• Overview • Definitions • Guidance for implementation • References • Appendix 1, Table 1, chemical identity of Bisphenol A • Appendix 2, Table 1, chemical identity of Di(2-Ethylhexyl) Phthalate
Overview — Overview
Overview
Medical devices are classified into 1 of 4 classes, where Class I represents the lowest risk and Class IV represents the highest risk. Class II, III and IV medical devices must be licensed or authorized under Part 1.1 of the Regulations before they may be imported or sold in Canada. A medical device licence is issued to the device manufacturer for each application submitted, provided the requirements of the Medical Devices Regulations are met. Manufacturers must apply for an amended medical device licence when certain changes are made to a licensed Class II, III, or IV medical device.
Policy objective
This guidance provides information to manufacturers and regulatory correspondents on how to complete the forms for a new medical device licence, or an amendment to an existing medical device licence, for Class II, III, or IV medical devices.
Scope and application
This guidance applies to applications submitted for new medical device licences and amendments to existing device licences for Class II, III and IV medical devices. For information on preparing applications to be submitted under Part 1.1 of the Regulations, please refer to the Guidance on Medical devices for an urgent public health need.
Note about guidance documents in general
Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively. Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied by industry. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met. As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We must make sure that such requests are justifiable and that decisions are clearly documented. This document should be read in conjunction with the relevant sections of other applicable guidance documents.
Definitions — Definitions
Definitions
• Overview • Definitions • Guidance for implementation • References • Appendix 1, Table 1, chemical identity of Bisphenol A • Appendix 2, Table 1, chemical identity of Di(2-Ethylhexyl) Phthalate Bisphenol A [BPA; Phenol, 4,4’ -(1-methylethylidene)bis-]: An industrial raw material that was identified for screening assessment under the Canadian Environmental Protection Act. BPA is mainly used as a raw material in the production of polycarbonates and epoxy resins. BPA or BPA-based polymers are used in the manufacture of a variety of medical devices, including resin-based dental composite restorative and prosthodontic materials, dental sealants, hemodialyzers, hemofilters and blood oxygenators. Please refer to Appendix 1, Table 1 for the chemical identity of BPA, including its Chemical Abstracts Services (CAS) registry number and synonyms. Device ID: The device identification number assigned by Health Canada. This identification number appears on the issued licence or authorization. Note: A single device ID may encompass several device identifiers. Di(2-Ethylhexyl) Phthalate (DEHP): A chemical additive that is used to make polyvinyl chloride (PVC) soft, flexible and kink-resistant. PVC plasticized with DEHP is currently used in a variety of medical devices, including blood bags, catheters, intravenous tubing and medical gloves. A medical device is considered to contain DEHP if the amount of DEHP in the device is more than or equal to 0.1% of the device’s mass (that is, ≥0.1% w/w). Please see Appendix 2, Table 2 for the chemical identity of DEHP, including its Chemical Abstracts Services (CAS) registry number, synonyms and known trade names. Medical device: A device within the meaning of the Act, but does not include any device that is intended for use in relation to animals. Identifier: A unique series of letters or numbers (or any combination of these) or a bar code that is assigned to a medical device by the manufacturer and that identifies it and distinguishes it from similar devices. Note: Examples of an identifier for a device are a catalogue, model, part number or software version. Licence application type: The application may be submitted as a single device, system, test kit, device group, device family or device group family. The term “test kit” applies only to in vitro diagnostic devices. For more information on licence application types, refer to the guidance for determining medical device application type. Manufacturer: A person who: sells the medical device under their own name, or under a trademark, design, trade name or other name or mark owned or controlled by the person and is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose These tasks may be performed by that person or on their behalf. “Person” includes a partnership, firm or association. Near patient in vitro diagnostic device (IVDD): Is intended for use outside a laboratory, for testing at home or at the point-of-care, such as a pharmacy, a health care professional’s office or the bedside. Regulatory activity (or application): A collection of all regulatory transactions throughout the process of a specific activity. Regulatory transaction: Filing of any information package sent by a company as part of a regulatory activity such as initial data, unsolicited and solicited data (e.g. initial package for a new licence application, response to a clarification request, etc.). This does not include company name and/or address change, manufacturing facility change or transfer of ownership transactions.
