E-LIQUIDS & E-CIGARETTES
Directive 2014/40/EU TPD-II [Art. 20 (2)].
The notification process is conducted in accordance with EU Implementation Decision 2015/2183 of 24 November 2015.
- Getting the Submitter ID;
- Assessment of compliance with TPD-II requirements; support in developement in case of lack of requirements;
- CLP classification of the mixture (we can check the accuracy of the given classification);
- Gather information of the notification with data about: manufacturer and products, target markets, emissions and consistency of nicotine dose, product characteristics, declarations of conformity, description of the production process, quali-quantitative formula, weights and volumes of ingredients;
- For each ingredient of the formulation, entering of: name and identification code, toxicological status, REACH position, CLP classification, production of attachments;
- 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 the 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;Delivery to the customer of a declaration of notification;Checking of ‘transition period’ and messages of ‘alert’ to schedule the selling of product;Mediation and assistance in the event of a dispute or requests from the authorities;Periodic updates of notifications according to the modalities defined by each Member State.
SAFETY DATA SHEETS – SDS
In compliance with Reach Regulation (EC) No 1907/2006 and subsequent modifications.
In order to ensure the confidentiality of your industrial secrets, SDS are issued by our own professionals and not by a third supplier. SDS are produced basing on of each single variant of flavour and nicotine, and in language of targeted market.
LABELING AND SUPPLY OF PACKAGING REQUIREMENTS
The packaging is the first connection to final user, but also to the Authorities responsible for assessing the compliance of products.
In order to produce a label conforming to regulatory standards we provide the mandatory and optional elements to realize the external packaging (mono or multilayer label, box and leaflet) in accordance with the TPD-II, and the CLP Regulation.
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.
Directive 2014/40/EU TPD-II [Art. 20(2)(b)].
The analysis include 23 chemical parameters, comprising the 23 parameters listed by the European Commission in accordance with EU Implementation Order 2015/2183 of 24 November 2015.
The analyses available are:
- nicotine (L-nicotine);
- aldehydes (butyraldehyde, isobutyraldehyde, propionaldehyde, formaldehyde, acetaldehyde, acrolein, crotonaldehyde);
- heavy metals (arsenic, cadmium, chromium, copper, lead, nickel);
- volatile organic compounds – VOCs (toluene, benzene, 1,3-butadiene, isoprene, diacetyl, 2,3-pentadione).
Support of Declaration of Security required by Directive 2014/40/EU TPD-II [Art. 20(2)(g)].
Toxicological tests are available on different cell lines:
Cell cultures of HUVEC / TERT2 cells will be used as targets for measuring the toxicity of the condensate eLiquids with the dosage of resazurine as a reading.
HUVEC / TERT2 cells will be grown in the presence of different concentrations of condensates obtained from eLiquids emissions and the toxic effects will be measured after 24 hours of cultivation.
The cell death of HUVEC / TERT2 cells will be determined in cell culture by LDH assay after 24 hours of cultivation in the presence of condensates obtained from eLiquids emissions.
These tests are not explicitly required by TPD-II, but we encourage our customer to carry out such kind of analyses to support the security statement required by the the notification and also to assess the safety of the product before placing it on the market.
In house quality control, we check nicotine content of e-liquids and analyse spectra by Ptr-MS (GC-MS if needed) daily. We provide results in the same day as we receive the samples, we can see if the eliquid formula matches the previous eliquids formulas and if they are conform to the company standards.
We can also build a quality control station inside your company, and give technical assistance.