Microbeads in Toiletries Regulations
PROPOSED FEDERAL REGULATION - VIA PART I OF THE GAZETTE
November 5, 2016
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Issues The environmental burden from plastic litter continues to increase globally, raising environmental, economic and aesthetic issues with complex challenges. Plastic waste entering water and marine ecosystems can come from various sources, the majority of which originate from land-based activities. These var... (Click for more)
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Published on November 5, 2016
Microbeads in Toiletries Regulations
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Issues The environmental burden from plastic litter continues to increase globally, raising environmental, economic and aesthetic issues with complex challenges. Plastic waste entering water and marine ecosystems can come from various sources, the majority of which originate from land-based activities. These various sources can generate different types of plastics in the environment, from plastic bags and bottles to microplastics, (see footnote 1) which include plastic microbeads. Plastic microbeads used in exfoliating or cleansing toiletries, (see footnote 2) also commonly referred to as personal care products, are expected to get washed down the drain when used by consumers and to enter wastewater treatment plants. After wastewater treatment, a portion is expected to reach, and accumulate in, ecosystems across Canada. Plastic microbeads have been reported in coastal British Columbia, the Great Lakes, the St. Lawrence, and in coastal Atlantic Canada. The scientific literature (see footnote 3) indicates that microplastics are readily taken up by a variety of non-human organisms and have shown adverse short-term and long-term effects in aquatic organisms such as marine mammals, fish, invertebrates and fish-eating birds. Although voluntary actions have been taken by industry to phase out the use of plastic microbeads in toiletries, there is a risk of reintroduction or continued import of toiletries that contain plastic microbeads in Canada. Therefore, under the authority of the Canadian Environmental Protection Act, 1999 (CEPA), the Government of Canada (the Government) is proposing to make the Microbeads in Toiletries Regulations (the proposed Regulations), which would prohibit the manufacture, import, sale or offer for sale of toiletries that contain plastic microbeads. Background Recognizing the risks that plastic microbeads pose to the environment, on March 24, 2015, the House of Commons voted unanimously for the Government to take immediate measures to add plastic microbeads to Schedule 1 of CEPA. As a result of the resolution of the House, the Department of the Environment (the Department) completed a scientific review and analysis of over 130 scientific papers, as well as a consultation with experts on the impacts of plastic microbeads on the environment. The science review concluded that plastic microbeads should be considered toxic to the environment under paragraph 64(a) of CEPA, as they are 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. On June 23, 2015, the Canadian Council of Ministers of the Environment (CCME), consisting of federal, provincial and territorial environment ministers, acknowledged efforts by industry to eliminate the use of plastic microbeads in consumer products and supported the Government’s scientific review of plastic microbeads. It was recognized that provinces and territories may take additional complementary actions to restrict the use of plastic microbeads. On August 1, 2015, a Notice of Intent was published stating that the Department was initiating the development of proposed regulations under CEPA to prohibit the manufacture, import, sale or offer for sale of personal care products that are used to exfoliate or cleanse and that contain plastic microbeads. “Plastic microbeads that are ≤ 5 mm in size” were added to the List of Toxic Substances in Schedule 1 of CEPA, to enable the Government to propose regulations to manage the environmental risk associated with the use of toiletries that contain plastic microbeads. Substance description, uses and sources of release Plastic microbeads can vary in chemical composition, size, shape, density, and function, and are manufactured for specific purposes. Plastic microbeads can be used in a variety of applications, (see footnote 4) including toiletries. Plastic microbeads can either be chemically or physically stable (i.e. when used as abrasives, exfoliates or cleansers) or unstable (e.g. when designed to break down due to a physical or chemical trigger to release other chemicals). Stable microbeads are most likely to remain for a long time in the environment. The plastic microbeads that are the focus of these proposed Regulations are known to be equal to or less than 5 mm in size and are used in toiletries (including nonprescription drugs and natural health products) such as scrubs, bath products, facial cleansers, and toothpastes. Unlike other applications that use plastic microbeads, these plastic microbeads are eventually washed down the drain when consumers use toiletries that contain them. As plastic microbeads are too small to be entirely captured by wastewater treatment plants, a portion of these microbeads enters the aquatic environment in Canada. Plastic microbeads have been found, along with other microplastics, in surface waters, sediments, and in aquatic organisms. A 2015 study in Paris, France, found that of the total amount of microplastics entering wastewater treatment, a significant amount (about 10%) was expected to be released into the environment. (see footnote 5) In Canada, they have been reported in coastal British Columbia, the Great Lakes, the St. Lawrence, and in coastal Atlantic Canada. Plastics, including microplastics, have also been measured on the shores of Lake Huron, Lake Erie, and Lake St. Clair. (see footnote 6) According to the submissions of 46 Canadian companies that were received in response to a survey notice issued under section 71 of CEPA (see footnote 7) in 2014, 37 were importers, 7 were manufacturers and 2 were both importers and manufacturers of toiletries that contain plastic microbeads. These companies imported toiletries that contained less than 100 000 kg of plastic microbeads and exported toiletries that contained between 1 000 and 10 000 kg of plastic microbeads. In the same year, Canadian manufacturers produced toiletries that contained approximately 10 000 kg of plastic microbeads. Actions in other jurisdictions Plastic microbeads have been identified as a concern by numerous international organizations. (see footnote 8) International activities on the