How would YOU re write article 18?

Martin Callanan wrote that at the moment, the odds of e cigs being removed from the TPD are incredibly slim, and that our best chance to still be able to vape more than a ‘cigie like’ beyond 2016 is an amended article 18 – (the latest version is below this post).

MEPs have told us what they think, and we are very thankful to those that have worked so hard on our behalf. We’ve heard from experts in the medical field, in the Public Health field, both for and against e cigs, and again many many thanks to all of them that have stood up for our cause, but what  if we vapers could re write article 18 of the TPD?  What would we write? What would YOU write? What would you amend, and what would you introduce?

Because are the experts right? Is the average e liquid strength 18mg/ml? Do most people only use  2nd generation eGos, and  buy from the local shop? What about flavours? And what about the power the Commission are trying to award themselves in all this?

For the full version of the entire latest draft TPD – click here – (this will help you understand what articles 16, 6, 12 etc are all about.)

Have your say in the comments section below, and lets come up with the vapers article 18 that reflects us – the vapers. If you would  like to send us a more detailed response, then please e mail us at campaign@saveecigs.com. We will be collating all the responses and sending them to MEPs.

TITLE III – NON TOBACCO PRODUCTS

Article 18

Nicotine-containing products

Electronic cigarettes

(Presidency’s proposal)

(Text as submitted to Coreper on 13 December 2013 in doc. 17506/13 ADD2 with latest modifications indicated by strikethrough for deletions and bold underlined for additions)

1.         The Member States shall ensure that electronic cigarettes and refill containers are only placed on the market if they comply with the relevant provisions of this Directive and with all other relevant Union legislation.

This Directive does not apply to products that are subjet to an authorisation requirement under Directive 2001/83/EC or to the requirements set out in Directive 93/42/EEC.

 

2.         Manufacturers and importers of electronic cigarettes and refill containers  shall notify the products with the competent authorities of the Member States in which the product is intended to be placed on the market. The notification shall be submitted in electronic form 6 months before the intended placing on the market. For products already placed on the market on the date referred to in paragraph 1 of Article 25, the notification shall be submitted within 6 months of that date. A new notification shall be submitted for each substantial modification of the product.

The notification shall, depending on whether the product is an electronic cigarette or a refill container, contain the following information:

  1. name and contact details of the manufacturer,  a responsible legal or natural person within the European Union, and, if applicable, the importer into the European Union;
  1. list of all ingredients contained in and emissions resulting from the use of the product, by brand name and type, including quantities thereof;
    1. toxicological data regarding these ingredients and their emissions, including when heated, referring in particular to their effects on health of consumers when inhaled and taking into account, inter alia, any addictive effect;
  1. information on nicotine dosing and delivery to blood streamand uptake when used under normal or reasonably foreseeable conditions;
  1. description of the components of the electronic cigarette; including, where applicable, the opening and refill mechanism of the electronic cigarette or refill containers;
  1. f.               description of the production process including series production and declaration that the production process ensures conformity with the requirements in this article;

 

  1. g.              declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions.

Where Member States consider that data are incomplete, they are entitled to request the completion of such data.

Proportionate fees may be charged by Member States for receiving, storing, handling and analysing the information submitted to them.

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, disposable electronic cigarettes or in single use cartridges. The cartridges or tanks shall not exceed a volume of 2 ml;  to be used in rechargeable electronic cigarettes or in disposable electronic cigarettes

 

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

c)      the liquid does not contain additives listed in paragraph 4 of Article 6;

d)     only ingredients of high purity and free from contaminants are used in the manufacture of the liquid; substances other than the ingredients referred to in paragraph 2(b) are only present in trace levels, if they are technically unavoidable during manufacture;

e)      only ingredients are used in the liquid that are not toxic hazardous to human health in heated or unheated form, with the exception of nicotine;

f)       electronic cigarettes deliver the nicotine doses consistently;

g)      electronic cigarettes and refill containers are child- and tamperproof;

 

h)     electronic cigarettes and the refill containers are protected against breakage and leakage and have a mechanism ensuring leakage free refilling.

