Table 1:

Summary and comparison of chemical risk management regulations and activities in Europe, Canada, the US and Australia with focus on phthalates.

Jurisdiction	Regulatory Authority	Agency	Actions	Status
EU	Regulation (EC) No 1907/2007 Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)	ECHA	Risk Assessment Reports conducted for DBP, DINP, and DIDP in 2003, for BBP in 2007, and for DEHP in 2008. New information to DINP and DIDP was summarized in a 2013 report. ECHA and Denmark submitted an Annex XV Restriction Report on DEP, DBP, BBP, and DIBP in 2016, proposing a ban of these phthalates in all products. RAC and SEAC published opinions on the Restriction Report in 2017. These recommendations were in favor of the proposed actions. These opinions were followed by an update of Annex XVII Entry 51 in Dec. 2018. Sunset date refers to the date after which a company needs authorization in order to put the product on the market.	On Candidate List (year of inclusion): – DEHP, DBP, BBP (2008) – DIBP (2010) – DMEP, DIHpP, DHNUP (2011) – DIPP (2012) – DPP, DHEXP (2013) – DHP (2014) – 610P (2015) – DCHP (2018) On Authorization List/Annex XIV (Sunset date): – DEHP, DBP, BBP, DIBP (Feb. 21, 2015), authorization applications were only received for certain uses of DEHP and DBP. – DIPP, DMEP, DPP, DIHpP, DHNUP (July 4, 2020) Restricted (Annex XVII): – Entry 51: DEHP, DBP, BBP in toys and child care articles; starting July 2020 in all articles and also including DIBP – Entry 52: DINP, DIDP, DNOP in toys and child care articles that can be placed in the mouth
EU	Regulation (EC) No 1272/2008 Classification, packaging and labelling of chemicals and their mixtures (CLP)	ECHA	According to Part 3 of Annex VI to CLP, a substance may be classified as carcinogenic, mutagenic or toxic for reproduction based on the following categorization: – Category 1A: Classification is based on human evidence – Category 1B: Classification is based on animal evidence (presumed human toxicant) – Category 2: Suspected human toxicant but evidence is not convincing to place in Category 1A or 1B	Fulfilling CLP criteria for Cat. 1B (reproductive toxicity): – DEHP, DBP, BBP, DIBP, DPP, DHEXP, DCHP, DIPP, DMEP Fulfilling CLP criteria for Cat. 2 (reproductive toxicity): – DNOP
EU	(EC) No 1223/2009 Cosmetic Products Regulation; Decision 2006/257/EC Inventory and nomenclature for ingredients in cosmetic products	ECHA	The Cosmetic Ingredient Database (CosIng) contains information on cosmetic substances and ingredients. A 2007 opinion by the EU Scientific Committee on Consumer products found DEP in cosmetics to be safe at current levels of use.	Prohibited in cosmetic products (Annex II of (EC) No 1223/2009): – DEHP (Ref 677) – DBP (675) – BBP ( 1152) – DMEP (678) – DPP, DIPP (1151)
EU	(EC) No 1935/2004 Food Contact Materials (FCM); (EU) No 10/2011 on plastic materials and articles intended to come into contact with food	EFSA	Opinion published in 2005 regarding use of DEHP, DBP, BBP, DINP and DIDP in food contact materials. Draft scientific opinion updating the 2005 document published and endorsed for public consultation Feb 6, 2019	Authorized for use as FCM (Annex I of (EU) No 10/2011): – As additives or polymer production aids: DEHP, DBP, BBP, DINP, and DIDP – As plasticizer in repeated-use FCMs for non-fatty foods: DEHP and DBP – As plasticizers in repeated-use FCMs: BBP, DIDP, and DINP – As plasticizers in single-use FCMs for non-fatty foods (with exceptions): BBP, DIDP, and DINP – DAP permitted as starting substance
EU	Other Authorities	ECHA, EC, and national agencies	– Directive 2009/48/EC, Toy Safety Directive: Phthalates (and other chemicals) classified as carcinogenic, mutagenic, or toxic for reproduction under CLP are prohibited in toys (with exemptions) – Directive 2011/65/EU, the Restriction of Hazardous Substances (RoHS) Directive, last amended by Directive (EU) 2017/2102, and Directive (EU) 2015/863 amending Annex II to Directive 2011/65/EU: restricting DEHP, DBP, BBP, and DIBP in electrical and electronic equipment (0.1 wt% maximum concentration). – Directive (EU) 2018/851, amending Directive 2008/98/EC on waste: Establishment of a new database by ECHA for waste treatment operators and consumers. The database will also contain information on products containing SVHCs on the Candidate List (thus, include phthalates on the Candidate List). – Additional national regulations regarding phthalates in place in Denmark and the Czech Republic
Canada	Bill C-307 (Phthalate Control Act) in relation to the Medical Devices Regulations (SOR/98–282) enabled by the Food and Drugs Act (R.S.C., 1985, c. F-27)	-	In 2007, Bill C-307 passed in the House of Commons after its third reading. The bill requires – regulations being made regarding DEHP in cosmetics under the Food and Drugs Act (see below), – the addition of certain products to Part I, Schedule I of the Hazardous Products Acta (Phthalates Regulations, see below), – the regulation of use and labeling of medical devices containing DEHP, and – the reassessment of BBP and DBP under CEPA 1999 (see below).	As published in 2008, manufacturers have to report if medical device contains more than 0.1 wt% DEHP.
