It is vital that every one of your staff members are aware of the current regulations and actually, the future of your business depends on it!

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Fact Sheet – Flavours

Fact Sheet – Nicotine Content and Health Benefit Claims

Fact Sheet – Promotions

Fact Sheet – Youth

Canada Consumer Product Safety Act – Info Sheet

Food and Drugs – Info Sheet

• Vaping products are regulated under TVPA and CCPSA unless therapeutic health claims are made. If therapeutic health claims are made, the product automatically falls under FDA regulations.
• It is prohibited to manufacture, import, advertise, or sell a consumer product that does not meet the requirements set out in regulations under the CCPSA. Consumer Chemicals and Containers regulations apply to vaping products, and other regulations may apply.
• As an interim measure, vaping devices with refillable tanks and other vaping device parts that hold or may hold vaping liquids with nicotine have been excluded from the scope of CCCR 2001 by subsection 4(4) of the CCPSA
• All products that contain 0.1mg/g of Nicotine to 65.9mg/g of Nicotine must follow the appropriate CCCR 2001 regulations for labeling a toxic product. Sale of Nicotine products over 66mg/g is illegal.
• Vaping products are subject to CCPSA enforcement AS OF MAY 23rd^, 2018
• ALL PRODUCT ON SHELVES AT THIS TIME THAT ARE NOT COMPLIANT TO CCPSA AND CCCR,2001 STANDARDS CANNOT BE LEGALLY SOLD IN CANADA.

Enforcement of CCPSA Regulations

Enforcement of these regulations is currently in effect. Inspections are aimed at verifying compliance of a consumer product and helping to prevent non-compliance. You are encouraged to ask your inspectors questions. They can provide references and documents to help you understand your obligations.

Inspectors may:

• Inspect locations where consumer product is manufactured, imported, or sold
• Verify that industry is compliant with applicable requirements under the CCPSA and its regulations
• Work with the industry to correct or remove products from the market that are non-compliant with the law
• Verify that required records are prepared and maintained.

In situations where compliance does not seem to be met or is questionable, Health Canada Can:

• Request suppliers to test or provide studies on product to verify compliances
• Work with suppliers to carry out product recalls and to take other corrective actions
• Issue orders to stop the manufacturing, importation, sale, etc. of a product or recall a dangerous product
• Inspect products, documents, or materials
• Disclose personal or business information, under specific criteria
• Prosecute as a criminal offence or apply Administrative Monetary Penalties.

Industry Responsibilities

• All manufacturers, importers, retailers, etc. are responsible for ensuring products they bring to market comply with the CCPSA and its regulations
• Making sure the products that they manufacture, import, advertise, or sell on the Canadian market do not pose a “danger to human health or safety”
• Keeping records to allow traceability of products within the distribution chain
  • Retailers: prepare and maintain documents that indicate the name and address of the person from whom they obtained the product, the location where they sold the product and the period during which they sold the product
  • Manufactures, Importers, Advertisers, sales, and tests: prepare and maintain documents that indicate the name and address of the person from whom they obtained the product or the person to whom they sold it, or both.
  • Keep these records for 6 years after the end if they year which they relate to
• Reporting of health or safety incidents with their consumer products
  • Any occurrences in Canada or elsewhere that resulted or may reasonably have been expected to result in an individuals’ death or serious adverse effects of their health, including serious injury
  • Defect or characteristic that may reasonably be expected to result in an individuals’ death or serious adverse effects of their health, including serious injury
  • Incorrect or insufficient information on a label or in instructions, or the lack of label instructions, that may reasonably be expected to result in an individuals death or serious adverse effects on their health, including serious injury
  • A recall measure that is initiated for human health or safety reasons by another jurisdiction or regulator (i.e. a recall in the USA of a product also sold in Canada)

Online Resources

Reporting Incidents to Health Canada:

www.canada.ca/report-a-product

Health Canada Vaping Website:

www.canada.ca/en/health-canada/services/smoking-tobacco/vaping.html

Guidance for vaping products not marketed for a therapeutic use:

www.canada.ca/en/health-canada/services/publications/product-safety/vaping-not-marketed-therapeutic-use.html

For more questions:

Hc.tcp.questions-plt.sc@canada.ca

Or call 1-866-318-1116 Toll Free

On Wednesday April 25, 2018 ECTA had the opportunity for a 1 ½ hour sit-down meeting with Health Canada. This meeting took place at 3pm at the Main Statistics Canada Building in Ottawa Ontario. ECTA was represented by ECTA President Daniel David, Board of Directors member Mike Meathrel, and Compliance Officer Rachel Longwell. The total number of Health Canada representatives was 12, and included members from the Tobacco Control Directorate, Consumer Product Safety Directorate, and the Regulatory Operations and Regions Branch.

