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Guidance for Responding to the Paragraph 71(1)(B) Notice Of

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Guidance for Responding to the Paragraph 71(1)(B) Notice Of Guidance for responding to the Notice with respect to certain nanomaterials in Canadian Commerce Published in the Canada Gazette, Part I, on July 25, 2015 TABLE OF CONTENTS 1. OVERVIEW ........................................................................................................................ 3 1.1- PURPOSE OF THE NOTICE .............................................................................................................................. 3 1.2- REPORTABLE SUBSTANCES ........................................................................................................................... 4 1.3- DETERMINING IF A SUBSTANCE IS AT THE NANOSCALE ............................................................................... 12 2. WHO DOES THE NOTICE APPLY TO? ...........................................................................13 2.1- REPORTING CRITERIA ................................................................................................................................. 13 2.2- EXCLUSIONS ............................................................................................................................................... 14 2.3- FLOWCHART ............................................................................................................................................... 15 Figure 1: Reporting Diagram for Nanomaterials. ............................................................................................ 15 2.4- EXAMPLES OF HOW TO DETERMINE WHETHER THE REPORTING CRITERIA ARE MET .................................... 16 2.5- DO I MANUFACTURE? ................................................................................................................................. 17 2.6- DO I IMPORT ? ............................................................................................................................................ 18 2.7- WHAT IS A MIXTURE? ................................................................................................................................. 19 2.8- WHAT IS A PRODUCT? ................................................................................................................................. 19 3. INFORMATION REQUIRED .............................................................................................20 3.1- BASIS FOR DETERMINING IF THE SUBSTANCE IS AT THE NANOSCALE FORM ................................................ 20 3.2- QUANTITIES ................................................................................................................................................ 20 3.3- NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM CODES ................................................................ 21 3.4- SUBSTANCE FUNCTION CODES AND CONSUMER AND COMMERCIAL CODES ................................................. 21 3.4.1- Code numbering system for substance function codes and consumer and commercial codes .......... 22 3.4.2- Substance Function Codes and Corresponding Descriptions ........................................................... 23 3.4.3- Consumer and Commercial Codes and Corresponding Descriptions ............................................... 27 3.5- INTENDED USES .......................................................................................................................................... 34 3.6- TITLES OF UNPUBLISHED OR PUBLISHED DATA OR STUDIES ........................................................................ 36 3.7- INFORMATION TO WHICH YOU MAY REASONABLY BE EXPECTED TO HAVE ACCESS ..................................... 36 4. SECTIONS OF THE NOTICE TO BE COMPLETED .........................................................37 Table 1: Applicable sections based on activity .................................................................................................. 37 4.1- SECTION 4 OF SCHEDULE 3 ......................................................................................................................... 38 4.2- SECTION 5 OF SCHEDULE 3 ......................................................................................................................... 39 4.3- SECTION 6 OF SCHEDULE 3 ......................................................................................................................... 40 5. REQUEST FOR CONFIDENTIALITY ................................................................................41 6. BLIND SUBMISSION ........................................................................................................42 7. DECLARATION OF STAKEHOLDER INTEREST ............................................................43 8. DECLARATION OF NON-ENGAGEMENT .......................................................................43 9. SUBMISSION OF VOLUNTARY INFORMATION .............................................................43 10. RESPONDING TO THE NOTICE ......................................................................................44 11. WHAT IF I NEED MORE TIME TO COMPLY WITH THE NOTICE? .................................44 12. CONTACT INFORMATION ...............................................................................................45 Page 2 of 45 This document provides guidance for responding to the Notice with respect to certain nanomaterials in Canadian commerce (the Notice) published in the Canada Gazette, Part I, on July 25, 2015, pursuant to paragraph 71(1)(b) of the Canadian Environmental Protection Act, 1999 (the Act). In case of discrepancy between this document and the Notice or the Act, the official versions of the Notice and the Act take precedence. 1. Overview 1.1- Purpose of the Notice Nanotechnology is a rapidly emerging field with the potential for use in a wide variety of applications across a broad range of sectors. Nanomaterials are substances that are manufactured at the nanoscale (between 1 to 100 nanometres, inclusive), or have internal or surface structures in the nanoscale (such as surface modified silica). Some nanomaterials exhibit unique properties which may give rise to new exposures and effects which need to be assessed for their potential risk to human health and the environment. Presently, consistent with chemicals, polymers and living organisms, nanoscale forms of substances that are not listed on the Domestic Substances List (DSL) are subject to the New Substances Notification Regulations (Chemicals and Polymers) under the Act. Nanoscale forms of substances listed on the DSL are considered existing nanomaterials and generally have not been considered in risk assessments conducted under the Act. Environment Canada and Health Canada want to ensure that nanomaterials currently in commerce in Canada are addressed as some may require further action to determine if they pose any potential risks to the environment or to human health, similar to the approach used with chemicals and living organisms. In 2011, the Canada-United States Regulatory Cooperation Council (RCC) Nanotechnology Initiative1 was launched to increase alignment in regulatory approaches for nanomaterials between Canada and the US to reduce risk to human health and the environment; to promote sharing of scientific and regulatory expertise; and to foster innovation. Completed in February 2014, the RCC Nanotechnology Initiative included a work element on Commercial Information.2 This work element was aimed at increasing knowledge of commercial uses of nanomaterials in Canada and the US. The primary output from this work element was a Nanomaterials Use Matrix which identified nanomaterials by type and use category based on the most up-to-date information, at the time, on commercially available nanomaterials. The nanomaterial types were cross-referenced with the DSL to identify nanomaterials which could be considered existing in Canada. The result is a preliminary reference list and may not be comprehensive of all nanomaterials. Ongoing engagement with stakeholders through voluntary initiatives and other fora will inform further development of the list of existing nanomaterials in Canada. 1 http://nanoportal.gc.ca/default.asp?lang=En&n=5A56CB00-1 2 http://nanoportal.gc.ca/default.asp?lang=En&n=57FB12B0-1 Page 3 of 45 The purpose of the Notice is to gather information on 206 nanomaterials identified as potentially in commerce in Canada from the primary reference list. The information collected from the Notice will support the development of a list of nanomaterials in commerce in Canada by confirming their commercial status, and subsequent prioritization activities for these substances, which may include risk assessment and risk management activities, if required. This will ensure that future decision making is based on the best available information. An electronic copy of the Notice is available at the following Web site: www.chemicalsubstanceschimiques.gc.ca. 1.2- Reportable substances Schedule 1 of the Notice lists 206 substances by their Chemical Abstracts Service Registry Number (CAS RN), which are listed in the table below. The substances are reportable under the Notice only if they have a size of between 1 and 100 nanometres, in at least one external dimension, or internal or surface structure, and if they are found in the list below. Please see section 2 of this document for more information on the reporting criteria CAS RN Name of the Substance 75-20-7 Calcium carbide (CaC2) 156-62-7 Cyanamide, calcium salt (1:1) 409-21-2 Silicon carbide (SiC) 471-34-1 Carbonic acid calcium salt (1:1) 592-01-8 Calcium cyanide (Ca(CN)2)
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