Chemical substances in Batch 12 of the Challenge

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 is proposed to be added to Schedule 1.

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.

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In July 2019, the requirements under the SNAc provisions for HMSSA (CAS RN 68583-58-4) were proposed to be rescinded.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 That review led to the recommendation that the requirements under the SNAc provisions for this substance be rescinded.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.

Substances that meet one or more criteria in section 64 of CEPA 1999
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
Substances that do not meet any of the criteria in section 64 CEPA 1999
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
Timelines
Date Substances affected Activity
July 27, 2019 CAS RN 116-66-5, 101200-53-7, and 68583-58-4 Publication in Canada Gazette, Part I of notice of intent to amend the DSL to vary the requirements under the SNAc provisions for CAS RNs 116-66-5 and 101200-53-7and 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 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 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 scope documents, where applicable.
July 3, 2013 CAS RNs 116-66-5, 68583-58-4 and 101200-53-7 Publication in Canada Gazette, Part II of 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 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 of the remaining 4 substances in this batch (CAS RNs 53-19-0, 515-03-7 and 13080-86-9) were released 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 proposes to add 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.

The remaining substance, chlorhexidine acetate (CAS RN 56-95-1), is included in the chlorhexidine moiety assessment and is no longer part of Batch 12.

In March 2015, the final screening assessments for substances in this batch [MDM (CAS RN 107-51-7) and M4Q (CAS RN 3555-47-3)] were released in the Canada Gazette, Part I: Vol. 149, No. 13 - March 28, 2015.

In June 2013, the final screening assessments for 9 of the 16 substances in this batch were released 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.

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.

Draft screening assessment and risk management scopes

In March 2014, updated draft screening assessments for 2 substances in this batch [MDM (CAS RN 107-51-7) and M4Q (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 the 4 remaining 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 of the 16 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 scope were also released in conjunction with these publications.

Launch of Batch 12 and submissions received

Information on substances in this batch was gathered from industry and interested stakeholders through a mandatory survey notice issued under section 71 of CEPA 1999. They were also invited to complete a voluntary questionnaire.

A notice related to the launch of Batch 12 was published in December 2009 in the Canada Gazette. The section 71 notice applied to all 16 substances in this batch.

Number of submissions received for this batch
Approximate number Type of response
160 Responses to mandatory section 71 notice (responses were received relating to 12 substances in the batch)
39 Requests for extension of the deadline for section 71 notice responses granted
10 Voluntary submissions of questionnaires (questionnaires were received relating to 5 substances in the batch)
55 Expressions of "stakeholder interest" (responses were received relating to 10 substances in the batch)
30 Other submissions (for example, studies, additional information) (submissions were received relating to 16 substances in the batch)
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