European Union negotiators reached a tentative agreement on tougher smoking rules after compromising over how to regulate the growing market for electronic cigarettes.
Representatives of EU governments and the European Parliament decided that the strongest e-cigarettes would need authorization as a medicine. This would apply to e-cigarettes with a nicotine strength of more than 20 milligrams per milliliter.
The deal reached late yesterday in Brussels aims to balance demands by national health ministers in June for essentially all e-cigarettes to be brought under the bloc’s pharmaceuticals legislation and a call by the EU Parliament in October to apply rules on general product safety to these goods, which deliver nicotine through inhaled vapor. Global e-cigarette sales will approach $2 billion this year and top $10 billion by 2017, according to Wells Fargo & Co.
“It is a good overall compromise,” Linda McAvan, a U.K. Socialist steering the draft law through the EU assembly, said today in Brussels after striking the accord with the Lithuanian government, which negotiated on behalf of member states because it holds the 28-nation bloc’s rotating presidency.
Diplomats from the EU will scrutinize the pact tomorrow. If they sign off, the deal would still need to be endorsed by the full 766-seat Parliament and by national ministers -- steps that are usually a formality after negotiators reach a breakthrough. The EU aims to complete the approval process by the time of Parliament elections in May.
The negotiated accord paves the way for stricter EU tobacco legislation requiring that cigarette packages feature a combined pictorial and text alert covering 65 percent of the front and back and that the health warnings appear at the top of the packs. Under current EU rules, anti-smoking images on packages are optional while text warnings are mandatory.
Tobacco kills as many as 695,000 people a year in the EU, or one person every 45 seconds, according to the European Commission, which says a third of Europeans still smoke. Smoking is the largest avoidable health risk in Europe, causing more problems than alcohol, drugs, high blood pressure, high cholesterol or obesity, says the commission, the EU’s regulatory arm.
The treatment of nicotine-containing goods like e-cigarettes threatened to derail the new tobacco legislation because the EU Parliament had voted against a plan, proposed by the commission and endorsed by the health ministers, to regulate them as medicines. The Parliament argued that e-cigarettes help curb tobacco smoking and deserve a lighter regulatory touch.
“They can definitely play a genuine role in helping smokers reduce their use of smoking tobacco, and this is recognized in the deal,” McAvan said.
Under the negotiated compromise, e-cigarettes that are above the threshold of 20 milligrams per milliliter would be regulated under a 2001 EU law on medicinal products. E-cigarettes that are below the threshold would fall under the new EU tobacco legislation unless the manufacturer specifically opts to seek authorization of them from member states as a medicine.
As part of a plan to ban the sale of cigarettes and roll-your-own tobacco with characterizing flavors, the negotiators reached a separate compromise to phase out menthol cigarettes by 2020. That is longer than three years demanded initially by health ministers.