The following summery is our interpretation of the information given by Health Canada during this meeting. These notes were given verbally by the directors in attendance and taken down in writing by ECTA members.

Agenda Items & Summary

1. Opening Introduction, ECTA structure and mandate

The meeting was opened with an explanation of ECTA’s history, mission statement, and a discussion on the vaping industry as a whole to help give Health Canada representatives a better understanding of how it operates. This was accompanied by a booklet containing materials for attendees to follow along with. The Table of Contents for this document is located in Appendix A (see below).

2. Demonstration and explanation of ECTA tools and services provided to members for S5 compliance

The purpose of this agenda item was to give an overview of the additional requirements ECTA members must adhere to such as VG/PG ratios and “Made on” dates. The intent was to demonstrate how these items fit on the already compliant labels, given their likely inclusion in the regulations.

Agenda item #2 addressed the tools currently available on the ECTA webpage that center around Bill S5 compliance. These tools included the size calculator, label maps, label templates, retailer checklists, and FAQ’s. The overall consensus is that all attendees were impressed with the work ECTA has put in to ensuring their members are prepared for Royal Assent, including the extra steps taken to ensure label indelibility. They informed us that upon Royal Assent, they are prepared to start enforcement of all CCCR and CCPSA regulations shortly thereafter. They are simply waiting for the go – ahead to begin.

3. Proposed Nicotine Warning

The purpose of this agenda item was to provide examples of nicotine warnings in terms of placement and size to detail the challenges we might face trying to incorporate them into the label. We hope these challenges will be considered during regulation development and would like to collaborate on this development.

Moving on to agenda item #3, some guidance was offered to Health Canada on the proposed Nicotine warnings size and placement. These warnings have not yet been included in CCCR/CCPSA requirements, however Health Canada hinted many months ago that they would be required in time. ECTA’s main concern is the size requirements of these warnings, considering a compliant label has minimal space to begin with. ECTA offered to work with Health Canada on the preparation of these warnings and any additional warnings to ensure they fit within the label’s without diminishing branding space.

4. Industry compliance status update (CCCR/CCPSA upon royal assent)

Purpose of this section was to identify issues with compliance of imported e-Liquid, and give a general overview of the preparedness of the industry for Royal Assent with hopes of receiving further clarification on what will be required prior to and following Royal Assent.

For agenda item #4 ECTA provided a rough idea of the industry’s preparedness for Bill S5 Royal Assent in terms of compliance, comparing ECTA members with non ECTA members, where the number of compliant ECTA members is approximately 95%.  The issue concerning importation of International E-Liquids from companies that do not fall under the same regulations as Canada, and therefore would not be considered compliant upon import, was also brought to attention.

5. Industry S5 compliance misconceptions

The purpose of Agenda item #5 is similar to that of #4, where common misconceptions were brought to the attention of Health Canada in hopes that potential solutions could be discussed and guidance on requirements could be given.

Agenda item #5 focused on misconceptions that exist in the vaping industry. ECTA identified the main cause of these misconceptions as lack of understanding, grey market mentality, doubting the governments capability to enforce, and mixed messages on social media. Health Canada responded by offering to provide an updated summary of the regulations to clarify what is expected. It was pointed out by Health Canada that rarely is a new industry informed of their classification before being regulated, but an exception was made in this case allowing for companies to prepare ahead of Royal Assent.

6. Nicotine testing classification of 0.1mg/mL

This section was included to remind Health Canada of the difficulties of testing for 0.1mg/mL and to seek clarification regarding the requirements for verifying nicotine concentrations for products currently on the market.

Agenda item #6 was briefly touched on, where ECTA proposed 0.1mg/mL was too low to accurately detect during testing to be the lowest concentration required for CCCR/CCPSA hazard labelling. Health Canada representatives clarified that this concentration is being considered as a consumer threshold to be used by enforcement when inspecting Nicotine Free products to ensure they are Nicotine Free. It was noted that Health Canada was open to discussion about increasing this limit to 0.3mg/mL however no conclusions were made.