management of marine litter, which includes microplastics and plastic microbeads, are under way by several United Nations bodies and organizations, the Asia-Pacific Economic Cooperation, the United Nations Convention on Biological Diversity, and the G7, among others. The issue of marine litter, including microplastics (and plastic microbeads), has garnered increased attention and interest in international fora. Canada participates in varied capacities in a number of international efforts related to this issue. For example, in June 2015, G7 countries adopted the G7 Action Plan to Combat Marine Litter, which identified priority actions to effectively reduce marine litter by focusing on four key areas: land-based sources; sea-based sources; removal; and education, research and outreach. One action specifically targets microbeads: “encouraging industry to develop sustainable packaging and remove ingredients from products to gain environmental benefits, such as by a voluntary phase-out of microbeads.” The United Nations, through several of its competent bodies and organizations, is also addressing the sources and impacts of marine litter and microplastics, and is taking action to manage this global problem. The United Nations Environment Programme’s Global Programme of Action for the Protection of the Marine Environment from Land-based Activities and the Regional Seas Programme have been developing and implementing activities on the management of marine litter on a global and regional scale. Actions in the United States Nine states in the United States (Illinois, Colorado, Wisconsin, Indiana, Maine, Maryland, New Jersey, Connecticut and California) have passed laws that prohibit the selling and manufacturing of microbeads in personal care products. On December 28, 2015, the Microbead-Free Waters Act of 2015 (H.R. 1321) was signed into federal law as an amendment of the Federal Food, Drug, and Cosmetic Act. The law will place restrictions on the manufacture or introduction, or delivery for introduction, into interstate commerce, of rinse-off cosmetic products containing microbeads. (see footnote 9) The restrictions on rinse-off cosmetic products containing microbeads will come into effect on July 1, 2017, for manufacture, and on July 1, 2018, for introduction or delivery for introduction into interstate commerce. For non-prescription drugs, the timelines are July 1, 2018, for manufacture, and July 1, 2019, for introduction, or delivery for introduction, into interstate commerce. Actions in Europe On December 9, 2014, the European Union Commission Decision 2014/893/EU established that rinse-off products containing microbeads are no longer allowed to use the European Union Ecolabel. The European Union Ecolabel is recognized throughout Europe as a trusted identifier of products with a reduced environmental impact. In the subsequent weeks, Austria, Belgium, the Netherlands, Luxembourg, and Sweden jointly called upon the Environment Council (ENV) in Brussels to institute a full ban on the addition of microbeads to personal care products. According to a petition response issued on April 29, 2015, an arm of the European Union Commission is gathering the necessary information and evidence for developing options to achieve a reduction of microplastics in cosmetic products. In addition, the Swedish Chemicals Agency, Kemi, proposed a ban on rinse-off cosmetics containing microbeads. Kemi is working in tandem with the Swedish Environmental Protection Agency to identify significant sources of microbead emissions into the aquatic environment and to develop regulatory actions to reduce them. A report on its findings is expected in June 2017. Actions in Australia In 2015, New South Wales and South Australia agreed to lead work on a jurisdictional phase-out of microbeads. The current proposal gives Australian companies the option of voluntarily removing microbeads from their products by July 2018. The Australian Environment Minister announced that the federal government will take action to institute a formal ban if, by July 1, 2017, it is clear that the voluntary phase-out will not achieve its objectives. Objectives The objective of the proposed Regulations is to contribute to the protection of the environment by reducing the quantity of plastic microbeads entering Canadian ecosystems. Description The proposed Regulations would prohibit the manufacture, import, sale or offer for sale of toiletries (see footnote 2) that contain plastic microbeads, including non-prescription drugs and natural health products. The types of toiletries covered include products used for exfoliating or cleansing such as bath and body products, skin cleansers and toothpaste. The proposed Regulations would not apply to prescription drugs. For the purposes of the proposed Regulations, plastic microbeads include any plastic particle equal to or less than 5 mm in size, which can vary in chemical composition, size, shape and density. The prohibition of the manufacture and import of exfoliating or cleansing toiletries that contain plastic microbeads, excluding natural health products or non- prescription drugs, is targeted to come into effect on January 1, 2018, with the prohibition of the sale or offer for sale of these products by July 1, 2018. Prohibitions would come into effect for the manufacture and import of exfoliating or cleansing non-prescription drugs and natural health products, (see footnote 10) such as toothpaste that contains plastic microbeads, on July 1, 2018, with a prohibition on the sale or offer for sale of these products by July 1, 2019. Regulatees are not required to submit reports or conduct product testing under the proposed Regulations. The proposal contains a requirement that the presence of microbeads in products be determined using an accredited laboratory to ensure that laboratory testing is performed to acceptable quality standards. This also serves to inform the regulated community of the laboratory standards that will be used to determine the presence of plastic microbeads or to verify compliance with the regulatory provisions. The proposed Regulations would not apply to a toiletry that contains plastic microbeads and that is in transit through Canada, from a place outside Canada to another place outside Canada. The proposed Regulations would also make consequential amendments to the Regulations Designating Regulatory Provisions for Purposes of Enforcement (Canadian Environmental Protection Act, 1999) [the Designation Regulations]. The Designation Regulations designate the regulatory provisions from CEPA regulations that refer to an increased fine scheme following a conviction of an offense involving harm or risk of harm to the environment, or obstruction of authority. Benefits