Guidance for implementation — Guidance for implementation
• Overview • Definitions • Guidance for implementation • References • Appendix 1, Table 1, chemical identity of Bisphenol A • Appendix 2, Table 1, chemical identity of Di(2-Ethylhexyl) Phthalate
When a new medical device licence is required
Under the Medical Devices Regulations, a new device licence is a pre-market requirement for: • any new Class II, III, or IV device that was imported or sold in Canada after July 1, 1998 unless the device is authorized under Part 1.1 of the Regulations • a licensed device whose licence type is being modified from the type in the original licence application (see the guidance for determining medical device application type) • a device previously authorized for sale for investigational testing, or under the special access provisions of the Regulations, that is now to be offered for general sale
When a medical device licence amendment is required
As per Section 34 of the Regulations, if a manufacturer proposes to make one or more of the following changes, the manufacturer shall submit an application for a medical device licence amendment including the information and documents set out in section 32 that are relevant to the change: • (a) in the case of a Class III or IV medical device, a significant change; • (b) a change that would affect the class of the device; • (c) a change in the name of the manufacturer; • (d) a change in the name of the device; • (e) a change in the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family; • (f) in the case of a Class II medical device other than a decorative contact lens, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented. (a) Significant Change (Class III or IV) A significant change to a Class III or IV medical device requires an amendment to your medical device licence or Part 1.1 authorization. A significant change is any modification that could impact the safety, effectiveness, or quality of the device. Examples include: • Changes to design, materials, software, or sterilization • Modifications to manufacturing processes or facilities Please refer to the significant changes guidance document for information on how to interpret “significant change” of a medical device, this will help you determine whether a change proposed to a Class III or IV medical device is significant. (b) Change in Device Class A change that would affect the class of the device requires an amendment to your medical device licence. (c) Change in Manufacturer’s Name or Address A change in the name or address of the manufacturer requires an amendment to the medical device licence. Note that the term “manufacturer” is synonymous with the business or corporate entity who owns the trade name of the device licence. Only 1 manufacturer can own the trade name for a device licence in Canada. Once a change to the manufacturer’s name is processed, the previous manufacturer must stop selling all devices in Canada for which the ownership has been changed. (d) Change in Device Name A change in the name of the device requires an amendment. (e) Change in Device Identifier A change in the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family, requires an amendment. (f) Change in Medical Conditions, Purposes or Uses (Class II) In the case of a Class II medical device other than a decorative contact lens, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented requires an amendment. Common pitfalls in amendment submissions • Submitting incomplete documentation • Misclassifying changes (e.g. treating a significant change as minor) • Failing to assess cumulative impact of multiple changes When in doubt, consult Health Canada early in the process by submitting an email to meddevices-instrumentsmed@hc-sc.gc.ca.
Applying for a medical device licence or medical device licence amendment
Device classification The rules to classify medical devices are outlined in Schedule 1 (Parts 1 and 2) of the Regulations. Part 1 of Schedule 1 addresses medical devices other than in vitro diagnostics. Part 2 addresses in vitro diagnostic devices. For further guidance on the classification of medical devices, refer to the: • guidance on the risk-based classification system for non-in vitro diagnostic devices or • guidance for the risk-based classification system of in vitro diagnostic devices After ascertaining the class of the device, complete and submit your application via the Regulatory Enrolment Process (REP), which facilitates the filing and processing of regulatory information. REP uses XML files generated by web-based templates for transmission to Health Canada, instead of using PDF forms. Templates and forms are used to capture the necessary information related to company, dossier, transaction, and application information. Detailed information is included below on the information to be included in these templates/forms. For information on how to submit via REP please refer to the Guidance Document: Regulatory Enrolment Process (REP) for Medical Devices. Health Canada will process your application in accordance with the following Guidance on managing applications for medical device licences. Company Template (CO) The Company Template (CO) ensures that Health Canada has the most up-to-date company and contact information at all times. The company enrolment process must be completed prior to submitting an application for a medical device licence. Item 1: Address Information This is the name and address of the company. A complete address must include: • street name and number or post office box • city, province or state • postal or zip code • country Item 2: Company Representative Information This is the name and contact information for every representative from a respective company that Health Canada may be interacting with during the life cycle of a medical device licence, including any associated applications or amendments. A contact listed on this template must include: • full name and job title of the contact person • telephone number, and email address of the contact person • preferred official language of correspondence Item 3: Company Contact Designation A representative