PBiT substances risk assessment and order amending the Domestic Substances List
The results of categorization indicate that there are 397 substances on the Domestic Substances List (DSL) that are Persistent, Bioaccumulative and inherently Toxic (PBiT) to non-human organisms, according to the categorization criteria. Preliminary research indicated that a high percentage of these substances may no longer be manufactured in or imported into Canada. To establish whether this was the case, surveys were conducted on these substances in 2001 and 2006 by issuing notices in the Canada Gazette, Part I, pursuant to paragraphs 71(1)(a) and (b) of the Canadian Environmental Protection Act, 1999 (CEPA 1999). There were no reports of industrial activity with respect to 148 of these PBiT substances; therefore, the likelihood of exposure to these substances in Canada resulting from commercial activity was considered to be low. The draft screening assessment for these 148 PBiT substances and the notice of intent to apply the Significant New Activity (SNAc) provisions were published in December 2006 for a public comment period. The final screening assessment was published in April 2008, followed by an order applying the SNAc provisions to 145 substances in June 2008. Three of the initial 148 PBiT substances were no longer considered eligible for the application of the SNAc provisions, on the basis of new information received during the public comment period. Since then, as a result of new information, requirements under the SNAc provisions have been rescinded for 49 of these substances. A further 3 rescissions and 84 amendments have been proposed. The SNAc requirements on the remaining 9 of the 145 PBiT substances will be revised, as needed, under appropriate groups as part of the SNAc Review.
- Applying Significant New Activity provisions
- Varying the requirements under the Significant New Activity provisions
- Rescinding the requirements under the Significant New Activity provisions
- Significant New Activity Notification risk assessment summary
- Aromatic Azo and Benzidine-based Substance Grouping
- Final screening assessment
- Background
Applying Significant New Activity provisions
View the Significant New Activity Publications under the Canadian Environmental Protection Act, 1999. Orders are subject to potential amendments under the Significant New Activity (SNAc) Review.
- Order amending the DSL that applies to 145 substances: Canada Gazette, Part II: Vol. 142, No. 13 - June 25, 2008.
For additional guidance on submitting information required as part of SNAc notifications, please see the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.
Varying the requirements under the Significant New Activity provisions
In February 2022, a notice of intent to amend the DSL to vary the requirements under the SNAc provisions for 1 of the 145 PBiT substances (CAS RN 64742-66-1) was published in the Canada Gazette, Part I: Vol. 156, No. 6 – February 5, 2022 for a 60-day public comment period. The proposed amendment is an outcome of the SNAc Review. The DSL amendment does not come into force until the final order is published in the Canada Gazette, Part II. Any current SNAc requirements remain in effect until then.
In July 2019, a notice of intent to amend the DSL to vary the requirements under the SNAc provisions for 84 of the 145 PBiT substances was published in the Canada Gazette, Part I: Vol. 153, No. 30 – July 27, 2019 for a 60-day public comment period. The proposed amendment is an outcome of the SNAc Review. The DSL amendment does not come into force until the final order is published in the Canada Gazette, Part II. Any current SNAc requirements remain in effect until then.
Rescinding the requirements under the Significant New Activity provisions
In July 2019, the requirements under the SNAc provisions for 3 substances (CAS RN 93918-79-7, CAS RN 113089-51-3 and CAS RN 119209-64-2) were proposed to be rescinded. These 3 substances were subject to the SNAc provisions as a result of the 2008 assessment of 145 PBiT substances. They were later included in the High Hazard Not in Commerce Substances SNAc Review Group, under the SNAc Review. That review led to the recommendation that the requirements under the SNAc provisions for these substances be rescinded. Furthermore, these substances are not currently in commerce in Canada. A notice of intent was published in the Canada Gazette, Part I: Vol. 153, No. 30 – July 27, 2019 proposing to rescind the requirements under the SNAc provisions of CEPA 1999 for these 3 substances. In July 2017, the requirements under the SNAc provisions for 32 substances included in the Aromatic Azo and Benzidine-based Substance Grouping were rescinded. These 32 substances were subject to the SNAc provisions as a result of the 2008 assessment of 145 PBiT substances. These substances have since been included in the Certain Azo Disperse Dyes Subgroup, and the March 2017 assessment of that subgroup concluded that these substances are no longer of concern to the environment. An order was published in the Canada Gazette, Part II: Vol. 151, No.14 – July 12, 2017 rescinding the requirements under the SNAc provisions of CEPA 1999 for these 32 substances.
