To what extent has the UK transposed the rules of the TPD?

 

The TPD lays down the rules for the sale and manufacture of e-cigarettes and e-liquids. There is little scope for the EU Member States to deviate from its rules but there are some areas where they can develop their own country-specific requirements. Here, we look at what TPD laws have been directly transposed by the UK government into UK law and where have they deviated.

TPD Law

Has it been directly transposed into UK law?

General Requirements

Paragraph 1 The Member States shall ensure that electronic cigarettes and refill containers are only place do nt he market if they comply with this Directive and with all other relevant Union legislation.

This Directive does not apply to electronic cigarettes and refill containers that are subject to an authorisation requirement under Directive 2001/83/EC or to the requirements set out in Directive 93/42/EEC.

Yes.

Note: Directive 2001/83/EC and Directive 93/42/EEC refer to requirements for the registration of medicines and medical devices prior to sale.

Notification Requirements

Paragraph 2 Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market. The notification shall be submitted in electronic form six months before the intended placing on the market.

Yes with an deviation. Rather than adopting the 6 month rule, the MHRA allows the sale of a notified product once it appears on the list of notified products on the MHRA website (approx. 6 weeks from notification submission).

Member States may charge manufacturers and importers proportionate fees for receiving, storing, handling and analysing the information submitted to them.

The MHRA has set fees at £150 per notification with an annual fee of £80.

Product Characteristics

Paragraph 3 Member States shall ensure that:

(a) nicotine-containing liquid is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml, in disposable electronic cigarettes or in single use cartridges and that the cartridges or tanks do not exceed a volume of 2 ml;

(b) the nicotine-containing liquid does not contain nicotine in excess of 20 mg/ml;

(c) the nicotine-containing liquid does not contain additives listed in Article 7(6);

[excerpt only]

Yes.

Packaging Requirements

Paragraph 4

Member States shall ensure that:

(a) unit packets of electronic cigarettes and refill containers include a leaflet with information on:

(i) instructions for use and storage of the product, including a reference that the product is not recommended for use by young people and non-smokers;

(ii)  contra-indications; 


(iii)  warnings for specific risk groups; 


(iv)  possible adverse effects; 


(v)  addictiveness and toxicity; and 


(vi)  contact details of the manufacturer or importer and a legal or natural contact person within the Union; 


Yes with a deviation (see below).

Paragraph 4 (cont.)

(b)  unit packets and any outside packaging of electronic cigarettes and refill containers: 


(i)  include a list of all ingredients contained in the product in descending order of the weight, and an indication of the nicotine content of the product and the delivery per dose, the batch number and a recommendation to keep the product out of reach of children; 


(ii) without prejudice to point (i) of this point, do not include elements or features referred to in Article 13, with the exception of Article 13(1)(a) and (c) concerning information on the nicotine content and on flavourings; and

Deviation: In most cases, the nicotine delivery per dose is not required on e-liquid packaging.

Health Warning Requirements

Paragraph 4 (cont.)

(iii)  carry one of the following health warnings: 
‘This product contains nicotine which is a highly addictive substance. It is not recommended for use by non- smokers’. 
or 
‘This product contains nicotine which is a highly addictive substance.’ 


Member States shall determine which of these health warnings is to be used;

Specific to UK: The UK has chosen the latter: 
‘This product contains nicotine which is a highly addictive substance.’ 


Article 12

Paragraph 2 The health warning laid down in paragraph 1 shall comply with the requirements specified in Article 9(4). The text of the health warnings shall be parallel to the main text on the surface reserved for these warnings.

Yes with a deviation (see below).

Health Warning Specification

Paragraph 2 (cont.)

In addition, it shall:

(a) appear on the two largest surfaces of the unit packet and any outside packaging;

Deviation: In the UK the health warning should “appear on both the front and back surfaces of the unit packet and any container pack”

Paragraph 2 (cont.)

(b) cover 30 % of the surfaces of the unit packet and any outside packaging. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with more than two official languages.

Specific to UK: English is the only official language so the warning should cover 30% of the surfaces (front and back).

What are the steps in the process to introduce the TPD into UK law?

 

The following steps detail the process for introducing the TPD into UK law:

 

Step 1:The relevant UK government department consults with government stakeholders.

 

Step 2: The department identifies the aims of the TPD and Article 20 and the relevant UK policies, and how the two will be brought into harmony so that transposition does not go beyond the minimum requirements of the TPD or create unintended consequences or an unnecessary risk of infraction in the UK.

 

Step 3: The department writes to the Reducing Regulation Committee (RRC) and Secretaries of State for any other affected departments detailing its intended plan for transposition.

 

Step 4: The department carries out a consultation to seek the views of industry stakeholders on the options for transposition, taking into account the RRC’s responses to the initial project plan, and including an impact assessment.

 

Step 5: The department revises plans for transposition according to the results of the consultation and seeks Cabinet Committee clearance for all consultation documents.

 

Step 6: The department completes plans for transposition, ensuring all steps are complete before the legal deadline set in the EU legislation, and notifies the European Commission once complete.

 

Can the UK disregard the TPD rules?

 

The UK and other member states can’t ignore the TPD regulations, but they can challenge them if they doubt the EU’s legitimacy in making them. If the challenge was valid – for example, if a rule did not meet the objectives of the Treaty on European Union (TEU) – then the UK courts may be able to suspend its implementation.

 

What would happen if the UK government didn’t transpose the TPD?

 

Failure to transpose the TPD into UK law by the EU’s deadline could have resulted in action against the UK government in both national and European courts.

 

Under the TEU, the European Commission can bring infraction proceedings before the European Court of Justice if a member state doesn’t comply. If the member state fails to correct the infraction, the Commission may take further action by either charging a lump sum or fining the member state on an ongoing basis. The UK has not yet had such an action brought against it.