E-liquids: the Greek regulatory framework

Law 4419/2016 (the Law) as amended, which came into effect on 20.09.2016 adapted the Greek legislation to the European Directive 2014/40/EU, i.e. the Tobacco Products Directive, also known as TPD, aiming to set out unified quality and safety requirements throughout the EU in relation to the electronic cigarette (e-cigarette) and e-liquids.

 

BASIC COMPLIANCE REQUIREMENTS IN RELATION TO LIQUIDS FOR E- CIGARETTES 

 

Law 4419 of 2016 and the Tobacco Products Directive

Law 4419/2016 (the Law) as amended which came into effect on 20.09.2016 adapted the Greek legislation to the European Directive 2014/40/EU, i.e. the Tobacco Products Directive, also known as TPD, aiming to set out unified quality and safety requirements throughout the EU in relation to the electronic cigarette (e- cigarette).

More particularly in relation to refill containers of liquid used for e- cigarettes (e-liquids) (either with or without nicotine), the Law imposes a number of obligations to manufacturers or importers of e-liquids.

 

1-    Notification

The manufacturers and importers of electronic cigarettes and refill containers must submit a notification to the competent department of the Ministry of Health in relation to any products which they intend to dispose in the market. The notification is submitted electronically 6 months before the proposed distribution in the market.

In relation to the e-liquids which were already in circulation at the time of entering into force of the Law, the notification deadline was 20.03.2017.

A new notification must be submitted for every material alteration of a product which was previously notified.

The notification must contain certain information specified in the Law, on the details of the manufacturer or importer, the ingredients of the product, toxicological data as well as a declaration on the safety of the product.

The notification and all supporting documents are submitted through an electronic platform. A separate notification and corresponding supporting documents are submitted for each product and a submission fee is payable per product notified.

The notification is subject to review and control by the competent authorities of each member state. In Greece, the competent authority is the Ministry of Health.

2-    Product specifications

The Law sets out the specifications with which all e-liquid products must comply, in particular in relation to the containers of the e-liquid, the levels of nicotine, the additives and ingredients, the dosage of nicotine and the safety requirements, as well as the instruction leaflet, the presentation restrictions of the product and the compulsory health warnings which must feature on the product’s package.

3-    Prohibitions

According to the provisions of the Law, a number of activities are prohibited or restricted in connection with e- cigarettes, such as the sale of refill containers in Greece from abroad or certain commercial communications.

4-    Annual submission of information

The manufacturers and importers of refill containers are required to submit annually to the competent department of the Ministry of Health a number of information regarding more particularly their sales volumes, the preferences of various consumer groups, the means of sale of the products and the summary descriptions of any market researches carried in connection with the foregoing.

5-    System of collection of information

The manufacturers, importers and distributors of e-liquids create and maintain a system for the collection of information regarding all possible harmful consequences of these products for the human health.

 

 

The “REACH” and “CLP” Regulations

E-liquids, being chemical mixtures, also fall under the provisions of the following EU Regulations:

–          Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH); and

–          Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP Regulation)

The General State Chemical Laboratory (G.S.C.L.), being the competent national authority supervising and controlling the application of the REACH and CLP Regulations in connection with chemical products, has issued directives adapting the application of the aforementioned Regulation specifically to the e-liquid containers, both in connection to labelling, packaging, warning and secure opening for the protection of children.

 

National Registry of Chemical Products

E-liquids must be registered at the National Registry of Chemical Products, maintained by the Department of Energy, Industrial and Chemical Products of the General Direction of the G.S.C.L..

Our office provides legal advice and support in connection with the application of the legislation, regulations and directives on tobacco products and e-cigarettes and assists importers, manufacturers and distributors with their compliance requirements in connection with the notification, the preparation of the supporting documents and the presentation and packaging of the products.

 

 

FOR ANY ADDITIONAL INFORMATION PLEASE FEEL FREE TO CONTACT US

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ADDRESS: 34 Akadimias Street, P. C. 10672, Athens, Greece

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*This publication is intended only to provide general information and does not constitute personal legal advice. We do not accept or assume any responsibility towards readers of the present document for any loss resulting from acting on the basis of this publication.