from each company must be designated for the following activities: • the designated renewal contact is the party that should be contacted/notified annually for licence renewal • the designated finance contact is the party that should be contacted for any questions or issues related to fees Dossier ID Request Form A dossier ID is required in subsequent REP templates to ensure that a regulatory transaction can be filed and transmitted to Health Canada through the Common Electronic Submission Gateway (CESG). Item 1: Manufacturer company and contact IDs This is the manufacturer of the device and the contact person at the location of the legal “manufacturer” to which the licence will be issued. The corresponding company and contact IDs can be found on the manufacturer’s final CO XML. Item 2: Regulatory company and contact IDs All regulatory correspondence will be sent to this contact (if different from the manufacturer contact ID), but the licence will be issued to the manufacturer. A third party may submit a medical device licence application. Third parties will be required to enroll their company for a Company Template (CO) prior, so that their assigned Company ID and Contact IDs can be used for this field. Item 3: Name of the device (as it appears on the label) The device name indicated for a system, medical device family or medical device group family must appear, at least in part, on the label of each member device. Only one name is to be entered. The device name on the application form will be used as the licence name unless the application is for a family of medical devices. In this case, a generic licence name that covers all possible trade names (for example, urinary catheters) should be used. The licence name usually reflects the types of devices that are contained within the licence and sometimes may vary from the device name. Item 4: Licence application type A manufacturer may apply for the following types of device licence: • Single medical device: Defined by a unique device name, sold as a distinctly packaged entity and does not meet the criteria for a medical device group, medical device family, medical device group family, system or test kit, and may be offered in a range of package sizes • Medical device family: A group of medical devices made by the same manufacturer that differ only in shape, colour, flavour or size, have the same design and manufacturing process and have the same intended use • Medical device group: A collection of medical devices, such as a procedure pack or tray, that is sold under a single name • Medical device group family: A collection of medical device groups that are made by the same manufacturer, have the same generic name specifying their intended use and differ only in the number and combination of products that comprise each group • System: A medical device comprising a number of components or parts intended to be used together to fulfil some or all of the device’s intended functions, and that is sold under a single name and manufactured by the same manufacturer • Test kit: An in vitro diagnostic device that consists of reagents or articles, or any combination of these, and is intended to be used to conduct a specific test For further assistance in ascertaining the appropriate licence application type for your product, please see the guidance for determining medical device application type. Regulatory Transaction Template (RT) The regulatory transaction template collects information pertaining to the regulatory activity and transaction (e.g. regulatory activity type, transaction description), including the designated regulatory contact for this submission. Item 1: Regulatory activity type The appropriate activity type should be selected to indicate the nature of the submission (e.g. amendment to an existing medical device licence). Activity types not listed are outside of the scope of REP and the corresponding guidance should be referred to for information on how to submit to Health Canada. Item 2: Invoicing information All invoicing and billing information will be sent to this contact. This person may be the same as the manufacturer contact, the regulatory contact, or it may be a third party. Third parties will be required to enroll their company for a Company Template (CO) prior, so that their assigned Company ID and Contact IDs can be used for this field. Application Information Template (AI) The application information template collects information related to the application and its corresponding devices. Item 1: Quality management system certificate Enter the MDSAP certificate number and the name of the recognized auditing organization that has issued the certificate. A legible copy of the certificate must accompany each new medical device licence application. For more information on the content and acceptance of quality management system certificates, please see the guidance on the content of ISO 13485 quality management system certificates issued by Health Canada recognized registrars (GD207). The certificate must be issued by a Health Canada-recognized auditing organization. Please see the current list of recognized auditing organizations. Item 2: Place of use Indicate on the application form by selecting yes or no as appropriate. Item 3: Medical devices containing drugs Non-IVD devices containing drugs If the device contains a drug or drug substance, which includes a pharmaceutical or biological drug, a biocide, or a natural health product, specify its: • brand or trade name • active ingredient(s) • manufacturer • drug identification number (DIN), biocide identification number, or natural product number (NPN) • Compliance with a pharmacopeia (if applicable) Medical device licences are issued in accordance with the Regulations. Manufacturers are responsible for ensuring compliance with any regulation(s) that may apply to the drug. Health Canada’s Drug/Medical Device Combination Products Policy addresses the regulation of products that contain both a drug and medical device if the distinctive nature of the drug component and device component is integrated in a singular product. Drug/medical device combination