Directive 2001/37/EC lays down maximum tar, nicotine and carbon monoxide yields for cigarettes marketed or manufactured in the Member States

Maximum levels of tar, nicotine and carbon monoxide must not exceed:

10 mg per cigarette for tar, 1 mg per cigarette for nicotine, 10 mg per cigarette for carbon monoxide.

The tar, nicotine and carbon monoxide yields of cigarettes must be measured based on ISO standards 4387, 10315, and 8454. 

Directive 6.5.01

The European Union publishes a list of tobacco testing laboratories.   

Ingredients

Article 6 of the Tobacco Products Directive 2001/37/EC requires that manufacturers and importers of tobacco products submit a list of all ingredients, and quantities thereof, used in the manufacture of those tobacco products by brand name and type.

It specifies the content of this list and requires that the list be accompanied by the toxicological data available to the manufacturer and importer.

Member States must ensure that the list of ingredients for each product, indicating tar, nicotine and carbon monoxide yields, is made public.

Directive 6.5.01

Under a Resolution adopted by the European Parliament (Art 56) on March 8, 2011, while tobacco products must be governed by a strict regulatory framework, the regulation of ingredients in tobacco products at EU and international level must follow a proportionate, risk-based approach reflecting scientific evidence; warns against any non science-based ban on any ingredient, which would effectively lead to the banning of European traditional blended tobacco products.

Resolution 3.8.2011

Report on the application of the Tobacco Products Directive 2001/37 EC

The first report on the application of the Tobacco Products Directive 2001/37 EC indicated that in the EU different reporting formats are used for the submission of tobacco products ingredient and emission information. The data sets delivered by manufacturers and importers to Member States are often incomplete. The first report therefore suggested that the Commission develops harmonised data collection methods that are based on a common EU format and improved definitions.

The Regulatory Committee under the Tobacco Products Directive set up a working group to support the Commission in this work. It consisted of the experts from 8 Member States and was chaired by the Commission. Two sets of formats were developed: one with the full ingredient information to national regulators and one with less requirements for the information to the public. The two draft ingredient reporting formats were presented to the Regulatory Committee under the Tobacco Products Directive on 16 October 2006 and the work was finalised on the basis of these discussions.

The common reporting formats (Practical guide, May 2007)  must facilitate and improve the transmission of the data from manufacturers and importers to the Member States and from them to the European Commission. Electronic submission of data would be the desirable form.

The European Commission adopted the Second Report on the application of the Tobacco Products Directive (2001/37/EC) on 27 November 2007.

Some suggestions for further development of the Directive, such as the inclusion of tobacco leaves and other tobacco plant parts in the definition of ingredients, were not discussed earlier. Others, such as further work on tobacco product ingredients or the mandatory use of pictorial warnings complement the ongoing work.

Report 11.27.07

A consultation meeting on the 2nd Report on the Application of the Tobacco Products Directive 2001/37/EC was organized by Directorate General for Health and Consumer Protection on April 28, 2008. 

On September 24, 2010, the European Commission launched a public consultation on revising by 2012 the Tobacco Products Directive (2001/37/EC).

The European Commission's Directorate-General for Health and Consumers on July 27, 2011 published the results of its public consultation, which ended December 17, 2010, regulating "harmful and attractive" substances in tobacco products among others. 

The European Commission published on December 19, 2012 the proposal for revising the 2001 Tobacco Products Directive.

The proposal proposed that for cigarettes, roll your own tobacco and smokeless tobacco with characterising flavours, such as fruit flavours or chocolate are prohibited. Additives associated with energy and vitality (e.g. caffeine and taurine), or creating the impression that products have health benefits (e.g. vitamins) must be prohibited. No flavourings are allowed in filters, papers or packages. Tobacco products with increased toxicity or addictiveness shall not be placed on the market. Member States shall ensure that provisions or conditions set out under REACH are applied to tobacco products as appropriate''.

Smokeless tobacco products with characterising flavours cannot be sold.

Proposal 12.19.2012.

The European Parliament on October 8, 2013, approved the proposal for revising the 2001 Tobacco Products Directive. MEPs and EU member States on October 23, 2013 began discussions on the proposal to revise the Tobacco Products Directive, but they remain divided on the issue of e-cigs.

