ISSUE UPDATE 2017 Inventory Update & Revised In-Commerce List (R-ICL) Prioritization Section 71 Survey

Transcription

1 ISSUE UPDATE 2017 Inventory Update & Revised In-Commerce List (R-ICL) Prioritization Section 71 Survey Date: February 8, 2017 To: Subject: CCTFA Brand Owners, Distributors, Custom Manufacturers, Regulatory Consultants 2017 Inventory Update & Revised In-Commerce List (R-ICL) Prioritization Section 71 Survey Background On January 14, the Government of Canada published the 2017 Inventory Update survey seeking to collect updated use and volume information pertaining to existing substances priorities identified under the Canadian Chemicals Management Plan (CMP). The survey targets approximately 1430 substances [Schedule 1]. This is a mandatory survey issued under Section 71 of the Canadian Environmental Protection Act, The survey can be found at: The purpose of this extensive survey [Parts 1 3] is to confirm the current commercial status of these substances in Canada to inform corresponding prioritization efforts and support future risk assessment and management activities under the CMP. Furthermore, this survey [Part 4] also is intended to confirm the current commercial status of select substances identified on the Revised In-Commerce List (R-ICL) for the purposes of prioritization for further assessment under the CMP. Does this Notice apply to you? (Implications for the Personal Care Products Industry) The onus of this survey is specifically on the manufacture or import of any of the identified substances [Schedule 1], whether alone, in a mixture or in specific manufactured items (see below), during the 2014 or 2015 reporting calendar year in excess of the minimum reporting thresholds as identified below. The survey is divided into several parts. Parts 1 3 are related to CMP inventory update considerations. Part 4 is specific to the R-ICL prioritization program recently initiated under the CMP. To assist you in determining if this Notice applies to you, review the following criteria: 1. Did you manufacture a total quantity greater than 100 kg of any of the substances identified under Schedule 1 Parts 1, 2, 3 in 2014 or 2015? 2. Did you import a total quantity greater than 100 kg of any of the substances identified under Schedule 1 Parts 1, 2, 3 in 2014 or 2015: a) Alone; 1

2 b) At a concentration equal to or above 0.1% by weight in a mixture or product; or c) Listed in Schedule 1 Part 3 at a concentration equal to or above 0.1% in a manufactured item that is: Intended to be used by or for children under the age of 6 years Intended to come into contact with the mucosa of an individual, other than eyes Intended to release this substance during conditions of use such that the substance may be inhaled or come into dermal contact with an individual 3. Did you manufacture or import a total quantity greater than 100 kg of any substances identified under Schedule 1 Part 4 that is a: a) Cosmetic; b) Food; c) Therapeutic product; or d) Natural Health Product Subject to the Food and Drugs Act or is intended to be a component of such products? IMPORTANT NOTE: As presently drafted, there is no explicit di minimis reporting criteria specified under Part 4. CCTFA is presently working with Health Canada officials to clarify a minimum reporting concentration (for incidental presence). The reason why the minimum reporting concentration was eliminated for this Section is that several of the reportable substances (active pharmaceutical ingredients) are intentionally used at relatively low concentrations (below 0.1%). Although we understand this consideration, it remains clear that the policy intent (i.e. prioritization) was not necessarily to focus on incidentally low concentrations. Look for a follow-up update from CCTFA as we look to affirm with officials how to approach these considerations, moving forward. If you answer YES to ANY of these criteria this Notice applies to you. Note: Any party meeting the reporting criteria on any given substance is legally obligated to respond to the survey. Although this survey covers a large number of substances, it is important to note that not all of the approximately 1430 priorities identified would be of interest from a personal care perspective. 2