7. Questions and feedback on legislation and proposed regulation. 

• We wanted to discuss POD systems and provide examples, specifically of pre-filled systems to identify the potential issue of adding CCCR requirements on individual PODS.
• We required follow up clarification on the requirements for Child Resistant Certifications for Tanks
• We wished to get clarification of E-Liquid brand elements, including fruits on labels, illustrations, and flavor names to improve our ability to advise members during the upcoming audit.

The last item on the Agenda covered, labelling requirements for closed POD systems, child resistant certifications for Tanks, and E-Liquid brand elements and illustrations. Attendee’s were unfamiliar with the POD systems and were given samples to clarify what they are and how they are used. The main issue discussed was the labelling requirements for POD systems as they do contain hazardous liquid, however are too small to be properly labelled following CCCR/CCPSA requirements. ECTA was given verbal confirmation that upon Royal Assent the PODs themselves will not be enforced, but the packaging they come in will be. Adding to this, they have informed ECTA that child resistant tanks will not be a requirement of Bill S5.

There is currently a great deal of confusion within the vaping industry over issues such as flavour names and branding elements allowed on labels come Royal Assent. They also informed us that they will not offer any interpretations on Bill S5 phrasing in regard to flavour names and Images considered appealing to children. The regulation states:

The example given was “Unicorn Milk”, while not technically falling under one of the 5 restricted flavour categories it certainly has an element that could be considered appealing to children. The best course of action for the industry regarding this issue is to avoid, at all cost, anything that could be considered appealing to a child.

The meeting closed with a question period and a show of gratitude from Health Canada representatives for the information ECTA brought to their attention regarding the vaping industry.

8. Other Business

Time allowed for general discussion, where we attempted to get into relative risk statements, couldn’t provide clarification at this point.

The Legislative summary of S5 can be found HERE.

Where the bill goes from here

Since S5 was first introduced in the Senate, the bill as amended by the House of Commons will return to the Senate for final review and approval prior to Royal Assent. Despite a few amendments, S5 has remained largely unchanged from the initial version passed by the Senate, so the review process is expected to be quite short. Upon completion of the Senate review, S5 will receive Royal Assent. While nobody knows exactly when S5 will receive Royal Assent, it is unlikely to be dragged out past mid-June.

What happens upon Royal Assent

Vaping products not marketed with therapeutic claims will fall under the Canada Consumer Product Safety Act (CCPSA), the Consumer Chemicals and Containers Regulations (CCCR, 2001), and other related acts and regulations. These Acts and Regulations come into effect immediately upon Royal Assent, and enforcement will begin very shortly thereafter.

Other sections of the bill such as marketing and reporting will require the development of regulations prior to implementation. The regulation development phase will include considerable consultation with stakeholders, and ECTA has already participated in preliminary discussions with Health Canada to that end. The regulations will take time to develop, and they are likely to be released in phases. Once complete, the newly developed regulations will include a delayed implementation period which will allow business time to make necessary compliance changes.

We want to emphasize that there will be no implementation delay when it comes to CCPSA & CCCR compliance. They come into force immediately upon royal assent per the Health Canada Notice to Industry.

ECTA members have been actively preparing for S5 Royal Assent since October 2017. Our compliance tools, services, and audits have been crucial to ensuring ECTA members are fully prepared for inspections and enforcement post-Royal Assent.

ECTA will continue to actively engage with Health Canada regarding regulation development while continuing to use our knowledge, experience, and resources to assist our members with all future compliance requirements.

Relevant reference links:

Status of the bill: en | fr

Bill S5: en | fr

Consultation Summary: Proposals for the Regulation of Vaping Products: en | fr

Health Canada Notice to Industry (Upon Royal Assent): en | fr

On January 18th, the Ontario Government released their summary of the proposed Smoke-Free Ontario Act (SFOA), 2017 Regulations ( en | fr ) for public consultation.

When it comes into force, the SFOA, 2017 will repeal the existing Smoke-Free Ontario Act (SFOA) and Electronic Cigarettes Act, 2015 (ECA) and replace them with a single legislative framework.

What does this mean?