In October 2016, the requirements under the SNAc provisions for CAS RNs 71720-89-3, 83027-51-4, 83027-52-5, 90218-20-5, 90459-02-2, and 114910-04-2 were rescinded. These 6 substances were subject to the SNAc provisions as a result of the 2008 assessment of 145 PBiT substances. These 6 substances have since been included in the Certain Azo Acid Dyes Subgroup, and the 2016 assessment of that subgroup concluded that CAS RNs 71720-89-3, 83027-51-4, 83027-52-5, 90218-20-5, 90459-02-2, and 114910-04-2 do not pose a risk to the environment or human health. An order was published in the Canada Gazette, Part II: Vol. 150, No. 21 - October 19, 2016 rescinding the requirements under the SNAc provisions of CEPA 1999 for these 6 substances.
In October 2016, the requirements under the SNAc provisions for CAS RN 71720-89-3, CAS RN 83027-51-4, CAS RN 83027-52-5, CAS RN 90218-20-5, CAS RN 90459-02-2 and CAS RN 114910-04-2 were rescinded. These 6 substances were subject to the SNAc provisions as a result of the 2008 assessment of 145 PBiT substances. These 6 substances have since been included in the Certain Azo Acid Dyes Subgroup, and the 2016 assessment of that subgroup concluded that CAS RN 71720-89-3, CAS RN 83027-51-4, CAS RN 83027-52-5, CAS RN 90218-20-5, CAS RN 90459-02-2 and CAS RN 114910-04-2 do not pose a risk to the environment or human health. An order was published in the Canada Gazette, Part II: Vol. 150, No. 21 - October 19, 2016 rescinding the requirements under the SNAc provisions of CEPA 1999 for these 6 substances.
In October 2016, the requirements under the SNAc provisions for CAS RN 59709-10-3 were rescinded. CAS RN 59709-10-3 was subject to the SNAc provisions as a result of the 2008 assessment of 145 PBiT substances. CAS RN 59709-10-3 has since been included in the Certain Azo Basic Dyes Subgroup, and the 2016 assessment of that subgroup concluded that CAS RN 59709-10-3 does not pose a risk to the environment or human health. An order was published in the Canada Gazette, Part II: Vol. 150, No. 21 - October 19, 2016 rescinding the requirements under the SNAc provisions of CEPA 1999 for this substance.
In October 2016, the requirements under the SNAc provisions for Solvent Red 4 (CAS RN 2653-64-7), CAS RN 73528-78-6, CAS RN 85392-21-8, NANPAP (CAS RN 85005-63-6), and NAPNPA (CAS RN 94199-57-2) were rescinded. These 5 substances were subject to the SNAc provisions as a result of the 2008 assessment of 145 PBiT substances. These 5 substances have since been included in the Certain Azo Solvent Dyes and Certain Monoazo Pigments subgroupings, and the 2016 assessments of those subgroupings concluded that Solvent Red 4 (CAS RN 2653-64-7), CAS RN 73528-78-6, CAS RN 85392-21-8, NANPAP (CAS RN 85005-63-6), and NAPNPA (CAS RN 94199-57-2) do not pose a risk to the environment or human health. An order was published in the Canada Gazette, Part II: Vol. 150, No. 21 - October 19, 2016 rescinding the requirements under the SNAc provisions of CEPA 1999 for these 5 substances.
In March 2015, the requirements under the SNAc provisions for TDBD (CAS RN 1871-22-3) were rescinded. TDBD was subject to the SNAc provisions as a result of the 2008 assessment of 145 PBiT substances. TDBD has since been included in the Certain Benzidine-based Dyes and Related Substances Subgroup, and the 2014 assessment of that subgroup concluded that TDBD does not meet the criteria for bioaccumulation or inherent toxicity to aquatic organisms. An order was published in the Canada Gazette, Part II: Vol. 149, No. 5 - March 11, 2015 rescinding the requirements under the SNAc provisions of CEPA 1999 for this substance.
In December 2014, the requirements under the SNAc provisions for CPAOBP (CAS RN 78952-70-2) were rescinded. CPAOBP was subject to the SNAc provisions as a result of the 2008 assessment of 145 PBiT substances. CPAOBP has since been included in the Certain Diarylide Yellow Pigments Subgroup, and the 2014 assessment of that subgroup concluded that CPAOBP does not meet the criteria for bioaccumulation or inherent toxicity to aquatic organisms. An order was published in the Canada Gazette, Part II: Vol. 148, No. 26 - December 17, 2014 rescinding the requirements under the SNAc provisions of CEPA 1999 for this substance.
