September 2015 Microbeads s.71 Walk-through Webinar- Speaking Notes Title slide (1) Hello, welcome to the overview of the Section 71 Notice with respect to microbeads in certain personal care applications. My name is Angelique Petropoulos from Environment Canada, and I will be your presenter today. This presentation will walk through the mandatory notice that was published on August 1st under section 71 of the Canadian Environmental Protection Act. All hyperlinks embedded in this presentation are functional and can be accessed through the downloadable PDF version of the presentation. Questions regarding this session may be sent to the Substances Management Coordinator and the contact information will be provided to you at the end of the presentation. Overview (2) We will give you an overview of section 71 of the Canadian Environmental Protection Act, referred to from here on as CEPA 1999. Following that, we will go through the mandatory notice itself, looking at who it applies to and the type of information that is required, as well as how to respond to the Notice. Contact information is also provided for any additional questions you may have. Section 71 of CEPA 1999 (3) Under section 71 of CEPA 1999, the Government can issue notices to gather information that is required to support the risk assessment and risk management of substances. If you are subject to the Notice, you are legally required to provide the information requested by the date specified. You are required to provide information in your possession or to which you are reasonably expected to have access, but you are not required to conduct testing to comply with this Notice. 1 September 2015 Microbeads s.71 Walk-through Webinar- Speaking Notes Examples of the type of information that a company is reasonably expected to have access to include import data and records, Safety Data Sheets and information from suppliers. Overview of the Notice (4) On August 1st, 2015, a Notice was published under section 71 of CEPA for microbeads in certain personal care applications. The deadline to respond to the Notice is October 15th, 2015 at 5 p.m. Eastern Daylight Time. An electronic copy of the Notice along with the supporting Guidance Document and the link to Environment Canada’s Single Window are available at the Chemical Substances Website. We highly recommend reading the guidance document as it contains details and examples that will help you better understand this Notice. Overview of the Notice cont’d (5) The Notice applies to microbeads which meet the following definition, found in Schedule 1 of the Notice: o microbeads are synthetic polymer particles that, at the time of their manufacture, are greater than 0.1 micrometers and less than or equal to 5 millimetres in size o It applies to particles that are solid at room temperature or 25 degrees Celsius. o The term synthetic means man-made and does not apply to ‘naturally occurring’ polymers, where o Naturally occurring means unprocessed, or substances that are processed only by manual, gravitational or mechanical means, by dissolution in water, by flotation or by heating solely to remove water; or extracted from air by any means. Persons Required to Provide Information (6) Schedule 2 of the Notice describes to whom the Notice applies, based on factors such as: type of activity with microbeads, for example import; calendar year of the activity; and the quantity of microbeads or mixtures or products containing microbeads. The Notice applies to any person who, during the 2014 calendar year, imported a total quantity greater than 10 kg of microbeads defined in Schedule 1 of the Notice. 2 September 2015 Microbeads s.71 Walk-through Webinar- Speaking Notes The Notice also applies to any person who, during the 2014 calendar year, exported a total quantity greater than 10 kg of microbeads defined in Schedule 1 of the Notice. Persons Required to Provide Information (cont’d) (7) The Notice also applies to any person who, during the 2014 calendar year, used a total quantity greater than 10 kg of microbeads defined in Schedule 1 of the Notice, in the manufacture of a mixture or product. For all of these activities (import, export and use), the mixtures and products must be intended to be applied to the human body for the purpose of exfoliating or cleansing, and the conditions of use are such that the substance may be released to water. Note that in this Notice, “use” refers to formulation activities, that is, using the substance alone to formulate a mixture or product. Responses should be submitted using the CMP online reporting system through Environment Canada’s Single Window. Information on how to submit your response will be provided later in the presentation. Note, when responding to the Notice, that if you have more than one facility, you must include information with respect to each facility in a single response on behalf of the entire company. Reporting Diagram for Microbeads (8) To help determine whether you are required to respond to the Notice, a Reporting Diagram is provided here and in the Guidance Document. Note that you can download the Guidance Document from the Chemical Substances website. Let’s take a look at the diagram. First, you need to determine if you had activities with microbeads as defined in Schedule 1 of the Notice during the 2014 calendar year. The first question asks about your activity and applies to 3 different activities: - Persons or companies, who imported, or exported mixtures or products intended for exfoliating or cleansing containing microbeads; and - Persons or companies, who used microbeads in the manufacture of mixtures or products intended for exfoliating or cleansing. If you answered “yes” to either of these questions, then the next question to consider is whether the total quantity of microbeads or a mixture or product containing microbeads that was imported, exported or used in 2014 met the reporting threshold. 