and costs Benefits to the environment and consumers In laboratory studies, plastic microbeads have been shown to have adverse short-term and long-term effects in aquatic organisms. (see footnote 11) Scientific literature indicates that plastic microbeads are readily taken up by a variety of organisms, such as fish, mussels, and several types of zooplankton. Some studies have shown that microplastics, which include plastic microbeads, can impede feeding behaviour in aquatic species, leading to reduced body growth and reproduction. Additionally, similarly to organic matter, plastic microbeads can adsorb persistent organic pollutants (POPs) such as polychlorinated biphenyls (PCBs) and dichlorodiphenyltrichloroethane (DDT) from the marine environment and are harmful to organisms that eat them. Plastic microbeads have been measured along with other microplastics in surface water, in sediments, and in aquatic organisms in Canada. Recently, plastic debris (primarily microplastics) has been measured on the beaches of Humber Bay. (see footnote 12) As evidence suggests that wastewater treatment plants are not able to remove all plastic microbeads, they are expected to keep accumulating in the aquatic ecosystem in Canada. Plastic microbeads may reside in the environment for a long time, and continuous release of the substance to the environment from toiletries sent down the drain may result in long term adverse effects on biological diversity and ecosystems. Although most of the benefits associated with eliminating plastic microbeads from toiletries are due to the voluntary phase out of the substance by industry, the proposed Regulations would ensure that plastic microbeads are no longer used and are not reintroduced into toiletries available in Canada. Finally, the alignment of the coming into force date for prohibition on the sale of toiletries that contain plastic microbeads in Canada with the U.S. coming into force date for introduction or delivery for introduction into interstate commerce, of rinse-off cosmetic products containing microbeads, would minimize concerns that Canada could become a dumping ground for toiletries that contain plastic microbeads manufactured in the United States. Costs to businesses Plastics sector The plastics sector comprises mainly small and medium-sized enterprises, 95% of which are Canadian-owned. Plastics are used by virtually every end-use segment of the economy. The unique attributes of plastics (including processability, light weight and corrosion resistance) have led to the creation of new products, and plastics have also displaced paper, glass and metal from traditional applications. Although there is a wide range of plastic products, three major product lines dominate: about 39% of shipments are packaging, 33% are construction products, and 14% are automotive components (the remaining 14% is for other products). In addition to being produced by companies within the defined plastic products industry, plastics production is a secondary activity of firms in other industry groups (for example plastic toys and furniture) and for internal consumption (such as plastic bottles made in-house by a shampoo manufacturer). Plastic producers also produce plastic microbeads for specific purposes, by varying their chemical composition, size, shape, and density. Plastic microbeads are not only used in toiletries but also in industrial settings (e.g. plastic blasting at shipyards, textile printing and automotive molding), for anti-slip and anti-blocking applications, as well as in medical applications. Based on the information received through a survey conducted under section 71 of CEPA, it is estimated that in 2014, about 10 000 kg of plastic microbeads were used to manufacture toiletries in Canada. Assuming this volume of plastic microbeads was all purchased from the plastic industry in Canada and a range of prices, for plastic microbeads, up to $30 per kilogram, (see footnote 13) microbeads sales would be less than or equal to $300,000 a year, in an industry that generated approximately $20 billion worth of shipments (see footnote 14) in 2012, according to Statistics Canada. Moreover, given that some of this quantity was likely imported, and given industry commitments to voluntarily phase out plastic microbeads from toiletries, the Canadian plastic sector is not expected to be significantly affected by the proposed Regulations. Personal care product sector The Canadian Cosmetic Toiletry and Fragrance Association Web site (see footnote 15) notes that Canadians purchase over $5.4 billion of personal care products each year, including products such as deodorant, shampoo, skin care products, make-up, fragrances, sunscreens and cavity-fighting toothpastes. It also notes that each year, the Canadian personal care product industry creates an average of over 7 000 new products. The proposed Regulations are not expected to significantly impact the personal care product sector in Canada, as information provided to the Government in March 2016 suggested that toiletries that do not contain plastic microbeads were already becoming available to consumers in Canada. A number of Canadian manufacturers of toiletries have indicated that they already sell toiletries that do not contain plastic microbeads, (see footnote 16) and a majority of Canadian manufacturers of toiletries that contain plastic microbeads communicated their plan to voluntarily phase out the use of plastic microbeads in toiletries by the time the prohibitions come into effect. These manufacturers are responsible for 99% of the total amount of plastic microbeads used in 2014 to manufacture toiletries. Several importers indicate that they already have access to toiletries that do not contain plastic microbeads at similar costs to toiletries that contain plastic microbeads. In addition, given actions taken in other jurisdictions (in particular the United States), the Department anticipates increasing availability of imported toiletries that do not contain plastic microbeads in Canada. Given the availability and the anticipated increasing availability of toiletries that do not contain plastic microbeads — via domestic manufacture and import — the proposed Regulations are not expected to have any impact on consumer choice (see footnote 17) or the cost of toiletries. Given normal inventory turnover cycles and expected timing of the proposed regulatory requirements, no cost to retail businesses is expected related to residual products that could no longer be sold, as a sell through period is allowed. The Department anticipates that this should be sufficient to allow for the sale of products and the elimination of inventory. Costs to Government The costs associated with enforcement