3 What do you need to do if the Notice applies to you? [Schedule 3] If you meet the criteria set out in Schedule 2 (listed above) for both the 2014 and 2015 calendar years you shall provide information prescribed in Schedule 3 for only the 2015 calendar year. If you provided information under the New Substances Notification Regulations under the Canadian Environmental Protection Act, 1999 for a substance listed in Schedule 1 Part 4, you are not required to respond to the Notice for that substance. This is a tiered survey with different reporting requirements corresponding to specific activities. On this basis, the types of information that are required to be provided vary. Parts 1 and 3 Part 2 product, a substance notifiers are required to respond to this mandatory survey and provide the information outlined under sections 4, 5, 6, 7, and 8 product, notifiers are required to respond to this mandatory survey and provide the information outlined under sections 4, 5, 6, 7, 8, and 9 Part 4 product, notifiers are required to respond to this mandatory survey and provide the information outlined under sections 4, 5, 6, 7, 8, and 9 Parts 3 and 4 - Meeting the reporting threshold (> 100 kg); imported in a manufactured item, notifiers are required to respond to this mandatory survey and provide the information outlined under sections 4, 5, 10, and 3 Note: This survey is substance-specific NOT site specific. Therefore, if you have more than one implicated facility in Canada, a single consolidated survey response should be filed covering all relevant corresponding activities (i.e. TOTAL consolidated use volume by substance for any given notifier). What are the designated manufactured articles covered under this survey? This survey only extends to a specific subset of manufactured articles of concern as identified by the Government of Canada. From the personal care products industry perspective, only the following designated manufactured article categories would apply: Intended to come into contact with the mucosa of an individual, other than eyes (therefore, manufactured items such as applicator wands would be exempt from notification) [Sections 1 and 2(ii), Schedule 2] 3

4 Intended to release the substance during conditions of use such that the substance may be inhaled or come into dermal contact with an individual [Sections 1 and 2(vi), Schedule 2] For the full list of designated manufactured items covered in the survey, notifiers are directed to review Sections 3 (c) under Schedule 2 of the survey notice. Survey Completion Notifiers are required to provide survey responses filed through Environment Canada s singlewindow (SWIM electronic reporting) portal at: Notifiers are required to respond to this mandatory survey within a 6-month reporting window. All survey responses are required to be filed on or before July 17, 2017 [3:00 PM EDT]. Declaration(s) of Stakeholder Interest OR Non-Engagement Parties who do not meet the reporting criteria outlined in this survey Notice, but who have current or potential future investigative or commercial interests in any of the designated substances (i.e. below the reporting thresholds) are encouraged to file a voluntary Declaration of Stakeholder Interest to ensure that they receive any follow-up correspondence that may pertain to the identified substances of interest. Parties who do not anticipate having any current or future commercial interest in any of the designated substances can file a voluntary Declaration of Non-Engagement which will serve as an indicator to the Government of Canada that you do not anticipate any interest on any of these designated substances. Requests for Extension Written requests for extensions can be submitted to seek addition time to complete this survey. Requests for extension must be submitted in writing prior to the close of the official reporting window, and must include a rationale in support of the request. Requests should be directed to the Substances Management Coordinator via the Substances Management Information Line (eccc.substances.eccc@canada.ca) Additional Tools INCI Cross-Reference This survey covers a large number of substances. To facilitate the identification of substances that MAY BE of interest to the personal care industry, CCTFA has conducted a cross referencing exercise comparing the Inventory Update substance list [SCHEDULE 1] with the INCI database. Note: The output from this cross-referencing exercise is not intended to be exhaustive and is only intended to help members identify some of the substances that may be of interest in the context of this survey. To be comprehensive, we recommend that members conduct cross-referencing exercises with their own product and/or raw material databases. 4

5 Need Additional Help? Consult the Inventory Update Guidance Document published in conjunction with this mandatory survey: Contact the Government of Canada s Substances Management Information Line: Telephone: OR eccc.substances.eccc@canada.ca Contact your CCTFA Regulatory Team: regulatory@cctfa.ca Your 2017 Inventory Update Checklist Identify designated substances of interest to your company. Cross-reference 2017 Inventory Update substance list to your product/raw material inventories/databases Verify if you have any reportable manufactured articles to take into account in your survey activities Identify substances of interest that exceed the reporting threshold (remember that the survey is substance specific not site or product specific; threshold applies to the TOTAL consolidated volumes for any given substance of interest to a given notifier) Determine if reportable chemicals meet the use concentration threshold Identify substances of interest that exceed the reporting threshold Complete and submit survey Complete Stakeholder Engagement or Non-Engagement Declarations (as appropriate) 5