In July 2014, the requirements under the SNAc provisions for CAS RNs 92-72-8, 92-76-2, and 135-63-7 were rescinded. These 3 substances were subject to the SNAc provisions as a result of the 2008 assessment of 145 PBiT substances. A review and analysis of new information related to the 3 substances was undertaken, and the 2013 assessment concluded that these substances are no longer considered to meet categorization criteria for bioaccumulation or inherent toxicity. Therefore, future use of these substances is no longer considered a potential concern to the environment. An order was published in the Canada Gazette, Part II: Vol.148, No. 16 - July 30, 2014 rescinding the requirements under the SNAc provisions of CEPA 1999 for these 3 substances.
Significant New Activity Notification risk assessment summary
One substance in this batch has been assessed for new activities notified through a Significant New Activity Notification (SNAN). One Significant New Activity Notification risk assessment summary has been published.
Aromatic Azo and Benzidine-based Substance Grouping
The following substances in this initiative have been included in the Aromatic Azo and Benzidine-based Substance Grouping under the Substance Groupings Initiative. As outlined in the notice of intent for this substance grouping, it was recognized that assessments and conclusions pertaining to some of the substances in this grouping may be subsequently updated as part of the subgroup assessment. The latest updates on the following substances can be found on the respective Aromatic Azo and Benzidine-based Substance Grouping pages.
| CAS RN | Chemical substance | Subgroup |
|---|---|---|
| 1871-22-3 | 2H-Tetrazolium, 3,3'-(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis[2,5-diphenyl-, dichloride (TDBD) | Certain Benzidine-based Dyes and Related Substances |
| 2537-62-4 | Acetamide, N-[2-[(2-bromo-6-cyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]- | Certain Azo Disperse Dyes |
| 2653-64-7 | Solvent Red 4 | Certain Azo Solvent Dyes |
| 3701-40-4 | Acid Red 99 | Benzidine-based Dyes and Related Substances |
| 6368-72-5 | Solvent Red 19 | Certain Azo Solvent Dyes |
| 6420-06-0 | Direct Violet 28 | Certain Benzidine-based Dyes and Related Substances |
| 6465-02-7 | Carbamic acid, [4-[[4-[(4-hydroxyphenyl)azo]-2-methylphenyl]azo]phenyl]-, methyl ester | Certain Azo Disperse Dyes |
| 15958-27-7 | Propanenitrile, 3-[[4-[(4-nitrophenyl)azo]phenyl][2-[[(phenylamino)carbonyl]oxy]ethyl]amino]- | |
| 19745-44-9 | Propanenitrile, 3-[4-[(5-nitro-2-thiazolyl)azo](2-phenylethyl)amino]- | |
| 24610-00-2 | Benzonitrile, 2-[[4-[(2-cyanoethyl)(2-phenylethyl)amino]phenyl]azo]-5-nitro- | |
| 25150-28-1 | Propanenitrile, 3-[[4-[(6,7-dichloro-2-benzothiazolyl)azo]phenyl]ethylamino]- | |
| 28824-41-1 | Propanenitrile, 3-[[4-[(4,6-dibromo-2-benzothiazolyl)azo]phenyl]ethylamino]- | |
| 31030-27-0 | Benzenamine, 4-[(2-chloro-4-nitrophenyl)azo]-N-ethyl-N-(2-phenoxyethyl)- | |
| 33979-43-0 | Propanenitrile, 3-[[2-(acetyloxy)ethyl][4-[(5,6-dichloro-2-benzothiazolyl)azo]phenyl]amino]- | Certain Azo Disperse Dyes |
| 41362-82-7 | Propanenitrile, 3-[[4-[(5,6-dichloro-2-benzothiazolyl)azo]phenyl]methylamino]- | |
| 42852-92-6 | Acetamide, N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-4-methoxy-5-[(phenylmethyl)-2-propenylamino]phenyl]- | |
| 55252-53-4 | Acetamide, N-[2-[(2-cyano-6-iodo-4-nitrophenyl)azo]-5-(diethylamino)phenyl]- | |
| 56532-53-7 | Acetamide, N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(dipropylamino)phenyl]- | |