activities are estimated to be less than $400,000 for the first five years after the proposed Regulations are enacted. These costs are associated with verification of compliance with the proposed Regulations, which would include site visits, sample analysis and review of written transit documents. There would be no reporting or testing notification requirements prescribed in the proposed Regulations. Costs associated with compliance promotion activities are estimated to be minimal and are associated with posting of information on the Department’s Web site, including frequently asked questions, responding to information or clarification requests, and through mail outs to stakeholders. “One-for-One” Rule The “One-for-One” Rule does not apply, as the proposed Regulations would not impose any administrative burden on businesses. Small business lens The small business lens does not apply, as identified small businesses (manufacturers and importers) are expected to have voluntarily phased out plastic microbeads from toiletries by the time the proposed Regulations are enacted and as no reporting or testing would be required to be conducted by regulatees under the proposed Regulations. Consultation On February 9, 2016, the Department published a consultation document for a 30-day public comment period, outlining key elements of the proposed Regulations. The CEPA National Advisory Committee (CEPA NAC) (see footnote 18) and relevant federal government departments were also consulted on the proposed Regulations. One CEPA NAC member urged the Department to align the microbeads size range requirements with those of the U.S. law and highlighted that other sources of microplastics in the environment would need to be addressed over the longer term. In addition, a formal public consultation session was held in Gatineau, on February 22, 2016. The purpose of the meeting was to clarify and obtain feedback on the key elements of the proposed Regulations. The stakeholder meeting was attended by approximately 40 representatives from industry, industry associations, environmental non-governmental organizations (ENGOs), other government departments and concerned citizens. More than 1 200 comments were received from stakeholders throughout the public consultation process: 8 from industry associations, 7 from ENGOs, 7 from other governments, 1 from a Canadian business, 1 from a federal political party, and more than 1 100 emails and 2 official petitions (containing more than 800 signatures) from citizens. A summary of comments and responses to these comments is presented below: Support for microbeads prohibition The majority of stakeholders (toiletries sector, plastic sector, provincial governments, ENGOs, indigenous groups and consumers) were supportive of the proposed Regulations. However, one Canadian citizen expressed concern that the focus should be on major contributors of plastic pollution such as rubber tires, ship paint, fleece clothing, and plastic packaging, and not on plastic microbeads in toiletries. Scope of the proposed Regulations Stakeholders requested that the proposed Regulations take into account all products containing plastic microbeads that could enter the wastewater system in Canada. Several ENGOs indicated that consumer and industrial products such as cleaning supplies, wet wipes, and anti-slip coatings are all potential sources of plastic microbeads that may reach the environment in all parts of Canada. As well, one provincial government advised the consideration of other toiletries that contain plastic microbeads, such as sunscreens and moisturizers that are not intended to be rinse-off products but may contain plastic microbeads that can have negative impacts on the environment, in addition to those that are used to exfoliate or cleanse. Response: Information on other sources that contribute to plastic microbeads in the environment is still emerging. There is sufficient evidence that plastic microbeads in toiletries that rinse off and wash down household drains are contributing to plastic pollution in our rivers and lakes. Accordingly Canada, like other jurisdictions (e.g. the United States), is proposing to take action to prohibit plastic microbeads in toiletries. The Government continues to work with international partners (through the United Nations and the Organisation for Economic Co-operation and Development) and domestic partners to address the broader issue of microplastics pollution, including other sources of plastic microbeads. Importer concerns An industry stakeholder noted that manufacturers are not currently required to declare the presence of plastic microbeads in their products; consequently, it is difficult to determine whether an imported product contains plastic microbeads prior to placing the order. For that reason, they recommend that importers of toiletries that contain plastic microbeads be exempt from the proposed Regulations. Response: The onus would be on the importer to ensure that the products they import into Canada meet all legal requirements and do not contain plastic microbeads. However, in Canada, cosmetic products are required to have mandatory ingredient labelling as per the Cosmetic Regulations, which may help importers identify if plastic ingredients, such as polyethylene, are used in these exfoliating or cleansing products. Given the feasibility of identifying the presence of plastic microbeads, the environmental risk associated with an exemption for imported toiletries, and the disadvantage this could create for domestic manufacturers, the proposed prohibition would apply to imported toiletries that contain plastic microbeads. Alternative risk management measures Several stakeholders requested that the Department consider alternative risk management measures in lieu of implementing formal regulations. Specifically, they suggested the addition of plastic microbeads to Health Canada’s Cosmetic Ingredient Hotlist (referred to as the Hotlist hereafter) as a viable risk management option. They indicated that the use of the Hotlist would increase efficiency by eliminating the need for extensive regulatory development and the accompanying approval process. In addition, they believed that the Hotlist would achieve greater industrial outreach since it is a well-established tool that is already familiar to stakeholders. Response: The Hotlist is an administrative tool that Health Canada uses to communicate to manufacturers and others that certain substances, when present in a cosmetic, may contravene (a) the general prohibition found in section 16 of the Food and Drugs Act; or (b) a provision of the Cosmetic Regulations. Section 16 of the Food and Drugs Act states that “no person shall sell any cosmetic that has in or