3 September 2015 Microbeads s.71 Walk-through Webinar- Speaking Notes - This Notice applies to microbeads, or a mixture or product containing microbeads that were imported, exported or used in a total quantity greater than 10 kg during the 2014 calendar year. If you are an importer or exporter of a mixture or product containing microbeads as defined in Schedule 1 and you answered ‘yes’ to the two questions, then you are required to respond to the Notice. If you are a user of microbeads, or a mixture or product containing microbeads as defined in Schedule 1, that is used to manufacture a mixture or product intended for use in exfoliating or cleansing, and you answered ‘yes’ to the two questions, then you are required to respond to the Notice. If you answered “no” to at least one of the questions, then you are not legally required to respond, however we encourage you to submit a voluntary Declaration of Stakeholder Interest or Declaration of Non-Engagement as applicable. These declarations will be discussed later in the presentation. Exclusions (9) The list of exclusions is found in Schedule 2 of the Notice. This Notice does not apply to microbeads as defined in Schedule 1, whether alone, in a mixture or in a product that: are in transit through Canada; are or are contained in, a substance or product regulated or registered under the: - Regulations for the Export and Import of Hazardous Waste and Hazardous Recyclable Material, - Pest Control Products Act, or - Fertilizers Act; are, or are contained in, a prescription drug within the meaning of “prescription drug” under The Food and Drug Regulations. Or Exclusions (cont’d) (10) As written in Schedule 3 of the Notice, where information required has already been submitted to the Minister of the Environment, or to the Minister of Health, it may be relied on as a response to any question in the Notice if: - the person agrees that the previously submitted information is their response to Schedule 3 to this Notice; and - the person identifies the program at Environment Canada or at Health Canada to which the information was previously submitted. 4 September 2015 Microbeads s.71 Walk-through Webinar- Speaking Notes Also, it is not necessary to report if: - a person solely imports, exports or manufactures microbeads alone and they do not use them in formulation activities. Information Required (11) Schedule 3 of the Notice lists definitions applicable to the Notice, and outlines the information that is required to be provided. If a company meets the reporting requirements, they have to complete the sections of the Notice related to their activities with the substance. This table is included in the guidance document and is designed to assist you in finding out which sections must be completed based on your activity. Section 5 of Schedule 3 (12) We will now walk through each specific section in the Notice and provide an explanation about how the information required should be provided. Section 5 is to be completed by importers and exporters and requires consumer and commercial information, concentration, proportion and Stock Keeping Unit information. The information required is as follows: The consumer and commercial codes that apply to the mixture or product containing microbeads as defined in Schedule 1. o These codes are listed in section 8 of the Notice and section 3.1.2 of the guidance document. o If none of the consumer and commercial codes apply to the substance, code C999 should be used, and a written description must be provided. o A written description is also required for codes C563 and C564. For each applicable consumer and commercial code listed, the total quantity of the mixture or product is required in kilograms; note that importers and exporters are not expected to report the quantity of microbeads alone. For each applicable consumer and commercial code listed, the concentration or range of concentrations by weight of microbeads in the mixture or product is required; For each applicable consumer and commercial code listed, the proportion or range of proportions, in percentage, of microbeads in the mixture or product that is used for exfoliating or cleansing purposes is required; and 5 September 2015 Microbeads s.71 Walk-through Webinar- Speaking Notes For each applicable consumer and commercial code listed, the number of distinct saleable stock keeping units, or SKUs, that contain microbeads is required. Stock Keeping Units are assigned by a company to individual products to track inventory. For example, if a person imported four different face wash products containing microbeads, each would have a distinct SKU, so there would be four individual SKUs. Section 6 of Schedule 3 (13) Section 6 is to be completed by users. The information required is as follows: The consumer and commercial codes that apply to the mixture or product containing microbeads as defined in Schedule 1. o These codes are listed in section 8 of the Notice and section 3.1.2 of the guidance document. o If none of the consumer and commercial codes apply to the substance, code C999 should be used, and a written description must be provided. o A written description is also required for codes C563 and C564. For each applicable consumer and commercial code listed, the total quantity of microbeads is required in kilograms; note that this differs from what is reported for import and export activities. For each applicable consumer and commercial code listed, the concentration or range of concentrations, by weight, of microbeads in the mixture or product is required; and For each applicable consumer and commercial code listed, the number of distinct saleable stock keeping units, or SKUs, that contain microbeads is required. Section 7 of Schedule 3 (14) Section 7 has to be completed by all reporters and requires information on company size. The information required is as follows: - the number of employees, including contract employees, of the business; and - the company-wide gross annual receipts for the 2014 calendar year. 6 September 2015 Microbeads s.71 Walk-through Webinar- Speaking Notes Request for Confidentiality (15) Section 313 of CEPA 1999 specifies that anyone who submits information in response to a section 71 Notice may request that the information submitted be treated as confidential. The Guidance Document can be consulted for more information on Requests for Confidentiality. Joint Reporting (16) Suppliers, who sell