JAC Vapour - The TPD and the Market

THE TPD AND THE MARKET

JAC Vapour’s second instalment in our series on the Tobacco Products Directive, a package of regulations developed by the European Commission to cover the rules surrounding the sale and use of tobacco and tobacco-related products within the EU.

One article of the directive (Article 20) in particular addresses the sale and use of e-cigarettes.

16th February 2016

WHAT DOES THE TPD MEAN FOR UK BUSINESSES?

OVERVIEW

• The UK Government is currently reviewing the TPD and is working to transpose it into law at the national level.

• In January 2016, the Government published their response to a consultation conducted in 2015.

• While the detail is still being finalised, it is expected that a light-touch approach will be adopted (within the required framework of the TPD).

• Two options were on the table when looking at how to implement the TPD:1. Implement the TPD at a minimum cost to business.2. Implement selected optional elements of the TPD (the Government’s preferred option).


OVERVIEW

• Why Option 2?• E-cig businesses would be responsible for covering the cost of implementation through

proportionate fees paid to the UK regulatory body.• In the UK, the MHRA will have responsibility for the regulation of e-cigarettes.• Following the consultation, the Government have confirmed their intention to recover

the cost of notification and verification procedures required by the TPD from businesses:• “The Government will introduce proportionate fees to recover its costs of meeting its

obligations under the TPD2, for tobacco products (including novel products) and e-cigarettes. Proposals to establish fee structures will be subject to separate consultation.”


OVERVIEW

• In order to help mitigate the expected cost to businesses, regulators will allow retailers to continue to sell through old stock produced or on the market prior to November 2016.• New products entering the market after November 2016 will have to be TPD compliant.• Any remaining non-compliant stock must be sold by May 2017 or removed from sale.

• E-cigarette companies will be obliged to inform or notify the regulator of their activities within the UK.

• The information required as part of the notification process is to include:1. “The person who puts a name, trademark or other distinguishing mark on it by which the

person is held out to be its manufacturer or originator.”2. “The importer of e-cigs to the UK.”3. “The manufacturer.”


OVERVIEW

• The notification process timeline:• When bringing new products to the market, the notification “must be submitted in

electronic form at least six months before the intended supply commences.”• Evidence of TPD compliance for existing products “must be submitted on or before 20th

November 2016.”• “For transition period products when the supply is intended to commence during the

period from 20th May to 19th November 2016, notification must be given by 20th May 2016.”

• Annual reporting due for submission by May 20th each year, taking effect in May 2017.• The annual report relates to activity in the preceding calendar year.


NOTIFICATION PROCESS

• The information required as part of the notification process includes:a) “The name and contact details of the manufacturer and the importer (if applicable). If

neither is based in the European Economic Area countries (EEA), they must supply the details of a responsible person within the EEA.”

b) “A list of all ingredients contained in, and emissions resulting from the use of, the product by brand name and variant, including quantities.”

c) “Toxicological data about the product’s ingredients (including in heated form) and emissions, referring to their effects on the health of consumers when inhaled and taking into account, among other things, any addictive effect.”



• The information required as part of the notification process includes:d) “Information on the nicotine dose and uptake when consumed

under normal or reasonably foreseeable conditions.”e) “A description of the components of the product including,

where applicable, the opening and refill mechanism of the e-cigarette or refill container.”

f) “A description of the production process and a declaration that the production process ensures conformity.”

g) “A declaration that the producer bears full responsibility for the quality and safety of the product when supplied and used under normal or reasonably foreseeable conditions.”



• Following the consultation, the Government has amended part of the notification process:• “Having considered the consultation responses the Government will not require

businesses to nominate a named person to collect any adverse events information. The Regulations will, however, obligate businesses to investigate and report such incidents to the Competent Authority along with the outcome of any action they may have taken in line with current requirements in TPD2 Article 20(9).”

• “When a notification has been completed, MHRA will publish all non-confidential information on a designated website in-line with the requirements of TPD2 Article 20(8). Manufacturers and importers will have the opportunity to specify information that they consider to be confidential when they submit a notification.”



• Where a product is subject to an update which is deemed to result in substantial modification, it is a requirement to notify the regulator.

• What does this mean? • At the very least it entails:• “Any change that would affect the health of the user or the human body.”• “Any change related to aspects of products defined by the TPD text.”


ANNUAL REPORTING

• Must be submitted annually on or before May 20th.• The first report, for products in the market before 31st December 2016, is due on May

20th 2017.• Annual reports must contain:• “Comprehensive data on the producer’s sales volumes in the UK, by brand and variant

name.”• “Information available to the producer on the preferences of consumer groups in the

UK, including young people, non-smokers and the main types of current users.”• “Method of sale of the product in the UK.”• “Summaries of market surveys carried out by the producer.”