on it any substance that may cause injury to the health of the user when the cosmetic is used.” Since plastic microbeads were not added to Schedule 1 of CEPA on the basis of toxicity to human health, they cannot be managed under the Hotlist. Exemptions One stakeholder recommended that the exemption pertaining to “prescription drugs” be removed from the proposed Regulations given that there exists an implicit understanding that prescription drugs are not toiletries. If this recommendation is not heeded, the stakeholder suggests that the current exemption requires clarification, as there is no formal regulatory definition of “prescription drugs.” Response: While the Government agrees that the exclusion of prescription drugs is implicit, the exemption has been maintained to provide clarity to regulatees on the scope of the proposed Regulations. “Prescription drug” is defined within section A.01.010 of the Food and Drug Regulations. Biodegradable alternatives Numerous ENGOs and governmental organizations, as well as more than 600 Canadian citizens expressed support of the prohibition of bioplastic microbeads. One ENGO indicated that there is no generally accepted standard for what constitutes a “biodegradable” plastic. Furthermore, it expressed concern that there is no reliable evidence pertaining to the performance of “biodegradable” plastics exposed to natural conditions consistent with the Canadian environment. Two stakeholders indicated that alternative natural or organic exfoliants (such as apricot kernels) should not be assumed to be implicitly safe, merely on the basis of their natural origins. Three stakeholders raised concerns that the total exclusion of bioplastic microbeads precludes the development of innovative biodegradable polymers. They maintain that the proposed Regulations would impede the development of emerging biotechnologies and unduly restrict markets for biomaterials with satisfactory environmental profiles. The stakeholders recommended that the proposed Regulations contain exemptions for biodegradable polymers and biopolymers that successfully exhibit biodegradation under acceptable test methods. One stakeholder recommended that Vinçotte International’s biodegradability certifications and the ASTM D7081-05 specification (see footnote 19) be considered acceptable means of defining a plastic’s capacity to biodegrade. Response: The Department does not intend to exempt biopolymers, such as polylactic acid (PLA) plastic, poly-hydroxy-alkanoate (PHA) or poly-hydroxy-butyrate (PHB), in the proposed regulatory approach. Several studies have been undertaken on biodegradable plastics which support this approach, including a study conducted by the California Department of Resources, Recycling and Recovery (see footnote 20) that showed that while certain alternatives may biodegrade to some extent over a period of a year, a significant percentage (20–50%) of these plastics will remain in the aquatic environment. In addition, a recently published United Nations Environment Programme (UNEP) report titled Biodegradable Plastics & Marine Litter concluded that “biodegradable plastics will not play a significant role in reducing marine litter.” The Department recognizes that there are various existing standards for biodegradable plastics. In response to the recommendation of using the ASTM D7081-05 specification to assess biodegradability, the Department notes that this standard was withdrawn in April 2014 and has not been replaced yet. In addition, the testing methods prescribed under the ASTM D7081-05 specification are not relevant to the Canadian environment. The testing is carried out at 30±2 °C under controlled laboratory conditions for 180 days. This temperature does not represent the surface water temperature in Canadian water bodies. A report published by the California Department of Resources Recycling and Recovery states that “ASTM does not have a test method for the cooler temperature test” and “cooler temperatures exist in the marine environment but would require longer testing periods.” Consequently, the insufficient evidence pertaining to the aerobic biodegradability of biopolymers in cool aquatic environments precludes an exemption from being established at this time. This is consistent with the U.S. legislative approach, which also does not exempt bioplastics. Testing and record keeping Two stakeholders recommended removing the “testing” section from the proposed Regulations to reduce complexity. They indicated that the proposed Regulations do not mandate any testing requirements and thus this section should not be included as a key element. Furthermore, the two stakeholders maintain that there should be no need for stakeholders to provide explicit documentation pertaining to how they satisfy the “in transit” exemption. Provided that their recommendation is not heeded, the stakeholders suggest that the bill of lading (see footnote 21) that typically accompanies all shipments should constitute sufficient documentation. Response: Regulatees are not required to submit reports or conduct product testing under the proposed Regulations. The requirement to use an accredited laboratory is outlined in the proposed Regulations to inform the regulated community of the laboratory standards that must be used to determine the presence of plastic microbeads or to verify compliance with the regulatory provisions by both regulatees and the Department, respectively. In order to determine compliance with the proposed Regulations, any official documents that accompany all shipments and that clearly indicate the consignee and the shipper name and address, the provenance or origin, the destination of the products, and the date of the direct shipment of the products may assist in assessing whether the in-transit exemption applies to a given situation. Coming into force Several stakeholders, including more than 700 Canadian citizens, submitted concerns through emails and petitions related to the coming into force timelines outlined in the proposal. The consultation document proposed that the prohibition of manufacture and import of cosmetics be targeted for December 31, 2017, and the prohibition of sale or offer for sale for December 31, 2018. Similar prohibitions were proposed to come into effect for the manufacture and import of non-prescription drugs and natural health products, such as toothpaste, on December 31, 2018, with a ban on sale of these products by December 31, 2019. To minimize microbead releases in Canada, a majority of stakeholders recommended that the coming into force timelines be expedited to align with those in the U.S. federal law. They expressed concerns that the current inconsistency between the Canadian and U.S. timelines could