Canada	Canadian Environmental Protection Act (CEPA), 1999 (S.C. 1999, c. 33)	ECCC, HC	DEHP, DBP, and DNOP were assessed in 1993–1994 by ECCC and HC under the Priority Substances Assessment Program. It was found that DEHP was harmful to human health. Several phthalates were subject to the categorization of the DSL based on persistence, bioaccumulation potential, and inherent toxicity to the environment. Based on Sections 68 and 74 of CEPA 1999, ECCC and HC published four State of the Science (SoS) reports regarding the Phthalate Substance Grouping in 2015: – Short-Chain Phthalate Esters – Medium-Chain Phthalate Esters – Long-Chain Phthalate Esters – DINP ECCC and HC also published a Proposed Approach for Cumulative Risk Assessment of Phthalates in 2015. In June 2017, DEHP was one of 50 substances announced as toxic as defined under Section 71 of CEPA 1999. In October 2017, ECCC and HC published a Draft Screening Assessment of the Phthalate Substance Grouping based on the SoS reports and also including 14 additional phthalates from the Domestic Substances List: – Short-chain: DEP – Medium-chain: DPrP, DEHP, DBP, BBP, DnHP, 79P, DIOP – Long-chain: 610P, DnOP, D911P, D911P-2, DIUP, DTDP	The 2017 Draft Screening Assessment concluded that only B79P and DEHP might be released to the environment at levels potentially harmful to the environment or its biological diversity (i.e., they meet the criteria under Section 64(a) of CEPA 1999). None of the substances in the Phthalate Substance Grouping is considered harmful to human health at current level of exposure. The 1994 conclusion regarding DEHP is still in place. The Draft Screening Assessment was open to public comments for 60 days after publication on Oct. 7, 2017. A final screening assessment decision has not yet been published. Phthalates were subject to the CMP Environmental Monitoring and Surveillance Program (2017–2018).11
Canada	Phthalates Regulations (SOR/2016–188) under Canada Consumer Product Safety Act (CCPSA) (S.C. 2010, c. 21)	HC	The first version of the Phthalates Regulations was registered in 2010 as SOR/2010–298 with principally the same content as the current version.	Annexed (Jun. 2016): – DEHP, DBP, BBP: Not allowed at concentrations above 1,000 mg/kg in toys or child care articles – DINP, DIDP, DNOP: Not allowed at concentrations above 1,000 mg/kg in toys or child care articles that can be placed in the mouth of a child under the age of 4 years
Canada	Cosmetics Regulations (C.R.C., c. 869), enabled by the Food and Drugs Act (R.S.C., 1985, c. F-27)	HC	DBP and DEP are primarily used in cosmetics, according to HC. A 2011 study by the Government of Canada identified DBP and DEP as the only phthalates present in significant quantity in cosmetics. The study concluded that the overall exposure to phthalates from use of cosmetic and personal care products is low and is unlikely to pose a health risk.12	Cosmetic Ingredient Hotlist (2009 update) includes DEHP as a prohibited ingredient in reflection of its addition to Schedule 1 of CEPA 1999 (Toxic substances list).