 

4. Member States shall require manufacturers and importers to ensure that:

(a)   unit packets of electronic cigarettes and refill containers include a leaflet with information instructions for use and storage, including a reference that the product is not recommended for use by young people and non-smokers, contra-indications, warnings for specific risk groups, information on possible adverse effects, on addictiveness and toxicity, and contact details of the manufacturer or importer and a legal or natural contact person within the European Union;

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

  1.                     i.       include a list of all ingredients contained in the product in descending order, and an indication of nicotine content and delivery per dose, the batch number  and a recommendation to keep out of reach of children;
  2.                   ii.       do not include elements or features referred to in Article 12, with the exception of paragraph 1(a) of Article 12 concerning the nicotine content;
  3.                  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 are used.

 

(c)  the health warnings shall comply with the provisions in paragraph 2 of Article 11.

 

5. Member States shall ensure that:

a)      commercial communications with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers are prohibited in information society services as defined in Article 1(2) of Directive 98/48/EC, in the press and other printed publications, with the exception of publications that are intended exclusively for professionals in the trade of the products and for publications which are printed and published in third countries, where those publications are not principally intended for the European Union market;

b)     commercial communications with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers are prohibited in the radio;

c)      any form of public or private contribution to radio programmes with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers is prohibited;

d)     any form of public or private contribution to any event, activity or individual with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers and involving or taking place in several Member States or otherwise having cross-border effects is prohibited;

e)      audiovisual commercial communications falling under Directive 2010/13/EU are prohibited for electronic cigarettes and refill containers;

f)       cross-border distance sales of electronic cigarettes and refill containers are regulated in accordance with Article 16.

 

6.      Member States shall require manufacturers and importers of electronic cigarettes and refill containers to submit to competent authorities on an annual basis comprehensive data on sales volumes, by brand name and type, as well as information on preferences of various consumer groups, including young people, non-smokers and main types of current users, as well as the mode of sale of the products. They shall also submit executive summaries of any market surveys carried out in respect of the above, including an English translation thereof.

Member States shall monitor the development of the electronic cigarette market as well as the market for refill containers, including any evidence of gateway use among young people and non-smokers.

7.      Member States shall ensure the dissemination of information received pursuant to paragraph 2 on a website with due regard to the protection of trade secrets.

Member States shall make available, upon request, all information received pursuant to this Article to the Commission and other Member States. Member States and the Commission shall ensure that trade secrets and other confidential information are treated in a confidential manner.

8.       Member States shall require that manufacturers, importers or distributers establish and maintain a system to collect information about all suspected adverse effects. If any of these operators considers or has reason to believe that electronic cigarettes or refill containers, which are in its possession and are intended to be placed on the market, are not of good safety or quality or is otherwise not in conformity with this Directive, the operator shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, as appropriate. In such a case the operator shall also be required to immediately inform the market surveillance authorities of the Member States in which the product is made available, giving details, in particular, of the risk to health and safety and of any corrective action taken, and of the results of such corrective action. Member States may also request additional information from the operator, for example on safety and quality aspects or any adverse effects.

9.      The Commission shall report on the potential risks to public health associated with the use of refillable electronic cigarettes at the latest on the date referred to in Article 25(1) and whenever needed thereafter.

 

In the case of products meeting the requirements of this Article, where a competent authority ascertains or has reasonable grounds for concerns that a given  electronic cigarette or a refill container, or a type of electronic cigarettes or refill containers, could present a serious risk to human health, it shall may take all appropriate measures and shall immediately communicate to the Commission and the competent authorities of other Member States the measures taken and any supporting data. The Commission shall determine, as soon as possible, whether the provisional measure is justified [following whenever possible appropriate consultations]. The Commission shall inform the Member State concerned, which will ensure appropriate follow-up.

Where, in the application of the first subparagraph of this paragraph, a given type of electronic cigarette or refill container, or a type of electronic cigarettes or refill containers has been banned on justified ground by at least three Member States, the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to extend such a ban to all Member States, if that measure is justified and proportionate.

10.    The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the wording of the health warning in paragraph 4(j). When adapting that health warning, the Commission shall ensure that it is factual.

 

11.    The Commission shall adopt by means of implementing acts a common notification format pursuant to paragraph 2 and the technical standards of the refill mechanism.

         These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21.

