Chemical substances in Batch 12 of the Challenge
- Risk management action milestones
- Adding substances to Schedule 1
- Applying Significant New Activity provisions
- Varying the requirements under the Significant New Activity provisions
- Rescinding the requirements under the Significant New Activity provisions
- Summary of Batch 12 substances and publications
- Timelines
- Final screening assessments and risk management approaches
- Draft screening assessments and risk management scopes
- Information gathering
Risk management action milestones
The risk management action milestones table outlines the risk management actions that were proposed for the chemical substance in this batch of the Challenge that met the criteria of section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). These proposed risk management actions were published in the risk management approach for this substance. For the complete wording of these proposed actions, please refer to the risk management approach.
Adding substances to Schedule 1
One substance in this batch has been added to Schedule 1.
- Final order adding mitotane (CAS RN 53-19-0): Canada Gazette, Part II: Vol. 154, No. 22 - October 28, 2020
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 Domestic Substances List (DSL) that applies to mitotane (CAS RN 53-19-0): Canada Gazette, Part II: Vol. 155, No. 15 – July 21, 2021.
- Order amending the DSL that applies to BAPP (CAS RN 13080-86-9): Canada Gazette, Part II: Vol. 154, No. 17 - August 19, 2020.
- Order amending the DSL that applies to musk moskene (CAS RN 116-66-5), HMSSA (CAS RN 68583-58-4) and CPPP (CAS RN 101200-53-7): Canada Gazette, Part II: Vol. 147, No. 14 - July 3, 2013.
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 July 2019, a notice of intent to amend the DSL to vary the requirements under the SNAc provisions for musk moskene (CAS RN 116-66-5) and CPPP (CAS RN 101200-53-7) was published in the Canada Gazette, Part I: Vol. 153, No. 30 - July 27, 2019 for a 60-day public comment period. The proposed amendments are an outcome of the SNAc Review. The DSL amendments do not come into force until the final orders are 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 HMSSA (CAS RN 68583-58-4) were proposed to be rescinded. HMSSA was subject to the SNAc provisions as a result of the 2013 screening assessment of substances in this batch. It was 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 this substance be rescinded. Furthermore, the substance is not currently in commerce in Canada. Therefore, a notice of intent to amend the DSL to rescind the requirements under the SNAc provisions for HMSSA (CAS RN 68583-58-4) was published in the Canada Gazette, Part I: Vol. 153, No. 30 - July 27, 2019 for a 60-day public comment period. Current SNAc requirements remain in effect until the final order is published in the Canada Gazette, Part II.
Summary of Batch 12 substances and publications
Chlorhexidine acetate (CAS RN 56-95-1) has been included in the chlorhexidine and its salts assessment and is no longer part of Batch 12.
ANMOM- (CAS RN 59709-38-5) has been included in the Aromatic Azo- and Benzidine-based Substance Grouping of the Substance Groupings Initiative and is no longer part of Batch 12.
CAS RN | Chemical substance | Proposed order and RIAS | Final screening assessment | Proposed risk management approach | Public comments on the draft screening assessment and risk management scope |
---|---|---|---|---|---|
53-19-0 | Mitotane | HTML | HTML | HTML | HTML |
CAS RN | Chemical substance | Final screening assessment | Public comments on the draft screening assessment and risk management scope |
---|---|---|---|
102-06-7 | DPG | HTML | None |
107-51-7 | MDM | HTML | Revised screening assessment published March 2014: HTML Screening assessment published January 2011: HTML |
116-66-5 | Musk moskene | HTML | None |
515-03-7 | Sclareol | HTML | None |
1333-86-4 | Carbon black | HTML | HTML |
3555-47-3 | M4Q | HTML | Screening assessment published January 2011: HTML |
13080-86-9 | BAPP | HTML | None |
14464-46-1 | Cristobalite | HTML | HTML |
14808-60-7 | Quartz | HTML | HTML |
68391-11-7 | Pyridine, alkyl derivatives | HTML | None |
68583-58-4 | HMSSA | HTML | None |
68937-51-9 | OMSSA | HTML | None |
101200-53-7 | CPPP | HTML | None |
Date | Substances affected | Activity |
---|---|---|
July 21, 2021 | CAS RN 53-19-0 | Publication in Canada Gazette, Part II, of an order amending the DSL to apply the SNAc provisions of CEPA 1999. |
October 28, 2020 | CAS RN 53-19-0 | Publication in Canada Gazette, Part II, of a final order adding a substance to Schedule 1. |
August 19, 2020 | CAS RN 13080-86-9 | Publication in Canada Gazette, Part II, of an order amending the DSL to apply the SNAc provisions of CEPA 1999. |
February 1, 2020 | CAS RN 53-19-0 | Publication in Canada Gazette, Part I, of a notice of intent to amend the DSL to apply the SNAc provisions of CEPA 1999, and start of 60-day public comment period. |
July 27, 2019 | CAS RN 116-66-5, 101200-53-7, and 68583-58-4 | Publication in Canada Gazette, Part I, of a notice of intent to amend the DSL to vary the requirements under the SNAc provisions for CAS RNs 116-66-5 and 101200-53-7 and to rescind the requirements under the SNAc provisions for CAS RN 68583-58-4, and start of 60-day public comment period. |
November 11, 2017 | CAS RN 53-19-0 | Publication in Canada Gazette, Part I, of a proposed order adding a substance to Schedule 1, and start of 60-day public comment period. |
