Compliance-TPD2-Regulations

Dear Valuable customer,

Everyone in the industry is aware that the UK government first passed a draft version of “The Tobacco and Related Products Regulations 2016” (hence forth known as TRPR-2016) – also known in the industry as Tobacco products directive 2 – in early 2015 and ran a public consultation on it from 2ndJuly to 3rd Sep, 2015. Following the consultation process, the UK government has now officially adopted the regulations governing electronic cigarettes, and all other tobacco products, on 22nd April, 2016. This new regulation is coming into force on 20th May, 2016 and can be accessed from here. This document aims to summarise the legislation, which is now officially known as “The Tobacco and Related Products Regulations 2016” No. 507.

When compared to the draft, not much has changed in the final version of the regulation, apart from an expansion on the rules around e-cigarette advertising, technical standards on the refill container and mechanism, notification fees and the official article numbers. It is still unclear in terms of technical specifications regarding testing standards and this is discussed later in this document. This document aims to summarise all the requirements under TPD2 and serves as a one stop shop for the compliance details and presents the information in a simple to understand, non-legal language.

INDEX

    1. Notification
    2. Notification Fees
    3. Product Requirements
    4. Technical standards for refill mechanism
    5. Product information and labelling
    6. Product presentation
    7. Advertising
    8. Cross-border distance sales
    9. Annual Reporting Requirement
    10. Vigilance Requirements
    11. Penalties
    12. Other considerations
    13. Legal Disclaimer

TPD2 Notification

  1. Any producers (i.e. manufacturers and those who rebrand products) are required to submit a notification to the MHRA through EU common entry gate portal and needs to include following:
      • Name and contact details of the manufacturer, importer or in case neither is based in a member state, a responsible person within a member State.
      • List of all ingredients and emissions and their quantities
      • Toxicological data and assessment and any addictive effects
      • Nicotine dose and uptake
      • Description of the product including opening and refill mechanism
      • The production process and a declaration that the production process ensures conformity to TPD2
      • A declaration that the manufacturer bears full responsibility for quality and safety

A detailed list of information and a common format for these notifications can be found here

All the notifications should be submitted to the MHRA at least six months prior to the product placement.

 Notification Fees

  1. Following the public consultation in January 2016, the Government has reduced the notification fees:
    • Notification Fee: £150
    • Substantial Modification fees: £80
    • Annual fees: £60

All prices are per SKU and products differing in nicotine strengths or PG VG ratios are considered different SKUs and thus require separate notifications.

 Product Requirements

    1. The e-liquid must be in a dedicated refill container not exceeding 10 millilitres
    2. In case of disposable e-cigarettes, the cartridge should not exceed 2 millilitres in volume
    3. The tank should not exceed a volume of 2 millilitres
    4. Nicotine concentration cannot exceed 20 mg/ml
    5. The e-liquid should not contain any additive referred to in regulation 16 (no vitamins, colourings or prohibitive additives in tobacco products)
    6. Must be manufactured using only ingredients of high purity
    7. Must not contain substances other than mentioned in the notification, unless in trace amounts which are technically unavoidable
    8. Must not include ingredients that pose a risk to human health in heated or unheated form (except for nicotine)
    9. The e-cigarette must deliver consistent levels of nicotine dose
    10. An e-cigarette or refill container must be child-resistant, tamper-evident and protected against breakage and leakage
    11. Must have mechanism for ensuring re-filling without leakages (see below for technical standards)

 Technical standards for refill mechanism

The refill container must have a securely attached nozzle at least 9 mm long which should be narrower than, and slots comfortably into, the opening of the e-cigarette. When the refill container is placed vertically, it must not emit (or release) more than 20 drops (~1 ml) of liquid per minute at standard atmospheric pressure between 15 and 25 degree Celsius.

OR

The refill mechanism operates by means of a docking system which only releases refill liquid when the e-cigarette and refill container are connected

Product information and labelling

  1. Each unit/packet of an e-cigarette or refill container must include a leaflet with at least the following information.
    • Instructions for use and procedure for refilling including diagrams
    • Storage conditions
    • Reference that the product is not recommended for use by young people and non-smokers.
    • Contra-indications
    • Warnings for specific risk groups
    • Possible adverse effects
    • Addictiveness and toxicity
    • Contact details of the producer (or of responsible person within a member state if the producer is not based in the member state).
  2. Each unit packet and container pack must also include:
      • A list of ingredients in descending order by weight
      • Nicotine content and delivery per dose
      • Batch number
      • A recommendation to keep the product out of the reach of children
      • A health warning: “This product contains nicotine which is a highly addictive substance”.