Prohibited use

General vaping will be prohibited in the following locations:

Exemptions for use

With the SFOA, 2017, the government has provided for exemptions, but only for smoking of tobacco, and the smoking and vaping of medical cannabis in:

An exemption is also available for the use of tobacco for traditional Indigenous cultural and spiritual purposes.

The only exemptions for vapour product not used for medical marijuana are:

One of the bullets states, “Expand the exemptions for the smoking of tobacco and the smoking and vaping of medical cannabis in designated guest rooms of hotels, motels and inns, and in controlled rooms of residential care facilities, designated veterans’ facilities and designated psychiatric facilities, to include all ecigarette use.”

Limits points of sale

These are no surprise and we thing would be expected. Products cannot be sold in: public hospitals, long-term care homes, pharmacies, grocery stores that contain pharmacies, post-secondary education campuses, certain Ontario government office buildings, primary and secondary schools and their grounds, child care centres, places where home child care is provided.

Prohibited Flavoured Vapour Products

While provisions for these exist, no flavours are restricted at this time.

Sale and Supply to Minors and Signage

This remains the same as it was with the Electronic Cigarette Act (ECA), 2015.

Display and Promotion

The SFOA, 2017 prohibits Display and Promotion but the regulations have defined an exemption for “Specialty vape stores” as follows:

Addition requirements for the exemptions are:

For those selling vaping product that do not qualify under the above exemption (i.e. C-stores), promotion and display will be limited to:

The full Summary of Proposed Regulation can be seen at the bottom of this article or online here: en | fr

What happens now?

Public consultation begins now and extends through March 3, 2018.

After reading their summary and assessment, we encourage everyone (business owners and vapers or even friends of vapers) to submit your comments to the Government of Ontario.

Email:  smokefreeontario2017@ontario.ca

Mailing Address:

Health Protection Policy and Programs Branch
Ministry of Health and Long-Term Care
393 University Avenue, Suite 2100
Toronto, ON
M7A 2S1

Silence is consent…

 Summary of Proposed Regulation

English

French

Here is what we know about labeling requirements under Bill S-5, soon to be the TVPA (upon Royal Assent):

The only thing that is not fully known is the exact verbiage required for warnings about Nicotine addiction, for which HC has provided insight. That exact wording will be written within the regulations.

That’s it…  Everything else is black and white.

Now there have been “arguments” about e-liquids containing less than 10 mg/mL falling outside of the scope of the CCCR, 2001. While that is true, legally (even as stated by HC), failing to apply CCCR, 2001 to any product containing nicotine could put your company at risk of selling a product that violates the CCPSA. Having these warnings may be excessive, an exaggeration of the risk or even a violation of that regulation, but it is highly unlikely that anyone will be fined or cited for OVER stating the risks (especially when it is being advised by HC).

There are also discussions being had with HC with regard to the lower limit for requiring CCCR, 2001 being raised from 0.1 mg/mL to 0.5 mg/mL.

All of that said, based on the facts, below are two examples of what a “compliant” label might look like for an ECTA member.  One that qualifies for the Exemption – small container under CCCR, 2001 (MDP < 35 cm2) and one that does not qualify for that exemption (MDP = 35 cm2 or larger)

Third Reading was a Liberal and NDP vs. PC vote which ended as 63 in favour to 27 opposed.

Status of the Bill

It is unfortunate that the Standing Committee of Justice Policy made none of the requested amendments that were submitted for Schedule 3, Smoke-Free Ontario Act, 2017.

Make no mistake about it, the bill as it was passed is devastating to vapers and the vaping industry in Canada. However, we have been told that there will be exemptions for vaping retail shops within the regulations.

This is what was presented in the proposed regulations for the Electronic Cigarette Act, 2015 (Bill 45) which were never finalized nor proclaimed:

The ministry is also proposing to permit the display and promotion of e-cigarette products (but not the testing or sampling of e-cigarettes) in places where they are sold, provided that the following conditions are met:

• Owner must inform its local public health unit in writing that it wishes to operate under the exemption;
• Products and promotional material must not be visible from the outside of the store;
• Individuals under the age of 19 would not be permitted to enter the shop;
• Customers could only access the store from outdoors or from areas in an enclosed shopping mall;
• Store could not be a thoroughfare (e.g. kiosk in a mall corridor).