USA	Toxic Substances Control Act (TSCA), amended 2016 by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, and others13	US EPA	In 2012, the US EPA published the Phthalates Action Plan, listing – DEHP – DBP – BBP – DIBP – DINP – DIDP – DnPP – DNOP as phthalates of interest due to toxicity, prevalence in the environment and widespread use and human exposure. US EPA, US FDA, and CPSC are intended to work together on a coordinated approach to address manufacturing, processing, distribution, and/or use of these phthalates. In 2014, the US EPA issued a Significant New Use Rule (SNUR) for DnPP which requires notification of the US EPA by manufacturers and processors regarding new uses of DnPP. DEHP, DBP, BBP, DNOP, DINP, DIDP, and DIBP were added in 2014 to the TSCA Work Plan for Chemical Assessments. DnPP was not added because it is no longer in commerce.	All eight phthalates are subject to Inventory Update Reporting to the TSCA Chemical Substance Inventory
USA	Additional Authorities	US EPA	– Safe Drinking Water Act: DEHP is allowed at a maximum contaminant level (MCL) of 0.006 mg/L – Clean Air Act: DEHP and DBP listed as hazardous air pollutants – Resource Conservation and Recovery Act: phthalates regulated as hazardous waste if discarded as a commercial chemical product – Emergency Planning and Community Right-to-know Act: DEHP and DBP are reportable to the Toxic Release Inventory (TRI) – Endocrine Disruptor Screening Program: Includes DEHP, DBP, and BBP
USA	Federal Food, Drug, and Cosmetic Act	US FDA	In 2001, the FDA published a safety assessment of DEHP released from PVC medical devices. In 2002, a draft guidance document for medical devices made with PVC containing DEHP was published. The document was not finalized. According to the FDA’s latest survey of cosmetics in 2010, DEP is the only phthalate still commonly used in cosmetics. DBP and DMP are rarely used.14 In 2012, the US Cosmetic Ingredient Review Expert Panel confirmed DBP and DEP as “safe as used” in cosmetics. The FDA published a Guidance Document in 2012 on the allowable level of DEHP in bottled water. The respective final rule (76 FR 64810) became effective in April 2012. In 2012, the Center for Drug Evaluation and Research published a “Guidance for Industry” document regarding limiting the use of certain phthalates (i.e., DEHP and DBP) in CDER-regulated products (e.g., prescription drugs).	FDA actions in place: – Fair Packaging and Labeling Act: any ingredient including phthalates has to be declared on cosmetic products (except in fragrances) – Rule 76 FR 64810 amending the FDA bottled water quality standards regulations (21 CFR 165): DEHP is allowed at a maximum contaminant level (MCL) of 0.006 mg/L – Title 21: Food and Drugs: Lists multiple phthalates allowed in various food-contact applications
USA	CPSC Rule “Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates” (82 FR 49938) under the Consumer Product Safety Improvement Act (CPSIA)	CPSC	In 2008, CPSIA amended the Consumer Product Safety Act of 1972. Section 108 of the CPSIA established permanent and interim prohibitions on the sale of certain consumer products containing specific phthalates. It had also directed the CPSC to convene a Chronic Hazard Advisory Panel (CHAP) to study the effects on children’s health of all phthalates and phthalate alternatives used in children’s toys and child care articles and to provide recommendations regarding prohibitions of any phthalates or phthalate alternatives. In 2014, CHAP issued its final report. In its conclusion, CHAP recommended to restrict eight phthalates permanently. The CPSC rule of 2017 (82 FR 49938, effective in April 2018) is a direct outcome of the results published in the CHAP report.	The 2014 CHAP report is to date the most comprehensive risk assessment of the phthalates listed in the US EPA Phthalates Action Plan. It evaluated 14 phthalates (DBP, BBP, DEHP, DNOP, DINP, DIDP, DMP, DEP, DIBP, DPENP, DHEXP, DCHP, DIOP, and DPHP) and six additional phthalate alternatives. CPSIA had restricted DEHP, DBP, and BBP in children’s toys and child care articles to less than 0.1%. The 2017 CPSC rule further prohibits levels greater than 0.1% of DINP, DIBP, DPENP, DHEXP, and DCHP in toys and child care articles.
USA	Other Activities	Other	In 2008, the National Research Council (US) Committee on the Health Risks of Phthalates published “Phthalates and Cumulative Risk Assessment: The Tasks Ahead”.15 The Centers for Disease Control and Prevention (CDC) has published a Phthalates Factsheet on the National Biomonitoring Program website. It includes links to Public Health Statements and ToxFAQs for DEHP, DnBP, DNOP, and DEP, all published between 1995 and 2002.16
California	Proposition 65 (officially: Safe Drinking Water and Toxic Enforcement Act of 1986) Safer Consumer Products (SCP) Program based on the Green Chemistry Law of 2008	OEHHA DTSC	OEHHA maintains a list of chemicals known to cause cancer, birth defects, or reproductive harm. Businesses are required to provide warnings on products if Californians might be exposed to chemicals on the list at or above certain levels by that product.17–19 SCP came into effect in 2013. DTSC publishes a list of candidate chemicals and priority products that might become subject to regulations under the SCP program.20, 21	The following phthalates are on the Proposition 65 list: DEBP, DBP, BBP, DIDP, DINP, and DnHP.22 The list is available at https://calsafer.dtsc.ca.gov/cms/search/
