risk to human health associated with, exposure to hydroquinone to the extent practicable from non-naturally occurring sources.
A risk management objective is a target expected to be achieved for a given substance by the implementation of risk management tool(s) and/or
instrument(s). The proposed risk management objective is to reduce exposure to hydroquinone.
As required by the Government of Canada's Cabinet Directive on Streamlining Regulation2, and criteria identified in the Treasury Board document entitled Assessing, Selecting, and Implementing Instruments for Government Action, the proposed risk management regulations, instrument(s) and/or tools were selected using a consistent approach, and took into consideration the information that has been received through the Challenge and other information available at the time.
In order to achieve the risk management objective and to work towards achieving the human health objective, the risk management being considered for hydroquinone pertains to a requirement for notification of the federal government regarding any proposed future uses. Additional restrictions on the use of hydroquinone in cosmetic products (nail systems and hair dyes) will be proposed. The government will also be proposing to regulate hydroquinone-containing health products as a prescription drug rather than available in over-the-counter products (e.g., skin lightening products).
It is proposed to create a provision whereby any future uses of hydroquinone would be subject to federal government notification.
Industrial chemical uses are governed under provincial health and safety regulations and all workplace chemicals must comply with the Controlled Products Regulations, which includes Workplace Hazardous Materials Information System (WHMIS) labelling, supply of Material Safety Data Sheets (MSDS) and worker training. In addition, it is proposed to create a provision whereby any proposed use of hydroquinone above a specific level in a manufacturing application would require that the federal government be notified.
The minute concentrations of hydroquinone as currently employed in the adhesives industry in specialty adhesives are trapped in the cured adhesive matrix and are not readily absorbed through the skin based on modelled exposure studies (Canada 2008). As there is negligible exposure to hydroquinone through adhesives, this sector will not be a candidate for risk management of hydroquinone.
Photographic chemicals are used by professional, artistic and hobby photographers and when purchased at retail, would be required to have appropriate short-term exposure labelling in accordance with the Consumer Chemicals and Containers Regulations,2001. This labelling helps to reduce unintentional short-term incidents, but will have an impact on long-term exposure as well if the user follows the safety warnings and uses the appropriate protective equipment. Therefore the Government of Canada considers that the risks posed by hydroquinone in photographic chemicals are already appropriately regulated under the Hazardous Products Act.
Hydroquinone is used as a formulant stabilizer at concentrations of no greater than 0.3% in an aquatic herbicide and in a microbiocide for use in oil field water injection recovery systems. These products are regulated under the Pest Control Products Act and because of their designations as restricted and commercial class, they are not for sale to the general public. Once the reassessment document is finalized, hydroquinone will be re-categorized from PMRA List 1 to List 4B for use only in the above-mentioned products. As pest control products are governed by a previously existing act, this sector will not be a candidate for risk management of hydroquinone underCEPA 1999.
The screening assessment report for hydroquinone notes that oral intake is the primary route of exposure for the general population. The primary oral intake source for the general public is from the consumption of foods such as pears, wheat and wheat breads, tea and coffee, rice, onions, cranberries, blueberries and red wine. Food and beverages are identified as the major source of exposure to hydroquinone for the general population of Canada, making up over 99% of the total intake for all age groups. Hydroquinone has also been detected in cigarette smoke and wood smoke. There is currently no evidence to indicate that the natural occurrence of hydroquinone in foods poses a risk to Canadian consumers. Fruits and vegetables are known to contain various naturally occurring substances which have been linked to important health benefits. Consumers are encouraged to continue to eat fruits and vegetables as recommended in Canada's Food Guide. As hydroquinone is a normal constituent in whole foods and is present in low concentrations, foods and beverages will not be a candidate for risk management underCEPA 1999.
Health Canada will propose to add hydroquinone-containing natural health products at any dose, except when in natural substances (e.g. plant materials), to Schedule F of the Food and Drug Regulations, so that they can be regulated as prescription drugs.
Issues pertaining to hydroquinone in cosmetics fall under the regulatory area of the Food and Drugs Act. Section 16 of the Act states that no person shall sell a cosmetic product that has in it any substance that may injure the health of the user when the cosmetic is used according to its customary method. To help cosmetic manufacturers satisfy this requirement, Health Canada has developed the Cosmetic Ingredient Hotlist--a list of substances which are restricted and prohibited in cosmetics. Hydroquinone is on the Hotlist as being prohibited for use in cosmetic products applied on the skin or mucous membranes. Health Canada will propose further restrictions on the use of hydroquinone in hair dyes and artificial nail systems through amendments to the Hotlist.
The proposed instrument will be published in the Canada Gazette, Part I, no later than July 2010, as per the timelines legislated in CEPA 1999.
Releases of hydroquinone will continue to be monitored under the National Pollutant Release Inventory.
It is expected that it will take approximately 12 months to place hydroquinone on Schedule F of the Food and Drug Regulations so that it can be regulated as a prescription drug.
The risk management scope for hydroquinone, which summarized the proposed risk management under consideration at that time, was published on January 19, 2008, and is available at www.ec.gc.ca/TOXICS/EN/detail.cfm?par_substanceID=236&
par_actn=s1. Industry and other interested stakeholders were invited to submit comments on the risk management scope during a 60-day comment period. Comments received on the risk management scope document were taken into consideration in the development of this proposed risk management approach document.
Consultation for the risk management approach will involve publication on July 5, 2008, and a 60-day public comment period.
The primary stakeholders include:
- the chemical manufacturing industry
- the Pest Management Regulatory Agency
Next steps / Proposed timeline
| Actions | Date |
|---|---|
| Risk Management Approach published on-line | July 5, 2008 |
| 60-day public comment period | July 5, 2008 to Sept. 3, 2008 |
| Response to comments on the Risk Management Approach | Winter 2008–2009 |
| Consultation on the draft instrument | Winter 2009–2009 |
| Publication of the proposed instrument | No later than July 2010 |
| Formal public comment period on the proposed instrument | No later than July–August 2010 |
| Publication of the final instrument | No later than January 2012 |
Industry and other interested stakeholders are invited to submit comments on the content of this proposed risk management approach or provide other information that would help to inform decision making. Please submit comments prior to September 3, 2008, since the Government of Canada will be moving forward with the risk management of hydroquinone after this date. Pursuant to section 313 of CEPA 1999, any person who provides information to the Minister underCEPA 1999 may submit with the information a request that it be treated as confidential. During the development of the risk management instrument(s) and/or tool(s), there will be opportunity for consultation on the proposed instrument(s). Comments and information submissions on the proposed risk management approach should be submitted to the address provided below:
Existing Substances Division
Place Vincent Massey, 20th Floor
351 Saint Joseph Boulevard
Gatineau QC K1A 0H3
Tel.: 1-888-228-0530 / 819-956-9313
Fax: 1-800-410-4314 / 819-953-4936
Email: Existing.Substances.Existantes@ec.gc.ca
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Footnotes
2 Section 4.4 of the Cabinet Directive on Streamlining Regulationstates that “Departments and agencies are to: identify the appropriate instrument or mix of instruments, including regulatory and non-regulatory measures, and justify their application before submitting a regulatory proposal”.
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