On December 18, 2013, the Council of the European Union approved a final compromise on the EU TPD    http://www.consilium.europa.eu/uedocs/cms_Data/docs/pressdata/en/lsa/140147.pdf]

The European Parliament on February 26, 2014 approved the compromise on the Tobacco Products Directive; it was adopted by the EU Council on March 14, 2014.

Flavorings - 1) Cigarettes and RYO tobacco cannot have any distinguishable "characterizing" flavor other than tobacco; 2) Menthol will be banned after a phase-out period of four years; 3) Other tobacco products like cigars and smokeless tobacco are exempted from the flavors ban; and 4) Additives necessary for manufacturing, such as sugar lost during the curing process, can continue to be used. 
Directive 3.14.2014

Product Information - Manufacturers will be required to report on "certain frequently used substances found in cigarettes and RYO tobacco" through a standardized electronic format.

Chemicals (REACH)

A proposal by Karl-Heinz Florenz, a member of the European Parliament and chairman of the Environment Committee, in March 2005, aimed at amending the EU Regulation, Evaluation, and Authorisation of Chemicals (REACH) law. REACH was tabled by the Commission in October 2003 to assess and authorize some 30,000 chemicals out of the 100,000 or so which are currently in use around Europe.

The purpose of the amendment by Karl Florenz aimed at introducing rules covering each substance newly classified or reclassified as c/m/r in category 1 or category 2 under the twenty-ninth adaptation of Directive 67/548/EEC.

A specific amendment relating to ingredients that "enhance the addictive effect of cigarettes" to be added in the list of chemicals to be tested under the legislation, was included in the draft REACH directive. "Many of the cigarette ingredients are currently approved as foodstuffs, but when they are mixed in a lit cigarette, the ingredients turn into carcinogenic substances, Florenz said. He added that registering the ingredients under REACH would lead to tobacco smoke being classified as carcinogenic".

Proposal 3.30.05

On December 13, 2005, the Council of Ministers of the European Union approved the REACH Directive.

The REACH Regulation No 1907/2006 was then approved by the European Parliament on December 13, 2006 and adopted by the Council on December 18, 2006.

Under Reach regulations, all EU producers using substances in their goods and manufacturing processes will be required to report to their suppliers any new information they have available on the hazardous properties of the substances they use, and any information affecting the risk management measures by June 2007,

REACH will allow the further evaluation of substances where there are grounds for concern and foresees an authorization system for the use of substances of very high concern.

REACH regulation has entered into force progressively since June 2007, and the registration process will take 11 years to be completed.  The calendar for registration depends on the risk of the substance and the quantity produced.

By June 2009, the European Chemicals Agency is likely to have identified the first list of ‘substances of very high concern’, which may later be subject to the prior authorization requirement.

All covered substances will have to be registered by 2018.

REACH also creates a new Chemicals Agency, to be based in Helsinki, which will be responsible for the authorisation process.

Regulation 12.18.06   Directive 12.18.06

Regulation 1907/2006 was amended by Regulation 134/2009 which provides for changes to Annex XI of REACH Regulation

Regulation 02.16.2009

link to REACH Legislation:

http://ec.europa.eu/environment/chemicals/reach/legislation_en.htm

Additives

Proposals by Karl-Heinz Florenz (European Parliament. Committee on the Environment, Public Health and Food Safety) in May 2007, provided for a ban on certain additives contained in the tobacco products in the European Union. The author called on the Commission to present a proposal, by 2008 if possible, for an amendment of Directive 2001/37/EC on tobacco products, containing at least the following:

- immediate ban on all additives shown by existing toxicological data to be carcinogenic and addiction- enhancing, in particular those forming carcinogens during pyrolysis (burning at a temperature of between 600 and 950 degreesC)

- introduction of a detailed registration, evaluation and authorisation procedure for tobacco

  additives

- automatic ban on all additives for which manufacturers and importers of tobacco products do not have complete data sets (including lists of all ingredients by brand name and type, along with their quantities and toxicological data).

These proposals were adopted by the European Parliament on September 12, 2007. They were approved on October 24, 2007.