The health warning must appear on both the front and back surfaces of the unit packet and any container pack, cover 30% of the area of each of those surfaces and must be in black Helvetica bold type on a white background, in a font size that ensures it occupies greatest proportion of the surface area and appears at the centre of that area.

 Product presentation

  1. The unit packet or container pack of an e-cigarette or refill container must not contain any element or feature that:
      1. Promotes the use of e-cigarettes by creating an erroneous impression about its characteristics, health effects, risks or emissions
      2. Suggest that it is less harmful than other e-cigarettes
      3. Has vitalising, energising, healing, rejuvenating, natural or organic properties
      4. Has other health or lifestyle benefits
      5. Refers to taste, smell or other additives (except flavourings) or absence of any such things
      6. Resembles a food or cosmetic product
      7. Suggests that it has improved biodegradability or other environmental advantages
      8. Suggests economic advantage by including printed vouchers or offering discounts, free distribution, two-for-one or other similar offers

The elements and features includes (but not limited to) text, symbols, names, trademarks, figurative or other types of sign.

 Advertising

No advertisement in a newspaper, periodical or magazine unless it is in a newspaper, periodical or magazine that is:

  • Intended exclusively for professionals in the trade of e-cigarettes or refill containers
  • Printed and published in a third country and is not principally intended for the European Union market

No advertisement in information society services (i.e. online services) unless it is:

  • To an information service which is intended exclusively for professionals in the trade of e-cigarettes or refill containers
  • An advertisement which is not principally intended for the European Union market
  • Necessary for the protection of public health or the protection of consumers (for e.g. it is for a recall of a defective, non-compliant product)

No Television advertisement is allowed, as per the below regulations:

  • No e-cigarette or refill container advertisement in live or on-demand television programmes
  • This does not apply to adverts whose production began before 19th May 2016

No sponsorship (i.e. public or private contribution) to any event or activity:

  • Which takes place in or has an effect in two or more member states (“a cross border event or activity”)
  • An individual taking part in a cross-order event or activity

 Cross-border distance sales

  1. A registration with the Secretary of State is required if:
    • A UK retailer who engages or intends to engage in a cross-border distance sale with a consumer located in any other member state
    • A non-UK retailer who engages or intends to engage in a cross-border distance sale with a consumer located in the UK
    • The Secretary of State must provide a confirmation of such registration and publish a list of registered retailers
    • A retailer must not supply a relevant product via cross-border distance sale to a consumer located in a member state in which such sales are prohibited in accordance with Article 18(1) of the Tobacco Products Directive
  2. The registration should include following information:
      • The retailers name and trading name
      • Address of each place of business used by the retailer
      • The date on which the retailer first supplied or intends to supply the product
      • The address of any website or any other information required to identify the website
      • A description of the details and functioning of the retailer’s age verification system
      • Confirmation of any registration provided by the competent authority of any member state (only for UK based retailers)
      • The name of any other member state to which the retailer has or is intending to apply for registration (only for UK based retailers)

 Annual Reporting Requirement

  1. A producer of an e-cigarette or refill container must submit the following information:
      1. Comprehensive data on the sales volume in the UK, by brand and variant name
      2. Any 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
      3. The mode(s) of sales in the UK
      4. Executive summaries of any market surveys carried out by the producer in respect of the previous three points
  2. This information must be submitted annually on or before 20th May each year and must relate to the preceding calendar year
  3. The first submission is to be made on or before 20th May 2017 in respect of the period beginning with 20th May 2016 and ending with 31st December, 2016

 Vigilance Requirements

  1. A producer of e-cigarettes or refill containers must establish and maintain a system for collecting information about all of the suspected adverse effects on human health of the product
  2. If a producer considers or has reason(s) to believe that a product which is intended to be supplied or has been supplied, is not safe, of good quality or in conformity with the TRPR-2016, then the producer must (as appropriate):
    • Immediately take the corrective action to bring the product into conformity with TRPR-2016
    • Withdraw the product
    • Recall the product
    • Must immediately inform the Secretary of State and the competent authority of any other member state giving details of:
      • The risk to human health and safety
      • Any corrective action take
      • The results of any corrective action taken
      • Supply any additional information requested by the Secretary of State or competent authority
  1. The TRPR-2016 confers powers to the Secretary of State under article 40 that will enable him/her to: including (but not limiting to)
    • Prohibit the supply of the, or that type of, product(s)
    • Requiring each supplier to recall the product(s)
    • Take follow-up measures to implement any conclusions of the European Commission in relation to the matter

Provided that the Secretary of State has reasonable grounds to believe that an e-cigarette or refill container could present a serious risk to human health.