So what happens now?

The Government is currently drafting proposed regulations that will be open for public consultation. Any exemptions will be listed in those proposed regulations.

We encourage EVERYONE (consumers and industry) to respond during the consultation period whether you agree or disagree with their proposal.

Different sections of the Act can be Proclamed at different times. Depending on what gets proclaimed for what date will determine what is in effect.

After consultation period on the proposed regulations, the final version will be posted and they will not be effective until the proclamation date for “that section”.

So it is business as usual (prepare for Federal Bill S-5) until Regulation for the Smoke-Free Ontario Act, 2017 are finalized and proclamation date(s) has been set.

Many presenters covering the wide range of topics within this bill were heard.  The transcripts for those meetings are not yet available as of this posting, but should be published on their website soon ( Transcript Index: en | fr ).

### UPDATE – December 9th:  Transcripts for these sessions were posted on December 8th.

Scheduled presenters for November 29th:

The online transcript (downloaded are below) can be found here: en | fr

Scheduled presenters for the first session on November 30th:

The online transcript (downloaded are below) can be found here: en | fr

Now the Committee has the following deadlines:

As you can see, that is a LOT a people covering a lot of topics with a very small number of meeting sessions and very little time.  The ECTA has always been in favour of fair and reasonable regulation, it is what we do and is the foundation upon which we were formed.  However, we are opposed to the process that the Liberal Government has enacted to rush this bill to Royal Assent.

Just as do the other Schedules within this bill, Schedule 3 deserves its own FULL debate, discussion and committee proceedings or what we will end up with is a significant number of unintended consequences that will affect the people of Ontario, up to and including potential avoidable death.

Obviously ECTA’s presentation to the Committee was on Schedule 3, the Smoke Free Ontario Act, 2017 and our recorded presentation and submission are below:

Downloaded Transcript (December 9th) of November 29th

Downloaded Transcript (December 9th) of November 30th

Several days ago, we posted a Summary of what is included in the bill, for your reference.

A motion was put forward for time limits and committee review on November 21st to end the debate on second reading of the bill within parliament.  That motion was “carried on division” on November 23rd,

The motion included the following limits:

The ECTA will be presenting to the Standing Committee on Justice Policy on Thursday, November 30th at 2:30p Eastern.

As anyone can clearly see from this timeline, these four, VERY different schedules are being rammed down the throats of Ontario residents:

Any one of these Schedules could (and should) be fully debated within the House on their own merit.

This is a very dark time for democracy in Ontario.

What to do now…

There is not much time to take action but we recommend that you send in a written submission to the Standing Committee on Justice Policy.  The period for submitting a brief ENDS on November 30th at 6pm Eastern.  Written submissions with supporting documents should be sent to the Clerk of the Standing Committee on Justice Policy:

Christopher Tyrell
Tel: 416-325-3883
Fax: 416-325-3505
comm-justicepolicy@ola.org

Room 1405, Whitney Block
Queen’s Park, Toronto, ON M7A 1A2

TTY: (416) 325-3538

And you MUST IMMEDIATELY contact your Member of Provincial Parliament (MPP) for an urgent meeting to discuss this bill. If you are a business owner, the MPP for the district in which your business operates is also a potential contact.

We recommend that you communicate with your MPP using one or more of the following methods (in order of preference for usual effectiveness):

And follow-up using the same or other method to see if they have any questions or would like additional information. The more they hear from you, the more likely it is that you will remain on their radar.

These regulations WILL affect your vaping business and/or you, personally.

Ideally, ECTA would like to see Schedule 3 completely removed from Bill 174 and resubmitted as a separate bill, but AFTER consulting with industry stakeholders and using science and facts for the legislation as opposed to ideology as a driving force to prohibition.

There is additional information and consumer action that can be taken from the Vapor Advocates of Ontario. They have a mechanism of emailing your MPP from their website. There have been more than 10,000 sent as of this posting:  https://vapingisntsmoking.ca/

Relying solely on ideological Public Health agencies for input using theories and myths has proven to be a public health hazard when it comes to the lives of smokers, their loved ones and vaping products.

Quit or die is no longer the only option to potentially save lives.