Proposal 5.9.07  Resolution 10.24.07

On July 9, 2010, the Commission's independent Scientific Committee for Emerging and Newly Identified Health Risks (SCENIHR) launched a public consultation on a pre-consultation opinion on the addictiveness and attractiveness of additives in tobacco products. It released a report titled Addictiveness and Attractiveness of Tobacco Additives which reports among other things that: no tobacco product additives that are addictive on their own have so far been identified; additives such as menthol facilitate deeper inhalation and may indirectly enhance the addictiveness of nicotine; methods used to quantify the addictive potency of additives have limitations because of technical challenges; the use of fruit and candy flavors appear to "favor smoking initiation" in young people; and distinguishing between direct effects of additives from indirect effects such as marketing is difficult.  

It was reported on January 20, 2011 that the European Commission received 82,000 comments on its public consultation about possible changes to its 2001 Tobacco Products Directive. The Commission usually receives a few hundred responses to its consultations.

Tobacco for oral use

In May 1992, the European Union (EU) prohibited the placing on the market of tobacco for oral use (including Swedish snus). The prohibition was introduced by Directive 92/41/EEC amending Directive 89/622/EEC
Under Directive 2001/37/EC, Member States must prohibit the placing on the market of tobacco for oral use (except chewing tobacco) without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden, which stipulates that the placing on the market in Sweden of tobacco for oral use may continue.

Directive 6.5.01

The European Court of Justice (ECJ) upheld on December 14, 2004 the European Union's ban on the sale of snus and other tobacco products for oral use in EU nations except Sweden, where a national measure prohibits the marketing of tobacco products for oral use. Judgement 12.14.04

On May 18, 2006, the European Court of Justice ruled that Finland violated European Union rules banning the sale of oral tobacco products by selling the products on ferries registered in Aland Islands, an administrative Province of Finland.  

Judgement 5.18.06

It was reported in early December 2008 that the European Union Minister for Migration and European Affairs Astrid Thors protested Finland’s ban on snuff sales and planned to urge the European Commission to review the snuff regulations in the EU.

On December 12, 2008 the European Commissioner for Health Androula Vassiliou reprimanded Astrid Thors for snus liberation campaign and advised Finland"s Minister of European and Migration Affairs to adhere to thetobacco directive adopted by the European Union.

In early April 2009, Sweden's Trade Minister Ewa Bjorling called on the European Union to lift its ban on Swedish snus. 

Mid- February 2011, in response to the European Union's proposed revision of its Tobacco Products Directive, Swedish Minister for Health and Social Affairs Goran Hagglund sent a letter to the European Commission, urging it to remove the EU ban on snus, saying the prohibition not only violates the principles of the free market, but is also "illogical" considering that snus is "significantly less damaging than cigarettes."  

Even though a recent European Commission opinion poll of member States revealed that a clear majority support a ban on all forms of smokeless tobacco products, the Swedish government vowed to continue its fight to get EU's ban on the sale of snus outside of Sweden lifted, with Trade Minister saying on August 1, 2011 the ban is not only unfair, but also perpetuates public ignorance regarding snus.  

Swedish Trade Minister Ewa Bjorling told the Dagens Nyheter daily on December 7, 2011  that EU Health Commissioner John Dalli has promised to take another look at the EU ban on the sale of snus except in Sweden, after an EU survey about current tobacco laws showed that EU citizens and industry representatives were in favor of lifting the snus ban, while most non-governmental organizations wanted to keep it.  Dalli "promised to take another look at what the survey showed and at developments in Sweden," Bjorling said. UBS analysts note that the European Commission's reconsideration of the export ban on Swedish snus to other EU countries comes at the same time the Food and Drug Administration looks at relative risk products in the US, and believe one of the key themes in 2012 for the US tobacco sector will be the ongoing debate around relative risk.

In response to a question raised by Paul Nuttall in early September 2011, UKIP MEP for the North West of England and a member of the Europe of Freedom & Democracy Party grouping within the European parliament, European Union Health Commissioner John Dalli said the European Commission does not believe changes should be made to the EU ban on snus except in Sweden

Smokeless tobacco products are addictive and hazardous to health, SCENIHR concluded. The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) in its opinion on smokeless tobacco products addressed their health effects and addiction potential. According to the opinion, which was published on February 17, 2008, after a public consultation on the health effects of smokeless tobacco products with particular attention to tobacco for oral use, moist snuff, which is called "snus" in Sweden, smokeless tobacco is addictive and withdrawal symptoms are broadly similar to those seen in smokers. The report also finds that all other smoke­less tobacco products contain nicotine, a potent addictive substance. Smokeless tobacco products contain various levels of toxic substances and these products are carcinogenic to humans.