products are subject to either the Medical Devices Regulations or the Food and Drug Regulations according to the principal mechanism of action by which the claimed effect or purpose is achieved. Please contact Health Canada if you are unsure if your product is a combination product at drug.device.classification-drogue.instrument@hc-sc.gc.ca. IVDD test kits containing controlled substances If the device is a test kit containing a substance listed in Schedule I, II, III or IV of the Controlled Drugs and Substances Act, it would need to be registered with the Office of Controlled Substances. For information on the process for applying for a test kit registration number, please see the Office of Controlled Substances. Item 4: Device history Indicate if the device has been previously licensed under Part 1 of the Regulations or authorized for sale in Canada under the investigational testing, special access, Part 1.1, or interim order authorization provisions of the Regulations. A device that has been previously authorized for sale under the investigational testing provisions will have an associated application number. A device that has been previously authorized for sale under the special access provisions will have an associated SAP request number. A device that has been previously authorized for sale under the interim order or Part 1.1 provisions will have an associated Authorization ID number. Please supply the appropriate number. Item 5: Compatibility of interdependent devices For a device intended to be used with another Class II, III, or IV device, a list of all medical devices that this device is intended to be used or function with is required. Include their licence number as well. An important requirement in demonstrating compliance with the applicable requirements of sections 10 to 20 of all medical devices intended to be used together is compliance with section 18 of the Regulations. Section 18 requires that when medical devices are intended to be used with other medical devices, they must: • be compatible with every other medical device with which they interact and • not adversely affect the performance of the combination of medical devices Failure to submit compatibility information for interdependent medical devices may lead to delays in the pre-market review of device licence applications. The Medical Devices Directorate will need to request the necessary information. Manufacturers will also need to assemble the device information and submit it for review. Manufacturers are reminded that the submission of evidence of compatibility for inter-dependent medical devices is a requirement under the Regulations. See also the notice to industry, dated April 30, 2002, on the licensing requirements of interdependent medical devices. Item 6: List of recognized standards complied with in the manufacture of the device Conformance with recognized standards is voluntary for manufacturers. A manufacturer may choose to demonstrate conformance with a recognized standard or may address the relevant issues in another manner. Refer to the guidance on using standards to support compliance with the Medical Devices Regulations. For Class II licence applications, the manufacturer is to list the recognized standards complied with. Alternatively, the manufacturer is to attest that they possess objective evidence that the device either: • meets an equivalent or better standard or • has been tested and alternate evidence of compliance with the applicable requirements of sections 10 to 20 of the Regulations exists For Class III and IV licence applications, the manufacturer must respond “YES” to the questions in the application form where applicable and provide appropriate documentation: • if the device conforms with recognized standards, the manufacturer may provide a “declaration of conformity form” indicating the standard(s) or submit detailed information as evidence of compliance • if the device does not conform with the listed recognized standards, but meets an equivalent or better standard, the manufacturer may provide a “declaration of conformity form” to indicate these equivalent or better standards • if the device does not conform with the listed recognized standards or does not meet an equivalent or better standard, the manufacturer is to include detailed information as evidence of compliance with the applicable requirements of sections 10 to 20 of the Regulations. If the manufacturer does not comply with any of these 3 options, a licence will not be issued. Item 7: Devices containing biological material This section of the application form must be completed in detail. Item 8: Priority review Manufacturers may complete this section if they wish to request a priority review for their application. Priority review will be granted to a Class III or IV medical device licence or amendment application intended for the diagnosis or treatment of a serious, life-threatening or severely debilitating disease or condition. There must be substantial clinical evidence that the medical device: • provides effective treatment or diagnosis of a disease or condition for which no medical device is currently licensed in Canada • provides significant risk-benefit improvement over existing therapeutic or diagnostic devices for a disease or condition that is not adequately managed by existing products marketed in Canada or • responds to an unforeseen or unmet urgent health need Applications requesting priority review will be screened in accordance with the standard 15-day performance target. They will be reviewed in priority if they meet one of the above criteria. Depending on the complexity of the application or the novelty of the product, this might lead to a shorter time to market. The current fees and service standards for reviewing Class III and IV licence applications will still apply (60 and 75 days). Applicants will be notified at screening acceptance whether their application was accepted for priority review. Application Attestation Form A completed application attestation form must be included with each application. Ensure that the appropriate application type is selected prior to completing