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Image used by courtesy of ASHOn 18 December 2013, in the Committee of Permanent Representatives (COREPER I) the EU Member States backed the final compromise text negotiated by the Lithuanian Presidency and the European Parliament on the Tobacco products Directive.

In the final trilogue (negotiations between the European Commission, the European Parliament and the Council) of 16 December, the preliminary agreement was found on all articles, with the exception on e-cigarettes, subject to final approval by Member States. The final agreement approved on 18th December includes regulation of electronic cigarettes.

 

Some core elements of the agreement include:

  • number of additives* to be put on the ‘priority list’ (15) and the deadline for manufacturers and importers to submit reports on additives that are on the ‘priority list’ (18 month);
  • prohibition of placing on the market of tobacco products with a characterizing flavours; it will also be possible to prohibit products with additives that have been shown to increase significantly and measurably the toxic or addictive effect;
  • transitory period of 4 years for mentholated tobacco products , which will be banned of summer 2020 (including the 2-year directive transposition in national law period);

  • the combined health warnings shall cover 65 % of the external area of both the front and back surface of the unit packet and any outside packaging; All cigarette and roll-your-own (RYO) tobacco products will display combined health warnings (picture and text) covering 65% of the front and the back of packages.  Minimum dimensions for the health warnings will ensure greater visibility and that certain pack types, like the ‘lipstick’ type, will no longer be allowed. There will be standardisation of certain aspects of cigarette packs and all promotional elements on tobacco packs as well as reference for example to taste or flavourings will be prohibited. Member States that want to introduce plain packaging can do it under the justifications and conditions provided for in the Directive.
  • tobacco for oral use (“Snus”) remains banned in the EU, except for Sweden, where it can be marketed in accordance with Article 151 of the Act of Accession of Austria, Finland and Sweden;
  • Member States may ban cross-border distance sales of tobacco products;
  • Tracking and tracing: an EU-wide tracking and tracing system with security features (e.g. holograms) for tobacco products to combat illicit trade will be put in place. Cigarettes and roll-your-own tobacco products will be the first to be phased in to this system, with other tobacco products following after;
  • e-cigarettes included into the scope of the Directive; Member States which regulate the e-cigarettes as pharma products will be able continue; maximum permitted nicotine concentration level of 20 mg/ml, use of refillable cartridges for e-cigarettes allowed and the maximum size of the single use cartridges of 2 ml;
  • concerning e-cigarettes strict safeguards were introduced allowing, inter alia, the Commission to ban via delegated acts given type of electronic cigarette or refill container, or a type of electronic cigarettes or refill containers, which has been banned on justified ground by at least three Member States.

The Commission submitted the Proposal for a Directive of the European Parliament and of the Council 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 on 20 December 2012. A General approach of the Council (EPSCO) was reached on 21 June 2013. ENVI Committee voted on 10 July 2013. EP Plenary voted on 8 October 2013. The political agreement reached is subject to technical finalisation and formal approval by the co-legislators.

The text as originally adopted by the European Parliament is here.

Source: Lithuanian EU presidency and European Commission

* Directive, recital 14a: Additives should only be allowed in tobacco products if they are included in a Union list of authorised additives. That list should also indicate any conditions or restrictions on the use of allowed additives. Tobacco products containing additives not included in the Union list or used in a manner that does not comply with this Directive should not be placed on the Union market.