| 59709-10-3 | Pyridinium, 1-[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl]-, acetate | Certain Azo Basic Dyes |
| 61799-13-1 | 3-Pyridinecarbonitrile, 5-[(2-cyano-4-nitrophenyl)azo]-2-[(2-hydroxyethyl)amino]-4-methyl-6-[[3-(2-phenoxyethoxy)propyl]amino]- | Certain Azo Disperse Dyes |
| 63133-84-6 | 1(2H)-Quinolineethanol, 6-[(2-chloro-4,6-dinitrophenyl)azo]-3,4-dihydro-2,2,4,7-tetramethyl- | |
| 63134-15-6 | Disperse Red 338 | |
| 63281-10-7 | 3-Pyridinecarbonitrile, 5-[[2-chloro-4-(methylsulfonyl)phenyl]azo]-4-methyl-2,6-bis[[3-(2-phenoxyethoxy)propyl]amino]- | Certain Azo Metal Complexes and Other Azo Substances |
| 63833-78-3 | 3-Pyridinecarbonitrile, 5-[(2-cyano-4-nitrophenyl)azo]-6-[(2-hydroxyethyl)amino]-4-methyl-2-[[3-(2-phenoxyethoxy)propyl]amino]- | Certain Azo Disperse Dyes |
| 68214-66-4 | Carbamic acid, [2-[(2-chloro-4-nitrophenyl)azo]-5-(diethylamino)phenyl]-, 2-ethoxyethyl ester | |
| 68400-36-2 | 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-6-[[4'-[(4-hydroxyphenyl)azo]-3,3'-dimethyl[1,1'-biphenyl]-4-yl]azo]-3-[(4-nitrophenyl)azo]-, disodium salt (NAAHD) | Certain Benzidine-based Dyes and Related Substances |
| 68516-64-3 | Propanenitrile, 3-[[2-(acetyloxy)ethyl][4-[(2-chloro-4-nitrophenyl)azo]-3-methylphenyl]amino]- | Certain Azo Disperse Dyes |
| 68877-63-4 | Acetamide, N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-[(2-cyanoethyl)-2-propenylamino]-4-methoxyphenyl]- | |
| 70210-08-1 | Disperse Red 151 | |
| 70660-55-8 | 1-Naphthalenamine, 4-[(2-bromo-4,6-dinitrophenyl)azo]-N-(3-methoxypropyl)- | |
| 71720-89-3 | 2-Naphthalenesulfonic acid, 5-[[4-(4-cyclohexylphenoxy)-2-sulfophenyl]azo]-6-[(2,6-dimethylphenyl)amino]-4-hydroxy-, disodium salt | Certain Azo Acid Dyes |
| 72828-63-8 | Benzonitrile, 2-[[4-[[2-(acetyloxy)ethyl]butylamino]-2-methylphenyl]azo]-3-bromo-5-nitro- | Certain Azo Disperse Dyes |
| 72828-64-9 | Disperse Blue 287 | |
| 73003-64-2 | 2,4,10-Trioxa-7-azaundecan-11-oic acid, 7-[4-[(2,6-dichloro-4-nitrophenyl)azo]-3-methylphenyl]-3-oxo-, methyl ester | |
| 73398-96-6 | Disperse Brown 21 | |
| 73528-78-6 | 3-Pyridinecarbonitrile, 5-[[4-[(2,6-dichloro-4-nitrophenyl)azo]-2,5-dimethoxyphenyl]azo]-2,6-bis[(2-methoxyethyl)amino]-4-methyl- | Certain Azo Solvent Dyes |
| 78952-70-2 | Butanamide, 2-[[3,3'-dichloro-4'-[[1-[[(2-chlorophenyl)amino]carbonyl]-2-oxopropyl]azo][1,1'-biphenyl]-4-yl]azo]-N-(2,4-dimethylphenyl)-3-oxo-(CPAOBP) | Certain Diarylide Yellow Pigments |
| 79542-46-4 | Disperse Red 349 | Certain Azo Disperse Dyes |
| 83027-52-5 | 1,7-Naphthalenedisulfonic acid, 6-[[2-(2-cyclohexylphenoxy)phenyl]azo]-4-[[(2,4-dichlorophenoxy)acetyl]amino]-5-hydroxy-, disodium salt | Certain Azo Acid Dyes |
| 83027-51-4 | 1,7-Naphthalenedisulfonic acid, 6-[[2-(4-cyclohexylphenoxy)phenyl]azo]-4-[[(2,4-dichlorophenoxy)acetyl]amino]-5-hydroxy-, disodium salt | |
| 83249-47-2 | Acetamide, N-[2-[(2-bromo-6-cyano-4-nitrophenyl)azo]-5-(dipropylamino)phenyl]- | Certain Azo Disperse Dyes |
| 83249-49-4 | Benzonitrile, 3-bromo-2-[[4-(diethylamino)-2-methylphenyl]azo]-5-methyl- | |
| 83249-53-0 | Methanesulfonamide, N-[2-[(2-bromo-6-cyano-4-methylphenyl)azo]-5-(diethylamino)phenyl]- | |
| 83249-54-1 | Methanesulfonamide, N-[2-[(2-bromo-6-cyano-4-methylphenyl)azo]-5-(dipropylamino)phenyl]- | |
| 85005-63-6 | 2-Naphthalenecarboxamide, 4-[(2,4-dinitrophenyl)azo]-3-hydroxy-N-phenyl- (NANPAP) | Certain Monoazo Pigments |
| 85392-21-8 | 3-Pyridinecarbonitrile, 5-[[2-chloro-4-(phenylazo)phenyl]azo]-2,6-bis[(3-methoxypropyl)amino]-4-methyl- | Certain Azo Solvent Dyes |