http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_013.pdf

The European Parliament on February 26, 2014 approved the compromise Tobacco Products Directive, which maintains the ban on snus except in Sweden

Directive 3.14.2014

Electronic cigarettes

The European Parliament on October 8, 2013, approved the proposal for revising the 2001 Tobacco Products Directive, which would:

-       regulate e-cigs, but *not* subject them to the same rules as medicinal products unless they are presented as having ‘curative or preventive properties’ with products with no such claims to contain under 30 mg/ml of nicotine, carry health warnings and sold only to consumers aged 18 and over;

-       subject e-cigs to the same advertising restrictions as tobacco products;

-       require e-cig manufacturers and importers to supply authorities with a list of all ingredients in their products.

MEPs and EU member States on October 23, 2013 began discussions on the proposal to revise the Tobacco Products Directive but they remain divided on the issue of e-cigs, as member States supported the European Commission's proposal to regulate the devices as medicines in their "general approach" to the TPD adopted in June, while the European Parliament, in its October 8th vote on the TPD, rejected that proposition, with MEP Linda McAvan, who is leading the negotiations in Parliament, saying the "gap is not about whether to regulate e-cigarettes, but how to regulate them."  Despite the widespread attention the e-cig issue received during the Parliament plenary vote, nomember State has indicated any change in stance so far, she noted. The UK has said it will continue to oppose regulating e-cigs as tobacco products.

On March 28, 2013, the European Parliament Environment, Health and Food Security Committee on the revised Tobacco Products Directive proposal, issued a draft proposal tightening the text of the TPD.

Proposal 3.28.2013

The Commission proposed a twin track approach to the regulation of e-cigarettes and other nicotine-containing products, with those products containing nicotine above a certain level to obtain authorization as medicines and those containing the substance below the threshold to be allowed on the market with health warnings. The EP rapporteur has requested a study on e-cigarettes and will make proposals once the study is available and after consulting colleagues and experts.

Linda MacAvan, rapporteur of the European Parliament Environment, Health and Food Security Committee on the revised TPD told theparliament.com on May 17, 2013, that MEPs have "taken a lot of evidence about e-cigarettes and the evidence I've seen tells me that for people that smoke e-cigarettes can help in terms of harm reduction," and therefore "[w]e need to make sure they're available widely on the market so that they can compete with cigarettes," which, she noted, is why a "medicines regulation wouldn't work in many countries, because in many countries you can only buy medicines at a pharmacy."

Explaining the proposal for a pre-authorization process for all new tobacco products on the EU market, McAvan said it would be similar to the US system for new tobacco products, which is managed by the Food and Drug Administration (FDA).

UK-based e-cig company SKYCIG launched June 17, 2013 a "write to your MEP" campaign that urges vapers to go to http://www.skycig.co.uk/ecita and write a letter to their local Member of the European Parliament to oppose e-cig regulations under the EU Tobacco Products Directive.

The European Parliament's Environment, Public Health, and Food Safety Committee (ENVI) on July 10, 2013 voted to back the European Commission's revised Tobacco Products Directive proposal to classify all e-cigs as pharmaceuticals regardless of the nicotine content, rather than the Commission's proposal for such a classification only for e-cigs with "4 milligrams or more of nicotine.

On January 22, 2014, the Parliamentary Committee on the Environment and Public Health (ENVI) passed the compromise on the EU TPD, approved by the Council of the European Union on December 19, 2013.

http://www.europarl.europa.eu/news/en/news-room/content/20131216IPR31001/html/Tobacco-directive-MEPs-reach-agreement-with-Council-of-Ministers

The European Parliament on February 26, 2014 approved the compromise on the Tobacco Products Directive; it was adopted by the EU Council on March 14, 2014.

E-cigs - 1) The TPD will cover e-cigs containing nicotine; 2) Nicotine liquids will have to be sold in child- and tamper-proof packaging and contain only "ingredients of high purity"; 3) E-cigs must deliver nicotine doses at "consistent levels under normal conditions of use" and come with health warnings, instructions for their use, information on "addictiveness and toxicity," an ingredients list, and information on nicotine content; 4) E-cig manufacturers will be required to notify Member States before placing new products on the market, report annually to Member States on their sales volumes, types of users and their "preferences and trends," and comply with existing rules for cross-border advertising and promotion of tobacco products.
Extr. of the Directive: Chap 20 Electronic Cigarettes 
Directive 3.14.2014
-

Fire-safe cigarettes

In early June 2007, Scotland's Labour Euro MP David Martin announced that the European Commission's Product Safety Committee will draft a legislation that would require all cigarettes sold in the country to meet reduced ignition propensity standards by 2009/10, so that they self-extinguish when not being smoked.  