the attestation form. Item 1: Class II licence applications Attestation of compliance with the applicable requirements of sections 10 to 20 of the Regulations Manufacturers of Class II medical devices must attest that they have objective evidence establishing that they are compliant with section 10, subsections 11(1) and 12(1) and sections 13 to 20 of the Regulations. For decorative contact lenses, manufacturers must attest that they have objective evidence establishing that they meet section 10, subsections 11(2) and 12(2) and sections 13 to 17 of the Regulations. Attestation of investigational testing for in vitro diagnostic devices (IVDDs) Manufacturers of Class II near patient IVDDs must attest that investigational testing of their device was conducted: • using human subjects representative of the intended patients and • under conditions similar to the intended conditions of use of the device Near patient attestation Manufacturers must attest that the device is not a near patient IVDD, if applicable. Signature A senior official of the manufacturer of the device must sign and date the application attestation form. Item 2: Class III and IV licence applications Along with the application form, a manufacturer must attest that the information requested in section 32, subsection (3) or (4) of the Regulations is complete. Please refer also to the: • guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including in vitro diagnostic devices (IVDDs) Signature A senior official of the manufacturer of the device must sign and date the application attestation form. Device Details Spreadsheet A completed device details spreadsheet must be included with each application that adds, changes, or deletes a device from a medical device licence. Device name changes can also be made on this spreadsheet. Ensure that the regulatory activities requested in the application are selected on the first sheet of the device details spreadsheet and follow the instructions found at the top of each corresponding sheet. Item 1: Identifier of device Only devices, components, parts and accessories listed on the application will be considered for licensing. Class I devices and spare parts that do not represent medical devices on their own should not be listed. Please refer to Health Canada’s policy statement on the working definition for nanomaterial. The working definition indicates that a nanomaterial is a material within 1 to 100 nanometers in at least one dimension. However, for the purposes of medical device licensing, the Medical Devices Directorate is requesting notification for devices containing nano-scale materials with a particle size between 1 and 1,000 nanometers. Please identify the specific type of nano-scale material that is present in each device listed in the licence application. Examples of a specific type of nano-scale material could include: • nano titanium dioxide • nano silver • quantum dots • nano polymers • nano glasses • nano ceramics • carbon nanotubes • nano-fibres See the definitions of “BPA,” “DEHP” and “identifier” in this guidance document. It is the manufacturer’s responsibility to determine whether a medical device contains ≥0.1% w/w of DEHP or is manufactured from raw materials containing or derived from BPA. The absence of an acknowledgment for a specific device will be taken to indicate the device: • does not contain ≥0.1% w/w of DEHP or • is not manufactured from raw materials containing or derived from BPA Other Information Item 1: Purpose or intended use of device A clean copy of the latest version of the instructions for use/package insert that includes the intended purpose, indications for use, or conditions for use, must be submitted with the application. For licence amendments, if there are changes to the instructions for use/package insert, a red-lined version of the revised pages should be submitted. Item 2: Class II review documents For details on the content and format of documents for Class II medical devices, including the labelling material, refer to the: • Health Canada IMDRF table of contents for medical devices applications guidance For high-level disinfectant or sterilant solutions and/or contact lens disinfectants, provide an existing DIN for a marketed product (if applicable). If no DIN is provided, Health Canada will request evidence of safety and effectiveness under section 35(1) of the Regulations when reviewing the application. For information on the safety and effectiveness evidence for high-level disinfectants and sterilants, please refer to the: • Guidance document on the safety and effectiveness requirements for high-level disinfectants and sterilants for use on reusable semi-critical and critical medical devices For information on safety and effectiveness evidence for contact lens disinfectants, consider ISO standards related to contact lenses and contact lens care products. Item 3: Class III and IV review documents For details on the content and format of review documents for Class III and IV medical devices, please see the: • Health Canada IMDRF table of contents for medical devices applications guidance Items 4: Refer to the medical device licence application fee form Instructions are provided on the fee form. They must be carefully followed to avoid delays in the processing of your application. Please also see the: • guidance document on fees for reviewing medical device applications
Before submitting a medical device licence application
Before submitting a new medical device licence application or medical device licence amendment application, make sure you: 1. Complete the device licence REP application forms and fee form. You may choose to have a regulatory correspondent complete and submit the application on your behalf. 2. Sign the application form, certifying that all the information in the application is accurate and complete. 3. Submit the quality management system certificate with the application. You or your regulatory correspondent may file the application and any supporting documentation using the Regulatory Enrolment Process (REP) and submit to Health Canada through the Common Electronic Submission Gateway (CESG).