result in the Canadian market absorbing U.S. manufactured products that are no longer saleable in the United States. One stakeholder recommended that the Department adopt similar time frames for the implementation of prohibitions as did the U.S. Microbead-Free Waters Act of 2015, as opposed to simply adopting similar prohibition dates. This approach would push the timeline back by an additional year. One industry association supported the coming into force dates as written in the consultation document. Response: Normal regulatory development timelines are being streamlined to ensure action is taken as quickly as possible. Publication of the final Regulations would be expedited, and they are intended to be developed for publication in the Canada Gazette, Part II, by the spring of 2017. The regulatory provision for the manufacture and import of cosmetics would come into force six months later than in the U.S. legislation, to provide industry stakeholders time to source or reformulate toiletries to comply with the Regulations. The three remaining regulatory provisions targeting the sale or offer for sale of cosmetics, the manufacture and import of non-prescription drugs and natural health products and the sale or offer for sale of these products would align with the U.S. federal law. Disposal of toiletries that contain plastic microbeads One stakeholder requested that the Department provide more information pertaining to activities to manage existing plastic microbeads. The stakeholder recommended that the proposed Regulations require companies to develop sustainable disposal procedures and establish effective take back programs to encourage consumers to return products. Response: While individuals can continue to use products for as long as they would like, if they wish to dispose of these products, the Department recommends that toiletries that contain plastic microbeads be disposed of in the garbage. This would ensure that the toiletries that contain plastic microbeads are contained and managed in an environmentally sound manner, for example, in a landfill. If the toiletries that contain plastic microbeads are packaged in a recyclable container, the contents may be emptied in the garbage and recycled according to the provincial/territorial or municipal waste management standards. Disposing of toiletries that contain plastic microbeads down the drain is not recommended as plastic microbeads are not fully removed from wastewater during treatment and will enter the environment through wastewater systems. Consumer awareness Several stakeholders suggested that the Department provide consumers with information on how to determine whether a product contains plastic microbeads, and strategies to prevent the purchase and import of toiletries that contain plastic microbeads. Many stakeholders requested that the proposed Regulations require that toiletries that contain plastic microbeads be clearly labelled. Response: Consumers who want to avoid purchasing and using toiletries that contain plastic microbeads are advised to read the label on the product for the common microbeads ingredients. Plastic microbeads used in toiletries that exfoliate or cleanse are mainly made of polyethylene (PE), but can be also be made of polypropylene (PP), polyethylene terephthalate (PET), polymethyl methacrylate (PMMA) and nylon. Consumers are encouraged to share their views and concerns with the companies that produce these products. Some consumer organizations, such as Beat the Microbead, have created apps to help consumers identify toiletries that do not contain plastic microbeads. Information to support regulatory impact assessment A wide range of estimated reformulation costs were provided by stakeholders, ranging from $5,000 up to as high as $1 million (if clinical testing were required); however, the majority agreed with the proposed estimate of roughly $27,000. With respect to raw material costs, stakeholders indicated that the raw material costs for alternatives to microbeads could be less than the cost of plastic microbeads and up to 10 times the cost of plastic microbeads. Stakeholders also provided information suggesting that most Canadian manufacturers and importers would be in compliance by the time the Regulations are enacted. Response: The information received was considered when assessing the potential impact of the proposed Regulations on industry. However, industry also communicated to the Department, in March 2016, that the majority of Canadian manufacturers are expected to have voluntarily phased out plastic microbeads by the time the proposed prohibitions come into effect. In addition, importers are expected to have access to toiletries that do not contain plastic microbeads, at costs similar to toiletries that contain plastic microbeads. The Department concludes that significant reformulation costs would not result from the Regulations. Further study Several stakeholders recommended that the Government monitor the health implications of human ingestion of fish and shellfish contaminated by microplastic pollution. One stakeholder indicated that the instream accumulation of microbeads and contaminant adsorption is not well studied and another stakeholder suggested that more research is required pertaining to microbead accumulation in low flow regimes associated with the dry weather predicted by current climate change models. One stakeholder indicated that the environmental impacts of microbeads in land disposal require further research. Response: No concerns related to human health were identified in the Science Summary and there is limited to no information on fish and seafood consumption being a source of exposure. Health Canada will consider any available new information on sources of exposure with implications to human health. The Department takes its role in achieving a clean, safe and sustainable environment seriously and it will continue to work with international partners (through the United Nations and the Organisation for Economic Co-operation and Development) and domestic partners to address the broader issue of microplastics, including other sources of microbeads. Rationale The environmental impact from plastic litter continues to increase globally. Plastic waste entering water and marine ecosystems can come from various sources, from plastic bags and bottles to microplastics, which include plastic microbeads. The plastic microbeads that are the focus of the proposed Regulations are used in toiletries. Unlike plastic microbeads used in other applications, those in toiletries are washed down the drain when consumers use toiletries that contain them. As plastic microbeads are too small to be entirely captured by wastewater treatment plants, there