Washington	Children’s Safe Products Act of 2008 and Children’s Safe Products Reporting Rule of 2011 The Pollution Prevention for Our Future Act (SB 5135-B)	Department of Ecology Multiple	The law limits the use certain chemicals and flame retardants in children’s products sold in Washington. It also requires manufacturers to report if children’s products contain any chemical on the list of Chemicals of High Concern to Children (part of the Reporting Rule).23, 24 The legislation requires state agencies to identify and regulate classes of chemicals that pose a health risk to sensitive populations and endangered species.25, 26	Phthalates in children’s products above 0.1% by weight are prohibited. The list of Chemicals of High Concern to Children was last amended in 2017 and includes DCHP, DEP, DIBP, DBP, DnHP, BBP, DEHP, DMEP, DNOP, DPP, DIDP, or DINP.27 Phthalates as a class are listed as priority chemicals in the Act.26
Maine	Safer Chemicals in Children’s Products Rules (Toxic Chemicals in Children’s Products Law of 2008)	Department of Environmental Protection	The Department maintains a list of chemicals of concern, of which some chemicals can be designated as chemicals of high concern and further as priority chemicals. Manufacturers selling certain children’s products in Maine containing any of the priority chemicals at levels higher than the minimum amount have to file a report with the Department.	Reporting required for DEHP, DBP, BBP, and DEP in certain children’s products, which are categorized as priority chemicals.28
Minnesota	Toxic Free Kids Act of 2009 (Minn. Statutes 2010 116.9401 – 116.9407)	Minnesota Department of Health	The Act was signed into law in 2009. It requires MDH to maintain a Chemicals of High Concern List and a Priority Chemicals List.29, 30	The latest update of the Chemicals of High Concern List was published in September 2016. It includes DCHP, DEP, DBP, DnHP, BBP, DEHP, DMEP, DMP, DAP, DPP, DIPP, DIDP, DINP, and some mono-ester phthalates.31 The Priority Chemicals List includes DEHP, DBP, and BBP.32
Vermont	Chemical of High Concern in Children’s Products Rule under Act 188 (2014), now 18 V.S.A. Ch. 38A	Department of Health	Manufacturers using chemicals designated by the State of Vermont as Chemicals of High Concern to Children are required to report information about these chemicals to the Health Department.33–35	On the list of Chemicals of High Concern to Children: DEHP, DNOP, DIDP, DINP, DEP, DBP, BBP, and DHEXP. Proposed additions to the list: DMEP, DPP, DCHP, and DIBP.36
Oregon	Toxic-Free Kids Act of 2015 (SB 478-B)	Oregon Health Authority	Manufacturers of children’s products sold in Oregon are required to report products that contain one or more high priority chemicals of concern for children’s health, and ultimately remove these chemicals or seek a waiver.37	The list of chemicals of concern for children’s health includes BBP, DEHP, DBP, DEP, DIDP, DINP, DHEXP, and DNOP.38
Australia	Industrial Chemicals (Notification and Assessment) Act 1989; Industrial Chemicals (Registration Charge—General) Act 1997; Industrial Chemicals (Registration Charge—Customs) Act 1997; Industrial Chemicals (Registration Charge—Excise) Act 1997; Industrial Chemicals (Notification and Assessment) Regulations 1990	NICNAS under the Australian Government’s Department of Health	NICNAS maintains the Australian Inventory of Chemical Substances (AICS) database where any new industrial chemical has to be included before its industrial use is permitted. Before a chemical is listed in AICS, NICNAS assesses it for health and environmental risks. However, several chemicals and products are not regulated by NICNAS, for example pesticides, agricultural products, and food. Priority Existing Chemicals include DEHP, DBP, BBP, DMEP, DEP, DIDP, DNOP, DINP, and DMP. List of endocrine active chemicals includes DEHP, DBP, BBP.	Industrial chemicals regulation in Australia is subject to reforms, which are currently underway. The new Australian Industrial Chemical Introduction Scheme (AICIS) will replace the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). With AICIS, updated Industrial Chemical Rules and Categorization Guidelines will come into effect. Tier II of IMAP assessment of 24 phthalates (see Table S1 in the SI) was completed in March 2019. The recommendations are focused on DEHP. It was identified as needing further evaluation and it is recommended to add DEHP to the list of chemicals routinely monitored in wastewater treatment effluents and surface waters.39
Australia	Australian Consumer Law of 2011, enabled by the Competition and Consumer Act of 2010	Australian Competition and Consumer Commission	The Australian Consumer Law enables the ACCC to ban products on a permanent or interim basis. A permanent ban of DEHP in children’s plastic items is in place.40	The law bans product that are intended for use by children three years of age or younger, contain more than 1% by weight of DEHP, and are products that can readily be mouthed by children three years of age or younger.41
OECD	-	-	DEHP, DBP, BBP, DMEP, 79P, DIHpP, DHNUP, and DNHpP have been sponsored under the Cooperative Chemicals Assessment Programme. Publications are available on DEHP, DBP, DMEP, 79P, DIHhP, and DHNUP. BBP and DNHpP have been sponsored for assessment, but no publication is currently available.42

Note:

^aThe Canada Consumer Product Safety Act (CCPSA) replaced Part I of the Hazardous Products Act in 2010.