References — References
References
• Overview • Definitions • Guidance for implementation • References • Appendix 1, Table 1, chemical identity of Bisphenol A • Appendix 2, Table 1, chemical identity of Di(2-Ethylhexyl) Phthalate • Cadogan D, Howick C. 1996. Plasticizers. In: Kroschwitz J, Howe-Grant M, eds. Kirk-Othmer Encyclopedia of Chemical Technology. New York: John Wiley & Sons Inc., 258-290. • Canada. 1999. Canadian Environmental Protection Act, 1999. S.C., 1999, c. 33, Canada Gazette Part III. Vol. 22, No. 3. Available from: Canada Gazette. • Howard PH, Meylan WM. 1997. Handbook of Physical Properties of Organic Chemicals. Boca Raton, FL: Lewis Publishers. • HSDB. July 18, 1990. Hazardous Substances Data Bank. National Library of Medicine, National Toxicology Information Program, Bethesda, MD. • Montgomery JH, Welkom LM. 1990. Groundwater Chemicals Desk Reference. Chelsea, MI: Lewis Publishers, Inc., 93-95. • RTECS. February 2000. Registry of Toxic Effects of Chemical Substances. National Library of Medicine, National Toxicology Information Program, Bethesda, MD.
Appendix 1, table 1, chemical identity of Bisphenol A — Appendix 1, table 1, chemical identity of Bisphenol A
Appendix 1 — Bisphenol A
• Overview • Definitions • Guidance for implementation • References • Appendix 1, Table 1, chemical identity of Bisphenol A • Appendix 2, Table 1, chemical identity of Di(2-Ethylhexyl) Phthalate Characteristic | Information Chemical Abstracts Services (CAS) Registry Number | 80-05-7 Domestic Substances List name | phenol, 4,4' -(1-methylethylidene)bis- National Chemical Inventories (NCI) namesTable 1 Footnote * | phenol, 4,4'-(1-methylethylidene)bis- (TSCA, PICCS, ASIA-PAC) 4,4'-isopropylidenediphenol (EINECS, PICCS) 2,2-Bis(4'-hydroxyphenyl) propane (ENCS) phenol, 4,4'-(1-methylethylidene)bis- (AICS, PICCS) 4,4'-(1-Methylethylidene)bisphenol (ECL) 4,4'-Bisphenol A (ECL) phenol, 4,4'-(1-methylethylidene)bis- (SWISS) bisphenol A (SWISS, PICCS) p,p'-isopropylidene diphenol (PICCS) diphenol methylethylidene (PICCS) bis[phenol], 4,4'-(1-methylethylidene)- (PICCS) bisphenol-a (PICCS) bisphenol, 4,4'-(1-methylethylidene)- (PICCS) 4,4-isopropylidene diphenyl (PICCS) 4,4'-dihydroxyphenyl-2,2-propane (PICCS) 2,2-di(4-hydroxyphenyl)propane (PICCS) 2,2-di(4-hydroxyphenyl) propane (PICCS) 2,2-bis-(4-hydroxy-phenyl)-propane (PICCS) Other names | bisphenol A diphenylolpropane BPA Chemical group | Discrete organics Chemical subgroup | Phenols Chemical formula | C15H16O2 Chemical structure | [Image: Chemical structure — https://www.canada.ca/content/dam/hc-sc/images/services/drugs-health-products/medical-devices/application-information/guidance-documents/application-new-amended-licence/appendix1/app1-ann1-equation.jpg] SMILES | Oc(ccc(c1)C(c(ccc(O)c2)c2)(C)C)c1 Table 1 Footnote * National Chemical Inventories (NCI) 2006: AICS (Australian Inventory of Chemical Substances) ASIA-PAC (Asia-Pacific Substances Lists)_Toc173920654 ECL (Korean Existing Chemicals List) EINECS (European Inventory of Existing Commercial Chemical Substances) ENCS (Japanese Existing and New Chemical Substances) PICCS (Philippine Inventory of Chemicals and Chemical Substances) SWISS (Inventory of Newly Notified Substances and Giflist 1 - List of Toxic Substances) TSCA (Toxic Substances Control Act Chemical