is a portion that enters and is expected to accumulate in the aquatic environment in Canada. In Canada, plastic microbeads have been reported in coastal British Columbia, the Great Lakes, the St. Lawrence, and in coastal Atlantic Canada. Scientific literature indicates that plastic microbeads are readily taken up by a variety of non-human organisms and have adverse short-term and long-term effects on aquatic organisms as plastic microbeads can impede feeding behaviour, leading to reduced body growth and reproduction. Given industry’s anticipated voluntary phase out of plastic microbeads from toiletries, Canadian manufacturers, importers and consumers are not expected to be significantly impacted by the proposed Regulations; however, the proposed Regulations would mitigate the risk of re-introduction or continued import of plastic microbeads in toiletries in the future. Therefore, the Government is proposing regulations that would prohibit the manufacture, import, sale or offer for sale of toiletries that contain plastic microbeads in Canada. Consequential amendments to the Designation Regulations would allow for the effective enforcement of the proposed Regulations, and promote compliance. Strategic environmental assessment The proposed Regulations have been developed under the Government’s Chemical Management Plan (CMP). The strategic environmental assessment (SEA) for the CMP (see footnote 22) concluded that such regulatory provisions will contribute to its goals of protecting and enhancing the quality of the water so that it is clean, safe and secure for all Canadians and supports healthy ecosystems, and also support the Federal Sustainable Development Strategy goals for protecting and enhancing the quality of the water. (see footnote 23) Implementation and enforcement Implementation An intensive compliance promotion approach would be adopted by the Department within the first year after the publication of the proposed Regulations, to ensure their effective and efficient implementation. The Department would develop and distribute compliance promotion materials (e.g. a fact sheet or Web site material) to ensure that the regulated community is aware of the requirements of the proposed Regulations. Working relationships have been established with industry and industry associations involved in the manufacture and import of products covered by the proposed Regulations. The Department would work with these organizations to ensure that the appropriate information is available to interested parties. As the regulated community becomes more familiar with the requirements of the proposed Regulations, these activities are expected to decline to a maintenance level. Enforcement The proposed Regulations are made under CEPA, so enforcement officers would, when verifying compliance with the proposed Regulations, act in accordance with the Compliance and Enforcement Policy for CEPA (1999) [hereinafter, the Policy]. Verification of compliance with the proposed Regulations would include, among other inspection activities, sample analysis, site visits and review of written transit documents. When, following an inspection or an investigation, an enforcement officer discovers an alleged violation, the officer would choose the appropriate enforcement action based on the following factors, as outlined in the Policy. Nature of the alleged violation: This includes consideration of the damage, the intent of the alleged violator, whether it is a repeat violation, and whether an attempt has been made to conceal information or otherwise subvert the objectives and requirements of CEPA; Effectiveness in achieving the desired result with the alleged violator: The desired result is compliance within the shortest possible time and with no further repetition of the violation. Factors to be considered include the violator’s history of compliance with CEPA, willingness to cooperate with enforcement officers, and evidence of corrective action already taken; and Consistency: Enforcement officers would consider how similar situations have been handled in determining the measures to be taken to enforce CEPA. Subject to the enforcement officer’s discretion, the following responses are available to deal with alleged violations of CEPA and its regulations: Warnings; Directions; Tickets; Ministerial orders; Environmental protection compliance orders; Detention orders for ships; Injunctions; Prosecutions; Environmental protection alternative measures; and Court orders following convictions and civil suits by the Crown to recover costs. More information on the Policy is available at the following address: https://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=5082BFBE-1. Contacts Brenda Tang Manager Economic Analysis Economic Analysis and Valuation Division Department of the Environment Telephone: 873-469-1495 Email: [email protected] Mary Ellen Perkin Manager Consumer and Cleaning Products Section Products Division Department of the Environment Telephone: 819-938-4483 Email: [email protected] PROPOSED REGULATORY TEXT Notice is given, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), that the Governor in Council, pursuant to subsection 93(1) of that Act, proposes to make the annexed Microbeads in Toiletries Regulations. Any person may, within 75 days after the date of publication of this notice, file with the Minister of the Environment comments with respect to the proposed Regulations or, within 60 days after the date of publication of this notice, file with that Minister a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent to the Director, Products Division, Environmental Protection Branch, Environment and Climate Change Canada, 351 Saint-Joseph Blvd., Gatineau, Quebec K1A 0H3 (fax: 819-938-4480; email: [email protected]). A person who provides information to the Minister may submit with the information a request for confidentiality under section 313 of that Act. Ottawa, October 27, 2016 Jurica Čapkun Assistant Clerk of the Privy Council Microbeads in Toiletries Regulations Interpretation Definitions 1 The following definitions apply in these Regulations. microbeads means the plastic microbeads set out in item 133 of the List of Toxic Substances in Schedule 1 to the Canadian Environmental Protection Act, 1999. (microbilles) toiletries means any personal hair, skin, teeth or mouth care products for cleansing or hygiene, including exfoliants and any of those products that is also a natural health product as defined in the Natural Health Products Regulations or a non-prescription drug. (produit de toilette) Application Non-application 2 These Regulations do not apply to prescription drugs within the meaning of section A.01.010 of the Food and Drug Regulations. Prohibition