Some time ago we talked about an UE directive to ban SNUS (except Sweden), cigarette tobacco flavouring, and cigarette pack shape standardising etc.
In the same draft there is an article about Nicotine Content Products and Nicotine Replacement Therapy.
According to this draft NCP must be classified NRP (medical product) when the maximum peak of nicotine in plasma concentration reach 4mg/ml
Maybe @mordr3d can explain which nicotine concentration, in e-liquid obviously, needs to reach this peak
follow the draft extract
3.7 Nicotine containing products (NCP)
NCP fall outside the scope of Directive 2001/37/EC and Member States have so far taken different regulatory approaches to address these products, including regulating them as medicinal products, applying certain provisions that are used for tobacco products or having no specific legislation.
The proposal stipulates that NCP that either have a nicotine level exceeding 2mg, a nicotine concentration exceeding 4mg per ml or whose intended use results in a mean maximum peak plasma concentration exceeding 4 mg per ml may be placed on the market only if they have been authorised as medicinal products on the basis of their quality, safety and efficacy, and with a positive risk/benefit balance. NCP with nicotine levels below this threshold can be sold as consumer products provided they feature an adopted health warning. The nicotine threshold identified in this proposal has been established by considering the nicotine content of medicinal products (Nicotine Replacement Therapies, NRTs) for smoking cessation which have already received market authorisation under the medicinal products' legislation.
The proposal removes current legislation divergence between Member States and the differential treatment between Nicotine Replacement Therapies and Nicotine Containing Products, increases legal certainty and consolidates the on-going development in Member States. It also encourages research and innovation in smoking cessation with the aim of maximising health gains. Given the novelty and rapid increase of the NCP market as well as their addictive and toxic character there is an urgency to act, before more people—unaware of the content and effects of these products—inadvertently develop a nicotine addiction.
Where NCP below the identified threshold are allowed, the labelling requirement set out in this proposal will better inform consumers about the health risks associated with the products.