products containing reportable substances and who wish to protect their formulation information, may work with their customers to submit a blind submission. A “Blind Submission” is a two-part submission where customers and their suppliers collaborate to meet the obligation to respond to the Notice. The customer provides as much information as they can in response to the Notice, while the supplier submits the remainder of the information, in a separate submission. Submission from each party should be submitted directly to the Substances Management Coordinator. Contact information is available at the end of the presentation. A cover letter should be included with both submissions to clarify that the supplier’s submission supports the customer’s submission. Blind submissions can be submitted using the Excel Reporting Form, available online. They can be submitted to the Substances Management Coordinator by email or mail. A “Joint Submission” is a single submission encompassing information from multiple submitters. The most common examples are an association submitting on behalf of their members, or major suppliers submitting on behalf of their customers. For more information or to discuss options for joint reporting, please contact the Substances Management Coordinator. 7 September 2015 Microbeads s.71 Walk-through Webinar- Speaking Notes Responding to the Section 71 Notice (17) If you meet the reporting requirements to respond to the Notice, you must provide a response no later than October 15th, 2015 at 5 p.m. Eastern Daylight Time. Responses should be submitted using Environment Canada’s Single Window Information System, elsewhere referred to as ‘reporting system’. If additional time is required you may apply for an extension by sending a request in writing to the Substances Management Coordinator at: substances@eg.gc.ca Extensions for the microbeads Notice will only be granted in exceptional circumstances and for a short period of time The request needs to be submitted by email or mail prior to October 15th, 2015 at 5 p.m. Eastern Daylight Time The request should include a brief rationale for the extension request, and the full company name and contact information We recommend that you submit your request at least 5 business days prior to the deadline to allow for processing. You are encouraged to refer to the Guidance document for completing the section 71 Notice, available on the chemical substances website and for more detailed guidance and examples on how to complete the required sections. Declaration of Stakeholder Interest (18) Completing the section 71 Notice is mandatory, if you meet the reporting criteria. Companies who do not meet the reporting criteria, but who have an interest in microbeads, are encouraged to voluntarily identify themselves as a stakeholder through the Declaration of Stakeholder Interest. For this Notice, submitters are invited to report interest, provide information or upload documents on the substances using the Environment Canada Single Window reporting system. Stakeholders completing the declaration should: o specify their known or potential activity with microbeads (for example import, manufacture or use); and o indicate whether their interest in microbeads is a past, current or future interest. Interested stakeholders may be contacted for further information regarding their interest in microbeads. Submission of Voluntary Information (19) 8 September 2015 Microbeads s.71 Walk-through Webinar- Speaking Notes Additional information can be submitted through a Declaration of Stakeholder Interest. - For example, if you did not have reportable activity in 2014, but had in previous calendar years, you are encouraged to provide this information voluntarily via a Declaration of Stakeholder Interest. Voluntary or supplementary data can be submitted through an open text field or by uploading documents. - When submitting data voluntarily, clearly identify the data as voluntary and provide the appropriate calendar year for which it applies. You are encouraged to provide additional information that is deemed beneficial for the program. Declaration of Non-Engagement (20) Another type of voluntary submission is the Declaration of Non-Engagement, which companies can submit to indicate that they were not engaged in the activities described in the s.71 Notice. You should only submit a DNE if you did not meet the reporting requirements to respond to the Notice and if you have no commercial interest in microbeads defined in Schedule 1 of the Notice. Conversely, if you have a current or future interest in microbeads, then you should submit the Declaration of Stakeholder Interest. How to Submit a Response (21) On the Chemical Substances website, you will find links to the Notice, associated guidance document, and CMP online reporting system. Responses to the Section 71 notice, Declaration of Stakeholder Interest, and Declaration of Non-Engagement should be completed electronically using the online reporting system available through Environment Canada’s Single Window to respond to the Notice. You must download the Excel reporting form from Single Window, and upload it back into the online reporting system once it’s completed. Guidance on Environment Canada’s Single Window is available online and a new CMP online reporting “How-To” guide has been developed. Although a link exists for the “How-To” guide, it links to the previous version so the updated version must be requested from Substances@ec.gc.ca. Please include “Request: CMP Online Reporting How-To guide” as a subject of your email. Contact Information (22) 9 September 2015 Microbeads s.71 Walk-through Webinar- Speaking Notes Any questions on how to complete the Notice should be sent to the Substances Management Coordinator. When submitting a question, clearly indicate “Microbeads Inquiry” in the subject line of your email, or in your call or voicemail. Please note that there have been ongoing phone issues and if you have not heard back in 3 days, please email the Substances Management Coordinator. Thank you! (23) That concludes our presentation on the Notice with respect to microbeads in certain personal care applications. Thank you! 10