October 28, 2017 | CAS RN 13080-86-9 | Publication in Canada Gazette, Part I, of a notice of intent to amend the DSL to apply the SNAc provisions of CEPA 1999, and start of 60-day public comment period. |
October 28, 2017 | CAS RNs 53-19-0, 515-03-7 and 13080-86-9 | Publication in Canada Gazette, Part I, of final assessment decisions under subsection 77(6), release of Government's proposed Risk Management Approach for Mitotane, and start of 60-day public comment period on the proposed risk management approach. |
March 28, 2015 | CAS RNs 107-51-7 and 3555-47-3 | Publication in Canada Gazette, Part I, of final assessment decisions under subsection 77(6). |
September 5, 2014 | CAS RN 56-95-1 | Chlorhexidine acetate, CAS RN 56-95-1, is included in an expanded assessment of chlorhexidine and its salts and is no longer part of Batch 12. |
March 29, 2014 | CAS RNs 107-51-7 and 3555-47-3 | Publication in Canada Gazette, Part I, and start of 60-day public comment period on (a) the updated draft screening assessments, (b) the new information received and (c) the proposal to pursue one of the measures as specified under subsection 77(2). |
July 6, 2013 | CAS RNs 53-19-0, 56-95-1, 515-03-7 and 13080-86-9 | Publication in Canada Gazette, Part I, and start of 60-day public comment period on (a) the draft screening assessments, (b) the new information received, (c) the proposal to pursue one of the measures as specified under subsection 77(2) and (d) the risk management scopes, where applicable. |
July 3, 2013 | CAS RNs 116-66-5, 68583-58-4 and 101200-53-7 | Publication in Canada Gazette, Part II, of an order amending the DSL to apply the SNAc provisions of CEPA 1999. |
June 29, 2013 | 9 of the 16 Batch 12 substances | Publication in Canada Gazette, Part I, of final assessment decisions under subsection 77(6). |
January 8, 2011 | Twelve of the sixteen Batch 12 substances | Publication in Canada Gazette, Part I, and start of 60-day public comment period on (a) the draft screening assessments, (b) the new information received, (c) the proposal to pursue one of the measures as specified under subsection 77(2) and (d) the risk management scopes, where applicable. |
January 8, 2011 | CAS RNs 116-66-5, 68583-58-4 and 101200-53-7 | Publication in Canada Gazette, Part I, of a notice of intent to amend the DSL to apply the SNAc provisions of CEPA 1999, and start of 60-day public comment period. |
June 23, 2010 | All Batch 12 substances | Deadline for submission of additional information by interested stakeholders, including on the extent and nature of the management/stewardship of Batch 12 substances. |
April 27, 2010 | All Batch 12 substances | Deadline for submission of information under the section 71 notice on Batch 12 substances (if no extension granted). |
December 26, 2009 | All Batch 12 substances | Release of Batch 12 of the Challenge and the accompanying technical documents. |
Final screening assessments and risk management approaches
In October 2017, the final screening assessments for 3 substances in this batch (CAS RNs 53-19-0, 515-03-7 and 13080-86-9) were released and the related notices were published in the Canada Gazette, Part I: Vol. 151, No. 43 - October 28, 2017. The final assessments concluded that 1 substance in this batch, mitotane, meets one or more criteria in section 64 of CEPA 1999. The Government has added this substance to Schedule 1 of the Act. A proposed risk management approach for mitotane was also released on this date for a 60-day public comment period.
In March 2015, the final screening assessments for 2 substances in this batch (CAS RNs 107-51-7 and CAS RN 3555-47-3) were released and the related notices were published in the Canada Gazette, Part I: Vol. 149, No. 13 - March 28, 2015.
In June 2013, the final screening assessments for 9 substances in this batch were released and the related notices were published in the Canada Gazette, Part I: Vol. 147, No. 26 - June 29, 2013.
ANMOM (CAS RN 59709-38-5) has been included in the Aromatic Azo- and Benzidine-based Substance Grouping of the Substance Groupings Initiative and is no longer part of Batch 12.
The remaining substance, chlorhexidine acetate (CAS RN 56-95-1), has been included in the chlorhexidine moiety assessment and is no longer part of Batch 12.
Draft screening assessment and risk management scopes
In March 2014, updated draft screening assessments for 2 substances in this batch (CAS RNs 107-51-7 and CAS RN 3555-47-3) were released and the related notices were published in the Canada Gazette, Part I: Vol. 148, No. 13 - March 29, 2014 for a 60-day public comment period.
In July 2013, the draft screening assessments for 4 substances in this batch (CAS RNs 53-19-0, 56-95-1, 515-03-7 and 13080-86-9) were released and the related notices were published in the Canada Gazette, Part I: Vol. 147, No. 28 - July 6, 2013.
New information was received from industry or interested stakeholders for each of the 16 substances in this batch. In January 2011, the draft screening assessments for 12 substances in this batch were released and the related notices were published in the Canada Gazette, Part I: Vol. 145, No. 2 - January 8, 2011. Risk management scopes were also released in conjunction with these publications.
Information gathering
2009 Mandatory survey - section 71 notice
In December 2009, a notice was issued in the Canada Gazette, Part I: Vol. 143, No. 52 - December 26, 2009 under section 71 of CEPA 1999. This section 71 notice applied to all 16 substances in this batch.
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