| 90218-20-5 | Benzenesulfonic acid, 5-amino-2,4-dimethyl-, diazotized, coupled with diazotized 2,4-, 2,5-and 2,6-xylidine and 4-[(2,4-dihydroxyphenyl)azo]benzenesulfonic acid, sodium salts | Certain Azo Acid Dyes |
| 90459-02-2 | 2,7-Naphthalenedisulfonic acid, 5-amino-4-hydroxy-3-[[6-sulfo-4-[(4-sulfo-1-naphthalenyl)azo]-1-naphthalenyl]azo]-, diazotized, coupled with diazotized 4-nitrobenzenamine and resorcinol, potassium sodium salts | |
| 90729-40-1 | 3-Pyridinecarbonitrile, 1-butyl-5-[[4-(4-chlorobenzoyl)-2-nitrophenyl]azo]-1,2-dihydro-6-hydroxy-4-methyl-2-oxo- | Certain Azo Disperse Dyes |
| 94199-57-2 | 2-Naphthalenecarboxamide, N-(2-ethoxyphenyl)-3-hydroxy-4-[(2-nitrophenyl)azo]- (NAPNPA) | Certain Monoazo Pigments |
| 127126-02-7 | Propanenitrile, 3-[[2-(acetyloxy)ethyl][4-[(6,7-dichloro-2-benzothiazolyl)azo]phenyl]amino]- | Certain Azo Disperse Dyes |
Final screening assessment
In April 2008, the Final Screening Assessment for Potentially Toxic Substances (145 PBiT substances) was published. The final screening assessment concluded that none of these 145 substances met any of the criteria set out under section 64 of CEPA 1999. Therefore, it was recommended to take no further action on these substances at that time.
Environment Canada and Health Canada considered the new information received during the public comment period on the draft screening assessment and the notice of intent to apply the SNAc provisions of CEPA 1999 to 148 PBiT substances. As a result, 3 of the initial 148 PBiT substances are no longer considered eligible for the application of the SNAc provisions.
For 2 of these PBiT substances, CAS RNs 13080-86-9 (BAPP - Batch 12) and 71032-95-6 (NDTHPM - Batch 9), evidence was provided indicating that they are presently in commerce in Canada. Therefore, these substances were added to and assessed under the Challenge Initiative.
A third substance, CAS RN 71832-83-2 (Pigment Red 48:5), has been found to no longer meet the categorization criteria for bioaccumulation and inherent toxicity. This substance was added to the Aromatic Azo and Benzidine-based Substance Grouping and was assessed under the Certain Monoazo Pigments Subgroup.
The draft screening assessment and the notice of intent to apply the SNAc provisions of CEPA 1999 to these substances were released on December 9, 2006, for a 60-day public comment period.
Background
The results of categorization indicated that there were 397 substances on the DSL that were PBiT to non-human organisms, according to the categorization criteria. Preliminary research indicated that a high percentage of these substances were no longer being manufactured in or imported into Canada. To establish whether this was the case, surveys were conducted on these substances in 2001 and 2006 by issuing notices pursuant to paragraphs 71(1)(a) and (b) of CEPA 1999 in the Canada Gazette, Part II.
Based on the survey results, there were no reports of industrial activity (import or manufacture) with respect to 148 of these PBiT substances in Canada, above the reporting threshold of 100 kg for the specified reporting years. These results suggested that the likelihood of exposure to these substances in Canada resulting from commercial activity at that time was low. In addition, no companies identified themselves as having an interest in any of the substances listed in the 2006 notice, providing further evidence that these substances were not of commercial interest in Canada.
Page details
- Date modified: