E-CIGARETTES SERVICES

The chemical, toxicological and other specific tests here below are suitable for every kind of hardware: first, second and third generation.

If your product is particularly innovative or original, please contact us for a preliminary feasibility assessment.

EU-CEG NOTIFICATION

Mandatory under Directive 2014/40 / EU TPD-II [Art. 20 (2)].

The notification process is conducted thanks to a mix of scientific, regulatory and IT competencies in accordance with EU Implementation Decision 2015/2183 of 24 November 2015.

You can count on a dedicated personal assistant, who coordinates the whole process and become a unique and qualified referent for each request from and to Member States.
All the documents concerning your notification process (analysis results, xml files, receipts, etc..) will be stored in a very safe dedicated section of our IT systems, shared with you to have your files always available.

The complete procedure customizable according to your needs, includes:

• Getting the Submitter ID;

• Entering of analysis results (analysis of emissions and consistency of nicotine dose);

• Assessment of compliance with TPD-II requirements; possible development of a specific proposal to reach compliance in case of any lack;

• Assembling of the notification with data about: manufacturer and person responsible for the products, target markets, emissions and consistency of nicotine dose, product characteristics, declarations of conformity, description of the production process;

• Production of the xml file and validation using the European Commission software according to the latest provisions from the dedicated team at the EU (SANTE team);

• Delivery of files (submitters, attachments and submissions xml) to Member States through the EU Common Entry Gateway (EU-CEG) of the European Commission;

• Direct notification follow-up with the dedicated office at the European Commission and with officials of each Member State of destination. Assistance on any revisions and required queries;

• Sending of the notification receipt produced by EU-CEG;

• Issue and delivery to the customer of a declaration of notification;

• Checking of ‘transition period’: after notification is mandatory to wait a ‘transition period’ before placing the product on the market; transition period is State-specific. We will watch over this timing and we will send you a message of ‘alert’ to schedule the selling of product;

• Periodic updates of notifications according to timing and procedures defined by each Member States.

CHEMICAL ANALYSIS OF EMISSIONS

Mandatory under Directive 2014/40 / EU TPD-II [Art. 20 (2) (b)].

The analysis includes 12 chemical parameters, indicated by the European Commission in accordance with EU Implementation Order 2015/2183 dated 24 November 2015. The vaporization is generated by a T-TRAP ™ (TRUSTICERT, Milan) a vaping machine, built conforming to ISO/DIS 20768 standard and compatible with every product on the market.
In case of e-cigarettes or cartomizers sold in bundle with a specific e-liquid ora pre-filled device, the test is performed using the connected product. Otherwise we will use a 18 mg/ml nicotine neutral base or the liquid you’d like to (minimum 16 mg/ml nicotine strength).

To avoid additional requests from the authorities, we suggest performing the complete analysis set, but it’s possible for us to configure the parameter combinations you desire.
If your main market is UK, we suggest you follow the MHRA guidelines.

Titration of aldehydes (butirraldeide, propionaldehyde, formaldehyde, acetaldehyde, acrolein, crotonaldehyde)
Titration of heavy metals (arsenic, cadmium, chromium, copper, lead, nickel)

The analyses are carried out by an accredited laboratory according to UNI CEI EN ISO/IEC 17025: 2005 standard.

NICOTINE CONSISTENCY DOSE

Mandatory under Directive 2014/40 / EU TPD-II [Art. 20 (3) (b), (f)].

The nicotine release consistency testing is performed on the aerosol produced by the device using a T-TRAP ™ (TRUSTICERT, Milan) a vaping machine built conforming to ISO/DIS 20768 standard and compatible with every product on the market.
The test report presents the three emission points values ​​and the consistency assessment according to AFNOR standards.

In case of e-cigarettes or cartomizers sold in bundles with a specific e-liquid or a pre-filled device, the test is performed using the connected product. Otherwise we will use a 18 mg/ml nicotine neutral base or the liquid you’d like to (minimum 16 mg/ml nicotine strength).

The analyses are carried out by an accredited laboratory according to UNI CEI EN ISO/IEC 17025: 2005 standard.

SUPPORT TO REACH COMPLIANCE

If you intend to sell your products in several Member States you have to take into consideration the different regulatory frameworks : each State transposed the Directive into a specific national law, resulting in several versions of the TPD-II differing for packaging, production and notification requirements.

We can support you to be ready to successfully enter a market, thanks to:

• Product conformity assessment in accordance with national TPD-II transposition and CLP Regulation;

• State-specific regulatory dossiers;

• Sending of newsletter with updates about TPD-II, REACH and CLP Regulation;

• Alerts and news with 'regulatory pills' to support marketing strategies.

SANITARY SURVEILLANCE

Mandatory under Directive 2014/40 / EU TPD-II [Ref. TPD Art. 20 (9)].

We constantly confer with Member States to adopt the most compliant programs following the latest guidelines.
The first State requiring a description of the Health Surveillance Program is the United Kingdom through MHRA, the Authority responsible for the implementation of the TPD-II.