Manufacture and importation 3 (1) A person must not manufacture or import any toiletries that contain microbeads on or after January 1, 2018, unless the toiletries are also natural health products or non-prescription drugs, in which case the prohibition applies on or after July 1, 2018. Sale or offer for sale (2) A person must not sell or offer for sale any toiletries that contain microbeads on or after July 1, 2018, unless the toiletries are also natural health products or non-prescription drugs, in which case the prohibition applies on or after July 1, 2019. Exemption — toiletries in transit 4 No person contravenes subsection 3(1) if the toiletries are in transit through Canada, from a place outside Canada to another place outside Canada. Presence of Microbeads Accredited laboratory 5 (1) For the purposes of these Regulations, the presence of microbeads must be determined by a laboratory that holds a certificate of accreditation to the International Organization for Standardization standard ISO/IEC 17025, entitled General requirements for the competence of testing and calibration laboratories. Certificate (2) The certificate referred to in subsection (1) must (a) be issued by an accrediting body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement; (b) cover the presence of microbeads; and (c) be valid at the time of the determination. Laboratory accredited in Quebec (3) The presence of microbeads may also be determined by a laboratory that holds a certificate of accreditation issued under the Environment Quality Act, CQLR c. Q-2 that covers the presence of microbeads and that is valid at the time of the determination. Consequential Amendment Designated Regulatory Provisions 6 The schedule to the Regulations Designating Regulatory Provisions for Purposes of Enforcement (Canadian Environmental Protection Act, 1999) (see footnote 24) is amended by adding the following in numerical order: This table shows the ammendment to the schedule to the Regulations Designating Regulatory Provisions for Purposes of Enforcement (Canadian Environmental Protection Act, 1999). Item Column 1 Regulations Column 2 Provisions 26 Microbeads in Toiletries Regulations (a) subsections 3(1) and (2) Coming into Force January 1, 2018 7 These Regulations come into force on January 1, 2018. [45-1-o] Footnote 1 Smaller particles of plastic are broadly referred to as microplastics. Footnote 2 For the purposes of these Regulations, toiletries mean any personal hair, skin, teeth or mouth care products for cleansing or hygiene, including exfoliants and any of those products that is also a natural health product as defined in the Natural Health Products Regulations or a non-prescription drug. Footnote 3 For more information on the scientific literature, please see the Science Summary report on microbeads at http://www.ec.gc.ca/ese-ees/ADDA4C5F-F397-48D5-AD17-63F989EBD0E5/Microbeads_Science%20Summary_EN.pdf. Footnote 4 Plastic microbeads are also used in industrial settings for plastic blasting at shipyards, garments and car parts, oil and gas exploration, textile printing, and automotive molding. Other plastic products that use microbeads include anti-slip and anti-blocking applications and medical applications (biotechnology and biomedical research). Footnote 5 For more information on this study, please see the Science Summary report on microbeads at http://www.ec.gc.ca/ese-ees/ADDA4C5F-F397-48D5-AD17-63F989EBD0E5/Microbeads_Science%20Summary_EN.pdf, page 11. Footnote 6 For more information on the presence of microplastics in Canada, please see the Science Summary report, page 15. Footnote 7 For more information on section 71 of CEPA, please see http://www.ec.gc.ca/lcpe-cepa/26A03BFA-C67E-4322-AFCA-2C40015E741C/lcpe-cepa_201310125_loi-bill.pdf, page 41. Footnote 8 “Microplastics in the ocean: a global assessment,” GESAMP, 2015. Footnote 9 Under the Act of Congress (H.R. 1321), the term “plastic microbeads” means any solid plastic particle that is less than five millimeters in size and is intended to be used to exfoliate or cleanse the human body or any part thereof. Footnote 10 Natural Health products are non-prescription drugs that are defined in the Natural Health Products Regulations. Footnote 11 For more information, please visit: http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/microb-eng.php. Footnote 12 “Microplastic pollution in St. Lawrence River sediments”; Can. J. Fish. Aquat. Sci. Footnote 13 These values are based on information received in March 2016, from industry, in response to a follow-up questionnaire to a survey conducted in 2015 under section 71 of CEPA. Footnote 14 Shipments are the value of goods shipped at the factory gate. Footnote 15 http://www.cctfa.ca/site/consumerinfo/Consumer_Information.htm as accessed on June 1, 2016. Footnote 16 The main category of alternatives that can be used to replace plastic microbeads in toiletries comprises natural exfoliates such as apricot seeds, walnut shells, bamboo, sugar, salt, almonds and oatmeal. Footnote 17 Consumer choice refers to the decisions that consumers make with regard to products and services. Footnote 18 CEPA NAC provides a platform for ensuring a full and open sharing of information between the federal, provincial, territorial, and aboriginal governments on all matters related to the protection of the environment and the management of toxic substances. It is the main intergovernmental forum for the purpose of enabling national action and avoiding duplication in regulatory activity among governments within Canada. Footnote 19 ASTM D7081-05: Standard Specification for Non-Floating Biodegradable Plastics in the Marine Environment — “This specification is intended to establish the requirements for labelling materials and products, including packaging, as ‘biodegradable in marine waters and sediments’.” Footnote 20 For more information, please see www.calrecycle.ca.gov/publications/Documents/1435%5C20121435.pdf. Footnote 21 It is a document issued by a carrier that details a shipment of merchandise and gives title of the shipment to a specified party. Bills of lading are used in international trade to help guarantee that exporters receive payment and importers receive merchandise. Footnote 22 Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals. Canadian Environmental Assessment Agency: http://www.ceaa.gc.ca/default.asp?lang=En&n=B3186435-1. Footnote 23 The public statement regarding the strategic environmental assessment for the Chemical Management Plan is available at the following address: http://www.chemicalsubstanceschimiques.gc.ca/plan/sea-ees-eng.php. Footnote a S.C. 2004, c. 15, s. 31 Footnote b S.C. 1999, c. 33 Footnote 24 SOR/2012-134
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