Many retailers across the province of Ontario have taken steps to help educate the public on the severity of what Bill 174 means, in it’s current state as it goes to Committee. This one in particular has caught our attention and it is a VERY real and accurate portrayal of the results from the bill as it is worded today:

Silence is consent…

As one can see by the extensive title of the bill, Bill 174 is an omnibus bill in that they have placed a lot of unrelated and controversial items within the same bill. We can’t say what the motivation might be for this approach, but this tactic has been used by different governments to push things through the the process by avoiding extensive debate of potential issues or as a political weapon against an opposing party, should they vote not to pass the bill.

Schedule 3, Smoke-Free Ontario Act, 2017 is the part that applies to vaping products.

Specific points of interest that we found in the bill are as follows:

Definitions to note

 “enclosed public place” means,

• the inside of any place, building or structure or vehicle or conveyance, or a part of any of them,
  • that is covered by a roof, and
  • to which the public is ordinarily invited or permitted access, either expressly or by implication, whether or not a fee is charged for entry,
• or a prescribed place; (“lieu public clos”)

“enclosed workplace” means,

• the inside of any place, building or structure or vehicle or conveyance, or a part of any of them,
  • that is covered by a roof,
  • that employees work in or frequent during the course of their employment whether or not they are acting in the course of their employment at the time, and
  • that is not primarily a private dwelling, or
• a prescribed place; (“lieu de travail clos”)

“prescribed” means prescribed by the regulations

“promote”, with respect to tobacco products, electronic cigarettes or a prescribed product or substance, means to use any commercial act or practice or to use any commercial communication, through any media or other means, that is intended to or is likely to,

• encourage its purchase or use or the purchase or use of a particular brand, or
• create an awareness of or an association with it, or with a brand or a manufacturer or seller; (“promouvoir”)

“use”, with respect to electronic cigarettes, includes any of the following:

• Inhaling vapour from an electronic cigarette.
• Exhaling vapour from an electronic cigarette.
• Holding an activated electronic cigarette.

Requirements for Sale/Advertisement

 Prohibited Use

No “use” (see definition) of vaping device in a public space, workspace, educational facilities, childcare facilities (including home childcare) or reserved seating area in sports/entertainment arenas. Exceptions can be granted by the regulations.

No “use” (see definition) of vaping devices in common areas of condominium, apartment building or university indoor (garage, party or entertainment room, hallway, lobby, etc.). Exceptions can be granted by the regulations.

No use of vaping products in a vehicle with a youth under 16 years of age.

Exemptions:

Enclosed Workplace: “person who smokes or holds lighted tobacco or to a medical cannabis user who smokes or holds lighted medical cannabis or who uses medical cannabis through an electronic cigarette in an indoor room in a residence that also serves as an enclosed workplace if the following conditions are met”

Hotel rooms: “person who smokes or holds lighted tobacco or to a medical cannabis user who smokes or holds lighted medical cannabis or who uses medical cannabis through an electronic cigarette in a guest room in a hotel, motel or inn if the following conditions are met”

Hospice facilities: “a medical cannabis user who smokes or holds lighted medical cannabis or who uses medical cannabis through an electronic cigarette in a hospice”

Testing/Research Facilities: “person who smokes or holds lighted tobacco, who smokes or holds lighted medical cannabis or who uses an electronic cigarette in a scientific research and testing facility for the purpose of conducting research or testing concerning tobacco products, vapour products or cannabis, as the case may be”

Inspector Power

Fines

The following fines apply:

What to do now…

If you are in Ontario, we encourage you to IMMEDIATELY contact your Member of Provincial Parliament (MPP) for a meeting to discuss this bill. If you are a business owner, the MPP for the district in which your business operates is also a potential contact.

We recommend that you communicate with your MPP using one or more of the following methods (in order of preference for usual effectiveness):

And follow-up using the same or other method to see if they have any questions or would like additional information. The more they hear from you, the more likely it is that you will remain on their radar.

These regulations WILL affect your vaping business and/or you, personally.

Ideally, ECTA would like to see Schedule 3 completely removed from Bill 174 and resubmitted as a separate bill, but AFTER consulting with industry stakeholders and using science and facts for the legislation as opposed to ideology as a driving force to prohibition.

Relying solely on ideological Public Health agencies for input using theories and myths has proven to be a public health hazard when it comes to the lives of smokers, their loved ones and vaping products.

Quit or die is no longer the only option to potentially save lives.

Silence is consent…