Substance Inventory) Table 1 Return to footnote * referrer | Table 1 Footnote * National Chemical Inventories (NCI) 2006: AICS (Australian Inventory of Chemical Substances) ASIA-PAC (Asia-Pacific Substances Lists)_Toc173920654 ECL (Korean Existing Chemicals List) EINECS (European Inventory of Existing Commercial Chemical Substances) ENCS (Japanese Existing and New Chemical Substances) PICCS (Philippine Inventory of Chemicals and Chemical Substances) SWISS (Inventory of Newly Notified Substances and Giflist 1 - List of Toxic Substances) TSCA (Toxic Substances Control Act Chemical Substance Inventory) Table 1 Return to footnote * referrer
Appendix 2, table 1, chemical identity of Di(2-Ethylhexyl) Phthalate — Appendix 2, table 1, chemical identity of Di(2-Ethylhexyl) Phthalate
Appendix 2 — Di(2-Ethylhexyl) Phthalate
• Overview • Definitions • Guidance for implementation • References • Appendix 1, Table 1, chemical identity of Bisphenol A • Appendix 2, Table 1, chemical identity of Di(2-Ethylhexyl) Phthalate Characteristic | Information | Reference Chemical name | di(2-ethylhexyl) phthalate | RTECS 2000 Synonyms | DEHP dioctylphthalate bis(2-ethylhexyl) phthalate | RTECS 2000 Registered trade names | Bisoflex 81 Eviplast 80 Octoil Plantinol DOP Staflex DOP | RTECS 2000 Chemical formula | C24H38O4 | RTECS 2000 Chemical structure | [Image: Chemical structure — https://www.canada.ca/content/dam/hc-sc/images/services/drugs-health-products/medical-devices/application-information/guidance-documents/application-new-amended-licence/appendix2/app2-ann2-equation.jpg] | Howard and Meylan, 1997 Identification numbers: | Identification numbers: | Identification numbers: CAS Registry Number | 117-81-7 | Cadogan and Howick, 1996 NIOSH RTECS | TI0350000 | RTECS 2000 EPA hazardous waste | U028 | HSDB 1990 OHM/TADS | 7216693 | HSDB 1990 DOT/UN/NA/IMCO shipping | No data | HSDB 1990 HSDB | 334 | Montgomery and Welkom, 1990 NCI | C52733 | No data CAS = Chemical Abstracts Services DOT/UN/NA/IMCO = Department of Transportation/United Nations/North America/International Maritime Dangerous Goods Code EPA = Environmental Protection Agency HSDB = Hazardous Substances Data Bank NCI = National Cancer Institute NIOSH = National Institute for Occupational Safety and Health OHM/TADS = Oil and Hazardous Materials/Technical Assistance Data System RTECS = Registry of Toxic Effects of Chemical Substances | CAS = Chemical Abstracts Services DOT/UN/NA/IMCO = Department of Transportation/United Nations/North America/International Maritime Dangerous Goods Code EPA = Environmental Protection Agency HSDB = Hazardous Substances Data Bank NCI = National Cancer Institute NIOSH = National Institute for Occupational Safety and Health OHM/TADS = Oil and Hazardous Materials/Technical Assistance Data System RTECS = Registry of Toxic Effects of Chemical Substances | CAS = Chemical Abstracts Services DOT/UN/NA/IMCO = Department of Transportation/United Nations/North America/International Maritime Dangerous Goods Code EPA = Environmental Protection Agency HSDB = Hazardous Substances Data Bank NCI = National Cancer Institute NIOSH = National Institute for Occupational Safety and Health OHM/TADS = Oil and Hazardous Materials/Technical Assistance Data System RTECS = Registry of Toxic Effects of Chemical Substances
