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Refill mechanism of electronic cigarettes (Article 20(13))

krakkajax

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A new mail rec'd today, that is interesting to share.

To interested parties,

We have received the attached text of a proposed Commission Implementing Decision on technical standards for the refill mechanism of electronic cigarettes (Article 20(13)). The draft proposal details a choice of two types of refill mechanisms:

1.a refill container possessing a non-detachable nozzle at least 1cm long, which is narrower than and slots comfortably into the opening of the tank of the electronic cigarette with which it is used and possessing a flow control mechanism that emits no more than 20 drops of refill liquid per minute when placed vertically; [We believe that the limit of 20 drops per minute is based on technical standards adopted by the French standards setting authority AFNOR]; or

2.a docking system which only releases refill liquids when the electronic cigarette and refill container are connected.

To inform our position we are asking UK stakeholders for any comments that they may have on the draft text and the impact of the rules set out in this Commission Implementing Decision. Please provide any comments by21 January 2016.

We are committed to consulting all interested stakeholders on the tertiary legislation being developed under the Tobacco Products Directivewithin the constraints of the Commission-led timetable. We have mailed this request to a contact list of interested parties, which we have compiled during our consultation on the implementation of the Directive. If however you think that there are further companies or organisations that might like to comment on this text please feel free to disseminate this request.

Please put “Refill Mechanisms of E-cigarettes” in the e-mail title of any comments that you provide and send to [email protected]

Regards

The Tobacco Control Team

And the document attached:

COMMISSION IMPLEMENTING DECISION

of XXX

on technical standards for the refill mechanism of electronic cigarettes

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC1, and in particular Article 20(13) thereof,

(1) Article 20(3)(g) of Directive 2014/40/EU requires Member States to ensure that

(1) Article 20(13) of Directive 2014/40/EU confers implementing powers on the electronic cigarettes and their refill containers have a mechanism that ensures refilling without leakage. Commission to lay down technical standards for the refill mechanism of electronic

(2) Given the toxicity of the nicotine-containing liquids used in electronic cigarettes and refill containers, it is appropriate to ensure that electronic cigarettes can be refilled in a manner that minimises the risk of dermal contact or accidental ingestion of such

(3) On the basis of feedback received from stakeholders and work carried out by an external contractor, technical standards have been identified which are intended to ensure that compliant refill mechanisms provide sufficient protection against leakage.

(4) The technical standards identified also comprise measures ensuring that consumers are properly informed of how to operate the refill mechanisms in order to ensure leakage free refilling.

(5) These technical standards should therefore constitute the basis for the technical standards to be adopted.

(6) Stakeholders may wish to provide the Commission with information on alternative mechanisms they have developed for leakage-free refilling, which may result in a revision of this decision.

(7) The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 25 of Directive 2014/40/EU,


HAS ADOPTED THIS DECISION:

Article 1

Subject matter

This Decision lays down the technical standards applicable to the refill mechanism of electronic cigarettes manufactured in or imported into the Union..

Article 2

Requirements for the refill mechanism

1. Member States shall ensure that refillable electronic cigarettes and refill containers are only placed on the market if the mechanism by which the electronic cigarettes are refilled complies with one of the following conditions:

(a) it entails the use of a refill container possessing a non-detachable nozzle at least 1cm long, which is narrower than and slots comfortably into the opening of the tank of the electronic cigarette with which it is used and possessing a flow control mechanism that emits no more than 20 drops of refill liquid per minute when placed vertically;

(a) it operates by means of a docking system which only releases refill liquids when the electronic cigarette and refill container are connected.

2. Member States shall ensure that refillable electronic cigarettes and refill containers include appropriate instructions for refilling including graphic illustrations as part of the instructions for use required by Article 20(4)(a)(i) of Directive 2014/40/EU. Refillable electronic cigarettes and refill containers with a refill mechanism of the
type referred to in paragraph 1(a) shall indicate the width of the nozzle or width of the opening of the tank in the instructions for use in a manner that enables consumers to identify the compatibility of refill containers and electronic cigarettes.

Article 3

Addressees

This Decision is addressed to the Member States.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission
 
A clarification to this, has now been sent, to explain in better detail:

Dear all,
This morning I sent out the following lines to all those who had previously contacted the MHRA with responses and/or requests for clarification.
This was because we have had a number of requests for clarification, most of which fall into the following three broad themes below.
We therefore provided clarification on these issues, which I am now forwarding to everyone on our original consultation list for information.
We hope you will also find this information helpful.
Please also remember that the consultation exercise closes on Friday 29 January.
Many thanks,

1.Who needs to submit a notification? The requirement to notify e-cigarettes and refill containers applies to ‘producers’. A producer is anyone who manufactures or imports or re-brands any of the products covered by the regulations. We are looking to implement the TPD is a pragmatic way so that importers do not need to submit a duplicate notification if the manufacturer or re-brander has already submitted a notification.

2.What about flavour and strength variants? We expect that each individual product will require a separate notification. This would include each flavour and strength variant.

3.Do retailers need to submit notifications? Retailers do not need to submit notifications unless they also qualify as a ‘producer’, for example by mixing their own e-liquids (refill containers).
 
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