 Penalties

  1. A person, producer or retailer is guilty of an offence if that entity breaches one or more provisions of the TRPR-2016 and is liable for:
    • On summary conviction:
      • In England and Wales to imprisonment for a term not exceeding three months, or a fine, or both
      • In Scotland, imprisonment for a term not exceeding twelve months, or a fine not exceeding level 5, or both
      • In Northern Ireland, imprisonment for a term not exceeding three months, or a fine not exceeding level 5, or both
    • On conviction or indictment to imprisonment for a term no exceeding 2 years, or a fine, or both
  2. If an offence under TRPR-2016 regulations is committed by a body corporate or partnerships, the officer (or partner) as well as the body corporate is guilty of the offence and liable to be proceeded against and punished accordingly.
  3. In any proceedings for an offence under the TRPR-2016 regulations:
      • It is a defence that the supplier or person exercised all due diligence to avoid committing the offence
      • It is a defence that the person did not know and had no reason to suspect that the advertisement was an e-cigarette advertisement
      • A defendant may not, without permission of the court, rely on the defence that the commission of the offence was due to the act or default of another person or the defendant’s reliance on information given by another person, unless the defendant has served a written notice to the prosecutor and which is served not less than seven clear days before the date of the hearing
      • A defendant may not rely on the defence by reason that the defendant relied on information given by another person, unless the defendant shows that it was reasonable in all circumstances to have relied on that information

 Other considerations for TPD2

The TRPR-2016 regulation provides clear information on how the e-cigarette market will be regulated and, what each player in the market is required to do, under these regulations. However, the regulation does not address the technical standards when it comes to testing the refill liquid and their emissions.

Firstly, there is no accepted method of analysis of these liquids or their emissions and this will probably be very difficult to achieve using a universal method of analysis considering the fact that different e-liquids may contain different types of compounds and, detection of these compounds depends very much on the method employed.

Further to this, the regulation does not specify up to what quantity will be considered a ‘trace amount’ (e.g. say all chemicals below 1 part per billion will be considered trace amounts). It only specifies that the e-liquids needs to be manufactured using only ingredients of high purity and only allows inclusion of trace ingredients that are technically unavoidable during manufacture. This poses a problem to the producers in that the flavourings used in manufacturing are produced by a third party and they will not be willing to disclose the exact ingredient information, share their manufacturing process or highlight the ingredients that are technically unavoidable during the manufacturing of their flavours.

Moreover, it is a well-known fact that the flavours often include essential oils (especially the ‘strong’ flavours) and these essential oils generally contains multiple compounds (sometimes thousands of them in varying quantities) and thus the regulation may prohibit their use in e-liquid.

Lastly, in the response to public consultation on the draft regulations, it was stated that the collection of information on the adverse effects will be done through MHRA’s Yellow Card portal. However, the accepted TRPR-2016 mentions that the producer or suppliers needs to establish and maintain a system for collecting information about all of the suspected adverse effects on human health of the product. This can only mean that consumers are free to either report the incidences directly to MHRA through the Yellow Card portal or can report to the original manufacturer or supplier who should also have a record keeping system and inform MHRA from time to time of such incidents and outcome of any investigations and any action that they may have taken.

Dr Dilip Arvind Bhuva

Chief Science and Compliance Officer, Xyfil Ltd.

If you would like any further information on the above article or any help related to TPD compliance please email compliance@xyfil.com or call 01772 888 778

Legal Disclaimer

The information provided in this document is accurate and represents the best information available to us – and believed to be reliable – at the time of publication. This information is given in good faith without any representation or warranty, expressed or implied, regarding its accuracy or correctness and we assume no liability – legal, personal or otherwise – resulting from its use. This information is a summary of interpretation of a legal document and thus by very nature of it, excludes many important facets or legal text of the original legislation. This information does not, in any shape or form, constitute as a legal advice.

Any manufacturer, supplier, or distributor must satisfy themselves that their product complies with all the relevant legislations. In no event shall Xyfil Ltd. or author of this document be liable for any claims, losses, or damages to any third party or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if Xyfil Ltd. has been advised of the possibility of such damages. We advise that the information provided in this document should be used along with all the relevant legislation and/or literature.

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