Canada Publishes Final Decision after Phthalate Substance Screening Assessment

Summary of screening assessment of the Phthalate Substance Grouping

Pursuant to sections 68 and 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of 14 phthalate esters (phthalates), known collectively as the Phthalate Substance Grouping.

Substances in this grouping were identified as priorities for assessment as they met categorization criteria under subsection 73(1) of CEPA or were considered a priority on the basis of other human health concerns. This screening assessment follows the August 2015 publication of four state of the science (SOS) reports and an approach document for cumulative risk assessment (CRA) of phthalates, and it presents information relevant to concluding on the substances in this grouping under section 64 of CEPA.

The Chemical Abstracts Service Registry Numbers, Domestic Substances List (DSL) names and acronyms for phthalates in the Phthalate Substance Grouping screening assessment are listed in the table below.

Substances in the Phthalate Substance Grouping

CAS 131-11-3: 1,2-Benzenedicarboxylic acid, dimethyl ester

CAS 84-69-5:  1,2-Benzenedicarboxylic acid, bis(2-methylpropyl) ester

CAS 5334-09-8:  1,2-Benzenedicarboxylic acid, cyclohexyl 2-methylpropyl ester

CAS 84-64-0:    1,2-Benzenedicarboxylic acid, butyl cyclohexyl ester

CAS 84-61-7: 1,2-Benzenedicarboxylic acid, dicyclohexyl ester

CAS 523-31-9:  1,2-Benzenedicarboxylic acid, bis(phenylmethyl) ester

CAS 68515-40-2: 1,2-Benzenedicarboxylic acid, benzyl C7-9-branched and linear alkyl esters

CAS 27987-25-3: 1,2-Benzenedicarboxylic acid, bis(methylcyclohexyl) ester

CAS 71888-89-6: 1,,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich

CAS 27215-22-1: 1,2-Benzenedicarboxylic acid, isooctyl phenylmethyl ester

CAS 16883-83-3: 1,2-Benzenedicarboxylic acid, 2,2-dimethyl-1-(1-methylethyl)-3-(2-methyl-1-oxopropoxy)propyl phenylmethyl ester

CAS 68515-48-0/ 28553-12-0:  1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich; 1,2-Benzenedicarboxylic acid, diisononyl ester

CAS 26761-40-0 / 68515-49-1: 1,2-Benzenedicarboxylic acid, diisodecyl ester; 1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich

CAS 3648-20-2:   1,2-Benzenedicarboxylic acid, diundecyl ester.

Fourteen additional phthalates on the DSL were included within the scope of the screening assessment in the context of their potential to contribute to cumulative risk from combined exposure to phthalates.

On the basis of the information presented in this screening assessment, it is concluded that all 14 phthalates in the Phthalate Substance Grouping do not meet the criteria under paragraph 64(c) of CEPA as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health. Also, the previous conclusion made in the 1994 PSL assessment of DEHP, that it meets the criteria under paragraph 64(c) of CEPA, remains valid.

Overall conclusion

It is concluded that DEHP meets one or more of the criteria set out in section 64 of CEPA, and that the other 14 substances in the phthalate substance grouping do not meet any of the criteria set out in section 64 of CEPA.

DEHP has been determined to not meet the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.

Public comment period on the risk management approach

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the proposed risk management approach document. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical Substances) website. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be addressed to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819‑938‑5212, by email to eccc.substances.eccc@canada.ca, or by using the online reporting system available through Environment and Climate Change Canada’s Single Window.”

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