VIGILANCE

• Producers, as defined earlier, will be required to:• “Establish and maintain a system for collecting information about suspected adverse

effects on human health.”• In the event that a producer has reason to believe that a product is not safe, of good

quality, or in conformity with regulations, the producer must (as appropriate) :a) Immediately take the corrective action necessary to bring the product into

conformity.b) Withdraw the product.c) Recall the product.


VIGILANCE

• The producer must also “inform the Secretary of State and/or competent authority in other EEA States, giving details of: a) Any risk to human health and safety.b) Any corrective action taken.c) The results of any corrective action taken.

• Age Verification• All online retailers must put in place adequate age verification systems to prevent the

sale of e-cigarettes to under-18s.• By either:

a) Taking payment by credit cardb) Age verification upon delivery


E-LIQUID MANUFACTURE

• Set guidelines on the safe manufacture of e-liquids will also form part of the UK’s implementation of the TPD.

• In order to meet compliance requirements, e-liquids:• “Must be manufactured using only ingredients of high purity.”• “Ingredients other those notified to the authorities may only be present in trace levels,

where such trace levels are technically unavoidable.”• “With the exception of nicotine, the ingredients used in the nicotine-containing liquid

may not pose a risk to human health in heated or unheated form.”• “Dose of nicotine must be delivered at consistent levels under normal conditions of

use. This means a similar level of nicotine should be delivered each time an e-cigarette is puffed for the same amount of time and with the same strength.”


PACKAGING REQUIREMENTS

• The new regulations will include specific requirements which cover the packaging of e-cigarettes and e-liquids.

• Packaging:• Must be child-resistant and tamper-evident.• Product must be protected against breakage and leakage.

• In addition, there are requirements relating to the design of products themselves:• Products must have a mechanism for ensuring that there is no leakage when refilling.• The practical mechanism specifications to achieve this, however, are yet to be

defined.


ADDITIONAL REQUIREMENTS

• Each unit packet of the e-cigarette or refill container must include a leaflet which contains the following information:

• Instructions for use and storage of the product, and a warning that the product is not recommended for use by young people and non-smokers.

• Contra-indications, possible adverse effects and warnings for specific risk groups.

• Addictiveness and toxicity.• Contact details of the producer.• A contact person within the EEA.


HEALTH WARNING

• Following their consultation, the Government has elected to use the shorter alternative message required by the TPD:• “The Government will amend the implementing regulations to require the warning

‘This product contains nicotine which is a highly addictive substance’ on e-cigarettes and refill containers. The Government will continue to explore with other Member States and the Commission the scope for interpreting the labelling requirements of TPD2 to apply only to products/refills/components containing nicotine at the time of sale.”

• “The Government has carefully considered the responses to this question. Non-nicotine e-cigarettes are outside of the scope of the TPD2, therefore will not be required to carry these warnings.”


HEALTH WARNING

• This health warning must be located:a) On both the front and back surfaces of the unit packet and any container pack and

cover 30% of the area of each of those surface.b) In black Helvetica bold type on a white background.c) In a font size that ensures the text occupies the greatest possible proportion of the

surface area reserved for it.d) At the centre of the surface area reserved for it.


HEALTH WARNING

• Any container pack of e-cigs or refill container may not include:a) Any text, symbols, names, trademarks, or other types of sign that encourages its

consumption by creating an erroneous impression about its characteristics, health effects, risks or emissions.

b) Claims of health or lifestyle benefits.c) Any suggestion that one product is less harmful than another.d) Claims of vitalising, energising, healing, rejuvenating, natural or organic properties.e) References to taste, smell or other additives (except flavourings) or the absence of any

such thing.f) Any suggestion or resemblance to a food or a cosmetic product.g) Any suggestion of improved biodegradability or other environmental advantages.h) Any economic incentives such as printed vouchers or discounts, free distribution, two

for-one or other similar offers.


ADDITIONAL OBLIGATIONS FOR UK DEVOLVED COUNTRIES

Scotland Wales

• Retailers required to register • Retailers required to register

• Provide name and address

• Individual: name and the address of the usual place of residence.

• Company: name and the address of its registered office.

• Partnership: name and the address of each partner’s usual place of residence.

• Moveable structure (a stall, a tent or a vehicle): the name of each local authority where the business is run.

• The address of each of the premises where a tobacco or nicotine business is run.

• Whether the person is selling: (i) tobacco or cigarette papers, (ii) nicotine products, or (iii) any combination of those items.

• In the case of premises consisting of a moveable structure, a stall, a tent or a vehicle, the name of each local authority in whose area the business is carried on.


ADVERTISING RESTRICTIONS

• Commercial advertising and communications (on and offline).• Printed commercial communications and advertising, including

press or other print publications promoting e-cigarettes.• Radio advertising.• Event sponsorship, public or private.

JAC Vapour - The TPD and the Market

Business

Transcript of JAC Vapour - The TPD and the Market