1.      The following nicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC:

(a)    products with a nicotine level equal to or exceeding 1 2 mg per unit, or

(b)   products with a nicotine concentration equal to or exceeding 2  4 mg per ml. or

(c)    products whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng of nicotine per ml.

2.      The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to update the nicotine quantities set out in paragraph 1 taking into account where this is necessary based on scientific developments and marketing authorisations granted to nicotine- containing products pursuant to Directive 2001/83/EC.

3.      Each unit packet and any outside packaging of nicotine-containing products below the thresholds set out in paragraph 1 shall carry the following health warning:

This product contains nicotine which is an addictive substance and can damage your health.

4.      The health warning referred to in paragraph 3 shall comply with the requirements specified in Article 10 8(4). In addition, it shall:


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

(b)   cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging. That proportion size shall be increased to 32 % for Member States with two official languages and 35 % for Member States with three official languages.

5.      The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the wording of the health warning requirements in paragraphs 3 and taking into account based on  scientific and market developments and to adopt and adapt the position, format, layout, designand rotation of the health warnings.

5a.   The provisions of of paragraphs (3) to (5) of this article shall be without prejudice to the application of Directive 2001/83/EC.

6.      Nicotine-containing products referred to in Article 18(1) and which are placed on the market before [entry into force + 24 months], may continue to be marketed until  [entry into force + 36 months].]

Now you have read it – have your say in the comment section.

Advertisements

5 thoughts on “How would YOU re write article 18?

  1. It has never been published in any scientific litterature that nicotine IS addictive. This is not proven. So the proposed warnings are not OK. Nicotine is however recognized as a “toxic substance” : it would be more appropriate.

  2. The 10 ml maximum refill container size (para 3a) is absurdly low in my opinion. It’s regularly sold in larger volumes than this, often significantly larger for bulk deals. I take it this and the 20 mg/ml limit makes it illegal to sell 500 ml of 74 mg/ml unflavoured DIY mixing supplies. I consider that a totally unreasonable infringement on my freedom. I guess I could live with the 20 mg/ml limit as that’s about what I mix down to anyway. This would still potentially limit my PG/VG mix choice though (ideally if I want 50/50 PG/VG then I need to be able to buy pure PG based NIC at at least 40 mg/ml unless my supplier does a custom mix for me or I buy appropriate proportions of both PG and VG based NIC). But only 10 ml in a bottle? That’s just ridiculous.

  3. 1
    a) nicotine-containing liquid is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml, disposable electronic cigarettes or in single use cartridges. The cartridges or tanks shall not exceed a volume of 2 ml;

    WHY not more than 10 ml ?? whats the point ?? 10 x 10 ml is still 100 ml, put that in a other container and i still have 100 ml, this is not only absurd, but it is also bad for the inviroment
    1 x 100 ml bottle is less garbage than 10×10 ml bottles, this rule is only good for the stores nothing else

    WHY max volume of 2 ml in a tank or cardrige ?? also no point, if i fill my tank 2 times than i still fape 4 ml ( i use bout 6-8 ml a day)

    2
    i don’t think it’s necessary to hold on the radio and television promotion in the way of advertisement
    but the crossborder communication and sales, is priority number one to hold on, the reason is that people can see whats on the market , or what the problems with the products are
    and how/ if they can fix it ( for example bad mods, bad DIY stuff, what or what not to use with DIY, what or what not to use or do when recoiling / wicking, or how to do it properly so there are no injuries)

    3
    In the case of products meeting the requirements of this Article, where a competent authority ascertains or has reasonable grounds for concerns that a given electronic cigarette or a refill container, or a type of electronic cigarettes or refill containers, could present a serious risk to human health, it shall may take all appropriate measures and shall immediately communicate to the Commission and the competent authorities of …………

    This whole piece about the regulation of bad stuff is to my opinion very dangerous for the e-sig, as i see it now, the eu is trying to ban the e-sig, this is a very easy way to do it
    ( just say all products exept those from tobacco industries or the ones the eu wants to stay, are dangerous )
    on the other hand, I agree the eu needs a rule to ban the real bad stuff

  4. Will a higher Nic content be available in Nic base (Propylene Glycol)? if not making a 20mg Juice (by anyone) will be impossible.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s