In early July 2007, European Union Consumer Protection Commissioner Meglena Kuneva confirmed to be planning to submit plans to require all cigarettes sold in the 27-nation bloc to meet "fire-safe" standards so they self-extinguish when not being smoked. Commission officials are drafting an EU-wide standard for the "fire-safe" cigarettes, similar to what was introduced in Canada and some US States, an official said.

As widely expected, the European Union's 27 governments on November 29, 2007 endorsed Consumer Affairs Commissioner Meglena Kuneva's proposal to require all cigarettes sold in the EU to be manufactured with fire-retardant paper and self-extinguish when left unattended, a standard that could take effect as early as 2008.  

http://europa.eu/rapid/pressReleasesAction.do?reference=IP/07/1818&format=HTML&aged=1&language=EN&guiLanguage=en

The European Commission's Committee of the General Product Safety Directive agreed to mandate the EU's standards making body CEN to develop a EU-wide standard for the "fire-safe" cigarettes.  The proposal submitted to CEN Technical Board was to accept the mandate and ask ISO to carry out the requested standardization work in parallel with CEN under the terms of the Vienna Agreement in ISO/TC 126 Tobacco and Tobacco Products.

EU CEN 6.27.2008

CEN accepted the mandate at the end of August and transmitted it to ISO, since CEN does not have a relevant Technical Committee (TC) to work on the mandate.

The CEN participant in the meeting of 6/7 November 2008 reported that ISO planned to accept the mandate and to constitute a joint TC, composed of members of ISO TC 92 "Fire safety" and ISO TC 126 "Tobacco and tobacco products", to develop the requested standard. The Commission insisted that the standard should be developed in the shortest possible time, in order to make this life-saving measure available in the EU. CEN, respectively ISO, could take account of the existing ASTM standard on RIP cigarettes.

The European Commission said August 5, 2008 that by 2011 at the latest, all cigarettes sold across the EU should meet "fire-safe" standards being developed by the independent European Committee for Standardisation so they self-extinguish if they are not being smoked.  Commission spokesman Ton Van Lierop said the new type of cigarettes will become mandatory by 2011. He added that the "fire-safe" requirement is not expected to lead to price increases. 

In early 2010, it was reported that fire-safe cigarettes were due to be introduced across the EU later this year, but work on developing an EU standard is running at least six months behind schedule.

The 12th Meeting of the Regulatory Committee  established under Article 10 of the Tobacco Products Directive 2001/37/EC took place on October 25, 2010. The Commission gave a presentation on the recent developments regarding RIP-cigarettes.

The work in the European Committee for Standardization (CEN) finished in October 2010 and the final document EN 16156 "Cigarettes Assessment of the ignition propensity ' Safety requirement" was adopted on November 16, 2010. Member States' standardisation organisations will have 6 months to include EN 16156 in their national standards collection. This European Standard complements a first standard published by CEN and ISO in September 2010, ISO 12863 “Standard test method for assessing the ignition propensity for cigarettes' Standard 9.15.2010.

EN 16156 was published in late December 2010. 

References to Standards EN 16156 (and EN ISO 12863) were published in part C of the Official Journal on November 17, 2011. Enforcement of fire safety requirement by Member States’ authorities is expected as of the publication date.

One of the Member States asked when the RIP cigarettes will have to be put on the market and how this will be achieved. The Commission clarified that there will be a transitional period of 6 months during which RIP should become national standard. Test method including the technical aspects is described in the ISO standard.

Meeting 10.25.2010

Notifications on proposals providing fire safety requirements for cigarettes in Finland were received by the EU Commisssion on December 27, 2007.

Proposal 12.27.07  Proposal 7.8.08

These proposals - that require all cigarettes sold in the country to be "fire-safe" and tested in accordance with ASTM Test Standard E2187-04 - were approved by the Finnish Parliament on December 19, 2008. Requirements shall come into force on April 1, 2010. Proposal 6. 26.08   Amendments 12.19.08

Romania approved EU standards in March 2011.