War within the EU European Commission acting against European Parliament s will on e cigarettes

By Dr Farsalinos

It seems that besides a public health disaster, the issue of e cigarette proposals by the European Commission is also a political scandal. It is just 48 days ago that the European Parliament voted for amendment170 concerning e cigarettes regulation. This was supposed to be the basis of any further negotiation, with the goal to make improvement and transform this amendment into regulation. Instead, the European Commission has completely bypassed the will and vote of the Parliament and has introduced a completely new proposal. Here are the main differences between the two proposals

European Parliament maximum nicotine concentration of 30mg/ml

European Commission maximum nicotine concentration of 20mg/ml

European Parliament flavorings allowed

European Commission flavorings banned (except from those present in NRTs)

European Parliament no restriction on refill liquids

European Commission refill liquids banned

European Parliament no restriction on devices

European Commission refillable atomizers banned, only single use cartos allowed

European Parliament no restriction on cross border sales

European Commission cross border sales prohibited

European Parliament request to report list of ingredients and emissions

European Commission e cigarettes should be free from contaminants

European Parliament advertisements prohibited

European Commission advertisements prohibited

It is obvious that the Commission s proposal contradicts almost every aspect of the amendment voted by the Parliament. This should be considered a scandal, shows disrespect towards the will of the MEPs and is an effort to bypass all procedures and implement a strange agenda of illegalizing e cigarettes. For example, they ask that e cigarettes should be free from contaminants while they know that this cannot happen and they know that even pharmaceutical NRTs have nitrosamines (at levels similar to e cigarettes). In any case, they have completely ignored science showing that nicotine is needed for e cigarettes to be effective, users self titrate their nicotine intake and any instructions on dosage are useless, and flavors are an important part in consumers efforts to reduce or quit smoking.

The European Commission is deciding on regulation contrary to Parliament proposals, contrary to scientific findings and contrary to public health interest

Have eu plans to regulate e-cigarettes as medicinal products gone up in smoke? – lexology

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The European Parliament rejected Commission proposals under the Tobacco Products Directive (“TPD”) to regulate e cigarettes as medicinal products in October 2013, but what does this mean in practice for the regulation of e cigarettes across the 28 EU Member States?

At present e cigarettes are regulated in a variety of ways across the various Member States across nine members states (including the UK) there are no specific rules relating to e cigarettes only existing consumer product safety legislation currently applies. In another eleven Member States (including Germany and the Netherlands), e cigarettes are considered medicinal products which subjects the products to stricter regulation. At the extreme, currently e cigarettes are prohibited in Greece unless specifically approved by the Health Ministry.

Under the original Commission proposal for the TPD, rules applying to e cigarettes would have been harmonized and e cigarettes would have been treated as medicinal products resulting in stricter regulation and a more costly approval process across the entire EU. Approvals for medicinal products cost on average f200,000 to secure. Regulating e cigarettes as medicinal products would also have limited sales points to pharmacies. The European Parliament rejected this proposal on in October 2013 and has now reached a compromise with the Council which will see the majority of e cigarettes regulated as consumer products.

While this should help to clarify the current regulatory uncertainty, the debate is far from over.

Although the full text of the compromise is not yet publicly available it is understood that the compromise sets mandatory safety and quality requirements, for example on nicotine content, ingredients and devices, as well as refill mechanisms. The new rules also make health warnings and information leaflets obligatory and introduce notification requirements for manufacturers and importers of e cigarettes, stricter rules on advertising and monitoring on market developments.

In relation to refillable e cigarettes the compromise contains a safeguard clause which could result in refillable e cigarettes being banned in the EU in the future.

The new rules are due to enter into force in 2016 (subject to adoption of the TPD in the course of 2014) and as such it is important that all manufacturers, exporters and importers of these products familiarize themselves with these new rules and begin considering securing any approvals that are necessary to ensure a smooth transition and continued access to the EU market.